Downing, Ross, and colleagues reviewed drug approval decisions of the FDA, the Canadian drug regulator, Health Canada, and the European Medicines Agency (EMA) between 2001 and 2010. They studied each regulator's database of drug approvals to identify novel therapeutics as well as the timing of key regulatory events, allowing regulatory review speed to be calculated. Canada and Europe were chosen as a comparison because they face similar pressures to approve new drugs quickly while ensuring they do not put patients at risk..
Drugs reach the market in the United States sooner.
The team found that the median total time to review was 322 days at FDA, 366 days at EMA and 393 days at Health Canada.
"Among the subsample of drugs approved for all three regulators, the FDA's reviews were over three months faster than those of the EMA or Health Canada," said Downing. "The total review time at the FDA was faster than EMA, despite the FDA's far higher proportion of applications requiring multiple regulatory reviews."
Downing added that most new drug therapies were first approved for use in the U.S. "Examining novel drugs approved in multiple markets, we found that 64% of medicines approved in both the U.S. and in Europe were approved for U.S. patients first, and 86% of medicines approved in both the U.S. and Canada were also approved first in the U.S." he said.
I would like to see a much faster review process for drugs for fatal diseases. People who already have a diagnostic death sentence should be more free to try unproven drugs. If you get told you have just months to live the drug regulatory agencies can't protect you as much as they can kill you by preventing you from trying experimental drugs that are your last chance before checking out of the Life Hotel.
Stanford researchers have developed a better way to detect which suspected harmful drug interactions are real.
STANFORD, Calif. -- A week ago, you started a new prescription medication for acne. Today, you feel dizzy and short of breath and have difficulty concentrating. Your symptoms are not listed in the package insert as possible side effects of the drug, but why else would you be feeling so odd?
Unfortunately, there's no easy answer. Clinical trials are designed to show that a drug is safe and effective. But even the largest trials can't identify irksome or even dangerous side effects experienced by only a tiny proportion of those people taking the drug. They also aren't designed to study how drugs interact with one another in the human body — a consideration that becomes increasingly important as people age and their medicine cabinets begin to overflow.
Now researchers at the Stanford University School of Medicine have devised a computer algorithm that enabled them to swiftly sift through millions of reports to the U.S. Food and Drug Administration by patients and their physicians and identify "true" drug side effects. The method also worked to identify previously unsuspected interactions between pairs of drugs, most notably that antidepressants called SSRIs interact with a common blood pressure medication to significantly increase the risk of a potentially deadly heart condition.
Why I think this is important: With web forms and web servers we have the potential to collect many times more data about individual medical and health histories. Then that data could be sifted through to discover more connections between drugs, diet, lifestyle, genetic variants, and many other factors. We could learn more faster if we just crowd sourced health histories and and genetic test results on a very large scale.
CHAPEL HILL, N.C. – The era of widely available next generation personal genomic testing has arrived and with it the ability to quickly and relatively affordably learn the sequence of your entire genome. This would include what is referred to as the "exome," your complete set of protein-coding sequences.
But as University of North Carolina at Chapel Hill medical geneticists point out, this avalanche of information also includes the totality of one's genetic mutations and as such arrives with both promise and threats associated with its use.
But some experts think we are going to hurt ourselves with it.
James P. Evans, MD, PhD is the Bryson Distinguished Professor of Genetics and Medicine at UNC and is a member of the Lineberger Comprehensive Cancer Center. He is also editor-in-chief of Genetics in Medicine, the journal of the American College of Medical Genetics. "What you're now dealing with is a real medical test, one that has the power to help, hurt and to confuse. I believe we need to think carefully about how to best use it and how that use should be regulated in order to maximize benefit and minimize harm," he said.
People hurt themselves every day playing tennis, driving cars, skateboarding, mountain climbing, and even bounding down stairs. There's no shortage of ways people do themselves harm. They delude themselves with bad ideas and make wrong choices. We do not, as a result, try to prevent them from doing most activities.
When the potential for harm is used to claim justification to restrict the flow of information I think we should look very critically at such claims. The easier the flow of information the greater the potential for innovations in its use. We suffer huge opportunity costs in innovations foregone when we restrict interpretation of valuable information only to certified experts. Yet these academics want to do just that.
"Now we are entering an entirely different era due to the advent of robust sequencing technology. We have now the potential to tell people very real and important things about their genomes. Some of those things can be very useful and very welcome if acted upon in the right way, but some of that information may not be very welcome to people: being at high risk for an untreatable disease such as dementia, for example."
As to regulation, Evans and Berg suggest that it need not be draconian but must be nuanced. "Basically, what we call for is that this new generation of medical testing be treated like other medical tests that involve complex medical information – and that there should be a reasonable expectation that an individual who gets it done has some relationship with a qualified care provider."
So they don't want you to get genetic testing or genetic sequencing done without supervision by a certified expert. I don't just find this position offense and excessively nannyish. I also find it as sub-optimal in terms of benefits because if it gets translated into regulatory policy it will greatly slow down the rate of innovation in interpretation and use of genetic testing data and medical testing data.
What we need: freedom from one-on-one dependence on certified experts. Then with genomic information is that it is so voluminous and genetic variants have so many different consequences for us that any one human being won't be able to be an expert on it. We really need complex information systems as advisers and interpreters of the data. We need competing companies building those information systems with others constantly rating and comparing the quality of advice provided. The old model of certified expert is just too slow and excessively paternal and controlling.
A report by Emily Singer for Technology Review brings a whole new twist to the open access movement for information. Needed: a heart defibrillator maker who will let you capture sensor data from the implanted device.
Hugo Campos is a man on a mission. He wants access to the data being collected inside his body by an implanted cardiac defibrillator. He believes that having this information could help him take control of his health—for example, by helping him figure out what triggers his frequent attacks of abnormal heart rhythms. While not life-threatening, they cause dizziness, fainting, and chest pain. But he says device makers are reluctant to make that information available, mostly for commercial reasons.
More data pooled together means more insights. Just as some people (e.g. Razib Khan) have released their genetic testing data into the public domain so could people with sensors embedded in their bodies. In fact, this will happen. Lots of people will stream real time sensor streams from their bodies to the internet for anyone to capture, watch in real-time, and analyze.
Collection of biological data used to be the sole preserve of scientists doing research. But with sensors and communications networks getting so cheap bottom-up biological and biomedical research is already starting as a result of increasing numbers of individuals uploading their test data web sites. Already this trend is yielding published research with valuable findings.
I expect we will be able to watch live feeds of assorted beating hearts all over the world. Gamers will let spectators watch their hearts beat and their brain waves change as they compete in online game tournaments. People will put sensors on their pets just as they put video cameras on them.
The rate of full genome sequencing has risen by about 1000 in a couple of years. That's because costs have dropped by orders of magnitude. The rapid cost drop looks set to continue.
This year, the world's DNA-sequencing machines are expected to churn out 30,000 entire human genomes, according to estimates in Nature magazine. That is up from 2,700 last year and a few dozen in 2009. Recall that merely a decade ago, before the completion of the Human Genome Project, the number was zero.
The vast majority of us will be able to afford to get our full genomes sequenced in a few years. Costs are now below $10,000 per genome and in larger quantities below $5,000.
What's needed to most rapidly make all this data useful? Massive comparisons between DNA sequences and details of individual health history, behavior, achievements, and physical attributes. What's needed to gather all this data? Web sites run by companies that provide DNA sequencing services while also doing polls and tests (e.g. personality tests, coordination tests, even scans of pictures uploaded by customers) of their customers to collect all the needed information to compare. Then the companies can use the DNA sequencing data of all their customers to compare and come to useful conclusions for their subscribers.
If regulators (that's you, FDA) would just stay out of the way then crowd sourcing the needed data could be done very rapidly by the private sector. This could cut years off of making discoveries about genetic variants via the traditional academic approach of getting grants and trying to recruit volunteers.
The folks at personal genetic testing company 23andme.com recruited Parkinson's Disease (PD) patients from mailing lists and other means and compared their genetic variants with a group of 23andme customers who also got their genetic variants tested by 23andme. They used the resulting data to discover 2 more genetic variants associated with Parkinson's Disease. The results demonstrate the speed, low cost, and power of web-based recruiting to do genetic research outside the traditional academic framework.
We conducted a large genome-wide association study (GWAS) of Parkinson's disease (PD) with over 3,400 cases and 29,000 controls (the largest single PD GWAS cohort to date). We report two novel genetic associations and replicate a total of twenty previously described associations, showing that there are now many solid genetic factors underlying PD. We also estimate that genetic factors explain at least one-fourth of the variation in PD liability, of which currently discovered factors only explain a small fraction (6%–7%). Together, these results expand the set of genetic factors discovered to date and imply that many more associations remain to be found. Unlike traditional studies, participation in this study took place completely online, using a collection of cases recruited primarily via PD mailing lists and controls derived from the customer base of the personal genetics company 23andMe. Our study thus illustrates the ability of web-based methods for enrollment and data collection to yield new scientific insights into the etiology of disease, and it demonstrates the power and reliability of self-reported data for studying the genetics of Parkinson's disease.
You can read the whole open access Plos Genetics research report at that link.
What's cool about this: Using a web site and cheap genetic testing services people can volunteer themselves as research subjects on a scale that historically has taken far more effort to organize. This approach can scale into the hundreds of thousands, and even hundreds of millions of people. There's a big network effect where the more people who get tested the more useful genetic testing becomes.
Direct-To-Consumer (DTC) genetic testing is what made the study above possible. Whether we will be able to continue to get our DNA tested without paying for a doctor's visit and additional testing mark-ups remains to be seen. In the United States the Food and Drug Administration (FDA) is taking a dim view of DTC genetic testing. See here, here, here, here, and here for more.
I see DTC genetic testing as the tip of a much bigger iceberg: The flow of huge amounts of biomedical data from all manner of test devices at home, in drug stores, in portable units people will carry, and from sensors embedded in the body. A business-as-usual regulatory environment where it is difficult to do medical testing outside of traditional locations such as hospitals and clinics will prevent the flood of testing data and greatly slow the rate of progress of biomedical science. DTC testing services and personal testing devices hold the potential to revolutionize biomedical research with crowd sourcing and also to revolutionize diagnosis and monitoring of health. In the universe of Arrakis it was said "the spice must flow". Our modern equivalent is "the data must flow". Think about it.
Washington, D.C. – Parents offered genetic testing to predict their risks of common, adult-onset health conditions say they would also test their children. That is the finding of a new study published in the May issue of Pediatrics (published online April 18). The study authors note these and other findings should put pediatricians on alert that parents may chose predictive genetic tests for themselves and for their children, and seek guidance from doctors about what to do with the information.
The tone of the press release is one of concern that parents will go and get their kids tested without professional supervision. Who knows what they might think and do with the information? Parents can already get their children genetically tested just like they can get themselves tested - all without medical supervision.
Personal genetic tests are available directly to consumers at drug stores and over the Internet. They are controversial, and generally marketed to adults for their own use. However, it might be only a matter of time before parents become the focus of advertising campaigns targeting their children for testing, says Kenneth P. Tercyak, PhD, associate professor of oncology and pediatrics at Georgetown Lombardi Comprehensive Cancer Center, a part of Georgetown University Medical Center.
"The findings of our study should remind clinicians and policy-makers to consider children when regulating genetic tests," says Tercyak, the study's lead author. "These tests usually don't offer a clean bill of health and can be hard to interpret even in the best scenario. They identify incremental risks for many common diseases. Most people carry some risk based on a combination of their family history, genetics, and lifestyle. A child's unexpected test results could trigger negative reactions among parents and children, and lead to conversations at the pediatrician's office that providers aren't prepared to have."
My view: Regulators should find something else to do with their time instead of trying to prevent people from getting their own or the childrens' DNA tested.
People who were interested in their own genetic sequences were also most interested in the genetic sequences of their children. The parents see value in getting more information. Since I generally see more information as better the reasoning of the parents makes sense to me.
Tercyak says the group of parents that were most interested in the test for themselves were interested in having their child tested too. In fact, parents made little distinction between the pros and cons of testing for themselves and for their children -- generally favoring the information, and believing it could lead to improved health maintenance, disease prevention, and other personal benefits during childhood and later on in the child's life.
Genetic tests are going to become more detailed and the number of insights we'll be able to get from our genetic tests will rise drastically in the next 10 years. The cost of genetic testing has fallen so fast that scientists are now much better positioned to tease out the functional significance of large numbers of locations in the genome where we differ from each other. I say let the information flow directly to us.
And yet something else looming in the background right now is the way medicine is practiced in the world today is changing, and has to change. I accept the proposition that from Galen to the 20th century medical doctors generally caused more harm than benefit (much of it due to the fact that they spread disease amongst their patients). Modern medicine is exceptional in that it actually works on a biophysical level. But a lot of the “low hanging fruit” has been picked, and due to the nature of medical research much of the “cutting edge consensus” is wrong. Medicine, like many fields, has been subject to information overload, and I’m skeptical of the ability of any human to keep up. The practice of medicine needs to be augmented by computational analytic tools, as well as a deeper understanding of the natural distortions which occur because of the nature of funding and the institutional framework of biomedical research in the United States, which exhibits an unfortunate trend toward careerism. Add on top of it the political, legal, and ethical variables, and medicine is a tangle which is far more than just applied human biology.
Those computational tools ought to allow us to directly receive biological information about ourselves from sophisticated software in cloud servers. Since computers will be needed to make sense of the flood of data why go to a doctor's office to have a doctor interpret what the computer screen says when you can read it yourself?
In another post Razib draws attention to websites that enable people to engage in Do It Yourself (DIY) biological science. It is just this sort of (rapidly growing) way of doing bottom-up genetics and health research that FDA regulation threatens.
In light of my last post, I want to point to some groups attempting to create some “bottom-up” biological science in the real world. In the Los Angeles area you have SoCal DIY Bio, and in northern California you have BioCurious. And you also have the DIYgenomics website. Apparently the Gene Sequencer for the SoCal DIY Bio needs to be repaired, so I thought I’d pass word on.
Imagine a future in which people use home medical testing devices and online genetic and medical testing services to collect information that they use to enroll themselves as long term research projects. Plummeting costs of full genome sequencing and advances in microfluidics promise to make genetic and other biological testing very cheap and widely available - if only regulators stay out of the way. But the threat of a large scaling up of regulatory restrictions on direct-to-consumer (DTC) genetic testing and medical testing could put the kibosh on all that.
I see the issue of DTC genetic testing as important for a few main reasons:
The bottom-up research holds great potential. The genetic testing company 23andme is already conducting 400 genetics research projects using customer genetic testing data. Imagine a world where many different teams (including people who are amateurs in genetics research) develop software to search for genetic correlations with diseases, behavior, or assorted traits and then the teams ask for volunteers. This effectively democratizes research. The research that advances most quickly is the research that the most people decide to help with genetic and medical testing results and by filling out web forms about their histories, preferences, habits, and abilities.
In the future a large chunk of medical research will get done by millions of people who will pay their own money to get themselves and friends and family tested. They'll pay this money in order to provide to scientists the raw test results needed to do analyses. People with a malady will pay for genetic and other testing that will provide researchers with the data that will otherwise to be too expensive to collect.
Many genetics bloggers are responding to the very real threat of stifling US FDA regulations of the genetics direct-to-consumer (DTC) testing industry. Researcher John Hawks proclaims himself a genetic libertarian. So am I. How about you?
Much news coming out of the FDA public meeting on direct-to-consumer (DTC) genetics. Dan Vorhaus was at the proceedings and reports on them ("Looking Ahead After the FDA’s DTC Meeting").
I believe that I have a fundamental right to my own biological information. What I mean is that, if anybody has biological information about me, I should be able to access and use it. Additionally, I think it is immoral for anyone to charge me excessive rates to access my own information. So that's where I'm coming from. I'm a genetic libertarian.
As Razib Khan has pointed out, it is not credible to argue that medical doctors know the details of genetic research on humans. The threat of FDA regulation of DTC genetics testing is all about the FDA empowering themselves and the medical doctors. It is not that they think we can't handle the truth. It is more likely they do not want to allow us to handle the truth. The idea we are going to stress out from genetic testing results does not stand up to scrutiny. People who get themselves genetically tested are not psychologically harmed by the results. People really can handle the truth.
You can think what you want about the value of the research done to date by 23andme , but in my mind, there’s one simple reason why the sorts of participant-driven research they’re doing can only be a good thing: all research is driven by curiosity, and the people most curious about a disease or trait are those who have it. While people may think of the academic research community as a machine with endless resources and limitless motivation, it’s not. People work on things they think are interesting; they sometimes follow “trendy” topics, or move into fields with more grant money, or get bored of a given problem and move on. So if the research in the trait you’re most interested in isn’t moving fast enough for you, well, tough luck.
We already have examples of individuals who have spearheaded discoveries for genetic diseases they or family members suffered from. The FDA's regulatory ambitions for DTC genetic testing are an obstacle for this sort of research.
Recall that one of the key players in the discovery of the gene for Huntington’s disease was a foundation started by a man whose wife had the disease (startlingly, the current president of the foundation apparently accused DTC companies of “raping” the human genome during the present FDA hearing). Recall also that James Lupski, curious about the cause of his Charcot-Marie-Tooth disease, simply sequenced his own genome to find it.
In the comments of Joe Pickrell's post "Nick" says the ability to contribute to the growth of genetic knowledge is one reason he chose to get himself tested by 23andme.
As a recent 23andme customer I think it’s fair to say that this aspect of the the 23andWe community was probably the biggest single factor in my decision to submit a sample for testing. I’m realistic to know that the current state of genomics knowledge can at best give indications of marginal risks for the various health conditions, and the fact that my results show a large set of common alleles (‘common things are common’ is one of the medical doctrines that applies equally well here) adds to the feeling that the ‘traits’ data, and the contribution to a developing field of science is at least as much part of the value of 23andme’s product as the medical report.
As long as people are free to get themselves genetically tested and genetically sequenced volunteer efforts to crowdsource genetic information to discover causes of diseases and traits can make a substantial and rapidly growing contribution to the rate of genetic discovery. The FDA is an obstacle to progress. It should get out of the way.
Michael Lee of the FDABlog draws my attention to his post on FDA deception as part of their attempt to regulate direct-to-consumer genetic test. Check out his video Did FDA's Jeffrey Shuren lie under oath about Google-backed 23andMe?
Michael's editorial text interspersed with the video makes great points. The worst statement from Shuren comes at the end where he basically calls for heavy regulation and a market dominated by large cap companies. Large regulatory agencies always end up getting captured by the big players and they work together to protect each other. But it is the small companies that are going to do the most innovation in new areas.
Anne Wojcicki's views are much closer to my own. We can do original and highly valuable science by crowdsourcing. We can get together as groups, pay to collect our own genetic and medical data, and submit the data to data chomping teams that organize on web sites. This approach is a challenge to the traditional gatekeepers and data owners.
The American Medical Association has predictably come out against allowing you to directly go and get yourself genetically tested. They want you to go thru a gatekeeper that has M.D. at the end of their name. I find this infuriating. I believe I have a right to get my full genome sequenced, to own the resulting data, and to get that data analyzed by whoever I want to pay to analyze it. Do you think you have the right to your own design? If so, oppose the FDA, the AMA, and Henry Waxman as they work to take that right away.
Razib Khan shares my fury on this and he says "This is a power grab, this is not about safety or ethics.".
In the very near future you may be forced to go through a “professional” to get access to your genetic information. Professionals who will be well paid to “interpret” a complex morass of statistical data which they barely comprehend. Let’s be real here: someone who regularly reads this blog (or Dr. Daniel MacArthur or Misha’s blog) knows much more about genomics than 99% of medical doctors. And yet someone reading this blog does not have the guild certification in the eyes of the government to “appropriately” understand their own genetic information. Someone reading this blog will have to pay, either out of pocket, or through insurance, someone else for access to their own information. Let me repeat: the government and professional guilds which exist to defend the financial interests of their members are proposing that they arbitrate what you can know about your genome. A friend with a background in genomics emailed me today: “If they succeed in ramming this through, then you will not be able to access your own damn genome without a doctor standing over your shoulder.” That is my fear. Is it your fear? Do you care?
In the medium term this is all irrelevant. Sequencing will be so cheap that it will be impossible for the government and well-connected self-interested parties to prevent you from gaining access to your own genetic information. Until then, they will slow progress and the potential utility of this business. Additionally, this sector will flee the United States and go offshore, where regulatory regimes are not so strict. BGI should give glowing letters of thanks to Jeffrey Shuren and the A.M.A.! This is a power play where big organizations, the government, corporations, and professional guilds, are attempting to squelch the freedom of the consumer to further their own interests, and also strangle a nascent economic sector of start-ups as a side effect.
You are so much more than your genes. So much more than that 3 billion base pairs. But they are a start, a beginning, and how dare the government question your right to know the basic genetic building blocks of who you are. This is the same government which attempted to construct a database of genetic information on foreign leaders. We know very well then who they think should have access to this data. The Very Serious People with a great deal of Power. People with “clearance,” and “expertise,” have a right to know more about your own DNA sequence than you do.
Also see my post Daniel MacArthur On Freedom Of Genetic Info And Paternalism.
Fellow bloggers: tell your readers about this!
Update: Michael Lee has more:
"The statement, for 23andMe in particular, that 'they are not doing their own research on the genetic profiles,'" said Stanford's Serafim Batzoglou, "is patently false." "Clearly this is false," said Russ Altman, also at Stanford. "I am reviewing [23andMe's paper] in my annual review of translational bioinformatics."
The FDA wants to discredit 23andme in order to make it easier to ban direct-to-consumer genetic testing. The FDA wants to keep us chained to the gatekeepers.
Update II: Here's a letter genetic anthropologist and US National Academy of Sciences member Henry Harpending telling the FDA we do not need the paternalism of the AMA when it comes to genetic information.
Dear FDA: I am writing to comment on the meeting to be held March 8-9 about direct to consumer (DTC) genetic testing (Docket FDA-2011-N-0066). I am especially motivated to write after reading the plea to you by the AMA that any DTC results of possible medical interest be censored to consumers. Their letter reflects an appalling paternalistic arrogance that would violate basic freedoms and impede public scientific understanding. I presume that if they could they would have you ban bathroom scales on the grounds that body weight must only be revealed in consultation with a “qualified medical professional.”
The AMA submission has two main themes. The first is that citizens are unable to understand the risks and predicted outcomes that might be reported and that experts are vital to provide guidance. My own experience is that I am perfectly capable of finding empirical risks from current literature, I expect I can do a much better and more thorough job than my personal physician, and even my teenage son can do it with no trouble. My own experience, again, is that only about 1 in 5 medical students know what Bayes’ Theorem is.
The second theme is that knowledge of potentially medically relevant genotypes can do some unspecified harm to customers. I have spent a total of six or so years on university IRBs, and this kind of worry is ever present. While there is much public loose talk about psychological harm and the like, within the committee room we all understand that the practice of witholding any data from subjects about themselves is nothing but protection from lawyers. I am perfectly free to refuse to participate in research and in clinical trials but I am not free to refuse to participate in federal censorship of knowledge of my own genotype.
I would urge you to keep freedom of information for consumers at the center of the table when you discuss regulation of the DTC genetic testing industry.
The AMA wants to stand between you and your genetic information. I am opposed. How about you? Writing letters to your elected representatives and to the FDA is one way to fight this.
Reacting to the American Medical Association's vile letter calling for a revocation of consumer rights to get their own genetic tests (really FuturePundit, stop holding back and tell your readers what you really think), Daniel MacArthur says the letter shows how the AMA struggles valiantly to keep medical paternalism alive.
In other words, the AMA is seeking to maintain its members’ traditional monopoly over the interpretation of genetic information – and they expect regulators to act as their enforcers, beating down the upstart DTC genomics companies who have wandered onto their sacred turf.
This is, of course, an absurd, desperate demand. If doctors think that people should consult them about their genomes, they shouldn’t run crying to the regulators to provide the necessary force; instead, they need to convince the public that a medical consultation adds genuine value to their genomic information. Unfortunately for the AMA, right now it’s far from clear that this is true: in many cases, DTC genomics customers are far better equipped to interpret their results than their doctors are.
Hey other bloggers: You too should be reacting to this outrage from the AMA. Reihan, Glenn I'm talking to you. Bureaucrats in the FDA are looking for cover such as this AMA letter to justify what they already want to do: crack down on direct-to-consumer (DTC) genetic testing. A crackdown on genetic testing might also open the door to a larger crackdown on DTC medical testing. Beat the drums against this.
The explosion of genetic and other information about the human body is so huge that single human minds can not be expected to get anywhere near mastering it. A general physician needs to know so many things about diseases, symptoms, diagnostic techniques, and treatments that it is ridiculous to suppose they can become experts on interpreting genetic information. It is a case of much more than one bridge too far. Interpretation will be best done by using web sites (commercial or otherwise) that specialize in the field. Get your data. Then pay for competing interpretations or go for free interpretations. Keep the government out of it.
Razib Khan also takes a dim view of the AMA's pretensions. Razib says you are what you are whether you know it or not and he sees marginal increases in self knowledge as tasty.
Over the past six months I’ve gotten really into analyzing genotypes of friends & family. Sometimes I talk about this excitedly, and people worry about the “risks.” When I ask what risks they’re worried about, usually people offer the vague and content-free fear of “what you could find out.” First, if you have family information, that’s usually much more powerful than the “disease risk” estimates that these firms are giving you. In 99% of the cases, if that’s your primary concern it’s not worth the money. Second, if you’re terrified about what ancestry inference might tell you, probably you should see a shrink. You are what you are, and you’ve always been what you are. As a matter of common sense psychology, on the margin a change in self knowledge can have a big effect, but usually it is just informational icing on the cake.
Naturally, this brings to mind John Prine and Dear Abby.
In a letter to the US Food and Drug Administration the American Medical Association argues that you should have to pay for a doctor's visit to get your genes tested. We need to speak out loudly and repeatedly against the efforts of regulators and economically interested parties to restrict our choices and access to tests. Some newly elected Congress critters looking to make a mark could do something useful by introducing legislation to curb the FDA's power to block direct-to-consumer (DTC) genetic testing services.
We urge the Panel to offer clear findings and recommendations that genetic testing, except under the most limited circumstances, should be carried out under the personal supervision of a qualified health care professional, and provide individuals interested in obtaining genetic testing access to qualified health care professionals for further information. While DTC genetic tests may offer some benefits to consumers, such as promoting awareness of the genetic bases of disease and increasing attention to healthy behaviors that prevent the onset of disease, the AMA is concerned about the potential of DTC genetic tests to cause harm to consumers and over time increase health care costs. Without the guidance of a physician, genetic counselor, or other genetics specialist, test results could be misinterpreted, risks miscalculated, and incorrect health and lifestyle changes pursued. At the very least, consumers will waste money purchasing tests with little value.
A trade association of medical doctors unsurprisingly favors your use of their services to get information that you should be able to pay for directly from suppliers.
If the danger of having information misinterpreted is a valid reason to restrict information then the FDA and AMA should have the power to restrict which diet books get published or who says what about their diets on talk shows. This amounts to a restriction on your freedom to read. The idea of "you can't handle the truth" is nonsense.
I am reminded that 23andme is now charging only $199 for genetic tests of almost 1 million locations in your genome. You might want to get tested before the FDA and AMA try to take way your right to do so.
An article in the New York Times draws attention to the problem of unrecognized cognitive impairment in some aging doctors.
And some experts warn that there are too few safeguards to protect patients against those who should no longer be practicing. “My guess is that John Q. Public thinks there is some fail-safe mechanism to protect him from incompetent physicians,” Dr. Norcross said. “There is not.”
Often the mechanism does not kick in until a state medical board has found it necessary to discipline a physician. A 2005 study found that the rate of disciplinary action was 6.6 percent for doctors out of medical school 40 years, compared with 1.3 percent for those out only 10 years.
In 2006, a study found that in complicated operations, patients’ mortality rates were higher when the surgeon was 60 or older, though there was no difference between younger and older doctors in routine operations.
Since our brains do not all deteriorate at the same rate (yes, your brain is deteriorating) it would help to know which physicians in their 60s are still at or at least near the top of their game. The ones with high blood pressure, high cholesterol, too much fat, insulin resistance, a history of alcohol or drug abuse, and other sources of wear and tear are going to be in worse shape on average. That holds for the rest of us as well.
What I'd like to see: Medical expert systems that check diagnoses as a way to spot deteriorating diagnostic skills. If such systems could reach the same conclusions as the best doctors in a specialty at a very high rate then expert systems could be used for quality control. An older doctor who too often reached different conclusions than his shadowing expert system could be required to undergo testing of medical competency.
Results of direct-to-consumer genetic tests may induce far less hand-wringing than previously speculated, researchers say.
Patients had no increases in anxiety after their results were revealed, nor did they make any changes in diet or lifestyle based on the findings, Eric Topol, MD, of Scripps Clinic in La Jolla, Calif., and colleagues reported online in the New England Journal of Medicine.
The curious are not hurt by the results of their curiosity. Hey, someone tell the state governments of California and New York since they seek to make personal genetic testing hard to get without approval of a physician.
People who had higher risk for disease did say they would get a greater number of screening tests in the future to monitor their health. But the team “observed no significant differences in the level of anxiety, dietary fat intake or exercise behavior between baseline and follow-up for the same as a whole,” they wrote.
Topol said the medical establishment remained skeptical about genome-wide tests, and that the results should assuage some fears about the technology. “We’ve shown that at least those people who are curious are not hurt, and they may benefit from the results,” he said.
“Our research showed no evidence whatsoever of anxiety or psychological stress,” said Eric Topol, MD, Director of Scripps Translational Science Institute, Chief Academic Officer of Scripps Health, and Professor of Translational Genomics of The Scripps Research Institute and senior author of the study. “This is particularly significant because it is the first large body of data we have to allay concerns around consumer anxiety related to genetic risk assessment. Not only can consumers handle their personal genetic information, but they are getting genomically oriented and anchored about such data.”
We should continue to be able to get all manner of genetic and other tests done for ourselves without need to take the time and money to see a doctor. We have the right to know our genetic testing results and medical tests.
Ever come across simplistic commentators who compare health care systems by comparing life expectancies? Most annoying. Many factors determine life expectancy aside from health care systems. Diets, exercise, even weather influence life expectancy. The need to control for these other factors make well done health care system performance comparisons non-trivial. The RAND Corp has taken an interesting approach to comparison of two health care systems: Older Americans who have more chronic diseases than similar aged older English live just as long as their English counterparts on average. This probably shows the higher amount of money spent per American patient really is buying life expectancy benefits.
Older Americans are less healthy than their English counterparts, but they live as long or even longer than their English peers, according to a new study by researchers from the RAND Corporation and the Institute for Fiscal Studies in London.
Researchers found that while Americans aged 55 to 64 have higher rates of chronic diseases than their peers in England, they died at about the same rate. And Americans age 65 and older -- while still sicker than their English peers -- had a lower death rate than similar people in England, according to findings published in the journal Demography.
The paper was co-authored by James Banks and Alastair Muriel of the Institute for Fiscal Studies and James P. Smith, distinguished chair in labor markets and demographic studies at RAND.
What I take away from this: If you want to maximize your life expectancy while waiting for rejuvenation therapies then choose a diet and lifestyle that will make your risk of chronic illnesses even lower than chronic disease rates in England and make sure you can afford the very best medical care. Given an ideal diet (i.e. a diet that is probably better than what you eat now), exercise, low exposure to pollutants, and other health-promoting practices you can delay the onset of chronic diseases. Then once they hit you can use cash and an excellent nearby research hospital (and, yes, quality of care varies considerably) to further delay the grim reaper.
Better to be sick in America.
"If you get sick at older ages, you will die sooner in England than in the United States," Smith said. "It appears that at least in terms of survival at older ages with chronic disease, the medical system in the United States may be better than the system in England."
The study expands upon an earlier analysis by Banks and Smith that found that Americans aged 55 to 64 suffered from diseases such as diabetes at rates up to twice those seen among similarly aged people in England. The trend was observed across all socioeconomic groups.
The American health care system (really an assortment of systems) is expensive. But it delivers a number of benefits. One is mentioned above: It does a better job of managing and treating chronic diseases of old age. But that's not all. It also does not make people wait as long. A person who has, say, a bad hip who has to wait for months to get it fixed loses work (which costs both the individual and the government money) and experiences a lot of pain while waiting. The queues that are characteristic of cheaper health care systems impose costs on customers/supplicants.
My favorite advantage of the American health care system is that it presents huge incentives to the market for the development of newer and better treatments. That's what makes the biggest difference to most of us in the long run. If you are many years away from your first life-threatening illness then the speed or thoroughness with which the current health care system treats you is less important than what future treatments it will offer you 10, 20, 30 or more years from now. I favor a health care system that offers huge incentives for new treatments and low barriers to entry for those treatments.
People want relief from disease and public and private sources spend big to find better ways to cure and avoid disease.
WASHINGTON—October 7, 2010—The U.S. invested $139 billion last year in health research from all public and private sources, according to Research!America's latest annual estimate. That amount represents only 5.6% of the $2.47 trillion overall U.S. health spending in 2009—or 5.6¢ of every health dollar—which varies no more than 0.2% from 2005 levels.
The estimate is available here: http://www.researchamerica.org/uploads/healthdollar09.pdf.
The 2009 investment grew by only 0.1% over 2008. This small increase can be attributed largely to the federal stimulus funding for research provided through the American Recovery and Reinvestment Act of 2009. Federal research investment was nearly $46.8 billion in 2009, up from $38.6 billion in 2008.
We are all growing old. We are all aging and our parts are breaking down and wearing out. A portion of those billions of dollars flows toward science technologies that will eventually put an end to aging. Human bodies will become as repairable as cars. Replacement organs, cell therapies, gene therapies, and even nanobots will, at some point in the 21st century, halt and reverse the process of aging. Will you still be alive when that day is reached?
In a Hastings Center special issue on personalized medicine Ronni Sandroff, editorial director of Health and Family at Consumer Reports, has an article Direct-to-Consumer Genetic Tests and the Right to Know: Genetic testing can be too much information, but that doesn’t mean it should be kept from consumers. (requires free registration)
Pathway Genomics Corporation and Walgreens announced in May that they would offer genetic testing collection kits at the drug chain. The Food and Drug Administration took notice. In a May 10th letter, the agency notified Pathway Genomics that its product, “intended to report customary and personal genetic health disposition results for more than 70 health conditions . . . Appears to meet the definition of a device as regulated under the Federal Food and Drug and Cosmetic Act,” thus requiring FDA approval. The company has delayed plans to market the product. A similar letter was sent to five other direct-to-consumer testing companies in June.
I think the FDA should step out of the way. We really do have a right to know our full DNA sequence or any subset thereof.
As for interpreting the results: If the FDA gets into the job of deciding which genetic variants have known effects on every disease, ability, function, and appearance of humans then the FDA will be biting off far more than it can handle. The FDA's decisions will tend to be very slow in coming with interpretations coming many years later than would otherwise be the case. As long as the companies providing test results do not cause harm by causing customers to make decisions that harm their health I do not think the direct-to-consumer testing companies should face much in the way of government regulation.
Current genetic tests do not yield definitive results on many of the conditions for which they try to assess risks. But as the meaning of more genetic markers become known ambiguous and contradictory interpretations will become less common.
Most telling, on July 22, the Government Accountability Office released a study in which it sent identical DNA samples to four genetic testing firms to test for fifteen common diseases and conditions. Contradictory results abounded. For example, various companies told a forty-eight-year-old male that he had average, below-average, or above-average risk for prostate cancer. These contradictions can be explained, in part, by the fact that companies analyzed different genetic “markers,” and that scientists disagree about what these mean in real-life situations.
As long as the companies state when each marker by itself does not predict 100% odds of getting some disease people should be able to receive interpretations of their test results from the test vendors.
I see a lot riding on the ability of companies to offer direct-to-consumer genetic tests and other forms of biological testing. We will have much faster product development and innovation if people can directly request tests and get test results. A faster rate of test development with less government regulation will accelerate the rate of biotechnological advance. A faster rate of advance will save lives in the long run.
A recent study from the RAND Corporation, one of the country’s most trusted analytic organizations, finds a current shortage of 3,800 anesthesiologists and 1,282 nurse anesthetists. However, if current trends continue, a dramatic shortage of anesthesiologists and a significant surplus of nurse anesthetists are projected by 2020.
This brings up some questions that I do not have answers for. But the questions are pretty interesting and worth investigating:
To put it another way: Should a 20 year old today choose surgery or anesthesiology as a career path? Are these safe bets? Or are they at high risk of getting heavily automated in the 2020s and 2030s?
The RAND researchers expect a 3% yearly increase in demand for anesthesiologists. That results in a doubling in 24 years. My guess is that at some point in those 24 years demand will peak and then start contracting due to automation.
In its baseline projection, assuming demand for services grow at the rate of 1.6 percent annually for both anesthesiologists and nurse anesthetists, the RAND study projects a shortage of close to 4,500 anesthesiologists and a surplus of close to 8,000 nurse anesthetists by 2020. However, if the growth in demand is assumed to be 3 percent to account for the aging population, the RAND study projects a shortage of physician anesthesiologists as high as 12,500 by the end of the decade. In this likely scenario, the surplus of nurse anesthetists by 2020 could be as high as 15,000.
The really highly paid and high skilled occupations are not immune to automation. Given that medical costs in the United States now exceed 17.35 of GDP and are on course to surpass 20% of GDP it makes sense to heavily automate the most expensive tasks in medicine. We can not afford the current trend in medical expenditures. Thing's got to give. What policies could increase the rate of automation of medicine?
In a prelude to overhauling its regulatory oversight of genetic diagnostic testing, the U.S. Food and Drug Administration will convene a public meeting next week to gather input from test makers and others.
I would prefer the FDA and like regulatory agencies stay out of genetic testing except perhaps to test for error rates and publish the results. The rate of innovation will be faster with less regulatory involvement.
Yes, genetic testing will serve as a cornerstone of personalized medicine - but only if it is allowed to grow rapidly without big costs involved in getting regulatory approvals.
The event reflects a turning point in genetic testing, a cornerstone of personalized medicine. Once mainly the domain of rare diseases, scientists have discovered a growing number of genetic variations linked to both the risk of more common disease and patients' response to drugs. The number of genetic diagnostic tests has expanded rapidly, and tests have become increasingly complex, making it more challenging to interpret and act on the results.
Genetic tests are data. The flow of genetic testing information is like the flow of so many other kinds of information: increasing rapidly, growing by leaps and bounds. All that data should flow unhindered by regulations.
The FDA does not see doctors capable of interpreting genetic test results. I'm thinking they'll use web sites that will pop up to do genetic sequence data interpretation.
"We don't think physicians are going to be able to interpret the results; they are relying on the labs that make them," says Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA. "So we think a third party should assess these devices."
Individuals shouldn't even need to go to a doctor in order to get their genes tested or fully sequenced. Testing and sequencing services should be available to accept tissue samples via web sites where people pay and then send in tissue samples.
Access to testing services without need to see a doctor should be allowed for much more than just DNA testing. Services for testing blood and assorted excretions (urine, stool, hair, nails, etc) should be available to the general public. Also, as microfluidic devices make mini home medical testing equipment practical we should be able to get a blood panel or other tests done at home.
More than one-third of U.S. physicians responding to a survey did not agree that physicians should always report colleagues who are incompetent or impaired by conditions such as substance abuse or mental health disorders. The report from the Mongan Institute for Health Policy at Massachusetts General Hospital (MGH), published in the July 14 Journal of the American Medical Association, also finds that substantial numbers of physicians feel unprepared to report or otherwise deal with impaired or incompetent colleagues.
"Our findings cast serious doubt on the ability of medicine to self-regulate with regard to impaired or incompetent physicians," says Catherine DesRoches, DrPh, of the Mongan Institute, who led the study. "Since physicians themselves are the primary mechanism for detecting such colleagues, understanding their beliefs and experiences surrounding this issue is essential. This is clearly an area where the profession of medicine needs to be concerned."
The medical profession would prefer less outside judgment (e.g. fewer malpractice suits, less second-guessing by insurance companies) on the basis that only professionals are competent to judge other professionals. That sounds great if the professionals really step up to the plate to do that judging and do so objectively.
Pediatricians are least up to their responsibility. Which leads me to wonder: what's the split on male versus female reporting of incompetence?
Almost 1,900 surveys were returned, and only 64 percent of the respondents agreed that physicians should always report impaired or incompetent colleagues. About 70 percent of respondents indicated feeling prepared to deal with an impaired colleague, and 64 percent felt prepared to deal with an incompetent colleague in their practice. Pediatricians were the least likely to report feeling prepared to deal with impaired or incompetent colleagues, while psychiatrists and anesthesiologists felt most prepared.
In a given year about 6% of American physicians fail to report an impaired or incompetent physician.
Direct, personal knowledge of an impaired or incompetent physician during the past three years was indicated by 17 percent of respondents, but only 67 percent of those with such knowledge actually had reported the colleague.
One wonders how many people suffer or die as a result. One also wonders how much money is wasted as a result.
People who favor immigration restriction and an end to racial preferences will find support for their positions in this report.
The most frequently cited reason for not reporting was the expectation that someone else would report, indicated by 19 percent, followed by the belief that nothing would happen because of the report, cited by 15 percent, and a fear of retribution, 12 percent. Among factors associated with not reporting were belonging to one- or two-person practices and being a member of an underrepresented minority or a graduate of a foreign medical school. Whether respondents came from a state with high, medium or low rate of malpractice claims was not associated with failure to report.
Leave it to someone else, nothing would happen because the rest of the medical profession will ignore the report, and, hey, don't want doctors ganging up on you. This reminds me of the police with their thin blue line. As a practical matter I think police have such dangerous jobs dealing with such dangerous people that they need a considerable amount of solidarity against the world. Doctors have much higher status and cushier working conditions. They should step it up on enforcing performance standards on each other.
TORONTO, Ont., July 6, 2010 — Nearly 60 per cent of Ontarians with rheumatoid arthritis — an autoimmune disease that causes chronic inflammation of the joints — were not seen by a specialist within a one year period to treat the debilitating disease, according to a new study. Even more concerning is that women of child-bearing age are less likely to see a specialist than women 45 or older, say researchers from St. Michael's Hospital, the Institute for Clinical and Evaluative Sciences (ICES), and Women's College Hospital.
A Canadian friend (living in southern Ontario at the time) complained to me for years that he couldn't get a general practitioner. Without a general practitioner he couldn't get a referral to a specialist. He got his medical care by going to emergency wards. This all made me very unkeen on Canadian health care as a model for the US.
Of course US health care has big problems of its own. But if you've got the cash (and/or plush insurance policy) you're better off getting your care in the US. The value of cash will be even greater in the future as political systems ration care in order to cut costs. You can be for the miracle of more market forces or the miracle of government as single provider. But come what may you are better off if you have lots of cash to pay for care directly (possibly in other countries if you are like Canadians who have little access to pay-for-service health care).
My advice to Americans: accumulate cash in a Health Savings Account with a high deductible policy starting while you are young. Put in the max contribution every year. Save money in other ways too. The accumulated cash will help pay for your health care when you get older. If you are young then for sure that cash will help you pay for rejuvenation therapies. Someone in their 20s who doesn't die prematurely will live long enough to get excellent rejuvenation therapies.
If you save up big piles of money (and are willing to travel) you'll be able to get those rejuvenation therapies sooner. The time gap between narrow and wide availability might be wide enough to be a matter of life and death for you. In your 40s, 50s, 60s? It is especially true for you.
Are new medical residents a threat to patients? According to Dr. David Phillips and Gwendolyn Barker from the University of California, San Diego in the US, fatal medication errors peak in July in teaching hospitals in particular, which coincides with the yearly influx of new medical residents who are given increased responsibility for patient care. Their findings1 are published in the Journal of General Internal Medicine², published by Springer.
If you are thinking about elective surgery then try to avoid July - at least at a teaching hospital.
They examined 244,388 US death certificates focusing on fatal medication errors as the recorded primary cause of death, issued between 1979 and 2006. They compared the observed number of deaths in July with the number of expected events in a given month for a given year. They also looked at whether there were any differences between deaths in and out of hospital in July as well as between counties with and without teaching hospitals
The authors found that inside medical institutions, fatal medication errors spiked in July and in no other month. This July peak was visible only in counties with teaching hospitals. In these counties, the number of July deaths from medication errors was 10 percent above the expected level. No similar link was observed for other causes of death or for deaths outside hospitals.
The medical profession needs to step up on the issue of quality control. Statistical process control, continuous improvement, root cause analysis, and the rest of the quality improvement techniques pioneered by the likes of W. Edwards Deming (one of my heroes) need to find a central place in how medicine gets done. Traditions like a huge turn-over in medical residents all in a single month need to be reexamined in light of the idea that fatal medical errors should be extremely rare. A 10% boost in death from medical errors in a single month due to an obvious cause should have been measured and detected many years ago.
While I'm at it: Medical residents forced to work long hours make more mistakes. Why is this still a problem in 2010? They also get into more car accidents. Hospitals falsify records in order to under-report resident hours worked. Beware.
Let me go on record as disagreeing with the Association for Molecular Pathology. Genetic testing should be available without consent of a medical doctor.
In response to recent announcements about consumer genetic tests being made available in retail drugstores, the Association for Molecular Pathology (AMP) today reiterated its position that these tests should be provided to the public only through the services of appropriate health care professionals that order tests from laboratories that are certified by CLIA for highcomplexity testing.
More generally, I'd really like to see wider availability of medical tests without a visit to a doctor's office.
Think about the general trend with information: more, direct and easier access, greater availability. Microfluidic devices that serve as labs on a chip are going to be the next big thing in medical testing. No need to have your blood sent to a lab when you can literally carry the lab in your pocket. No need to go to a drug store or a doctor's office to get a test done.
Eventually we'll have medical testing devices embedded in our bodies doing real time monitoring to detect problems as soon as they happen. You'll wave a smart phone over your body to read your embedded test lab, the phone will analyze the results, and then it'll pass the results up to a diagnostic server on the web to get run thru expert systems to do difficult diagnoses.
Regulations that keep visits to a doctor's office in the loop block the sorts of innovative real time diagnostics that should be the future of medicine.
W. Edwards Deming would not be surprised. Lower cost hospitals are not lower quality - at least for congestive heart failure treatment.
The costs that hospitals incur in treating patients vary widely and do not appear to be strongly associated either with the quality of care patients receive or their risk of dying within 30 days, according to a report in the February 22 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
"Hospitals face increasing pressure to lower cost of care while improving quality of care," the authors write as background information in the article. However, critics have expressed concerns about the trade-off between the two goals. "In particular, might hospitals with lower cost of care and lower expenditures devote less effort to improving quality of care? Might the pursuit of lower cost of care drive hospitals to be 'penny wise and pound foolish,' discharging patients sooner, only to increase re-admission rates and incur greater inpatient use over time?"
Lena M. Chen, M.D., M.S., of the University of Michigan, Ann Arbor, and colleagues conducted a national study of hospitals that discharged Medicare patients who were hospitalized for congestive heart failure or pneumonia in 2006. For each condition, the researchers used data from national databases to examine the association between hospital cost of care and several variables: 30-day death rates, readmission rates, six-month inpatient cost of care and a quality score based on several performance indicators for each condition.
Costs of care for each condition varied widely. Care for a typical patient with congestive heart failure averaged $7,114 and could range from $1,522 to $18,927, depending on which of the 3,146 hospitals discharged the patient. Cost of care for a typical patient with pneumonia averaged $7,040 and varied from $1,897 to $15,829 per hospitalization among 3,152 facilities.
"Compared with hospitals in the lowest-cost quartile [one-fourth] for congestive heart failure care, hospitals in the highest-cost quartile had higher quality-of-care scores (89.9 percent vs. 85.5 percent) and lower mortality [death] for congestive heart failure (9.8 percent vs. 10.8 percent)," the authors write. "For pneumonia, the converse was true. Compared with low-cost hospitals, high-cost hospitals had lower quality-of-care scores (85.7 percent vs. 86.6 percent) and higher mortality for pneumonia (11.7 percent vs. 10.9 percent)."
This makes sense in the United States especially because providers and consumers of health care services both lack sufficient incentives for lower costs. The payers aren't the receivers of medical treatments. The overall system encourages massive spending. So there's lots of potential for cost cutting. Also, the pursuit of higher quality can cut costs in lots of ways. Achieving higher quality requires better understanding of a process and correction of flaws in the process. In a hospital that includes cutting infections, cutting surgical mistakes, cutting drug dosage mistakes, and other improvements that lead to better outcomes at lower cost.
The state of Michigan, which used a five-step checklist developed at Johns Hopkins to virtually eliminate bloodstream infections in its hospitals' intensive care units , has been able to keep the number of these common, costly and potentially lethal infections near zero — even three years after first adopting the standardized procedures. A report on the work is being published in the February 20 issue of BMJ (British Medical Journal).
Peter Pronovost, M.D., Ph.D., a professor of anesthesiology and critical care medicine at Johns Hopkins University School of Medicine and a patient safety expert, says the widely heralded success in Michigan — the first state system to tackle in a wholesale fashion infections in central-line catheters ubiquitous in intensive-care units — has significantly changed the way physicians think about these infections.
A checklist for inserting catheters saves money and lives. This is not high tech.
The checklist contains five basic steps for doctors to follow when placing a central-line catheter: wash their hands; clean a patient's skin with chlorhexidine; wear a mask, hat, gown, and gloves and put sterile drapes over the patient; avoid placing a catheter in the groin where infection rates are higher and remove the catheter as soon as possible, even if there's a chance it might be needed again at some point.
Central lines are used regularly for patients in the ICU to administer medication or fluids, obtain blood tests, and directly gauge cardiovascular measurements such as central venous blood pressure. Each year roughly 80,000 patients become infected and 30,000 to 60,000 die at a cost of $3 billion nationally. Before heading to Michigan, Pronovost tested the checklist at Johns Hopkins Hospital, where catheter infections have also been virtually eliminated.
That these practices aren't already practiced in every hospital tells us there's probably still plenty of low hanging fruit in the area of medical quality improvement. Oh, and Johns Hopkins is also trying to boost herd immunity of their employees. Good idea.
One can try to spend larger sums of money to prevent very few deaths (more here). But if the goal is really to save lives then a relentless pursuit of process improvements to achieve higher quality will save more lives and save money at the same time.
Dogs with cancer in the US are now entitled to receive experimental drugs – before the drugs are available for humans. Twelve trials are under way on groups of 15 to 60 dogs, and in several of them cancers have disappeared.
"We've had dramatic remissions in dogs with really aggressive cancers," says Chand Khanna, head of the Comparative Oncology Trials Consortium newly formed in Bethesda, Maryland, by the US National Cancer Institute. "We've also had responses allowing dogs to have their original cancers surgically removed," he says.
I'd like to see a change in US Food and Drug Administration policy where people with just a few months left to live should be free to try drugs that are currently in stage I trials or even drugs which have only been tried on other animals. If you are going to die then you should be free to try anything. If I had several months left to live due to cancer I'd rather try experimental drugs even if they might kill me sooner. If the result was simply to rule out the further use of an otherwise promising drug as least I'd die for some constructive purpose.
One of the defining attributes of our era is an excessive desire on the part of our intellectuals to restrain other people from being mean to various groups of less fortunate people. In a blog post about how people like to signal their domination (no kidding, and economists have still not come up with an economic system that works while allowing everyone to feel dominant) economist Robin Hanson argues that public health messages aimed at fat people are basically cruel to those fat people.
Yet it is completely crazy to imagine that fat folks have not yet heard that fat might be unhealthy or unattractive. Believe me, they’ve heard! If they are choosing to be fat, they are doing so reasonably informed of the consequences. Our constant anti-fat “public health” messages are not at all kind – such messages just serve to put fat folks down, and lift the rest of us up. If anyone is so clueless as to need constant reminders, it is those who can’t see their own over-bearing domination, such as putting down fat folks to lift themselves up.
Being a hyper-rational economist Hanson assumes (incorrectly) that everyone knows where they stand in terms of being overweight and what consequences they face as a result. Um, no. One third of the overweight do not even believe they are overweight and the denial at the obese level is much higher.
A National Consumers League survey conducted by Harris Interactive in 2007 found that adults consistently identify themselves as being less severely overweight than they actually are. Eighty-two percent of obese people surveyed considered themselves to be simply overweight; among those who were in fact only overweight, close to 1 in 3 believed that they were normal weight.
I bet the majority of obese people can't list most of the increased medical risks that come as a result of being obese. In case you want to know, among the increased risks from obesity: insulin resistance, diabetes mellitus, hypertension, dyslipidemia, cardiovascular disease, allstones and cholecystitis, and sleep apnea. That list is far from complete. Also add osteoarthritis and gout. Then there's your brain: increased risk of dementia and Alzheimer's Disease. I doubt most obese people know they are at increased risk of all these diseases or even most of them.
A lot of true and not nice facts need constant repetition.
Changes in medical policy and health care funding will not address the biggest causes of lower life expectancy in the United States as compared to some other industrialized countries. Poor diet choices and lack of exercise are more important than the health care system.
Two teams, one led by Pierre-Carl Michaud of the Rand Corporation in Santa Monica, California, the other by Samuel Preston of the University of Pennsylvania in Philadelphia, have dug into international health statistics to ask why US citizens can expect to die earlier than their counterparts in the richest European nations.
Michaud concludes that the blame lies largely with high rates of chronic disease caused by poor diet, lack of exercise and the lingering effects of tobacco use from a time when smoking was more prevalent in the US than in Europe.
Years of bad habits take their toll. The medical technologies of today can not reverse that damage. Once you get enough mutations to, say, trigger liver cancer you are checking out of the Life Hotel. Organ failures usually cause death because demand for donor organs far exceeds the number of donor organs available. Strokes kill because we can't repair brains and we lack the technology to repair blood vessels before they burst and kill lots of brain cells.
Now, you ought to look at your diet and habits and try to make at least small changes that'll tip the odds more in your favor. Close enough to a store to walk? Want to visit a friend who lives a mile away? How about walking? Choosing between vacations where one is more sedentary and the other provides greater potential for physical exercise? Choose the latter. Then there's food. Try this: Just eat a vegetable before you eat whatever you want to eat. If you do not want to deny yourself junk food at least preface it with something good for you.
Even if you eat the Mediterranean diet and jog 50 miles per week you can drop dead from a stroke or suddenly experience an auto-immune disease that rips apart some internal organs. Even if you become a vegan and swim laps every day you can suddenly experience kidney failure or get diagnosed with advanced stomach cancer. You could go for colonoscopy exams every year and still die from colon cancer. You could go for yearly physicals and go on preventative blood pressure drugs and still develop heart disease. The realm of the biotechnologically feasible today still falls far short of what we need to prevent death from our major killer diseases of today.
What matters for most of us today is not the size of our medical co-pays or deductibles. I know people who've gone without medical insurance for years without seeing a doctor (as compared to myself who goes for years with medical insurance and I still do not see a doctor). No, what matters most is the state of medical technology 10, 20, 30, or even 40 or 50 years from now. What matters is the rate of advance of biomedical science and biotechnology. Lots of factors play into that rate of advance. I am worried about how government policy changes might affect the incentives for new drug and new treatment development in the private sector.
But other things matter as well. Technologies from other industries play a big role in making biomedical advances possible. The rate of advance of computing technologies matters for multiple reasons (even printers can help make miniature microfluidic devices). Computers make CAT scans and other scans possible. Computers make the da Vinci Surgical System possible. Computers automate lots of medical testing lab work. Microfluidic devices are possible because of work in the computer industry to make computer chips. Microfluidic will enable home lab-on-a-chip testing as well as much more rapid and accurate testing in hospitals and clinics.
The regulatory environment is important too. Some economists believe the US Food and Drug Administration slows the development of new treatments and causes net harm. If this is true then for those of us who still have major health care problems only in our futures have an interest in lowering the barriers for introduction of new treatments.
As long time readers know, I have a strong desire to reverse the aging process and live thousands of years until killed by a trauma (accident, murder, or other unavoidable event). I watch a lot of political developments from the standpoint of whether they will speed or slow down the rate of biomedical scientific and technological advance. For this reason I want to draw your attention to recent blog posts by The Atlantic writer Megan McArdle. Megan's primary objection to current legislation to change health care delivery is the danger that incentives could be lowered for developing new drugs and other treatments.
My objection is primarily, as I've said numerous times, that the government will destroy innovation. It will do this by deciding what constitutes an acceptable standard of care, and refusing to fund treatment above that. It will also start controlling prices.
Now, at this point in the discussion, some interlocutor starts chanting what I've come to think of as "the mantra": othercountriesspendlessandhavelongerlifespans. Then they ask me how I can ignore the overwhelming evidence that national health care is superior to our terrible system. Now, what's odd about this is that all of those countries do precisely what I am concerned about: slap price controls on the inputs, particularly pharmaceuticals. Their overwhelming evidence indicates that I am 100% correct that a government run system in the US will destroy the last really profitable market for drugs and medical technology, and thereby cause the rate of medical innovation to slow to a crawl.
To which Matt rejoinders that all the Dutch insurance companies are private. Indeed they are, but they're essentially tightly regulated utilities. There's no market discovery of drug prices; instead, the prices are set by looking at an average of the rates paid by government systems in nearby countries. The government decides what is reimburseable. It further defines the basic health package that everyone gets, though as I understand it most people also purchase top-off insurance. The supplemental insurance functions more like an actual insurance market. As I understand it, there's considerable pressure to stop that. And the markets are in peripheral services that mostly aren't reimbursed by health insurance here, either, like eyeglasses and dental.
Megan argues that by a utilitarian calculus price controls and other interventions favored by the left will kill more people in the long run. This seems obviously correct to me.
I suspect that Holbo, and many of my interlocutors, are made intensely uncomfortable by the idea that their root assumption--that they are on the side of reducing human suffering and lengthening lifespans--might be wrong. There are a bunch of ways you can deal with this disturbing possibility. You can scream at me. You can posit a highly speculative world in which government and academia suddenly, and for no apparent reason, get a lot better a inventing devices and mass-market drugs than they have so far proven. You can claim, falsely, that government and academia already do all the work producing useful drugs. You can assume that slashing pharma profits 80% will have no impact on their behavior, or at least, only change the behavior you want to change.
Or you can bite the bullet and say, we should save lives now at the expense of lives later. There's philisophic justification for that choice. But that opens up a whole can of worms about things like global warming. It helps if you phrase it aggressively: "How dare you suggest that someone should suffer now when we can treat them, so that someone who's not even born yet can live?" and don't think much about the equally inflammatory alternative formulation: "How dare you suggest that billions and billions of people suffer and die for the sake of a few uninsured Americans right now?" Geometric progressions are a bitch. So is figuring out the right discount rate for the lives of future world citizens, as William Nordhaus and Nicholas Stern can attest.
Megan is right that countries with price controls are far smaller sources of incentives for new drug development than the American market. Price controls cut incentives in drug development just as they do in other markets. There's nothing special about health care that makes it less reliant on market incentives for innovation. In fact, given the regulatory obstacles and costs for new drug development the size of the incentives for new drug development must be huge to make new drug development happen.
The size of the incentives for drug development and other treatment development is what matters most to me in the health care debate. I'm not worried about whatever maladies I've developed to date. I am really worried about whatever disease I'm going to get some day for which there is no cure today. Most of you should share this same worry. Unless you have a fatal disease right now your primary concern should be over long run incentives. Drugs take many years to come to market. Incentives of today determine how much effort is made today to produce new drugs 10 years from now.
Think about your medical future the way I do: Something really bad will go wrong with you eventually that we can't cure or fix today. We can hope for more time before that day happens. Time gives us more treatments - especially if the incentives are there for more treatments. I hope that nothing goes seriously wrong in the next 20 years and so that when I do get something deadly my chances of getting a curative treatment will be much higher than today.
Right now the list of debilitating and fatal diseases associated with aging is quite long. Right now many diagnoses mean you are toast. Your stay in the life hotel is coming to an end. These are diseases that super-diagnosticians (e.g. the fictional Dr. House) can't do squat about. So I think thoughts like: Will my kidneys fail? Will I have to go on some artificial kidney machine that gradually messes up my metabolism? Will I have to live tethered to that machine much of the time with all sorts of activities off-limits? Then will I end up getting bone and other problems before dying? Or maybe my colon will develop Crohn's or IBD (inflammatory bowel disorder). Totally unfun according to someone I know with IBD. Don't get too far from a toilet.
But wait, there's plenty more. Will I get painful arthritis in my knees? Gotta say, people I know who have had knee surgery tell me they still suffer chronic knee pain. Chronic pain is something I am very sure I do not want to live with. My episodes with pain that have lasted days or weeks were very convincing on this point. I sure want pharma companies and venture capitalists on Sand Hill Road to see big dollar signs for coming up with ways to coax stem cells to make new knee joint materials. Will I get any number of cancers? I've helped a close relative die from cancer. I do not want that horrible horrible fate. I want a cure. I want pharma companies to see the potential for massive profits from producing a cure or two or three.
Then there's the brain. Will I develop dementia or Alzheimer's Disease? Slow death of my identity while I forget so many cherished memories and scientific understandings and friendships and insights? That's my idea of a living horror show. Slow brain death lasting over years. I want profit-seekers to save me from that fate.
I do not see a realistic substitute for the profit-seeking treatment developers. Sure, one can point to treatments developed totally without profit motive. But the vast majority of the drugs on the market today started out inside of profit-seeking corporations and their development was funded by corporations. Academia provides a lot of useful discoveries that enable new avenues of treatment development. But the role of academia is not a substitute for industry labs driven by the desire to bring products to market. Take for example the da Vinci surgical system which provides greater precision and Minimally Invasive Surgery (MIS). This is a product brought to market by Silicon Valley profit-seekers. It takes a profit-seeking corporation to do the product testing and development needed to make a commercial product. Parenthetically, about three quarters of the da Vinci systems sold to date were to US customers. US patients are deriving far more benefit from this technological advance than patients in Europe or Japan or other countries.
Megan sees the current health care reform bills in Congress as pushed by people who also want to destroy profit motives in medicine. I agree with her about not trusting people with their motives. They do not get what drives medical innovation and entrepreneurship.
At the heart of it, in most of these debates, both sides are saying "I don't want to go here because once I do, I'm afraid I'll end up there." They don't trust the other side, and usually, they're right not to. In this case, I think that the political logic of an expensive new health care plan will push us faster and further towards price controls on key inputs, and somewhat hamfisted "one-size-fits-all" standard-of-care recommendations. I am reinforced in this belief by the fact that many of the people pushing health care reform are also enthusiastic proponents of . . . price controls on key inputs, and national standard-of-care recommendations. I don't trust them when they ask me to focus on just this bill right here.
Other government interventions in health insurance have driven up costs. So lucky I do not live in New York state.
One has to ask on which side to err when controlling medical costs. Keep in mind not just the short term but also the long term costs. Long term costs depend most heavily on the rate of innovation.
The other reason I think the worries are legitimate is that as the government is on the hook for more medical costs, its incentives change. The fact is, it wouldn't be hard to manipulate a significant number of sick people into forgoing a lot of expensive care. The Obama administration's point, which is well taken, is that it's problematic to give doctors financial incentives to bias their advice towards treatment. The problem is, it's also problematic to give them, or their employers, incentives to bias their advice towards undertreatment. Every compensation scheme on the table does one or the other. And I think Americans are inherently more comfortable with a bias towards proaction than inaction, even if the latter is cheaper and more restful.
Robert Wright notes that "we already ration health care; we just let the market do the rationing." This is a true point made by the proponents of health care reform. But I'm not sure why it's supposed to be so interesting. You could make this statement about any good:
"We already ration food; we just let the market do the rationing."
"We already ration gasoline; we just let the market do the rationing."
"We already ration cigarettes; we just let the market do the rationing."
And indeed, this was an argument that was made in favor of socialism. (No, okay, I'm not calling you socialists!) And yet, most of us realize that there are huge differences between price rationing and government rationing, and that the latter is usually much worse for everyone. This is one of the things that most puzzles me about the health care debate: statements that would strike almost anyone as stupid in the context of any other good suddenly become dazzling insights when they're applied to hip replacements and otitis media.
In spite of having said and excerpted all of the above obviously lots of facets of the health care debate have not been addressed in this one post or in Megan's posts. US health care spending is headed toward 20% of GDP and my sense of the rate of innovation acceleration we are getting for 15, 16, 17% of GDP is that we aren't getting anywhere near an optimal return on investment. Partly this is because a lot of health care spending goes for labor that is not easily automatable (at least not yet). Money spent on that labor does not lead to anywhere near as much treatment development as money spent on drugs. So a small fraction of total health care spending (that portion spent on drugs) delivers a bigger impact in terms of better future treatments.
In this post I do no offer a solution for this observation (though I have some ideas). I'm just saying that, geez, for such a large fraction of the GDP devoted to health care I'd really like to see a lot more progress in treating diseases. We still have no cures for all those diseases I mention above and many others I didn't list. The health care sector should be measured just as much by the rate of progress in developing new treatments as by the cost effectiveness and quality of delivery of current preventative care and current treatments.
Want still more to read on health care policy? Megan also praises pharmaceutical advertising for alerting her to the benefits of Ambien CR which has greatly improved her sleep quality. Also, Tyler Cowen takes a look at a paper comparing the efficacy of health care in different nations to extend life expectancies. Also, Alex Tabarrok looks at a paper that finds Consumer Driven Health Care Plans cut costs and improved use of preventative care. Health Savings Accounts with high deductible insurance provide an example of these sorts of plans. Also, this is an interesting paper: How Does The Quality Of Care Compare In Five Countries? Though one really can't usefully compare the US as a single country to other countries because we have people here on very different types of medical plans and living radically different lifestyles. European countries are much smaller and more homogeneous.
Update: Megan points out that in the current competitive market without price regulations the market leads the pharmaceutical companies to innovate. Click thru and read the whole thing. Our lives are at stake.
As for the second question, this is where I realize that liberals often really just do not grok what libertarians are about. For them, this is a battle between people who like health care companies, and want to defend them, and people who like the government. But I don't care about the pharmaceutical companies qua pharmaceutical companies. The pharmaceutical companies are interested in what is good for pharmaceutical companies. I am interest in what is good for society.
I am not under the delusion that those are necessarily the same thing. "What's good for General Motors is good for America" was a Great Society slogan, not a libertarian, or even a conservative one. Right now, pharmaceutical companies spend a great deal of effort on innovation because they have to in order to survive. But if survival means ditching the R&D labs and churning out low-cost copies of things they've already invented, then I'm pretty sure that's what they'll do. To paraphrase Adam Smith, it is not to the benevolence of pharma that I look, but to its self interest. In the current system, that self interest means inventing new drugs.
In other words, I'm not in favor of business. I'm in favor of competition.
As Megan points out, a larger role for government will lead to pressures to cap prices which will kill innovation. No way are university labs going to compensate for reduced incentives in the private sector.
Update II: If you think that most drugs come from academic research read Derek Lowe who explains the central role of pharmaceutical companies in drug development. Without big pharma we'd see far fewer new drugs.
The persistent confusion over what's done in industry and what's done in academia has been one of my biggest lessons from running this blog. The topic just will not die. A few years ago, I ended up writing a long post on what exactly drug companies do in response to the "NIH discovers all the drugs" crowd, with several follow-ups (here, here, and here). But overall, Hercules had an easier time with the Hydra.
Now, there is drug discovery in academia (ask Dennis Liotta!), although not enough of it to run an industry. Lyrica is an example of a compound that came right out of the university labs, although it certainly had an interesting road to the market. And the topic of academic drug research has come up around here many times over the last few years. So I don't want to act as if there's no contribution at all past basic research in academia, because that's not true at all. But neither is it the case that pharma just swoops in, picks up the wonder drugs, and decides what color the package should be.
Since drug approval rates are declining the drug industry already faces a serious economic problem that should concern us all. If drug approval rates do not pick up then as existing drugs go off patent the amount of money available for drug development is going to decline.
Aside: why are drug approvals on the decline? I wonder if we've reached a point of declining returns on classical chemical compound drugs. Most of what we need to do to fix our bodies requires gene therapy, cell therapy, and nanomachines that all can carry out far more complex tasks than chemical compounds can do. Until these more advanced approaches become mature enough to move into widescale usage we might be looking at a down period for patented drug sales and drug development.
WASHINGTON — For years, Senator Arlen Specter of Pennsylvania has been the National Institutes of Health’s most ardent champion on Capitol Hill. Having survived two bouts with cancer, open-heart surgery and even a faulty diagnosis of Lou Gehrig’s disease, he has long insisted that research that results in medical cures is the best service that government can provide.
But even lobbyists are stunned by the coup Mr. Specter pulled off this week. In return for providing one of only three Republican votes in the Senate for the Obama administration’s $787 billion economic stimulus package, he was able to secure a 34 percent increase in the health agency’s budget — to $39 billion from $29 billion.
Specter made a good deal. The medical research spending will speed the rate of advance in our understanding of the causes of diseases. The fiscal stimulus bill was going to pass anyway. He made sure it accomplished at least one constructive result.
We are all getting older every day. The faster medical research moves forward the sooner we will reach the day when we can start turning back the clock on our bodies and gradually make ourselves young again.
I suspect such a large single year increase in NIH funding will have the effect of getting approval for more risky and less mainstream grant proposals. This might let some less conventional approaches get investigated and perhaps open up some fruitful lines of research.
Obviously analysis of medical records for millions of people can not substitute for randomized trials for new treatments that are not yet in use. However, some UPenn researchers claim they have demonstrated that at least in some cases different treatments can be compared by examining computerized medical records.
PHILADELPHIA – For years controversy has surrounded whether electronic medical records (EMR) would lead to increased patient safety, cut medical errors, and reduce healthcare costs. Now, researchers at the University of Pennsylvania School of Medicine have discovered a way to get another bonus from the implementation of electronic medical records: testing the efficacy of treatments for disease.
Often illnesses have multiple potential treatments. In many cases the best treatment is not known. But randomized medical trials are expensive and pose ethical problems as well. If we only had more electronic data about courses of treatment and outcomes in theory it might be possible to tease out of the data which sorts of treatment work best for different categories of patients.
An obvious bias with medical records is that doctors likely used characteristics of patients in determining which treatment to give them. But as the sum total of all research-accessible medical records covers an increasing length of time even that problem is surmountable by comparing records from time periods before and after treatments came into widespread use. Also, countries, regions, and individual doctors differ in terms of preferred treatments. These preferences on the part of individual doctors serve to partially randomize patient treatment choices.
What is surprising to me is that this press release claims that their use of electronic medical record (EMR) databases in this manner is a first of its kind. Is that true?
In the first study of its kind, Richard Tannen, M.D., Professor of Medicine at the University of Pennsylvania School of Medicine, led a team of researchers to find out if patient data, as captured by EMR databases, could be used to obtain vital information as effectively as randomized clinical trials, when evaluating drug therapies. The study appeared online last week in the British Medical Journal.
“Our findings show that if you do studies using EMR databases and you conduct analyses using new biostatistical methods we developed, we get results that are valid,” Tannen says. “That’s the real message of our paper — this can work.”
I expect medical records to become much more useful due to several factors: 1) longer numbers of years tracked for each person; 2) More medical tests per person; 3) eventually detailed DNA sequencing per person; and 4) eventually home sensors will continually collect information about each person from sinks, toilets, cameras, and even sensors on bedstands that'll monitor breathing and other biosigns. Adverse drug reactions will be compared against DNA sequencing results. Bedstand monitors will catch early signs of sleep apnea and insomnia.
While I view most fiscal stimulus program elements as wastes the plan to boost electronic medical records collection will pay back with higher quality care and an acceleration of the rate of advance of biomedical research.
In January 2009, President Barack Obama unveiled plans to implement electronic medical records nationwide within five years, arguing that such a plan was crucial in the fight against rising health care costs. Of the nearly $900 billion in Obama’s planned stimulus package currently before the United States Senate, $20 billion is proposed for electronic health records.
Once we get home medical sensors and medical sensors embedded in our bodies the business model for medical care will change drastically. Rather than going into a doctor to describe your symptoms so that the doc can order tests the continual streams of sensor readings will flow into expert systems running on web servers. If you start feeling ill you'll be able to call up a web page where you can describe your symptoms. The system might recommend a sensor pill to swallow or that you spit into a home microfluidic sensor device to collect more information. Then you'll get referred by the expert system software to a doctor for treatment.
A couple of articles in the New York Times draw attention to business models in medicine that slow the rate of improvement in medical service delivery.
Two main causes of the system’s ills are century-old business models, for the general hospital and the physician’s practice, both of which are based on treating illness, not promoting wellness. Hospitals and doctors are paid by insurers and the government for the health care equivalent of piecework: hospitals profit from full beds and doctors profit from repeat visits. There is no financial incentive to keep patients healthy.
“The business models were all created decades ago, and acute disease drove those costs at the time,” says Steve Wunker, a senior partner at the consulting firm Innosight. “Most businesses in this industry are looking at their business model as entirely immutable. They’re looking for innovative offerings that fit this frozen model.”
Why have old business models lasted so long in medicine? It seems hard to price wellness maintenance as compared to pricing procedures and consultations. How to incentivize individual doctors to keep patients healthy? It is a lot easier to say it is a worthy goal than to describe a system for doing it that would work financially. Anyone have suggestions along these lines?
I would like to see far more automation of diagnosis. This requires wider spread use of electronic medical records so that the data which medical expert systems need will exist in electronic form. It also requires an economic model for medical care that provides incentives for automation. Medical expert systems can make better diagnostic decisions because the huge and growing quantity of medical test results and the large number of diseases and treatments really test the limits of the human mind to process all that information. Medical expert systems can free up smart doctors to do more original creative work such as medical research and product development.
Most doctors in private practice still do not use electronic medical records systems, making them outliers in a world where a very large fraction of all high information work is done using electronic information systems. Digital medical records make the discovery of better medical practices possible.
The Marshfield Clinic, a large doctors’ group in Wisconsin, shows that computerized records can indeed improve the quality and efficiency of medicine. Yet the Marshfield experience suggests that the digital record becomes truly useful only when patient information is mined to find patterns and answer questions: What treatments work best for particular categories of patients? What practices or procedures yield the best outcome?
This group of doctors have used their medical software system to help cut total costs by allowing them to manage diabetic care more efficiently.
From mid-2004 through the third quarter of this year, the percentage of the clinic’s diabetic patients with blood cholesterol at or below the recommended level rose to 61 percent, from 40 percent earlier. The percentage with satisfactory blood pressure increased to 52 percent, up from 32 percent.
Over the same span, hospital admissions among Marshfield’s diabetic population fell — to 311 per 1,000 patients a year, from 360. Because a hospital stay for a diabetes patient ranges from $8,000 to $22,500, according to national statistics, Marshfield’s results translate into an annual cost saving of $7.3 million to $20.5 million.
But for the average private practice a reduction in the hospitalization rate of patients isn't going to boost revenues. The money saved probably all flows to insurers. The system lacks incentives for most medical providers to go after these forms of savings and care improvement.
A medical marketplace which rewards use of expert systems, electric patient records, and reduction of total costs by use of more effective and productive methods of purveying treatments is what we need. How do we get there?
A study published this week in the Archives of Internal Medicine suggests that broad adoption of IT systems may provide significant health benefits for patients. Researchers at the Johns Hopkins University School of Medicine, in Baltimore, rated clinical information technologies at 41 hospitals in Texas and compared those results with discharge information for more than 160,000 patients. Technologies recorded included electronic note taking, treatment records, test results, drugs orders, and decision-support systems that offer information concerning treatment options and drug interactions. The researchers found that hospitals that rated highly on automated note taking had a 15 percent decrease in the odds that a patient would die while hospitalized. Hospitals with highly rated decision-support systems also had 20 percent lower complication rates. Researchers found that electronic systems reduced costs by about $100 to $500 per admission.
The US Food and Drug Administration (FDA) and similar agencies in other industrialized countries get politically punished more for approving drugs that turn out to have unexpected side effects. At the same time they few rewards for taking risks to approve drugs that might turn out to deliver large benefits. The willingness of politicians to criticize the FDA when drugs turn out to cause unexpected harm probably plays a role in a very large reduction in the rate at which the FDA approves drugs.
Why do terminally ill patients have to wait so long to get access to the only treatments that hold any promise of saving their lives? And why is it not their right to decide?
The problem has been magnified in recent years as the number of new drug approvals has fallen dramatically. The FDA approved just 16 new drugs last year, and is on pace to approve only 18 this year. That's down from a high of 53 in 1996 and 39 in 1997.
After a few high-profile drug scares, such as the 2004 withdrawal of Vioxx from the market, FDA officials have become gun-shy about approving new products. After all, the agency receives scathing criticism from Congress and the press when an approved drug turns out to be more risky than expected -- but rarely for keeping beneficial ones off the market.
This trend does not bode well for the development of rejuvenation therapies. The FDA will hold off approval of an anti-cancer drug for people who have a fatal disease. Never mind that people who have a fatal disease are going to die anyway. The FDA won't let people take a risk when they have little to lose. That makes no sense to me.
Rejuvenation therapies are going to treat that fatal disease called aging. Absent those therapies we are all going to die from complications of aging. Weakened immune systems will allow cancer cells to grow and spread. Weakened hearts and clogged arteries will lead to heart attacks and strokes. Aged brains and probably aged immune systems will allow junk to accumulate in our brains leading to neural cell death and eventual death from Alzheimer's or other brain diseases.
Faced with rising risks of death combined with increasing pain and disablement people should be given wider latitude to try new and unproven therapies. Once diagnosed with terminal illnesses people should be freed from government mandated restrictions on available therapies.
Here's another example of how better medical treatments could save time, boost incomes, boost economic output, and raise quality of life. The costs of raising kids with developmental defects is very high and if we could only avoid these defects in babies we would gain a great benefit.
New research suggests that the average household with children with autism not only spends thousands of dollars toward educational, behavioral and health care expenses each year, but also suffers from a lesser-known cost that hits them up front – a sizeable chunk of missed household income, perhaps as much as $6,200 annually.
The study, published in April’s edition of Pediatrics, paints a more detailed financial picture of how expensive life can become for parents of children with an autism spectrum disorder.
“To our knowledge, this is the first U.S. study that examines this front half of the ‘money in, money out’ equation,” said economist Guillermo Montes, Ph.D., the study’s lead author and a senior researcher at the Children’s Institute, a not-for-profit organization affiliated with the University of Rochester, where he also serves as a faculty member in the division of General Pediatrics. “To collect data on expenses is fairly straightforward– it’s a survey report. But projecting earning potential and then stacking that against actual income requires complex statistical modeling.”
The study is based on data from the National Household Education Survey on After School Programs and Activities in 2005, a telephone questionnaire that drew on parents of more than 11,000 children, kindergarten-age through eighth grade. Parents reported if their child had an autism spectrum disorder, or ASD (that is, if he or she had ever been diagnosed with autism or a pervasive developmental disorder), their total household income and their highest level of education. Several other demographic details were collected, including the parent’s age, type of family (two parent or otherwise) and whether they lived in an urban or rural locale.
The economic benefits of medical research are very high and I think medical research is underappreciated for its benefits. Costs of health problems of mind and body show up in lots more ways than just high medical bills or inability of a sick person to go to work. Families pay big tolls when a child has major disabilities.
The federal Office for Human Research Protections has ruled that it is perfectly fine for hospitals to use checklists to remind doctors and nurses to wash their hands and follow other sanitary procedures — provided the goal is to improve the quality of care given to patients. But if those hospitals want to analyze what impact the checklists might have in reducing infections, that counts as research and they must first seek approval from institutional review boards.
So if no checklists are used that is okay. Or if checklists are always used that is okay. But don't dare try to run a comparison between using and not using checklists with data collected to compare the results. That's experimentation and that isn't allowed without going thru a bureaucratic process.
Japanese manufacturers made huge strides in quality by making lots of changes in their processes aimed at eliminating sources of error and defects. This philosophy of continuous improvement works best when the obstacles to changes are few and where the consequences of changes can be measured. A deep embrace of this approach would do wonders for improving the quality of medical care - quality improvements that are sorely needed both for patient health and to control costs.
A patient’s positive or negative emotional state has no direct or indirect effect on cancer survival or disease progression, according to a large scale new study. Published in the December 1, 2007 issue of CANCER, a peer-reviewed journal of the American Cancer Society, the study found that emotional well-being was not an independent factor affecting the prognosis of head and neck cancers.
We need immune therapies and gene therapies against cancer. We need more science and more biotechnology. Wishful thinking won't cut it.
A new study finds that survival for elderly patients with lung cancer has changed little despite large increases in healthcare expenditures for lung cancer treatment. The study by Harvard University, National Cancer Institute, and National Bureau of Economic Research researchers, published in the December 1, 2007 issue of CANCER, a peer-reviewed journal of the American Cancer Society, finds that average life-expectancy rose by less than one month between 1983 and 1997, while costs rose by over $20,000 per patient.
But the study period ended in 1997. The bigger effects of the money come in the longer term.
Lung cancer remains the top cause of cancer death in the United States, with an estimated 160,390 deaths expected to occur in 2007.
The U.S. spends more than five billion dollars a year on detection, determining the disease severity, and treatment of lung cancer. This is a significant increase over the last few decades, mirroring similar increases in general healthcare spending over the same period.
But throwing lots of money at treatments has one really beneficial effect: The lure of that money encourages drug companies and venture capitalists to spend money to develop newer and better treatments. Big markets attract new players. In a way it is disappointing that only $5 billion a year spent on lung cancer in the United States. All else equal I'd rather that the venture capitalists would see lung cancer as a $25 billion a year market. Fortunately the other forms of cancer also cost billions to treat. So we are probably looking at tens of billions a year spent on all forms of cancer. Lots of money for drug companies and VCs to chase.
The Bush Administration proposed fiscal year 2008 budget for the National Institutes of Health will once again lag behind the rate of inflation and cause an inflation-adjusted cut on US federal biomedical research funding.
Meanwhile, funding for the National Institutes of Health, which oversees medical research, would rise nearly 2 percent to about $28.7 billion.
Biomedical research funding will deliver more benefit per dollar spent than any other form of government spending. Eventually this research is going to lead to the reversal of aging and the end of death from aging.
In inflation adjusted dollars US federal government funding of all research peaked in 2003 and has been declining since then.
Bush's budget is 4.2% bigger than last year's. He raises defense spending by more than 10%. Spending on veterans and foreign aid soars by double digits. There's more money for programs ranging from Pell college grants to national parks.
Defense and homeland security will get $658 billion or about 22 times as much as the NIH budget for biomedical research. Just the increase in defense and war spending will amount to about twice as much as the total NIH budget. I do not feel better defended and better served by that defense and war spending increase. I figure it will result in a much lower average life expectancy than we'd get if the money was spent on medical research. Worse, the war spending creates big figure costs such as maimed soldiers who'll earn less and need government programs to help care for them.
The total war budget of $163 billion, sought in the 2007 fiscal year, is projected to be $141 billion in 2008 and just $50 billion in 2009, far enough in the future that the estimate is little more than a place holder.
Think about that. Pull the troops out of Iraq and free up money to increase biomedical research by a factor of 5. The war does nothing to make us safer and probably has a net negative effect on our security. We could instead spend money on research that'll cure all the diseases we are going to get as we age. Eventually the money will produce biotechnologies that allow us to rejuvenate our bodies.
Funding for biomedical research, which has been flat for several years, may now begin to grow. The House proposal would give NIH a 2% increase this year, adding $620 million to the current budget of $28.6 billion. The austerity since 2003 has taken a toll, NIH officials say, as inflation significantly eroded NIH's buying power and reduced the number of new and competing grant awards from 10,300 to fewer than 9100.
The percentage of grant proposals funded has been dropping. Scientific and technological knowledge, once discovered, delivers us benefits year after year into the future. The sooner we get the knowledge the more total benefit we'll get from that knowledge. We spend less than 1 percent of the US federal budget on biomedical research. That's a mistake. We could derive greater benefit from a much bigger effort.
A Plos Medicine article reviews the sources of cancer funding in the European Union and the United States and finds Europe is greatly lagging in per capita spending in cancer research from funding sources which are not for-profit businesses. The US federal government's National Cancer Institute alone (not the only source of cancer research funding at the federal level) spends more than two and a half times the total spent by all non-commercial sources for cancer research in Europe.
In our survey, we identified 139 noncommercial funding organisations that collectively spent 1.43 billion on cancer research for the year spanning 2002–2003. Absolute spending in 2002/2003 on cancer research varied widely across the EU, ranging from 388 million in the United Kingdom to 0 in Malta, with three countries spending greater than 100 million, nine greater than 10 million, and ten less than 1 million. Of all the countries in the survey, only Bulgaria failed to report their spending, and only Malta spent nothing on cancer research in 2002/2003 (Figure 1).
In Euros the 3.6 billion for the US National Cancer Institute is more than two and a half times the 1.43 spent by all European noncommercial sources.
The EU spends a greater proportion of its cancer research funding on cancer biology than does the US (41% compared with 25%). The US spends a greater proportion of its cancer research funding on research into prevention and treatment than does the EU (prevention, 9% in the US compared with 4% in the EU; treatment, 25% in the US compared with 20% in the EU) (Figure 2). Data published by the US National Cancer Institute has been fully validated, whereas the EU uses self-reported, top-level CSO categories for 62% (n = 74) of the organisations from which financial data was obtained. The size of the two pie charts in Figure 2 is representative of the sizes of the annual budgets: in 2002/2003, the US National Cancer Institute spent 3.60 billion, compared with the EU spending of 1.43 billion.
But wait, the gap is even bigger.
The average per capita spent across the entire EU (including European Commission and Trans-European Organisation spending) was 2.56 (US$3.30), while the per capita spent in the US was 17.63 (US$22.76)—seven times greater. This gap is reduced to 5-fold if the US spending is compared with the spending of the 15 EU countries only (Figure 5). Average cancer research spending as a percentage of GDP across the EU was 0.0152%, and the median was 0.0056%. As a percentage of GDP, the US spent four times as much as the average across the entire European survey; this difference remained the same when the US percentage was compared with the percentage spending by the 15 EU member states.
I would be happy to see Europe try to seriously compete with the United States in biomedical science funding. I would be happy to see Europe act more pro-life and anti-death and less lame and pathetic. We would all benefit if the European countries tried as hard as America to conquer cancer and a large variety of other old age killers. Do I even need to mention that the general advances in biomedical science and technology that come from research on diseases of old age will inevitably produce biotechnologies we need for rejuvenation therapies?
In his entry in his "Scream this from the rooftops" series Alex Tabarrok came across a research paper with evidnce that European drug price controls are causing Europeans to produce far less commercially funded medical advances as well.
EU countries closely regulate pharmaceutical prices whereas the U.S. does not. This paper shows how price constraints affect the profitability, stock returns, and R&D spending of EU and U.S. firms. Compared to EU firms, U.S. firms are more profitable, earn higher stock returns, and spend more on research and development (R&D). Some differences have increased over time. In 1986, EU pharmaceutical R&D exceeded U.S. R&D by about 24 percent, but by 2004, EU R&D trailed U.S. R&D by about 15 percent. During these 19 years, U.S. R&D spending grew at a real annual compound rate of 8.8 percent, while EU R&D spending grew at a real 5.4 percent rate. Results show that EU consumers enjoyed much lower pharmaceutical price inflation, however, at a cost of 46 fewer new medicines introduced by EU firms and 1680 fewer EU research jobs.
Europeans, like most of the rest of the world, are freeloading off of US medical research funded by our federal government, states, private foundations, and private sector companies. We would all benefit if they stepped up to the plate and spent on medical research as much as Americans do.
While many complain about the continuing rise of health care costs which far exceeds the overall rate of inflation, in a New York Times op-ed piece Marginal Revolution blogger and economist Tyler Cowen argues high US health care costs accelerate the rate of medical research and development and saves many lives in the longer run.
But the American health care system may be performing better than it seems at first glance. When it comes to medical innovation, the United States is the world leader. In the last 10 years, for instance, 12 Nobel Prizes in medicine have gone to American-born scientists working in the United States, 3 have gone to foreign-born scientists working in the United States, and just 7 have gone to researchers outside the country.
Tyler says European-style government cost controls would save money in the short run but slow innovation and therefore shorten lives and cost more in the long run. I agree.
Europeans fund a small fraction of the medical research that Americans fund.
In real terms, spending on American biomedical research has doubled since 1994. By 2003, spending was up to $94.3 billion (there is no comparable number for Europe), with 57 percent of that coming from private industry. The National Institutes of Health’s current annual research budget is $28 billion, All European Union governments, in contrast, spent $3.7 billion in 2000, and since that time, Europe has not narrowed the research and development gap. America spends more on research and development over all and on drugs in particular, even though the United States has a smaller population than the core European Union countries. From 1989 to 2002, four times as much money was invested in private biotechnology companies in America than in Europe.
Dr. Thomas Boehm of Jerini, a biomedical research company in Berlin, titled his article in The Journal of Medical Marketing in 2005 “How Can We Explain the American Dominance in Biomedical Research and Development?” (ostina.org/downloads/pdfs/bridgesvol7_BoehmArticle.pdf) Dr. Boehm argues that the research environment in the United States, compared with Europe, is wealthier, more competitive, more meritocratic and more tolerant of waste and chaos. He argues that these features lead to more medical discoveries. About 400,000 European researchers are living in the United States, usually for superior financial compensation and research facilities.
Americans do not live longer than people in other countries in part because the innovations that get funded in America get used around the world. In Canada and some European countries drugs are sold for lower prices than in the US. So drug companies make most of their profits and therefore get most of their revenue to fund research by selling products in the United States. Effectively the United States is subsidizing medical research for the rest of the world.
What I'd like to see: Policies should be aimed at automating the delivery of care. The large armies of nurses, technicians, office workers, and other deliverers of health care rarely innovate. Automation of their work would increase the rate of innovation by freeing up money and labor to do more research and development.
The problem we have is that the high price of medical care funds both innovation and waste. The number of dollars that goes to innovation is relatively small as compared to the dollars that go to delivering care using existing technology with lots of labor. High prices of drugs provide an incentive for drug companies to develop new drugs and other better treatments. But high costs for labor do not provide as much of an equivalent incentive to innovate to improve medical industry labor productivity. The demand for medical care is too inelastic due to the ways medical care is paid for.
I'd like to see much larger budgets for government-funded medical research. Currently the US federal and state governments are increasing their medical care spending faster than the rate of inflation while increasing medical research spending is growing more slowly than the rate of inflation (one of the unappreciated costs of the very expensive Iraq war btw). 18 out of 19 NIH institutes were proposed for budget cuts for fiscal year 2007. Note that if their budgets were maintained at the same level of nominal dollars they'd get cut about 3% due to inflation. This is exactly the wrong direction. The $2 billion per week burn rate of the Iraq war would more than quadruple federal research spending if the war was ended and the money shifted to research. That would save many lives.
Government funded research spending is a small fraction of government funded health care. Medicaid alone was projected at $338 billion in costs for 2006. Add in Medicare which is projected to be $450 billion in fiscal year 2007 and the total cost of just those two health programs (i.e. not including costs of federal employee health insurance, VA hospitals, etc) is about $800 billion. That's about 27 times the amount spent on federally funded medical research and the ratio is rising.
Right now, one of the reasons why we have a long-term fiscal problem is that health care costs, themselves, are projected to grow way above the rate of inflation. We're projecting Medicare costs will grow out over the course of the budget window about 9 percent per year.
This points to a problem in Tyler's analysis: Yes, huge medical funding has accelerated medical research, past tense. But the costs are getting so huge that cost controls are getting placed on medical expenditures and those cost controls will cut into the profits for new drugs and treatments far more than they cut into care delivered with existing technology. At the same time, government funding of research is dropping. We are therefore at risk of a gradual decrease in both public and private funding of medical research and development.
Seems to me we need policies that will make research and development a rising fraction of total money spent on health care. One idea: Make NIH spending a fixed percentage of Medicare spending. When Medicare spending rises 9% then the far smaller NIH spending should rise as well. How about making NIH spending 10% of Medicare spending?
Another suggestion: How about big prizes for achievements that increase labor productivity in health care? For example, how about a multimillion dollar prize for the first surgical team that removes 10 gall bladders in a record setting time and then another prize for the next time that bests the previous record time? Also, how about multimillion dollar prizes for the first totally robotic surgery for each of several popular types of surgery? $10 million and $20 million dollar prizes are very small potatoes compared to the trillions spent on health care. But the innovations that the prizes would spur would pay back in the tens and hundreds of billions of dollars.
St. Paul, MN -- With projected costs of ischemic stroke in the United States expected to top $2.2 trillion dollars by 2050, the American Academy of Neurology (AAN) is urging Congress to further increase funding for the National Institutes of Health (NIH).
This estimate is probably a big overestimate because of the advances in biomedical technology that will occur between now and 2050. Stem cells therapies will start doing artery repairs certainly by 2025 and probably sooner. Also, drugs will come on the market that raise cardiovascular health improving HDL cholesterol and will work synergistically with drugs that lower the harmful types of cholesterol. Also, drugs that target different ways to lower general cholesterol will come on the market as well. Plus, gene therapies and drugs that improve vein and artery health by rejuvenating stem cells and other vascular cells will also make it onto the market by the 2020s.
Having said all that, this report in Neurology still serves the useful purpose of pointing out just how expensive each of the major diseases are in a single affluent country. The international costs are of course much higher. The size of these costs argue for greater efforts to develop treatments that will prevent stroke as well as other diseases. Each disease case avoided amounts to a large economic cost avoided as well as an increase in life expectancy and health.
A study published August 16, 2006 in the online edition of Neurology, the scientific journal of the AAN, found the total cost of stroke from 2005-2050, in 2005 dollars, is projected to be $1.52 trillion for non-Hispanic whites, $379 billion for African Americans and $313 billion for Hispanics.
"With the cost of stroke reaching $2.2 trillion, it is essential the NIH have the resources to halt this impending epidemic," said Catherine M. Rydell, CEO and Executive Director of the AAN. "The NIH has the ability to perform the research that can save countless lives and billions of dollars in health care costs if Congress would adequately fund its mission. The AAN will continue to work with our partners at the American Stroke Association, a division of the American Heart Association, and others to stress to Congress the importance of funding NIH."
The AAN is strongly supporting a budget increase of five percent, or $1.4 billion, to bring overall funding for the NIH FY-07 budget appropriation to $30 billion.
The researchers claim that rising rates of obesity and diabetes might cause an increase in the rate of stroke. This argument is plausible in the short to medium term.
"Doing the right thing now ultimately could be cost-saving in the future, but we have a long way to go before all Americans receive adequate stroke prevention and emergency stroke care," she says. "If our society is not going to do it for the right reasons, perhaps we can do it because it's going to be obscenely expensive."
Brown and her colleagues say their $2.2 trillion estimate is extremely conservative, because it is based on current rates of the conditions that put people at higher risk of stroke -- such as diabetes, cardiovascular disease and obesity. Such conditions are projected to become even more common in the future.
The $2.2 trillion estimate includes the cost of everything from ambulances and hospital stays to medications, nursing home care, at-home care and doctor's visits. They also include lost earnings for stroke survivors under age 65, based on current median salaries for each ethnic group. Earnings of those over 65 weren't included.
The aging of Western populations will force raises in retirement ages. Earnings losses from stroke therefore are probably underestimated by their assumption of only counting people under 65 as workers.
What can Americans do to decrease this looming bill? No matter what their age or ethnicity, individuals can cut their own risk of a future stroke by quitting smoking, losing weight, eating healthily, exercising, and keeping their blood pressure, cholesterol levels and any heart-rhythm problems under control, says Brown.
Meanwhile, doctors and hospitals can do a better job of providing preventive care and screening to patients with high blood pressure, clogged arteries and heart-rhythm problems. And, they can improve their use of a post-stroke drug called tPA.
We should strive to eat healthy diets. But we should also press for acceleration of the development of stem cell therapies, gene therapies, microfluidics, and other avenues of research that will lead to enormously more powerful therapies. We need rejuvenation therapies based on Strategies for Engineered Negligible Senescence (SENS). SENS therapies will make stroke and heart attacks extremely rare.
The economic pay-off of medical research will be enormous when cures for cancer are developed. A couple of academic researchers claim that a cure for cancer would have an economic value of $50 trillion for Americans alone. Add in the value of the cure to other industrialized societies that the total value of the cure likely exceeds $100 trillion.
A new study, to be published in a forthcoming issue of the Journal of Political Economy, calculates the prospective gains that could be obtained from further progress against major diseases. Kevin M. Murphy and Robert H. Topel, two University of Chicago researchers, estimate that even modest advancements against major diseases would have a significant impact – a 1 percent reduction in mortality from cancer has a value to Americans of nearly $500 billion. A cure for cancer would be worth about $50 trillion.
"We distinguish two types of health improvements – those that extend life and those that raise the quality of life," explain the authors. "As the population grows, as incomes grow, and as the baby-boom generation approaches the primary ages of disease-related death, the social value of improvements in health will continue to rise."
Many critiques of rising medical expenditures focus on life-extending procedures for persons near death. By breaking down net gains by age and gender, Murphy and Topel show that the value of increased longevity far exceeds rising medical expenditures overall. Gains in life expectancy over the last century were worth about $1.2 million per person to the current population, with the largest gains at birth and young age.
"An analysis of the value of health improvements is a first step toward evaluating the social returns to medical research and health-augmenting innovations," write the authors. "Improvements in life expectancy raise willingness to pay for further health improvements by increasing the value of remaining life."
Murphy and Topel also chart individual values resulting from the permanent reduction in mortality in several major diseases – including heart disease, cancer, and diabetes. Overall, reductions in mortality from 1970 to 2000 had an economic value to the U.S. population of $3.2 trillion per year.
In 2005 the US economy produced $12.4 trillon worth of goods and services. So the value of a cancer cure equals over 4 years of US economic output.
The enormous economic value of curative treatments for cancer and similar magnitude economic value for cures for other major killers such as stroke and heart disease mean we can get huge the future returns on investment in public spending for basic biomedical research. This means increased biomedical research funding by governments is pretty easy to justify when viewed in economic terms. Yet in order to fund a war, pork, and other wastes the Bush Administration has sought to cut biomedical research spending in inflation-adjusted terms and even proposed a freeze in nominal dollar terms (which means that real research spending goes down by the rate at which inflation goes up).
The numbers bandied about above understate the coming return on decades of basic biomedical research. Rejuvenation therapies will lengthen working careers and brain rejuvenation will boost productivity for most years worked. Minds which have both youthful vigor and the knowledge and skills accumulated from decades of work will achieve much greater feats and operate at much higher levels of productivity.
Because the rate of advance of research can not be forecasted accurately I think there's a tendency on the part of policy makers and the public to underestimate the future return on biomedical research and in other forms of research as well. Our accumulating body of knowledge is going to reach a critical mass at some point in the next 50 years where the vast majority of diseases become curable and replacement or rejuvenation of worn aged body parts becomes commonplace. We ought try much harder to make that day come sooner.
Medical research will pay off with cures to diseases and eventually full body rejuvenation within the lifetimes of some of us alive right now and yet George W. Bush wants to freeze the NIH budget.
In stark contrast to his initiative for physical sciences [ScienceNOW, 1 February and 3 February], President Bush today proposed a budget freeze for the National Institutes of Health (NIH) in 2007, holding its funding steady at $28.6 billion. The proposal, part of the President's overall budget request to Congress, is drawing concern and even outrage from biomedical research advocacy groups, who worry that NIH is losing ground after its budget was doubled from 1999 to 2003. Now the budget proposal, which curbs domestic discretionary spending while boosting funding for national defense, must wind its way through Congress before being approved in some form later this year.
This is being penny wise and pound foolish. A freeze is really a cut by whatever the rate of inflation turns out to be. So medical research is getting cut 2% or 3%. Yet medical research is, in my opinion, the best value per dollar of government spending.
Under the president's request, the budget of the National Institutes of Health, which doubled from 1998 to 2003, would rise by 0.7 percent, to $28.7 billion next year. That is much less than what would be needed to keep pace with the costs of biomedical research, which are rising more than 3.5 percent a year.
For the National Science Foundation, Mr. Bush will request $5.6 billion in 2006, an increase of 2.4 percent, budget documents show. Mr. Bush requested an increase last year as well, but Congress ended up making a small cut in the agency's budget for this year.
At the Food and Drug Administration, buffeted in recent months by concerns about drug safety, the budget would increase by 4.5 percent, to $1.9 billion.
Aside on the FDA budget increase: What we need are more drugs in the drug pipeline, not more regulation of the drug development process.
The Bush Administration announced almost a year ago that funding of most categories of research was not going to keep up with inflation. The latest announced NIH budget increase for FY 2006 is even smaller than the 2% increase for fiscal year 2005.
The US federal budget is running a large deficit. Cuts have to be made. But medical research is a penny-wise pound-foolish place to cut spending. What we need are better treatments that are more cost-effective. Advances in medical science and in supporting technologies will some day yield treatments that are both much cheaper and much more effective. During transition phases early and less effective treatments cost more than not being able to do anything at all to treat a disease. But more advanced treatments that attack problems at the root level will inevitably cost less.
If we delay efforts to find cheaper and more effective ways to treat diseases then the avoidable cost in the long run of using less effective and more expensive treatments is going to dwarf the sums saved by cuts in medical research.
The Congressional Budget Office estimates that the combined cost of Medicare and Medicaid alone will consume a larger share of the nation’s income in 2050 than the entire federal budget does today. By 2050, the combined cost of Social Security, Medicare, Medicaid, and interest on the national debt will rise to 47 percent of gross domestic product — more than double the level of expected federal revenues at the time. Without reform, all federal spending would eventually go to seniors. Obviously, the system will correct before we reach that point. But how?
The industrialized countries with aging populations are faced with a future of much higher taxes and benefits cuts as well. The unfunded liabilities for the care of old people are literally orders of magnitude larger than the amount spent on medical research. Take that $28.7 billion dollar figure cited above for the NIH research budget. Sound like a large number? The new Bush Administration proposal for the fiscal year 2006 budget is $2.57 trillion dollars for an economy that will be somewhere in the neighborhood of approximately $12.5 trillion per year based on an increase from the fourth quarter of 2004.
Current-dollar GDP -- the market value of the nation's output of goods and services -- increased 5.3 percent, or $152.1 billion, in the fourth quarter to a level of $11,967.0 billion. In the third quarter, current-dollar GDP increased 5.5 percent, or $157.4 billion.
But, barring cuts in entitlements, in 2050 Medicare and Medicaid alone may cost proportionately more than all of the US federal government today. So their costs alone could become be about 2 orders of magnitude more than is currently spent by the US federal government on medical research.
Of course government spending is only one portion of total medical spending. So even if medical entitlements programs are scaled back the portion of total GDP that goes to medical costs could be much higher than it is today.
While projections from current trends yield a bleak financial situation in 2050 it seems reasonable to assume that medical science is going to advance greatly by 2050. Even without higher levels of funding for medical research the rates of advance of biotechnology and biomedical science are likely to produce effective and cheap treatments by 2050. Some of those advances will produce cheaper treatments. Therefore I am less concerned about financial crises brought on by aging populations in the Western industrialized countries in 2050 than I am in the medium term, say 2025. We need to make medical advances come sooner so that we can cut costs, reduce the incidence of degenerative diseases, and increase the number of years people can work before Western countries get caught up in economic stagnation caused by higher taxes.
Here is another financial way to state my basic argument: Western governments have committed themselves to provide enormous quantities of medical care in the coming decades that those governments can not afford to deliver. The political debate on how to handle these commitments tends to center around whether to raise taxes, cut benefits, impose price controls, or inject more market forces into medical care. All four of those responses have either substantial downsides or insufficient upsides or both. Some of the approaches will even make the problem worse while also producing lower living standards. Let us consider each potential response in turn.
First off, taxes can be increased. But taxes raised beyond some point cease to produce a net revenue gain because people will respond to high tax rates by working less. This will slow economic growth and therefore in the long run will reduce the size of the underlying economy available to be tapped to pay for old age benefits. The United States could end up like European countries that have slower economic growth, lower per capita GDPs, higher taxes, and lower labor market participation rates.
Benefits cuts are still not happening in the United States and still seem a distant prospect. In fact, Republican President Bush added a new expensive drugs benefit a couple of years ago. No politician wants to propose benefits cuts and therefore government finances will get worse before cuts become politically feasible. Yet benefits cuts seem inevitable in the 2010s, 2020s, and beyond since the working population will oppose tax increases that are large enough to pay for all promised benefits.
Price controls are really backdoor benefits cuts. Price controls will produce decreases in the quality of service and will produce queues and rationing of the sort seen in Canada and Britain. Price controls also (and most importantly in my view) reduce incentives for development of new treatments by reducing the profits from new treatments. Hence price controls will make the financial crunch even worse by delaying the development of cost effective treatments.
Then there is the injection of more market forces into medicine. I'm all for this and favor health savings accounts for this reason. However, my judgement is that market forces alone can not prevent medical costs from becoming a huge weight on living standards because the public is going to demand governments to pay for medical bills that individuals can not afford. We are therefore politically limited in how much market forces will be allowed. Also, markets transfer the bulk of the benefits of innovation to customers and therefore underreward and underfund innovation. Markets provide even worse incentives for funding the scientific research needed to develop better medical treatments. If the government, as such a huge buyer of medical care, wants to benefit from innovative cost-saving biotechnology then the government will need to fund more research that will enable the development of that biotechnology.
Given that the four major alternatives discussed above have major downsides why not consider science as a potential solution? After all, science will eventually produce solutions that cheaply cure or prevent all the major diseases. The only question is when. Acceleration of the rate of advance could not only reduce the size of future liabilities but could also have the very attractive added benefit allowing us all to get healthier and stay healthier for much longer.
The biggest reason I can see for why medical research isn't taken seriously as a policy tool to solve the problem of unfunded old age medical care entitlements is that it is hard to predict the rate of advance of medicine. If a government wants to build a road across a continent it can get fairly realistic cost and time projections. Then the government can set out to build the road fairly confident that the goal can be accomplished in a time frame and for a cost not too far from original projections. But science by its very nature seems unpredictable. We have been pursuing the development of cancer cures for decades with tens of billions spent to date and still can't cure most cancers.
But the unpredictable nature of science ought to be considered in light of the substantial downsides of all the alternatives. We have a huge problem with aging populations. The problem doesn't get the attention it deserves in part because tallies of numbers of tens of trillions of dollars of liabilities and descriptions of trends in dependency ratios of workers to retirees and children are rather bleak to discuss and depressing to ponder. Debate on the issue easily deteriorates into a partisan battle about the New Deal and the proper role of government. Ideologues are quick to run to take up defensive positions against perceived ideological attacks by the other side, leaving them ill-disposed to think through rational analyses of the problems posed by aging populations. Does the US Social Security old age retirement program face a financial crisis? Perceived (and in some cases real) attacks on its very moral legitimacy prevents the financial problems of Social Security from being discussed rationally in too many cases. Ditto for programs for medical care for the aged. We need to move beyond the ideological sparring and look for better solutions.
Precisely because scientific research takes a long time to produce desired results we need to greatly increase the push to advance biomedical science and biotechnology now. We can't wait until the budget deficits are even larger, taxes are even higher, medical care rationing has become commonplace, the economy is stagnating, and the task of finding money to allocate to research is even more difficult. As things stand now medical treatment spending is going up faster than inflation while medical research spending is going up more slowly than inflation. Medical research spending ought to rise as fast as medical treatment spending rises.
My modest proposal for funding medical research: Change the major medical entitlements programs to require that 10% of all medical entitlements budgets go to fund medical research. Then when medical entitlements spending inevitably goes up medical research spending will go up proportionately. Yes, that will make the financial numbers for the medical entitlements programs look worse in the short run. But the money thereby spent will produce much larger savings for those programs in the longer run and will also produce treatments that will lead to great improvements in the health of the vast majority of people.
The proposed NIH budget would provide $15.5 billion for new (competing) and continuing (non-competing) research project grants, a 0.4% increase of $56 million. This would fund about 38,746 total projects, 402 less than this year. The average new research project grant would be funded at $347,000, about the same amount as in FY 2005.
One question I have: Is the current allocation of money in the NIH between staff researchers and grant-funded researchers optimal? My guess is that less funding for NIH staff and more funding for academic researchers would produce more total research progress. Anyone have any useful insights into this?
Scott Gottlieb M.D., recently departed US Food and Drug Administration (FDA) Director of Medical Policy Development, a practicing physician and fellow at the American Enterprise Institute, argues that the FDA is making cancer drug approval harder and more costly.
Even more concerning, there is also a whiff of caution coming from the agency's cancer division--the Oncology Drug Advisory Committee (ODAC)--where delays on the approval of new drugs can have a dramatic impact on the lives of patients who are suffering from terminal disease.
At a meeting last month, outside advisers to ODAC as well as rank-and-file FDA medical reviewers expressed criticism of the applications they are seeing and a desire to clamp down on the number of cancer drugs qualifying for accelerated approval. Accelerated approval regulations allow the FDA to approve products based on preliminary test results, with the proviso that the company continues with clinical trials after the drug is marketed.
The chair of the FDA's cancer drug advisory committee rejected the idea that cancer drugs should be allowed onto the market if they are reasonably safe and have some degree of effectiveness (known as "efficacy") with the understanding that oncologists will determine their value through routine use of the drug.
Higher costs per drug developed translate into fewer drugs being developed at any one time and fewer new drugs available in the future.
The FDA is moving toward making it harder for a new drug to be approved if it can not be demonstrated to work better than the off-label use of an existing drug.
The other point of contention at the cancer advisory meeting was whether it is appropriate for the FDA to require drugs up for accelerated approval for treatment of a specific kind of terminal cancer to prove that they were superior to other drugs being used off-label to treat the same cancer.
The debate turned on the FDA's consideration of Inex Pharmaceutical's application for accelerated approval of Marqibo vincristine sulfate liposome injection to treat relapsed, aggressive non-Hodgkin's lymphoma (NHL). The FDA noted that no products have been approved for the indication, and suggested that the committee consider whether a number of products that are used off-label for the indication should be considered "available therapy." By suggesting that ODAC consider off-label uses as available therapies, the FDA dramatically raised the bar for approval of Marqibo.
Imagine you have relapsed NHL. Suppose there is an existing drug that works against it for some though not all people. Would you want the FDA to hold another drug off the market that also works for some but not all people? Or do you think you should have the right to choose between the two drugs or even to take both of them?
I believe that once someone has been given a diagnosis of a fatal disease that they should be given the equivalent of a "get out of the FDA drug approval jail free card". In other words, once your days are numbered due to a specific diagnosed disease you should be free to take any experimental therapy and drug and biotech companies should be free to sell you any experimental therapy without the FDA being able to stop them.
A smaller step in the right direction would be to replace the existing membership of the above mentioned Oncology Drug Advisory Committee (ODAC) with a new membership made up of people with diagnosed cancer. There are plenty of scientists, epidemiologists, and medical doctors walking around today with diagnosed cancers. So the committee would not have to lack for expertise. But what it would cease to lack is a great sense of urgency and a sense that patients should be given more choices.
If you are going down the elevator for the final check-out from the big hotel of life why should the government have any power to prevent your trying any therapy imaginable on your way down? Someone close to me is dying from metastatic cancer and I do not understand why the government should have any power at all over what experimental treatments someone such as this person might try. The government can not protect people from death. The government can not regulate death out of existence. But the government can and does impose such costs and obstacles on the drug development process that the rate of development of new drugs is greatly slowed and the date at which various diseases become curable gets pushed much farther into the future than it needs to be.
Last night Charlie Rose conducted a group interview of Robert Klein, campaign chair for the Calfornian Proposition 71 embryonic stem cell funding initiative, Brook Byers, partner at venture capital firm Kleiner Perkins Caufield Byers, and Susan Desmond-Hellman, president of product development for Genentech. The general area of discussion was about biotechnology and medicine. These three interviewees all agreed on one very important point: only innovation can solve the problems caused by high and rising health care costs. It was gratifying to see these figures make an argument that is familar to readers of my blogs. Scientific and technological advances will be the ultimate solutions to the rapidly rising costs of medical care.
The view that innovation is the solution to our health care cost problems is not a new one. The late Lewis Thomas M.D., who was director of the Memorial Sloan-Kettering Cancer Center and the author of many essays on biology, was making that argument decades ago. Later in his life in 1992 Thomas repeated the argument that only scientific advances can produce the treatments that will make the major diseases of our time cheap to treat.
To be sure, we do have some spectacular surgical achievements in the headlines--the transplantation of hearts, kidneys, livers, and the like--but these are what I have called halfway technologies, brought in to shore things up after the still- unexplained diseases of these organs have run their course. And these measures, plus the new advances in diagnostic precision, account for a large part of the escalating costs of health care today. It seems obvious, to me anyway, that the only practical policy for bringing down those costs will be by more and more basic research in biomedical science, in the hope and expectation that we can then begin to understand, at a deep level, the underlying events in human disease. Sooner or later I am confident that this will be accomplished, and I hope for the sooner.
In one of his Lives Of A Cell books (this is an old memory, forget which one, probably Lives Of A Cell: Notes Of A Biology Watcher) published some time in the 1970s Thomas noted that before the advent of effective treatments of tuberculosis the many tuberculosis sanitariums were very expensive to operate. But he pointed out that once effective drugs against TB were developed the vast bulk of the sanitariums were quickly shut down as their patients were quickly and cheaply cured of TB. Thomas contended that expensive treatments are expensive because they fail to fix the underlying causes of diseases and that just about any really effective treatment is going to be pretty cheap. I agreed with him then and decades later I've grown only more confident that he correctly saw the fundamental problem (far more important than tort law, regulations, tax law, government entitlements programs, or market failures) that is the root of high medical costs.
"In my own early professional life when I was an intern on the wards of Boston City Hospital the major threats to human life were tuberculosis, tetanus, syphilis, rheumatic fever, pneumonia, meningitis, polio, septicemia of all sorts. These things worried us then the way cancer, heart disease, and stroke worry us today. The big problems of the 1930s and 1940s have literally vanished."
A few of those diseases have made a come-back of sorts. But all are still problems of much lower orders of magnitude than they were a century ago. But what is most important to note is that when effective treatments were found for them the costs of preventing and treating them became a small fraction of the costs that those diseases previously inflicted on their victims, families of victims, and the rest of society.
Aside: One surprise in the Charlie Rose show discussion came from the venture capitalist Brook Byers. Byers says there are multiple groups in the United States and England that are working on nanoscale-level devices for very rapidly and cheaply sequence whole human genomes. Byers expects this problem to be solved in a few years.
The solution to the problem of cheap DNA testing will lead to much lower costs for drug development. How? Well, one way is that during clinical trials it will be possible to use smaller sets of trial participants to check out which genetic patterns each drug works best and worst with. Also, many drugs are held off of the market because they are too harmful to some subsets of society who have particular genetic sequences. Clinical trial participants who have adverse reactions to new drugs will be able to have their DNA sequences checked to see if genetic causes for the adverse reactions can be identified. Then drugs that would otherwise never be sold to the public can be approved for use with subsets of the population who are genetically compatible with those drugs. We will each have drugs that we can't use due to some genetic variations we each have. But more drugs will be able to make it onto the market than can be approved today.
The ability to quickly identify which genetic sequences make some people have adverse reactions to a given drug or to have much higher responsiveness to a drug (e.g. because their liver doesn't break it down as quickly) will also allow drug developers to more quickly and easily puzzle out the mechanisms by which the drugs vary in how they interact with different people. The knowledge of the genetic variations involved in drug response differences will allow drug developers to build animal models of genetic variations that cause different reactions to drugs and to design drugs that eitehr work with a larger set of genetic variations or to design different drugs for different genetic variations.