August 26, 2010
Drug Success Against Malignant Melanoma
A drug aimed at a genetic mutation common with malignant melanoma reduces tumors in most patients who had the mutation.
An experimental drug designed to block the effects of a genetic mutation often found in patients with malignant melanoma, a deadly cancer with few existing treatments, significantly shrank tumors in about 80 percent of those who carried the mutation.
Click thru and read all the details.
A small percentage of the patients experienced disappearance of tumours. But do not expect it at a doctor's office any time soon.
Further studies are needed before the drug can be approved by the FDA.
I find this infuriating. Once you've been given a death sentence diagnosis and have months to live why should you have to die without being able to try experimental treatments?
Stage IV metastatic variety of melanoma has a 5 year survival rate below 20% and even lower in some cases. Malignant melanoma diagnosis amounts to a check-out notice from the Life Hotel. Such check-out notices ought to entitle you to a "Get out of the FDA jail card" where you get to try experimental treatments.
How about we give the lab rats and rhesus monkeys a break and do medical experiments on FDA bureaucrats instead? It's not as though they'd be missed.
Melanoma is not the third largest cancer killer - here are the numbers for the US (2010 estimated deaths):
1. lung - 157,300
2. colon/rectum - 51,370
3. breast - 40,230
4. pancreas - 36,800
5. prostate - 32,050
6. leukemia - 21,840
7. lymphoma - 21,530
8. liver - 18,910
9. bladder - 14,680
10. esophagus - 14,500
11. ovary - 13,850
12. brain - 13,140
13. kidney - 13,040
14. stomach - 10,570
15. melanoma - 8700
Stage IV melanomas are those 4mm thick or greater. Survival is indeed poor for these lesions. Novel treatments for incurable conditions need to move along faster.
At the moment they just control what drugs come to market. Just wait till the government controls all of healthcare.
Thanks for the correction. I deleted that sentence. I found that claim while digging for info about the post. It seemed odd and I should have double-checked elsewhere.
Perhaps the data you reported was for Queensland or some place like that.
In the US, check with your doctor for "Named Patient" or "Compassionate Use" programs. These may help you get those unapproved products.
Not getting FDA approval doesn't mean doctors can't use the drug. Plenty of people get drugs that haven't yet been approved; if they work often enough and with few enough side effects, they will eventually get approved.
This just means the FDA doesn't know enough about it to put their stamp of approval on it. It is in no way banned; if you're sick and your doctor thinks you need this drug, you can get it if your health insurance will pay.
Seems to me... a simple hack is needed.
How big can you make a case study and how many people can you put in a case study? How about ALL of them?
Ahhh, but who PAYS for this.
second hack, can you pool money similar to what we used to call insurance, but only for experimental case studies? I mean it wouldn't be medical insurance because it only pays for experimental treatments.....
Maybe someday the government will stop treating us like children too immature to decide what goes into our own bodies, and we'll *all* have "Get out of the FDA jail cards."
The FDA and its kindred agencies are not Constitutional. Congress should re-instate the original meaning of the Commerce Clause which only deals with trade between the states - nothing else. The so-called independent agencies also violate the separation of branches by including executive, judical and legislative powers.
Flushing the whole lot would improve your health as well as your wallet.
What is really needed is a legally recognized way to release the Drug companies, FDA and everyone else involved from liability for negative effects, faulty diagnosis, and dying while on the placebo. Secure that and you'll have a right to expect the FDA to move.
The FDA has killed more Americans than any other government agency, and that includes the War and Navy departments. (I won't use the mealy-mouthed "department of defense" euphemism.)
One important reason for FDA caution is that sick patients (and those who love them) will cooperatively spend their life savings on snake oil. Patients and their families need protection from this kind of thing.
Perhaps the FDA could allow more leeway if companies weren't allowed to charge for such experimental drugs?