Developing and winning regulatory approval for new medicines can now take as long as it takes to raise a child to adulthood. But, can we make the FDA’s standards flexible enough to allow vital new drugs onto the market in a timely fashion, yet strict enough to protect us from potentially dangerous medicines?

Sidney Wolfe of Public Citizen’s Health Research Group and Kenneth Kaitin, a professor at the Tufts University School of Medicine look at challenges of developing — and approving — new medicines.....

.........The approval process for drugs is heavily tilted toward establishing evidence of benefit, but statistically underpowered to detect all but the most commonly occurring harms. Consequently, a number of new drugs have been withdrawn when dangerous, sometimes fatal, side effects are discovered, often within their first seven years after release. Also, serious new adverse reactions or drug interactions that require stronger warnings are usually detected within the first seven years after a drug’s release.

http://cognoscenti.wbur.org/2013/12/...kenneth-kaitin

Google "Thalidimide"

Or Bextra, Vioxx, Tysabri, Exubera, Avandia, Raptiva and Darvon just to name a few others.

Thalidomide is approved and on the market for certain cancers and leprosy. There's a lesson here somewhere.

there's the regulatory side and then there's the economic side, not going to get into the patent protection games, etc. but wow, drug companies are laying off employees and consolidating like mad and snapping up biotechs that are into cancer treatments, rare diseases etc. because of the money to be made because of the orphan drug act and cancer. something not quite right there.

as far as pd, who would have thought that l-dopa would still be the most effective drug treatment after 40 years? who would have thought that after the success of fetal transplants in the late 20years ago(?) - maybe there were some in the early 2000's? we still would have no disease altering treatment yet, at least 6 with gene therapy or growth factor infusions all having terrific phase1 results and failing in phase2? the more informed we are, logically the better informed we can require our representatives to be, our doctors to be and so on on these issues. so thanks for your posts tupelo3!!

then even with good old dependable carbidopa/levodopa, there are only a few manufacturers and there is always the threat they can play games with supply and demand if the govt ever tries to regulate prices happened in canada and england, not sure if there any CL is manufactured in the U.S. anymore.

hope for the best but plan for the worst, try to have at least a month's worth of drugs on hand, natural disasters happen and there's no govt stockpile of drugs.

the lesson of thalidomide is that the FDA back then might have been slower than the review agencies in europe or the mfg filed for approval later in the U.S., and mfg didn't test the drug in pregnant animals. if it had been a U.S. mfg, the U.S. might have had the thalidomide babies and not the rest of the world. that was a case of gross negligence.
http://blogs.fda.gov/fdavoice/index....ation-matters/

Is the pipeline too slow? In my opinion, yes. There are many reasons for this. One of which is, I believe, that when it comes to PD we are too risk adverse.

The danger of emerging side effects, possibly many years in the future, has got to be weighed against the advantages a therapy gives.

For instance, how would we judge a therapy that removed all Parkinson's symptoms and had no immediate side effects, but unknown to anyone when introduced killed you after 20 years?

Until the 20 years were up it would be thought a wonder drug: no symptoms, no side-effects and no fatalities. Any PwP who delayed more than a year or two would be thought to be acting irrationally.

And, even once the terrible long term consequences of the therapy became known, how many PwP would choose never to take it?

Now suppose the terrible consequence happened not after 20 years, but after 1 year or 2 years, or whatever. What period would it need to be before you started the therapy?

John