Imagine for a moment you need a car. You have a certain model in mind. It’s absolutely perfect: price, performance, and features. But the dealer only has one in stock… and it has no windshield.
“Look,” the salesman says, “buy the car today, and we’ll install the windshield as soon as we get one in stock.”
He knocks a point off the interest rate on your loan, throws in free tires for life… and you sign on the dotted line. The car isn’t quite perfect, but how long can it take to get a new windshield?
In our little scenario here, the answer is maybe up to 12 years. Or, worse, there is no windshield… and there never will be.
Welcome to the exciting world of fast-tracked drugs. Where the Food and Drug Administration (FDA) approves drugs before they’re fully proven. With the promise the maker will deliver the proof in a reasonable amount of time.
Except they often don’t. Or provide inadequate proof. Or finally reveal the drug is unsafe or simply doesn’t work.
But don’t worry. It’s only a problem if you – or anyone you know and love – have to take the drug. Then you’re immersed in a giant game of Russian roulette.
What’s going on here?
Fast-Track Is Great in Theory…
Big Pharma puts a lot of effort into developing billion-dollar drugs. Drugs that hit two targets are especially profitable…
- Many people are affected by a health issue, and
- There’s no known cure or especially effective treatment for the condition.
Cystic fibrosis (CF) is a good example. About 10 million Americans carry the defective gene that causes this disease. And tens of thousands of them suffer with CF.
The problem gene causes thick, sticky mucous to build up in organs – with the lungs and digestion most often affected. Medical advances have extended the lives of folks with CF. But just a few years ago; the average life expectancy of someone with CF was 12 years. And those years were miserable.
The FDA developed their fast-track program for diseases like this. A drug company may develop a promising drug for CF… but jumping through the FDA’s normal hoops can take years. Years during which people may be suffering needlessly.
So drugs that show promise early on for diseases in desperate need of an effective treatment can be fast-tracked. The deal being that the drug company has to provide the rest of the proof within a reasonable span of time.
And that’s where the trouble starts.
… but Often Sucks in Practice
Let’s say you’re a Big Pharma executive. Your company developed a CF drug, and the FDA has approved its use via the fast-track process. Now you’re making money hand-over-fist with a rare FDA-approved drug for this awful disease.
Your shareholders are happy. But they still expect another big winner to be in the pipeline. Here’s where fast tracking seems to go wrong. Because once that drug is in play, there’s less incentive to focus on follow-up trials.
A study of cancer drugs approved under the FDA’s fast-track approval process looked at drugs approved between 1992 and 2010. The drugs proved useful for 26 of the 47 “indications” originally approved. But the follow-up studies on these drugs took up to 12.6 years to complete.
Meanwhile, the drugs were found to be useless for 21 – almost half – of their applications.
A researcher in India uncovered weaknesses in the fast-track system from half a world away. But his research was strong enough to be included in the U.S. National Library of Medicine’s files.
This scientist found, “Many drugs that are relatively new to the market [find] their way out as fast as they entered it.”
He found the FDA sometimes approved drugs based on “trivial” data submitted by marketers. He also listed a number of quickly approved drugs that had to be withdrawn for serious side effects.
More Fast-Track Problems Uncovered by Top Experts
If I told you the London School of Economics and Harvard Medical School had a problem with the FDA’s fast-track process, you’d probably take note. These are two of the most trusted academic institutions in the world.
Scientists from these two schools published fast-track concerns in the Journal of the American Medical Association.
The researchers looked at drugs given fast-track approval between 2009 and 2013. And they found some disturbing trends…
- Post-approval studies tended to be small (less reliable)
- Only 42% of post-approval trials showed the drugs were effective
- One-third of the original benefit claims remained unproven after 5 years
Finally, a study published in BMJ – formerly the British Medical Journal. This flagship medical journal published a study from Yale, Harvard, and other leading medical sources. The results weren’t pretty…
Speaking to FDA fast-track approval, the study found “… few controlled studies published after approval that confirmed efficacy using clinical outcomes for the original FDA approved indication.”
In other words, fast-track approval can have little connection to reality.
So, what’s your best option? Probably taking the approach that many in the medical profession do. And that’s to avoid taking any drug that’s been on the market less than 5 years. (Fast-tracked or not.)
Then, there’s at least a fair chance any problems will have already come out.
About the Author: Jason Kennedy is a celebrated investigative health writer and the author of The X-Factor Revolution and Beyond the Blue Zone. With over 10 years of experience working with today’s leading alternative and anti-aging doctors, Jason shares his insider status and access to the latest breakthroughs with thousands of readers from around world.
Johnson, J.R., et al, “Accelerated approval of oncology products: the food and drug administration experience,” J Natl Cancer Inst. Apr 20, 2011; 103(8): 636-644.
Chary, K.V., “Expedited drug review process: Fast, but flawed,” J Pharmacol Pharmacother. Apr-Jun 2016; 7(2): 57–61.
Naci, H., et al, “Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration,” JAMA. Aug 15, 2017; 318(7): 626-636.
Pease, A.M., et al, “Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review,” BMJ. May 3, 2017; 357: j1680.
© Copyright 2017 Discovery Health Publishing, Inc. All Rights Reserved.