Beware of deregulation in drug development

The 21st Century Cures Act passed congress on Dec. 7th and was signed into law on Dec 13th by President Obama.  This is a huge bill with something in it for everyone, and lots to criticize. As a retired researcher who spent nearly 40 years of my life writing research grants mostly to the National Institutes of Health (NIH), I applaud the long overdue increase in funding for the NIH. Funding had steadily decreased in an alarming fashion since sequestration in 2013.  Inflation adjusted loss of funding for the NIH reached 22% in a 2 year period: 2013-15.  But now there is a chance to catch up for these losses, in part because of The 21st Century Cures Act.  It is well documented that reduced federal funding leads to fewer grants, fewer new discoveries and a loss of talented scientists.  I have seen this first hand.  Research scientists and patient advocate groups welcome the prospect of more funding.

However, there is an ugly underbelly to the 21st Century Cures Act.  Perhaps not so well appreciated is the further erosion of the power of the FDA in keeping us safe from drugs that can be harmful, or that are just ineffectual.  It took lots of courage for a young FDA scientist in 1960 to stand up to the powerful drug industry trying to promote a poorly researched drug named thalidomide.  Frances Oldham Kelsey was the FDA scientist who kept thalidomide off the U.S. market and blocked approval for 19 months, thus saving thousands of babies from being born with severe deformities in the US.  In other countries, without a strong FDA, sales and marketing for pregnancy-associated nausea remained unchecked and tens of thousands of severely deformed babies were born resulting in untold suffering across the globe.

In the name of accelerating drug development, the FDA’s authority and the lengthy process of FDA approval have steadily been eroded over the last few decades and the 21st Century Cures Act could come as a fatal blow, especially with a new government bent on deregulating.  Lobbyists from the pharmaceutical and medical device industries and allied patient advocacy organizations are touting predicted miracle breakthroughs based on the law’s aim to weaken regulations and promote rapid drug development.  Most egregious is the use of anecdotal clinical experience as evidence that drugs are safe and effective; allowing antibiotics on the market based on pre-clinical evidence, that is, laboratory or animal studies, with little testing in humans; weakening the already limited evidence needed to approve medical devices (for example a stent for a coronary artery).  Similar concerns have been voiced in several leading medical and science publications (New England Journal of Medicine, JAMA, Science and Nature).

As stated by Michael Carome (Director, Health Research Group, at Public Citizen)  in the LA Times, “If universal praise for a measure makes your B.S. detectors twitch, you’re on the right track. The 21st Century Cures Act is a huge deregulatory giveaway to the pharmaceutical and medical device industry, papered over by new funding for those research initiatives”.  Nothing in this act addresses the main problem the public sees with the drug industry: unaffordable prices.   As stated by Elizabeth Warren “When American voters say Congress is owned by big companies, this bill is exactly what they are talking about”.

Consider Merck’s Vioxx, a painkiller and arthritis drug that the FDA approved in 1999. Vioxx was taken off the market in 2004 after it was shown to raise the risk of heart attacks. By then, 88,000 Americans had heart attacks while taking Vioxx, 38,000 of them fatal.

Personally, I will be a lot more averse to taking a new medication that has not stood the test of time!  And this is what I would recommend to my patients.

David Posnett MD

Sources:

1)    http://faseb.org/Science-Policy-and-Advocacy/Federal-Funding-Data/NIH-Research-Funding-Trends.aspx

2)    https://www.congress.gov/bill/114th-congress/house-bill/6

3)    Mike Debonis, Washington Post https://www.washingtonpost.com/news/powerpost/wp/2016/12/07/congress-passes-21st-century-cures-act-boosting-research-and-easing-drug-approvals/

4)    Michael Hiltzik, LA Times: http://www.latimes.com/business/hiltzik/la-fi-hiltzik-21st-century-20161205-story.html

5)   Gregg Gonsalves et al. The Hill   http://thehill.com/blogs/congress-blog/healthcare/307020-lawmakers-must-ask-tough-questions-about-the-21st-century

6)  Dark Remedy by Trent Stephens

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About D. Posnett MD

Emeritus Prof. of Medicine at Weill Cornell Medical College
This entry was posted in Health Care. Bookmark the permalink.

3 Responses to Beware of deregulation in drug development

  1. John Hooker says:

    This addresses an important issue: the price of drugs in the US. It shouldn’t be up to the press to raise awareness of the abuses that have occurred recently regarding, for example, the price hikes of Epipen. There are many other abuses that go unreported. This has to change. There are intelligent ways to control pharmaceutical prices – without affecting funding for research, be that private or public, which is the relentless argument against price controls that the pharmaceutical industry flags any time the issue comes up.

  2. Excellent point. Western European countries control pharma prices. So could we.

  3. Pingback: Another Trump attack on the FDA | Resist and Replace

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