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Is the FDA Next on the Hit List?

February 7, 2017

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Donald Trump has vowed to push for deregulation at the Food and Drug Administration, the country’s watchdog for protecting the safety of the food we eat and the medicines we take.  There now, don’t you feel better already?

According to the New York Times, a leading contender as Trump’s pick to head the FDA is Jim O’Neill, a former HHS official during the Bush II administration. O’Neill is a libertarian and associate of billionaire Trump supporter Peter Thiel (who, incidentally, has reportedly bought a big property in New Zealand and acquired kiwi citizenship just in case things don’t go well here).  O’Neill is a managing director of an investment firm founded by Thiel and former director of the Thiel Foundation. He is not a doctor, unlike previous FDA directors. (Two other names being floated are Dr. Scott Gottlieb, a former FDA official with strong ties to pharmaceutical and biotech companies, and Dr. Joseph Gulfo, a former biotech and medical device executive.)

More to the point, according to the Times, O’Neill has advocated what he calls “progressive approval”, meaning that drugs shown to be safe could be FDA-approved for use before they were proven to be effective for whatever they’re being prescribed for. He proposes to prove their efficacy after they’ve been legalized. This would be a major reversal of decades of FDA policy which has usually required large clinical trials on humans to prove that they actually work.

Advocates for this kind of deregulation claim that this would make drugs available to patients much quicker.  But even a layman can see that the major benefit would accrue to the drug manufacturers who could transfer most of the risk and cost of clinical testing to patients taking the drugs and sell a lot of them before the drugs had been proven to actually cure anything.

In fact, the FDA already moves faster than similar regulatory agencies in any other developed country.  In 2015, two-thirds of new drugs were approved first in the US. Moreover, the “21st Century Cures Act”, passed by large bi-partisan majorities and signed by President Obama in December, sped up the approval process for some drugs by easing requirements for the level of evidence when approving a drug that has already been authorized for other diseases.

Studies have shown that although expedited paths to approval are being used more frequently, there is little evidence that most of the drugs being approved in this manner are actually innovative, rather than slight variations on previously approved medicines. According to a number of studies, since the mid-1990s about 85 to 90 percent of new drugs don’t offer any clinical advantages for users. However, they are usually much more expensive than older medicines that do virtually the same thing.

You may have noticed that there are a lot of prescription drug commercials on TV.  In fact, the amount spent by Big Pharma on promotion increased from an average of $3.6 billion in 2011-13 to $5.2 billion in 2015. (The US, by the way, is the only country except New Zealand that allows ads for drugs aimed directly at consumers.)

Big Pharma always cites the high cost of research and development for new drugs to justify the high cost to patients of newer drugs still under patent, but the Washington Post reported in 2015 that 9 out of 10 of the largest drug manufacturers actually spent more on sales and marketing than for R&D. (The exception, Roche, spent roughly equal amounts for each.) Even the American Medical Association has called for a ban on drug advertising directly to consumers. For information about how much gets spent on what, click here.

You might have also seen TV ads for certain drugs and a few minutes later ads soliciting participation in class action suits against exactly the same drugs.  Weird, right? Well, it turns out that Big Pharma firms have made enormous payouts to settle lawsuits for complications from well-advertised drugs, but still made big profits from the sale of the same drugs.  It’s just a cost of doing business.

A few Democratic members of Congress have tried to address some of these issues noting that the FDA and Big Pharma are already too cozy. Elizabeth Warren, for example, denounced the “Cures Act” for providing  “tiny fig leaf of funding” for NIH and opioid abuse as “political cover for huge giveaways to giant drug companies.” The measure authorized only $1.8 billion for the so-called “cancer moonshot”. But these are voices crying out in the wilderness.

Research, development, and approval for prescription drugs is a highly complicated business. But placing the FDA in the hands of a tool of Big Pharma is certainly not the best way to go, even if it is totally in keeping with the rest of Trump’s nominations.

One final observation:  Jim O’Neill has served on the board of the Seasteading Institute, an endeavor supported by Peter Thiel aimed at establishing new nations on interlocked floating vessels in international waters.  Think an endless Carnival cruise, or maybe “Waterworld.”  Or watch this video, and ask yourself if you want this guy in charge of our food and medicine.

 

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