High anxiety at FDA over leadership, faster drug and medical device oversight

http://www.protectpatientsblog.com/wp-content/uploads/sites/69/2016/09/Food_and_Drug_Administration_logo.svg_-300x129.pngTo hear some powerful proponents tell it, Uncle Sam needs to really hurry up the government’s approval of drugs and medical devices. He’s got to make oversight over them easier, lighter, and less complex.

But consider just some of the health news in recent days:

What’s the inescapable diagnosis about the federal Food and Drug Administration, specifically, and U.S. oversight, generally, on prescription drugs and medical devices? It’s flawed, and it desperately needs its own care and considerable attention. This is no secret. The recently passed, $6.3 billion 21st Century Cures Act funds and pushes for this reform, perhaps giving too much leeway, I have written, to Big Pharma and big medical device makers.

Off-kilter approach to dire needed change

I’ve also written about the Trump Administration’s off-kilter approach, thus far, to the FDA. With the advice of Peter Thiel, a Silicon Valley entrepreneur, the president has talked with venture capitalists with little deep experience in medical science or health care about heading the FDA. One of the reported finalists for this mission-critical post is a self-avowed libertarian who has said that he knows of no patients who are forced to take a drug or to use a medical device, so, they should do so at their own risk, with little government oversight such as rigorous tests for safety and effectiveness.

The administration, with the help of the majority GOP on the Hill, is slowly filling its top posts. And the anxiety about the FDA’s future and the administration choice to lead it has become palpable among medical and public health experts, as well as leaders in Big Pharma and device makers, too.

The Los Angeles Times, in a Sunday page one story, used the $94,000-a-year cancer drug Tarceva as an example of what can go awry when drugs get raced through a regulatory process. The newspaper says that a 2010 decision by the FDA expanded use of the drug, “despite warnings from a panel of experts who said there was little evidence it actually worked.” As the Los Angeles Times reported:

The FDA’s decision resulted in more harm than the hundreds of millions of dollars wasted on a drug that was ineffective for 90 percent or more of patients.  Over the years, thousands of patients were prescribed a drug that had no chance of helping them but could frequently cause terrible rashes covering their faces and bodies, according to prescription data and adverse event reports. Some patients with the most aggressively growing cancers died before trying other treatments that may have lengthened their lives.

In my practice, I certainly see the terrible harms that dangerous drugs and defective devices can cause. I’m glad that the media keep pointing out problems with bad drugs and medical devices. I’m pleased to see lawmakers like Sen. Chuck Grassley (R.-Iowa) investigate Big Pharma and orphan drugs. I’ve written about these price-gouging practices.

I’ve also written how the president hasn’t inspired great public confidence that he knows how to improve regulatory oversight over prescription drugs, especially with their soaring prices, and medical devices. With Tweets and broad statements, he suggests he gets the significance of problems in this sector. But then he backs away, or undercuts his pronouncements with countervailing deed or statement.

Make no mistake about it: Soaring drug costs are one of the big drivers of the nation’s constantly rising health care expenses, and Americans are both terrified by this and sick of it. Crushed by the cost of drugs and medical services, many are postponing needed care because they can’t afford it, especially if they have health insurance but are saddled with high-deductibles that they must pay out of their own pocket first. More than a quarter of Americans know someone in their family who is struggling with medical debt, which I consider unconscionable. Medical debt is the No. 1 cause of bankruptcy.

We all admire Silicon Valley’s transformational innovation, and how technology has improved our lives. But when it comes to our health, and critical components of modern caregiving like drugs and medical devices, none of us wants to be a guinea pig for wealthy entrepreneurs wishing to test their economic theories and political ideologies.

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