Just as an experiment, try Googling the name of U.S. Sen. Amy Klobuchar along with the phrase "life-saving medical devices." It is an expression she uses when referring to the products of Minnesota's med-tech industry, and she uses it a lot.
It's almost a script, in fact. Rarely does the senator invoke the cause of the state's device manufacturers without adding the assertion that the goods they produce -- and by extension, the profitability of their industry -- are all that stands between consumers and an early grave.
As a politician who has made a name for herself as a consumer advocate on a host of noncontroversial issues, including lead in children's toys, bacteria in spinach and mystery charges on cellphone bills, Klobuchar is remarkably less consistent when it comes to the safety and effectiveness of the products of the medical-device industry, not to mention our return on the billions of dollars spent on its wares. She is always careful to give lip service to the idea of ensuring the safety and effectiveness of drugs and medical devices, but her actions in Congress this month have done just the opposite.
Thanks to Klobuchar, the ability of the Food and Drug Administration to monitor the safety of drugs and medical devices is about to get a lot weaker.Klobuchar-inserted provisions in the so-called FDA reform bill that just passed the Senate carry out two specific favors for the makers of these products, who stormed on Washington in support of their demands last fall in the form of 225 registered lobbyists, half of whom had previously held positions in the government, and whose largest trade associations, the National Electrical Manufacturers Association and AdvaMed, have raised funds for Klobuchar, according to a report published in February by the consumer-advocacy group Public Citizen. In the name of speeding along supposedly innovative technologies that supposedly save lives, Klobuchar has helped to weaken an already toothless approval pathway for retread medical products, and has helped to do away with a hard-fought conflict-of-interest policy regulating the review of medical devices. Let's take these one at a time.
Under the current system, the makers of medical devices are allowed to submit products with modest to high potential for harm under two pathways. One pathway -- known as premarket approval, or PMA -- is for devices with very high risk. The other, an expedited pathway known as 510(k), is for moderate- to high-risk products that are supposedly just improvements on existing products. The vast majority of medical devices in these categories take the second path to market, and at the prodding of the device industry, Klobuchar has argued that the 510(k) pathway is slow and confusing and stymies progress. As a result, the new FDA bill includes Klobuchar-penned language that instructs regulators to take the fastest possible course in approving these retread devices, and actually limits what regulators can ask of manufacturers in their review of such products. If politicians telling scientists to keep their questions to themselves doesn't bother you, it should.
Is the 510(k) pathway too burdensome? The FDA meets its mandated goals on keeping up with submissions -- it reviews 90 percent of them in three months and 98 percent of them within five months. I've had longer waits for paychecks from employers in the private sector. Not only is the 510(k) pathway fast, it is flawed. According to a report published last summer by the Institute of Medicine, the process is already so weak it should be torn up and rebuilt from scratch. New drugs require two randomly assigned, placebo-controlled clinical trials showing their safety and effectiveness. New medical devices require only one successful trial, and even then, the design of that trial can take all sorts of shortcuts that amount to shoddy science. New devices submitted under 510(k), however, need only prove that they are fundamentally similar to devices already approved -- they do not need to conduct any clinical trials at all. As the IOM stated, the 510(k) pathway is not a law capable of ensuring medical devices are safe and effective, and "furthermore ... it cannot be turned int one."
Klobuchar, on the other hand, believes the retread road to market should zip along even faster, even though recalls have doubled in the last five years while submissions for approval have remained the same. As proof, she has cited a GAO report showing that it now takes longer to get 510(k) products approved than it used to within the FDA as it practiced in 2005, under the laissez faire oversight of President George W. Bush. Well, imagine that. On a more basic level, how can anyone make a serious argument, as Klobuchar has attempted, that a new device is "life-saving," if it is so similar to another product that it needs no testing? The arrival of seat belts was a life-saving innovation. The arrival of the 2013 Honda Odyssey is not. Nor should we call the tweak of a stent, knee or implantable defibrillator "life-saving" if it is so similar to something else that it requires no analysis. To do so is to manipulate our fear of illness in order to promote an industry that extracts billions from the economy for an uncertain, small or even negative effect on public health.
Last, Klobuchar has worked to end the hard-fought provision ensuring a limit on the number of experts with conflicts of interest who are allowed to evaluate new medical products. She has done this in spite of the fact that the FDA has had no trouble filling its committees with authorities who have not been on the payroll of the companies making the goods they are reviewing. "We believe allowing such individuals to serve basically undermines the credibility of the review committees in the eyes of the public," says Michael Carome of Public Citizen, which has testified in opposition to Klobuchar's work in softening the new FDA bill. "I think these are actions of someone who's trying to satisfy the major industry in her state, and who wants to keep lobbyists and potential campaign contributors happy."
David Healy, the author of a powerful new critique of the health care industry titled "Pharmageddon," has written about the manner in which private industry has so thoroughly seized control of the data and debate surrounding medicine that we cannot even see how we are spending more and living shorter lives with every "life-saving" advancement dropped on our doorstep. Both science and politics now serve the medical industry, rather than health, and all we can clamor for is more access to this parasitic system. In fact, our faith in the medical industry, the pills, and the tests we take to warrant their use -- the notion that all new medical technology is vital and life-saving -- is the only belief that seems to unite conservatives and progressives in this bitterly divided country of ours. As such, when it comes to the business of medicine, "we are all North Koreans, now," as Healy says. In other words, Klobuchar is not the only politician to do the bidding of the drug and device industries. But as a supposed consumer champion, she is surely one of the most misguided.
Paul John Scott is a writer in Rochester.
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