Did Big Pharma & medical device makers win most in 21st Century Cures Act?

VPJoeBiden_PresidentObamaPresident Obama is expected to sign the $6.3 billion 21st Century Cures Act, capping a rare, multi-year, bipartisan push to significantly improve the nation’s health care. The Senate, with Vice President Biden presiding and winning salutes from political colleagues and patient advocacy groupsapproved the act 94-5.

Proponents say it has many benefits to go around, as I’ve written, providing:

  • a $4.8 billion boost to the National Institutes of Health to support an array of innovative research in its facilities, as well as at universities, medical schools, academic medical centers, and major hospitals;
  • $1.8 billion of the NIH funding is targeted for the Obama-proposed, Biden-led “cancer moonshot” to better coordinate care and find improved treatments;
  • another $1.5 billion of the NIH sum will go for Obama’s Precision Medicine Initiative, which seeks to target medical care better depending on individuals’ genetics and lifestyles;
  • $1.5 billion more of the NIH allocation is aimed for the president’s BRAIN initiative to better understand not only the workings of the mind but to battle Alzheimer’s;
  • $1 billion to help combat the opioid drug abuse epidemic that is killing record numbers of Americans;
  • And $500 million to help the federal Food and Drug Administration hire more staff and deal better with its identified gaps in overseeing timely, responsive oversight of drugs and medical devices.

The measure also gives significant new recognition to the importance of mental health, raising it as a priority, coordinating its delivery, rewarding efforts to attack psychosis and to keep the mentally ill out of jails, and supporting other improvements. (At the same time, however, advocates fear that any progress on mental health via the 21st Century Cures Act could be wiped out if Republicans, as promised, repeal and replace the Affordable Care Act, aka Obamacare).

Because the bill is almost 1,000 pages and lobbyists, politicians, and advocates have swarmed over it for almost three years, and up to its Senate passage, it may be years before American patient-consumers fully share in its benefits—or suffer its harms.

Critics have ripped parts of the bill, particularly as it affects the federal Food and Drug Administration, Big Pharma, and medical device makers. Elizabeth Warren, the Massachusetts Democrat, assailed the FDA portions of the bill saying they were a giveaway to corporate interests. But she failed to win support for changes from fellow senators. I see cases in my practice involving dangerous drugs and defective and harmful products, and as a result, I’ve had lots of experience with Big Pharma and medical device makers. That makes me inclined to side with the view that, along with the 21st Century Cures Act’s benefits, patient-consumers should be extremely wary of claims that the FDA should sidestep established processes to speed potentially beneficial drugs and medical devices to the public.

Trudy Lieberman, a seasoned reporter with long experience in health care coverage, dissects the act’s proposed changes at healthnewsreview.org, a nonprofit health watchdog site. She makes persuasive arguments how these changes move the nation backward on the safety and effectiveness of drugs and medical devices.

She calls the bill:

“The culmination of a 20-year drive by conservative think tanks and the drug industry that began during the Clinton Administration to ‘modernize’ the FDA, loosen regulation over drug and device makers, reduce the number of clinical trials needed to approve a drug, and permit advertising for off-label drug uses, all of which would help drug and device makers expand their markets.”

She says the legislation allows makers to win approval for their products by substituting for rigorous, extensive clinical trials submission of so-called “real world evidence.” This will come from less reliable sources like insurance claims and observational studies. Makers may be allowed to hand in data summaries rather than full results of testing on drugs and medical devices. Regulators may be forced to give greater weight to so-called “patient experiences,” which may amount to anecdotal evidence that’s collected by advocacy groups and the makers themselves.

The 21st Century Cures Act—wrapped up in the high emotion of Biden’s personal and professional campaigning (he lost his son Beau to cancer and the bill was seen as a last and signature legislative effort after the vice president’s decades in politics)—rests on a foundation of iffy financing. Republicans a year ago agreed in principle to the act but sought time to figure how to pay for it. In the end, they defeated Democrats’ insistence on long-term, sustained funding, and while pledging support for at least a year, the GOP set up the law so money in it must be renewed each fiscal year. Further, Republicans took billions of dollars from a preventive health fund set up under the Affordable Care Act, aka Obamacare, to help pay for the cures act, along with sales from the nation’s strategic petroleum reserves. Stripping money for preventive care, critics say, will harm efforts, for example, to reduce smoking by adults and youths.

I know health care policy can be nothing less than daunting to most of us. The details that go into drug and medical devices approvals are complex enough to give many folks a migraine. If a medication reduces tumors but doesn’t save lives and costs a fortune, should it win regulatory approval? If a drug is safe but not necessarily effective, does it get a green light? The folks over at the Freakonomics blog and podcast deserve credit for their skeptical look at drug approvals, notably how the FDA must try to find the narrow path between too fast and easy with resultant injuries and even deaths (see thalidomide and DES) or taking too long, being excessively careful, and, as a result, withholding key therapies for those in dire need (see antivirals and HIV-AIDS). Unfortunately, for most of us, our crucial experience with the American health system occurs most when we or our loved ones are sick, and maybe desperate. But in a democracy, we need to act as watchdogs over this important sector, always.

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