Nel's New Day

December 8, 2016

FDA’s Losses

I’m addicted to The Rachel Maddow Show, as anyone who knows me can tell you. She’s one of the very few bright lights since November 9, 2016. Last night she had a particularly spectacular segment on Donald Trump’s (DT) proposal for the head of the Food and Drug Administration. As we’ve watch the attempted destruction of the United States through DT’s nominees, this one—hard as it may be to believe—seems to stand out.

The transition team is considering Jim O’Neill, a managing director for Silicon Valley billionaire Peter Thiel’s Capital Management. Thiel himself is an interesting figure who believes that the United States was destroyed in the 1920s when women got the vote. Last summer he was the first openly LGBT person to speak at the GOP convention and endorsed the platform that opposes hate-crime laws, HIV funding, and appropriate bathroom use by transgender people, calling it a “distraction.” At the same time, he supports laws to deny services to LGBT people.

Thiel pays students to drop out of college and sponsored Hulk Hogan’s lawsuit against the Gawker that outed Thiel almost ten years ago. The lawsuit was an objection to the “damaging way of getting attention by bullying people even when there was no connection with the public interest”—odd when one considers that this is DT’s MO. The co-founder of PayPal donated $1.25 million to DT’s campaign and was appointed to the highly homophobic transition team where he worked with Ken Blackwell who compares homosexuals to arsonists.

But I digress. Back to Jim O’Neill. As a board member of the Thiel-backed Seasteading Institute, he supports creating mini-cities at the bottom of the ocean to save the world from the devastating place that the United States has become. In a 30-minute speech, O’Neill said, “We can all wish that existing governments will somehow stumble into freedom, but if we want to achieve freedom, seasteads are by far the best prospect.” The video of this speech has magically disappeared from the Seasteading website since he was considered for the FDA position but is still available here. Thiel’s reason for Seasteading is to avoid taxes because he could use the “cities” to morph offshore companies into offshore countries with no responsibility or accountability to any government.

With no medical or scientific background, O’Neill thinks that drugs don’t need to be independently tested before they go on the market. Two years ago, he announced that his idea to reform the FDA was “approving drugs after their sponsors have demonstrated safety—and let people start using them, at their own risk, but not much risk of safety. Let’s prove efficacy after they’ve been legalized.” When he was in George W. Bush’s Health and Human Services Department, he opposed the regulation of companies that perform laboratory-developed drug tests with algorithms. Another of O’Neill’s beliefs is that anti-aging medication will reverse aging and that people can live forever.

The FDA has control over regulations for food, drugs, medical devices, dietary supplements, cosmetics, and tobacco—much of the consumption in the U.S. O’Neill claims that the lack of a free market in health care causes negative health consequences that would not occur in a free market. At the same time DT is attacking the free market system. Republicans decry DT’s interference that brought $7 million to Indiana’s Carrier as “crony capitalism” as well as his pride in dropping stock prices for Boeing with one tweet. DT also claims that he will “bring down drug prices,” against causing drops in pharmaceutical stocks.

O’Neill has also said that organ donors should be allowed to be paid. “There are plenty of healthy spare kidneys walking around, unused,” he said in a speech at a 2009 Seasteading conference.

This week, Congress readied the weakening of the FDA for DT by passing the 21st Century Cures Act. On the surface—and from the mainstream media—the public may believe that it should embrace the bill. To do so would ignore the ability of ineffective or dangerous medicines to easily reach people without reining in drug prices. Passing the bill, however, was a given because it funds Vice-President Joe Biden’s “Cancer Moonshot” initiative which covers all the rank stench of its other effects.

Some of the bill’s promises are already in existence, for example a six to ten month turnaround for evaluations of almost all new drug applications. There is also no evidence that current requirements cause higher drug prices. These are some of the negative provisions:

  • The funding for such programs such as addressing the opioid addition is not guaranteed for next year or after that.
  • The promised “patient-focused” drug development merely means that a brief statement about this experience will be made public.
  • Earlier provisions helping the public have disappeared from the final bill: (1) requiring third parties to certify the safety of medical devices after modification by companies; and (2) granting permission for shorter or smaller clinical trials for medical devices.
  • A provision allowing the FDA to use “real world evidence” for drug testing relies on the Secretary’s discretion. (Consider O’Neill’s “discretion” as Secretary of the FDA.)
  • The act eliminates “informed consent” when “the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.” The FDA gets to decide “minimal risk.”
  • Stem-cell therapies are slightly expedited through cutting back testing and permitting these in the marketplace before they have been proved effective and safe. This provision benefits wealthy Texan Ed Bosarge, who runs a stem-cell firm, gave $3 million to GOP Mitch McConnell’s super PAC, the Senate Leadership Fund and donated another $4.7 million to other GOP super PACs since Citizen United.
  • The bonus for the pharmaceutical company is their new ability to promote “off-label” uses of drugs, widely expanding their markets and avoiding the requirement of FDA approval for new indications.
  • The act cuts $3.5 billion, or about 30%, from Obamacare’s Prevention and Public Health Fund, which fosters work to prevent Alzheimer’s disease, hospital-acquired infections and other conditions.

Promoters of the act complained that the FDA acted as a bottleneck for drug companies, but the agency usually acts as a rubber stamp for them: it approved 89 percent of last year’s applications for new drug uses. Lessened scrutiny is demonstrated by such events as the need to pull Merck’s Vioxx, a painkiller and arthritis drug the FDA approved in 1999, five years later because it raised the risk of heart attacks. By then, 88,000 people in the U.S. suffered from heart attacks, and 38,000 of these people died.

Essure, a device implanted in women’s fallopian tubes as an alternative to permanent surgical sterilization and marketed by Bayer, received expedited approval in 2002 based on “two nonrandomized, nonblinded, prospective studies that lacked a [control] group and enrolled a total of 926 women.” Since then, research shows serious potential side effects and concerns that it is not safer than tubal ligations as well as appearing less effective in preventing pregnancy. Essure is still on the market but is required to have health risks warnings on the label.

Winners of the bill are the drug companies, medical device manufacturers, the National Institutes of Health, and Joe Biden. Losers are the FDA, aging and deteriorating labs, randomized clinical trials, customer advocacy groups, and regenerative medicine that would expand treatments for stroke victims and people suffering from Alzheimer’s, Parkinson’s and diabetes. The final draft does not permit new regenerative medicine products to skip the Phase 3 trials.

About 1,455 lobbyists on behalf of over 400 companies and other organizations at a cost of $500,000 succeeded in pushing through the legislature. It offers “something for everyone,” funding important projects while adding danger and unnecessary expenditures that benefit drug companies. If O’Neill is nominated and confirmed as the FDA Secretary, he will create more danger for people in the United States.

The bill passed the House in 392-to-26 with my representative, Kurt Schrader, in the majority and preening about his “success.” The Senate supported it in a 94-5 vote, and I’m proud of both my Oregon senators who voted in the minority, agreeing with Sen. Elizabeth Warren (D-MA) who said that she knows “the difference between compromise and extortion.” She called the NIH funding a fig leaf, “and most of that fig leaf isn’t even real. Most of the money won’t really be there unless future Congresses pass future bills in future years to spend those dollars.” Warren knows that most of her Democratic colleagues were bought off with false promises.

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