How Trump's FDA Pick Will Shred the Healthcare Safety Net

It takes a village to sabotage a healthcare system. Just this week, the GOP has worked diligently to make the unpopular GOP health bill even more heartless by effectively taking away the nearly universally supported ban on pre-existing conditions, which Margot Sanger-Katz at The New York Times points out would create the impressively cruel joke of setting cancer patients up to buy an insurance plan that (surprise!) doesn't have to cover chemotherapy.

Meanwhile, Scott Gottlieb, a long-time critic of the FDA's pesky safety regulations, testified before the Senate Health, Education, Labor, and Pensions (HELP) Committee in order to lead the agency. All the while, Tom Price and Seema Verma, heads of the Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS), respectively, await a vote to require the poor to work for Medicaid in Kentucky, something that's been tried with welfare before and failed to do anything but increase human misery.

Who will survive in Trump's America? The answer will be decided not only by elected officials, but appointed ones—Scott Gottlieb at the FDA, Tom Price at HHS, and Seema Verma at CMS. Together, this trio will shred the health care safety net.

They will make it easier for companies to sell risky drugs
Drug approval would be so much faster and cheaper for manufacturers, if only we could get rid of the regulations that safeguard what we put into our bodies.

Trump is committed to doing just that. He pledges "to get rid of a tremendous amount of regulations" and accelerate an already speedy FDA review process, which was put into place after the agency prevented the thalidomide birth defect crisis in the US in the early 1960s.

"We're going to streamline the FDA," Trump promised in late January, after a meeting with Big Pharma execs, clearly stirred by their heartbreaking pleas to lower the tax rate. "We have a fantastic person that I think we'll be naming fairly soon, he's going to streamline the FDA."

That person is Gottlieb, a nominee with an impeccable background in dishing hot stock tips and a bank account lined with nearly half a million bucks in just over two years from drug and device companies, according to ProPublica's Dollars for Docs.

Some shrug off Gottlieb's conflicts as Hey, he's good at business, but remember: In 2005, during Gottlieb's first stint at the FDA, he couldn't participate in planning a response to the avian flu outbreak, because even he said a "reasonable person would question my impartiality."

And though Gottlieb promised in his testimony yesterday that the science will guide him, he hasn't exactly been quiet about what he believes should guide the science: the market. Gottlieb has publicly opposed embryonic stem cell research, for example, not because of science, but because venture capitalists were "voting with its dollars for adult stem-cell research" and he also believes the "market should find a cure for AIDS."

Gottlieb also fears the FDA acts at the expense of the market, because it is too hung up on safety, a position that Senator Elizabeth Warren (D-MA) confronted him about. In a 2012 National Affairs article, Gottlieb argued that the FDA's review culture has "some downsides: In so heavily prioritizing one of its obligations—the protection of consumers—the FDA has sometimes subordinated and neglected its other key obligation which is to guide new medical innovations to market…on the whole, the agency's reviewers believe it is appropriate to prioritize safety over speed."

Prioritizing safety over speed is exactly what we want from a FDA commissioner. "Approval of drugs on the basis of a small number of studies, short studies, or studies with only intermediate endpoints can lead to more useless and risky drugs on the market," says Jerome P. Kassirer, distinguished professor at Tufts University School of Medicine. "Such drugs are good for the industry's bottom line, but not for the public."

While it is true that drugs may cost $2.5 billion to bring to market, no one wants a surprise when they take a drug prescribed by their doctor. "Cutting drug regulation may make it less expensive to companies to bring drugs to market, but the drug industry may start to look like the supplement industry over time—less and less regulation, and more and more snake oil," says Gregg Gonsalves, co-director of the Yale Global Health Partnership.

They will make it harder for the poor to get care
While Trump and Gottlieb seek to lower the requirements for manufacturers to put drugs in our medicine cabinets, Seema Verma, the head of Centers for Medicare and Medicaid Services, and Tom Price, head of Health and Human Services, want to make it harder for the poorest Americans to get them.

Though Trump promised to "save Medicaid" and do so "without cuts," Verma and Price sent a letter to governors that suggested state reforms include "premium or contribution requirements," which opens the door to making the poorest pay or work for their healthcare.

As the architect of Medicaid projects in Kentucky, Indiana, and Ohio, Seema Verma has made a name for herself by forcing the poorest Americans to pay into savings accounts, a move intended to make sure they have access to healthcare, but not too much. Because their "own dollars are at stake," Verma co-wrote in a Health Affairs article, "they have 'skin in the game' and therefore an incentive to make cost-conscious healthcare decisions."

But charging premiums for people on Medicaid predictably "drive[s] low-income people into debt and/or make[s] coverage more difficult for them to maintain," according to Families USA. "The bottom line is there is little evidence that the approaches she favors actually work to improve care, make people more responsible, or as she says, give people 'dignity,'" says Judith Solomon, vice president for health policy at the Center on Budget and Policy Priorities.

Charging poor people for medicine isn't the worst idea that Verma and Price have. Kentucky soon may introduce a work requirement for non-disabled adults on Medicaid. But this is backwards: Medicaid makes it easier for people to find jobs. "A work requirement would likely reduce the number of people who could access care through Medicaid," writes Hannah Katch, a senior policy analyst at the Center on Budget and Policy Priorities, "and there's no evidence that it would increase employment among poor families."

While Verma has recused herself from the vote on Kentucky's work requirement, Price does not have to do so and believes the work requirements are "restorative to people's self-worth." Without a single vote from the public or Congress, Gottlieb, Verma, and Price will substantially undercut healthcare access for the people who need it the most.

Update 5/10/17: The Senate confirmed Gottlieb as head of the FDA in a 57-42 vote.

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