As White House gets its way, CDC and FDA chiefs shred their agencies’ credibility

cdcredfield-150x150fdahahn-150x150What the White House wants, it apparently will get — even if that hangs out to dry the prized nonpartisan reputations of the Federal Food and Drug Administration  and the Centers for Disease Control and Prevention.

The political meddling and leadership errors at two of the nation’s premier health agencies, critics say, will have disconcerting effects on the nation’s well-being, notably on science- and evidence-based efforts to combat the toll of the Covid-19 pandemic.

Those numbers keep soaring and changing almost as fast as they can be typed: 180,000-plus Americans have been killed by novel coronavirus, which also has infected more than 5.9 million of us in a little more than half a year.

President Trump sought to distract the public from his administration’s poor pandemic response with political convention pageantry that involved the shattering of ethics law and political norms, even as two of his top health officials embarrassed themselves professionally in incidents that cost two agency flacks their jobs.

What confidence can the public retain in the nation’s top leaders, especially at the FDA, if they cannot correctly handle basics of a study on a potential, blood-based Covid-19 treatment without throwing around false claims that it provides either a “35% reduction in patient mortality” or a “35% improvement in survival?”

And how could the CDC decide in sudden and stealthy fashion to tell Americans who have been exposed to individuals with Covid-19 but without symptoms that they should skip getting tested?

Stephen Hahn, a cancer specialist and head of the FDA (shown above, left), has apologized for the giant numeric gaffe he and his agency (including its newbie top spokeswoman) communicated about convalescent plasma. It is a treatment employing protective antibodies from the blto help newly infected patients fight off diseases, including potentially Covid-19.

Robert Redfield, a virus expert and the CDC’s chief (shown above, right), has issued a wobbly walk-back of his agency’s publication of confusing guidance on Covid-19 asymptomatic testing.

The CDC has not pulled from its web site the new coronavirus test information, denounced by leading experts and governors of some of the nation’s largest state.

The FDA has maintained the emergency approval it granted for convalescent plasma, though the FDA has dismissed two flaks involved in communications about it.

The wild and evidence-light zig zagging in the federal response to the pandemic is fueling huge concerns as millions of families deal with the chaos and uncertainty of youngsters return to K-12 schooling and adolescents heading to colleges and university.

It also casts big clouds over the “warp speed” efforts to develop a coronavirus vaccine and whether this important infection-fighting tool will be credible, safe, and effective. Or will it be part of a politically driven October surprise?

Another testing debacle

President Trump has obsessed about his counter factual belief that more testing leads to higher Covid-19 cases, confusing the detection of the disease with an all but magical means of lessening its infection harms.

So, critics may not have been totally surprised when the CDC, with no public notice and in a stealth switch in policy as it has tried before, changed its influential guidance on Covid-19 testing. As the Washington Post reported, the agency, replaced its “advice that everyone who has been in close contact with an infected person should get tested to find out whether they had contracted the virus. Instead, the guidance says those without symptoms ‘do not necessarily need a test.’” As the newspaper continued:

“[L]eading infectious-disease experts predicted that, after months of public health exhortations encouraging people to get tested, the turnaround could heighten public confusion, impede contact tracing and lead to more cases.”

Governors of the nation’s largest states — including in Arizona, California, Connecticut, Florida, Illinois, Texas, New Jersey and New York — rejected the CDC guidance and criticized the agency, as did a group representing 3,000 local health departments, including those for 30 of America’s biggest metropolitan areas. The American Medical Association questioned the policy change.

Redfield backtracked, telling multiple media outlets that testing for asymptomatic people with coronavirus exposure “may be considered.” But he voiced concern that test availability still cannot meet the huge demand and big backlogs may be undercutting the needed swift reporting of results.

That only led to more fire at him and the administration for failing to provide a nation testing strategy and employing federal power to coordinate and execute from early on a testing system that experts say would have been crucial to a better, less lethal Covid-19 response that has existed.

Changes in CDC guidelines on testing can be important because of their potential effect on insurers’ willingness to cover the diagnostic tool, experts noted. They also argued that the government’s top infection-fighting organization should not encourage in any way the notion that testing should be a casual or optional matter. It is a critical part of strategies and tactics, for example, to keep open health care enterprises as well as other workplaces and schools, especially colleges and universities. Aggressive testing plans have allowed more than 750 colleges to detect and deal in critical ways with 26,000-plus Covid-19 infections among students, faculty, and staff.

Media reports, however, have detailed how top officials at the White House pressured health experts to change the CDC testing guidelines, effectively helping to achieve the president’s political goal of less testing and lower reported cases of Covid-19.

An intriguing aspect of the timing of the CDC action, as well as that of the FDA, has focused on the health of Dr. Anthony Fauci, the much respected and top infectious disease expert. Fauci had to undergo surgery to remove a throat growth tied to excess speaking. He has been sidelined by anesthesia and his doctor’s orders to refrain from talking as he heals from his operation. He has expressed concern about the CDC and FDA actions.

The blood plasma mess

The FDA also found itself mired in a medical-political mess, as the president pushed for yet another lightning (magical) treatment for Covid-19, focusing now on convalescent plasma.

This is the antibody-rich portion of the blood, extracted from patients who successfully have fought a coronavirus infection. The plasma contains proteins the body manufactures to battle a given disease and it has proved helpful to transfuse those newly infected this blood product.

The challenge for now is that the research is under way and, to many, inconclusive, notably because this treatment has not been subjected to a randomized clinical trial. This is the rigorous, multiphase, “blinded” from bias testing that is the gold standard in providing evidence of the safety and effectiveness of prescription drugs, medical devices, and medical treatments. Clinical trials can be complicated, resource-heavy study and they require time to run.

Studies are under way but have not produced data convincing enough so that experts like Fauci, the overall head of the National Institutes of Health, and other clinical specialists are ready to endorse convalescent plasma for Covid-19 patients, even for “emergency approval” by the FDA.

The president has disagreed, based on preliminary findings on the treatment and his “gut” — which also has led him to theorize about and effectively hype: injecting disinfectants or forcing sunlight into the body; the debunked effectiveness and use of the risky anti-malarial drug hydroxychloroquine; and  oleandrin, a poisonous plant extract.

The president has called the antibodies in the blood a “beautiful ingredient” and urged convalescent plasma’s use, pressuring the FDA to give it emergency approval on the evening before the GOP convention began. He promoted the move as a “truly historic moment” and his spokeswoman called convalescent plasma “a major therapeutic breakthrough.”

Doctors and researchers were stunned, especially as that 35% figure became a prominent part of the publicity and the serious experts whose study was referenced by the White House could not find that datapoint in the extensive written materials they had made public.

Here is how the New York Times Editorial Board dissected the information boner by the president, the head of the Health and Human Services department, and most specifically by Hahn, the head of the FDA:

“As he has since explained on television and Twitter, his initial assessment conflated two different things: relative risk reduction (that is, how much a treatment reduces the risk of death in one group of patients compared to a different group) and absolute risk reduction (that is, how much a treatment reduces the risk of death in a group of patients compared to the rest of the population who didn’t get the treatment). To proponents of convalescent plasma therapy, this might seem like an inconsequential flub: Why split hairs if lives were saved?

“But the survival benefit Dr. Hahn initially mentioned applies only to a narrow subset of patients: Those younger than 80 years old who were hospitalized but not on ventilators and who received plasma with high levels of antibodies within three days of diagnosis were 35% less likely to die than those who received plasma with low levels of antibodies. If the former group of patients were compared instead to the wider population, the benefit would shrink considerably. (The data in question also has several other serious limitations, which the commissioner did not acknowledge or address.)”

Hahn, facing an expert firestorm over his bungled numbers, apologized. He committed an error in his field equivalent to equating Kurt Suzuki’s .258 batting average for the Nationals and other big league teams over 14 years to the .278 figure for Eddy Alvarez in seven years the minors before he became a “miracle” player for the coronavirus-depleted Marlins.

The FDA commissioner subsequently ousted the agency’s spokeswoman for 11 days — Emily Miller, whom the New York Times noted was sent to the FDA by the White House and “had little experience in health care. She had spent years working in Washington for Republicans, including the former Texas Congressman Tom DeLay and Senator Ted Cruz of Texas, and as a journalist for One America News, the conservative cable network.” Wayne L. Pines, a health care communications consultant (another flack), also did not have his contract renewed, the FDA said.

Phew. In my practice, I see not only the harms that patients suffer while seeking medical services, but also the high value they can experience by staying as healthy as they can — and outside of the U.S. health care system. That system had its big problems before the pandemic, including with infections acquired in care giving institutions (hospitals and nursing homes), misdiagnoses, and medical errors — the third leading cause of death in the nation, by some expert estimates.

That said, we need to protect and improve the health system more than ever, notably with big support for public health and medicine based in science and evidence. It is hard to believe that the federal pandemic response is becoming shakier and more erratic by the moment.

The gross missteps by the FDA and CDC — arm-twisted by the president and his men — creates real risk for Americans and the hope that the nation can successfully battle Covid-19. Yes, finally, with face covering and more distancing, and selective shutdowns of bars and many mass gatherings the awful summer surge seems to be subsiding some.

That does not mean the disease will roar back, especially as evidence builds that contact with individuals early in their infection or who may be asymptomatic or with mild cases themselves cannot create problematic hot spots, such as occurred with a business conference in Boston or with student gatherings at reopening schools, or, yes, maybe in that unacceptable Trump political event on the people’s once-protected ground — the White House and the Washington monument.

Huge and growing hopes rest in how a prospective vaccine might be the game changer with Covid-19. But convincing a skeptical public that it is safe, effective, affordable, and accessible is becoming a giant challenge, especially as the federal government embraces science denialism and politicizes public health. It’s mighty tough to persuade doubters to get a shot in the arm hyped by people who keep shooting themselves in the foot.

We’ve got a lot of work to do in the days ahead and we can’t expect the coronavirus to disappear or be behind us, as if by magic.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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