Califf confirmed to head FDA as Biden picks interim science advisors

califf-150x150The Biden Administration finally has a Senate-confirmed head of the federal Food and Drug Administration, as well as two new interim Cabinet-level appointees to advise the president on scientific matters.

Still, the struggles to fill top health policy posts shows that leadership in the field is tough to find and keep. And it is harder still for the chosen to keep the public and various constituencies satisfied — particularly during a coronavirus pandemic and with political partisanship at peak vitriol.

For regular folks, the quandary can mean that, at a time when government services may be needed most, they may be under their greatest pressure and least performance level.

That is a reality that smacked in the face Dr. Robert M. Califf, a cardiologist with deep experience in medical research and briefly the FDA commissioner under President Obama. Califf, 70, will return to the agency he headed for a year to tackle a formidable and increasing list of challenges, as the New York Times reported:

“[Caliif] will have plenty of work to do. The agency is facing an end-run around its tobacco control authority with companies marketing synthetic tobacco in flavors attractive to teenagers. Lawmakers are eager to see changes in how the agency fast-tracks drugs to the market after the controversial approval of the Alzheimer’s drug Aduhelm. And the agency has a lengthy backlog of foreign inspections to contend with, as roughly 80% of active drug ingredients come in from overseas.”

The FDA is also taking justifiable heat for the way it oversees prescription drugs. This is especially true with its industry-friendly practices of expediting approval and allowing medications onto the market. Regulators too often approve drugs based not on whether they improve or extend the lives of patients but on far-lesser factors, so-called surrogate endpoints, such as whether the costly, complex meds ease symptoms or show success, say, in shrinking tumors for a time. Critics question the independence of the FDA, particularly with its staff involved in revolving-door employment with Big Pharma, which also pays fees that make up an increasing portion of the agency budget.

A narrow path to role as FDA commissioner

Califf — who pledged to Sen. Elizabeth Warren, the Massachusetts Democrat and a chief critic, that he would refrain from seeking employment with or compensation from any drug or device company for four years after his term as commissioner — had a rocky confirmation in his reprise.

He won Senate confirmation on a 50-46 vote (versus his previous 89-4 approval), with four Democrats opposing him and six Republicans supporting him. Senators assailed him for the FDA’s lethally poor performance on preventing and quelling the opioid abuse and drug overdose crisis, his long relationships through his research career with Big Pharma, and the agency’s dealings on drugs that can be used in abortions.

Califf took to social media to thank Biden and the Senate for giving him a reprise at the FDA, writing:

“I promise each member of the FDA team and the American people my commitment to doing the best I can, relying on the integrity of science and the FDA’s continued application of science in meeting our awe-inspiring responsibilities.”

He outlined some priorities for himself and the agency, including improving the collection and rigorous application of data in decision making and ensuring that the FDA plays its vital role in battling the pandemic, especially with scrutiny of and oversight over vaccines and coronavirus drug therapies and in working with government and private-sector colleagues to battle anti-science disinformation and medical bunk.

Bullying costs a science boss his job

While the administration has argued that it will rely on evidence-based health policy approaches and, unlike its predecessor, would be known as a pro-science government, that aspiration took a black eye with the bullying misconduct and resignation of Eric Lander, a pioneer in genetic sequencing and Biden’s much ballyhooed top science advisor.

Though Lander came to his job with glittering credentials, his staff told personnel investigators that he acted like a jerk, screaming at staff, cutting them off, belittling, and bullying them. Biden had pledged that his administration would be a model — not a toxic — workplace, and the president angered many by allowing Lander to resign, rather than firing him. Biden also did this, the Washington Post reported:

“To replace [Lander] on an interim basis, Biden selected Francis Collins to serve as science adviser to the president and co-chair of the President’s Council of Advisors on Science and Technology. Alondra Nelson, who is a deputy director in the office, will temporarily lead the office until permanent leadership is named. The director of the office requires Senate confirmation … Collins recently stepped down as director of the National Institutes of Health, after leading the agency for more than 12 years. He played an integral role in the administration’s Covid-19 response as he oversaw the largest supporter of biomedical research in the world. Collins will continue to run a research lab at NIH, which he has overseen since 1993. Nelson serves as the office’s deputy director of science and society. She is a professor at the Institute for Advanced Study, an independent research center in Princeton, N.J., and was previously the president of the Social Science Research Council.”

The president, in recent days, has been forced to buck up his health policy leaders. The grumbles have grown about Xavier Becerra, a lawyer and 12-term congressman who heads the sprawling Health and Human Services agency that includes the FDA and the federal Centers for Disease Control and Prevention. Critics say that Becerra has been too passive and slow to make needed changes at HHS, which took a political beating under the previous administration. Rachel Walensky, the CDC chief, also has been under fire for her agency’s handling of the pandemic, particularly in its efforts — and hers — to communicate broadly and well the nuances of appropriate public health responses to the coronavirus.

Keeping changes in perspective

To be sure, the current administration’s troubles with its health leaders is far from the mess that enveloped officials in the term of President Trump.

His HHS chief was jettisoned after reporters found he was taking taxpayers for a ride, flying on expensive private flights or military charters to marginal events at swanky spots and taking his spouse, too. The previous administration’s CDC head also was ousted after it became public that she was buying and selling stocks in Big Tobacco, an industry that she would regulate and is a major source of big harms to Americans’ health. The FDA had three chiefs in the former administration’s four-year term, and HHS and the federal health system was inappropriately politicized and under relentless attack by Trump, officials in the White House, and political partisans.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damages that can be inflicted on them by dangerous drugs, as well their struggles to access and afford safe, efficient, and excellent health care. The ordeals regular folks confront in health care have skyrocketed due to cost, complexity, and uncertainty of treatments and prescription medications, too many of which turn out to be risky and problematic drugs.

Doctors and hospitals, as well as patients, must rely on the independence, vigor, and rigor of federal health officials, especially in the FDA and CDC, to provide the best, timeliest, and most insightful, evidence-based information on prescription drugs and medical treatments for the good of us all. We can’t doubt the nation’s health leaders, wondering if they are just passing through a post on their way, in a dizzying carousel, into a private-sector gig that pays them obscene sums. We can’t worry that regulatory experts are too beholden to industries they oversee, especially Big Pharma. Unacceptable.

We have much work to do to ensure that the federal health system and U.S.-supported scientific research stands up to the pounding they are taking during the pandemic. We need to rebuild public confidence in health agencies and their labors. We have much work to do.

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