How can Americans tell when the Food and Drug Administration has become so politically impaired that it cannot serve its mission to protect the public? One measure is when pharmaceutical manufacturers become the voice of caution and prudence about when new vaccines should be released to the public.
Hell has frozen over. Nine leading pharmaceutical and biotechnology companies issued a joint statement this week to assure the public they will not distribute their vaccines for Covid-19 before their safety and effectiveness have been firmly established.
There’s no question that the FDA is politically impaired. The Trump administration cowed it into announcing emergency use authorization for hydroxychloroquine and chloroquine for the prevention and treatment of coronavirus infection, only to revoke it later for lack of effectiveness and worries about adverse effects. A nervous public was then told of Operation Warp Speed for the development of a Covid-19 vaccine. We then witnessed the administration make a public display of its pressure on FDA leaders to approve a vaccine before the November elections.
The FDA’s leaders have done little to convince the public they will not capitulate to pressure from the Trump administration.
Trust in the FDA is an essential ingredient in introducing new drug therapies and successful vaccination programs. People won’t have confidence in medicines or vaccines that have not been evaluated by a credible and independent source.
This need was a driving motivation for the federal government to establish what was to become the FDA in 1906. Back then, consumers could not be sure which medicines were “snake oil” and which were “ethical” products that were not tainted or did not make false claims of benefits.
Over the ensuing decades, as the pharmaceutical industry took shape and began sophisticated marketing operations, the FDA became an important counterforce to the commercial objective to sell as much product as possible. That industry relied on the FDA to stop commercial practices that could pose greater risks than benefits.
Without a functioning FDA, pharmaceutical manufacturers can lose this important guardrail.
Except, apparently, when the guardrail is damaged. Incredibly, it is the long-term reputational risks and business motives of the pharmaceutical industry that are left to prevent a collapse in public trust. Vaccine makers are sensing this could currently be the case, with huge numbers of Americans expressing hesitancy about the Covid-19 vaccines in development because of the warp speed at which they are to receive FDA approval. So the companies are pledging to withhold their vaccines from commercial distribution until they themselves are satisfied they can be used with the confidence the FDA is otherwise expected to generate.
Should the public be grateful? We shouldn’t have to ask.
The two of us have a combined eight decades in health care. We have seen a lot during that time. But we never would have expected to see the pharmaceutical industry feel compelled to step into the role FDA is mandated to fill. It is ironic and tragic at the same time.
The political impairment the FDA is now experiencing is not irreversible. Leadership at the FDA strong enough to withstand pressure from an administration attempting to bend the agency to its political will — or an administration that would not pressure the agency to bend in such a way — could eventually win back public confidence.
The American people should have confidence that the FDA will protect us from half-baked or potentially harmful therapies. It’s unconscionable that we must rely for that instead on protection fueled in part by the business objectives and reputations of pharmaceutical and biotech companies.
Russell Teagarden is a member of the New York University School of Medicine’s Working Group on Compassionate Use and Pre-Approval Access. Arthur L. Caplan is professor of bioethics and the founding head of New York University School of Medicine’s Division of Medical Ethics.
The Priceless value added by the leaders biopharmaceutical industry to people’s cure and prevention, over a century, is priceless and should continue through next century.
Pharmaceutical companies have a longer life than any political appointees so it’s not surprising that they have a stronger felt need to ensure the credibility of their products than do the regulators. Those of us with decades experience working with the FDA have generally seen commitment and even consistency within the agency, but we’ve seen scientific competence far less often. The scientific competence lies within the companies that are doing the science and creating the products. I recall my efforts in teaching FDA regulators about our science had to begin by disabusing them of firmly ingrained science myths before they could take on new information.
As for leadership strengths within the FDA, how can one account for the current widely advertised and sold CBD compounds which mimic claims of Chinese snake oil that launched the Pure Food and Drug Act?
There is nothing tragic about pharmaceutical companies exercising quality control over their products. That is what responsible businesses do. Unlike the FDA, they aren’t being swayed by political pressure. The profit motive is far better at regulating nefarious conduct than the FDA.
Do some of the commenters here think that we haven’t been paying attention to the strong arm tactics being used against every government institution that can be bullied? Are there credible reasons an intelligent person should trust anything the FDA would approve under the current administration?
Of course Big Pharma is taking matters into their own hands here! They’re shoveling buckets of money into COVID-19 vaccine development, and they can see a big loss looming when millions of people say ‘thanks but no thanks, we’ll wait and let someone else be the first lab rats.’ Why shouldn’t we be skeptical when Big Pharma failed to invest in vaccine development over the last several decades because it didn’t pay them enough?? Lobbying congress is expensive these days!
Big Pharma has gotten big concessions from Congress over the years at the expense of American consumers, and now they think they can be seen as the White Knights riding in to protect Americans from the bully in chief. Well, a lot of us aren’t going to buy that.
This is a big lose/lose for everyone. The current administration has kicked science around in the mud for nearly 4 years and has heavily politicized every aspect of the COVID-19 pandemic over the last 8 months, lying about the most basic aspects of public health and promoting conspiracy theories. Now the president wants a quick and dirty vaccine to boost his chances for reelection. We need a vaccine we can trust, yet the pathophysiology of COVID-19 is far from being fully explicated. Are we supposed to take the word of the FDA or Big Pharma that the endpoints chosen to determine “safe” and “effective” are sufficiently valid? Even people who aren’t anti-vaxxers have a right to be skeptical about the safety and effectiveness of any COVID-19 vaccine that appears at warp speed in the next few months. The current administration, the FDA and Big Pharma have only themselves to blame for that.
So much indignation, so little consistent thought. You accuse the FDA of being Trump lackies. Trump accuses the FDA of being the deep state. The truth seems to lie between two possible ends of a spectrum. One end is that neither of you know what the FDA really does, who they are, or how carefully they work in an environment of not being able to say anything without permission. Alternatively, you actually know what you are saying and are a hypocrite who has so much contempt for your readership that you cannot believe that they will connect your dots. My guess is that the truth encompasses a bit of both.
Art, last I read you on Medscape (very recently), you opined on who should get the vaccine first. On Medscape, you were suggesting that the most vulnerable populations including prisoners should get the vaccine first. This sounds very noble, but if you don’t trust FDA, then it is all just continuing research, right? Please refer to 45 CFR 46 and then perhaps you might revise your recommendations or you are unwisely repeating the history of faulty ethical decision-making. Please be consistent or are you really suggesting that one do research on prisoners and other non-consenting vulnerable persons? Aren’t you an ethicist? You should know this stuff better than I. I’m just an ex-FDA lacky and yes your comments are contemptuous and condescending. FDA cannot fight back verbally, but they do their jobs consistently regardless of who is in charge. This I know.
How will Americans trust vaccines? How about reading the research papers that Phase 3 trials will generate for a change, and not spreading mass vaccine skepticism purely from political paranoia.
This is just rich. Political rags masquerading as scientific sources (including STAT) gin up stories about the compromised FDA leading Pharma firms to take advantage of the public mistrust. Then STAT reports on the news they helped create. How circularly quaint!
Pharma is clearly supporting its self-interest. It’s precious that Pharma is attempting to show “credibility” when it faces no downside, no legal blame, and is being fully funded by the US Government.
They , the government and pharmacy cos have left us , the people, not believe anything they say, After the Opiod lies and coverups!
If by “long term reputational risks and business motives” the writers refer to the financial cost of paying compensatory and punitive damages for product liability actions, I would agree. Remember this the next time someone says that there are too many lawsuits. It is the experience of past litigation that motivates current caution.