Boston, Massachusetts 2021-07-19 04:35:54 –
NDon’t worry about conflict, but there are drugs to approve.
Unfortunately, the Food and Drug Administration is facing a loss of confidence, thanks to the controversial approval of an expensive Alzheimer’s disease drug whose evidence seems questionable at best.
Approval criteria have been questioned, and the FDA’s deputy commissioner has asked federal oversight agencies to investigate transactions with Biogen.
This is hardly a definition of transparency.
This episode talks about the relationship between agencies that charter drug reviews and public health protection and companies that seek to benefit from these drugs and have to pay the FDA a significant fee as part of their negotiations. It just renews your concerns.
And now, another prominent FDA employee is exacerbating the problem of perception.
In a statement at an industry event last month, Patrizia Cavazzoni, a former Pfizer executive who heads the drug review department, complained about an advisory board tasked with drug evaluation. These are panels of outside experts, but the FDA is not obliged to accept their recommendations.
Specifically, she suffered from conflicts of interest rules that regulate who the FDA can use for the Commission.
“We have very strict conflicts of interest rules, and the pool of advisory board members is frustrated that there are some advisory boards that seem to have no experts in this area, at least to me. Limited to points. “She said. “That’s what we’re thinking,” she said, “last but not least, we need to partner with the industry on this,” as part of an extensive review ongoing in her department. I added.
For one thing, it’s not entirely clear whether the lack of qualified professionals is as big a problem as she claims. And second, this was a difficult moment to raise the issue.
Please let me explain.
Twenty years ago, the FDA faced complaints about the financial relationship between panelists and businesses. Therefore, the authorities drafted the guidelines and then issued a series of rules in 2008. Nevertheless, the FDA is constantly creating exceptions through the exemption process in some scenarios, such as when there is a shortage of sufficient professionals.
Still, the pharmaceutical industry complains that the rules prevent the best experts from joining the committee too often. In 2011, Margaret Hamburg, then FDA Commissioner, filed the same complaint.
on the other hand, Number of exemptions It’s small. “I think the concern about finding non-conflicting professionals is the bright red herring. They have demonstrated that they can find professionals, which is shown by the small number of exemptions. “More,” said Michael Carome of the advocacy group Public Citzen.
However, Cavazzoni also said that “the exemption process is not always a way to address this issue,” but did not explain why.
So what do we know about the scope of the problem that Cavazzoni is looking at? rare.
I asked the FDA for data on the lack of qualified professionals and why the exemption process is inadequate.
Unfortunately my I couldn’t answer the question. Instead, the spokesperson said: “We continually review the advisory board process to ensure that they are efficient and set to provide the FDA with as thorough advice as possible. We look forward to hearing feedback from stakeholders regarding this and achieving greater consistency within these important advisory forums. “
A paper However, what is posted on the MedRxiv preprint server may provide some clues about the FDA’s thinking.
The treatise surveyed more than 400 people, half of whom were members of the committee and half of whom were rejected as panelists. Because of the conflict. The “general opinion” is that current conflict policy can reduce the quality of professionals by eliminating qualified professionals and the overall quality of input to the Commission. It was a thing. Conclusion: The FDA needs to review its conflict policy.
But given that half of those people were excluded due to the conflict, this smells like sour grapes.
In any case, one of the authors is an FDA employee and has proposed to eliminate the total exclusion of universities that benefit from industry grants. Exempt certain institutional investments such as investment trusts and pension funds held by panelists. It then raises the current $ 50,000 annual threshold for individual holdings of the company.
To some extent, I can understand some concerns.
According to Genevieve Kanter, an assistant professor of medicine at the University of Pennsylvania, there are shades of gray to consider.so Research In 2014, she found a strong link between the biased voting by committee members who also served as company executives, but not the members receiving research funding. “We have to make more subtle differences in how we define economic conflicts of interest,” she told me.
Another possibility is that existing policies can lead to more committee vacancies.In fact, the percentage of empty slots Creeping up – – For unknown reasons, March this year reached 18%, compared to 14% four years ago. In addition, science and medicine are constantly evolving, and sometimes the number of specialists available to a particular committee reviewing highly specialized topics is limited.
“Can you find someone without conflict? The answer may vary by field of treatment,” Harvard University professor Daniel Carpenter, who studied the FDA, told me. “But not everyone does.”
The situation is further complicated by the relationship between the FDA and the pharmaceutical industry. Pharmaceutical companies are required to pay FDA fees each year to cover the operating costs of government agencies. In fiscal year 2021, pharmaceutical companies will pay $ 4.6 million.
But this turns the industry into a kind of FDA client.
And this brings us back to the Biogen controversy.
The FDA is increasing pressure not only to approve more drugs more quickly, but also to address unmet medical needs such as Alzheimer’s disease. Often at the top of the list. In fact, Biogen was the first approved treatment for the disease in almost 20 years.
However, the advisory board was difficult for the agency. Last November, the panel unanimously voted not to recommend drugs for approval because of uncertainty about study data and patient interests. But anyway, after the FDA gave approval, three panel members resigned and one blamed the authorities. letter It was distributed to the media.
This happened just four days before Cavazzoni spoke to an industry gathering. And she said:
“I’m going to say that I may not be welcomed by everyone, but I speak with personal observation,” she said. “We need to think about how to get back to the root reason of the advisory board. The advisory board really listens to the thoughtful opinions of the experts in response to the thoughtful questions they ask. And emotional … see how you can get rid of some of the bass or overtones. “
To be fair, it wasn’t clear if she was talking about the Biogen Conference. And the conflict between the committee’s experts was not an issue. However, I could not help noticing the timing.
And the inconvenient consequences of that committee meeting may only add momentum to further consider the committee’s membership. Pharmaceutical companies are likely to be enthusiastic.Moderated Alkermes CEO Richard Pops session, Immediately supported her feelings. “We have to help you [conflicts] rule. They are overly restrictive, “he told her. “There are no experts there.”
Unfortunately, making concessions to the pharmaceutical industry by loosening the rules has significant drawbacks. Oppositions are more likely to be suppressed or eliminated, and the quality of scientific dialogue may be reduced. And it doesn’t help anyone.
Then what should I do? Work harder to find members of the committee. Yes, it’s easy to say. And yes, this proposal may frustrate some people. But that’s better than lowering the standard. And now, the FDA should focus everything on raising the bar.
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