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Trump’s pick for FDA to test ‘due diligence’ of Agency’s science

We Are Quoted

Nyah Phengsitthy, Bloomberg Law, November 25, 2024

Marty Makary, an outspoken critic of the nation’s food and drug regulator, stands to shake up the FDA’s standards in science and decision-making under President-elect Donald Trump.

The Johns Hopkins surgeon selected Nov. 22 by Trump to lead the US Food and Drug Administration may have laid out his blueprint for a potential agency overhaul if confirmed as commissioner—and it starts with his criticisms over vaccine policy, food safety, and the pharmaceutical industry.

Makary has taken numerous shots at FDA decisions, including the agency’s approval of Covid-19 vaccines by Moderna Inc. and Pfizer Inc., its “cozy relationship” with drug manufacturers, and the approval of a drug to treat Alzheimer’s. He’s also offered judgment on the nation’s food supply, questioning the various chemicals in foods and infant formula.

While some of his opinions have drawn opposition, his critiques put to practice could reshape areas of the agency that have come under scrutiny, health policy experts say. His challenge on vaccine approvals, food safety, and the status quo ideas in the medical establishment signal a commissioner who won’t allow the agency to lower its standards and will tap more into science and decision-making.

“A lot of what he’s been talking about are things we need to be thinking about,” said Diana Zuckerman, president of the National Center for Health Research. “When you have somebody who’s outspoken on the side of public health, I think that’s something we should hear.”

[….]

“Dr. Makary seems like a person who could be persuadable by an evidence-based argument,” said Peter Lurie, president of the Center for Science in the Public Interest and former associate commissioner for public health strategy and analysis at the FDA.

“But the most consistent through-line between the HHS, CDC, and FDA nominees seems to be being vaccine-skeptical or worse.”

‘Sticking to the Science’

Though it’s unclear how Makary’s concerns will play out as chief, he could demand the agency carry out deeper examinations and assessments in its everyday decisions.

The FDA in recent years has come under fire for some scientific conclusions and the information used to back its regulatory decisions. This includes its authority over e-cigarettes, the abortion pill mifepristone, laboratory-developed tests, and major drug approvals.

“You want to have that person very much sticking to the science, so that we know that these new medicines, medical devices, whatever comes to the market, is truly safe and effective,” said Reshma Ramachandran, an assistant professor at Yale School of Medicine.

“He has a pretty profound background in research, so that gives me some comfort knowing he will hopefully continue to follow the science in making decisions.”

Makary also “recognizes the value of not letting approval standards dip dangerously low,” said Holly Fernandez Lynch, a professor of medical ethics at the University of Pennsylvania. She pointed to when he criticized the FDA for approving Alzheimer’s drug aducanumab despite safety concerns.

The author and professor has taken issue with the lack of transparency between the agency and pharmaceutical industry. He’s also a critic of the Orphan Drug Act, which allows manufactures to secure protections for rare disease drugs when they hit the market.

“He wants to make sure that the agency’s decisions are being made from a scientific perspective, and not being unduly influenced by the sponsors who are bringing forward the products,” Ramachandran said. “I’m hoping he’ll maintain that thinking to make sure the agency is doing its due diligence in its work.”

[….]

Food Safety

Makary’s agenda may test the FDA’s oversight on food safety—another area that has been scrutinized in recent years.

He has called the food supply “poisoned” with “highly addictive chemicals.” He’s also scrutinized the amount of seed oils in infant formula, and questioned why Froot Loops are sold with different food dyes in the US than in Canada.

His appointment would come as the FDA rolls out its Human Foods Program, which was created under the agency’s largest reorganization.

Notably, the program is in the midst of establishing a framework to assess chemicals in food already on the market—a move that was criticized for being conducted through an ad hoc basis and largely behind closed doors.

Makary could take “positive steps” in regulating and eliminating “harmful components that are still allowed in food, supplements, food containers and packaging,” according to Ana Santos Rutschman, professor at the Charles Widger School of Law at Villanova University.

“Among all the nominations so far in the public health space, this is the candidate with the strongest credentials,” Rutschman said. “And I think that there is, at least for now and in theory, room for some positive developments at the FDA.”

To read the entire article in Bloomberg Law, click here.

Vivek Ramaswamy’s crusade to change FDA could boost biotech, and himself

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Daniel Gilbert, The Washington Post, November 25, 2024

Vivek Ramaswamy, an outspoken ex-biotech executive turned fierce critic of the industry’s main regulator, is now in a position to reshape the agency he derides as the “Failed Drug Administration” in ways that could benefit him personally.

Newly tapped by President-elect Donald Trump to co-lead an initiative to slash the federal bureaucracy, Ramaswamy has heaped criticism on the Food and Drug Administration for “unnecessary barriers to innovation.” At the same time, the company he founded, Roivant Sciences, is pursuing studies for three drugs that, if positive, could land before the FDA during Trump’s second term. His stock in Roivant is worth about $670 million.

Ramaswamy argues that the FDA should err on the side of approving promising therapies faster and then monitoring their effects after doctors start prescribing them. The agency should place “greater emphasis on post-approval surveillance for safety issues to protect patients, rather than adding time and cost to innovative development,” he said in a statement. He highlighted the FDA’s standard requirement of two trials for approval and suggested a single trial — which would generally save biotech firms time and money — would be adequate.

Ramaswamy, with billionaire Trump adviser Elon Musk, is spearheading the “Department of Government Efficiency,” an outside-government project to streamline bureaucracy and carry out “mass head-count reductions,” the two wrote in a Wednesday op-ed. Ramaswamy left Roivant’s board in February 2023 when he launched his presidential campaign but is still one of its largest shareholders.

“It’s an obvious conflict of interest,” said Diana Zuckerman, president of the nonpartisan think tank National Center for Health Research, who points out that the FDA has already lowered its standards considerably to speed novel drugs to market. “Some people might think, ‘He’s a knowledgeable person.’ He’s a knowledgeable person with a vested financial interest in what he’s saying.”

In an interview, FDA Commissioner Robert Califf said he knows and respects Ramaswamy but pushed back on some of the entrepreneur’s harshest criticisms, such as once questioning the need for the agency. “We tried that,” he said, pointing as an example to the drug thalidomide that caused birth defects in babies in the 1960s, “which is why the FDA exists in its current form.”

“Almost every additional authority at FDA has been because of a catastrophic public health event that harms people,” he said.

Califf defended the two-trial standard, particularly for new drugs when there are already effective therapies available, while emphasizing that the FDA frequently accepts less evidence for potentially life-changing therapies. As for Ramaswamy’s financial stake in biotech, Califf said, “at FDA, you’re not allowed to make decisions about industries in which you have a vested interest.” He added, “I would just say, the amount of money he has invested and what’s at stake speaks for itself.”

[….]

Of all novel drugs approved in 2020, more than half relied on a single such trial, one study found.

On Saturday, Ramaswamy praised Trump’s choices to lead the FDA and other health agencies, saying he had met with them and “it’s clear they’re serious about reducing cost & they understand innovation is a key part of the solution.” Marty Makary, whom Trump tapped to lead the FDA late Friday, has emerged as a forceful critic of the agency’s culture, faulting it in a 2021 op-ed for a “counterproductive rigidity and a refusal to adapt.”

Ramaswamy made his name as a wunderkind biotech analyst on Wall Street while earning a law degree at Yale, before striking out on his own as an entrepreneur. He told Forbes for a 2015 cover story that Roivant would be the “Berkshire Hathaway of drug development.”

[….]

Ramaswamy pulled off what was at the time, in 2015, the largest public offering in biotech, raising $360 million with the listing of Axovant, a Roivant subsidiary developing an Alzheimer’s drug. Controversy followed as a clinical trial failed to show a benefit and the stock value collapsed.

Roivant has gone on to develop several drugs that won FDA approval, but it has made a bigger splash for its savvy dealmaking.

[….]

Roivant executives have told investors its pipeline of experimental drugs could someday be worth $10 billion a year in sales. Ramaswamy holds a roughly 7 percent stake in the company, in addition to stock options to purchase millions more shares.

Trial results for two drug candidates — one to treat an autoimmune condition that causes a skin rash and muscle weakness, another for an eye inflammation disease — are expected in the second half of 2025, executives have said. The trial for the autoimmune condition is designed to support FDA approval without a second one, the company has said.

Roivant declined to comment.

Ramaswamy criticized the FDA during his failed bid for the GOP presidential nomination, a campaign where he sought to distinguish himself with a provocative style on an array of subjects. He called the agency “corrupt” and its actions “hypocritical, harmful & unconstitutional” in July 2023.

After he endorsed Trump, he continued to slam the agency. “It’s not at all obvious that we’re better off for having an FDA at all,” he said in May, dedicating an episode of his podcast to the issue. He suggested that the private market could be a better judge of what patients should trust, similar to how customers rely on J.D. Power ratings to buy cars. “The FDA has actually crowded out the rise of those alternative intermediary institutions,” he said.

[….]

Several academic scholars interviewed for this story said they disagree with Ramaswamy’s contention that conducting two major clinical trials to replicate results is unnecessary.

Sanket Dhruva, a professor at the University of California at San Francisco School of Medicine, acknowledged that clinical trials are expensive and add to the cost of developing new medicines. Still, he said, “What about costs that are passed on to the health-care system using tests and treatments that are relatively unproven?” He argued that approving less-studied drugs can give patients false hope or cause them harm and add to higher insurance premiums.

[….]

Read the full article in The Washington Post here.

F.D.A. names a new chief of medical devices

We Are Quoted

Christina Jewett, The New York Times, Oct. 22, 2024

The Food and Drug Administration on Tuesday announced that Dr. Michelle Tarver, an agency veteran, will be the new director of the medical device division.

Dr. Tarver will face a slate of pressing tasks, that include addressing calls to strengthen standards to protect the public from issues like racial bias in artificial intelligence software and hastily authorized and faulty cardiac devices, like external defibrillators.

She will also confront the challenge of restoring credibility to a division clouded by ethical lapses of Dr. Jeffrey Shuren, her predecessor, and of navigating her way in an agency with close ties to the industry.

In addition, Dr. Tarver is assuming the position at a time of stunning technological advancement, overseeing research and potential approvals of devices meant to tap into brain signals to restore speech and movement.

The division reviews thousands of medical products that are central to medical diagnosis and surgery, like DNA tests and surgical staplers. Other devices are implanted in the body for decades, including pacemakers and hip prostheses. The division has a budget of about $790 million and a staff of about 2,500.

A 15-year veteran of the agency, Dr. Tarver is viewed by those inside the F.D.A. as a candidate who would sharpen the division’s focus on safety and quality. She is an ophthalmologist who continues to treat patients on the weekends, and she is also trained as an epidemiologist and has developed ways to measure patient preference in medical care.

“Dr. Tarver demonstrates a true passion about data, science, medicine and the evidence, all of which are critical to supporting and driving the F.D.A.’s decisions,” Dr. Robert Califf said in an announcement to agency staff Tuesday. “She works to build collaboration and transparency in achieving the strategic priorities for the center and the agency.”

Dr. Tarver said in a statement that she was honored to lead the division and planned to “remain committed in our service to public health and ensuring all patients in the U.S. have access to high-quality, safe and effective medical devices.”

Dr. Shuren headed the division for 15 years and has been credited with speeding the pace of approvals and solidifying the United States as a destination for medical device study and innovation. He has also been divisive, facing pressure from the start of his tenure to strengthen lax device-approval standards. Those calls have continued unabated over the years. The American Medical Association, a major doctors group, voted in 2023 on a resolution urging the agency to raise the bar on product authorizations and to more carefully monitor the safety of approved products.

Dr. Shuren announced his retirement in July, and the agency has said he will leave by the end of the year.

An investigation by The New York Times found that his official work had overlapped for years with that of his wife, Allison Shuren, a lawyer for major medical device companies. The F.D.A. acknowledged ethics violations, saying that Dr. Shuren should have sought authorization or stepped aside in some matters, but asserted that the lapses had not affected regulatory decisions.

In recent weeks, two lawmakers called on the inspector general of the Health and Human Services Department to investigate whether those matters were “simply an appearance of impropriety or actual inappropriate and unethical conduct.”

Before joining the agency in 2009, Dr. Tarver had been an assistant professor at the Johns Hopkins School of Medicine.

At the F.D.A., she became a medical officer in the ophthalmology unit, and then took on other roles, including working with the division’s patient engagement advisory committee.

Dr. Tarver later moved on to an F.D.A. office focused on emergency preparedness and response as well as digital health.

Maria Gmitro, president of the Breast Implant Safety Alliance, said she had been impressed with Dr. Tarver’s warmth and willingness to listen. Ms. Gmitro said she had raised concerns about whether women were aware that they received recalled breast implants that were associated with rare cases of blood cancer.

Ms. Gmitro said Dr. Tarver helped her group in a practical manner, working to open access to data on age and gender for an analyst examining reports of harm related to breast implants.

“So we are very optimistic with Dr. Tarver being in this position,” Ms. Gmitro said. “I’m hopeful about the progress that can happen.”

Diana Zuckerman, president of the National Center for Health Research, a nonprofit that tracks F.D.A. device policy, said she had found Dr. Tarver to be concerned about patient safety and “in making sure that patients understand the risks and benefits” of devices.

Scott Whitaker, president of AdvaMed, the largest device industry trade association, said the group was pleased with Dr. Tarver’s appointment.

[….]

Dr. Tarver will face skepticism from advocates for people who have had unwanted symptoms after LASIK surgery, such as distorted vision and eye pain.

Dr. Tarver was a leader in the agency’s ophthalmology division for years and played a role in F.D.A.-backed research on the procedure. Yet after more than 15 years of advocacy and an agency proposal in 2022 to strengthen warnings to prospective patients, no change has come about, said Paula Cofer, who suffered harm from LASIK and served as a patient representative on a 2008 panel on the matter.

The F.D.A. has said it is still reviewing comments submitted on the 2022 proposal. Among its opponents are clients of Dr. Shuren’s wife, which include a group of prolific laser surgeons and a company that makes LASIK lasers.

“She’s been involved in LASIK device policy at the agency for what, 15 years, and during this time, the agency has failed to act on evidence of high rates of harm to the public due to LASIK devices,” Ms. Cofer said. “This is just not passing the smell test.”

To read the entire New York Times article, click here.

Can a boob job kill you? The untold trauma of thousands of women suffering from ‘Breast Implant Illness’, leaving them in agony for years… yet some doctors refuse to accept it is real

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Isabelle Stanley, The Daily Mail, September 9, 2024

When mother-of-three Holly took the drastic step of having both her breasts removed, she did so believing it might save her life.

Breast cancer had claimed her mother when Holly was just 14 and her own chances of developing the disease now stood close to 90 percent.

Yet within months of the surgery and the breast reconstruction that followed, Holly felt like she was closer to death than ever before – struggling with a range of debilitating conditions including chronic pain, blurred vision and difficulty breathing.

‘I kept getting sicker and sicker,’ she told DailyMail.com. ‘I felt like I was going to die.’

It wasn’t until Holly, 57, stumbled across a Facebook support group with 50,000 women whose symptoms matched her own that she believed she had finally discovered the cause of her illness: Breast Implant Illness, or BII.

There is little support for sufferers, with some medical professionals preferring to dismiss BII entirely, but an increasing number of women – from working moms to celebrities – are speaking out about their experiences.

Crystal Hefner, wife of late Playboy founder, Hugh Hefner, had her breast implants removed in 2016 at the age of 38 telling Facebook followers that ‘my breast implants slowly poisoned me’.

Another former Playboy model and alleged former mistress of Donald Trump, Karen McDougal, had hers taken out the same year.

‘I would get sick every couple of months and be sick for six to eight weeks at a time,’ McDougal told People magazine at the time. ‘It just never went away.’

Still, despite these stories and BII cases being reported around the world for more than 30 years, the condition is neither widely researched nor well understood.

It is thought by medical professionals to be caused by either auto-immune or inflammatory responses to implants which, in turn, trigger a series of mental and physical conditions such as anxiety, rashes and chronic pain.

And the skyrocketing number of cases of women having their breast implants removed is difficult to ignore.

‘Removals have been going up for the last five years,’ confirms Dr Scot Glasberg, president of research group The Plastic Surgery Foundation.

Some 250,000 American women receive implants each year, and as many as 74,000 had their implants removed in 2023, a 40 percent increase from 2019, according to the latest data from The Aesthetic Society, a global organization of plastic surgeons.

Dr Glasberg says there is a ‘host of reasons’ behind the rise. ‘[Yet] the biggest is that women are worried about breast implant-related tumors and concerned over breast implant illness.’

BII has been reported by women regardless of whether their breast implants remain intact or rupture and leak. And the physical toll can be crippling.

It certainly was for Holly, who found herself so sick she couldn’t work while racking up $100,000 in medical bills.

She saw dozens of specialists in the ten years that followed the onset of her BII, yet none of them could figure out what was wrong.

[….]

Many plastic surgeons question whether the condition is truly real – ‘Unfortunately, it hasn’t reached the status of a defined illness [widely recognized by the medical community],’ Dr Glasberg said.

[….]

This lack of concrete medical advice has left thousands of American women with nowhere to go, resorting to online forums and support groups for guidance.

One such group, Breast Implant Illness and Healing by Nicole, has more than 190,000 members, receiving over 70 posts a day from women sharing symptoms and asking for advice.

Abbey Williamson, 28, from Columbus, Ohio, first discovered the group after multiple specialists told her she was ‘crazy’ for linking her debilitating symptoms to BII.

The police officer and mother-of-one had silicone implants put in in 2020 after feeding her daughter changed the shape of her breasts and left her self-conscious.

Abbey soon became sick, collapsing at work and on patrol and even having to be hospitalized.

[….]

‘I had doctors roll their eyes at me when I mentioned BII,’ Abbey told DailyMail.com. As her symptoms got worse, her friend who is a nurse recommended she join the Facebook group.

‘I scrolled for hours and just read women’s posts about the same thing. Honestly, that page quite literally saved my life, and changed my life, because I don’t know if I would ever have made the decision to explant had I not had that community.’

Abbey had her implants removed in 2023 and claims that her symptoms disappeared almost immediately.

‘I remember coming out of surgery and it was like I could see again,’ she said, ‘the rashes went away, I had no more joint pain, I could work out again.

‘I have not passed out or had a single episode like that since they were removed.’

The disbelieving attitude of health care professionals is a common theme among the women who spoke to DailyMail.com.

‘Women tell me they go to their doctors and say I don’t know what’s wrong with me,’ says Diana Zuckerman PhD, founder of the National Center for Health Research, ‘and doctors say, well you’re getting older, you’re 30.

‘Or they say ‘you’ve got children, you’re not getting enough sleep’.

‘It’s a combination of women not being listened to and doctors not knowing what to do, especially plastic surgeons being defensive and not helpful.’

Breast implants are a billion-dollar industry, bringing in an estimated $1.54 billion in revenue in 2021 alone, according to The Aesthetic Society.

‘There’s enormous money and pressure against doing better research,’ says Zuckerman, ‘there is so much money on the other side of this issue.’

Now, as more independent tests are done, the results are rather different, she says. And the picture they paint is increasingly damning.

One 2020 study, published in the Annals of Plastic Surgery by plastic surgeon Dr Lu-Jean Fang of 750 women with BII, found removing the implants caused a statistical improvement in every one of their symptoms.

Fang said the results showed the condition is real and that women’s symptoms are very likely caused by their implants.

‘This is real,’ agrees Zuckerman, ‘and it can be very serious, but we still don’t know how often it happens.

The Food and Drug Administration now lists the condition as a potential side effect of breast implants – a major step forward, according to BII believers.

‘Symptoms such as fatigue, memory loss, rash, ‘brain fog,’ and joint pain may be associated with breast implants,’ states the FDA’s official website.

And around five years ago, the FDA required doctors provide patients with a checklist of potential complications, although Zuckerman says this doesn’t always happen and might be counteracted by the surgeons assuring their clients they are still safe.

‘As is true with all informed consent forms, patients often don’t read them carefully and what they remember is what the doctor told them,’ she says.

Holly and Abbey claim that they were never explicitly warned about the risks by their doctors.

‘Maybe it was in the terms and conditions small print, but they never told me,’ insists Holly, who says she’d been assured that her silicone implants were ‘lifetime devices’ that would leave her feeling healthy and looking the same.

[….]

In 2022 – 12 years after the operation – and with her condition finally confirmed by a plastic surgeon, 57-year-old Holly joined the soaring number of American women having silicone implants removed from their bodies.

[….]

‘With the implants I had 30 symptoms,’ Holly tells the Mail through her tears. ‘Afterwards, I could breathe again. I could finally take a deep breath.’

Read the whole article here.