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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

News Stories & Editorials, We're In the News

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.

He Regulated Medical Devices. His Wife Represented Their Makers.

In the News, News Stories & Editorials, We're In the News

Christina Jewett, The New York Times, August 20, 2024

When he announced in July that he would be retiring from the Food and Drug Administration later this year, Dr. Robert Califf, the agency’s commissioner, praised him for overseeing the approval of more novel devices last year than ever before in the nearly half-century history of the device division.

But the admiration for Dr. Shuren is far from universal. Consumer advocates see his tenure as marred by the approval of too many devices that harmed patients and by his own close ties to the $500 billion global device industry.

One connection stood out: While Dr. Shuren regulated the booming medical device industry, his wife, Allison W. Shuren, represented the interests of device makers as the co-leader of a team of lawyers at Arnold & Porter, one of Washington’s most powerful law firms.

Dr. Shuren signed ethics agreements obtained by The Times that were meant to wall him off from matters involving Arnold & Porter’s business. But it’s not clear how rigorously the ethics agreements were actually enforced. His wife’s law firm refused to provide a list of clients — and the agency had no legal authority to require it, said Michael Felberbaum, a spokesman for the F.D.A.

In a review of thousands of pages of court documents and F.D.A. records and dozens of interviews with current and former agency staff members and advocates, The Times identified some clients and several instances in which the Shurens’ roles intersected.

Her partner at the helm of the firm’s life sciences team began representing Theranos, the discredited blood testing company, in 2015, demanding that the F.D.A. halt an inspection at its sites in California. While Dr. Shuren said he was recused from the matter, court records suggested he remained involved.

In another case, Ms. Shuren’s firm was working on a $63 billion acquisition of the company Allergan in 2019 when Dr. Shuren initially declined to urge a recall of the company’s breast implants tied to a rare cancer.

The couple’s work overlapped again in 2022 when Dr. Shuren announced a proposal to strengthen warnings given to patients preparing for LASIK vision correction surgery. Two of Ms. Shuren’s clients opposed the plan; the recommendations have yet to be put in place.

In response to inquiries over several weeks about these cases, the F.D.A. initially said it had no indication that Dr. Shuren had violated ethics rules and needed time to “substantively evaluate” follow-up questions from The Times. In a statement Friday, Shannon P. Hatch, an F.D.A. spokeswoman, said the agency had found that “it appears there were certain instances from about 10 years ago for which Dr. Shuren should have either recused himself or sought ethics authorization to participate to avoid any potential appearance of bias.”

Ms. Hatch confirmed that the lapses occurred in the Theranos case as well as another one identified by The Times involving Alcon, an eye care drug and device company that was a client of Ms. Shuren’s.

In 2014, Alcon went before an agency committee convened to advise on whether to approve a lens implanted in the eye. According to a meeting transcript, Dr. Shuren signed off on the appointment of eight new voting members and a new chairman for the hearing, which recommended approval.

Ms. Hatch said the agency “has no indication that any F.D.A. regulatory decisions were impacted by Dr. Shuren’s wife’s employment nor that Dr. Shuren made any decisions in the interest of parties other than the public served by the F.D.A.”

While the agency conducts a nationwide search for Dr. Shuren’s replacement, he will work in the commissioner’s office to help ensure a smooth transition, according to the July statement by Dr. Califf announcing his retirement.

The F.D.A. said Friday, “Dr. Shuren has been advised of the need to exercise greater caution in matters concerning his recusal obligations and will be provided additional administrative support to better ensure future compliance.”

Neither Dr. Shuren nor Ms. Shuren responded to requests for interviews.

When The Times initially requested Dr. Shuren’s ethics records from the division he led, an official in the information disclosure unit wrote that the request was “complex” and would take up to two years to fill. Four months later, the F.D.A. provided an agreement that turned out to be two pages long after a lawyer for The Times had requested that a branch of the F.D.A. other than Dr. Shuren’s address the matter.

During the decade and a half of overlapping career trajectories, “Dr. Shuren has not requested, nor has he received any waiver or agency authorization to participate in any particular matter relating to his wife’s employment or any of her clients,” Mr. Felberbaum said.

[….]

Ms. Shuren earned from $1 million to $5 million, according to her husband’s financial disclosure form in 2018, the only one that estimated her income. Dr. Shuren’s F.D.A. salary is $400,000 a year.

Dr. Shuren led an office with about 2,500 staff members and a budget of about $790 million. He oversaw thousands of devices, ranging from tests to detect blood-lead levels to IV infusion pumps to ventilators.

Dr. Peter Lurie, a former F.D.A. associate commissioner, said he hoped the next division chief would shape a legacy that is more impartial toward device companies.

A surge in injuries

Early in his tenure, Dr. Shuren dismissed criticism from the business community over what it viewed as the slow pace of device approvals compared with Europe. Citing Europe’s lower standards and safety problems, he told The Times in 2011 that the F.D.A. would stand firm.

“We don’t use our people as guinea pigs in the U.S.,” he said at the time.

But congressional leaders on both sides of the aisle pressured the agency for faster medical device approvals. By 2014, Dr. Shuren pledged to make the United States the first place for device makers to sell their products.

[….]

In a recent presentation, he boasted that the number of first-in-the-world approvals had soared to 125 in 2023, from 25 in 2009.

“Do things now come here first?” he asked at a conference in May, referring to the new devices. “The answer is yes.”

Over time, Dr. Shuren drew closer to the medical device industry. In 2012, he co-founded a nonprofit called the Medical Device Innovation Consortium with a former executive from Medtronic, a leading device company.

To do so, Dr. Shuren secured a waiver from agency ethics rules, which prohibit federal officials from serving on boards of nonprofits to avoid divided loyalties or interests.

Most of the consortium’s board members were device industry executives, and many of its staff members had previously worked for the industry’s lobbying organizations.

As a board member, Dr. Shuren expanded the nonprofit while facing disturbing episodes at the agency over harm done by medical devices. Thousands of women reported injuries and side effects from Essure devices — small metal birth-control implants that dislodged from the fallopian tubes, tore delicate anatomy or caused allergic reactions. Other women were outraged to discover that an F.D.A.-cleared device called a power morcellator used to pulverize uterine growths might have actually spread their cancer.

Dr. Shuren promised in 2019 that a consortium project called NEST, or the National Evaluation System for Health Technology, would “empower the F.D.A. to more quickly identify, communicate and act on new or increased medical device safety concerns.”

The group has “obviously failed to do that,” said Diana Zuckerman, the president of the National Center for Health Research, a consumer watchdog group.

Agency critics have compared the NEST effort to a fox guarding a henhouse, citing the industry’s leadership at the consortium and a lack of specific safety accomplishments.

Last year, the American Medical Association, the nation’s largest physician group, raised “serious safety concerns” about medical devices, highlighting secrecy around reports of device-related injuries and a system that allowed many devices onto the market with little to no testing in humans.

The F.D.A. defended its approval process, saying it had increasingly sought more evidence before clearing products for sale. Regarding NEST, the agency noted a report by the U.S. Government Accountability Office, a watchdog agency, that said the program would begin monitoring the safety of two types of medical devices in December.

Medical specialists have also raised concerns about the safety and effectiveness of some devices approved during Dr. Shuren’s tenure. They include the CoolSculpting device, which was meant to zap fat but disfigured some people, and the Q-Collar sports safety device, which some experts say may offer little protection from injuries to the brain.

[….]
But safety issues multiplied on his watch. The most urgent F.D.A. recalls of devices that can cause serious injury or death have ticked up, to nearly 100 so far this year, from 29 in 2012, the first year such measures were tracked in an agency database. In March, a heart device was recalled after 49 deaths were linked to a specific concern.

Reports of device-related injuries soared to 900,000 in 2023, up from about 190,000 in 2012, according to Device Events, a company that makes F.D.A. data user-friendly for subscribers.

Dr. Hooman Noorchashm, a Harvard-trained cardiothoracic surgeon, said he believes the problems are a result of low standards and deference to industry. He emerged as a critic of Dr. Shuren’s after his wife died of a cancer that he said was spread by a power morcellator.

“Essentially,” he said, “he’s pumping medical products into the U.S. marketplace, outside of an evidence-based paradigm.”

Theranos hires Ms. Shuren’s team

When Dr. Shuren was named acting director of the medical device division in 2009, agency lawyers drafted an ethics agreement to prevent conflicts of interest involving his wife and her law firm. Top officials were to screen potential issues of concern, and other agency officials were to take the lead in such cases, according to the document.

[….]

A major test occurred in 2015. Daniel A. Kracov, Ms. Shuren’s partner in running the firm’s drug and device team, began representing Theranos.

At the time, he was challenging the F.D.A.’s authority to conduct an inspection at two Theranos offices in California. F.D.A. officials were concerned that the company was shipping its “nanotainer” blood-storage device without agency clearance. Theranos records for 2015 and 2016 show a $1.6 million payment to Arnold & Porter for legal services.

Dr. Shuren said around that time that he was recused from dealing with Theranos, recalled Alberto Gutierrez, then the F.D.A.’s senior scientist on diagnostic tests. But Dr. Gutierrez said he had not been informed that the agency expected another official to step in for Dr. Shuren, and Dr. Gutierrez continued to send him periodic emails about Theranos. Walter Brown, a lawyer for Mr. Balwani, gave the judge 91 documents that he said proved Dr. Shuren was dealing with Theranos matters.

Alison Daw, a lawyer representing the F.D.A., argued that Dr. Shuren had not had substantial involvement.

[….]

Breast implants tied to cancer

In the spring of 2019, the drug and device maker Allergan was under scrutiny at the F.D.A.: Women were developing a rare form of lymphoma linked to the company’s textured breast implants, which had been recalled by more than 30 countries.

At the same time, Arnold & Porter was engaged in legal issues involving Allergan. In April, a member of Ms. Shuren’s team began to defend Allergan in a California lawsuit over Botox pricing. The firm was also ushering AbbVie through a $63 billion acquisition of Allergan — a success Ms. Shuren’s team highlights on the firm’s website.

Mr. Felberbaum said Dr. Shuren was not aware of either the Botox case or the acquisition.

[….]

In May, Dr. Shuren and another F.D.A. official announced that the implants would not be recalled. In June, AbbVie announced its decision to purchase Allergan for $63 billion.

In July, Dr. Shuren and the other official reversed course and said that they would urge a recall, citing additional reports of injuries and deaths related to the lymphoma. Ms. Baumann of Arnold & Porter said that the firm represented AbbVie over antitrust questions and that Ms. Shuren had not worked on the matter.

[…]

To read the entire article, click here.

Testimony of Grace Drew at the FDA Advisory Committee Meeting on Imfinzi for Resectable Non-Small Cell Lung Cancer

Policy, Testimony & Briefings

July 25, 2024

Thank you for the opportunity to speak today. My name is Grace Drew. I am a medical student at the University of Texas Health Science Center at Houston, and today I’m speaking on behalf of the National Center for Health Research. Our nonprofit research center analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from pharmaceutical companies or any companies with financial ties to our work, and therefore we have no conflicts of interest.

We appreciate the chance to participate in FDA Advisory Committee meetings like this one, which bring together experts to examine data based on complex treatment regimens. We agree with the questions raised by FDA scientists about whether the trials conducted on durvalumab adequately address the possible benefits of perioperative treatment compared to neoadjuvant or adjuvant treatment.

We all understand the need for improved treatments for non-small cell lung cancer. Patients deserve the best possible treatments based on the best possible evidence. Obviously, overtreatment can be as problematic as undertreatment, because excessive drug dosing can cause unpleasant or dangerous adverse effects, toxicity, as well as significant financial burden to patients.

We agree that the AEGEAN trial met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in event-free survival. However, we agree with FDA scientists that the design of the AEGEAN study does not allow for a within-trial assessment of the individual contributions of durvalumab given concurrently with chemotherapy in the neoadjuvant phase compared to durvalumab given in the adjuvant phase. This is especially important because emerging data from completed trials of neoadjuvant only, adjuvant only, and perioperative immune checkpoint inhibitor regimens across other drugs in the class raise questions about the need for immune checkpoint inhibitors in both perioperative phases of therapy.

Even more important, we agree with the FDA’s concern that the AEGEAN trial indicated a nonsignificant reduction in disease-free survival in the patients that received durvalumab both before and after surgery. Since it is not statistically significant, this could have occurred by chance or could be a lasting effect of the durvalumab and platinum chemotherapy treatment before surgery. This nonsignificant finding contributes to the uncertainty about whether it is beneficial for patients to receive durvalumab both before and after surgery, rather than one or the other.

We agree with the FDA scientists that it is not appropriate to conclude that durvalumab improves disease-free or overall survival, although we also agree that the data suggest that durvalumab probably doesn’t reduce disease-free or overall survival. While the overall survival rate exceeded expectation, it was not significantly greater than the overall survival of the placebo patients, and therefore could have occurred by chance. In addition, the results may be biased because the patients in the modified resected set may have differed from the placebo group in ways that affected disease-free survival. Thus, we cannot conclude that durvalumab given both before and after surgery improved overall survival.

In conclusion, the one statistically significant benefit — event-free survival — could have been due to durvalumab given either concurrently with chemotherapy in the neoadjuvant phase or in the adjuvant phase. The other results show no statistically significant benefit in terms of disease-free or overall survival. The FDA is responsible for making a decision based on studies that are adequately designed to address the benefit of perioperative treatment as compared to neoadjuvant or adjuvant treatments.  Unfortunately, better designed trials are necessary to determine the safest, most effective regimen for durvalumab therapy. Thank you.

The Oncologic Drug Advisory Committee voted unanimously (11-0) that the FDA should require clinical trials that determine the individual contributions of treatment given before and after surgery before approving drugs to be given during both periods. They did not vote on whether Imfinzi should be approved for use before and after surgery despite the lack of evidence that both times are more beneficial than one or the other.

Open Letter to the FDA: You’re Protecting the Wrong People

News Stories & Editorials, We're In the News

Suzanne B. Robotti, MedShadow, July 23, 2024

The FDA revealed on June 18, 2024, that an unnamed number of drugs on the market right now were approved based on potentially fraudulent testing and data.1 This means there’s a risk that these medications may not be safe or effective.

The name of the testing company that produced falsified data—Synapse Labs Pvt. Ltd. (Synapse) in Pune, India—was divulged by the FDA but not the names of the hundreds of drugs that were tested by them or, more specifically, the drugs for which data was found to be fake. Why? The agency said that information surrounding how, where, and by whom any drugs are tested is “confidential commercial information.”

Are you shocked? I am. And I think we all should be.

By withholding drug names, the FDA is saying that a pharmaceutical company’s right to confidentiality is more important than people’s safety. It’s protecting pharmaceutical companies’ trade secrets and reputations, while failing at its core mission: ensuring that all drugs sold in the United States are both safe and effective. As Diana Zuckerman, PhD, President of the National Center for Health Research, succinctly said: “This is an outrageous situation where companies are notified but patients aren’t.”

Not only are these drugs still on the market and able to be prescribed, the FDA is giving all companies who used Synapse Labs a full year to retest elsewhere and resubmit that new data in order to retain their approved status.

Another disturbing fact: While most of the hundreds of drugs under question are generic versions of existing prescription drugs, some new drug applications incorporated Synapse-prepared (and potentially fraudulent) data. While there are ways for the consumer to check to see if generic drugs have been compromised—we’ll tell you how in the next section—it’s impossible for someone to check if a new drug was passed through based on faulty data. As a member of an FDA Advisory Committee that reviewed selected new drugs before the FDA approved or rejected them, I’m aghast to learn that the studies we were handed to review for new drugs may have been falsified!

Here’s How to Check If Your Drug Is Still Safe and Effective

Unfortunately, MedShadow doesn’t know of any way to find out if the brand-name drug you are taking is one of the drugs in question. If you are concerned about the safety, efficacy, or side effects of any medication, it’s a good idea to consult your health care professional and your pharmacist.

However, there are ways to check affected generic drugs. Generic drugs are an important part of the drug market, accounting for nine out of ten prescriptions filled.2 Generic alternatives to brand-name drugs ensure competition that can lower the cost of drugs and limit shortages of medicines.

The FDA reviews and potentially approves generic versions of a brand drug.3 Many drugs have multiple manufacturers–each with a slightly different generic version of the brand name drug–but all are deemed to be equivalent to the original in efficacy and safety. If, for any reason, the FDA no longer considers the data sufficient to determine whether the drug is equivalent to the original, it gives the drug a “BX” designation. You can call your pharmacist or doctor and ask if your generic’s therapeutic equivalent (TE) status has been changed to BX or you can look up your medications yourself here.4 To search for your specific drug, you’ll need the “applicant holder” (the manufacturer of your specific drug), which can be found on the bottle or packaging, often in fine print.

But to be clear, you will not find a neat list that reveals the Synapse-tested drugs that may be falsified. You will find many drugs from years past that retain their generic designation from the FDA and other drugs from which the FDA has withdrawn or downgraded its equivalency designation, including some generic versions of Cialis (tadalafil), Viagra (sildenafil), and Lipitor (atorvastatin).

The European Union decided to be more transparent than the FDA and published a list of generic drugs in question.5,6 Anyone in the U.S. is free to explore it, too, of course, and I encourage you to do so. (Note, though, that drugs may have different names in Europe and the database is very difficult to navigate.) Unfortunately, the list is limited to generics.

Do Generic Drugs Work and Are They Safe?

According to the FDA website: “FDA’s review process ensures that generic medications perform the same way in the human body and have the same intended use as the name brand medication. Health care professionals and consumers can be assured that FDA-approved generic drug products have met the same rigid standards as the innovator drug. All generic drugs approved by FDA have the same high quality, strength, purity, and stability as brand-name drugs.”7

But this assurance to the American public is useless if doctors and patients can’t be sure these standards are enforced. In the case of generics, which are so prevalent, these must be equivalent to the brand-name drugs in dosage, effectiveness and safety.

This matters enormously because if the contents of a drug don’t precisely match the listed ingredients, then the person taking that drug is at risk of:

  • Not receiving enough of the drug to be effective
  • Taking in the drug at a level that could be toxic or harmful
  • Taking in ingredients not listed, potentially causing an allergic reaction or consuming ingredients that are not approved for human use
  • Taking in substitute ingredients that have a similar effect but are cheaper and potentially not indicated for your condition

In database research done recently by Bloomberg, the media outlet speculated that generics for Cialis, Viagra, and Lipitor might have been in the fraudulent Synapse group because their therapeutic equivalence rating was changed during the window of time that fit the Synapse alert.

An Urgent Call to Action for Drug Safety

Here at MedShadow, an independent nonprofit, we work to make sure that Americans are educated about, and can protect themselves from, harmful side effects of prescription drugs. This is hard enough to do when regulatory agencies are doing their jobs well.

So I want to offer suggestions to help us all be safer while we wait for more meaningful action from the FDA.  Be extra vigilant about noticing any new reactions to any medication (generic or brand-name) you are taking. For example, if you’re on a blood pressure pill, take your pressure at home every few days to compare your readings to the past. High blood pressure can cause headaches and chest pain, while low blood pressure creates a risk of dizziness, falling and fainting. If your usual medication seems to be ineffective or creating bad outcomes, talk to your doctor right away.

This Synapse fraud is a serious breach of public trust. It’s not just a case of a contractor not doing a good job, say, painting your living room. The FDA has our health in its hands. But now we are asked to accept fraud by a lab that claimed to be testing our medications. We have a right to know what we are putting into our bodies and the effect this may have as far as science knows. And we have a right to know it now.

The FDA’s mission is simple and clear: all drugs need to be both safe and effective. Withdrawing drugs from the market that do not meet this standard may be difficult, but it must be done. Having served on the FDA Drug Safety and Risk Management Advisory Committee, I know that the FDA exists to protect the public, not the pharmaceutical companies. But now is a moment when the FDA needs to demonstrate that commitment with decisive action.

Read the article on MedShadow here.

 

1. U.S. FOOD AND DRUG ADMINISTRATION. (2024, JUNE 18). NOTIFICATION TO PHARMACEUTICAL COMPANIES: CLINICAL AND BIOANALYTICAL STUDIES CONDUCTED BY SYNAPSE LABS PVT. LTD. ARE UNACCEPTABLE. FDA.

2. U.S. FOOD AND DRUG ADMINISTRATION. (2023, APRIL 21). GENERIC DRUGS. FDA.

3. U.S. FOOD AND DRUG ADMINISTRATION. (2021, MARCH 16). GENERIC DRUGS: QUESTIONS & ANSWERS. FDA.

4. U.S. FOOD AND DRUG ADMINISTRATION. (2024). ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS. FDA.

5. EUROPEAN MEDICINES AGENCY. (2024, JUNE 5). SYNAPSE – REFERRAL. EMA.

6. EUROPEAN MEDICINES AGENCY. (2024). SYNAPSE – ARTICLE 31 REFERRAL: LIST OF MEDICINES CONCERNED BY THE PROCEDURE (ANNEX I). EMA.

7. U.S. FOOD AND DRUG ADMINISTRATION. (2023, APRIL 21). OVERVIEW & BASICS. FDA.

Revolving door: You are free to influence us “behind the scenes,” FDA tells staff leaving for industry jobs

News Stories & Editorials, We're In the News

Peter Doshi, BMJ, July 1, 2024

During his final three years at the US Food and Drug Administration the physician scientist Doran Fink’s work focused on reviewing covid-19 vaccines. But a decade after joining the agency Fink had accepted a job with Moderna, the covid vaccine manufacturer, and was undergoing mandatory FDA exit requirements. As he left for the private sector, the FDA’s ethics programme staff emailed him guidelines on post-employment restrictions, “tailored to your situation.”

The email, obtained by The BMJ under a freedom of information request, explained that, although US law prohibits a variety of types of lobbying contact, “they do not prohibit the former employee from other activities, including working ‘behind the scenes.’”

The legal ability to work “behind the scenes” is enshrined in federal regulations and highlights a “critical, critical loophole” in US revolving door policy, says a leading consumer advocate. Craig Holman, a government affairs lobbyist for the organisation Public Citizen, told The BMJ that the rules forbid various forms of direct lobbying contact but permit lobbying activity that is indirect.

“So, people will leave government service and can immediately start doing influence peddling and lobbying,” Holman explained. “They can even run a lobbying campaign, as long as they don’t actually pick up the telephone and make the contact with their former officials—and that’s exactly the advice that’s being given here.”

Diana Zuckerman, president of the non-profit National Center for Health Research and a decades long regulatory policy analyst, was surprised to learn of the FDA’s advice. “I guess I had this vision that they actually had meaningful restrictions on what people could do for at least a year” after federal service, she said. Advice given behind the scenes, Zuckerman argues, is precisely “what makes FDA scientists and staff valuable.”

The documents obtained by The BMJ show that the FDA’s advice regarding work done “behind the scenes” was not limited to a single email but appeared several times in emails to Fink and in emails to Jaya Goswami, an FDA medical officer who reviewed Moderna’s covid vaccine before leaving for a position with the manufacturer

[….]

The FDA’s guidance seems to be part of the standard boilerplate advice sent to employees by FDA staff responsible for ethical compliance. It has also been included, since June 2017, on an FDA web page detailing post-employment restrictions.4

Zuckerman finds FDA’s proactive provision of advice on behind-the-scenes work particularly troubling. “I just think that this is the key to the revolving door … It’s one thing to know it happens, and it’s another thing to know that the [FDA] ethics folks are saying, ‘Don’t worry, you can do this.’”

Peter Lurie, president of the Center for Science in the Public Interest in Washington, DC, and former associate commissioner at the FDA, suspects that in providing employees with advice on behind-the-scenes work the FDA ethics staff were simply carrying out their proper function. “It seems to me that the job of the ethics office is to interpret the law for the outgoing person, and that is what they are doing,” he says.

But Lurie expressed concern over the perils of allowing behind-the-scenes work. “It does seem contrary to the public interest that an ex-official would be quarterbacking activities behind the scenes, especially for a ‘particular matter’ on which they had worked. As a practical matter, this policy likely plays out in a way that advances the interests of big pharma, as that’s where many officials head after FDA.”

[….]

Last month US lawmakers introduced bills to amend the law regulating restrictions on departing employees. Both bills seek to prohibit former health sector employees from serving on the boards of manufacturers of drugs, biological products, or devices after public service. [….]  So far, none of the bills have passed.

To read the original BMJ article with footnotes and additional information, click here.

CPTF Testimony at the FDA Listening Session on Advisory Committee Meetings

Policy, Testimony & Briefings

June 13, 2024

Hello, my name is Laura Lytle. I am the Health Policy Director for the National Center for Health Research (NCHR), a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies, treatments, and products are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

I am grateful for the time today to share NCHR insights on the composition of FDA Advisory Committees. It’s crucial to ensure that these committees are composed of individuals who can provide objective, science-based recommendations. Here are our key areas of concern:

Consumer Representatives: Some consumer representatives lack the necessary scientific expertise to effectively analyze data and critique research design. Additionally, some may have affiliations with industry or products under review, which could lead to conflicts of interest. It’s essential to ensure that consumer representatives truly represent the consumer perspective and possess the required scientific competence. According to FDA guidance, candidates for these positions should meet two criteria: the ability to analyze scientific data and critique research design, and an affiliation with and active participation in independent consumer and community-based organizations, or a history of advocating for the public interest. Many consumer representatives selected would be better suited for positions as patient or industry representatives because they lack the necessary ability to analyze scientific data and critique research design, and many have strong ties to industry or the products they are reviewing. This can lead to conflicts of interest or an inability to make decisions in a scientifically neutral manner.

Financial Conflicts of Interest: The current FDA policy on conflicts of interest is too narrow, allowing individuals with recent financial ties to the industry they are reviewing to serve on Advisory Committees. Transparent disclosure of all financial ties to the company whose product is crucial to maintaining objectivity and trust.

Thank you for your dedication to this important issue and for your time today.

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FDA Brings Lab Tests Under Its Oversight

News Stories & Editorials, We're In the News

Judy George, MedPage Today, April 29, 2024

The FDA issued its final rule to regulate laboratory-developed tests (LDTs), the agency said Monday.

LDTs are in vitro diagnostic products (IVDs) designed, manufactured, and used within a single clinical laboratory. They can be used to measure or detect markers like proteins, glucose, cholesterol, or DNA to help provide information about a patient’s health, including diagnosing, monitoring, or determining treatments.

Historically, the FDA has generally exercised enforcement discretion for most LDTs, meaning it has not enforced applicable requirements. LDTs were certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and regulated by the Centers for Medicare & Medicaid Services, which did not require the tests to show clinical validity.

The final rule amends existing regulations and makes explicit that IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. It phases out the agency’s enforcement discretion so IVDs manufactured by a lab largely would be treated the same as other IVDs.

“LDTs are being used more widely than ever before — for use in newborn screening, to help predict a person’s risk of cancer, or aid in diagnosing heart disease and Alzheimer’s,” FDA Commissioner Robert Califf, MD, said in a statement. “The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work.”

A growing body of evidence indicates that some LDTs raise public health concerns because they don’t provide accurate test results or don’t perform as well as FDA-authorized tests, said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a press conference.

[….]

Comments posted on the agency’s proposed rule helped shape the FDA’s thinking, leading to a 4-year phase-out period of the FDA’s general discretion approach, Shuren pointed out. “After this phase-out, the FDA generally will expect IVDs manufactured by either a non-laboratory or laboratory to meet the same requirements, though certain IVDs manufactured by a laboratory may fall within one of the agency’s target enforcement discretion policies,” he said.

Those discretion policies extend to LDTs that were marketed before the final rule was issued, certain tests that may help meet an unmet need, and LDTs approved by the New York State’s Clinical Laboratory Evaluation Program (CLEP).

The FDA’s final rule was met with mixed reviews. “We strongly support FDA’s decision to regulate lab-developed tests because it is unconscionable that thousands of tests are being used by patients and consumers that have never been evaluated by independent experts to make sure they are accurate,” said Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, D.C.

“Unfortunately, this final rule has compromised on a crucial issue: it ‘grandfathers’ the thousands of tests — some dangerously inaccurate — that are already on the market, rather than requiring them to be proven to accurately diagnose serious medical conditions or genetic vulnerabilities,” Zuckerman told MedPage Today. “The previously proposed version of this LDT rule did not have that giant, deadly loophole — a loophole that was also in the VALID Act that Congress had considered on lab-developed tests.”

Last month, several speakers at a House subcommittee hearing voiced concerns that, if the FDA proposed rule passed, labs would incur significant costs to meet compliance.

[….]

Others saw the final rule today as a step forward. “The FDA is putting patients first by beginning to make many lab test developers prove their tests are accurate and clinically reliable before they are offered for use on patients,” said Patricia Kelmar, JD, of the public advocacy group U.S. PIRG.

[….]

To read the entire article in MedPage Today, click here.

Testimony of Dr. Diana Zuckerman at the Tobacco Products Scientific Advisory Committee Meeting on General Snus

Policy, Testimony & Briefings

June 26, 2024

I’m Dr. Diana Zuckerman, president of the National Center for Health Research. Our center is a nonprofit public health think tank that scrutinizes the safety and effectiveness of medical and consumer products, and we don’t accept funding from companies that make those products. Our largest program focuses on cancer prevention and treatment.

Thank you for the opportunity to share my views today. My expertise is based on my current work as well as my post-doc training in epidemiology and public health, and as a former faculty member and researcher at Yale and Harvard.  I’ve also previously served as professional staff in the US House of Representatives and US Senate, at the Dept of Health and Human Services, and the White House.  I’m a founding Board member of the nonprofit Alliance for a Stronger FDA, which educates Congress about the need to financially support the essential work of the FDA.

The question today is whether General snus should continue to be labeled as safer than other tobacco products.  I will focus on the scientific evidence, which I personally found challenging due to lack of some key information. So, I will raise the questions that weren’t a focus of the FDA review, and I respectfully encourage you to try to get the answers to these questions today. Several panel members and previous speakers have already asked some of these questions.

  1. We all know the risks of smoking, including cancer, lung disease, and cardiovascular diseases.
  2. Equally important: Most smokers start smoking as children or teenagers and most of these diseases are diagnosed decades later – usually in the patients 50’s or 60’s or even later. That’s more than 30 years later—often 40 or 50 years later, or even later.

In contrast, the data being discussed today found:

  1. A significant increase in several serious cardiovascular diseases, and these were diagnosed in studies that followed relatively young white men. For example the Araghi et al. study published in 2022 included 9 million person years of study, which sounds impressive, but averaged 22 years, including some men that were followed for only 5 years
    • Those results indicate some serious risks are evident apparently at a younger age than found with cigarettes.
  1. There was no increase found in oral cancers, despite previous evidence that smokeless tobacco can cause oral cancers. However, oral cancers usually develop in people in their 50’s or older, and many of the individuals in these studies were younger.  My question is whether the follow-up for these individuals in any of these studies is long enough to draw conclusions about oral cancer.  In addition, information provided in previous research indicate that snus in Sweden differs from snus sold in the U.S. and therefore the data provided on Swedish consumers may differ from the impact on U.S. consumers.  I hope you will ask that question.

Bottom line:

  1. How good is the evidence that using the General snus sold in the U.S. is safer than smoking cigarettes in either the shorter term (10 or 20 years) or longer term (30, 40, or 50 years)?
  2. How often do General snus users also use other tobacco products or switch to other tobacco products? Apparently the answer is often, so does the nicotine in General snus make it more difficult to quit tobacco use and instead result in continued use of snus and other tobacco products?
  3. Can the information available be understood by teenagers or adults who consider using snus if it has a modified risk claim – which will be perceived as a seal of approval by the FDA? If the lack of information makes it so difficult for me to make sense of the risks of snus, I have to assume they will too.

Thank you for the opportunity to share these views.  I encourage you to ask these questions and make sure the answers make sense.

 

Feds declare turf, rubber playgrounds “generally safe’

News Stories & Editorials, We're In the News

Ellie Borst, Politico E&E NEWS, April 18, 2024

Toxic heavy metals or associated air pollutants from recycled tire crumbs used for synthetic turf and rubber playgrounds “generally” do not put people at risk of illnesses, according to a long-awaited federal report.

A joint effort by EPA, the Centers for Disease Control and Prevention, and the Consumer Product Safety Commission, the report is the first comprehensive study on the risks of harmful chemical exposure on turf fields or rubber playgrounds and comes more than eight years after the three federal agencies first teamed up.

“Although chemicals are present in the tire crumbs, as expected, and exposures can occur, those exposures are likely limited,” Annette Guiseppi-Elie, national program director for EPA’s Chemical Safety for Sustainability research program, said during a webinar Wednesday.

Researchers studied 25 participants, both adults and children, playing on three synthetic turf fields over different durations and temperatures to see if they would be exposed to dangerous levels of chemicals well-known for human health harms.

The report reinforces EPA’s long-held stance that turf or rubber play areas are safe.

Concerns over the issue surfaced decades ago when researchers found the recycled tire crumbs, also a popular infill material for turf fields, contained traces of neurotoxic metals such as lead and zinc. Those concerns ballooned in 2016 following a “60 Minutes” report that aired the stories of former high school football players who said their cancer diagnoses could be traced back to turf fields.

Diana Zuckerman, president for the National Center for Health Research, said the report was “very disappointing” and “not a credible response” to concerns.

“I had hoped this report would be more cautious in saying this is what we know, this is what we don’t know,” Zuckerman said. “When they said this was generally not a problem … it means that most people won’t have a problem, but it doesn’t mean that nobody will have a problem. And it doesn’t mean that hardly anybody will have a problem. We don’t know how many people are playing on these fields that may be vulnerable.”

Melanie Taylor, president and CEO of the Synthetic Turf Council, said the council was “pleased to see it reaffirms what other research has shown: synthetic turf and its system components are safe.”

The report did not measure exposure to “forever chemicals,” or PFAS, a recent point of controversy in the “turf wars” due to the chemicals’ connections to cancer and other serious health effects.

[….]

To read the entire report, click here.