Category Archives: We Are Quoted

Danica Patrick reveals she had breast implants removed after suffering complications

Katie Kindelan, Good Morning America, May 2, 2022


Former NASCAR driver Danica Patrick revealed she had her breast implants removed after suffering medical complications she believes were caused by the implants.

Patrick, who turned 40 in March, shared in an Instagram post that she had her implants removed this month, nearly eight years after undergoing breast augmentation surgery.

“I wasn’t sure I was ready to share this…. but then I remembered that true vulnerability is sharing something you’re not really ready to. So here it is,” Patrick wrote on Instagram, before going on to describe the complications she said she faced.

Patrick said she first noticed complications about three years after getting breast implants, including weight gain and hair breakage.

Nearly two years ago, at the end of 2020, Patrick said the “wheels came off” with her health.

“I had cycle irregularity, gained more weight, my hair wasn’t looking healthy at all and my face was a different shape (weird I know),” she wrote, adding that she also faced dizziness, adrenal fatigue, hypoglycemia, leaky gut and more. “So I went down the rabbit hole to figure it out. I did every test that could be done.”

Patrick wrote that she went to multiple doctors, took thyroid medications, tried a 90-day protocol to heal her gut and at one point was taking “up to 30 pills a day” to improve her health, all to no avail.

Ultimately, Patrick said she came to the conclusion that she had breast implant illness, a term coined by clinicians and patients to describe symptoms reported by women after breast reconstruction or augmentation using implants, according to the Food and Drug Administration.
After undergoing surgery to remove the implants, Patrick said she quickly noticed improvements to her health.

“Within hours after surgery this is what I noticed – my face had more color and less dark circles … my face started producing oil again,” she wrote. “I could take a 30% deeper breath into my chest already, and I had so much energy when I woke up.”

[….]

What to know about breast implant illness

Breast implant illness is not yet a recognized medical term but is described by experts as a “diagnosis by exclusion,” according to Diana Zuckerman, Ph.D., president of the National Center for Health Research, who has studied the health impact of breast implants for over 30 years.
“Diagnosis by exclusion means that there is no test for it, but there are tests for other things that have the same symptoms or similar symptoms,” Zuckerman said. “And if there is no other reason for this array of symptoms, then there are doctors who will call it breast implant illness.”

There are as many as 40 symptoms of breast implant illness, but the most common symptoms include joint and muscle pain, fatigue, memory problems or brain fog, hair loss and difficulty breathing, according to Zuckerman.

She said Patrick’s story of taking years to get to a diagnosis is not uncommon for women who suffer health complications due to breast implants.

It can take years for breast implants to start causing complications, which makes it more difficult to link complications back to breast implants, according to Zuckerman, who was not involved in Patrick’s care. She also noted that many of the symptoms of breast implant illness can, and are, attributed to other things.

“When [women] go to the doctor and say, ‘I have joint pain. I’m really tired,’ the doctor will say things like, ‘No wonder you’re tired, you have a young child,’ or, ‘No wonder you’re tired, you’re 45 years old. You’re not 25 years old anymore,” said Zuckerman.

“So there’s been this, some might call it gaslighting, but this sense that these are common symptoms and they could be anything,” she said. “But, what is distinct about them is there are so many women who are experiencing them, and there are very good studies showing when women have these symptoms and they have their breast implants taken out, almost all of them get better.”

Breast implant surgery is considered an elective procedure that is done not only for cosmetic reasons but also for women undergoing breast reconstruction after a medical procedure such as a mastectomy.

Saline-filled and silicone gel-filled are the two types of breast implants approved for use in the United States, according to the FDA.

Breast implants may cause damage if they leak in the body, or because they can cause scar tissue to build in the body, according to Zuckerman.

“When women have a breast implant, their body almost always forms a scar tissue capsule around the implant,” she said. “The body is basically protecting itself by surrounding this foreign body, this breast implant, with scar tissue, and that scar tissue can get very thick and can get very hard and be a bad symptom in that it can be painful.”

Zuckerman said that the popularization of social media has helped women with similar symptoms connect and share their experiences, leading to greater awareness and more diagnoses of breast implant illness.

Patrick wrote on Instagram that she watched “over 100 stories on YouTube” of women with breast implant complications.

“Social media has really made the big difference here,” Zuckerman said. “It wasn’t until Facebook and other social media options became available that women could really share their stories.”

“We’ve certainly known women who’ve spent tens of thousands of dollars on tests and specialists, and nothing helped and then they went online and found a Facebook page or some other social media, and they started reading these stories of other women that sounded just like them,” she said.

[….]

Zuckerman, a member of the working group that advised the FDA on implant safety, said she advises women who are thinking of getting implants to make sure they also have the resources to get them removed later on if needed.

“Don’t get them unless you can afford to have them taken out,” she said. “A lot of women spend all this money getting them put in, and then when they get sick, they don’t have the money to get them taken out. It costs just as much, sometimes more, to have them taken out.”

To read the entire story, click here.

Bella Hadid regrets getting a nose job at 14. How young is too young for plastic surgery?

Jenna Ryu, USA TODAY: March 21, 2022


For years, Bella Hadid denied she’d had plastic surgery. But now, she’s changing her tune and speaking about a cosmetic procedure she regrets: the nose job she got when she was 14. 

“I wish I had kept the nose of my ancestors,” Hadid told Vogue last week. She’s the daughter of Dutch-born former “Real Housewives of Beverly Hills” star Yolanda Hadid and Palestinian real estate developer Mohamed Hadid. “I think I would have grown into it.”

And it’s not uncommon for teens to get cosmetic procedures. According to the American Society of Plastic and Reconstructive Surgeons, nearly 230,000 cosmetic surgeries were performed on teens ages 13-19 in 2017, and some as young as 15 are even documenting their plastic surgeries on social media. 

According to Dr. Steven Pearlman, a board-certified facial plastic surgeon, it’s legal to perform plastic surgery on anyone under 18 — as long a parent or legal guardian consents. However, some experts caution it can be “damaging” and “concerning” for teens who are under 18 to get cosmetic procedures while their bodies are still developing.

“Girls nowadays live in a culture with so much pressure to change their appearances, whether it’s putting on makeup or something more extreme like cosmetic surgery,” says Leora Tanenbaum, feminist and author of “I Am Not a Slut.”

[….]

Pearlman says that in his experience with young patients, “it’s more often that the psychological impact of a rhinoplasty, (like) improved self-esteem, surpasses the physical changes to their nose.”

However, he says teens need to be emotionally mature enough to understand the complications that come with surgery. Though there’s aren’t additional risks for teens, potential side effects of a nose job, for example, include bleeding, infection, poor wound healing or scarring according to the American Society of Plastic Surgeons.

“Some teens are more psychologically mature than others, but it’s important to note that their brain development is not at a point where they can really think through long term implications and they aren’t able to fully appreciate what the consequences might be,” explains Diana Zuckerman, president of the National Center for Health Research.

In addition, research shows that teens between the ages of 13 and 19 are especially vulnerable to peer pressure and more likely to have an unhealthy fixation on physical beauty, which may drive some to get procedures that they will later regret.

“There’s probably nobody as self-conscious as a 14 year-old girl,” Zuckerman says. “Some people have features that may make them self-conscious and it can be psychologically debilitating, but it’s also true that as people get older, they get less self-conscious and their face comes into their own.”

A ‘no win situation’

Though the decision to get plastic surgery can be empowering, experts say the marketing of these procedures to young girls is not: Rather “it’s almost always damaging” when social media and influencers force an impossible blueprint of beauty onto teens. 

“The current message is, ‘This is what you’re supposed to look like, and if you don’t, it should be fixed,” Zuckerman says. “And often these teens never even considered these features as ‘imperfections’ until they were pointed out to them.”

[….]

“For minors and parents considering having these procedures done, think about the price you will be paying societally by making this decision. Because for every individual, no matter how empowering it is for them personally, that strengthens and reinforces the pressure for everyone else,” Tanenbaum says.

Ultimately, it is up to the teen and their parent to make an informed decision about proceeding with plastic surgery.

But in an ideal world, Zuckerman hopes plastic surgeons and practitioners will use their discretion to hold off on performing cosmetic procedures on teens.

“I think it’s in parents’ and children’s best interests to delay those decisions partly because the standards we have about what is beautiful will likely change… but I know parents can feel pressured by their teenage children, and they just want their kids to be happy,” she says.

“So it would be great if surgeons had some kind of basic ethical decision of denying certain kinds of surgeries until a teenager is of age, like at least 18.”

To read the entire article, click here 

She’s the reason Arizona has a law requiring surgeons to warn patients about the dangers of breast implants

Bianca Buono and Katie Wilcox, Arizona News 12 NBC: February 22, 2022


PHOENIX — Migraines. Headaches. Insomnia. Difficulty breathing. Trouble swallowing.

Robyn Towt survived three bouts with cancer. But it was breast implants that made her the sickest.

“I couldn’t figure out what was wrong with me,” Towt said.

At first, it was a mystery. She had recently survived breast cancer then had a double mastectomy with breast reconstruction. The cancer was gone, so why was she feeling so badly?

“My entire team of doctors failed me,” Towt said.

Towt said her team of doctors never mentioned that her breast implants could cause those side effects. She started doing her own research, desperate to figure out why she was feeling this way.

[….]

Undisclosed risks

Diana Zuckerman, president of the National Center for Health Research, has been outspoken about the dangers of implants for years.

“One of the things that’s been so tragic for all these years is how many women got sicker and sicker and sicker, year after year after year, going to doctors saying what’s wrong with me and the doctor saying, you know, I don’t know, do these tests and try to figure it out,” Zuckerman said.

“And then they finally discover on social media, that there are tens of thousands of women with exactly the same health problems they have, who also happen to have breast implants, and then they get their implants out, and they get better.”

Zuckerman has been pushing for acknowledgment from the FDA that breast implant illness exists, advocating for more research around what exactly causes it and pushing for transparency when it comes to the risks.

She says the FDA took a step in the right direction last year when the agency announced breast implants would be equipped with a black box warning.

The FDA boxed warning informs patients of the following:

  • Breast implants are not considered lifetime devices
  • The chance of developing complications increases over time
  • Some complications will require more surgery
  • Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
  •  BIA-ALCL occurs more commonly in patients with textured breast implants than smooth implants, and deaths have occurred from BIA-ALCL
  • Breast implants have been associated with systemic symptoms

“They’re going to have what’s called a black box warning, that’s like the kind of warning you see on cigarette packages that tell you cigarettes can kill you,” Zuckerman said.

Arizona’s first-of-its-kind bill

Even still, that warning wasn’t always relayed by plastic surgeons to patients. That’s why lawmakers in Arizona decided to take matters into their own hands.

“We have to do something,” said state Sen. Michelle Ugenti-Rita.

Consultations for breast augmentations look different now in Arizona than they did a year ago.

That’s because a first-of-its-kind bill has passed in Arizona created to protect women against a badly kept secret involving breast augmentation surgery: breast implant illness.

“I was shocked to learn that there were so many women with very very similar stories and experiences. And yet there was nothing being done from the medical community’s perspective and point of view,” Ugenti-Rita said.

[….]

To read the entire article click here.

FDA’s agenda in limbo as Biden’s nominee stalls in Senate

Matthew Perrone, Fox13: February 08, 2022


WASHINGTON — (AP) — President Joe Biden’s pick to lead the Food and Drug Administration has stalled in the narrowly divided Senate, an unexpected setback that could delay decisions on electronic cigarettes and a raft of other high-profile health issues pending at the agency.

Biden nominated Dr. Robert Califf for the job in November after a 10-month search that critics complained left a leadership vacuum at the powerful regulatory agency, which has played a central role in the COVID-19 response effort.

Califf, a cardiologist who was an FDA commissioner under President Barack Obama, was viewed as a safe choice who could easily clear the Senate, given his 2016 confirmation by an overwhelming vote, 89-4.

But his latest Senate bid has been snared by political controversies on both the left and right that threaten to sink his nomination and leave the FDA in limbo for months — possibly even until a new Congress convenes next year.

No vote has been set on Califf’s nomination as Senate Democrats, the White House and other administration officials make a full-court press to lock up the votes needed to pass the 50-50 chamber. Former FDA officials warn that failure to move on Califf’s nomination will make it even harder to find and confirm future nominees.

“If he can’t get confirmed it bodes poorly for almost anyone else who could be nominated,” said Dr. Stephen Ostroff, who twice served as acting FDA commissioner. “What you’re seeing here is a lot of extraneous issues inserting themselves into the confirmation process and the same thing would happen to virtually anyone else nominated.”

Five Senate Democrats are opposing Califf due to his consulting work for drugmakers and the FDA’s track record of overseeing addictive painkillers that contributed to the U.S. opioid epidemic. That group includes Sens. Joe Manchin of West Virginia and Maggie Hassan of New Hampshire, both from Republican-controlled states ravaged by the epidemic.

With Sen. Ben Ray Luján of New Mexico absent and recovering from a stroke, Democrats need the support of six Republicans to confirm Califf.

[….]

The White House long assumed enough Republicans would support Califf to easily overcome any Democratic defections, given his strong support from the pharmaceutical lobby. Indeed, Califf seemed to be cruising toward confirmation after a cordial hearing before the Senate’s health committee in December, which included friendly exchanges with most of its Republican members.

But two days after his appearance the FDA eased longstanding restrictions on abortion pills that allowed women to order them through the mail. Although Califf had no role in that decision, dozens of anti-abortion groups lobbied Republicans to vote against him based on earlier changes impacting the medications while he was at the FDA.

[….]

“It is troubling to see Dr. Califf judged on issues that are a very small part of the FDA’s responsibilities,” said Steven Grossman of the Alliance for a Stronger FDA, which represents industry, patient and consumer groups that interact with the agency. “This narrow focus increases the likelihood there will be more and longer periods when FDA is without permanent leadership.”

The White House is unlikely to send another FDA nominee to Capitol Hill if Califf can’t clinch 50 votes, noted Grossman, a former HHS and Senate staffer.

In that scenario, the current acting FDA chief, Dr. Janet Woodcock, could continue leading the agency for months to come — potentially into next year. She can serve as acting commissioner as long as Califf’s nomination is pending, followed by another 210 days after it is withdrawn or expires, under federal law.

[….]

Last week Sen. Elizabeth Warren, D-Mass., announced her support for Califf after he agreed to not work for any pharmaceutical company for at least four years after leaving the FDA. Califf has recently served as a board director or adviser to more than a half-dozen drug and biotech companies, according to his ethics disclosure form.

“I think all this publicity that ‘maybe Califf isn’t going to make it’ is going to get people more focused on why they want Califf there,” said Diana Zuckerman, of the nonprofit National Center for Health Research. “I think he still has a very good chance.”

To read the entire article, click here.

What’s Wrong with the FDA?

Shannon Brownlee and Jeanne Lenzer, Washington Monthly: January 20, 2022


If Robert Califf, the White House nominee for commissioner of the U.S. Food and Drug Administration, is confirmed by the Senate, he’ll take the reins of an agency with its reputation in tatters. Once revered as the global leader in drug regulation, the FDA has approved one bad drug and medical device after another over the past 30 years, leaving staff demoralized and overseas regulators scratching their heads. Meanwhile, about a third of Americans refuse to get vaccinated for COVID-19, in part because they distrust government and scientific institutions.

In the case of the FDA, at least some of that mistrust is deserved even if the COVID vaccines are generally safe. (We’ve both taken them.) The most recent FDA disaster erupted in June, when officials approved the Alzheimer’s drug Aduhelm over the objections of the agency’s biostatistician and an 11-member committee of expert advisers. The data submitted by Biogen, the drug’s manufacturer, failed to show that Aduhelm is effective. It also poses a significant risk of harm, including brain bleeds and swelling in about a third of test subjects. Agency higher-ups decided to overlook these shortcomings and put the drug on a fast track for approval.

[….]

The Aduhelm debacle and other FDA blunders can be traced to declining scientific standards at the agency and increasingly cozy ties with the companies it regulates.

[….]

All of which suggests there’s not much chance that Califf would be the reformer the FDA needs. With eternal hope that the full Senate will reject him or, if he’s confirmed, he and the White House will pursue a reform agenda, we talked to several experts about their priorities for fixing the agency. In their view and ours, the following represent the top five actions that need to be taken.

1. Enforce commitments made by drugmakers.

The FDA awards expedited or fast-track approvals for drugs with a promise by the manufacturer that it will conduct further, more rigorous studies. However, by 2018, according to a recent review, companies followed through on only 38 percent (166 of 437) of drugs.

[….]

2. Rescind the approval of drugs that cause harm but don’t benefit patients.

When follow-up studies show that drugs are ineffective or dangerous, the FDA needs to pull them. Right now, drugs are still being prescribed to patients even though rigorous clinical trials have shown they don’t work. The agency recently allowed four out of six widely used (and heavily advertised) cancer drugs to stay on the market after their follow-up studies failed to show any benefit. Only five of 54 costly, toxic cancer drugs approved by the agency between 2008 and 2012 improved survival rates.

[….]

3. Restore rigorous scientific standards.

Many experts, including multiple FDA insiders, have complained about the progressive decay of scientific standards at the agency. This has only gotten worse since 2016, with the passage of the 21st Century Cures Act, which gives the FDA enormous leeway in what kinds of studies it demands of companies in order to get their drugs approved. The FDA needs flexibility, says Steven Goodman, associate dean of clinical and translational research at Stanford, “but it has been erring on the side of lowering the scientific bar.”

For most drugs, companies should be required to produce two randomized clinical trials, the gold standard of medical science, showing that the drug provides meaningful benefit. Fewer drugs should be approved based on a “surrogate marker,” often an imaging study or blood test that is affected by a drug but may have little to do with whether or not patients benefit. “Too many FDA decisions have been based on wishful thinking rather than medical evidence,” says Diana Zuckerman, president of the National Center for Health Research, a Washington, D.C.–based public health think tank.

4. Clean house.

Somebody needs to jam the revolving door at the FDA. Physicians, scientists, and administrators come to the agency from industry, push industry-friendly decisions, and then leave government for new, lucrative positions in the private sector.

Take Patrizia Cavazzoni, the head of the FDA Center for Drug Evaluation and Research, who oversaw the approval of Aduhelm. Before joining the agency in 2019, Cavazzoni spent nearly two decades in high-level positions with the pharmaceutical giants Pfizer, Eli Lilly, and Sanofi-Aventis. After overruling the FDA advisory committee’s resounding vote against Aduhelm, she suggested that industry “partner” with the FDA in choosing committee members, an idea that violates the whole point of having outside, independent advisers.

[….]

5. Stop Big Pharma financing.

Finally, President Biden should call on Congress to fully fund the FDA by repealing the legislation mandating that the drug industry pay for its own reviews. “What really needs to happen is to mitigate the power that Pharma already has over the FDA,” says Erick Turner, professor of psychiatry at Oregon Health & Science University and a former member of an FDA advisory committee. That can’t happen as long as the FDA is dependent on industry money.

[….]

To read the entire article, click here.

Breast Augmentation and Plastic Surgery Are on the Rise – What Are the Risks?

Juliana Guarracino, Honeysuckle Magazine: December 29, 2021


In the past year, the Brazilian butt lift (BBL) has swarmed many TikTok feeds with women sharing their experiences, both good and bad. From 2017 to 2019, the number of BBL procedures has increased by about 38 percent. This is despite a 1 in 20,117 patient mortality rate when performed by a board-certified plastic surgeon in the United States, which is higher than the death rate of outpatient surgery overall. This has accompanied an overall 33 percent increase in cosmetic surgery for women between 2000 and 2020. Though, with a growing number of patients, the safety measures meant to guarantee their safety are disputed among experts.

[….]

What Are the Risks of Breast Augmentation Surgery?

A lot of information on social media, according to Youn, tends to be advertisements, rather than credible material. There is little regulation, however, on who is able to perform plastic surgery in the United States. As Youn mentioned, not all doctors seem to put patient safety first. By law, any licensed doctor can perform plastic surgery regardless of their field and qualifications. Board certification is also not required for plastic surgeons. With such a lack of legal oversight, the idea behind this checklist is that it can help inch patients and surgeons closer to honest and informative conversations.

“With breast augmentation, it is very appealing that a patient may want it so badly, [overlooking] that there are potential downsides or risks or maintenance,” said Dr. Allison Lied, board-certified plastic surgeon and member of HealthyWomen’s Health Advisory Council. Recent regulations seek to provide patients with the information necessary to make an educated decision. Since cosmetic surgery is elective, it is especially important that there be informed consent as the procedure has the ability to put a healthy individual into a potentially life-threatening condition, according to both Lied and Youn. “I think [checklists are] good because it makes the patient slow down and consider those potentials.”

With these new mandates, surgeons must review the checklist with patients, and to confirm their understanding, patients must initial and sign the document. While this may be satisfactory enough to ensure that patients receive all information needed to guarantee their safety, Dr. Diana Zuckerman, president of the National Center for Health Research, is still concerned about the enforcement of the regulation.

“There is nothing to stop the surgeon… from saying ‘I have to give this [checklist] to you and you have to sign it, but honestly this is the safest procedure possible, and breast implants have been studied and you really don’t have to worry at all,’” Zuckerman said. While she is glad to see further regulation, she questions how the FDA will be able to ensure the thoroughness of the consultation and discussion of the checklist. “Are the women actually reading [the checklist]? Are they understanding it?”

Despite the checklist being comprehensive and informative, the design of the checklist may hinder a patient’s ability to understand the surgery and how a patient’s health may be affected, according to Zuckerman. “It starts with information you’ve already heard about… then, by the time they get to page four or five where the more important information is, are [patients] even going to be paying attention?”

The Best Breast Augmentation Information Versus FDA Hesitation

Before the release of the FDA’s most recent mandate, The Breast Implant Working Group, which includes Zuckerman along with surgeons, health policy experts and patients, spoke with the FDA to request a checklist that is more “user-friendly” than the one that the FDA had planned to release. Suggestions included clarifying potential risks, such as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a cancer of the immune system, and Breast Implant Illness (BII), which includes symptoms like memory loss, chronic fatigue and a low-grade fever. They also advised implementing a more comprehensive list of possible symptoms with stronger descriptions. The Working Group recommended that the FDA work with manufacturers to create a certification course for surgeons using their implants as well in order to address the issue of enforcement for the checklist. While these experts and advocates believed that these revisions would help to ensure informed consent for patients, the FDA proceeded with their own checklist, largely ignoring the recommendations made by the team.

[….]

While it is understandable that the FDA would be cautious about passing new regulations on something that is perhaps novel and under-researched, this is not the case for breast augmentation. With 193,073 individuals receiving breast augmentation surgery in 2020, the FDA’s hesitancy to recommendations and research may prove more dangerous than beneficial.

“No matter what’s in writing and what’s required, once you are in the doctor’s office and it’s just you and the doctor or you and the nurse, what is there to ensure you are getting accurate information?” said Zuckerman. Patients can do their own research on surgeons and procedures, but experts and policy makers in the field can further support their education and safety. For those women going under the knife and the experts supporting them, being listened to may be what defines the future of women’s health. “It’s one thing to have a good idea, another to implement this idea and another idea to enforce it.”

To read the entire article, click here.

Biden’s Drug Agency Nominee Returns With Deeper Industry Ties

Alex Ruoff, Jeannie Baumann and Celine Castronuovo, Bloomberg Business: November 23, 2021


President Joe Biden’s choice to lead the Food and Drug Administration made millions of dollars from health and drug companies since his last stint in government, raising new questions about his ties to firms the agency oversees.

Robert Califf was paid $2.7 million by Verily Life Sciences, the biomedical research organization operated by Alphabet Inc., and sits on the boards of two pharmaceutical companies, AmyriAD and Centessa Pharmaceuticals PLC. He also reported ties to 16 other research organizations and biotech companies, ethics and financial disclosure documents show.

Califf’s deep industry ties have prompted at least two Democratic senators to oppose his nomination, complicating his path to confirmation and echoing concerns that emerged when he was last nominated. While Califf previously was paid largely as a consultant for drugmakers before, in recent years he’s been hired as a top adviser and board member to major health-care companies creating innovative technologies and medicines.

[….]

Consulting, Stock Options

Califf’s reported income from the health industry skyrocketed between stints at the FDA.

Califf was a paid consultant for Johnson & JohnsonGlaxoSmithKline PLCAstraZeneca PLC, and Eli Lilly from 2009 to 2016, according to disclosures compiled by ProPublica. During this time he collected fees ranging from $2,160 to $9,000. Califf had also disclosed accepting consulting fees from drugmakers Amgen Inc.Eli Lilly & Co., and Merck & Co.

After his time leading the FDA, Califf earned $56,299 in fees from the biopharmaceutical firm Cytokinestics Inc. and unvested stock options worth as much as $5 million from Centessa Pharmaceuticals.

Califf is an expert in clinical trial research and cardiovascular medicine and founded the Duke Clinical Research Institute, a large academic center that received more than half its funding from the drug industry.

This kind of expertise is almost impossible to acquire without working with or for the pharmaceutical industry, David Magnus, director Stanford Center for Biomedical Ethics, said. Drugmakers have historically provided the funding for most clinical trials, he said.

[….]

During his first tour at the FDA, Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, Howard Sklamberg, who was a deputy commissioner under Califf, said.

“He was very, very, very careful,” Sklamberg, who’s now an attorney at Arnold & Porter LLP, said.

He may have more ties to track this time.

“It seems he would have to recuse himself from a large number of decisions,” Lisa Bero, chief scientist for the University of Colorado Center for Bioethics and Humanities, said.

Califf’s years of ties to the pharmaceutical industry don’t seem to have been “a deciding factor” in the White House’s nomination decision, Diana Zuckerman, president of the National Center for Health Research, said in an interview with Bloomberg Law.

“Dr. Califf has these other very important, positive attributes of having been FDA commissioner, having been a high-level person at FDA even before he was commissioner, and having a track record of showing his commitment to scientific evidence,” Zuckerman said.

The plan offered by Califf to manage his financial interest appears to fairly standard and routine, New York University bioethicist Arthur Caplan said. “I don’t find it disqualifying that he has industry ties,” he said, adding that he’s breaking ties with for-profit, academia, and other think tank types of organizations. Califf “showed himself to be independent and fair” when he was last at the agency, Caplan said.

To read the entire article, click here.

Biden to Choose Robert Califf to Lead F.D.A., Despite Drug Industry Ties

Sheryl Gay Stolberg and Sheila Kaplan, The New York Times: November 12, 2021


WASHINGTON — President Biden on Friday is expected to nominate Dr. Robert M. Califf, a former commissioner of the Food and Drug Administration, to lead the agency again, several people familiar with the planning said. The move would end nearly a year of political wrangling as the White House vetted then dropped several candidates after complaints that some were too close to the pharmaceutical industry.

In the end, White House officials might have concluded that they could not find a suitable candidate with no industry ties. Dr. Califf, 70, a respected academic and clinical trial researcher who ran the agency during the last year of the Obama administration, has long been a consultant to drug companies and ran a research center at Duke University that received some funding from the drug industry.

During his previous stint as commissioner, Dr. Califf sought to permit pharmaceutical companies to advertise off-label uses for F.D.A.-approved products, a practice that is not permitted under the strict regulations governing drug advertising. But the proposal, which many public health experts considered dangerous, was blocked by others in the Obama administration, according to a person familiar with it.

A cardiologist who has seen the harmful effects of smoking on the heart, Dr. Califf has been a forceful advocate for tobacco control; before he was the F.D.A. commissioner, he was the agency’s deputy commissioner for medical products and tobacco. In an appearance with other former commissioners this year, he said, “I have never seen more capable or nastier lawyers than what I experienced in trying to deal with the tobacco industry.”

He added, “It was awesome and quite frightening for public health.”

For the past two years, after stepping down as the vice chancellor for clinical and translational health at Duke University, Dr. Califf has worked as senior adviser to Verily Life Sciences, a health technology firm, and its sister company Google Health. He has encouraged Verily to focus on addiction, cardiovascular health and management of chronic diseases, according to a person at the company who spoke on the condition of anonymity.

[….]

Dr. Califf’s relationships with pharmaceutical companies as a clinical trials researcher proved to be a liability during his Senate confirmation process in 2016. Mr. Manchin blasted him for “big pharma ties” and voted against him.

Dr. Califf was confirmed for the job in a vote of 89 to 4; in addition to Mr. Manchin, Senators Edward J. Markey, Democrat of Massachusetts; Richard Blumenthal, Democrat of Connecticut; and Kelly Ayotte, Republican of New Hampshire, voted against him. But other Republicans, led by Senator Mitch McConnell of Kentucky, then the majority leader, voted in favor.

That support may be one reason Mr. Biden picked Mr. Califf: His selection drew mixed reaction.

“It is surprising that the White House has seemed really tone-deaf on conflicts of interest and very close ties to the industry,” said Diana Zuckerman, the president of the National Center for Health Research, a nonprofit think tank.

But others said they believed that Dr. Califf’s industry experience should not bar him from the job, noting that he has disclosed his ties in publishing the results of clinical trials.

“The truth of the matter is industry develops drugs — you have to work with industry. The issue is disclosure in publication,” said Ellen V. Sigal, the founder and chairwoman of the nonprofit Friends of Cancer Research, which accepts industry funding. “Rob has done many, many clinical trials with industry, but he has not been a pawn of industry. He’s completely committed to transparency, integrity and science.”

[….]

But Dr. [Aaron] Kesselheim objected to Dr. Califf’s efforts, when he was the commissioner, to allow drug companies to advertise off-label uses for their products, noting that patients can be endangered by drugs that are prescribed for uses that the F.D.A. has not approved. “That to me is a red flag,” Dr. Kesselheim said. “Hopefully, he’s moved past that as an idea, because it would be a terrible idea.”

[….]

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Biden picks ex-FDA chief Robert Califf to again lead agency

Matthew Perrone and Zeke Miller, AP News: November 12, 2021


WASHINGTON (AP) — President Joe Biden on Friday is tapping Dr. Robert Califf, a former Food and Drug Administration commissioner, to again lead the powerful regulatory agency, according to a person familiar with the decision.

Califf’s nomination comes after months of the concern that the agency near the center of the government’s COVID-19 response has lacked a permanent leader. More than a half-dozen names were floated for the job before the White House settled on Califf.

Biden is to make the formal announcement later Friday, said the person familiar, who spoke on the condition of anonymity to preview the announcement.

A cardiologist and clinical trial specialist, Califf, 70, served as FDA commissioner for the last 11 months of President Barack Obama’s second term. Before that, he spent one year as the agency’s No. 2 official after more than 35 years as a prominent researcher at Duke University, where he helped design studies for many of the world’s biggest drugmakers.

Since leaving the government, he has worked as a policy adviser to tech giant Google, in addition to his ongoing academic work at Duke.

[….]

Califf arrived at the FDA in 2015 determined to modernize how the agency reviewed drug and device study data. But his brief time as commissioner was dominated by unrelated pharmaceutical controversies, including the surging epidemic of opioid addiction and overdoses.

He was among the first FDA officials to publicly acknowledge missteps in the agency’s oversight of painkillers like OxyContin, which is widely blamed for sparking the ongoing opioid epidemic, now driven by heroin and fentanyl.

“If addiction to opioids and misuse of opioids is an enemy then we at the FDA — like every other part of society — underestimated the tenacity of the enemy,” Califf told The Associated Press in a 2016 interview. “So we’ve got to adjust.”

Califf’s extensive work with the drug industry drew scrutiny during his Senate confirmation hearing, though he was ultimately confirmed by an overwhelming margin. Given the pressing need for a permanent commissioner, he is expected to again win bipartisan confirmation. He also has the backing of the powerful pharmaceutical and medical device lobbying groups in Washington.

[….]

FDA watchers said Califf had several key advantages over other candidates vetted for the job, several of whom would have faced more scrutiny in the Senate.

“He knows how the FDA works, and he avoided making any outrageous decisions as commissioner,” said Diana Zuckerman of the non-profit National Center for Health Research. “Those are essential if the FDA is going to regain the public trust.”

His first tasks would include easing burnout and boosting morale among the FDA’s 18,000 employees. The agency’s medical reviewers have been straining for months under a crushing coronavirus pandemic workload, while the agency’s reputation for scientific independence has been battered by a string of public controversies.

Two congressional committees are investigating the agency’s June approval of the much-debated Alzheimer’s drug Aduhelm against the recommendation of its outside experts, three of whom resigned over the decision. Then in September, two top FDA vaccine regulators announced they would leave the agency after disagreeing with the Biden administration plan to make COVID-19 vaccines boosters widely available.

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Biden expected to tap Califf as FDA commissioner

Emily Kopp, Roll Call: November 12, 2021


President Joe Biden is expected to tap Robert Califf to again serve as commissioner of the Food and Drug Administration.

Califf, who previously helmed the FDA in the final year of the Obama administration, is seen as a status quo choice.

Independent experts say Califf has decades of experience in the development and conduct of clinical trials. That resume has brought Califf in frequent contact with both the FDA and the pharmaceutical industry he would be charged with regulating.

[….]

Califf had such strong bipartisan support that when Trump took office in early 2017, many pharmaceutical and medical device industry officials expressed hope he would continue on as the FDA’s leader.

“My feeling about Califf is that he’s a political compromise. His nomination shows the power of pharma. But despite his close ties to pharma, he has always talked about the importance of solid scientific evidence.” said Diana Zuckerman, president of the National Center for Health Research, a think tank in Washington, D.C. “I have some confidence that Dr. Califf is not someone who likes controversy. That is different than Dr. Woodcock who doesn’t seem to mind controversy at all. I’m hopeful he will really focus on the science in a way that has been missing lately at FDA.”

Califf’s background

Califf is a longtime cardiologist and a professor in the school of medicine at Duke University. Califf also served as founding director of the Duke Clinical Research Institute, a partnership between the university and pharmaceutical companies with the goal of innovating clinical trial design. He led it for a decade. The research institute receives about half of its funding from the pharmaceutical industry and half from the government, according to a 2020 report. He founded the Clinical Trials Transformation Initiative, a collaboration between the FDA and Duke on improving the speed and reducing the cost of clinical trials, which collaborates with pharmaceutical companies.

Califf is also an executive at Verily Life Sciences, formerly Google Life Sciences, an Alphabet Inc. company.

[….]

But Califf has in several public statements voiced support for more patient input at the FDA.

Critics say this advocacy is often financed by the pharmaceutical industry, and the FDA often does not distinguish between authentic advocacy and these conflicts of interest.

Califf has also called for other changes to clinical trials supported by the pharmaceutical company, including greater reliance on real-world evidence pulled from electronic health records outside of a clinical trial and on biomarkers, biological signals a drug is working before it shows a clinical benefit.

“Of course, the devil’s always in the details. It’s fine to be supportive, for example, of biomarkers as a way to get information about potential benefits but it needs to be backed up by solid science,” said Zuckerman.

At the FDA, Califf would likely have to respond to an ongoing investigation by the Health and Human Services inspector general into the approval of the Alzheimer’s drug aducanumab. It was approved through FDA’s accelerated approval pathway based on the difference it made with a controversial biomarker, amyloid plaques.

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