Category Archives: News Stories & Editorials

Will the FDA change how it vets drugs following the Alzheimer’s debacle?

Max Kozlov, Nature, May 13, 2022


Nearly a year after the US Food and Drug Administration (FDA) gave the green light to a controversial drug to treat Alzheimer’s disease, lawmakers are attempting to amend the process that led to its approval.

The House Committee on Energy and Commerce, which oversees drug safety and biomedical research, announced last week that it hopes to grant the FDA greater authority to rescind accelerated approvals if a company fails to complete follow-up studies on the treatment in a reasonable amount of time.

The provision, which was introduced as part of an FDA funding reauthorization bill, likely to be passed before September, comes on the heels of the agency’s 2021 approval of aducanumab, an antibody drug shown to reduce the accumulation of plaques in the brain associated with the progression of Alzheimer’s. Despite a nearly unanimous vote against the approval by an independent panel of experts, the agency fast-tracked the drug, which was developed by Biogen, a biotechnology company based in Cambridge, Massachusetts. Three advisory-panel members resigned in protest against the decision, and the approval is the subject of multiple investigations by federal regulators.

Aducanumab is not the only reason that this drug-approval pathway is coming under fire: since its inception, the programme has led to 279 treatments reaching the market, with nearly two-thirds in the past decade alone (see ‘Growing momentum for accelerated approval’). The programme’s increasing popularity signals a shift away from its original intent, says Diana Zuckerman, president of the National Center for Health Research, a non-profit organization in Washington DC. “Accelerated approval started out as a special programme for a small number of drugs, and now most cancer drugs are going through accelerated or some other expedited pathway,” she says.

Companies, moreover, have been slow to produce the follow-up studies promised as part of the approval process. The FDA has limited power to compel them to provide the data, but the legislative proposal — which could still change significantly as it wends its way through the House of Representatives and the Senate — could grant it more authority to do so.

Days before his appointment in February, FDA commissioner Robert Califf pledged to make accelerated-approval reform a priority for the agency. Researchers who spoke to Nature agree that reforms are needed to protect the integrity of the programme, and that the proposed legislation is a good start. But they also recommended more agency oversight and other changes that would further prevent pharmaceutical firms from abusing this route to the market.

“Instead of the drug companies living up to and working to ensure that they are employing the accelerated-approval pathway as intended, we have too many that are willing to take advantage of the loopholes where they can find them,” says David Mitchell, president of Patients for Affordable Drugs, a non-profit organization in Washington DC, who serves as a consumer representative on the independent panel that reviews cancer drugs for the FDA.

The need for speed

The FDA created the accelerated-approval pathway in 1992, largely in response to the HIV–AIDS crisis, to get urgently needed drugs to the market without delay. Instead of demonstrating efficacy through clinically-meaningful endpoints, such as patient survival or reduction of symptoms, drug candidates reviewed under this pathway often rely on what are known as surrogate endpoints, which may be faster or easier to track than conventional clinical-trial endpoints. For example, tumour shrinkage is a common surrogate used in cancer-drug clinical trials, but this metric is not necessarily linked to a direct benefit to patients.

Gregg Gonsalves, an epidemiologist and global health specialist at Yale University in New Haven, Connecticut, was among the group that persuaded the FDA to adopt this programme. “We pushed for this accelerated approval pathway because people were dying,” he says. “I’m HIV positive, so I get the desperation and need for hope.”

The pathway has turbocharged the number of immunotherapies and cancer treatments on the market. But some of these drugs cost hundreds of thousands of dollars per year, despite, in many cases, limited data showing their clinical utility. Gonsalves argues that the programme has been co-opted by the pharmaceutical industry to speed approvals. Cancer treatments approved through the pathway have made it to market on average about three years earlier than they would through standard routes. And a single study using surrogate endpoints could be enough to get a treatment on the market.

Part of the problem, says Caleb Alexander, an internal-medicine specialist and epidemiologist at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, is that drug companies aren’t upholding their end of the bargain with timely post-market studies confirming the benefits of the drug. Some researchers question whether companies are given too much time to produce such data. A 2021 analysis found that 13% of drugs granted accelerated approval between 1992 and 2016 hadn’t been converted to full approval within five years — and remained on the market for a median of 9.5 years without the data needed for conversion.

[….]

Post-market trials can take a long time, especially for slowly-progressing conditions such as neurodegenerative diseases, says a spokesperson for the Rare Disease Company Coalition, an organization in Washington DC that represents 21 pharmaceutical firms.

It is also difficult for companies to recruit participants, because people would much rather be guaranteed an approved medicine than risk getting a placebo. Instead of demanding that a company stop selling a drug that hasn’t been converted to full approval, says Zuckerman, the agency often requests that the company voluntarily withdraw it from the market. “The FDA loses an enormous amount of leverage once a product is approved,” says Alexander.

[….]

How effective the proposed rule changes for the US FDA would be is unclear. Although they would make it easier for the agency to withdraw approval, they would also lengthen the bureaucratic process of rescinding approvals. This defangs the provision, Zuckerman says. She would have preferred to stick with an earlier proposal, which would have automatically revoked approvals once confirmatory trials were one year overdue.

Zuckerman also recommends that the FDA commissioner’s office create a separate independent advisory group to review agency approvals that go against advisory panel recommendations — as happened for aducanumab. “The vast majority of advisory-committee votes recommend approval, so when they don’t recommend approval, there’s usually a really good reason,” she says.

Alexander suggests using health-care coverage as leverage. The US Centers for Medicare & Medicaid Services (CMS) in Baltimore, for example, decides which treatments will be funded for tens of millions of US residents. Earlier this year, concerned about the efficacy of aducanumab, the CMS stated that it would cover the annual US$28,800 cost of the drug only for people enrolled in clinical trials.

Although that decision is nearly unprecedented, Alexander thinks that the CMS should consider a lower reimbursement rate for other accelerated-approval treatments that have not yet gained full approval. Such a move could “light a fire underneath manufacturers” to complete their trials, he says. “Why should taxpayers be on the hook for paying the full price of a drug when we don’t know the full scope of its safety and effectiveness?” he asks.

[….]

Reform won’t be simple. Once a medicine enters the market, Mitchell says, “drug companies aren’t anxious to find a reason to take it off”.

Still, many researchers and drug-safety advocates are eager to see change. “We started out trying to fix a pendulum that was too far in one direction,” says Zuckerman, “and look how far we’ve come in this direction now.”

To read the entire article, click here.

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.

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.

The road ahead for Califf’s confirmation

Marisa Fernandez, Axios and Yahoo News: November 15, 2021


It’s taken about 10 months for President Biden to name a nominee for the role of permanent FDA commissioner — former FDA chief Robert Califf — and it’s unlikely his confirmation will be complete before the end of 2021.

Why it matters: The agency has been without a Senate-approved commissioner for nearly a year, all while playing a central role in the response to the ongoing COVID pandemic.

The selection of the former commissioner came after the White House dropped several prior candidates, including acting commissioner Janet Woodcock, who faced strong opposition over her pharmaceutical ties, the New York Times reports.

[….]

What to watch: Califf was confirmed in 2016 by an 89-4 vote, but he’ll still face some questions over his ties to the pharmaceutical industry. Democratic Sens. Joe Manchin, Ed Markey and Richard Blumenthal, who voted against Califf last time, all reiterated their concern on Friday.

  • He was the founding director of the Duke Clinical Research Institute, where he worked closely with drug companies and received consulting fees prior to his first stint as FDA commissioner. More recently, he’s served as a senior adviser for Verily and Google Health.
  • “The public has been asking if they can trust the FDA to ensure that the benefits outweigh the risks for Alzheimer’s drugs, cancer treatments, and implanted devices,” Diana Zuckerman, president of the National Center for Health Research, a non-partisan non-profit think tank, told Axios.

[….]

To read the entire article, click here.

Biden Picks Robert Califf to Head the FDA for a Second Time

Chloe Tenn, The Scientist: November 12, 2021


President Joe Biden announced today (November 12) his nomination of Robert Califf for the role of commissioner of the US Food and Drug Administration. Califf previously helmed the FDA for the Obama administration in 2016, but many of his plans were left unfinished during his 10-month tenure, reports STAT. His nomination will need to be confirmed by the Senate before he can assume the position again.

While commissioner, Califf made efforts toward reforming medical digital data systems and regulating tobacco products like e-cigarettes, according to STAT. Some of his initiatives, such as creating a collaborative organization to collect and distribute medical data nationally and improving the FDA hiring system, did not take effect.

After leaving the FDA commissioner position in 2017, Califf joined Verily, a biotechnology company with the same parent company as Google. There he led efforts to streamline and modernize clinical trials and medical data collection. He was also a consultant for pharmaceutical companies like Merck, Biogen, and Genentech, reports The New York Times.

[….]

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

[….]

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.”

[….]

To read the entire article, click here.

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.

[….]

To read the entire article, click here.

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.

[….]

To read the entire article, click here.

Biden chooses Robert Califf, former Obama FDA chief, as agency commissioner

Laurie McGinley, Washington Post: November 12, 2021


President Biden is expected Friday to nominate former Food and Drug Administration commissioner Robert M. Califf to return as the agency’s head, ending a difficult, months-long search to find a leader for the sprawling bureaucracy on the front lines of the coronavirus pandemic.

The announcement is expected later in the day, according to people familiar with the decision who spoke on the condition of anonymity because they were not authorized to discuss the issue.

Califf, 70, a renowned cardiologist and researcher, is senior adviser for Verily, a research organization devoted to the life sciences, and Google Health. He served as FDA commissioner during the last year of the Obama administration. Before that, he had a long career at Duke University School of Medicine, where he founded the Duke Clinical Research Institute, one of the largest academic clinical trial operations in the world.

Many FDA experts see Califf as a safe choice — an experienced hand who is unlikely to make abrupt changes as the agency navigates a tumultuous period marked by high-pressure reviews of coronavirus vaccines and therapies and hot-button issues involving Alzheimer’s treatments, opioids and tobacco products. An expert on clinical trials and other types of health data, Califf is likely to press for better evidence in assessing drugs and devices.

But others hoping for fresh leadership see Califf’s nomination as a missed opportunity. Some are uncomfortable with his longtime relationships with the pharmaceutical industry.

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“I think he would be terrific,” said Harlan Krumholz, a cardiologist at Yale School of Medicine. “It is critically important to have a commissioner who can step in and knows the job and knows how to make policy decisions.”

Even some of the agency’s toughest critics say Califf is acceptable.

“Rob Califf is a good choice,” said Aaron S. Kesselheim, a professor of medicine at Harvard Medical School who has faulted the FDA for approving drugs on what he considers flimsy evidence. “Califf certainly spent the vast majority of his early career working on clinical trials … and understands the value of rigorous data.”

But Califf’s longtime industry relationships have drawn criticism from some who argue the agency already is too close to the companies it regulates.

“Califf has a long history of extensive financial ties to Big Pharma, most significantly through pharmaceutical industry funding of the Duke Clinical Research Institute,” said Michael Carome, director of nonprofit Public Citizen’s Health Research Group, a consumer advocacy organization. “We need someone to tilt in the opposite direction and be more pro-public health and less pro-regulated industry.”

Some past critics, however, have softened their views of Califf. Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank, said that while she still considers Califf’s industry ties to be a shortcoming, “He has certain qualities that are very good for the position. He has experience at the FDA and a commitment to science. That’s very important.”

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