Category Archives: We’re In the News

What’s Wrong with the FDA?

We're In the News

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.

Biden’s ‘Cancer Moonshot’ Turns Toward Pollution

Brain Cancer, In the News, We're In the News

Ariel Wittenberg and Nico Portundo, E&E News: February 3, 2022

President Biden made an emotional pledge yesterday to “end cancer as we know it” by reinvigorating the Cancer Moonshot initiative he first launched in 2016, just one year after his son Beau succumbed to the disease.

“I committed to this fight when I was vice president. It’s one of the reasons, quite frankly, why I ran for president,” Biden told a room of cancer patients, survivors, caregivers, researchers and advocates.

A lot has changed since Biden first launched the program. This moonshot doesn’t come with any new funding, for example, but the White House says recent progress in cancer therapeutics, diagnostics and patient-driven care, as well as public health lessons learned during the Covid-19 pandemic, mean the initiative can be successful.

Another change in the renewed moonshot: an acknowledgment that environmental exposures can cause cancer.

While the previous Cancer Moonshot largely focused on funding research for treatments and cures for cancer, the renewed effort—whose goal is to reduce cancer death rates by 50 percent in the next 25 years — includes multiple initiatives to prevent cancer.

That includes addressing pollution.

“President Biden described seven areas of focus in which to make progress to end cancer as we know it today,” White House Cancer Moonshot Coordinator Danielle Carnival told E&E News in a statement. “Cancer prevention is one of those pillars and limiting exposure to carcinogens is an important part of preventing cancer.”

[….]

Though many in the environmental health field have long understood that chemical exposures can cause cancer and change peoples’ cancer outcomes, that fact hasn’t always been acknowledged by the broader medical community, which has focused more on genetic causes (Greenwire, May 4, 2021).

Linda Birnbaum, who formerly lead the National Institute of Environmental Health Sciences, told E&E News that she “tried really hard” to get the agency involved in the first moonshot initiative but was met with resistance from the National Cancer Institute.

“Environment is just not something they think about,” she said. “I’m glad to see it is at least mentioned this time.”

[….]

‘Just one sentence’

Indeed, cleaning up pollution is just one part of one of the new moonshot’s goals, which also include diagnosing cancer sooner, preventing cancer, addressing inequities, targeting the right treatment for each patient, and ramping up progress against rare and childhood cancers, among other things.

Environmental health experts were quick to note that merely acknowledging chemicals’ impact on cancers is only a first step, and say that the administration would have to do a better job at curbing pollution in order to truly “end cancer as we know it.”

In all of the pomp and circumstance surrounding the new moonshot’s launch, the experts note that environmental factors were mentioned just once in a fact sheet, and not at all in remarks from the president, vice president or first lady. Rather, much of the White House material on cancer prevention focuses on whether the mRNA technology used in Covid-19 vaccines to teach the immune system to respond to the virus could also teach bodies to stop cancer cells when they first appear.

“mRNA technology, yes, let’s spend as much money as we can to try and develop that vaccine, and maybe it will work,” said Diana Zuckerman, president of the National Center for Health Research. “But if you really wanted bang for your buck, you would want to look at environmental issues where prevention will really improve peoples’ health and reduce cancers, and that’s just one sentence here.”

Julie Brody, executive director of the Silent Spring Institute, said she wanted the moonshot to “take a bigger approach to prevention and environmental chemicals in particular,” citing a “revolution in how we think about causes of cancer” since the previous moonshot was launched.

[….]

But when White House officials discussed cancer prevention in a call with reporters earlier this week, environmental issues didn’t come up at all.

“We know cancer is a disease where we have too few effective ways to prevent it,” said one senior administration official. “There are some: don’t smoke, for example. But we don’t have lots of effective ways right now to prevent cancer.”

American Lung Association Senior Vice President for Public Policy Paul Billings agrees that there’s not one chemical like tobacco that could be the focus of prevention efforts. But, he said, “If you really want to end cancer as we know it, we do need to deal with things like environmental exposures.”

[….]

To read the entire article, click here.

Covid Booster Costs Spur Calls to Shift From Free Jabs for All

We're In the News

Celine Castronuovo, Bloomberg Law, April 11, 2022

The U.S. government’s Covid-19 vaccine funding may have to shift from a model of free shots for all to one in which the government only subsidizes boosters for targeted populations, public health analysts say.

Annual Covid-19 boosters for all Americans, tailored to the prevalent virus strain, would cost billions of dollars each year and may not be the most sustainable and effective path in responding to future variants. Analysts say reserving booster recommendations to those most at risk would be more cost-effective.

“Given the much greater expense of Covid boosters compared to flu shots and the time needed to revise and manufacture Covid vaccines, we need to hope we won’t need annual shots,” said Diana Zuckerman, founder and president of the National Center for Health Research.

It “would make sense to prioritize by focusing efforts to persuade and administer boosters to those most likely to benefit,” she said.

If the Biden administration were to purchase enough second-round booster doses for all eligible Americans, it would need to secure as much as $9.4 billion in additional funding, according to a Kaiser Family Foundation analysis.

[….]

“The provision of vaccines on a long-term basis is probably going to devolve back to our fractured private and public sectors, instead of being paid for exclusively by the federal government,” said Brook Baker, a professor at Northeastern University School of Law and a senior policy analyst at Health GAP, an advocacy group focusing on equity in access to HIV medications.

Health policy watchers say the general population could need additional boosters if more infectious and deadly variants emerge. But existing evidence on booster efficacy and the price tag for shots in every American arm means the federal government should prioritize updated vaccines for older and immunocompromised people, and vulnerable populations elsewhere, they say.

[….]

Vulnerable Populations

Lower infection severity among younger populations, and waning enthusiasm for additional shots support an approach of prioritizing older and other higher-risk Americans in booster campaigns, analysts say.

“We are likely to only boost those who are vulnerable every year against COVID-19, unless we get a more deadly variant, in which case we will all need a booster shot that year,” Monica Gandhi, an infectious disease doctor and professor at the University of California, San Francisco, said in an email.

Gandhi argued that the U.S. should follow the example of countries like Germany and Sweden, which have only recommended fourth doses for adults ages 70 years and older. She cited an Israeli study that didn’t show a fourth dose substantially benefited health-care workers under the age of 65.

“The need for further doses of the vaccine to boost antibodies will depend on clinical characteristics of the individual that may predispose to severe breakthrough infections,” like underlying health conditions, Gandhi said.

Only 45% of fully vaccinated Americans have received a first booster dose so far, according to CDC data. “The administration should not assume that everyone needs boosters now or will get them even if they need them,” Zuckerman said.

Purchasing doses at levels higher than existing demand would also mean unnecessary waste, Gandhi said. “Shots do expire, so purchasing them and having them go to waste is a waste of taxpayer money,” she said.

Instead, the administration could wait on additional research on multi-variant vaccines in development before recommending additional boosters to lower-risk people, Baker said.

“It’s a question of balancing current risks and against the possible benefits of recalibrated vaccines,” Baker said.

Long-Term Costs

Policy analysts also see a situation in the future in which the federal government no longer purchases doses directly from Pfizer and Moderna.

Providing boosters via health insurance, though, could exacerbate existing health inequities, said Leighton Ku, director of The George Washington University’s Center for Health Policy Research. “What’s terrible about Covid, and frankly speaking so many diseases, is people who are poor and vulnerable get hit the hardest.”

“I’ve always worried that the people who are uninsured are people who are low income and who are more vulnerable in so many ways,” Ku said.

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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

Breast Cancer, In the News, News Stories & Editorials, Uncategorized, We're In the News

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

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

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.

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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.

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“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.

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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.”

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Equal Access to Merck Covid Pill Imperiled by Prescribing Rules

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Celine Castronuovo and Jeannie Baumann, Bloomberg Law: December 2, 2021

The potential for Merck & Co’s Covid-19 pill to stave off severe disease could be thwarted by prescription requirements that will make access more difficult for some of the hardest-hit Americans, health researchers say.

The drug gained a key recommendation from the Food and Drug Administration’s advisory committee in a 13-10 vote. Merck’s antiviral drug molnupiravir—if authorized by the agency—would offer for the first time in the U.S. an at-home treatment option for patients with mild to moderate Covid-19 who are at risk of severe disease. The company says it expects its pill to work against the new omicron variant.

Molnupiravir, like all existing Covid-19 treatments, likely will only be available with a prescription. But that could pose a challenge for minority groups that disproportionately experience language, transportation, and other barriers that limit easy access to primary care providers.

Existing safety and efficacy data on molnupiravir didn’t take “into consideration the minority population that may not have full access to a primary care physician in order to receive a prescription in order to take the drug, aside from going to an emergency room,” Roblena Walker, a member of the FDA Antimicrobial Drugs Advisory Committee, said at the Nov. 30 meeting after the vote.

The concerns further highlight health disparities that the pandemic brought to the forefront.

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Access Barriers

Easy access to primary care services, economic stability, and other social factors can play a role in the rate of Covid-19 infection and the severity of illness among communities of color, policy analysts say. U.S. life expectancy dropped an average of 1.5 years during the pandemic but for Black Americans, it was 2.9 years—widening an existing gap between Black and White Americans.

People in the U.S. who are Black, Asian, or Native American are typically less likely to have a usual primary care provider, according to a 2019 annual health disparities report from the Agency for Healthcare Research and Quality. Data from the report also showed that lacking health insurance makes people more likely to not visit a physician regularly.

All existing Covid-19 interventions, except for vaccines, need prescriptions before being administered, Diana Zuckerman, founder and president of the National Center for Health Research, noted.

“There’s every reason for this treatment to require prescription,” Zuckerman said. She noted the modest benefit molnupiravir showed in existing trial data—it reduces the risk of hospitalization or death among adults with mild to moderate disease by 30%—and the concerns that remain, including whether the antiviral pill could lead to additional mutations of Covid-19.

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Affordability

Monoclonal antibodies, such as the ones from Regeneron Pharmaceuticals Inc. and Eli Lilly & Co., target the same patient population as molnupiravir, but they’re more expensive and must be administered in infusion centers.

The federal government should help make sure that cost doesn’t also present a barrier to Merck’s at-home treatment, Zuckerman said.

“If a decision is made to make this drug available, it should be available for free,” Zuckerman said. She added that community clinics “should have Covid testing there, and they should have access to this drug there in order to make it available to everybody who needs it.”

Zuckerman added that federal authorities’ goal for reducing drug access disparities should be to limit the costs patients, especially those without health insurance, would have to pay for the drug.

The federal government ordered about 3.1 million courses of molnupiravir to be made available to patients, with an option in its contract to purchase more than 2 million additional courses.

Target Population

Another obstacle to access is the limited research done on the drug’s impact on people with underlying conditions or other factors that may put them at greater risk for infection and serious illness from Covid-19.

Heart disease, a chronic illness, or some other condition that weakens a person’s immune system makes them more vulnerable to severe Covid-19 illness, according to the Centers for Disease Control and Prevention. FDA committee members, including those who voted in favor of recommending the Merck pill, addressed the need for more specific data to determine if molnupiravir could benefit these at-risk groups.

“There needs to be studies in vaccinated individuals, studies in those with prior infection, studies in immunocompromised, particularly to understand safety,” Antimicrobial Drugs Advisory Committee chair Lindsey Baden said Nov. 30.

Given the Merck trial’s focus on unvaccinated individuals, the federal government could ultimately decide to restrict treatment access to those who are at higher risk and who have not gotten a Covid-19 shot— a move Zuckerman said could spark “tremendous political backlash.”

“People at high risk who are unvaccinated are unvaccinated, for the most part, because they didn’t want to get vaccinated,” she said. She added that making the drug available only for this population could prompt criticism because “nobody wants to encourage people to be not vaccinated.”

While an antiviral Covid-19 drug may not bring substantial benefits for all Americans, Zuckerman said getting tested for free at community clinics and getting vaccinated are among the other options available to stay protected against Covid-19 for those who are uninsured and without a primary care provider.

“The bottom line is for people without insurance, getting vaccinated is, by far, the best thing they can do,” she said.

To read the entire article, click here.

Biden’s Drug Agency Nominee Returns With Deeper Industry Ties

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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.

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Consulting, Stock Options

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

Califf was a paid consultant for Johnson & Johnson, GlaxoSmithKline PLC, AstraZeneca 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.

The road ahead for Califf’s confirmation

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

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

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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

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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.

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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.”

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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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