Category Archives: News Stories & Editorials

The road ahead for Califf’s confirmation

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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.

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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.

[….]

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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.”

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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.

[….]

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

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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

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

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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.

[….]

“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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Biden yet to nominate new FDA chief even as delta surges

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Justine Coleman and Alex Gangitano, The Hill, August 8, 2021

President Biden has yet to nominate a permanent head of the Food and Drug Administration (FDA) at a time when the government is navigating a surge in COVID-19 cases from the delta variant.

It’s unclear why the post remains vacant more than six months into Biden’s presidency, but some experts suggest politics may be getting in the way.

Some Democratic senators are pushing back on the prospects of acting Commissioner Janet Woodcock being named to the permanent role, but health care experts are warning that the administration needs to fill the position immediately.

[…]

Biden selected Woodcock, a longtime FDA regulator, to serve as the acting commissioner in January but has since received pushback, including from senators and anti-opioid advocates on that move.

Several Democratic senators have voiced opposition to Woodcock, citing her time at the FDA when opioid painkillers were approved, later contributing to an epidemic that has left many Americans dead.

“I continue to have concerns about Dr. Woodcock as a potential permanent FDA Commissioner, especially given the role she played in approving and labeling opioid-based medications,” Sen. Maggie Hassan (D-N.H.), a member of the Senate Health, Education, Labor and Pensions Committee, said in a statement. “That’s why I’ve called on President Biden to put forward an FDA commissioner who will act independently from the industry that he or she regulates.”

Sen. Joe Manchin (D-W.Va.), a centrist, has also called on the administration to prioritize nominating a different commissioner, citing concerns about the opioid epidemic and the FDA’s controversial approval of the Alzheimer’s drug Aduhelm.

“Dr. Woodcock is not the right person to lead the FDA,” he wrote in a June letter to Biden.

Two months earlier, Sen. Catherine Cortez Masto (D-Nev.) vowed to oppose a potential Woodcock nomination.

Her prospects have not improved over the summer.

In a statement, Sen. Ed Markey (D-Mass.) called for a “permanent, qualified, trusted” commissioner to address the pandemic and opioid epidemic. Without specifically mentioning Woodcock, he said, “The FDA needs a leader who will learn from the agency’s past mistakes to ensure it never makes them again.”

Other names floated for commissioner include Zeke Emanuel, former health policy adviser in the Obama administration and an architect of the 2010 Affordable Care Act; Michelle McMurry-Heath, CEO of the Biotechnology Innovation Organization; Katherine Luzuriaga, director of the University of Massachusetts Center for Clinical and Translational Science; and Florence Houn, who worked at the FDA during multiple administrations.

[….]

Some experts emphasized that it’s more important to get the right nominee than to rush one through the Senate.

“It’s taken the administration rather a long time to make a decision,” said Diana Zuckerman, president of the National Center for Health Research. “It makes it even more important that they make the right decision, not just be pushed into making a decision in the next X number of weeks or months.”

Zuckerman called for the Biden administration to prioritize choosing a nominee with a “very strong public health perspective,” noting that Woodcock has become an “untenable” candidate amid the opposition and “controversial” decisions at the agency during her tenure, which dates back to 1986.

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My breast implants are making me sick — and I’m not alone

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Pamela Appea, Salon: June 20, 2021

In November 2016, a few weeks after I had breast implant surgery, I came down with an unexpected case of thrush (an unappealing fungal infection characterized by a thick white coating on my tongue). As a Black married mother of two, even though I was still sick, I tried — but failed — to power through and take care of my kids. With intense flu-like aches, pain, and fever, it hurt to eat, drink, swallow, or even open my mouth. I couldn’t properly brush my teeth for several days.

Unfortunately, my primary care physician was on vacation. Panicked, I called the Manhattan oncologist whom I had seen a few weeks earlier. He’d been very kind to me following my DCIS breast cancer diagnosis, unilateral mastectomy and post-surgical treatment. The officer’s medical team could barely understand me when I tried to make the appointment on the phone.

“I don’t think you have thrush — didn’t I just see you a few weeks ago?” he said, trying to put me at ease as I stared at his cheerful neon tie. (I think he prided himself on his fun ties.)

It was torture opening my mouth so the doctor could diagnose me.

“Okay, that’s the worst case of thrush I’ve seen in some time,” the seasoned specialist said. He said he was putting me on antibiotics stat. I asked — or rather, wrote on a notepad, since I couldn’t speak clearly — if there could be any connection between the my immune system and the very new breast implant that was now in my body. The oncologist emphatically dismissed the notion as impossible.

Once he got the results of my lab work back, my physician said there was no evidence of anything wrong; I should bounce back in a few days. “These things sometimes happen,” he told me, smiling as he ushered me out.

While the antibiotics eventually cleared up the thrush, unfortunately I have never fully bounced back. In subsequent years since my breast implants were put in, it became even more clear that something was going on with my immune system. But none of my doctors really listened.

Although it was not formerly recognized by the medical community until recently, Breast Implant Illness (BII) has, in the past few years, finally received attention from both media and researchers. Nicole Daruda founded a Facebook’s support group, called Breast Implant Illness Healing by Nicole, in 2013; now, it boasts over 145,000 members. Daruda tentatively estimates that 50,000 women in the US have BII, although precise research-backed numbers are not readily available

“We are overwhelmed by women trying to join the Facebook group to be educated about Breast Implant Illness,” Daruda said. She estimates that 3,000 to 5,000 women message the group’s moderators every month. To try to meet the demand, Daruda later founded a nonprofit, Healing Breast Implant Illness Society of North America.

Research is just barely starting to emerge on BII. One study, published in Annals of Plastic Surgery in 2020, followed 750 women suffering from Breast Implant Illness over a multi-year time period. Once these women surgically removed their breast implants, the vast majority reported the majority of their symptoms had significantly improved or disappeared entirely.

Awareness appears to be growing, too. A wave of celebrities are talking more openly about breast implants and their health and wellness — including Victoria Beckham, Ayesha Curry, Ashley Tisdale, Chrissy Teigen and others.

A documentary that touches on the subject of BII, “Explant,” is screening right now at the Tribeca Film Festival. The film follows Michelle Visage, one of the celebrity judges on “RuPaul’s Drag Race.” Visage, a media personality, singer, DJ and actor who was well known for her signature Double-D breasts, found that doctors didn’t take her seriously when she told the specialists her immune system was out of whack. Visage experienced chronic health issues, including Hashimoto’s disease, that she now attributes to her breast implants.

Awareness of BII is crucial given the popularity of breast implants. Since 1998, the number of breast augmentation procedures in the US has increased threefold; now, they are one of the most sought-out cosmetic procedures.

“The desire for breast augmentation seems so powerful regardless of what else is going on in the world,” said Dr. Diana Zuckerman, founder of the National Center for Health Research. “What most concerns me is how reluctant most plastic surgeons have been to make sure their patients know the risks before making a decision.”

Because breast implant technology has existed for decades, many women erroneously believe they are safe.

[….]

In the years after my implant, some of my symptoms mirrored women on support groups I found online, which is how I figured out I had Breast Implant Illness. While symptoms sometimes waxed and waned, I got used to experiencing a host of autoimmune and other symptoms like insomnia, brain fog, extreme breathlessness, cuts that took weeks to heal, rashes, frequent colds and much more.

But BII is no longer regarded as a myth. Many or even most doctors, including plastic surgeon Dr. Anthony Youn, believe Breast Implant Illness is real. Dr. Youn acknowledges it is a controversial topic among many of his fellow American plastic surgeons.

“If you’re happy with your breast implants and you don’t believe they are adversely affecting your health, then there is no need for treatment. If you are sick and believe your implants may be the cause, speak with your primary care physician and a board-certified plastic surgeon about whether explantation may be a possible solution for you,” Dr Youn said. “There are many causes of the symptoms of Breast Implant Illness (BII) that don’t involve breast implants, so it’s often best to rule those out first,” he continued.

In his 17 years of practice in the metro Detroit region, Dr. Youn, a member of the American Society of Plastic Surgeons and The Aesthetic Society, has performed surgery on thousands of women who elected to get breast implants. Anecdotally, he estimates the number patients who later returned to his practice stating they had Breast Implant Illness symptoms is an extremely small percentage.

[….]

Though not all women with breast implants go on to develop Breast Implant Illness, all women deserve education, informed consent, insurance coverage and most important information about potential risks. If, in 2015, there had been an FDA Breast Implant Black Box Warning (which was officially unveiled in late 2020), I honestly never would have gotten breast implants in the first place.

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The Role of Environmental Regulations in the Fight Against Cancer

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NYC NPR, May 10, 2021

Last month, President Biden announced he wanted to boost funding for research on cancer and other diseases. But experts say that the fight against cancer will be tough to win if there isn’t also a focus on preventing the disease by regulating carcinogens. The Environmental Protection Agency has historically been slow to act on known carcinogens and much more research is needed to find out exactly which toxins are making us sick.

Diana Zuckerman, president of the National Center for Health Research, joined The Takeaway to discuss what it would take to win the war on cancer.

To listen, click on the play button on https://www.wnycstudios.org/podcasts/takeaway/segments/role-environmental-regulations-fight-against-cancer

Biden’s ‘end cancer’ pledge begs for environmental oversight

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Ariel Wittenberg, E&E News: May 4, 2021

President Biden pledged last week to “end cancer as we know it,” a bold promise focused on boosting funding to the National Institutes of Health for a special Advanced Research Projects Agency-Health.

ARPA-H would be similar to the Department of Energy’s Advanced Research Projects Agency-Energy, or ARPA-E, acting as a technology incubator by funding high-potential, high-impact projects that are too early for private-sector investment, but with the “singular purpose to develop breakthroughs to prevent, detect and treat” diseases.

“I can think of no more worthy investment. I know of nothing that is more bipartisan,” Biden told Congress last week. “So let’s end cancer as we know it. It’s within our power. It’s within our power to do it.”

But public health experts who have spent their careers examining environmental causes of cancer say it may not be possible to truly stop cancer without EPA stepping in.

The agency has been infamously slow to stop the use of known carcinogens for decades. Those include benzene, arsenic and asbestos, which is responsible for 40,000 deaths per year alone.

“We know that several chemicals are known to cause cancer in humans and others are highly suspect,” said Bob Sussman, an attorney and former EPA official now representing multiple groups in asbestos litigation against the agency. “There are many causes of cancer, but if we don’t address chemicals, we won’t get the job done.”

EPA could help Biden on his mission if it were faster to regulate not just asbestos but also PFOA, phthalates and bisphenol A, said Linda Birnbaum, who formerly led the National Institute of Environmental Health Sciences.

Listening to Biden’s address to Congress, she said, she was happy to hear the president “talking about major changes in how society functions.”

“But the focus was on treatment and cures,” she said. “I’m not opposed to treatment and cures, but I think it’s better to prevent if you can.”

Diana Zuckerman, president of the National Center for Health Research, agreed that the nation needs a “two-pronged attack” to end cancer.

“You can’t talk about even reducing cancer without talking about environmental toxins,” she said.

She noted that while Biden did mention a need to research cancer “prevention” during his speech, the medical community often refers to cancer screenings as prevention.

“Screening isn’t prevention; it’s early detection. You’ve already got the cancer; we just found it early,” she said. “If you want to prevent it, you have to deal with what causes it in the environment.”

Asked whether EPA sees a role in Biden’s quest to “end cancer as we know it,” the agency responded only, “EPA is fully on board with President Biden’s agenda.”

It’s not exactly clear what that means. Biden did not mention a role for the agency during the cancer portion of his speech to Congress. But the president’s quest to end cancer is famously motivated by his late son, Beau Biden, who died of glioblastoma in 2015.

[….]

Margaret Kripke, a professor of immunology at the University of Texas’ MD Anderson Cancer Center who has been studying the environmental causes of cancer for years, served on the President’s Cancer Panel in the early 2000s. The culmination of her work on the panel was a report on environmental causes of cancer that said “the true burden of environmentally-induced cancer has been grossly underestimated.”

The paper also took aim at EPA, complaining that “ubiquitous chemicals,” like bisphenol A, were still found in many consumer goods despite growing evidence of links to cancer.

“Not a whole lot has changed since then,” Kripke told E&E News last week, “except that we do know more about cancer and how it works, and how chemical exposures work.”

Unfortunately, she and Birnbaum concur, not everyone agrees about what type of evidence is needed to prove a given chemical causes cancer.

[….]

Kripke said EPA might be empowered to regulate more carcinogens if there were more research, either in the lab or in epidemiological studies.

“I do think it’s on the regulatory agencies, because there are a lot of things that are clearly carcinogenic that are regulated in other countries that are not regulated here,” she said. “But at the end of the day, the agencies can only act on the basis of information, and that information ultimately comes from the research efforts.”

That’s where she hopes Biden’s new mission can help. She said cancer funding is often determined by panels of researchers, who themselves can be biased toward funding research similar to their own. If the purpose of an ARPA-H organization is to fund research that would have difficulty obtaining funding otherwise, she said, studies on the health impacts of chemicals could fit that bill.

“If they are going to have a little broader thinking about what is appropriate for funding than traditional panels made up of people doing current cancer research, then maybe there might be a better opportunity to propose studies on cancer-causing agents or chemicals,” she said.

The Department of Health and Human Services did not respond to a request for comment on whether, if approved by Congress, a new ARPA-H would emphasize environmental causes of cancer.

But Zuckerman said she is skeptical that an ARPA-H would mean more funding for research on environmental carcinogens. While ARPA-E, at the Department of Energy, does fund applied and demonstration research for new technologies — the kinds of work private companies don’t find economical — Zuckerman noted that the research is often then picked up and used by companies looking to make money.

“You may get a huge infusion of cash, and yay for that, but it is still within a system where, at the end, there are people who want to earn money off this research,” she said. “You can earn a lot more money off a cancer treatment than you can off reducing pollution.”

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