Category Archives: News Stories & Editorials

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.”

 [….]

 To read the entire article click here.

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.

[….]

To read the entire article, click here.

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.

To read the entire article, click here.

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.”

You can read the entire article here https://www.eenews.net/stories/1063731675

To Stay: Two More Cancer Indications With ‘Dangling Approvals’

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Kerry Dooley Young, Medscape News: April 29, 2021

Two more cancer indications that had been granted accelerated approval by the US Food and Drug Administration (FDA) are going to stay in place, at least for now. This was the verdict after the second day of a historic 3-day meeting (April 27–29) and follows a similar verdict from day one.

Federal advisers so far have supported the idea of maintaining conditional approvals of some cancer indications for a number of immunotherapy checkpoint inhibitors, despite poor results in studies that were meant to confirm the benefit of these medicines for certain patients.

On the second day (April 28) of the 3-day FDA meeting, the Oncologic Drugs Advisory Committee (ODAC) supported the views of pharmaceutical companies in two more cases of what top agency staff call “dangling accelerated approvals.”

ODAC voted 10-1 in favor of maintaining the indication for atezolizumab (Tecentriq) for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.

ODAC also voted 5-3 that day in favor of maintaining accelerated approval for pembrolizumab (Keytruda) for first-line cisplatin- and carboplatin-ineligible patients with advanced/metastatic urothelial carcinoma.

The FDA often follows the advice of its panels, but it is not bound to do so. If the FDA were to decide to strip the indications in question from these PD-1 medicines, such decisions would not remove these drugs from the market. The three drugs have already been approved for a number of other cancer indications.

Off-label prescribing is not uncommon in oncology, but a loss of an approved indication would affect reimbursement for these medicines, Scot Ebbinghaus, MD, vice president of oncology clinical research at Merck & Co (the manufacturer of pembrolizumab), told ODAC members during a discussion.

[….]

Another participant at the meeting asked the panel and the FDA to consider the burden on patients in paying for medicines that have not yet been proven to be beneficial.

Diana Zuckerman, PhD, of the nonprofit National Center for Health Research, noted that the ODAC panel included physicians who see cancer patients.

“You’re used to trying different types of treatments in hopes that something will work,” she said. “Shouldn’t cancer patients be eligible for free treatment in clinical trials instead of paying for treatment that isn’t proven to work?”

[….]

To read the entire article, see https://www.medscape.com/viewarticle/950165

FDA Scrutinizes Pricey Cancer Drugs

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Politico Pulse: April 28, 2021

What should be done about expensive cancer drugs on the market that might not work? That could be the first thorny question to confront Woodcock, who is acting FDA commissioner while Biden weighs whether to nominate her for the full-time role.

The FDA is convening an expert panel this week to discuss whether the agency should revoke approved uses of three therapies that, despite positive signs from early research, failed to help patients with certain cancers live longer. All three medicines were approved under Woodcock’s tenure as drug chief and after increasingly speedy reviews.

Drug regulators “wanted to get these drugs to market as quickly as possible,” said Diana Zuckerman, a drug safety expert and president of the National Center for Health Research, who is presenting several times at this week’s meeting. “That was clearly their goal and they succeeded in doing it. But now there is a reckoning.”

What the companies say: Genentech, Merck and Bristol-Myers Squibb, the companies at the center of the debate, say their drugs still have value against the cancers in question, they just need to do more research. And Genentech on Tuesday applauded the advisory panel’s vote to keep its drug on the market for triple-negative breast cancer, one of the approvals in question.

To see the entire Politico Pulse, read https://www.politico.com/politicopulse/.

Can California’s public universities mandate COVID-19 vaccines?

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Robert M. Kaplan and Diana Zuckerman, Ph.D., Monterey Herald: April 26, 2021

Last week, the University of California and the California State University system proposed mandating COVID-19 vaccines for faculty, staff, and students beginning in the fall.  Only those with medical conditions aggravated by vaccination or those with legitimate religious objections would be excused.  The policy is consequential: Public university students, faculty and staff include nearly 1,000,000 Californians. But is the mandate feasible? And, should the California universities dive headfirst into what promises to be a complicated controversy?

With waning competition for shots, public health officials now worry about vaccine hesitancy. Lower vaccination rates give more opportunities for variants to develop and could make the pandemic last longer. We all benefit when more people are vaccinated.  Yet, national polls by Stanford and YouGov show that about 20% of Americans will refuse to be vaccinated, and one in three estimate their likelihood of getting vaccinated is below 50%. Only 20% strongly agree that vaccines should be mandated and 45% report that vaccinations should be strictly voluntary.

Requiring vaccinations may be legal. Since 1905, courts have consistently upheld vaccination mandates, but with some exemptions.  Although 50 states and Washington D.C. can require vaccines for primary schools, all states allow medical exemptions.  Further, 45 states permit religious exemptions and 15 recognize philosophical objections.  Only 16 states allow post-secondary institutions to require vaccinations for influenza or hepatitis B.

Despite these precedents, the UC/CSU proposal could be derailed because current CDC policy only allows mandates for vaccines approved by the Food and Drug Administration. Technically, no COVID vaccine is currently approved. Instead, the three vaccines have been authorized under a different vetting mechanism called Emergency Use Authorization.  Unlike FDA approval, EUA is a temporary agreement that allows medical products to be used in emergency situations based on FDA’s determination that the benefits “may” outweigh the risks.  That requires a less rigorous standard of evidence than FDA approval. Before the pandemic, EUAs were only used to speed emergency treatments to a relatively small number of people threatened by Ebola, Zika, and anthrax.

To be fair, each of the three authorized (but unapproved) COVID vaccines underwent rigorous testing in large studies. However, the FDA had announced that full approval of these vaccines would require following study participants for “at least one to two years.”  For the EUA’s,  FDA permitted just two months of follow-up and stated that while two months was the minimum to determine safety, it wasn’t sufficient to determine how long the vaccines would be effective.

With the EUAs in hand and bolstered by promising early results and extremely high demand for vaccines, companies had no incentive to continue the trials. Despite advice by scientists to continue studies with the inclusion of a control group, all three companies provided the vaccine to participants who had received a placebo. The ethical reasons for this are obvious; however, the consequence is that a rigorous evaluation of the long-term benefits and side effects is no longer possible in the absence of a placebo control group.

What do we know about safety?  137 million Americans have had at least one dose of the vaccine.  Although at least half have experienced bothersome reactions, very few have reported serious side effects that resulted in permanent damage or death. The FDA and CDC have two systems to track real-world reactions. V-SAFE is an app that regularly asks vaccinated individuals to report any health problems. Unfortunately, very few individuals use it.  The other system, the Vaccine Adverse Event Reporting System (VAERS) is designed for health care providers to report bad reactions to vaccines.   As with V-SAFE, reporting is not enforced and therefore reactions are under-reported.  The current systems are limited because they were not designed to accurately determine how many people experience adverse events.

UC/CSU should be commended for proposing a bold strategy to address a serious problem.  A mandate to vaccinate university communities could turn the campuses into COVID safe zones. However, it is likely to encounter serious legal challenges if none of the vaccines are FDA approved before the mandate is implemented. Instead of waiting for the FDA to deny approval for insufficient evidence, the UC and CSU systems could use their exceptional creativity and research capability to produce better evidence that would inform the FDA about the long-term scientific safety and effectiveness of the vaccines.

Robert M. Kaplan is a faculty member at Stanford University’s Clinical Excellence Research Center and a former Associate Director of the National Institutes of Health. Diana M. Zuckerman is the President of the Washington DC-based National Center for Health Research. She is an expert on the safety and effectiveness of medical products. You can view the original article here. 

Conflicts Galore: Upcoming Accelerated Approval Cancer Panel May Be Tainted By Industry Relationships

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Sarah Karlin-Smith, Pink Sheet: April 21, 2021

Six members of the FDA Oncologic Drugs Advisory Committee received conflict of interest waivers to participate in the agency’s upcoming three-day meeting to review the accelerated approval of six checkpoint inhibitor indications after the three cancer immunotherapies at issue failed to confirm clinical benefit in post-market trials raising questions about whether industry influence may heavily factor in the committee’s decision making.

The high number of waivers could mean that a majority or close to a majority of the panelists will have conflicts based on the typical number of advisors on FDA panels. The agency used to be subject to waiver limits but the 2012 FDA Safety and Innovation Act removed these restrictions.

ODAC’s 27-29 April meeting, part of the agency’s broader industry-wide effort to evaluate accelerated approvals for oncology drugs, is unprecedented in the number of drugs and indications up for accelerated approval withdrawal. The committee will discuss two indications for Tecentriq (atezolizumab); three for Keytruda (pembrolizumab); and one for Opdivo (nivolumab).

[….]

Vinay Prasad, a hematologist-oncologist at the University of California San Francisco acknowledged that it may not always be easy to find unconflicted experts but, he said they do exist. He also argued that in this case you might be able to look at other professionals like internists who study research methods and FDA approvals, for example for panel members.

[….]

Diana Zuckerman, president of the National Center for Health Research said that while FDA needs some people with clinical expertise who understand the illness and issues with the treatment, it doesn’t need an entire panel of these people. She said that one way FDA can find more qualified experts is by looking at schools of public health where academics rarely get money from industry and they have expertise in understanding clinical trials as well as biostatics.

Even if the academic’s salary isn’t directly funded by their work with industry, there are multiple reasons to be concerned that work on industry trials with the same drugs creates conflicts.

“There’s research showing that researchers feel more positively about drugs that they’ve studied. That’s normal human behavior. You feel proprietary towards something that you’ve studied. You also have a relationship with the company,” said Adrian Fugh-Berman a professor Pharmacology and Physiology at Georgetown where she directs PharmedOut, a project that focuses on evidence-based prescribing and studying industry marketing practices.

The person may also be thinking about how their behavior on the committee may impact other research opportunities the university or they in particular have with the company, she explained.

“Are you going to get more research grants for the company if you kill their drug?” Fugh-Berman said.

[….]

Over the past 12 months ODAC has had two other committee meetings where four waivers were granted but that is far from typical. Most agency advisory committees don’t have any waivers or at most have one or two, per data from FDA from 2018 onward.

FDA is supposed to publish an annual report to Congress on advisory committees that include information on waivers but the latest report available online was from fiscal year 2016. FDA did respond to questions about whether more updated data exists and where it can be found.

​To read the entire article, see https://pink.pharmaintelligence.informa.com/PS144196/Conflicts-Galore-Upcoming-Accelerated-Approval-Cancer-Panel-Includes-Many-Industry-Relationships

4 in 10 Adults Over 50 Consult Online Reviews When Picking a Doctor

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Steven Reinberg, HealthDay: April 14, 2021

Finding a new doctor can be a daunting task. For help, many older adults turn to online reviews, a new study finds.

In fact, many people rate online reviews as highly as they would a recommendation from friends and family when picking a doctor, the new research found.

“Doctors and policymakers should know that many older adults are viewing and valuing online ratings and reviews when choosing physicians,” said researcher Dr. Jeffrey Kullgren. He’s an associate professor of internal medicine at the University of Michigan in Ann Arbor.

[….]

Diana Zuckerman is president of the National Center for Health Research, a nonprofit think tank that conducts research on a range of health issues. She said that choosing a doctor is a complex undertaking.

“The trouble with these ratings is they’re not based on how good the physician is,” said Zuckerman, who wasn’t involved in the new study. “They’re usually based on convenience issues, like how long do you have to wait in the waiting room, how nice is the doctor, and does the doctor listen to you. These are all nice things, but they’re not really the important things.”

[….]

In all, the survey found that 40% of adults aged 50 to 80 have used online doctor rating sites and trust them almost as much as recommendations from family or friends for choosing a doctor. Also, online ratings were seen as more important than where a doctor went to medical school or trained.

[….]

Women, people with more education and those with chronic conditions were the most likely to turn to online rating sites, the investigators found.

[….]

Zuckerman said that most people don’t have the expertise to rate a doctor in ways that are meaningful in terms of how good a physician is or how good the medical care that they’re going to get is.

Often, online ratings should be taken with a grain of salt, she said, because you don’t know exactly what the ratings are based on.

The recommendation of friends or family members can be helpful, but in the end, it’s going to be how your experience with a doctor measures up to your needs and expectations that are important. And you shouldn’t be afraid to change doctors if you’re dissatisfied with your care, she adonvised.

Zuckerman agreed with the researchers that it’s up to policymakers and clinicians to set standards and criteria for online reviews. Patients, too, need to understand the pros and cons of online ratings.

You can read the entire article here.