Tag: Califf

  • U.S. FDA Says Misinformation ‘Leading Cause of Death’

    U.S. FDA Says Misinformation ‘Leading Cause of Death’

    The role of misinformation in the vaping industry was not mentioned when past and present commissioners of the U.S. Food and Drug Administration came together recently to discuss the role misinformation plays in public health.

    The group say the agency needs partners in combatting public health misinformation, and industry, clinicians, patient advocates and academic leaders all have a role to play.

    “Realistically, FDA needs help,” Mark McClellan, who served as FDA Commissioner from 2002-2004, said at the 2023 Innovations in Regulatory Science Summit sponsored by the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI).

    On the FDA’s own website there are youth vaping prevention posters available to be used by various groups including doctors, schools, and state and local public health agencies. These claim, amongst other dangers, that “[n]icotine can rewire a teen’s brain to crave more nicotine and can create addiction,” despite there being no scientific basis for this claim.

    While there is currently a lack of trust in officials from public health agencies, individuals still have trust in their own physicians, community leaders, and others who are “close to their experience,” McClellan said during a panel discussion among past and present FDA commissioners about how to counter the problem of misinformation and restore trust in the agency.

    However, a 2021 study in the International Journal of Environmental Research and Public Health found that more than 75 percent of U.S. physicians believe that nicotine directly contributes to cancer and cardiovascular disease.

    On the FDA’s website, the agency states, “while nicotine has a number of toxic effects on the body, it is not the primary cause of cancer and other chronic smoking-related diseases. More than 7,000 chemicals are present in cigarette smoke, including more than 70 that can cause cancer.”

    Janet Woodcock, the agency’s Principal Deputy Commissioner who served as Acting Commissioner from 2021-2022, said patient advocates are trusted and often aligned with FDA’s mission but that their reach is often limited to the disease areas where they are focused, leaving prevention and treatment of common diseases as areas where misinformation can proliferate, according to an article from Regulatory Focus.

    “I actually believe that misinformation is the leading cause of death right now in the U.S. because whether we’re looking at COVID or chronic disease, people are making bad choices driven by the information that they get,” said current FDA Commissioner Robert Califf, who also served in the role from 2016-2017. “We were just not prepared for what broad access to the Internet would do to communication channels.”

    Califf called out the academic community for not doing more on the misinformation front and said some of their criticism of FDA and other public health agencies is having unintended consequences.

    “As a public agency, we need to be critiqued, but I think often the people that are doing the critiquing assume that the agency’s going to be there in the future in the way that they expect it to be there,” Califf said. “So, they’re critiquing it to make it better. But to a lot of unsuspecting people that hear it, it just completely erodes their belief in the institution.”

    In an FDA-funded study last year, researchers found that the use of electronic cigarettes costs the United States $15 billion annually in healthcare expenditures—more than $2,000 per person a year. The study, published on May 23 in Tobacco Control, was the first to look at the healthcare costs of e-cigarette use among adults aged 18 and older, according to researchers at the University of California San Francisco School of Nursing.

    The study was found to be rife with misinformation after it claimed that healthcare expenditures for a person who uses e-cigarettes are $2,024 more per year than for a person who doesn’t use any tobacco products. Chuck Dinerstein, director of medicine at the American Council on Science and Health (ACSH), who has over 25 years of experience as a vascular surgeon, said that in order to get their data, researchers developed a model using the National Health Interview Survey (NHIS), a household survey of the general population in the U.S. that includes detailed questions on health and use of tobacco products.

    “The researchers point to a study using NHIS data that per smoker—meaning combustible—attributable healthcare expenditures are $5,602,” explained Dinerstein. “The finding of this study, for both those exclusively using e-cigarettes and the dual users, is roughly a third as much. E-cigarettes reduce healthcare utilization and costs.”

    Scott Gottlieb, who served as FDA Commissioner from 2017 to 2019, said rapid response to online misinformation is critical and floated the idea of giving industry more leeway to counter false or misleading information about products. It is currently illegal for any vaping product manufacturer to make health claims concerning e-cigarettes, including saying they are safer than combustible cigarettes.

    While commissioner, Gottlieb championed e-cigarettes as a way to help adults stop smoking. 

    “We’ve seen FDA weigh in, admirably, around some dangerous disinformation on specific products,” he said. “But that can’t be the business of the FDA.”

    Margaret Hamburg, who served as FDA Commissioner from 2009-2015, said that while some of the larger issues around misinformation are difficult to solve, FDA can take concrete steps to restore public confidence in its role. That boils down to showing why FDA matters, how the agency does its work and opening up some of the processes that have historically not been transparent, she said.

    “Despite so much that is going on that is hard for FDA to control, the work of the agency and its trustworthiness can be demonstrated,” Hamburg said.

    That transparency is especially important in areas where there is the most controversy, McClellan said.

  • FDA to Review Oversight Rules After Juul Debacle

    FDA to Review Oversight Rules After Juul Debacle

    Robert Califf / Credit: Modern Healthcare

    The head of the U.S. Food and Drug Administration Tuesday said he has commissioned an independent review of the agency’s food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews, according to AP.

    The announcement comes as FDA Commissioner Robert Califf attempts to push past several controversies that have dominated his second stint running the agency, including his issuing of a marketing denial order (MDO) to e-cigarette maker Juul Labs and later having to rescind that order.

    “Fundamental questions about the structure, function, funding and leadership need to be addressed” in the agency’s programs, Califf said in a statement. The agency’s Center for Tobacco Products (CTP) is facing challenges navigating policy and enforcement issues from “an increasing number of novel products that could potentially have significant consequences for public health.”

    Califf said the non-profit Reagan-Udall Foundation — a non-governmental research group created by Congress to support FDA’s work — would convene experts to deliver evaluations within 60 business days of both the food and tobacco operations.

  • Califf to Take on Synthetic Nicotine if Made FDA Chief

    Califf to Take on Synthetic Nicotine if Made FDA Chief

    Robert Califf vowed to close the synthetic nicotine loophole if appointed commissioner of the U.S. Food and Drug Administration, according to a report by Vaping360.

    During Califf’s nomination hearing on Dec. 14, Wisconsin Senator Tammy Baldwin expressed concern over reports that companies are switching to making flavored synthetic nicotine products in the wake of FDA marketing denial orders.

    “As FDA commissioner, how would you work to address the rise in youth use of synthetic nicotine, and will you commit to working with Congress to ensure that the FDA has the authorities and resources it needs to crack down on these products?” Baldwin asked.

    In response, Califf first noted that is crucial to appoint the right person to succeed Center for Products Director Mitch Zeller, who plans to retire in April 2022.

    “Secondly,” Califf continued, “this is not limited to children. I may have some family members using synthetic nicotine, I learned as I was going through the paces here. And what people don’t realize is that there are two enantiomers of nicotine—one of which is not occurring in nature—that are in this product, and its properties are not known.

    “So we’ve got to close this loophole,” Califf added, “so that we make sure that we understand the risks and benefits, and particularly deal with the issues in children.”

    The Senate Health, Education, Labor & Pensions Committee will vote soon on whether to recommend Califf’s nomination to the full Senate. If the committee approves him, the former commissioner can expect full Senate confirmation to be the new commissioner soon, probably in January.

  • Biden Taps Ex-FDA Boss Califf To Lead Agency Again

    Biden Taps Ex-FDA Boss Califf To Lead Agency Again

    Robert Califf

    U.S. President Joe Biden today announced that he would nominate Robert M. Califf, a former commissioner of the Food and Drug Administration, to lead the agency again, reports The New York Times.

    A cardiologist and long-time consultant to drug companies, Califf ran the FDA during the last year of the Obama administration

    “Dr. Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” Biden said in a statement.

    Califf has been a forceful advocate for tobacco control; before he was the FDA 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. It was awesome and quite frightening for public health.”

    After stepping down as the vice chancellor for clinical and translational health at Duke University, Califf has worked as a senior adviser to Verily Life Sciences, a health technology firm, and its sister company Google Health. Califf, who remains an adjunct professor of medicine at both Duke and Stanford University, is on the corporate board of Cytokinetics, a biopharmaceutical company, according to its website.

    Califf said he was honored to be nominated for the position “at a critical time for our country,” adding, “There’s a lot of work to do, and if confirmed I look forward to rejoining the great team at the FDA to help in their inspiring mission to serve the public.”

    The FDA has had seven different commissioners, including Califf, since 2012, when Margaret Hamburg left the post.

  • Biden Taps Former FDA Chief Califf to Again Lead Agency

    Biden Taps Former FDA Chief Califf to Again Lead Agency

    Former U.S. Food and Drug Administration Commissioner Robert Califf is expected to return to the regulatory agency after President Joe Biden nominated the cardiologist for the position. According to the Washington Post, if confirmed by the Senate, Califf would take over an agency poised to make key decisions on the vaping industry, as well as coronavirus vaccines and treatments while facing criticism of recent controversial drug approvals and widespread burnout due to the ongoing pandemic.

    Robert Califf/ Credit: Duke University

    Califf previously served as commissioner for nearly a year in Obama’s second administration after an overwhelming vote in his favor. The White House has not finalized its decision, and the people with knowledge cautioned the situation could still change. But nine months into its search for a permanent FDA chief, Califf is now viewed as the leading candidate for the job.

    Despite the agency’s prominent role in the nation’s coronavirus response, it has been without a permanent leader since Biden took office in January. Califf would replace acting Commissioner Janet Woodcock, the agency’s longtime drug chief, who has helmed the agency for nine months. Califf returned to cardiology after his tenure at FDA and currently works for the Duke Clinical Research Institute, but also took a position leading health policy at Google’s parent company Alphabet in 2019.

    While he garnered support from many senators in his 2016 confirmation process, Sen. Bernie Sanders (I-Vt.) voiced concerns about his industry ties and said he could oppose the vote. Califf at the time had written papers with pharmaceutical industry executives and consulted for drug and device makers.