Equal Access to Merck Covid Pill Imperiled by Prescribing Rules – Bloomberg Law, December 2, 2021: 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.
Biden’s Drug Agency Nominee Returns With Deeper Industry Ties – Bloomberg Business, November 23, 2021: President Biden’s choice to lead the FDA 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.
The road ahead for Califf’s confirmation – Axios and Yahoo News, November 15, 2021: Former FDA chief Robert Califf has been nominated to head the agency again. We tell Axios that “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”
Biden Picks Robert Califf to Head the FDA for a Second Time – The Scientist, November 12, 2021: Former FDA Commissioner Robert Califf has been nominated to be the new FDA Commissioner. He has excellent experience, but like all the FDA candidates the White House considered recently, he has close ties to industry.
Biden to Choose Robert Califf to Lead F.D.A., Despite Drug Industry Ties – The New York Times, November 12, 2021: Is Biden nominee Dr. Califf the best choice to head up the FDA. The New York Times describes his pros and cons, and we point out that the White House doesn’t mind his Pharma ties.
Biden picks ex-FDA chief Robert Califf to again lead agency – AP News, November 12, 2021: Robert Califf will be nominated as FDA Commissioner today. We told AP “He knows how the FDA works, and he avoided making any outrageous decisions as commissioner. Those are essential if the FDA is going to regain the public trust.”
Biden expected to tap Califf as FDA commissioner – Roll Call, November 12, 2021: Robert Califf will be nominated to again serve as FDA commissioner. We tell Roll Call that he’s a political compromise, close to Pharma but avoiding the controversy that happens when FDA ignores scientific evidence.
Biden chooses Robert Califf, former Obama FDA chief, as agency commissioner – Washington Post, November 12, 2021: President Biden is expected to nominate former FDA Commissioner Robert Califf to return as the agency’s head, and we explain why this political compromise makes sense despite his industry ties.
Breast Implants will now come with Black Box Warnings, List Risks – Legal Reader, November 9, 2021: Will FDA’s requirements to warn patients about the cancer risks and other serious risks of breast implants be enough to adequately warn women considering implants? Experts disagree.
Breast Implants will now come with Black Box Warnings, List Risks – Will FDA’s requirements to warn patients about the cancer risks and other serious risks of breast implants be enough to adequately warn women considering implants? Experts disagree.
When it comes to clinical trials, healthcare’s diversity problem is standing in the way of medical advancement – Fortune, November 5, 2021: The lack of diversity in clinical trials is standing in the way of medical advancement. CPTF president Dr. Diana Zuckerman explains how that delayed progress in treating triple negative breast cancer, which is more common among Black women.
Patients Must Be Warned of Breast Implant Risks, F.D.A. Says – The New York Times, October 27, 2021: The FDA has placed black box warnings on breast implant packaging and told manufacturers to sell the implants only to health providers who review the potential risks with patients before surgery. The Cancer Prevention and Treatment Fund asks who will enforce that?
FDA continues operating without a Senate-confirmed, permanent leader – Homeland Preparedness News, September 28, 2021: Should you be concerned about the lack of a permanent FDA Commissioner? NCHR explains why the new Commissioner needs to be someone who cares about public safety and public health.
How Fauci and the NIH Got Ahead of the FDA and CDC in Backing Boosters – KHN, September 16, 2021: How did Fauci and the NIH and the White House get ahead of the FDA and CDC in backing boosters? NCHR’s president explains the conflicting perspectives. And when the data are not conclusive, the question is what is the best strategy for you? And to defeat the pandemic? They may not be the same.
Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data – BMJ, August 20, 2021: The FDA is being criticized for not holding an advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine. Will it undermine public confidence?
Biden yet to nominate new FDA chief even as delta surges – The Hill, August 8, 2021: FDA needs a new focus on public health that protects patient safety and ensures strong scientific evidence. We explain to The Hill that making the right choice is as important as making a decision soon.
7 things to know about bad COVID-19 tests – CBS 5, July 29, 2021: This CBS 5 investigation about FDA emergency use authorizations (EUAs) for COVID tests will shock you! Thanks to Kris Pickel, you can find out why so many COVID tests and antibody tests were not accurate and how many we still aren’t sure of.
Beleaguered FDA in talks for drug-company funding – Eleanor Laise, Marketwatch, July 13, 2021: Fees paid by drug companies make up half of the FDA’s revenue. Dr. Diana Zuckerman explains how these fees often influence FDA decisions and sacrifice patient safety.
My breast implants are making me sick — and I’m not alone – Pamela Appea, Salon, June 20, 2021. It’s not in our heads: More women are speaking up about how their breast implants are making them sick. And Healing Breast Implant Illness Society of North America and National Center for Health Research are making sure women know they are not alone.
Emergency Use Authorization vs. Full Approval: What are the Implications? – Laurie Saloman, Contagion Live: June 20, 2021 Emergency use authorizations, or EUAs, have gotten a lot of attention during the COVID-19 pandemic. The concept of the U.S. Food and Drug Association (FDA) authorizing a product or treatment quickly and without going through a full and complete review process was first introduced in 2005. At that time, … Continue reading Emergency Use Authorization vs. Full Approval: What are the Implications?
The Role of Environmental Regulations in the Fight Against Cancer – NYC NPR, May 10, 2021: President Biden wants a new agency within NIH to “end cancer as we know it.” Dr. Diana Zuckerman explains to NPR that EPA needs to do more to help prevent cancer.
Biden’s ‘end cancer’ pledge begs for environmental oversight – 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. 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.
To Stay: Two More Cancer Indications With ‘Dangling Approvals’ – 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 … Continue reading To Stay: Two More Cancer Indications With ‘Dangling Approvals’
FDA Scrutinizes Pricey Cancer Drugs – Politico Pulse, April 28, 2021: Will FDA maintain approval for cancer drugs that are proven to not work? We were hoping for a reckoning, but that doesn’t seem likely as the doctors on the FDA Advisory panel tell FDA that they are hopeful that the drugs will eventually be proven to work.
Can California’s public universities mandate COVID-19 vaccines? – Monterey Herald, April 26, 2021: Dr. Diana Zuckerman and Robert Kaplan address the possibility of mandatory vaccinations at California public colleges and strategies to ensure policies can withstand legal choices.
Conflicts Galore: Upcoming Accelerated Approval Cancer Panel May Be Tainted By Industry Relationships – 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 … Continue reading Conflicts Galore: Upcoming Accelerated Approval Cancer Panel May Be Tainted By Industry Relationships
4 in 10 Adults Over 50 Consult Online Reviews When Picking a Doctor – 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. Dr. Diana Zuckerman, president of the National Center for Health Research, said that choosing a doctor is a complex undertaking.
What Genentech is doing to fix biotech’s diversity problem – Fortune, April 7, 2021. There’s a big problem with clinical trials: a lack of diversity. This problem led researchers to believe that Black women did not develop breast cancer as frequently as white women and created a gap in understanding how different treatments work. How can companies like Genentech start increasing diversity in clinical trials?
The FDA Cut Off COVID Vaccine Testing. That Was a Really Bad Idea. – Washington Monthly, March 26, 2021: Not since the polio vaccine became available in April 1955 have Americans been so excited about getting a shot. But behind the scenes, there’s a lot we don’t know because of a decision made back in December by the FDA. The agency allowed manufacturers to effectively stop their clinical trials as soon as they were authorized to market their vaccines, making it impossible to learn how long the vaccines work and for whom.
The Differences Between the Vaccines Matter – Hilda Bastian, The Atlantic: March 7, 2021 Public-health officials are enthusiastic about the new, single-shot COVID-19 vaccine from Johnson & Johnson, despite its having a somewhat lower efficacy at preventing symptomatic illness than other available options. Although clinical-trial data peg that rate at 72 percent in the United States, compared with 94 and 95 percent for the … Continue reading The Differences Between the Vaccines Matter
Janet Woodcock revolutionized the way the FDA reviews cancer drugs, inspiring her supporters and raising concerns for detractors – STAT News, March 1, 2021. The FDA is approving more new cancer drugs than ever before, after FDA’s drug chief Janet Woodcock loosened FDA standards. Now cancer doctors are Woodcock’s most vocal backers in her campaign to be FDA Commissioner. But critics say too many approved cancer drugs aren’t proven to help patients live longer.
Drug Industry Pushes FDA to Solve Growing Inspection Backlog – Politico, March 2, 2021. The FDA is under pressure from the pharmaceutical industry to address the growing backlog of drug inspections — nearly a year after Covid-19 prompted the agency to halt most plant visits. From March through September, FDA inspected just three plants outside the U.S. and 52 within the U.S., well below the 600 and 400, respectively in each of the prior two years. NCHR president reports device inspections have also dropped dramatically.
J&J COVID-19 Vaccine Wins Unanimous Backing of FDA Panel – Medscape Medical News, February 26, 2021. An FDA advisory panel lent their support today to a rapid clearance for Janssen/Johnson & Johnson’s COVID-19 vaccine, but several researchers expressed concerns to the panel about the lower standards of EUAs, including CPTF’s president Dr. Diana Zuckerman.
What you need to know about J&J’s newly authorized one-shot COVID-19 vaccine – ScienceNews: February 27, 2021. On February 27, the FDA authorized Johnson & Johnson’s COVID-19 vaccine for use in the U.S. The other two authorized vaccines are made by Pfizer and Moderna. None are FDA approved. All show effectiveness, but there are too few serious COVID-19 cases in any of the studies to conclude how well it prevents hospitalizations or deaths.
Who Will Be the Next F.D.A. Chief? – New York Times: February 20, 2021. One month into his presidency, President Biden still has not named a candidate to head the Food and Drug Administration, a critical position at a time when new vaccines and coronavirus treatments are under the agency’s review. This has spurred a public lobbying campaign by supporters of the two apparent front-runners, Dr. Joshua Sharfstein, a former high-ranking F.D.A. official and Dr. Janet Woodcock, the acting commissioner.
FDA blasts Merck’s Keytruda data for new breast cancer indication – Stat News, February 5, 2021. The cancer drug Keytruda is a medical and financial juggernaut, but it may not win FDA approval for early-stage triple negative breast cancer. FDA medical reviewers agreed there is a need for new treatments, but Keytruda did not impress them with its small benefit of “questionable clinical meaningfulness” and serious safety issues. NCHR’s Dr. Zuckerman said “This is one of the most negative reviews I’ve ever seen.”
Patients Continue to Be Inadequately Informed of Risk for Breast Implant-Associated ALCL – Cancer Therapy Advisor, February 8, 2021. Although the risk for breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) has been well-documented, patients considering breast implants continue to be inadequately informed of the propensity for disease development. Awareness of BIA-ALCL has risen since 2020, but adequate safeguards have not yet been put in place, according to experts in the field, including Dr. Diana Zuckerman of the National Center for Health Research and their Cancer Prevention and Treatment Fund.
A C.D.C. analysis describes anaphylaxis after people have received the Pfizer-BioNTech vaccine as ‘rare’ – New York Times: January 11, 2021 Allergic reactions to Covid vaccines are rare, but serious, and every site that administers vaccines must be prepared to recognize and treat them, health officials warn.
Congressman calls for FDA to continue vaccine trials – ABC, December 29, 2020. Rep. Lloyd Doggett of Texas wrote to the FDA urging COVID-19 clinical trials to continue until they have more data.
Covid-19: Should vaccine trials be unblinded? – BMJ, December 29, 2020. Volunteers in COVID-19 vaccine studies want the vaccine, not placebos, but stopping studies early could be dangerous.
How Effective Is the Mask You’re Wearing? You May Know Soon – The New York Times, December 16, 2020. A CDC division is working with an industry standards group to develop filtration standards — and products that meet them will be able to carry labels saying so.
FDA Panel Reviewing Pfizer Vaccine Leaves Out Some Experts Who Raised Concerns – POGO, December 9, 2020. FDA’s COVID19 vaccine panel did not include experts who raised concerns about Pfizer’s data at a previous meeting.
Four ways Trump has meddled in pandemic science — and why it matters – Nature, November 3, 2020. Donald Trump’s response to the COVID-19 pandemic looms large in the election. One issue that resonates with the research community, including CPTF, is the extent to which the current president and his administration have meddled with science and scientific advice during the pandemic — often with disastrous results.
HEALTH CARE BRIEFING: FDA Vaccine Rules Challenged as Weak – Bloomberg Gov, October 23, 2020. Scientists and advocates challenge coronavirus vaccine testing standards at FDA advisory meeting.
FDA Panel To Lay Regulatory Groundwork For COVID-19 Vaccine – NPR, October 22, 2020. Dr. Diana Zuckerman spoke about testing for vaccine safety at the FDA advisory meeting on Covid-19 vaccine approval.
FDA Promises Strong Safety Standards for Covid-19 Vaccines as It Convenes Advisory Panel – WSJ, October 23, 2020. FDA promises strong safety testing for coronavirus vaccines even as current standards criticized at advisory meeting.
FDA Vaccine Rules Challenged as Weak at Advisory Panel Meeting – Bloomberg Business, October 23, 2020. Scientists and advocates criticize weak Covid-19 vaccine standards at FDA Advisory Panel Meeting.
Study finds removing breast implants improved symptoms – AzFamily.com, October 1, 2020. The FDA is finally encouraging better information about the risks of cancer, breast implant illness, and other health problems for women considering breast implants. But we agree with patients that the agency could do so much more.
FDA Updates Breast Implant Labeling Recommendations to Help Inform Patients About Dangerous Potential Side Effects – Cure, September 29, 2020. Makers of breast implants should include a black box warning about cancer and other serious risks, along with a patient decision checklist for patients to sign, according to final guidance issued by the FDA.
How the Coronavirus Pandemic May Affect Cancer Clinical Trials – Cancer Therapy Advisor, August 18, 2020. The dangers of Covid-19, especially to cancer patients, are upending access to clinical trials for cancer treatments.