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.
MLB’s return plan mirrors the Bundesliga’s. The key difference? It’s in the U.S., not Germany. – Washington Post, June 3, 2020. There are lots of challenges facing major league baseball’s efforts to avoid the coronavirus. We explain that one of the biggest challenges are the hot spot states where baseball teams are supposed to play.
DOT Wants to Weaken Its Own Power to Penalize Airlines Over Consumer Complaints – Fair Warning July 1, 2020. Are airlines doing all they should to make flying safe again? Filling every seat is not a good idea, and that’s just one of many problems that make flying and buying airline tickets risky.
We can’t ever go to the doctor with our guard down’: Why Black women are 40% more likely to die of breast cancer – Fortune Magazine: June 30, 2020 Black Americans are dying from the COVID-19 pandemic at a disproportionately high rate, and are also much more likely to die from many other health problems. Black women are less likely to develop breast cancer but 40% more likely to die from it than White women. The reasons behind this awful disparity are wide-ranging, and include systemic problems both within healthcare and far beyond it.
CRS: Congress Can Rein In FDA’s Flexible COVID-19 Vaccine Trial Policies – Inside Health Policy, June 03, 2020. The Congressional Research Service says Congress could rein in FDA’s COVID-19 policies by passing a law, and NCHR explains why that is a good idea.
Hahn Defends Using Less ‘Robust’ Data During COVID, But Critics Contend It Has Gone Too Far – Informa Pharma Intelligence, June 04, 2020. NCHR asserts that anecdotes are not data sets, this problematic situation can been seen in new drugs for coronavirus.
Allergan is trying to track down women with breast implants it recalled nearly a year ago – Fortune, June 3, 2020. Allergan has asked small nonprofit organizations to help inform tens of thousands of women that they have a type of breast implant that has been recalled due to increased cancer risks.
A Patient’s Guide to Telemedicine – Drugwatch, May 20, 2020. NCHR advises Drugwatch about preparing ahead of time for telemedicine visits in order to make the best out of the appointment.
FDA Warns Allergan Over Breast Implant Studies – International Consortium of Investigative Journalists, May 19, 2020. The FDA warns Allergan over failure to complete breast implant studies.
How MLB is navigating the coronavirus pandemic to play ball – ESPN, May 19, 2020. We explain to ESPN the importance of quarantining and social distancing, even in a time where sporting events will start to reopen.
‘They killed her’: Why are breast implants still putting millions of women at risk? – Fortune, May 18, 2020. Breast implants and the other “medical aesthetics” products that are driving profits are also endangering women’s health.
You Can’t Travel, but You Can Vacation at Home – AARP, May 12, 2020. In times of coronavirus stress, here are ideas for a relaxing home-cation, because everyone needs time off.
Tests for COVID-19: Has the FDA said yes too many times? – The Hill Opinion Contributors, May 6, 2020. Most tests being sold in the U.S. aren’t proven to be accurate by unbiased scientists. Here’s what you need to know.
Coronavirus Relief Act Gives Drug Makers New Sway Over FDA – Pogo, May 5, 2020. Under the $2 trillion coronavirus relief law, makers of over-the-counter drugs will pay the FDA to oversee their products and will gain new sway over the consumer protection agency.
‘Bad advice from the president’: Trump touts unproven coronavirus drugs – Politico: March 20, 2020. We find that the president’s suggested programs allowing the administration to get experimental drugs to people quickly outside of clinical trials is bad advice.
Celebrities Are Getting Coronavirus Tests Faster Than Everyone Else – Insider, March 13, 2020. We explain why celebrities have been tested for coronavirus before sick patients who need a diagnosis.
FDA considers black box warning for all breast implants – WCPO Cincinnati, February 09, 2020. The FDA may finally require blackbox warnings for women considering breast implants, due to complications connected to implants after a mastectomy.
Artificial Intelligence Is Rushing Into Patient Care – And Could Raise Risks – Kaiser Health News, December 24, 2019. AI systems are not as rigorously tested as other medical devices, and the recalls show these apparent and serious risks.
No Shortage of Controversies for New FDA Commissioner – The Wall Street Journal, January 29, 2020. New FDA Commissioner Stephen Hahn faces tug of war over controversial issues in health, including e-cigarettes, stem-cell research, and the use of cannabidiol (CBD).
Everything is designed for men, even drugs – Vox, January 16, 2020. Designing medicine around the “average man” is so dangerous. We need more inclusivity in clinical trials — for women, for people over 65, and for people of color.
Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound – MedTech Dive, January 10, 2020. FDA warning letters to medical device manufacturers slid by nearly 90% between 2015 and 2019, but may be set to rebound upward in 2020.
Schools Seek Ways to Curb Vaping Among Students – The Wall Street Journal, January 6, 2020. With the rise of vaping related illnesses, schools turn to new tactics to deter students from vaping.
Roundup 2019: Breast implants, mesh, paclitaxel-coated devices among hot topics at FDA expert panels – MedTech Dive, December 23, 2019. As the FDA approves medical devices, it is essential that the public is made aware of inadequate post-approval studies and spotty adverse event reporting.
I Visited a ‘Private ER’ Where People Pay Up to $5,000 a Year to Skip the Hospital— Take a Look – Insider, December 19, 2019. The ER system is broken; the country’s emergency medicine system is misused, overused, and wildly expensive.
Medical Professors are Supposed to Share Their Outside Income With the University of California. But Many Don’t. – Annie Waldman, ProPublica, December 6, 2019 For nearly two decades, Dr. Neal Hermanowicz has led the movement disorders program at the University of California’s Irvine campus, where he earns more than $380,000 a year in salary and bonuses. The widely respected expert on Parkinson’s and Huntington’s diseases adds to his income by consulting for drug … Continue reading Medical Professors are Supposed to Share Their Outside Income With the University of California. But Many Don’t.
Not Just Blowing Water — Vaping Presentation Will Sort Myth and Reality – Walla Walla Union Bulletin, December 3, 2019. As school districts nationwide have been caught flat-footed and struggle to banish vaping on campuses, the short term effects of vaping having seemingly created significant and life changing health issues.
How Minnesota Schools are Doubling Down on Anti-vaping Efforts – MinnPost, December 2, 2019. Teens and young adults make up the bulk of those vaping-related hospitalizations resulting from serious lung damage, causing Minnesota schools to double down on anti-vaping efforts.
Report Claims More Women than Men Injured by Medical Devices – Medical Plastics News, November 28, 2019. A report published by the International Consortium of Investigative Journalists has revealed more women than men have been injured by a medical device.
FDA Challenged Over Metal Implants ‘Public Health Travesty’ – International Consortium of Investigative Journalists, November 14, 2019. The FDA needs to require better research before implants are approved and put in patients’ bodies, instead of just counting problems after the implants are used by thousands of patients.
FDA Advisers Hear About Problems, Research Needs With Metal Implants – MedPage Today, November 14, 2019. Comparing different implants could prevent many women and men from harm resulting from metals and other substances that set off negative reactions in patients.
FDA’s Special Treatment Of Big Tech Faces Mounting Scrutiny – Kevin Stawicki, Law360, November 12, 2019. The U.S. Food and Drug Administration is taking heat from prominent lawmakers over a special approval pathway for health software products sold by Apple, Samsung and other major tech companies, opening the door to a congressional showdown over whether the agency has the right to start such a program. The … Continue reading FDA’s Special Treatment Of Big Tech Faces Mounting Scrutiny