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FDA to Weigh In on Tylenol Warnings About Autism, ADHD by Sept. 15
With a growing number of Tylenol lawsuits being pursued by families that allege inadequate pregnancy warnings were provided about the risk of autism and attention deficit hyperactivity disorder (ADHD), the U.S. government indicates that the FDA will submit its views on the labeling for over-the-counter acetaminophen products by Sept. 15.
Tylenol (acetaminophen) has been widely used by pregnant women for decades, largely due to the widespread belief that it was safe for unborn children. However, lawsuits now allege that the drug makers have failed to disclose information about the growing evidence that in-utero exposure to acetaminophen may cause autism or ADHD.
Earlier this year, plaintiffs in the litigation submitted a template of proposed acetaminophen pregnancy warnings that could have been provided for consumers, recommending pregnant women use the lowest effective dose for the shortest possible time.
Each of the complaints raises similar allegations, indicating that information has been available to the manufacturers for decades about the link between autism and Tylenol, as well as ADHD, and other developmental problems. However, rather than warning about the acetaminophen risks, the drug has been actively promoted as safe for use by pregnant women.
GSK Sues Pfizer Claiming RSV Vaccine Patent Infringement
GlaxoSmithKline on Wednesday sued Pfizer in U.S. court, alleging patent infringement over Britain-based GSK’s respiratory syncytial virus vaccine.
GSK claims New York-based Pfizer’s RSV vaccine, Abrysvo, infringes on four of its patents related to the antigen used in its own shot.
GSK is demanding a jury trial and seeking monetary damages, including lost profits and royalties resulting from Pfizer’s alleged patent infringement. The British drugmaker is also asking a judge to prevent Pfizer from manufacturing and selling Abrysvo in the U.S. for adults 60 and older.
GSK said it is not seeking to limit the use of Abrysvo for preventing RSV in infants, a separate shot specifically designed to protect newborns. The FDA is expected to make a final decision on that vaccine in August.
J&J’s Attempt to Force Baby Powder Cancer Settlements Through U.S. Bankruptcy System Rejected for Second Time
For the second time this year, a federal court has dismissed the bankruptcy filing of a Johnson & Johnson subsidiary, which was created solely for the purpose of forcing plaintiffs to accept Baby Power cancer settlements that would only pay a small portion of the damages a jury may award at trial.
Over the last several years, Johnson & Johnson has faced tens of thousands of Johnson’s Baby Powder lawsuits and Shower-to-Shower lawsuits, each involving similar allegations that asbestos particles in the talcum powder products caused users to develop ovarian cancer, mesothelioma and other injuries.
In a memorandum opinion, U.S. Bankruptcy Judge Michael B. Kaplan rejected the second filing, and dismissed the bankruptcy proceeding once again, indicating that it was “filed in bad faith.”
New Director Named at National Institute of Allergy and Infectious Diseases Following Dr. Anthony Fauci’s Retirement
Dr. Jeanne Marrazzo will be the next director of the National Institute of Allergy and Infectious Diseases, the National Institutes of Health announced in a news release on Wednesday.
Marrazzo is expected to begin her role in the fall, NIH said. She will take over from Dr. Hugh Auchincloss Jr., who has served as acting director since Dr. Anthony Fauci stepped down from the post in December.
Marrazzo is currently the director of the Division of Infectious Diseases at the University of Alabama at Birmingham and was a frequent guest on CNN during the COVID-19 pandemic.
With a budget of $6.3 billion, NIAID is the second largest center at the NIH, behind the National Cancer Institute. It supports research to advance the understanding, diagnosis and treatment of infectious, immunologic and allergic diseases. The institute played a pivotal role in the nation’s response to the COVID-19 pandemic, including the development of pathbreaking vaccines.
Walgreens Is Now Offering RSV Vaccines for Older Adults
Walgreens is now offering the respiratory syncytial virus vaccine for older adults nationwide, the pharmacy chain said on Tuesday.
People ages 60 and older can schedule an appointment this week through Walgreens’ app, website, by phone or by visiting their local pharmacy.
This is the first RSV season in which older adults have the option to get vaccinated against the virus. The Food and Drug Administration approved the first RSV vaccines, made by Pfizer and GSK, last spring.
Walgreens is offering both Pfizer’s and GSK’s shots, which are administered as a single dose.
Henrietta Lacks’ Family Settles Lawsuit With a Biotech Company That Used Her Cells Without Consent
More than 70 years after doctors at Johns Hopkins Hospital took Henrietta Lacks’ cervical cells without her knowledge, a lawyer for her descendants said they have reached a settlement with a biotechnology company that they accused of reaping billions of dollars from a racist medical system.
Tissue taken from the Black woman’s tumor before she died of cervical cancer became the first human cells to continuously grow and reproduce in lab dishes. HeLa cells went on to become a cornerstone of modern medicine, enabling countless scientific and medical innovations, including the development of the polio vaccine, genetic mapping and even COVID-19 vaccines.
Despite that incalculable impact, the Lacks family had never been compensated.
Lacks’ cells were harvested in 1951 when it was not illegal to do so without a patient’s permission. But lawyers for her family argued that Thermo Fisher Scientific Inc., of Waltham, Massachusetts, continued to commercialize the results long after the origins of the HeLa cell line became well known. The company unjustly enriched itself off Lacks’ cells, the family argued in their lawsuit, filed in 2021.
Repeating History: California County Plugs Budget Gap With Opioid Settlement Cash
Over the past two years, as state attorneys general agreed to more than $50 billion in legal settlements with companies that made or sold opioids, they vowed the money would be spent on addiction treatment and prevention. They were determined to avoid the misdirection of the tobacco settlement of the 1990s, in which billions of dollars from cigarette companies went to plug budget gaps instead of funding programs to stop or prevent smoking.
But in at least one California county, history is repeating itself. And across the country, many local leaders are finding themselves in similar positions: choosing between paying bills due today or investing in the fight against an ongoing crisis.
The settlement funds are the result of thousands of lawsuits filed against a host of healthcare companies, including Johnson & Johnson, McKesson, CVS Health, and Walmart, for aggressively promoting and distributing painkillers. The money should remediate the effects of that corporate behavior, say attorneys general, treatment providers, and those directly affected by the crisis.
Dealing With Big Pharma and Their Drug Prices Can Make Anyone Sick
Did you realize since 1998 Big Pharma has spent 4.8 billion on lobbying members of Congress so pharmaceutical costs do not go down for the consumer? In the year 2020, there were 1502 registered pharmaceutical lobbyists in Washington DC. This equates to nearly three lobbyists for every elected member of Congress! Polls show 80% of the American public wants Medicare to negotiate drug charges with the big drug companies, but Congress will not pass legislation allowing them to do so. Pharmacy prices go up at an alarming rate, and the American consumer is left holding the bag.
How can that be? If 80% of the public wants lower drug prices, why are our elected officials failing to get pricing that exists in Mexico, Canada and Europe? Why do Americans pay more for the exact same drug? The answer is simple, Big Pharma writes checks to politicians and legislation stops dead in its tracks. At the same, it is reported that 3 in 10 Americans are not taking at least one of the medications they have been prescribed because they cannot afford them.
If there is anything the right, the left, the center, and everyone else in America should grasp, Big Pharma is making billions on the back of the American public when they charge considerably more than what they charge the rest of the world. It needs to stop, and it needs to stop now. I would hope that members of both parties would jump on this bandwagon and move to protect the people they represent. Enough is enough. It makes me want to take an aspirin or two … while I can afford it.
