Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.
Lawsuit Alleges Gardasil Caused POTS, Chronic Fatigue and Other Symptoms After HPV Vaccine
A recently filed lawsuit indicates a teenager experienced a progression of symptoms caused by the Gardasil HPV vaccine, which started with a sore throat and ultimately resulted in seizures, respiratory failure and other illnesses, including postural orthostatic tachycardia syndrome (POTS), which contributed to a complete failure of her health and almost resulted in her death.
The complaint was filed by Hannah Davis on March 9, in the U.S. District Court for the Western District of North Carolina. Like a growing number of similar claims, the lawsuit accuses Merck & Co. of failing to properly research the side effects of the Gardasil HPV vaccine, and deceptively marketing the injection as safe and effective.
Gardasil was first introduced in 2006, for the prevention of HPV infections, which can be sexually transmitted and lead to the later development of cervical cancer. Following years of aggressive marketing by the drug maker, the vaccine has been commonly administered to young girls and boys before adolescence and potential sexual activity. However, in recent years, a number of teens and young adults have reported Gardasil caused POTS and other autoimmune disorders, which emerged shortly after receiving the injection.
Merck now faces Gardasil lawsuits brought by individuals nationwide, each indicating they were diagnosed with conditions that were never disclosed to parents or the medical community, even though the manufacturer knew or should have known about the risks.
68 Now Sickened, 4 Lose Eyeballs in Outbreak Linked to Eyedrops
An alarming outbreak of extensively drug-resistant bacteria linked to eye drops has now sickened 68 people across 16 states, according to the latest update from the Centers for Disease Control and Prevention. At least 16 people have been hospitalized, eight have lost vision, and four have had their eyeballs surgically removed (enucleation). One person has died, which was reported earlier.
The agency first released a health alert on the outbreak on February 1. At that point, the outbreak had sickened 55 people in 12 states, with one death reported in a Washington patient. In an update emailed to Ars on February 22, the CDC said the case count had reached 58, with five cases of vision loss and one enucleation.
The continued rise in cases and severe outcomes highlights the challenge of fighting the germ behind the outbreak, which is an extensively drug-resistant form of Pseudomonas aeruginosa. It has the unwieldy name of Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa — or VIM-GES-CRPA, for short.
The VIM-GES-CRPA outbreak strain is rare and has never been seen in the U.S. before. Health officials think it was brought into the country in contaminated eye drops manufactured by Global Pharma, a Chennai, India-based manufacturer. The products were sold under the brand names EzriCare Artificial Tears and Delsam Pharma’s Artificial Eye Ointment, which were available nationwide via Amazon, Walmart and other retailers.
AbbVie’s Humira, 5 Pfizer Drugs Among Those With Price Hikes That Exceeded Inflation Rate
Pfizer is the runaway winner of the United States’ first Who Can Raise Prices Higher Than the Rate of Inflation contest.
Among 27 medicines whose price hikes exceeded the rate of inflation in the fourth quarter of 2022, Pfizer had five, which was three more than any other company. The list was released by the White House on Wednesday.
Also included was AbbVie’s megablockbuster Humira, Johnson & Johnson’s recently approved lung cancer therapy Rybrevant and Gilead’s high-profile CAR-T treatments Tecartus and Yescarta.
The quarterly release is the first of its kind following the passage of the Inflation Reduction Act (IRA), which includes a provision to penalize companies who raise prices on Medicare Part B medicines faster than the rate of inflation. Companies who fail to pay the mandated rebates will be docked 125% of the amount of the fine, due in 2025, according to the release.
FDA Advisers Back Pfizer’s COVID Treatment for Full Approval
Advisers to the U.S. Food and Drug Administration on Thursday overwhelmingly backed full approval of Pfizer‘s (PFE.N) oral antiviral COVID-19 treatment Paxlovid for adults at high risk of progression to severe disease.
The FDA’s panel of outside experts voted 16-to-1 in favor of the drug’s benefits outweighing its risk for some adults with mild-to-moderate COVID-19.
The agency is expected to make a formal approval decision by May and typically follows the advice of its expert advisers but is not required to do so.
A full approval will eventually allow Pfizer to sell Paxlovid – which consists of two drugs in pill form – at market rates on the private market in the U.S., rather than through government contracts as it has been thus far.
FDA: COVID Rebound Occurs Regardless of Paxlovid Use
U.S. News & World Report reported:
Food and Drug Administration staffers endorsed the use of Paxlovid in adults at high risk of severe COVID-19 ahead of a meeting of the agency’s outside experts on Thursday to decide on the pill’s full approval.
Over 8 million courses of the treatment have been administered in the U.S., according to federal data. In some instances, like with President Joe Biden and leading infectious disease expert Anthony Fauci, Paxlovid patients experienced a rebound in COVID-19 symptoms and tested positive for the virus after previously testing negative.
But in documents published online this week, agency officials supported the use of Paxlovid, arguing that “rebound may occur as part of the natural progression and resolution of COVID-19 disease, irrespective of PAXLOVID treatment.”
FDA staffers cited an analysis showing that rates of COVID-19 symptom rebound were similar between people who took Paxlovid and people who took a placebo. The documents stated that overall symptom rebound rates ranged from 10-16%.
Plan to Make mRNA Vaccines in Developing Countries Needs U.S. Funding, Backers Say
For much of the coronavirus pandemic, poor and middle-income countries struggled to secure doses of the most successful vaccines, which use cutting-edge messenger-RNA technology.
As wealthy countries hoarded doses, the World Health Organization and its partners came up with a path forward: a network of mRNA “vaccine hubs” for poorer countries to share technology and eventually make mRNA vaccines of their own, rather than rely on donations by wealthy governments.
But three years into the coronavirus pandemic, the U.N.-backed program to build a network of self-reliant research and manufacturing sites is struggling. It is seeking a large increase in funds to ensure its sustainability, its backers say, raising concerns about the long-term future of the program.
The United States has yet to respond to a funding request for $100 million, sent late last year by the effort’s backers. The support would about double its funding overall.
FDA Looks Into Dental Device After KHN-CBS News Investigation of Patient Harm
In the wake of a joint investigation by KHN and CBS News into a dental appliance that multiple lawsuits allege caused grievous harm to patients, the FDA has begun looking into the product, the Anterior Growth Guidance Appliance, or AGGA, according to a former agency official.
Additionally, KHN and CBS News have learned that the Las Vegas Institute, a training company that previously taught dentists to use the AGGA, now trains dentists to use another device it has described as “almost exactly the same appliance.” That one is called the Anterior Remodeling Appliance, or ARA.
The FDA’s interest in the AGGA was revealed by Cara Tenenbaum, a former senior policy adviser in the agency’s device center who has said the FDA should investigate the product, which has been fitted on more than 10,000 dental patients, according to court records.
“The FDA is looking at what authorities they may have around this device — what they may be able to do,” Tenenbaum said. “Now, of course, whether or not this device is FDA regulated, it still needs to be safe.”
LG Chem Locks in $200 Million Vaccine Supply Deal With UNICEF
Korea’s LG Chem is stepping up to the plate with a deal to manufacture essential vaccines for millions of infants and children.
The company has locked up a $200 million deal with the United Nation’s Children’s Fund (UNICEF) to supply both its polio shot Eupolio and its pentavalent vaccine Eupenta, which protects against diphtheria, pertussis, tetanus, hepatitis B and meningitis.
Beyond this deal, LG Chem plans to further cement its role in fighting infectious diseases by developing “improved” combination vaccines based on Eupolio, Park Heui-sul, head of LG Chem’s specialty care business unit, said in a statement.
