Falsified Data: Hundreds Of Popular US Generic Drugs May Have Safety Issues
The FDA has learned that a research company in India falsified the data used in key studies to gain approval of their medications, which include the generic versions of Viagra and Lipitor, Bloomberg reported. The findings could have major implications about whether the drugs are safe to take and whether insurers will retroactively decide not to cover them.
Bloomberg:
Generic Viagra, Cialis, Lipitor Safety In Question After FDA Finds False Data
Generic versions of erectile dysfunction drugs Viagra and Cialis, among other medications, were allowed on the US market using potentially problematic data that call into question their safety and efficacy, a Bloomberg analysis found. The US Food and Drug Administration alerted brand-name and generic companies June 18 about a research company in India that had falsified the data used in key studies to gain approval of their medications. Data from the researcher, Synapse Labs Pvt. Ltd., may have been used in hundreds of drugs, which remain available for sale on pharmacy shelves and in Americans’ medicine cabinets. (Edney, 7/9)
NPR:
Shortages Of Ozempic And Other Drugs Harms Type 2 Diabetes Patients
Jim Cox had heard of people with Type 2 diabetes who were unable to get Ozempic because the drug was being used off-label for weight loss. He just didn’t think the shortage would affect him. He has the disease too, but he takes a different drug called Trulicity, which is in the same class of GLP-1 drugs as Ozempic. But “then I went up to my local pharmacy to get my Trulicity and they said, ‘Sorry, we're out,’” Cox says. “I couldn't renew my prescription.” (Lupkin, 7/10)
Also —
Bloomberg:
Purdue Pharma Wins Short Window To Negotiate New Deal With Sackler Family
Purdue Pharma LP secured a two-month window to negotiate a new pact with members of the Sackler family as the OyxContin maker and its owners brace for a potential wave of civil opioid lawsuits after the US Supreme Court scuttled an earlier $6 billion settlement. Judge Sean Lane said during a Tuesday court hearing in New York that he’d extend for 60 days an injunction that, for years, has paused opioid litigation against the billionaire family while Purdue, government authorities and victims lawyers attempted to effectuate the earlier settlement. (Randles, 7/9)
Reuters:
First Trial Against Abbott Over Premature Infant Formula Kicks Off In Missouri
The first trial against Similac baby formula maker Abbott over claims that its formula for preterm infants used in neonatal intensive care units causes a potentially deadly bowel disease got underway with opening statements on Tuesday, as a lawyer for a mother suing the company urged jurors to hold it liable for her child's lifelong injuries. Jake Plattenberger of TorHoerman, a lawyer for Illinois resident Margo Gill, told the St. Louis, Missouri state court jury that Abbott made "no attempt to tell physicians in a clear and direct way" that its products could cause necrotizing enterocolitis (NEC) in premature babies. (Pierson, 7/9)
Reuters:
SEC Blasts Pfizer's Bid For $75 Million From Insider Trading Victims' Fund
One of the most notorious insider trading schemes in U.S. history has led to a $75 million fight between drugmaker Pfizer and the U.S. Securities and Exchange Commission. That sum is what remains of a fund to compensate victims of insider trading by the now-shuttered hedge fund SAC Capital, which reaped more than $275 million in profits in 2008 from trading on unlawfully obtained clinical data about a prospective Alzheimer's drug. SAC Capital and related entities paid more than $600 million in 2013 to resolve the SEC's case in the largest insider trading settlement in U.S. history. (Frankel, 7/9)
Reuters:
Pfizer's Chief Scientist Mikael Dolsten To Step Down
Pfizer said on Tuesday Chief Scientific Officer Mikael Dolsten, a key figure behind the development of its COVID-19 vaccine, would step down after a more than 15-year career at the drugmaker. Dolsten, aged 65, served as the head of Pfizer's research and development after he joined the company through its $68 billion acquisition of Wyeth in 2009. He became the company's chief scientist in 2010. (7/9)
Stat:
Biotech Layoffs: Larger Firms Being Hit To A Greater Degree Than In Years Past
After getting laid off from Bristol Myers Squibb last December, Jennifer Ariazi is trying her best to be a Vulcan. Ariazi, a former BMS senior principal scientist, is a devout “Star Trek” fan. And she has made a personal mantra out of emulating the stoicism and tough-minded logic that define the fictional humanoid species. Layoffs happen. It’s a business. You’ve gotten through this before. (Wosen, 7/10)
