Novartis CEO Justifies Decision To Delay Telling FDA About Manipulated Data For $2.1M Gene Therapy Drug
Novartis CEO Vas Narasimhan said the company "thoroughly, aggressively" investigated whether the issue would effect patient safety. The FDA, after publicly rebuking the company, came to a similar conclusion that patients aren't at risk because of the lapse in judgment. Other pharmaceutical industry news looks at Gilead's pricey HIV drug, cell therapies, the cost of a snakebite, and more.
The New York Times:
Novartis C.E.O. Defends Company’s Decision To Withhold False Data From The F.D.A.
The chief executive of Novartis on Wednesday defended the company’s decision to delay telling the Food and Drug Administration about manipulated data involving its $2.1 million gene therapy treatment, saying that it “thoroughly, aggressively” investigated the issue and that patient safety was never threatened. Vas Narasimhan, the chief executive, also indicated in a call with investors that the company was forcing out a small number of scientists who were involved in the manipulated data. (Thomas, 8/7)
The Wall Street Journal:
Novartis CEO: Knew About Zolgensma Data Problems Before FDA Approval
Mr. Narasimhan explained that the company waited to tell the regulator because it was completing the investigation and that none of the delays were related to its drug application with the U.S. drug watchdog. “We made the decision to progress our quality investigation prior to informing FDA and other regulatory authorities so that we could provide the best information and technical analysis--which we did promptly on completion on June 28,” said Mr. Narasimhan. (Martuscelli, 8/7)
Stat:
Novartis CEO: 'We Tried To Do The Right Things' In FDA Data Scandal
“I think everyone in our organization can stand proud that we tried to do the right things in this instance,” Narasimhan told financial analysts on a conference call. “We understand the agency has a different perspective, which we respect, but we’ve tried to be transparent, thorough, science-based, and, most importantly, patient-oriented to ensure that we never compromised patient safety, efficacy, or product quality during any moment during all of this.” (Garde, 8/7)
The Hill:
Novartis CEO Says Organization Can 'Stand Proud' After Hiding Manipulated Data From FDA
The FDA has indicated it might pursue civil or criminal penalties against the company, and that it would have delayed the drug's approval if it knew about the manipulated data. Both the FDA and Novartis said the drug is still safe to use and will continue to be sold. (Hellmann, 8/7)
Stat:
‘Every Man And His Dog’ Does Cell Therapy. Vor’s New CEO Says The Company Wants To Be Different
Three years after Pulitzer Prize-winning writer and oncologist Dr. Siddhartha Mukherjee founded Vor Biopharma, the company finally has its first executive. Robert Ang, formerly the chief business officer for Neon Therapeutics (NTGN), will be Vor’s first chief executive officer, the company announced Wednesday. Vor is one of several startups developing cell therapies for cancer, though specifics about the company’s plans had been sparse until recently. In May, the company’s scientific founders published a preclinical proof-of-concept paper in the Proceedings of the National Academy of Sciences that laid out just what they hope the company will do. (Sheridan, 8/7)
Reuters:
Patient Groups Push Back Against Gilead's Pricey HIV Prevention Treatment
Gilead Sciences Inc hopes to soon introduce a pricey new pill to prevent HIV in people at risk of contracting the infection, but the drugmaker faces opposition from an unusual source: patient advocates. Such groups have traditionally lobbied for insurance coverage of newer HIV drugs regardless of expense. But at least three U.S. organizations now question whether Gilead’s Descovy would be the best option for most people at risk of exposure. (Beasley, 8/7)
Kaiser Health News:
Price Of Snakebite Drug Is Sky High, But New Competitor Unlikely To Lower Costs
Dr. Steven Curry has treated patients with snakebites since the 1980s — long enough to remember when the treatment represented its own form of misery. The first medication he used sometimes caused an immune reaction called “serum sickness” — patients broke out in a severe, itchy rash. About 20 years ago, the drug CroFab entered the market and dramatically reduced the adverse reactions associated with treatment, said Curry, who works at a Phoenix hospital. He is a medical toxicologist, a specialist in treating patients harmed by poison or venom. (Heredia Rodriguez, 8/8)
Milwaukee Journal Sentinel:
Biologic Drug Makers Pay Doctors To Prescribe Risky, Pricey Medications
All three efforts were part of a massive drug company push to boost the sale of expensive, immune-suppressing drugs to treat autoimmune conditions such as psoriasis and rheumatoid arthritis. The drugs, many of which are biological medicines, called biologics, were introduced two decades ago and have hit $45 billion in sales, despite escalating prices and mounting reports of serious side effects. (Fauber, 8/7)
