Medical Scope Maker Sees Jump In Sales Despite Ties To Superbug Outbreaks
In news about another surgical tool, concerns that the laparoscopic power morcellator can spread cancer in women prompt 12 lawmakers to urge the Government Accountability Office to investigate.
Los Angeles Times:
Superbug Outbreaks: Device Maker Olympus Reports 14% Jump In Scope Sales
Embattled device maker Olympus Corp. posted a 14% increase in sales of medical scopes worldwide despite health officials linking its instruments to superbug outbreaks at U.S. hospitals. The Japanese company, which also makes cameras and microscopes, said Thursday that the strong performance of its gastrointestinal endoscopes led to record-breaking sales and profit for its medical business in the latest quarter ending June 30. The company's increased sales have sparked criticism from some federal lawmakers and patient advocates who say it's wrong for Olympus to benefit financially because design flaws in its duodenoscopes have contributed to the spread of deadly bacterial infections. (Terhune and Petersen, 8/7)
The Wall Street Journal:
Members of Congress Call On GAO To Investigate Surgical Tool
Twelve members of Congress sent a letter to the U.S. Government Accountability Office Friday asking the agency to investigate a controversial gynecological device that can spread cancer in women. ... A GAO investigation would heighten scrutiny of the Food and Drug Administration’s approval and monitoring of the power morcellator, which had been used in tens of thousands of minimally invasive procedures a year. The device is used primarily in hysterectomies, to slice up common benign uterine masses known as fibroids so the bulky tissue could be removed through tiny incisions. (Levitz, 8/7)
Meanwhile, a federal judge tells the FDA that it can not regulate against the "truthful promotion" of a drug for unapproved uses -
The New York Times:
Court Forbids F.D.A. From Blocking Truthful Promotion of Drug
A federal judge said on Friday that the Food and Drug Administration could not prohibit the truthful promotion of a drug for unapproved uses because doing so would violate the protection of free speech. The decision, by a district judge in Manhattan, could inhibit the ability of the F.D.A. to regulate one aspect of pharmaceutical marketing. Pharmaceutical companies have collectively paid billions of dollars in fines in recent years after being accused of marketing drugs for unapproved uses. (Pollack, 8/7)
The Washington Post:
FDA Barred From Restricting Company’s Promotion Of Fish-Oil Drug
A federal judge barred the Food and Drug Administration from blocking a drug company’s efforts to promote an unapproved use for pills derived from fish oil, saying the firm’s claims are protected by the First Amendment. U.S. District Judge Paul Engelmayer granted Amarin Corp. preliminary relief. ... Amarin’s suit against the FDA will continue, but the company will be allowed to begin marketing the off-label use immediately, under the judge’s decision. (Johnson, 8/7)
And a vaccine maker targets a common childhood ailment -
Reuters:
Novavax Hopes To Crack Elusive Vaccine For Common Respiratory Virus
A Maryland-based biotech company believes it can solve a riddle that has baffled Big Pharma for decades: how to protect against a virus that infects almost every American child. If mid-stage trial data proves positive, Novavax Inc will be closer than any drug developer to a vaccine for respiratory syncytial virus, or RSV, which affects those most with compromised immune systems - including young infants and the elderly. (Grover, 8/10)