In the same week that Bausch & Lomb decided to permanently withdraw its ReNu with MoistureLoc contact lens solution from shelves worldwide, the Center for Disease Control and Prevention (CDC) confirmed on Friday (May 19) that the product was the cause of an increased incidence of Fusarium keratitis.
Monthly Archives: May 2006
Fosamax Linked to Serious Injury
While physicians say they’re rare, Fosamax users can be susceptible to “dead jaw” disease or commonly known as jaw rot. Fosamax, an osteoporosis drug belonging to the bisphosphonate family, can lead to “dead jaw” syndrome — a painful condition that causes ulcers, tooth loss and exposed bone.
Doctor Links Fusarium Keratitis to Bausch & Lomb Solution
Dr. Deepinder Dhaliwal, Director of Refractive Surgery at the University of Pittsburgh Medical Center, has tested the ReNu with MoistureLoc contact lens solution and found the fusarium keratitis fungus growing within it. The results were turned over to the CDC. This is a significant discovery since, in all likelihood, Bausch & Lomb officials will blame contact lens solution users for the fungus. This finding makes that harder to do.
U of Pitt Med Center Doc Finds Fusarium in Bausch & Lomb Product
As part of the CDC’s investigation of Bausch & Lomb’s eye contact solution ReNu with MoistureLoc, a University of Pittsburgh Medical Center doctor was able to grow the fusarium keratitis fungus from the contact lens solution. Dr. Deepinder Dhaliwal, the Director of Refractive Surgery at UPMC found the dangerous fungus within the contact lens solution and gave her results to the CDC.
Ketek Facing the Heat
US Senate Finance Committee Chairman Charles Grassley (R-IA) has called on the maker of Ketek, Sanofi-Aventis, to produce its investigator as part of a probe of the company’s handling of the antibiotic. The letter released last night by Mr. Grassley, an Iowa Republican, is the second one he has sent to the FDA about the drug, which is made by Sanofi-Aventis SA. He told the agency he wants to interview a special agent in its criminal-investigations division, whose name was redacted from the letter.
Boston Scientific Issues New Warning on Defibrillators
Boston Scientific warned doctors that close to 1,000 of its cardiac implantable defibrillators may short circuit and fail to work properly leaving its patients vulnerable to cardiac problems. The company said that it learned of the failures after purchasing Guidant in April for $27.5 billion. U.S. regulators imposed sanctions on Guidant in December because of quality-control flaws after the recall last year of 109,000 defibrillators linked to at least seven deaths. Many recalled devices were sold years after Guidant learned of the flaws and began making models free of the problem.
FDA: Bausch & Lomb Failed to Promptly Notify
The FDA said yesterday that ReNu maker Bausch & Lomb failed to promptly report 35 cases of the fusarium keratitis infection. The failure to inform the FDA within a 30 day time period is part of a larger list of 20 violations the FDA listed after inspecting the Greensville, SC plant.
American Medical Association Missed Vioxx Warnings 5 Years Ago
In 2001, the American Medical Association missed an opportunity to warn the public about the potential danger of Merck’s drug Vioxx, according to a front page story in the Wall St. Journal. According to the Journal article, “Dr. Hrachovec had been reviewing data on a Food and Drug Administration Web site indicating that patients in a Vioxx clinical trial had suffered more heart attacks than the journal article about the trial reported. “It bothers me there is more data from the trial than has ever been published and the New England Journal still hasn’t published an editorial or any kind of update,” she said. “My concern is that doctors are still using this and exposing their patients to higher risks of heart problems and they just don’t even know that that’s the case.”
If the warning had been published, one can only imagine the amount of suffering that could have been avoided. What a shame!
Doing the Vatican Shuffle
The Vatican announced today the appointment of two bishops to new posts in the United States. One of them, Bishop Donald Wuerl will be moving from the relatively obscure but heavily Catholic area of Pittsburgh to the metropolitan and politically charged Archdiocese of Washington. Wuerl, a former lieutenant of John Cardinal Wright, studied and worked in the Vatican before being ordained a bishop in 1986. Within Catholic circles, Wuerl has the reputation of an erudite, skilled manager who’s enforced the “No Tolerance” policy on sex abuse predators. We’ll have to wait and see what he does in Washington. As you know, his predecessor, Theodore Cardinal McCarrick, lobbied hard against any civil reforms in Maryland that would have helped victims of clergy abuse.
The other appointment comes in the wake of the retirement of Joliet Bishop Joseph Imesch. He will be replaced by J. Peter Sartain of Little Rock Arkansas. Imesch was recently embroiled in scandal for his mishandling of a clergy sex abuse case dating back to the 1960’s.
More News on Bausch & Lomb
I was quoted in today’s Boston Globe as a result of Bausch & Lomb’s decision to halt permanently the worldwide sales of its ReNu with MoistureLoc. As the paper stated, I think the decision confirms what we’ve suspected all along, namely, that the problem lies in the solution itself.