Merck refutes allegations of false data, ghostwriting
CHICAGO According to a report in the Journal of the American Medical Association, Merck purposely gave the Food and Drug Administration incomplete clinical trial data from its painkiller drug Vioxx in an effort to get the drug on the market and keep it there, according to the Washington Post.
The report also said that Merck used “guest authorship and ghostwriting” to make it appear that research done by its employees or contractors was the work of scientists at medical schools and universities. In turn, this made the findings of the research more credible and therefore boosted the drug’s profile.
The clinical trials in question involve deaths appearing in patients taking the drug who were experiencing mild dementia. Originally, the FDA said that 29 people taking Vioxx died in a clinical trial that was testing whether the drug could slow the progression of dementia. In that same trial, 17 people died while taking a placebo. Actually, the report should have stated that 34 people died while taking Vioxx and only 12 deaths occurred in the placebo group.
Merck stated in its FDA filing that, it only reported deaths that occurred while patients were “on treatment” and up to as long as three months. But, in-house documents had results of patients had results of patients who died while on the drug as well people who stopped taking the drug and yet still died. Eventually, the company reported all the data to the FDA, two years later.
In response to the “ghostwriting” accusation, Merck’s lawyer James Fitzpatrick said: “It is correct that Merck would sometimes use an outside company to compile the literature in a field and do the first draft, much the way a professor would use a research assistant to do the same thing.”
JAMA though believes the articles were completely written by Merck scientists and that doctors and researchers were paid off to use their names on the papers. One scientist though came in defense of Merck and said that he was, “directly involved in a very substantive way” in a paper that JAMA said was done by Merck and not outside authors.
To date, the drug has cost the company $4.85 billion in lawsuits, which the company paid off in a joint fund.
FDA approves Alcon’s Patanase for nasal allergy symptoms
HUENENBERG, Switzerland Alcon announced that the Food and Drug Administration has approved Patanase (olopatadine hydrochloride) nasal spray for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older.
“We look forward to providing doctors the opportunity to prescribe Patanase to their patients who need and want a fast-acting nasal spray that quickly relieves symptoms,” said Kevin Buehler, Alcon’s senior vice president of global markets and chief marketing officer. “We are excited to enter the nasal market and are confident that this new addition will continue to grow our topical allergy franchise.”
Clinical studies found that patients treated with Patanase, two sprays per nostril, twice daily, demonstrated significantly greater decreases in symptoms compared to the placebo nasal spray. Additionally, onset of action was evaluated in three studies, in which patients with seasonal allergic rhinitis were exposed to high levels of pollen and then treated with either Patanase or placebo nasal spray, two sprays in each nostril, after which they self-reported their allergy symptoms hourly for the subsequent 12 hours. Patanase nasal spray was found to have an onset of action of 30 minutes and a 12-hour duration of affect after dosing, which was statistically significant compared to the placebo spray.
“For patients who suffer every allergy season with symptoms that make life in those months miserable, Patanase offers relief beginning in minutes in a convenient steroid-free nasal spray,” said one study’s lead investigator, Eli Meltzer. “The fact that it works quickly is important. Patients in our fast-paced society want rapid improvement and relief from their nasal allergies.”
Patanase nasal spray, an extension to Alcon’s market-leading ocular allergy product line, will be available in May of this year.
EPA sets up collection sites in eight states for used meds
BUFFALO, N.Y. The Environmental Protection Agency, recognizing that trace amounts of pharmaceuticals are showing up in drinking water, has begun urging consumers living near any of the Great Lakes to bring their old medications to official collection centers.
The EPA is helping pay for more than 70 collection points in eight states that will take old medicine—along with electronic waste like computers, cell phones and televisions—from April 19 through April 27. The agency has set a goal of collecting 1 million pills during an Earth Day initiative aimed at the more than 30 million people who live around the Great Lakes, which are by far the largest source of fresh drinking water on the planet.
The collection sites are being established in New York, Illinois, Indiana, Michigan, Minnesota, Ohio, Pennsylvania and Wisconsin.
“We’re trying to raise public awareness on disposing of pharmaceuticals properly and we’ve had a very good response from communities on water districts. This is information that needs to get out there,” EPA spokeswoman Phillippa Cannon said Tuesday.