It is from pharma, but it is noteworthy.
Friday January 18, 4:20 pm Eastern Time
FDA panel rejects Bristol-Myers' Pravachol combo
(UPDATE: Updates throughout)
By Lisa Richwine
SILVER SPRING, Md., Jan 18 (Reuters) - A U.S. advisory panel on Friday urged regulators to reject Bristol-Myers Squibb Co.'s (NYSE:BMY - news) bid to co-package its cholesterol-lowering pill Pravachol with aspirin, two drugs used to protect the heart.
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The final decision now goes to the Food and Drug Administration (FDA), which usually follows the panel's advice.
Panel members, who voted 7-1 with one abstention against the combination, expressed various reservations about making the dual product available. Some said they worried that co-packaging increased risks that aspirin would be used inappropriately. Others were concerned that the combination would not offer adjustable Pravachol doses.
Pravachol, the company's best-selling drug in 2000, is one of a family of widely prescribed drugs known as statins that lower high cholesterol, a major contributor to heart disease, the leading killer of Americans.
Millions of heart disease patients who take statins also are told to take daily doses of aspirin to prevent blood clots that can cause heart attacks, strokes, and other cardiovascular problems.
The company presented data from several large trials showing that people taking Pravachol and aspirin had a lower risk of cardiovascular problems than with either alone. The company argued that packaging the drugs together would make taking them more convenient, leading to better patient compliance with doctors' orders.
In one study, only half of patients who were told to take aspirin where doing so in one study, said Dr. Thomas Pearson, a University of Rochester cardiologist. Patients who do take aspirin may take the wrong dose, or they may mistakenly choose another anti-inflammatory drug that does not offer aspirin's cardiac benefits.
The combination product ``would provide the enhanced convenience and reassurance for patients and health care providers,'' Pearson said.
Dr. Alan Hirsch, a panel member from the University of Minnesota Medical School, said there was not enough evidence to show the combination would enhance patient compliance. ``This is basically conjecture at this point,'' he said.
Another panel member, Beverly Lorell of Boston's Beth Israel Deaconess Medical Center, said she worried that the combined product would make it more likely for patients to mistakenly take aspirin before surgery, putting them at risk for dangerous bleeding.
``The issue of convenience is outweighed by the very real risk of packaging a very potent antiplatelet agent with something else,'' Lorell said.
In addition, physicians might be inclined to prescribe the combination product and neglect to switch patients to other Pravachol doses when needed, some panelists said.
``We respect the opinion of the advisory committee,'' Bristol-Myers spokeswoman Bonnie Jabobs said after the panel vote. She said the company had no further comment.
Bristol-Myers shares ended Friday's session down 75 cents, or 1.5 percent, at $47.94 on the New York Stock Exchange. |
