Package Inserts Prepared By Drug Companies Which Exagerrate Benefits And Downplay Risks Need To Be Addressed
(Posted by Tom Lamb at DrugInjuryWatch.com)
In the October 21, 2009 edition of The New England Journal of Medicine (NEJM) there is a Perspective piece, “Lost in Transmission — FDA Drug Information That Never Reaches Clinicians”, by Lisa M. Schwartz, M.D., and Steven Woloshin, M.D., that will ring true with most patients who have used prescription drugs.
From that NEJM editorial, two of the primary points raised by the authors are:
- “Much critical information that the Food and Drug Administration (FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles.”
- [A]lthough the US “federal stimulus package included $1.1 billion to support comparative-effectiveness research” no money has been allocated to “disseminate existing but practically inaccessible information about the benefits and harms of prescription drugs.”
Reporter Matthew Perrone does a good job of breaking down this NEJM editorial piece for us in his October 21 AP news article, "Drug safety experts urge FDA to make drug safety info more accessible to patients", published by the Chicago Tribune. He starts by sharing part of his discussion with Dr. Lisa Schwartz:
"The take home point is that just because a drug is approved doesn't mean it works very well," said Schwartz, in an interview with the Associated Press. "You really need to know more to see whether it's worth the cost."
He then focuses on the the fact the FDA-approved label for a prescription medication often comes up short as regards the drug's efficacy, or benefits:
In the case of Sepracor Inc.'s blockbuster sleeping pill Lunesta, it's virtually impossible to tell how well the drug works based on the labeling, which only indicates that it worked better than placebo, or a dummy pill.
Only by wading through the FDA's 403-page internal review of Lunesta do the details emerge: patients fell asleep 15 minutes faster and slept 37 minutes longer, on average.
"Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvement in next-day alertness," the authors state.
Despite that lackluster finding, the drug has grown into a $600 million-a-year drug for Sepracor, helped by the company's advertisements featuring a green Lunesta moth.
Next, Perrone's October 21 AP article shows how important safety information may not only be missing from a drug's package insert but, furthermore, how the FDA makes this critical information hard to find and hard to understand:
The authors [Schwartz and Woloshin] point to the example of Novartis' Zometa, which was approved in 2001 to prevent skeletal fractures in cancer patients with brittle bones. The drug was approved in both 4-mg and 8-mg doses, despite FDA findings of increased kidney damage and death with the higher dose.
FDA went back and added language about kidney toxicity in 2008, but the information about death rates is still missing from the label.
While FDA reviews are posted online, they are often hundreds of pages long and written in extremely dense medical language.
In closing, Perrone reports that a spokesman for the FDA declined his invitation to comment or be interviewed for his article about the points raised by Dr. Schwartz and Dr. Woloshin in their October 2009 NEJM editorial piece.
Here, we welcome your Comments about the adequacy of drug labels as concerns the disclosure of balanced and comprehensive information about the benefits versus risks of prescription medications.
P.S. Here is a clarification issued by the AP regarding the October 21, 2009 Matthew Perrone article referenced in this post:
October 27, 2009
WASHINGTON (AP) — In an Oct. 21 story about drug labels, The Associated Press erroneously described the Novartis drug Zometa. Zometa was approved in 2001 to treat excessive calcium levels, not to treat a form of osteoporosis in cancer patients. Also, the drug was approved only in a 4 milligram dose, not in both 4 milligram and 8 milligram doses. A corrected version of the story appears below.
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