Merck accused of misrepresenting Vioxx data
Pharma Compliance Alert, April 23, 2008
New allegations against Merck and its arthritis medication Vioxx could keep the FDA from relaxing its rules about off-label promotion, according to a New York Times article.
The FDA is considering a proposal to allow pharmaceutical manufacturers to use reprints of peer-reviewed journal articles to promote off-label uses of drugs. New allegations claim Merck knew about Vioxx problems for years before it acted. The allegations, printed in an article in the Journal of the American Medical Association (JAMA) raise questions about the peer-review process.
The article, based on a analysis of court documents, claims Merck failed to disclose an internal analysis that found Alzheimer’s patients taking Vioxx had a three times greater risk of death than patients taking a placebo.
Merck withdrew Vioxx in 2004 and is currently working on a $4.85 billion deal to settle thousands of lawsuits filed by people claiming they were harmed by taking Vioxx.
The criticism from JAMA doesn’t end there. Another article accuses Merck of writing its own articles about Vioxx, then paying physicians to put their names on the articles. The JAMA article doesn’t just single out Merck for this practice, but says ghostwriting appears to be common in the pharmaceutical industry.
Merck responded by issuing a press release saying it believes the comments in JAMA “are false, misleading, or lack context.” A full, unbiased evaluation of the documents “shows significant errors in the conclusions put forward by the authors of the JAMA articles,” the statement added. The company also said it provided complete mortality data to the FDA.
Comments
0 comments on “Merck accused of misrepresenting Vioxx data ”
Related Products
-
ePharm5 InDepth
EPharm5 e-mail newsletter delivers the top 5 developments in pharma business innovation, with original research, interviews...
-
Big Pharma Performance Before, During and Beyond the Global Recession
This report assesses the performance of the leading 15 pharmaceutical companies up to, during and beyond the recent global...
Most Popular
- Articles
-
- Q/A: Volume requirement for reporting hydration services
- Featured blog post: Nurses face felony charges after reporting physician to the Texas Medical Board
- Catch up on what's new with injections and infusions
- Topic: CMS, OESS post new security compliance review information, checklist
- What does case-mix index mean to you?
- QA:Coding multiple initial infusions
- Capturing all necessary codes for IUD insertion and removal can be challenging
- News and briefs: Oklahoma Osteopathic Association against residency bill change
- OB services: Coding inside and outside of the package
- HIPAA Q&A: Level of encryption needed for email
- E-mailed
-
- Q/A: Volume requirement for reporting hydration services
- Featured blog post: Nurses face felony charges after reporting physician to the Texas Medical Board
- Catch up on what's new with injections and infusions
- New conflicts of interest create new challenges
- Joint Commission Center announces handoff communication solutions
- Inside best practice: Reduce patient falls with a stoplight
- Identify modifiable risk factors to prevent patient falls
- Hospitalist-surgeon comanagement has no effect on outcomes
- HIPAA Q&A: Level of encryption needed for email
- Case Management Monthly, June 2012
- Searched