Clinical trial was a Vioxx marketing tool, researchers say.
In what the editor of the Annals of Internal Medicine Annals of Internal Medicine (Ann Intern Med) is an academic medical journal published by the American College of Physicians (ACP). It publishes research articles and reviews in the area of internal medicine. Its current editor is Harold C. Sox. called the first "documentary evidence A type of written proof that is offered at a trial to establish the existence or nonexistence of a fact that is in dispute.
Letters, contracts, deeds, licenses, certificates, tickets, or other writings are documentary evidence. that proves the existence of seeding trials," a study in that journal's August 19 issue showed how a clinical trial of Vioxx, called ADVANTAGE, was created not to answer scientific questions but to market the drug and increase prescriptions. (Kevin E Hill et al., The AD VANTAGE Seeding Trial: A Review of Internal Documents, 149 Annals an·nals
1. A chronological record of the events of successive years.
2. A descriptive account or record; a history: "the short and simple annals of the poor" Internal Med. 251 (2008), www.annals.org/cgi/content/full/149/4/251.)
"One of the features of a seeding trial," said Annals editor Harold Sox in an e-mail interview, "is that its scientific value to society at large is low relative to the risks that patients take when they agree to participate."
The study analyzed Merck's internal and external correspondence about ADVANTAGE in documents produced as a result of litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.
When a person begins a civil lawsuit, the person enters into a process called litigation. brought by plaintiffs who alleged injury resulting from the drug. (McDarby v. Merck, 949 A.2d 223 (NJ. Super. App. Div. 2008).) Quoting Merck employees in internal documents calling ADVANTAGE a seeding trial and detailing its origins in the company's marketing division, the researchers concluded that the clinical trial "was actually a sophisticated marketing tool designed to allow optimal 'seeding' of positive experiences with Vioxx among customers--primary care physicians--before its approval." They also noted that this purpose was hidden from participants, investigators, and institutional review board members.
Approved by the FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. in May 1999, two months after ADVANTAGE began, Vioxx was withdrawn in September 2004 after another trial showed a heightened risk of cardiovascular problems in patients taking the drug. Subsequent reports identified results, omitted from the published reports of ADVANTAGE and another trial, that showed similar cardiovascular problems.
In an editorial accompanying the Annals study, Sox noted that "seeding trials can occur only because the company does not disclose their true purpose to anyone who could say 'no.'"
That includes not only the 600 doctors and their approximately 5,500 patients who participated in ADVANTAGE, but also Sox himself. Five years ago, Annals published the results of ADVANTAGE, showing that Vioxx was as effective as other medications in treating osteoarthritis osteoarthritis
or osteoarthrosis or degenerative joint disease
Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. and was less likely to cause stomach problems. Although an earlier study, VIGOR, showed similar results for treatment of rheumatoid arthritis rheumatoid arthritis
Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. , the Annals editors "thought [ADVANTAGE] had a useful message that would benefit some doctors," Sox said in an e-mail.
In his editorial, Sox noted that no one from Merck told the journal about ADVANTAGE's true purpose. Instead, the editors learned of it in 2006 through a doctor, David Egilman, who served as an expert for the plaintiffs in the litigation and is a co-author co·au·thor or co-au·thor
A collaborating or joint author.
tr.v. co·au·thored, co·au·thor·ing, co·au·thors
To be a collaborating or joint author of: "He and a colleague . . . of the current analysis.
Jonathan Edelman, the executive director of Merck's global center for scientific affairs, wrote a letter in response to the Annals editors, claiming that ADVANTAGE had a "legitimate scientific purpose" and noting that the authors of ADVANTAGE's critique are "paid consultants to plaintiffs' lawyers in the Vioxx litigation against Merck."
Egilman said in an e-mail interview that no one without access to these litigation documents could have known about ADVANTAGE's marketing purpose. (The documents used in the study are now publicly available at http://dida.library.ucsf.edu.)
And, he said, "if there was a possible refutation ref·u·ta·tion also re·fut·al
1. The act of refuting.
2. Something, such as an argument, that refutes someone or something.
Noun 1. [of the current study], Merck can use any documents it wants to make any point it thinks it can make. It didn't make any."
Last November, Merck settled with many Vioxx litigants who had claims of heart attacks and ischemic stroke Noun 1. ischemic stroke - the most common kind of stroke; caused by an interruption in the flow of blood to the brain (as from a clot blocking a blood vessel)
ischaemic stroke . More recently, the Third Circuit allowed a consolidated securities fraud class action against the company to move forward: Judge Dolores Sloviter Dolores Korman Sloviter is a judge on the United States Court of Appeals for the Third Circuit. Born to a Jewish-American family in 1932 in Philadelphia, Pennsylvania, she attended Philadelphia High School for Girls. She graduated from Temple University in 1953 with an A.B. found that there was sufficient evidence that Merck had continued to reassure investors that Vioxx was safe, even as its safety was questioned by independent researchers. (In re Merck & Co., Inc., Securities, Derivative, and ERISA See Employee Retirement Income Security Act.
See Employee Retirement Income Security Act (ERISA). Litig., 2008 WL 4138476 (3d Cir. Sept. 9, 2008).)
Mark Lanier, a Houston attorney who represents Vioxx plaintiffs, said the Annals study marks the medical community's formal recognition of a practice that plaintiff lawyers have long known.
"We knew of this seeding study and made an issue of it to the jury in Ernst, the very first Vioxx trial. Merck persisted in trying to keep the information out of the general scientific domain, but it is now out there for the world to see. This will not affect the settlements in place, but it may affect future studies that have marketing as their point-while wearing the mask of science."