Fw: Missing Data on Celebrex ~ Full Study Altered Picture of Drug

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From: " Ilena Rose " <ilena@...>

Sent: Thursday, August 09, 2001 10:29 AM

Subject: Missing Data on Celebrex ~ Full Study Altered Picture of Drug

> http://www.washingtonpost.com/ac2/wp-dyn/A33378-2001Aug4?language=printer

>

>

> Missing Data on Celebrex

> Full Study Altered Picture of Drug

>

> By Okie

> Washington Post Staff Writer

> Sunday, August 5, 2001; Page A11

>

>

> When editors of the Journal of the American Medical Association sent

> medical expert M. Wolfe an unpublished study on the blockbuster

> arthritis drug Celebrex last summer, he was impressed by what he read.

>

> Tested for six months in a company-sponsored study involving more than

> 8,000 patients, the drug was associated with lower rates of stomach and

> intestinal ulcers and their complications than two older arthritis

> medicines -- diclofenac and ibuprofen.

>

> JAMA's editors wanted to rush the findings into print, and Wolfe and a

> colleague provided a cautiously favorable editorial to accompany it. But

> in February, when Wolfe was shown the complete data from the same study as

> a member of the Food and Drug Administration's arthritis advisory

> committee, he said he saw a different picture.

>

> " We were flabbergasted, " he said.

>

> The study -- already completed at the time he wrote the editorial -- had

> lasted a year, not six months as he had thought, Wolfe learned. Almost all

> of the ulcer complications that occurred during the second half of the

> study were in Celebrex users. When all of the data were considered, most

> of Celebrex's apparent safety advantage disappeared.

>

> " I am furious. . . . I wrote the editorial. I looked like a fool, " said

> Wolfe, a Boston University gastroenterologist. " But . . . all I had

> available to me was the data presented in the article. "

>

> JAMA's editor, D. DeAngelis, said the journal's editors were not

> informed about the missing data. " I am disheartened to hear that they had

> those data at the time that they submitted [the manuscript] to us, " she

> said. " We are functioning on a level of trust that was, perhaps, broken. "

>

> The study's 16 authors included faculty members of eight medical schools.

> All authors were either employees of Pharmacia, Celebrex's manufacturer,

> or paid consultants of the company. For company-sponsored studies, JAMA

> now requires a statement, signed by an author who is not employed by the

> company, taking " responsibility for the integrity of the data and the

> accuracy of the data analyses, " DeAngelis added.

>

> Geis, a vice president for clinical research of Pharmacia and one

> of the authors, said that only the first six months of data were presented

> because, after that, more patients withdrew from the comparison groups

> than from the Celebrex group, biasing later findings. He said a

> three-member executive committee, composed of authors who were not

> Pharmacia employees, approved the decision.

>

> " The intention really was not to be deceptive in any way, " he said.

> " People thought that six months was the appropriate analysis. "

>

> With inclusion of the later data, " the actual difference between Celebrex

> and [the other drugs] are not as wide as they were at six months, " he

> acknowledged. " But I think in the end, it does show that Celebrex has a

> superior safety profile. "

>

> After reviewing the full study, the FDA's arthritis advisory committee

> concluded that Celebrex offers no proven safety advantage over the two

> older drugs in reducing the risk of ulcer complications, said FDA

> spokesman Cruzan. The company has requested a change in the drug's

> labeling to state that it is indeed safer, but the FDA has asked for

> additional information before making a decision.

>

> Meanwhile, the JAMA article and editorial have likely contributed to

> Celebrex's huge sales. " When the JAMA article comes out and confirms the

> hype, that probably has more impact than our labeling does, " said

> J. Temple, director of medical policy at the FDA's Center for Drug

> Evaluation and Research.

>

> , a professor of clinical pharmacology at the University of

> British Columbia, said he complained to JAMA after noticing differences

> between the published report and the data presented to the FDA. He praised

> the Public Citizen's Health Research Group, a consumer organization, for

> filing a lawsuit that led to the agency's putting all drug studies

> presented to its advisory committees on its public Web site.

>

> " Otherwise, we still wouldn't know this, " said. " We would still be

> in the dark. "

>

>