Drug Company Lies About Celebrex in JAMA

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Drug Company Lies About Celebrex in JAMA

 

http://www.mercola.com/2001/aug/8/celebrex.htm

 

By Susan Okie

 

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

expert Dr. M. Michael Wolfe an unpublished study on the blockbuster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, Catherine 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.

 

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 Susan

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 Robert J.

Temple, director of medical policy at the FDA's Center for Drug Evaluation

and Research.

 

James Wright, 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

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, " Wright said. " We would still be in

the dark. "

 

Washington Post, August 5, 2001; Page A11

 

 

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Dr. Mercola's Comment:

OK folks, here is your question for today:

 

Who makes Celebrex?

 

If you answered Pharmacia you were correct.

 

Now the question very few of you will get right;

 

What else does Pharmacia own?

 

Pharmacia Corporation was created in April 2000 through the merger of

Pharmacia & Upjohn with Monsanto Company and its G.D. Searle unit. Pharmacia

employs 59,000 people worldwide and has research, manufacturing and

administrative sales operations in more than 60 countries.

 

So Pharmacia owns Monsanto. And what does Monsanto do or make?

 

If you guessed Round Up insecticide and that they control nearly all the

genetically modified seeds, you answered correctly.

 

So here we see a HUGE integrity glitch in the company that essentially lied

by not telling the full story, so their drug would have favorable reviews in

JAMA so they could make more money.

 

Do you really want to trust a company that would do this and believe that

their GMO plants that they are introducing are any different?

 

Folks, this is a huge problem and I only just recently realized that

Pharmacia owned Monsanto. I was hugely concerned about the GMO issue

previously, but in light of this new information I truly believe we need to

be especially vigilant about these foods.

 

Getting back to Celebrex, as I said back in February when this first hit the

FDA panel:

 

Celebrex is the number one anti-inflammatory drug, so this is important

information. Many people are taking this drug under the impression that it

will reduce their risk of ulcers.

 

The market for analgesics is about TEN BILLION dollars per year. That is one

big number. That is why this is an important drug to watch. It is important

to remember that anytime you are dealing with numbers that large there will

inevitably be corruption, greed and negative influences that are a part of

the story if drugs are involved.

 

So ALWAYS be alert to deception. As one of my friends, Dr. Tom Stone, is

fond of saying " The PLANET is RULED by GREED and DECEIT! "

 

Don't you find it interesting that Pharmacia, the drug's manufacturer can

not even prove that this new drug is any less damaging than aspirin. That is

supposed to be the huge advantage of this drug. It is supposed to cause less

GI toxicity.

 

Celebrex has also been shown to reduce beneficial protaglandins and increase

your risk for heart attack.

 

Related Articles:

 

Celebrex Not Shown to Lower Ulcer Risk

 

COX-2 Drugs May Damage Kidneys

 

Some Drugs Can Increase Risk of Birth Defects

 

FDA Panel Votes to Approve New Celebrex™ Alternate

 

 

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