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FDA Suppressing Vital Data On Prescription Drugs

28 Pages Of Information On New

Wave Of Painkillers Withheld

By Roger Dobson and Jeanne Lenzer

The Independent - UK

6-12-5

 

Vital data on prescription medicines found in millions of British

homes has been suppressed by the powerful US drug regulators, even

though the information could potentially save lives.

 

An investigation by The Independent on Sunday shows that, under

pressure from the pharmaceutical industry, the American Food and Drug

Administration routinely conceals information it considers

commercially sensitive, leaving medical specialists unable to assess

the true risks.

 

One team of investigators found that 28 pages of data had been

removed from the FDA files on one of a new family of painkillers

because of confidentiality.

 

Last week a major research study led by Professor Julia Hippisley-Cox

at Nottingham University, revealed that ibuprofen, the

supposedly " safe " painkiller, increases the risk of heart attack by

almost a quarter. The finding was a particular blow to thousands of

users who have already switched from the best-selling drug Vioxx,

which was withdrawn last year after evidence that it too could

increase the risk of heart attacks.

 

Key information about Vioxx and other drugs that form part of the new

generation of painkillers called Cox-2 inhibitors had been

suppressed, it emerged. Now researchers are questioning the

reliability of the data about other drugs, including the full range

of painkillers.

 

Dr Peter Juni, one of the team of Swiss investigators who helped to

expose the risk of the new-generation drugs, claims his efforts were

obstructed by the FDA.

 

" As part of the Freedom of Information Act, the agency is required to

make available its reports on all drugs that are approved.

Unfortunately, these reports are not as useful as they could be, " he

and his team say in an editorial in the British Medical Journal.

 

" For example, only 16 out of at least 27 trials of celecoxib that

were performed up to 2002 in patients with musculoskeletal pain were

included in the relevant reports... In the case of valdecoxib, we

found that many pages and paragraphs had been deleted because they

contained trade secret and/or confidential information that is not

disclosable. "

 

Dr Juni, senior research fellow in clinical epidemiology at the

University of Berne, is demanding that drug companies be legally

required to make public any adverse effects as soon as they become

available. Researchers also want more independent research, with

financial firewalls between drug companies and doctors carrying out

clinical trials.

 

Last year The Lancet published trial results that showed that

unacceptable heart risks linked to the drug rofecoxib (sold as Vioxx)

were evident four years before it was finally withdrawn by its maker.

 

The Lancet's editor, Richard Horton, said at the time that the

discovery pointed to lethal weaknesses in the FDA's approach. He

said: " Too often the FDA saw and continues to see the pharmaceutical

industry as its customers, a vital source of funding for its

activities, and not as a sector of society in need of strong

regulation. "

 

It emerged that FDA supervisors had attempted to suppress a report by

Dr David Graham, associate director of the FDA's own Office of Drug

Safety, showing that patients taking Vioxx suffered five times as

many heart attacks as patients taking another pain reliever,

naproxen.

 

Dr Graham's supervisors refused to allow him to present his

conclusions at a meeting in France and later sought to interfere with

the publication of his study results when they were scheduled to

appear in The Lancet. Merck, the drugs company behind Vioxx,

subsequently acknowledged the risk of heart attacks, and the article

was published.

 

Speaking yesterday, Dr Juni said: " In some instances we had great

difficulty in disentangling data. Not all the trials were reported,

and it was difficult to see which results went with which trial. In

some cases it took my group more than 1,000 hours to disentangle the

information. We say that safety data from trials should be made

available publicly. "

 

The older drugs involved - ibuprofen, naproxen and diclofenac - have

been around for so long that all are out of patent. Some earlier

studies have suggested that they increase heart attack risks but this

has been overlooked because they cause the more serious side effects

of bleeding in the stomach or the development of ulcers.

 

The FDA has also run into trouble over antidepressants. Internal

memos and a secret government report showing an increased incidence

of suicide among children taking antidepressants surfaced in July

last year. The report, by Dr Andrew Mosholder, an expert at the FDA's

Office of Drug Safety, presented an analysis of 22 studies of 4,250

children on nine different antidepressants, and found that their risk

of " suicide-related events " was twice that of children given a

placebo. But that information was suppressed by the agency. After the

report was leaked, Dr Robert Temple, formerly the associate director

of medical policy at the FDA's drug evaluation centre, defended the

FDA's actions saying the results were " prem-ature " . The agency is

investigating the leaking of the report.

 

In later reviews, Dr Mosholder's findings were confirmed and the FDA

ordered a stringent black-box warning to appear on the labels of anti-

depressants.

 

The relationship between the FDA and the drug companies has triggered

congressional investigations in the United States. But when it comes

to revealing data and FDA analyses, Dr Temple said that non-approved

data - as well as some safety and efficacy data regarding drugs

currently on the market - is " proprietary information " and that it

would be a " criminal offence " to reveal it. " That is something only

Congress can change, " he said.

 

UNDER SUSPICION

 

Viagra

 

US officials are investigating reports of blindness linked to the

anti-impotence drug. Its makers, Pfizer, said the cases were " rare "

and none was reported among the 13,000 people in its clinical trials.

 

Hormone replacement therapy (HRT)

 

A review of clinical trials showed HRT increased risk of stroke by 29

per cent. Royal College of Obstetricians and Gynaecologists said it

should only be used in the short term.

 

Vioxx

 

The arthritis painkiller used by 80 million patients was withdrawn by

its makers, Merck, last September. It could have caused 140,000 heart

attacks, almost half of which were fatal.

 

Seroxat

 

Fears that the drug could cause an increased risk of suicide if

prescribed to depressed teenagers led to a ban for under-18s. Side

effects include addiction.

 

Steve Bloomfield

 

©2005 Independent News & Media (UK) Ltd.

 

http://news.independent.co.uk/uk/health_medical/story.jsp?story=646243