US regulator suppresses vital data on prescription drugs on sale

[cal04]

US regulator suppresses vital data on prescription drugs on sale in Britain

Despite calls for more transparency after revelations about the side effects of ibuprofen, the FDA has withheld 28 pages of information on a new wave of painkillers. 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was a particular blow to thousands of users who have already switched from the best-selling drug Vioxx, which was withdrawn last year after evidence that it too could increase the risk of heart attacks.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.''

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

[Lori Price CLG]

1. Once again, (an agency of) the US govt *is* the terrorist n/t

[seafan]

2. This will enrage people when they start finding out about it.

Everybody just make sure to have a safe place to stand back when this house of lies comes roaring down.

It's going to be soon.

[halobeam]

3. Here's a tinfoil thought...

who would benefit from taking over the counter pain meds off the shelf?

hmmmmmmmmmmmmmmmmmmmmmmmmmm

[seafan]

4. The same people that don't want Americans to have access to

reimported medicines from Canada.....

...the same people who give obscene amounts of money to the Republican Party.....

...the same companies that spend 3% of their entire operating budget on research and 97% on marketing new drugs that are inadequately tested....

...the same people who send representatives to hover in your MD's waiting rooms, sucking up valuable time from Dr/patient interaction, hawking the latest miracle drugs for cholesterol control, arthritis, male enhancement...

....basically, people who don't give a damn about the public health and longevity in America, just their bottom line.

[1monster]

7. And here is another tinfoil thought: Who benefits when those who

take ibuprofen (and other drugs) develop heart (and other) problems? Who will be selling the new fangled heart, blood, pressure, circulatory, and cholesterol management drugs?


US Drug Companies and the FDA: Creating future medical problems for future profit

[leesa]

5. The FDA is incredibly corrupt. Totally in the pocket of Big Pharma

[DeepModem Mom]

6. kick