Canada To Toughen Drug Approval Process Says Minister of Health
CategoriesWhile The FDA is hearing testimony on the "Cox-2 effect" - heart attacks caused by pain drugs in the Vioxx class, Canada's Health Minister promises "dramatic changes in the way prescription drugs are approved and monitored" The minister said the new process will include public input -- even public hearings -- before new prescription drugs are approved.
It is interesting to note that animal tests seem to be implicated in the drugs disaster that is shaking the foundations of pharmaceutical medicine. Medicalnewstoday quotes John J. Pippin, M.D. of the Physicians Committee for Responsible Medicine (PCRM) who is advising the FDA how experiments on mice, dogs, and other animals misled scientists and ultimately contributed to a tragic outcome for human patients exposed to Vioxx and other drugs.
PCRM's report reveals that Vioxx and other COX-2 drugs actually had a heart-protective effect in mice and other animals, exactly opposite of how the drugs later performed in humans. The report also reveals that once clinical trials started showing that the drugs caused heart problems in humans, the pharmaceutical companies ignored this information and instead pointed to the animal tests as "evidence" that the drugs were safe. As Dr. Pippin illustrates in the report, the Vioxx animal testing debacle is not unique. Over the years, millions of patients have been exposed to harmful drugs, such as Rezulin and Baycol, that seemed safe in tests on mice, dogs, rats, monkeys, horses, and other animals."Reliance on animal tests enabled the FDA to approve Vioxx," says Dr. Pippin. "It is time to turn to newer, more reliable human-based methods such as studying drug metabolism using human liver subcellular fractions." Liver toxicity is the major reason for drug re-labeling and withdrawal, and it often does not show up in dogs and other animals.
It is also significant that the widespread use of painkillers, especially in heart patients, seems to be linked to the side effects of another widely prescribed class of drugs - Lipitor and its cholesterol lowering cousins. One of the side effects of these drugs are - sometimes atrocious - muscle pains. Reports of that effect seem to be widespread, judging from the numerous comments by readers of this article on Lipitor and this other one. How could the FDA miss this one? Perhaps the agency's far too close relation with the drug makers can explain that such glaring indicators of drug induced damage to health are 'overlooked'.
Meanwhile, the European Medicines Agency has warned doctors to "be cautious" about prescribing Cox-2 inhibitor drugs, but has fallen short of more drastic action. Reforms are welcome. Perhaps Canada can lead the way? Here is what The Globe and Mail says about Canadian health minister's public statement.
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February 16, 2005 - Globe and Mail
Health Canada to revamp drug approvals By ANDRÉ PICARD
Canada's Health Minister is promising dramatic changes in the way prescription drugs are approved and monitored after the debacle involving popular painkillers used by arthritis sufferers. Ujjal Dosanjh said the new process will include public input -- even public hearings -- before new prescription drugs are approved.
He also promised to beef up the monitoring of adverse reactions (when drugs make people ill or kill them) and said he has not ruled out creating an independent, arm's-length agency to ensure drugs sold in Canada are safe and effective.
"We want to move to more openness, more transparency, more accountability and, of course, more public input from all the stakeholders involved in the process," Mr. Dosanjh said in a teleconference with reporters.
Today in Washington, the drug safety committee of the U.S. Food and Drug Administration begins much-anticipated hearings on the safety of cox-2 inhibitors. This class of drugs includes Vioxx, Celebrex, Bextra and Mobicox, popular painkillers that, in recent months, have been linked to an increased risk of heart disease.
"I would like to see something similar in Canada," Mr. Dosanjh said. But he waffled on whether hearings were needed specifically on cox-2 inhibitors, saying Health Canada has been working on the issue assiduously for several months.
He said that Canada may follow Australia's lead and order warnings about cardiovascular risks on the packaging of all cox-2 inhibitors and also advise patients taking more than 200 milligrams daily of the drugs to discuss their treatment regime with a doctor. (Health Canada now advises people who take cox-2 inhibitors at the relatively high doses of between 400 and 800 mg daily to discuss alternatives with their doctors and whether "the risk of cardiovascular side effects outweigh the benefits."
The minister revealed that since Vioxx was withdrawn for sale in Canada on Sept. 30 of last year, 10 Health Canada employees have been working full-time reviewing the risks and benefits of cox-2 inhibitors.
"The review is one of the most demanding, complex and costly the department has undertaken in recent years," Mr. Dosanjh said. He said it will take six to eight more weeks before a final decision is made and all options, up to and including withdrawing market authorization for cox-2 inhibitors, were being considered.
More important, however, Mr. Dosanjh said this kind of scrutiny of drugs, both before and after they are approved for sale, will become common, and he hinted that new money will be allocated in the coming federal budget to do so.
Jacques Lefebvre, vice-president of communications at Rx & D, the group representing Canada's research-based pharmaceutical companies, said the minister's initiative took him unpleasantly by surprise, and he was scrambling to get more details before commenting.
"This is an odd way to announce or deliver policy," he said.
Mr. Lefebvre said industry "already works with Health Canada to ensure that drugs are safe and effective and will continue to do so." He said he could not comment on the idea of public hearings until specifics were available. "We believe patients have a key role to play in health care, but we need to identify how they can best provide that input."
Consumer activists welcomed the news.
"Public hearings would be a very helpful addition to Canada's drug-approval process," said Louise Binder, co-chairwoman of the Canadian Treatment Advocates Council, which lobbies for better access to treatment for people with HIV/AIDS.
"There are a number of stakeholders that have valid and important information about the safety and efficacy of drugs, and there is currently no forum for them to be heard."
Ms. Binder, however, said an independent drug review agency is not necessary.
"There's no lack of independence at Health Canada. They can do this well, but they need the resources, and that's what's lacking right now," she said.
The U.S. FDA announced yesterday that it will create a new independent Drug Safety Oversight Board to monitor drug-safety issues and ensure that physicians and consumers get information in a more timely manner.
Terence Young, the chairman of Drug Safety Canada, a group that lobbies for safer drugs, also welcomed the move toward openness and transparency, saying the current process of approving and monitoring drugs is far too secretive.
"It's a whole new world out there since Vioxx, and it appears that the Minister of Health understands that," he said. "It's what we've been saying for years: Transparency is the key to drug safety."
Mr. Young said an independent agency to monitor drug safety and efficacy is not only desirable, but essential. He said Health Canada is too cozy with industry, and it simply doesn't work to have the same department that approves drugs monitor them once they are on the market.
"We don't let Air Canada investigate its own crashes, and we can't let Health Canada investigate its own drug crashes," he said.
See also:
Monday, February 21, 2005 - Commentary
With COX-2 decision, no longer any doubt about FDA corruption and U.S. drug racket
Following the death of as many as 60,000 Americans from COX-2 inhibitors (source: British Medical Journal, author Dr. David Graham, FDA drug safety researcher), an FDA advisory panel has now voted to allow the drugs to return to the market with full FDA safety approval. The fact that a single COX-2 drug has reportedly killed more Americans than the entire Vietnam War is apparently not sufficient for the FDA to characterize it as unsafe.Tuesday, February 22, 2005 - Globe and Mail -
Weak law blamed in Vioxx case
Canadian regulators say they lack the power to force drug companies to research specific safety concerns once a medication is on the market, despite the suspicion of heart-attack risk that swirled around Vioxx and other painkillers for years. Mark Bethiaume, director of Health Canada's marketed pharmaceuticals division, said those who feel the department failed to protect the public from the dangers of Vioxx and other cox-2 drugs misunderstand Health Canada's abilities.February 23, 2005 - Globe and Mail
Health Canada too slow to act on drug-safety plan, experts say
Researchers who submitted a pla
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