Avery shocking news appeared in today's Star Please read on .....
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Health Canada slammed over drug safety
Thousands die, MPs are told

Report decries lack of scrutiny


ROBIN HARVEY
LIFE WRITER

Health Canada is failing to effectively protect Canadians who take prescription drugs, a parliamentary report says.

"We want to sound the alarm," says Rob Merrifield vice-chair of the the all-party Standing Committee on Health. "This is a very serious problem."

Among the report's recommendations:

New drugs should be put "on probation" so any dangerous reactions or problems can be identified after they are released to the general public.

A closer inspection of all clinical drug trials, including the formation of a public database containing information on drug trials whether or not they are completed.

Tougher standards for drug research ethics boards.

Independent, unbiased and publicly funded information on prescription drugs for all Canadians and the enforcement of laws prohibiting drug ads aimed directly at consumers.

Making doctors and drug manufacturers report adverse reactions within 48 hours of their occurrence.

Research trials on new drugs that use human subjects are not effectively monitored, the report says. And Merrifield said in an interview the committee heard testimony that some clinical trials used "fabricated" research in drug studies.

"There is no single national body mandated to provide oversight for the ethical conduct of human research in either the public or private sector," the report says.

Health Canada is also lax in keeping tabs on dangerous or adverse drug reactions once health products are approved, the report says. Merrifield said these reactions have been estimated to cost from 10,000 to 20,000 lives a year. In 2002, Health Canada received 8,500 reports of adverse drug reactions in Canada, and 106,000 foreign reports, but had only 13 people to analyse the information.

"Health Canada estimated that half of newly approved therapeutic health products have serious side effects identified only after ... exposure within the larger population," the report says.

The report — "Opening the Medicine Cabinet: First Report on Health Aspects of Prescription Drugs", released yesterday and tabled by the Standing Committee on Health — accused Health Canada of taking a "passive approach" to consumer drug safety.

Merrifield says the manner in which drugs are tested and approved is too secretive. The report says Canada's existing drug testing system "discourages openness to protect commercial interests" and that "Canadians may be harmed by the lack of scrutiny and by a dearth of independently assessed information."

The report also says: "Although the data generated (from research) may be viewed by Health Canada and is sometimes included in published scientific and clinical reports, most of it remains confidential and unavailable to the individuals using the products."

This is because some doctors and scientists involved in the testing are hampered by confidentiality agreements that in many cases effectively muzzle them, Merrifield says.

"Several witnesses suggested ... that questionable activities (about drug clinical trials) went unreported due to fears of retaliation," the report says.


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`Canadians may be harmed by the lack of scrutiny and by a dearth of independently assessed information'
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The committee heard that there is a lack of independence in drug research.

"In addition to these areas where there is a strong potential for conflict of interest, (drug manufacturers) have final approval over publication and usually seek positive reports published in established medical journals to raise awareness of their products and to promote their use," the report said.

However, the report said Health Canada does not have the resources to effectively monitor drugs for such effects once they are already on the market. "The committee is very concerned about the lack of staff resources ... to address adverse drug reaction reports," the report said.

And although it is illegal to advertise prescription drugs directly to the public the practice occurs regularly, Merrifield says, and Health Canada does not always enforce the laws.

The committee agreed to study the issue of prescription drugs last June. It conducted cross-country hearings for two months last fall.

Yesterday, Health Canada released the results of a poll on how well it informs Canadians of health product safety information.

Health Canada commissioned Decima Research Inc. to survey Canadian consumers and health professionals, including physicians, pharmacists, nurses, dentists and naturopaths.

Consumers view health products as generally, if not completely, safe to use, the poll found.

Consumers are most likely to believe in the safety of prescription drugs (84 per cent say they are very or generally safe), in comparison with non-prescription drugs (75 per cent) and natural health products (72 per cent.)

Health professionals hold similar opinions to that of the general public about the safety of prescription drugs (83 per cent say they are very or generally safe) and non-prescription drugs (74 per cent).

More than eight in 10 consumers and a similar proportion of health professionals express confidence in the current system for safeguarding the safety of prescription drugs, the poll found.

More than one in three (37 per cent) consumers claim to have personally experienced an adverse drug reaction, in most cases resulting from a prescription drug.

Health Canada uses a variety of ways to let Canadians know about drug safety.

They include: public advisories and warnings issued by the media, the Canadian Adverse Reaction Newsletter, letters to health professionals by manufacturers and/or Health Canada, Regional Adverse Reaction Centres, as well as using Health Canada's Web site and electronic mailing list.

Jacques Lefebvre, a spokesman for Canada's Research-Based Pharmaceutical Companies, said he supports the call for mandatory reporting of adverse drug reactions, and for national standards for clinical trials.

Lefebvre said he could not comment on how many deaths can be attributed to adverse reactions and did not know the source of the parliamentary committee's estimate.

He also said direct-to-consumer advertising is not a priority for the pharmaceutical industry, but it wants to make information about drugs more accessible.
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Just bought some medication yesterday only

Thanks and regards.
Biomed

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"Change before you have to" : Jack Welch

Another article just to show.. paise se yahan bhi sab kuch hota hai

http://www.healthcoalition.ca/whistleblowers.html
http://www.health4all.com/newsmar.asp

Thanks and regards.
Biomed

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"Change before you have to" : Jack Welch