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Big Pharma may get speed-up of new drug approvals

Health Canada putting private profit before public health.

Michael McBane: Health Canada working with drug industry to lower drug safety Straight Goods News staff

Michael McBane, national coordinator of the Canadian Health Coalition, writes that Health Canada is working with the drug industry and with drug industry-funded groups to lower the drug safety standards and speed new drugs to market, thereby increasing the likelihood that Canadians will be exposed to dangerous new drugs.

A study conducted by Dr. Joel Lexhin, a physician and professor of health policy at York University, was released by the Canadian Centre for Policy Alternatives. It likewise finds that Health Canada's initiatives favour private profit above public health.

According to McBane, the changes to drug regulations are intended to replace the Food and Drug Act, which is mandated to protect public health.

  "The problem is serious, but it will become more serious still when the process is put on steroids."

The new changes eliminate the precautionary principle; therefore, the drug industry will no longer have to demonstrate the safety of its products. Arthur Schafer, director of the Centre for Professional and Applied Ethics at the University of Manitoba, says that rather, new products would be presumed safe unless critics can prove that they are more harmful than beneficial.

McBane cites the arthritis drug Vioxx as an example of what can happen when drug safety is not properly researched. Vioxx was withdrawn in 2004 because it caused many thousands of heart attacks and killed an estimated 68,000 people in the USA. At least four other drugs approved by Health Canada between 2005 and 2007 have since been withdrawn because they were unsafe.

Tory MP Terence Young, who took part in Health Canada's consultations, believes Health Canada is putting lives at risk by approving too many drugs too quickly.

Young's family were victims of unsafe drugs. Pepulsid, in combination with bulimia, caused his daughter's death ten years ago. The drug was pulled from the Canadian market in August 2000.

Dr. Lexchin's study similarly notes highly suggestive research linking faster regulatory approval to increases in safety problems.

"While faster approvals get drugs to market more quickly, they may also compromise safety — an important consideration as an increasing number of people are exposed to new drugs that ultimately are pulled from the market because of safety concerns," Dr. Lexchin says.

Schafer warns, "The problem is serious, but it will become more serious still when the process is put on steroids."

David Lee, director of the office of legislative and regulatory modernization at Health Canada, denied that Health Canada would lessen safety standards for drugs. He said the purpose of the consultations was to modernize the regulations for prescription drugs and medical devices.

Health Canada held its final consultation on proposals to alter regulations governing prescription drugs and medical devices in Ottawa on January 19-21, 2011.

Related individuals, organizations and significant events
Who's calling the tune: Harmonization of drug regulation in Canada

Links and sources
  Drug safety: Health Canada thanks you for not enquiring
  A bitter pill: Consultations on drug safety appear to be stacked in favour of industry, which could be bad news for the public
  Critics irked by federal drug talks
  Harmonizatin of drug standards may put private profit before public health
  Too many drugs allowed on market — MP

Posted: January 30, 2011

  Health care
  Public services

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