Remembering Thalidomide

 “The process for reviewing and approving new cancer drugs in Canada takes almost twice as long as that in the United States and is longer than the approval times in Europe, concludes a new report from the Fraser Institute, Canada’s leading public policy think-tank.

 The result has Canadians waiting significantly longer for new, potentially life-saving cancer drugs.

‘Cancer is the leading cause of premature death in Canada. Unfortunately, the review and approval process for new cancer-fighting medications is unnecessarily longer in Canada than other industrialized countries,’ said Dr. Nigel Rawson, Fraser Institute senior fellow and author of Access to New Oncology Drugs in Canada Compared with the United States and Europe.

‘Why are review times longer in Canada than in the United States and Europe? This raises serious questions as to whether the drug evaluation system in this country is beneficial or detrimental to Canadians with cancer.’”

  • Canadians wait almost twice as long as Americans for new, life-saving cancer drugs, By Nigel Rawson, Fraser Institute.org, Release Date: July 25, 2012

To understand my criticism of the Fraser Institute, one must remember our own history. In the 1960’s, a drug known as Thalidomide was found to cause birth defects. The drug was supposed to help pregnant woman with morning sickness get over their nausea. While, it did do that, it also had dangerous ramifications: it led to birth defects in the unborn child.

This drug was approved in Canada, Australia and Europe. However, what is most interesting is that the drug was not United States. The Food and Drug Administration (FDA) refused to approve the thalidomide saying further studies were needed. Therefore, the US is distinct in the Western World as not having any “Thalidomide babies”. They were saved from babies born without limbs because they had a unique, independent and distinct approval process.

In dealing with things like Health Care, it is hard to say that regulation is important but it is. For, medicine largely attempts to deal with unknowns. Or put differently, in many cases, while the symptoms are known, many of the underlying issues are not. A doctors’ aim is to stem the symptoms and prolong life. Therefore, if people are feeling better and living longer, a doctor’s job is done.

However, sometimes, like in the case of Thalidomide, some elements are not taken into account. Or look at the recent excitement in the Multiple Sclerosis Community about Liberation Therapy. Earlier this decade, an Italian Doctor claimed that his therapy – Liberation Therapy – solved the MS question. This has led a variety of government reactions. The FDA in the States has warned against its use. (U.S. FDA warns against controversial ‘liberation therapy’ for MS, Sheryl Ubelacker, The Canadian Press, As posted by the National Post | May 10, 2012 5:14 PM ET). Some governments have decided to do research into the therapy; while others have paid for their citizens to receive the treatment (Liberation Therapy: Saskatchewan Sends MS Patients To U.S. For Clinical Trial Of Controversial Treatment, Jan. 12/12, The Canadian Press, As posted by the Huffington Post). With that being said, increasingly doctors and patients are questioning its effectiveness (MS patient regrets his ‘liberation’ therapy, by Marianne Takacs Toronto Star, November 20, 2010; ‘No measurable change’ in MS symptoms from liberation treatment: study, by Helen Branswell, The Canadian Press, As posted by the Globe and Mail, Published Thursday, Jun. 07 2012, 6:25 PM EDT). Through all of this no definitive answer has come to the fore. In many ways, we have not learned from our past; and, our medical system jumps to conclusions. Therefore, creating room for error.

This is why it is important to have an unrushed system that looks at science, and not depend on other jurisdictions approval process, for answers on the safety of medication. In Australia’s case, their independent physicians raised flags about Thalidomide in 1961. For, Australian Dr. McBride announced his conclusions in The Lancet, in December 1961. In a letter, he noted a large number of birth defects in children of patients who were prescribed Thalidomide. This was one of the first indications of the truth that would later follow: the unknown issues from a drug can be just as bad as using the drug itself.

There are many ways we can deal with these unknown issues. The Americans deal with it through the legal system. They have large and reoccurring class actions suits. If you don’t believe me just watch American television. On weekends, one American law firm or another advertises how you can be rewarded for your illness or the death of a loved one due to the use of a medicine or medical procedure. This individualist approach in my opinion leads to unnecessary deaths. Drugs and treatments are rushed to market with all sorts of warnings with only one hope: that the revenue from the drug is more than the costs of litigation and marketing.

As a Liberal, I believe we should protect the “Other”. This approach requires Canadians to have a rigorous and independent review process for drugs, medical appliances and medical devices. A system of precaution would be best. For, pharmaceutical companies – in my opinion – should have to prove safety and not use a risk based approach which dominates the Canadian system today.

Furthermore, it also allows me to support the changes to our food and safety regime that came forth in 2004. For that approach made it clear that Vitamins, Minerals, Herbal Remedies, Homeopathic medicines, Probiotics and other Natural Health Products had to match the same safety protocols prescribed to medications. Or put differently, all health products should not cause any harm. This is an approach of cautiousness that all Canadians can live with because it “Protects the Other”. Without those protections, drugs which are ineffective (Common Alzheimer’s Drug Found Ineffective, By Reuters, Posted in Huffington Post.com, Updated: June, 16, 2011) or dangerous (http://commonground.ca/2012/01/prescription-drug-deaths/) might come to market. This might mean peer review is necessary, it also means that time is important. Therefore, rushing drugs to market as the

Fraser Institute suggests is the wrong way to deal with this issue. Let our system be an independent one so that we can ensure the safety of our citizens.

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