The Dominion - Andrea Smith

Dominion Radio #8

Stuart Neatby — Sat, 23 Feb 2008 19:04:35 +0000

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The Cancer industry, Canada's legacy in Indonesia, and fighting Irving in court

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http://www.dominionpaper.ca/files/dominion/audio/Dominion Radio 8.mp3

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Dominion Radio broadcasts grassroots news from across the country, focusing on stories and voices silenced by the mainstream media.

Episode #8:

A discussion with Taylor Gray, Energy Advisor with the Conservation Council of New Brunswick about their efforts to take on Irving's proposed LNG refinery in Saint John, NB.
An interview with journalist and Cape Breton University Professor Garry Leech about the proposed Canada-Colombia Free Trade Agreement.
Devra Davis uncovers the sordid history of government, industry, and scientists efforts to obscure the commonly known causes of cancer such as smoking, benzene, and asbestos.
David Webster of the East Timor Alert Network looks back at Canada's role in facilitating the legacy of the late Indonesian President General Suharto, one of the biggest mass murderers of the twentieth century.

EPA Proposes New Rules for Human Dosing Experiments

Wed, 12 Oct 2005 21:53:39 +0000

Critics argue too many loopholes remain

photo: USDA

The US Environmental Protection Agency (EPA) unveiled a new set of guidelines this month that, according to the agency, "establish stringent enforceable ethical safeguards" on research conducted by third-parties intentionally exposing human subjects to pesticides. Susan Hazen, from the EPA's Office of Prevention, Pesticides, and Toxic Substances, says that the agency wants "to send a clear signal to the public that unethical research should never be conducted and will not be accepted by EPA." The rules pertain to third-party human dosing studies, where human subjects are intentionally exposed to chemicals which have no medical benefit. While previously banned by the EPA, they are now mandated by the Appropriations Act, 2006, signed by Bush on August 2nd, which states the EPA must have a set of rules in place for third-party intentionally human dosing studies no later than February 1, 2006.

The Act bans testing chemicals on "volunteers" who are children, infants or pregnant women.

But such a clear ethical message isn't readily found in the details of the rules. The thirty-page document, intended for public comment, holds numerous contradictions and loopholes. Testing on "abused or neglected" children is acceptable without permission from parents or guardians. Another ethically contentious rule is the EPA's ability to use industry studies conducted overseas, performed in countries that have minimal or no ethical standards for testing, so long as the tests are not done directly for the EPA. And while numerous sections detail the strict conditions of subjecting pregnant women, children and infants to intentional chemical exposures, they are ultimately undermined by a rule stating that unethical research (which includes research on pregnant women and kids) can be used should they provide important data needed for a regulatory decision.

And what of the consequences for conducing unethical research? Action the EPA can take includes refusing to rely on unethical research and disqualifying the institution that approved or conducted the research from receiving federal funding.

The revised rules require that studies, whether conducted or sponsored by the EPA or by another party such as industry or academia, comply with the Common Rule: the current ethical standards for research conducted or supported by the US federal government. Researchers are required to submit study protocols to the agency's Human Studies Review Board for scrutiny before they are conducted. Once the study is completed, researchers must report to the EPA on how the ethical standards were met.

Such a process is meant to prevent the ethical violations of previously submitted trials. To date, the EPA has received 24 human dosing studies. Most have not been published, and are therefore not peer reviewed. Some bioethicists and scientists have raised additional concerns with the studies. In a report examining six of the human dosing experiments submitted by industry to the EPA, Dr. Alan Lockwood stated that "all had serious ethical or scientific deficiencies – or both." These deficiencies include inappropriate methods and distorted result, and lack of informed consent. For example, in one study investigating the health effects of the pesticide cholrpyrifos, the subjects were informed that "low doses of these agents [cholinesterase inhibitors] have been shown to improve performance on numerous tests of mental function." What subjects weren't told was that none of the chemicals classified as performance enhancers are organophosphates, a class of chemicals well-known to negatively affect the central nervous system.

Another ethical issue not addressed by the proposed rules is conflict of interest. The $10 billion dollar chemical industry certainly has a lot at stake in the issue. When the EPA proposed a moratorium on the submission of human dosing experiments in 2001, the chemical industry sued – and won. Welcoming the decision to allow human pesticide testing, industry representatives stated that "the EPA does not need to be overly restrictive when it sets pesticide exposure levels." Industry favours human dosing studies because they can be used to establish levels of no adverse effect (NOELs), often at levels higher than those from animal studies. In terms of environmental regulation, that means that more pesticides can be applied, and higher exposures seen as acceptable.

However, many scientists agree with industry's position on the need for human studies. Reversing the prior moratorium on the use of human subjects, a National Academy of Science (NAS) panel reviewing the issue stressed that the use of human subjects was appropriate only to answer important regulatory questions that could not be answered without such studies, and in such incidences, there exists a public benefit to using "the best available science." The logic is that other methods, such as animal testing, often provide limited and inaccurate answers as to the health effects in humans. Yet human dosing studies are often conducted over short durations, such as a period of 6 months, and are therefore not long enough for most negative health conditions, such as cancer, to manifest. Moreover, EPA's proposed rules diverge from the NAS recommendations in a number of important respects. They ignore the recommendation for an independent review panel, and permit a far broader range of research than initially proposed. Erik Olsen with the Natural Resource Defence Council suggests, "if the rule stays as this draft has proposed, the floodgates will open for human testing."

Andrea Smith looks at criticisms of the EPA's new human testing regulations for pesticides as being riddled with "loopholes"

Social Determinants of Health

Sat, 23 Apr 2005 06:11:17 +0000

New WHO commission examines more than biology

An indian family on a motorcycle. A new WHO commission is investigating the relationship between economic inquality and health. photo: WHO

Although it has received little fanfare, public health advocates are hopeful that a new World Health Organization (WHO) Commission on Social Determinants of Health will act to improve people's health around the world. Inequalities in health have been deepening–both within countries and between them–and a growing body of research suggests that these inequalities are not the result of individuals' biology or health choices, but the result of the social conditions in which people live and work.

The WHO convened the Commission to recommend interventions and policies to reduce disparities in health status resulting from social determinants. Social determinants such as poverty, literacy, and employment affect the health of populations, leading some people to be healthier than others. Key amongst these factors are conditions of material deprivation, such as lack of income, but some propose that the gap between rich and poor itself accounts for people's health. For example, countries with less social inequality (such as Cuba) contain lower mortality rates than do the wealthiest classes in societies where large gaps between the rich and poor exist (such as the United States).

A vast body of research on these determinants has accumulated and according to the Commission, it is now time to put that knowledge into action. Canadian Minister of State for Public Health, Dr. Carolyn Bennett, who attended the formal launching of the WHO Commission, agrees: "Finding strategies to improve these social determinants is equally, and in some cases more, important than medical care and improving personal health behaviours."

Two Canadians, Monique Bégin and Stephen Lewis, will sit on the panel. Lewis is currently UN Special Envoy for HIV/AIDS in Africa and Bégin served as Minister of National Health and Welfare during the implementation of the Canada Health Act. Canada's representation on the Commission is fitting given that Canada has been at the forefront of research on the social determinants of health. Canadian researchers have come up with a list of eleven social determinants, which include not only medical services, early education, education and employment, but also social exclusion and income distribution.

"It is about opportunities in life and control over one's life, in addition to social conditions that shape the physical environment one lives in," says Michael Marmot, Commission chair and Director of the International Centre for Health and Society. Writing in the British medical journal The Lancet, Marmot says that "the Commission will seek to have public policy based on a vision of the world where people matter and social justice is paramount."

While the aims of the Commission resonate with the values of social justice, some are skeptical. The Commission points to interventions such as nutrition programs in Latin American schools as examples of successful strategies. By providing families with subsidies to enable their children to attend nutrition clinics and enroll in school, the children are able to stay in school and pay attention. However, programs like these are unlikely to address the facts of poverty, especially income inequality between countries.

Addressing the roots of social injustice will require substantial reform, and will likely be resisted by economic forces, and the Commission's proposals will likely face formidable obstacles in some areas. Anticipating this opposition, Marmot's team intends to focus its efforts within "a group of countries where there is commitment to rapid action to overcome the social barriers to health among political leaders, health officials, civil society groups and other stakeholders." The Commission is to operate until March 2008. Only time will tell if the Commission will have the support it needs to turn its talk on health inequality into action.

UPDATE: EPA Cancels Childhood Environmental Exposure Research Study

On April 8th, 2005, the US EPA announced it was canceling the Children's Health Environmental Exposure Research Study (CHEERS). According to Stephen Johnson, Acting Administrator of the EPA, the study was axed due to misrepresentation and controversy. Critics were concerned about CHEER's ethical implications, particularly the risk of families increasing their use of household chemical hazards in order to qualify for the study so they could receive compensation which included $970 and a video camera. Questions of ethics were compounded when it became known that the American Chemical Council, the chemical industry's trade group, provided $2.1 million to the study. Initially the EPA had halted the study and sent it for an independent review, but Johnson said, "the study cannot go forward, regardless of the outcome of the independent review. EPA must conduct quality, credible research in an atmosphere absent of gross misrepresentation and controversy."

A new WHO commission is investigating the relationship between economic inquality and health. Andrea Smith looks at some of the factors they're studying.

Cosmetics Industry Under Fire

Mon, 28 Mar 2005 06:39:57 +0000

Health effects of chemicals, endocrine disruptors, "penetration enhancers" questioned

Women and men in Berlin marked International Women's day by drawing attention to the relationship between women and chemicals -- X is the symbol for toxic chemicals. Photo: Beatrice Vohler, wecf.org

On March 8th, women around the world acted to acknowledge their struggle for equality and justice. For some, this year's International Women's Day served as a platform from which to draw attention to a range of issues typically not identified as affecting women in particular- including chemical contamination.

"Women are particularly at risk from dangerous chemicals, through their work, at home, in the family or when shopping," said Sascha Gabizon, Director of Women in Europe for a Common Future (WECF). As research continues to reveal how chemicals such as endocrine disruptors act to affect fetal development, while others bioaccumulate and can be passed on through breast milk, chemical hazards has come to be understood as a women's issue. WECF was one of several organizations which came together to organize the Women and Chemicals March 8th action where over a hundred women and men gathered in Berlin to form a massive X out of cloth -- the symbol for toxic chemicals.

The action was coordinated by a coalition of environmental and women's organization, and was a show of support for REACH, a draft law in the European Union that requires the registration, evaluation and authorization of all chemicals. Should REACH be approved in its strongest form, REACH could lead to the identification and phasing out of many harmful chemicals within three years of its implementation. The task remains a daunting one, particularly given the paucity of information on toxicity and health effects on most chemicals.

Women are particularly at risk of being exposed to chemicals whose short and long-term health effects are unknown though the use of cosmetics, shampoos, creams and other personal care products. Exposure to chemicals found in personal care products can occur through absorption through the skin, or through being ingested after application. Some companies, such as L'Oreal and Estee Lauder, are now adding nanoparticles to their products to act as "penetration enhancers" -- to deliver ingredients even deeper into the skin. Some worry that these particles ability to breech the skin - whose purpose is to keep harmful substances out -- may have unintended consequences for user's health.

In the United States, only 11 percent of the 10,500 cosmetic ingredients on the market have been reviewed at all -- and those evaluations have been conducted by the industry-sponsored Cosmetic Ingredient Review. Although the US FDA does not require safety testing on cosmetics, they do require companies to post a warning label on personal care products that have not been safety tested. After pressure from the Environmental Working Group (EWG), the US EPA warned companies to comply with the law or face persecution. Should companies comply, EWG estimates that over 99% of cosmetic products could be labeled.

According to Health Canada's Cosmetics Programme, "only ingredients that do not pose an unreasonable health and safety risk to the Canadian public, when used according to directions, are allowed in cosmetic products." Like the US, cosmetic companies are not required to submit information on product safety to Health Canada. Industry is only required to notify Health Canada of the full ingredients in cosmetics. However, Health Canada can request that the manufacture provided safety information. With recent changes to the Cosmetics Regulation, companies will be required to notify consumers of the full ingredients of cosmetic products by 2006. It is hoped that this labeling will enable consumers to avoid products that are of concern to them, and assist individuals to identify ingredients to which they have sensitivities.

But it is likely that labeling alone will be no match for the million-dollar cosmetics industry's advertising campaigns. Long-time recipient of criticism, the cosmetic industry has faced accusations of marketing an image of youth and whiteness -- a physical image few resemble yet damaging to the physical and social well being of many. And as the events of this International Women's Day suggest, it is likely that potential health hazards from chemical exposure will be added to the list.

Activists in Europe are questioning the health effects of chemicals, endocrine disruptors, and "penetration enhancers" in cosmetics, writes Andrea Smith

Cancer prevention in Canada

Fri, 25 Feb 2005 06:42:27 +0000

Are we doing all we can?

Prevention campaigns emphasizing lifestyle choices will do little to protect residents of industrial areas. For example, Sarnia, Ontario--known as Chemical Valley--residents' higher rates of cancer have been attributed to the local activities of petrochemical companies.

Approximately 68,000 people will die this year from cancer in Canada, and an estimated 1 in 3 will be diagnosed with the disease during their lifetime, a situation that has drawn the concern of many. Yet according to the National Cancer Leadership Forum (NCLF), an organization representing cancer care and advocacy agencies across the country, the federal government has yet to implement a cancer control strategy.

In 2002, the federal government announced it had devised the Canadian Strategy for Cancer Control, a plan to improve the coordination and delivery of treatment, prevention, palliative services and research in Canada. Proponents of the strategy state that it is unique because all major cancer players in Canada sat at the table during its development, including provincial cancer agencies, major charities, research agencies, professional associations, patient advocacy groups and pharmaceutical companies. The strategy was developed after numerous consultations with representatives from the cancer care sector, who saw it as a means of meeting the need for a more coordinated and concerted effort to address cancer.

To date, the Canadian Strategy for Cancer Control is still an idea on a shelf. Fed up with the federal government's lack of action, the National Cancer Leadership Forum launched its Canadian Campaign to Control Cancer (CC2C). The campaign aims to inform the public of what the National Cancer Leadership Forum sees as the government's lack of commitment to the treatment, detection and prevention of cancer. Mobilizing public support through circulating a petition, they hope to impress upon politicians the urgency of taking action.

While focusing on palliative care and treatment, the campaign also addresses the need for prevention. People are urged to quit smoking, improve their diet, increase their physical activity, and avoid overexposure to the sun, activities which can reduce an individual's risk of developing cancer.

Yet not all have received the Canadian Campaign to Control Cancer with open arms. Numerous health and environmental activists have argued that the prevention strategies suggested by the CC2C aren't what Canadians need. "Yes, more funding and action are needed on cancers linked to smoking, diets poor in fruits and vegetables, obesity, and over-exposure to sunlight," says cancer prevention activist Liz Armstrong. "However, there also needs to be much more focus and action on cancer hazards over which Canadians personally have no control." While the Canadian Campaign to Control Cancer addresses those activities that increase an individual's risk of developing cancer, it does nothing to address the causes of the rising prevalence of cancer within the population as a whole. Environmental health activists point to the role of the approximately 500 new chemicals being used in commercial processes each year, on which no or minimal toxicological information is available. And as the ecosystem becomes more and more permeated with chemicals from agricultural, industrial and residential uses, so to do the human residents. Scientists have called the chemical contamination of humans "body burden." Armstrong points out that "Every Canadian carries such a burden, from the moment of conception throughout life. With more and more evidence that childhood and other cancers begin in utero, this ought to be at the top of the cancer prevention agenda at every level of government." To make the situation more troubling, cancer is only one of the potential negative health outcomes resulting from exposure to environmental contaminants.

Some have also questioned whether the omission of environmental contaminants is to defend the interests of the several major pharmaceutical companies sponsoring the campaign. Dr. Bell, from the Canadian Association of Physicians for the Environment (CAPE) notes "drug companies, like all corporations, never involved themselves in a project unless it will enhance their bottom line." Drug companies have a vested interest in detection and treatment, as they profit from the sale of their products. Prevention on the other hand, particularly the type that would reduce the overall cancer rate, isn't a profitable affair. Anne Rochon Ford of the national working group, Women and Health Protection questions the companies' role in the Canadian Campaign to Control Cancer. Ford says "there is both a real and perceived conflict of interest present when the funders will profit financially from the success of this campaign." Such criticism is not meant to detract from the importance of ensuring adequate resources for the treatment of cancers, but instead to highlight the need for prevention strategies that will protect the public's health, in the present and future.

Why isn't addressing environmental causes of cancer in the government's official cancer control strategy, Andrea Smith asks.

No CHEERS for the EPA

Sun, 19 Dec 2004 10:08:38 +0000

Study halted over ethical controversy

Promotional material indicating items that CHEERS participants will receive. source: EPA

On November 11, 2004, the U.S. Environmental Protection Agency (EPA) announced it was temporarily suspending the Children’s Environmental Exposure Research Study (CHEERS) after public outcry to news that the study had accepted $2.1 million from the American Chemistry Council.

CHEERS aims to provide researchers with knowledge about how children ingest, inhale, or absorb pesticides, phthalates, brominaed flame retardants, and perfluorinated chemicals. Sixty children under 13 months of age will be monitored for two years, and their families will be asked to keep records of their pesticide and household product use. As little is known about how and to what extent children come into contact with these chemicals, researchers see this knowledge as useful for characterizing children's exposure in risk assessments.[1]

In October, the EPA accepted $2.1 million towards the study from the American Chemistry Council (ACC), a chemical industry lobby group whose members include Dow, Exxon, and Monsanto. According to an EPA news release, "public-private partnership is essential to finding solutions to today's complex environmental issues."[2] Yet this public-private partnership is one which has granted the ACC "considerable leverage" in the study, as well as special advance access to study results that the public and independent scientists will not have.[3]. CHEERS critics such as the Environmental Working Group and the Organic Consumers Association see this as a guarantee that the results will be biased in favour of industry.

Kenneth Cook of the Environmental Working Group (EWG) wrote in a letter to Michael Leavitt that the EWG "strongly supports greater study of children's exposure to chemicals, but not through a 'partnership' between polluters and the government that grants the regulated industry access to, and power over critical aspects of study design, study methods, data collection, data review and analysis, and data interpretation.[4]" Such research should be completely independent of industry funding to ensure the accuracy of the results.

Evidence of the toxicity of many of the chemicals being researched exists. For example, polybrominated diphenyl ethers (PBDEs) which are used as flame retardants on electrical equipment, fabrics and carpets have been shown to bioaccumulate in animal and human tissue. Studies have also shown that PBDEs can disrupt thyroid hormone balance and interferes with brain development. In fact, concern about PBDEs is so great that the State of California has nominated PBDEs to the National Toxicology Program for assessment of their carcinogenicity and neurotoxicity.[5]

"We aren't criticizing these companies for not doing studies, we criticize them for ignoring and/or burying the mountains of already existing research that clearly indicate many of their products are dangerous"
--Organic Consumers' Association

"We aren't criticizing these companies for NOT doing studies, we criticize them for ignoring and/or burying the mountains of already existing research that clearly indicate many of their products are dangerous" states the Organic Consumers Association. "We also criticize them for being responsible for some of the most vile environmental crimes this planet has ever seen. Exxon still hasn't paid a dime to clean up the Valdez oil spill. Dow continues to claim that Agent Orange is safe and had no negative impacts on U.S. soldiers or the Vietnamese."[6]

The ethics of recruiting of low-income families is also cited as a concern. Each family who completes the study will receive $970, a free video camera, a T-shirt, calendars, and a framed certificate of appreciation. Critics are concerned that low-income applicants may increase their toxic chemical use in order to be eligible for the study and rewards. While the study does not require participants increase their chemical use, it does require that chosen applicants demonstrate that they regularly use the toxic chemicals under investigation in and around their home.

Although the EPA cites that the study has already been approved by several institutional review boards, this approval was gained prior to study's receipt of ACC funds. Thus the EPA is 'taking the extraordinary step – of sending the study design for another external, independent review'[7] which will likely be completed by spring 2005.

[1] US EPA, National Exposure Research Laboratory, Office of Research and Development. Fact Sheet: A Children's Environmental Exposure Research Study. November 8, 2004. http://www.epa.gov/cheers/images/fact_sheet.pdf.

[2] US EPA. Office of Research and Development. News Release: EPA Partners with American Chemistry Council to Study Young Children's Exposure to Household Chemicals. October 12, 2004. http://www.epa.gov/cheers/images/news_release_101204.pdf.

[3] American Chemistry Council. Long-Range Research Initiative, Newsletter. Fall 2004. http://www.uslri.org/news.cfm?id=newsletters.

[4] Cook, K. Letter to the EPA. Environmental Working Group. Washington, DC http://www.ewg.org/issues/humantesting/20041029/letter_20041015.php

[5] US Department of Health and Human Services. National Toxicology Program. Report on Carcinogens. 10th ed. Carcinogen Profiles. 2002.

[6] Organic Consumer Association. EPA & Chemical Industry To Study Effects Of Known Toxic Chemicals On Children: Question & Answers. http://www.organicconsumers.org/epa-alert.htm.

[7] Acting Deputy Assistant Administrator for Science, Office of Research and Development, US EPA. "Memorandum: Children's Environmental Exposure Research Study." November 8, 2004.

http://www.epa.gov/cheers/images/panel_memo.pdf.

The EPA set out to monitor the health effects of pesticides and household products. Andrea Smith finds out who is funding the study, and why.

Vioxx Populi?

Sat, 06 Nov 2004 09:49:58 +0000

Withdrawal raises questions about drug approval in Canada

The molecular structure of Vioxx. The drug approval process for drugs like Vioxx in Canada is largely controlled by the pharmaceutical companies that develop them.

On September 30th 2004, Canadians learned that Vioxx was being voluntarily withdrawn from the market by its producer, Merck & Co. Inc. A COX-2 selective non-steroidal anti-inflammatory drug (NSAID), Vioxx had been approved in Canada since October 1999 for the treatment of acute and chronic symptoms of osteoarthritis, rheumatoid arthritis, acute pain and menstrual pain. At the time, Vioxx was tenth most commonly prescribed drug in Canada, with three million prescriptions for it written in the last year alone. Merck withdrew the drug following the results of a study of the drug’s effectiveness for preventing colon polyps which demonstrated that people who use Vioxx for 18 months or longer have an increased risk of stroke and heart attack.

Since Merck's announcement, numerous class action suits have been launched against the company. The plaintiffs claim that Merck failed to adequately test the safety of the drug and warn physicians and pharmacists of the potential for adverse cardiovascular events. The case of Vioxx raises questions of how a drug with serious side effects made it to the market and stayed there for five years. More generally, it raises questions about the process of drug approval and consumer protection in this country.

In order for a drug to be approved, Health Canada requires data from animal or laboratory tests and from clinical trials. The clinical trials must "prove that the drug has potential therapeutic value that outweighs the risks associated with its use." Typically, clinical trials involve between 2000-3000 people and only investigate the effects of a drug for a short period of time. New drugs do not have to be tested against existing treatments – they only have to show that they are more effective than a sugar pill. And unlike the US, the data submitted to Health Canada is not available to the public, making it difficult for physicians and the public to evaluate a new drug. Some critics say that these policies enable pharmaceutical companies to produce and patent multiple and more expensive variations of the same drugs. These more expensive drugs are then marketed as new and improved treatments for the same conditions. Because the data is not public, and thanks to aggressive marketing campaigns, many doctors will prescribe the newer, more expensive medication without knowing whether it is more effective or not.

Most post-market research on pharmaceuticals is undertaken by the industry, generally to evaluate the effectiveness of the drug for other conditions, such as Merck's study of the usefulness of Vioxx in preventing colon polyps. This means that most studies do not get to be conducted by independent researchers who do not have a vested interest in a drug's approval.

Health Canada's Health Products and Food Branch reviews evidence of a drug's safety and effectiveness submitted to them by the manufacturer, and makes the decision as to whether or not the drug is acceptable for marketing. After a drug is approved, it is monitored through the voluntary submission of adverse drug reactions reports to the Canadian Adverse Drug Reaction Monitoring Program (CADRMP). Consumers or physicians can report drug reactions – but consumers are not aware of the program, and there are no incentives for physicians to file reports. However, companies are required to report any further findings of adverse reactions.

Within its first year of being on the market, CADRMP received 151 reports describing 417 suspected adverse reactions to Vioxx. Of these reports, 91 were classified as serious, including 5 deaths associated with Vioxx and 25 reports of suspected cardiovascular reactions. As reports are made to the CADRMP on a voluntary basis, they do not provide an indication of the prevalence of suspected drug reactions. As a result of a study conducted in 2000 in which patients taking Vioxx experienced an increased risk of heart attacks and stroke, Health Canada issued an advisory in 2002 stating that Vioxx should be used with caution in patients with a history of heart disease.

Concerns around the safety and marketing of pharmaceuticals are further fueled by proposed changes to Canada's Health Protection Act. Slated revisions include partial and full introduction of direct-to-consumer advertising. In the US, Merck spent $160.8 million (US) in 2000 advertising Vioxx to Americans, and made $1.5 billion (US) in sales. The US experience with direct-to-consumer advertising has driven up prescription drug costs, compromising public safety by encouraging the widespread use of drugs whose safety and side-effects are not well-known. While the Health Protection act currently forbids promotion of prescription drugs to the public via advertising, Health Canada has been extremely lax in enforcing the legislation since 2000. Direct-to-consumer advertising could mean that Canadians would be exposed to more prescription drugs, such as Vioxx, whose safety was uncertain.

As a recent editorial in the medical journal The Lancet observed, "[the] Vioxx story is one of blindly aggressive marketing by Merck mixed with repeated episodes of complacency by drug regulators." (The Lancet, October 7, 2004) Hopefully the example of Vioxx will be treated as an opportunity to re-evaluate slated revisions to Canada's Health Protection Act, and perhaps motivate efforts to increase the awareness of and incentives for adverse effects reporting, create a mandatory clinical trial registry that would force drug companies to report both negative and positive trial results, and enforce the prohibition of direct-to-consumer advertising. Because of Vioxx, Health Canada may have to convince the Canadian public that it is capable of serving the public's best interests.

» Canadian Health Coalition: Direct-to-Consumer Prescription Drug Advertising: Health Canada's Proposals for Legislative Change

» Women And Health Protection: Just say NO to direct-to-consumer-advertising of prescription drugs

In the wake of revelations about side effects and effectiveness of Merc's Vioxx, Andrea Smith looks at the drug approval process in Canada.