Direct-to-Consumer Advertising (DTCA)
Consultation Workshop
SUBMISSION - WORKING GROUP ON WOMEN AND HEALTH PROTECTION
Direct-to-consumer advertising of prescription drugs
Prepared by the Working Group on Women and Health Protection
The Working Group on Women and Health Protection is a national coalition of women's health groups, public interest organizations, researchers, journalists and health professionals working on women's health issues, which formed in September 1998 to discuss the proposed changes to Canada's health protection legislation.
The aim of this working group is to jointly develop policy recommendations on proposed changes to Canada's Health Protection Legislation which will promote greater gender equality, improve on existing safeguards to protect women's health, and ensure a greater voice for women in decision-making and policy development.
We welcome Health Canada's recent adoption of a Women's Health Strategy in March 1999, as a first step towards practical implementation of the recommendations on health in the Beijing Platform for Action, to which Canada is a signatory.
The Beijing Platform for Action calls on national governments to:
"Take all appropriate measures to eliminate harmful, medically unnecessary or coercive medical interventions, as well as inappropriate medicalisation and over-medication of women."
This is especially relevant to the current discussion on direct-to-consumer (DTC) advertising of prescription drugs in Canada.
Given the heavy emphasis on drugs for healthy women in US DTC advertising, the proposal to allow DTC advertising is a concern not only for the Canadian public as a whole, but also very specifically for women. The US has seen extensive public advertising campaigns for products such as estrogen therapies for menopause, bisphosphates to prevent osteoporosis, and classes of drugs in which over-prescribing to women has been identified as a problem, such as tranquillisers and antidepressants. As the primary care providers in the home, women are also the target audience for ads for a wide range of drugs used by all family members.
The box on the next page lists a few examples of DTC ads found to be in violation of US FDA regulations last year, including drugs promoted to women.
Box 1: Education for the US public - of a special kind Examples of 1998 and 1999 violations. Reported in: Drug concerns get F.D.A. reprimands over advertising, by Robert Pear. New York Times, March 28, 1999
In TV commercials for the menopausal hormone treatment Premarin, "multiple distracting visual images and activity occur during the audio presentation of the risk information" but the benefits were described clearly, against a visual background without any distractions. The US FDA asked Wyeth-Ayerst to stop running this and certain other advertisements because of the "broad and ambiguous health claims" made about Premarin, promising benefits that had "yet to be substantiated". In other words the FDA found that they were making claims without the evidence to back them.
In an ad for the birth control injection Depo Provera, the risk information was jumbled in the visual and audio parts of a TV commercial to such an extent that the FDA judged that these messages, "virtually insure that consumers will have trouble fully comprehending the information."
Bristol-Myers Squibb used women athletes in advertisements promoting the use of its drug Pravachol to reduce the risk of heart attack. The FDA judged this to be misleading because Pravachol's use to protect against heart attacks had never been tested in women.
The FDA judged an ad for a cholesterol lowering drug, Lescol, overstated the drug's benefits and did not acknowledge that it could cause liver problems. The FDA judged this to be "false, misleading, unbalanced and incomplete information to consumers." Novartis, the manufacturer, was also found to have nusled consumers by suggesting that this drug cost less than other cholesterol-lowering medicines, when "Lescol may cost more."
The FDA objected to an advertisement for Caverject, an alternative to Viagra for impotence, because the manufacturer, Pharmacia & Upjohn, omitted the fact that Caverject must be injected into the penis. Merck & Co. exaggerated the effectiveness of its anti-baldness drug Propecia, suggesting it was guaranteed to prevent hair loss in men, according to the F.D.A. An ad in Time Magazine showed a man looking anxiously into the mrrror and said, "Starting today, you need not face the fear of more hair loss." Propecia can slow hair loss, but it does not necessarily stop the process of balding or prevent hair from falling out.
In a recent ad in Time magazine, Glaxo-Wellcome did not mention the common side effects of its herpes drug, Valtrex, and used such small type to say that "there is no cure for genital herpes" that this statement would have been easy to miss.
Manufacturers of three drugs for allergy that are widely advertised, Allegra, Claritin, and Zyrtec, were all found to have made unsubstantiated claims that their product was the best of the three drugs.
According to IMS Health, a pharmaceutical market research company, the top ten drugs by DTC advertising budget in the US in 1998 included three allergy drugs, two cholesterol lowering drugs, one drug for baldness, one for osteoporosis prevention, two antidepressants (one of which is marketed for smoking cessation) and one drug for stomach ulcers. The industry argues that DTC advertising gets drugs to consumers faster, thus preventing much more expensive hospitalization and progression to more serious illness. As one wry commentator put it, "If consumers don't get to see the ads, they'll end up in hospital with terminal baldness."
Why worry about DTC advertising?
Prescription drugs differ from other consumer goods because of their potential harmful as well as potential beneficial effects, the seriousness of many health conditions requiring prescriptions, and the extra vulnerability of people who are ill and are seeking care. DTCA also differs from other forms of advertising in that a person cannot simply go out and buy the product, they must go to their doctor first to ask for a prescription.
The aim of advertising is to increase product sales. If the industry is successful in advertising its drugs to the public, this means more visits to the doctor to request drugs, more people using prescription drugs and more prescriptions per person. The massive growth in spending on DTC advertising in the US, from US $55 million in 1991 to more than US $1.2 billion last year, indicates that this form of advertising is likely to be paying off. As was mentioned above, because of the potentially large audience, DTC advertising tends to concentrate on drugs for healthy people, such as disease prevention drugs, contraceptives and hormones. It also tends to concentrate on newer drugs because aggressive promotion soon after a drug's launch helps a company to maximize the returns on investment in drug development.
Newer is not necessarily better
To market a new drug in Canada, a manufacturer needs to show that it has the desired effect (i.e. is better than placebo for a specific use), that it is acceptably safe and that product manufacturing is adequate. From 1991 to 1997, 577 new patented drugs were marketed in Canada. Of these, only 50, or 8.7%, were thought to be either breakthrough drugs or substantial improvements over existing treatments. Of the rest, 287 or 49.7% were "line extensions", new dosage forms or other modifications of existing products, and 240 or 41.6% offered moderate, little, or no therapeutic improvement.
Beyond their usual higher cost, one worry about advertising aiming to convince the public to take recently launched drugs, as opposed to established therapies, is that so little is known about drug safety when a drug first comes to market. Usually 2000 to 3000 people have taken the drug in pre-marketing studies. Any harmfiil effect occuring in less than about 1 in 800 people has little to no chance of being discovered. Many serious harmfiil drug effects occur less commonly than this. If a new drug is heavily advertised soon after its launch, it may be taken by hundreds of thousands of people in a very short time. The US General Accounting Office reviewed post-approval risks of new drugs approved between 1976 and 1985.1 Fifty-one percent of the drugs were found to have serious adverse effects not detected before approval. This was the ease for one of the first drugs to be heavily advertised to the public in the US in the early 1980's, benoxaprofen (Oraflex), an anti-arthritis drug. It was withdrawn only five months after its US launch in 1982, following reports of severe reactions, including deaths. The US FDA called a moratorium on DTC advertising soon after, which was lifted in 1985 following public and stakeholder consultations.
Too recent a history of widespread unnecessary harm
DES Action Canada is one of the member groups of the Working Group on Women and Health Protection. DES (diethyistilbestrol) is a synthetic estrogen that was widely used in pregnancy from 1941 to 1971. As early as 1953 it was found to be ineffective in preventing miscarriage and premature labour, the main reasons for its use in pregnancy. Promotion for this indication continued long after well-designed scientific studies showed that this drug was not effective. DES was also widely promoted, "for routine prophylaxis of all pregnancies"… with claims that it helped produce… "bigger and stronger babies, too." In 1971 DES was found to cause a rare form of vaginal cancer among women exposed before birth. It has since been linked to malformations of the reproductive organs in both women and men, and pregnancy and fertility problems.
An estimated 200,000 to 400,000 Canadian women took this drug in pregnancy. The US National Cancer Institute estimates that 4.8 million women were prescribed DES in the US.
Another member group is Breast Cancer Action Montreal. Breast cancer is a disease that could benefit greatly from improvements in treatment; it still kills many Canadian women. Breast Cancer Action was formed by women who have been diagnosed with breast cancer, and provides information, support and advocacy for better health services.
A representative of Breast Cancer Action travelled to Washington DC last year for public hearings on whether the US FDA should approve tamoxifen to prevent breast cancer, a use that has not been approved in Canada. Tamoxifen is an effective breast cancer treatment. However, the organization disagrees with the approval of its use to prevent breast cancer, given the contradictory evidence on whether it is effective, the fact that most "high risk" women given the drug would never develop breast cancer anyway without it, and the real possibility of harm. This drug increases the risk of endometrial cancer and development of blood clots that are fatal if they travel to the lung. The FDA approved the drug for "reduction in the incidence of breast cancer" rather than prevention because not enough evidence was in to know whether the drug really prevented breast cancer.
As the enclosed ad shows, however, the manufacturer is encouraging all women over 35 to go to their doctor to find out their risk status and take the drug if they are high risk. The ad doesn't list the risk criteria, adding to the underlying message that all women should be anxious about breast cancer and that taking a drug can allay that anxiety. The WHO Ethical Criteria specifically state that "language which brings about fear and distress should not be used." Women harmed by the Meme breast implant also participate in the Working Group. They charge that these implants were not properly tested before marketing in Canada and were withdrawn after being found to be defective. Had they been widely promoted to the public as well as to doctors soon after their launch, who knows how many more women would have been harmed?
A large urban women's health clinic is another member of the Working Group. One of their concerns is that direct-to-consumer advertising will encourage many older women to request bone mineral density scans and new drugs for osteoporosis prevention, when bone density has been found to be a very poor predictor of fracture risk and drugs to prevent osteoporosis are of questionable value for many postmenopausal women.
"Direct-to-doctor" and "indirect-to-consumer" promotion: a poor track record The aims of the Working Group are to ensure that any changes to health legislation and to the administration of health services in Canada help to ensure a high degree of consumer protection, transparency and accountability in decision-making. Regulation of drug promotion is one area where Canada falls short, with lax enforcement that depends largely on industry self-regulation by the Pharmaceutical Manufacturers Association of Canada (PMAC), or, in the case of published advertisements, on the Pharmaceutical Advertising Advisory Board (PAAB), whose members include both the advertising and pharmaceutical industries, creating a fundamental conflict of interest.
Neither PMAC nor PAAB publishes information on committee deliberations or on code breaches in enough detail for the public or health professionals to be able to find out if an ad they saw or an event they participated in was found to violate regulatory guidelines. In contrast, detailed information on violations is published regularly in countries such as France and the United States that have direct government regulation of drug promotion.
Section 9(1) of the Food and Drugs Act, states that:
- "No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its composition, merit or safety." The principle is sound, but it needs to be enforced, with active monitoring, effective sanctions and corrective actions for violations, and full public accountability in decision-making.
- At an international level, Canada has supported the World Health Organization (WHO)'s efforts to contribute to better regulation of drug promotion. WHO's Ethical Criteria for Medicinal Drug Promotion, ratified by the 1988 World Health Assembly, aims to ensure that drug promotion is in keeping with national health priorities and principles of rational drug use. At successive World Health Assemblies, Canada has supported resolutions calling on national governments to implement effective regulation of drug promotion, based on the WHO Ethical Criteria. This is sorely needed in Canada.
- In both its regulatory standards governing promotion to doctors and in transparency and accountability in decision-making, Canada falls short of the US, which relies on direct regulation of all forms of drug promotion by the FDA. DTC advertising is unlikely to be the same in Canada as it has been in the US. Given our lack of adequate regulation, it will probably be worse.
- We should not be talking about further deregulation of drug promotion in Canada to allow DTC advertising of prescription drugs, but how we can make sure that the legislation we have is properly enforced. This should include a more thorough look at indirect advertising aimed at the public than is contained in the 1996 Therapeutic Products Programme policy paper on the distinction between advertising and other activities. The emphasis in this policy is on assisting "manufacturers and associated third parties in the dissemination of non-promotional information about drugs that will not be subject to legislation pertaining to drug advertising." If the aim is public safety and protection from deception and fraud, it is crucial that all communications from manufacturers about their products, whether they are carried out directly or through associated third parties, are subject to section 9 (1) of the Food and Drugs Act.
Advertising by any other name is still advertising
Two features distinguish advertising: its aims and who produces it. The aim of advertising is to increase product sales. It is produced by or on behalf of a company that stands to gain financially from an increased volume of product sales. One of the key principles of the WHO Ethical Criteria is that promotion should not be designed so as to disguise its real nature, for example as educational or scientific activities. Deregulation of drug promotion should similarly not be disguised as an educational initiative.
Recommendations:
- Direct-to-consumer advertisements of prescription drugs should not be allowed, given the lack of evidence of health benefits and the serious potential for harm.
- Regulation of drug promotion in Canada is a public responsibility and should not be left to industry self-regulation. It should be carried out dfrectly by Health Canada or by a legislated independent body, at arm's length from both the pharmaceutical and advertising industries, with the legislated authority to actively monitor and enforce compliance, including sanctions and corrective actions, and with full procedures in place for public reporting and for transparency and accountability of decision-making.
- The public needs access to up-to-date, accurate, comprehensive and unbiased information on the pros and cons of all treatment options, both drug and non-drug, as well as the option not to treat, for the health conditions and illnesses they face. People need access to this information as a part of necessary public health services. (Box 2 lists the guiding principles of the UK National Health Service's initiative to integrate patient information into publicly provided health services.) To ensure lack of bias, information providers should have no financial links to product manufacturers or the health industries.
- Information materials and activities produced by organizations with financial backing from pharmaceutical companies about those companies or their "competitors" products should be subject to the same regulations as advertising directly produced by the sponsoring company.
- Given the problem of unnecessary medicalization faced by women, such as having a stage of life defined as a "deficiency state" or a "disease risk" needing drug treatment, and the widespread overprescribing of psychotropic drugs to women, regulation of drug promotion should include representation by women's organizations and explicit attention to gender equity. Promotional messages for health professionals that contribute to further gender inequality, target women for treatment inappropriately, or foster a disrespectful attitude towards women patients should be prohibited.
The Working Group on Women and Health Protection is a growing coalition of women's health, consumer, and public interest organizations, as well as academic researchers working on women's health issues. The Working Group first formed as a coalition following a consultative meeting on "Proposed Changes to Canada's Health Protection Legislation - Women's Health and Responsible Regulation," held in Toronto, September 12-13, 1998.
Representatives from the following organizations participated in the September meeting:
- the Alliance for Public Accountability,
- Breast Cancer Action Montreal,
- the Breast Cancer Prevention Coalition,
- the Canadian Health Coalition,
- the Canadian Women's Health Network,
- the Winnipeg Women's Health Clinic,
- the Consumers Association of Canada,
- DES Action Canada
- Health Action International,
- the Medical Reform Group of Ontario,
- the National Network on Environments and Women's Health,
- the Women's Network on Health and the Environment,
- the World Alliance on Breastfeeding Action,
Since September, the Working Group also includes participation from organizations of women harmed by breast implants, women with HIVIAIDS, the national Centres of Excellence for Women's Health, and a provincial rural women's health network.
The Working Group on Women and Health Protection is currently funded by the Women's Bureau of Health Canada, the National Network on Environment and Women's Health; DES Action Canada also contributed to the first meeting of this coalition. Member groups are funded separately. Neither this coalition nor its member groups has any financial links to the pharmaceutical or advertising industries.
Working Group on Women & Health Protection74 Plateau Crescent, Toronto, ON M3C 1M8
Phone: (416) 447-1649 Fax: (416) 446-7763
email: bmains@interlog.com
Box 2: General Principles for giving information to patients, UK National Health Service (Reproduced in: Entwistle et al. International Journal for Quality in Health Care 1996; 8(5): 428)
Information should be up to date, timely, accurate and consistent, and if possible, based on evaluated research with professionals and users involved in its development and evaluation.
Information should be accessible to all patients, in accordance with their information needs and ability to comprehend (i.e. it must be free, attractively presented and in appropriate language format).
Information should be integrated into a planned programme for shared decision making with feedback from patients and professionals used to refine the information and materia1s.
Patients should be able to control how much information they are given at any one time and be enabled by the health care team to understand the information they are given.
Information must be presented in a way that ensures confidentiality - (with the exception of special circumstances) a patient's explicit consent should be given before disclosure of information to relatives and carers.
Information should include all available treatments or management options, including non-intervention, with comprehensive and unbiased information about outcomes (risk and benefit) based on a systematic review of research evidence, noting uncertainties and gaps in scientific knowledge.
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Reality Check: A few Myths about DTC Advertising
Myth:
Direct-to-consumer advertising of prescription drugs helps to empower consumers, enabling them to participate in informed decisions about their health care with their doctors.
Reality Check:
"The problem is that inherently those ads are misleading, not because of the adverse safety profile but because one comes away with the idea that the drug works in every instance."- David Kessler, ex FDA Commissioner, on television ads; Quoted in: TV DTC advertising soars in the US. Scrip 1998, June 10; 2342:15.
To participate in informed decisions about care, people need full, unbiased, accurate information about the pros and cons of all treatment choices, both drug and non -drug, as well as the option not to treat, where it is appropriate. They need an overview of what can be done for their condition, what they can expect, both good and bad, and help with decision-making. If they're making a decision about a prescription drug, they are dealing with a potentially toxic substance and often with a serious health condition. This is why it is important to have both the advice of a health professional and additional information sources. Advertising aims to sell a product. It will always present the product in as positive a light as possible. It will never fulfill the function of telling consumers they really don't need to take the advertised product, they'll get better anyway on their own. It will never tell them that in fact a competitor's products are superior. We can never expect these things from advertising. No one expects them from a car ad. Why expect them from an ad for a medicine? We've also never seen this sort of unbiased information in any advertising of medicines to doctors.
No matter how strict the guidelines governing advertising, a company will always be tempted to present their product in as positive a light as possible, and to underplay its negative side. Unfortunately, with advertising of medicines all too often this has translated into exaggerating benefits and downplaying risks. It might not be a problem if we were talking about the wonders of a new perfume. However, downplaying the risks and exaggerating the benefits of a medicine can be dangerous. It can also be dangerous to convince people they need a drug when they don't.
Myth:
The type of promotional abuses we see in the US wouldn't happen here. After all, in Canada healthcare is recognized as a public responsibility, so the government has a higher stake in making sure that advertising of medicines is ethical and contributes to the best possible use of health care resources.
Reality Check:
Regulation of drug promotion is one area of healthcare where Canada falls far below the standard set in the US. This is because in the US drug promotion is directly regulated by the FDA. In Canada, we depend on industry self-regulation. Most forms of drug promotion aimed at doctors are covered by the Pharmaceutical Manufacturing Association of Canada (PMAC)'s Code of Marketing Practices. This includes the big budget items like sales representatives (drug detailers) who pay personal visits to doctors to promote drugs. It also includes conferences and continuing medical education sponsored by companies. In Canada, industry sponsors are allowed to be involved in developing the agenda for educational symposia and choosing speakers. A 1997 FDA guideline no longer allows this in the US.
Published ads are regulated by the Pharmaceutical Advertising Advisory Board (PAAB), a semi- autonomous organization. It is not run by the industry alone, but has the drug industry on its board along with representatives of advertisers, medical media, health professionals and consumers. PAAB has an arm's length relationship to government, but not to industry. It was set up in 1975 as a compromise by Health Minister Marc Lalonde, who had threatened to bring in direct government regulation because of concerns about the inadequacy of industry self-regulation. PAAB pre-screens published ads, which is a positive feature as it can prevent problem ads from ever reaching the press. However, if pre-screening is based on weak standards and/or does not adequately enforce code standards, it does not effectively prevent misrepresentation of a product's benefits and risks.
The ad for Evista (raloxifene) included in this package was pre-screened by PAAB but it promotes the drug for unapproved uses. Evista has not been approved to prevent breast cancer, to protect against heart disease, or to relieve symptoms of menopause. It has only been approved to prevent osteoporosis. The information on fracture prevention is extremely misleading. Although it refers only to evidence about symptomless fractures that were visible on x-ray, this is not mentioned.To date, there is no evidence that Evista has any effect on fractures that women could feel. Many symptomless spine fractures cause no problems at all for the rest of a person's life. This is very different from a drug that prevents a woman from breaking a hip or from pain and disability.The information on fracture prevention is also based on "pooled treatment groups" including some women taking twice the recommended dose.
Is there fair balance of benefit and risk information? This ad fails to mention that Evista can cause deep vein thrombosis, blood clots that usually form in the leg, but can also travel to the lungs and be fatal, in about 3 in 1000 women who use it. The ad also fails to mention that in animal studies, Evista caused cancer of the ovaries. If PAAB thought this ad was OK, clearly anything goes.
Another ad included in this package, for the antidepressant Effexor (venlafaxine), misleadingly represents the drug's benefits. The headline and quote imply that the drug is a beffer treatment for depression than competitors because of its action on two types of neurotransmitters. This is a fine idea in theory, but the proof is in the pudding -- or in this case, in the clinical studies of how well the drug works. It has not been shown to be more effective than other antidepressants that affect only one neurotransmitter, yet PAAB pre-screened and accepted this ad.
Ultimately, the Food and Drugs Act states that advertising should not be deceptive or misleading, and empowers the Health Protection Branch to stop advertising that causes risks to the health of Canadians; the HPB can also force a company to change unethical marketing practices. Both the PMAC and PAAB codes are voluntary.
In Canada:
There is no active monitoring of most forms of drug promotion. No one is watching companies to make sure they promote their products ethically to doctors, pharmacists or other health professionals; pre-screening of ads is a positive feature, but unfortunately is based on a low standard for balance of product benefit and risk information, accuracy of claims, and the scientific evidence used to back claims;
If a company is found to violate the PMAC code, it is fined. A bigger fine accompanies each violation within a twelve-month period. Then, amazingly, the company is granted a clean slate at the beginning of the next year. For a large multinational, even the highest possible fine levied by PMAC - $20,000 - does not represent an effective disincentive. Companies might easily be tempted to see such fines as "the price of doing business" especially if they can increase their sales dramatically by stretching the truth a little. The public, doctors, pharmacists and other health professionals can't find out if an ad or a promotional activity was found to be misleading or inaccurate. This keeps people from knowing if they've been duped. It also stops them from getting a clear idea of what is and is not acceptable practice. This type of information on US violations is available from the FDA, and much of it is published on their web site.
Self-regulation of drug promotion does not work. We should not be talking about deregulating further in Canada, we should be talking about what kind of changes we could make to our current system to bring regulation of drug promotion in line with health priorities.
To quote David Kessler, ex-Commissioner of the US Food and Drug Administration:
"Once a new drug has been approved, a company is under intense pressure to promote it as vigorously as possible. There's a risk that patients who don't need it will be exposed. That's why the role ofthe F.D.A. is critical." (Drug concerns get F.D.A. reprimands over advertising, by Robert Pear. New York Times, Sunday, March 28, 1999)
Myth:
It is paternalistic to ban direct-to-consumer advertising because such a ban assumes people can't decide for themselves whether to trust the information they see in ads. It also assumes that doctors know best.
Reality Check:
There is no reason to believe that the general public is less likely to be duped by misleading advertising of medicines than doctors. After all, doctors should have learned principles of rational prescribing during their medical training. They should know to use greater caution in prescribing most new drugs because when a drug is first put on the market, it has been taken by too few people and for too short a time to know much of anything about rare harmful effects or long-term effects. They should know not to prescribe antibiotics to people who have colds and the flu or other viral infections. To minimize resistance to new drugs, doctors should also be careful not to prescribe powerful new antibiotics for initial treatment of common bacterial infections that are likely to respond to older antibiotics.
Studies of how appropriately a doctor prescribes consistently show that doctors who rely most heavily on drug promotion as an information source prescribe less appropriately. Prescribing appropriateness is measured in these studies as: whether a drug was prescribed for a condition it is meant to treat; whether the right dose was used; whether unnecessarily harmful drugs were avoided; and whether the least expensive of equivalent drugs was prescribed.
Doctors are not making a decision about their own health care; they are providing treatment advice to patients. The way many doctors prescribe drugs could be much improved, and in several provinces medical educators and health service providers have developed projects to improve prescribing.
Are advertisements to patients likely to improve doctors' prescribing? This seems unlikely, given what is known about promotional influences on doctors and the quality of their prescribing.
A medicine used in the right way by the right person for the right condition can be a powerful cure or provide comfort that was otherwise unattainable. The same medicine - used in the wrong circumstances or in the wrong way - can be at best useless and at worst life-threatening.
The aim of DTC advertising of prescription drugs is to increase sales. No fluff about education or empowerment can hide this basic fact. Even the industry does not deny this aim; they simply say that more drugs translate to better health. These calculations, like the slick presentations in advertising materials, tend to emphasize the benefits of medicines and forget to count their risks. Harmful effects of medicines (ADRs) are estimated to cause around 100,000 deaths per year in the US. (Lazarou et al. JAMA 1998; 279:1200-1205) At a similar rate, this translates to 9,000 to 10,000 deaths per year in Canada. ADRs were estimated to cause 1.5 million people in the US to be so seriously injured in 1994 that they were hospitalized or needed to prolong their hospital stay. It isn't hard to figure out that if more drugs are sold, more people will use them and the risk of harmful drug reactions - including deaths, disability and serious injury - will increase.
For a real lesson in paternalism towards women, check out a few US DTC ads for menopausal women. (See attached example) Forget menopause? The underlying message is that there is something wrong with being 50'ish and a woman, and she'd better use drug treatment to cure herself of this terrible affliction.
Myth:
We can develop a compromise solution to introducing DTCA in Canada. Instead of having direct ads, produced by a company, we can have joint educational efforts involving the industty and non-profit groups to produce educational advertisements.
This will be a win-win situation, satisfying the industry's needs to expand their markets, helping non-profit groups to gain a higher profile and financial security, and maintain an emphasis on education, meeting the needs of the Canadian public.
Reality Check:
An ad is an ad is an ad, no matter what it's called. Either we allow the industry to advertise to the public in Canada or we don't. If a company is advertising a product, working with a non-profit to produce "educational materials" as part of an advertising campaign won't stop the company's aims from being to increase sales. It would be unrealistic to expect anything else from a manufacturer who must after all survive within a competitive marketplace. It may make it more difficult for the public to recognize the materials as advertising, however.
If all treatments must be mentioned, is the sponsoring company going to agree to pay for something that says its product usually shouldnt be used, its product is not as good as a competitor's or is more expensive but hasnt been found to work any better?
A non-profit group which receives funding from a company to produce advertising/educational materials together with that company is not in an equal position or able to fully control the content of those materials. It is financially dependent on the company, both for current and future funding. This type of relationship creates a fundamental conflict of interest.
"Because patient associations are so intent on gathering and passing on information about drugs under development, they have become useful vehicles for pharmaceutical companies for disseminating information about new medicines at the pre-launch stage."
- Sean Milmo, journalist writing in a pharmaceutical industry trade magazine, A matter of patients, Pharmaceutical Visions 1996; 5(1):68-72.
"What companies would do and I was actually part of the process, is create a demand for a product before it was actually released. We went around to various communities and organized public health education seminars on migraines and that topic was really popular. ..seminars that we actually charged five dollars for, another marketing tactic that makes the patient think that this thing isn't being funded by a major pharmaceutical company. We held these seminars right across Canada."
- John Martens, ex Glaxo employee. In: Mintzes B. Blurring the Boundanes: New Trends in Drug Promotion. Amsterdam: HAI, 1998
"…researchers believe it helps to prevent heart disease; and it may provide protection against colon cancer, Alzheimer's disease and stroke… On the other hand, questions remain about the link between hormone therapy and breast cancer, largely due to inconsistent research results."
- Fact Sheet on Hormone Replacement Therapy, Osteoporosis Society of Canada, April 1998.
Ross Duncan
Ross_Duncan@hc-sc.gc.ca
Tel: (613) 941-6226, Fax: (613) 941-6458
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BIBLIOGRAPHY
United States General Accounting Office. FDA Drug Review: Postapproval Risks 1976-1985, Washington 1990, GAO/PEMD-90-15.
Drug concerns get F.D.A. reprimands over advertising, by Robert Pear. New York Times, March 28, 1999
Patented Medicines Pricing Review Board. Tenth Annual Report for the Year Ended December 31, 1997. Ottawa: PMPRB, 1998
Michols DM, Director General, Drugs Directorate. Dissemination of Policy on Advertising versus other Activities.[Letter to stakeholders posted on-line]; Ottawa: Health Protection Branch, January 12, 1996
Entwistle et al. International Journal for Quality in Health Care 1996; 8(5): 428)
TV DTC advertising soars in the US. Scrip 1998, June 10; 2342:15.
Drug concerns get F.D.A. reprimands over advertising, by Robert Pear. New York Times, Sunday, March 28, 1999
Mintzes B. Blurring the Boundaries: New Trends in Drug Promotion. Amsterdam: HAI, 1998
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