Pharmas-co-dependence exposed Would it be time to say, “No thanks”?

Exposing pharmacodependence Is it time to say “Thanks, but no thanks”? Pierre Biron, M.D., Ph.D. 1. Montreal, Quebec resident and retired pharmacologist 1. Dr. Pierre Biron can be reached by email at biron.pierre@videotron.ca. 1. Dr. Martin Plaisance 1. A nephrologist in Sherbrooke, Quebec 1. Author affiliations for Paul Lévesque, M.D. 1. A Montreal-based emergency medical practitioner Family doctors need to be aware of how far the pharmaceutical business will go to sway them, how this compromises their professional autonomy, lessens the potency of their prescriptions, and depletes the public health care system. Hence, the article’s title. Pharmas is for pharmaceutical firms, co for teamwork or cooperation, and dependence denotes our reliance on financial support from the pharmaceutical sector. Pharmaceutical business marketing affects our institutions’ budgetary, editorial, educational, therapeutic, and regulatory agendas as well as their interactions with the media. Our prescription histories reveal our participation in the problem facing the pharmaceutical industry. Section 2: Lack of innovation Since the 1990s, the majority of “new” pharmaceuticals introduced to the market have not significantly outperformed the medical benefits offered by older, less expensive treatments whose hazards were well-known. These new products include “me-too” medications, fresh formulations, pharmacologic breakthroughs, widened indications, and goods produced employing novel delivery systems or manufacturing techniques. Most do not truly represent therapeutic advancements or address the needs as seen by family doctors. However, they do lead to an increase in drug use. Technological advancement does not equate to therapeutic advancement. section before section after Aggressive marketing is the response from the industry. Because of their sheer scale, pharmaceutical firms are able to lobby with great political influence and employ hordes of medical reps to attract physicians. Advertising that targets prescribers receives disproportionately more funding than genuine innovation; opinion leaders are generously supported; CME is frequently funded; multi-center clinical trials with pre-established protocols are supported; and population medicalization and medication is encouraged. Market-driven goals skew our perceptions of health and evidence-based medicine. The industry asserts its claim by collaborating with numerous medical and scientific endeavors and offering to support institutions, societies, associations, foundations, publishers, advertising agencies, and other businesses. When business and health care, promotion and education, and commerce and research come too near to one another, the road becomes treacherous1,2 because their principles are fundamentally dissimilar. Opinion leaders Previous SectionNext Section In its 2006 Global Corruption Report, the non-governmental organization Transparency International recently suggested a code of behavior. 3 The Lancet editors approved of this code. 4 Physicians were specifically advised not to endorse health products in which they had a financial interest and not to sign up as speakers for a health products company. Conflict of interest can occur when a partnership moves from research to marketing and doctors start getting paid as consultants or speakers. This was the first time that an international non-governmental organization had explicitly assigned a meaning to the “co” in pharmas-co-dependence, which tarnishes the image of integrity and independence of our medical institutions, despite the fact that it only takes direct aim at specific opinion leaders who accept payment in exchange for repeated presentations and overly enthusiastic interpretations of specific clinical trials. Sections before and after new product sections All too frequently, so-called innovations are promoted in a way that overstates projected benefits, downplays known and unknowable hazards, omits direct and indirect costs, and reduces the use of existing goods and non-drug alternatives. The new items are frequently useless, expensive, and even harmful. Sections before and after new indicators Sometimes innovation involves a brand-new indicator that has yet to gain widespread acceptance and that has important economic ramifications. We are seeing a continual lowering of target values and normality thresholds in preventive pharmacotherapy, which occasionally results in alarmist screening and is followed by negative or nearly useless prescriptions. We observe public health initiatives that logically must result in doctor visits and pharmaceutical prescriptions. These campaigns are headed by those who spread false information about illnesses, are becoming more divisive, and soon will be referred to as “preventive hounding.” Regulation SectionPrevious SectionNext Section Lack of transparency in the approval process and laxity Knowledgeable observers have lost faith in the pharmaceutical business and drug regulatory bodies because they are approving drugs and indications that have no significant medical advantages, have marginally better efficacy than placebo, or have only been proven effective on surrogate endpoints. Without a direct comparison to the standard of care, approval is given. The approval is given despite the fact that the sample used in the study was not representative, the effectiveness has not been clearly proven, the safety has not been adequately verified, and the direct and indirect expenses substantially outweigh any potential advantages. Pharmacovigilance practices that are lax and opaque There are significant flaws in the US Food and Drug Administration’s effort to protect the public, according to a recent review into the agency. It is alarming that an Institute of Medicine report on drug safety5 called for significant changes and new rules. The same worries—that pharmacovigilance is being overlooked in favor of the clearance process by both the authorities and the promoters—were recently voiced by the former Director of Health Canada’s Health Products and Food Branch in Canada. section before section after publishing trial results No matter the internal validity, external validity, or power of trials submitted for review or published, when they have been funded by the product’s promoter, their interpretation tends to favor a new product over competing products. The same bias affects meta-analyses. Negative outcomes are not always made public. Scientific spinning, which ranges from semantic ambiguity to statistical manipulation, is more frequently published in the top academic journals. section before section after Detailed prescription In order to ensure therapeutic benefit, a number of requirements must be completed before a prescription can have any pharmacologic value beyond its placebo effect. In order to make the correct diagnoses, prescribers must thoroughly evaluate the medical and pharmaceutical histories of their patients. They need to identify the best therapy strategies, the appropriate pharmacologic classes, the appropriate products, the appropriate dosages, and appropriately inform patients after having reasonable, valid, and quantifiable therapeutic objectives. Prescribers need to keep an eye on patients’ compliance, reaction, tolerance, and tenacity of the objectives and change or stop the treatment as necessary over a longer period of time. It is a significant matter to prescribe. section before section after training programs and ongoing medical education We have permitted the drug sector to finance the majority of continuing medical education activities in order to make up for insufficient financing. The industry will provide ongoing product information rather than ongoing medical education if we leave the funding of continuing medical education in its hands. Medical professionals who are knowledgeable and whose sources of education and information are rigorous, independent, open, and devoid of prejudice, distortion, and misinformation are needed by society. We need doctors who write fewer, higher-quality prescriptions, with caution and constraint, and who steer clear of unsuitable prescriptions that result in preventable—and occasionally fatal—reactions and their associated preventable expenditures. We need doctors who can spot drugs prescribed “under influence” for non-urgent conditions and who keep their therapeutic toolkits to a select group of well-established drugs they have mastered the art of using sparingly. section before section after Where do we begin implementing change? with instruction Medical educators have started to steer clear of instances where vendors exploit them the same way they do with academic journals. Sponsors must not be allowed to have an impact on the subjects, presenters, or financial results. We must provide family physicians with the knowledge they truly require, well-established products, verified indications, and nonpharmacologic techniques. The assignment of credits to sponsored continuing medical education seminars is open to debate. with professionals Healthier drug policies are being demanded by consumers, academics, consumers, publishers, and educators from all around the world. Some people are quite critical of how pharmaceutical corporations court physicians and market their medicines, and they share our opinion that it would be better to decline drug samples, paid meetings, paid surveys, and visits from pharmaceutical personnel. Others criticize the allowed, camouflaged direct-to-consumer advertising that converts prescribers become pushers. utilizing our institutions “It’s time to summon the pharmaceutical business to account. The industry has demonstrated that it is sufficiently adaptable to change if society demands it. 6 We require a new agreement, a revision of the game’s rules, new regulations to control the interaction between the industry and the government, and new ethical standards to control that between the industry and the medical community. Sections prior and following the conclusion Family doctors have a responsibility and a right to acquire their education and information in a setting free from the sway of marketing consultants. Family physicians can contribute to reducing the unfavorable impacts and additional expenses related to new products and indications when their efficacy is dubious by being firsthand observers of polypharmacy. When learning about new things is presented to them as a gift, they must examine it critically. They need to acquire the “No thanks” phrase. Footnotes SectionPrevious SectionSectionNext conflicts of interest 0 did not declare The authors’ opinions are presented in the remarks. Publication does not imply support from the Canadian College of Family Physicians. The College of Family Physicians of Canada has copyright. Section References from Before Les dérives de l’industrie de la santé, St-Onge J-C. 1. St-Onge J-C. L’envers de la pilule. Montreal, QC: Écosociété; 2006. Écosociété, 2004. Montreal, QC. Transparency International is third. 1. Corruption and health; 1.5 Corruption in the pharmaceutical industry; 1.5.3 The corrupting influence of money on medicine; Transparency International Annual Report 2006. Transparency International, 2006 [accessed 2007 May 22]. Berlin, Germany. It is accessible at: www.transparency.org/publications/gcr/download gcr. 4. [Editorial] Health care fraud costs lives. Lancet 367:447 (2006). Medline 5. The National Academies’ Institute of Medicine. The public’s health will be promoted and protected in the future of medication safety. Institute of Medicine, Washington, DC, 2006 [accessed May 22, 2007]. Accessible at: www.iom.edu. The law and ethics of the pharmaceutical industry, Dukes G. 6. 2006; San Diego, CA: Elsevier. Related content Commentary: “Pharmacodependence Shown on the Finger” by Pierre Biron, Martin Plaisance, and Paul Lévesque: Is it time to say “Thank you”? Can Fam Physician 53: 1643–1645 in October 2007 Total Text Total Text (PDF)