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  1. Ethical Transparency and Government Regulation of Canada’s Medical Research Industry Lindsay Meredith and Geoffrey Poitras Simon Fraser University Vancouver, BC CANADA

  2. Ethical Transparency • The ability to perceive ethical intentions is a key element in the approval of medical research studies • Transparency is opaque when the ethical intention is difficult to perceive • The primary corporate objective of shareholder wealth maximization (SWM) is ethically opaque  SWM depends on the expected price for the corporation’s common stock

  3. Ethics and Pharmaceuticals • Prescription drugs are among the most important miracles of modern science • Development and marketing of such drugs are largely the preserve of corporations (Pfizer, Merck, AstraZeneca, GlaxoSmithKline …) • Is SWM consistent with ethical standards required to maintain public safety?

  4. Examples of pre- FFDCA (1938) Problems • Banbar, a worthless "cure" for diabetes • Lash-Lure, an eyelash dye that blinded some women • Foods deceptively packaged or labeled • Radithor, a radium-containing tonic that sentenced users to a slow and painful death • Wilhide Exhaler, which falsely promised to cure tuberculosis and other pulmonary diseases

  5. The 1937 Elixir Sulfanilamide Incident • The FFDCA (1938) was inspired by the deaths of over 100 people in the US in Sept. and Oct. 1937 due to the introduction of use of diethylene glycol (antifreeze) to create an liquid elixir for delivery of Sulfanilamide (an effective drug in pill and tablet form for treatment of ailments such as streptococcal infection) • Operative legislation at that time was the Food and Drugs Act of 1906 • Recognized as obsolete. • Circa 1937, Congressional action was stalled. FFDCA (1938) required: -- drugs be labeled with adequate directions for safe use -- mandated pre-market approval of all new drugs: a manufacturer had to prove to FDA that a drug were safe before it could be sold. -- prohibited false therapeutic claims for drugs,

  6. Pre-1962 Regulation of Medical Products and Devices in the US • The 1957-1961 thalidomide tragedy is the horrific story often associated with the lack of adequate oversight of drug marketing • Unlike other countries such as UK, Canada, Australia, Sweden, and Germany, the US was able to avoid a widespread impact from thalidomide due to Frances Kelsey repeatedly exercising the limited powers under the 1938 Federal Food, Drug and Cosmetics Act (FFDCA 1938) • The operative regulatory authority under this law gave the FDA 60 days to review a drug application to determine ‘safety’ not efficacy. • If the FDA reviewer told a drug company that its application for a medication was incomplete, it was considered withdrawn and the company would have to submit more data when it resubmitted the application (starting another 60 day approval cycle).

  7. Unethical Actions of Drug Companies • US drug company did low level recall when deaths from Elixir Sulfanilamide identified in 1936 • German pharmaceutical company Chemie Grunenthal objected when German government withdrew thalidomide in Nov. 1961 • Tragic consequences continue in the modern era with OcyContin, Neurontin, Paxil, Accutane, Baycol, Aprotinin and Vioxx where the dangers of long-term cumulative effects emerged only after extended periods of time in the market place.

  8. Merck and Vioxx • Dr Bruce M Psaty (Cardiovascular Health Research Unit, University of Washington, Seattle) traced some of the path of Vioxx development, drawing on internal Merck communications. • In November 1996, Merck scientists hypothesized that patients taking Vioxx would have higher rates of heart disease than those taking an aspirinlike comparison treatment • By April 1998, Merck scientists knew of evidence that COX-2 inhibitors such as Vioxx reduce the production of prostacyclin, which prevents platelet aggregation. • On the basis of this biologic evidence, it would be reasonable to hypothesize that the treatment of patients with Vioxx might increase the risk of heart attack and stroke compared with either an aspirinlike treatment or with placebo (no active treatment) • Merck knowingly excluded patients with heart problems from clinical trials required for FDA approval

  9. Ethical Approval of Medical R&D • Failures of the past have resulted in an elaborate system of regulation of the safety and efficacy of medical products and devices • Phase I-III + IV combined with patent protection • Much the same structure in Canada as in US • The regulatory process has institutionalized the place of ethics in the approval process • Institutional Review Boards (IRB) in US • Research Ethics Boards (REB) in Canada

  10. Diagram 3 Source: P. 286 Steinman et al., “Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents” Annals of Internal Medicine Volume 145 Number 4, August 2006.

  11. Recommendations Set countrywide REB adjudication standards Harmonize standards within & among REB’s Review Ethics Boards

  12. Recommendations Clinical Trials • Record ALL trials (positive & negative) by public central registry (Phase 4 esp.) • Source all Phase 1 & 2 trials by country of origin • Set “real” research standards

  13. Recommendations Clinical Trials • Watch for Market Seeding trials hidden in research protocols (Phase 3 & 4 “Me Too” drugs – statins, NSAIDS, mood disorder drugs) • Create independent research evaluation agencies

  14. Recommendations Opinion Leaders • Full disclosure for corporate/opinion leader relationships viz. conflicts of interest on REB’s and formulary boards • Full disclosure of all corporate educational sponsorships

  15. Recommendations Opinion Leaders • Transparency of “Research Front” firms acting for pharmaceutical companies or doctors • Ban on “Ghost Writing” • Opinion leader disclosure of clinical trial recruitment fees, consultancies, speaker fees, on-line conference fees, etc.

  16. Recommendations General Practitioners • Disclosure of clinical trial recruitment fees • Evaluate Phase 4 protocols for research standards and/or market seeding

  17. Recommendations General Practitioners • Ensure all Phase 4 trials are registered and results made public • Track “Off-Label” prescription patterns

  18. Recommendations Institutional Facilities • Ban “Facilities Infiltration” via donated drugs/supplies • Set policies for sales rep access to medical personnel and patients

  19. Recommendations Institutional Facilities • Ban preceptorships or allow only after institutional review • Public disclosure of corporate marketing expenditures to doctors, hospitals & universities

  20. Recommendations Opinion Leader/GP Interaction • Improve monitoring to minimize biased information transfer from opinion leaders due to less than arm’s length relationships with companies • Educate residents to recognize B2B “relationship marketing” & filtered information from sales reps

  21. Recommendations Business to Consumer (B2C) Marketing • REB’s should ensure full clinical file reporting • Competition Bureau should monitor to ensure complete disclosure of side effects and contraindications in B2C advertising

  22. Recommendations Public/Private Sector Accord • Public sector participation in formulating research & marketing regulations for the Canadian medical products industry • Monitored trial period of self-regulation in research and marketing practices by private sector corporations and The Canadian Medical Association