Conflicts of Interest James G. Anderson, Ph.D. Department of Sociology & Anthropology

Questions What situations represent a Professional Conflict of Interest? How extensive are conflicts of interest? What challenges do they pose for the traditional physician commitment to act on behalf of the patient? What has been the medical profession’s response? How do professional groups deal with this problem? What steps should the medical profession take to cope with conflicts of interest?

Definition Conflict of interest refers to any situation in which an individual with responsibilities to others (including professional responsibilities) might be, consciously or unconsciously influenced by financial, or other factors that involve self interest (JAMA, 1994)

The Problem Current practices provide doctors with financial incentives that may conflict with patient’ interests Doctors’ financial well-being are tied to medical care providers, suppliers, pharmaceutical companies, third- party payers These arrangements may predispose physicians to provide too many or too few services or to make inappropriate referrals Patients may receive poor quality care or be harmed Patients and society pay for wasteful services

Types of Conflicts of Interest Conflicts between the physician’s interest (usually financial) and the patient’s interest Conflicts that divide a physician’s loyalty between a patient and a third-party

The Changing Context of Medicine Monetarization of medicine Third-party payment Increased supply of physicians/hospital beds Changes in hospital payment Technology Loss of physician autonomy The federal government

Incentives to Increase Services Fee-for-service practice Kickbacks for referrals Self-referral to medical facilities in which the physician invests Income from dispensing drugs, medical products, ancillary services Hospital purchase of physician practices Payments made by hospitals to recruit and bond physicians Gifts to physicians by medical suppliers

Audiologists Receive commissions/gifts from hearing aid manufacturers Dispense hearing aids

Physicians Physicians receiving kickbacks for prescribing drugs. Physicians dispensing drugs/products Physicians referring patients to a hospital that provides them with office space, directorships, etc. Physician-Owned Hospitals/clinics/ancillary services

Dentists Visits to 50 dentists in 28 states and DC Examination plus 1 crown cost $500 Dentists ask what were his insurance limits Estimates range from $460/1 crown to $29,850/21 crowns

Optometrists Accept fees, gifts from manufacturers of lens, optical appliances, etc.

Physicians and Third Parties Physician referral for ancillary services in which they have a financial interest British pharmaceutical companies owns eleven cancer centers that provide care.

Columbia/HCA Rewards to MDs for referring patients Purchase of physician practices Discharged hospital patients sent to home health care agencies owned by Columbia Staff MDs provided profit incentive to reduce care

Financial/Commercial Relationships University faculty consultants for 90% biotechnology companies 50% of faculty researchers serve as consultants for biotechnology companies Physicians have a financial stake in % of ancillary medical facilities

Incentives to Decrease Services HMO financial incentives Control of access to physicians Gatekeepers Management of care by physicians Payment incentives

Physician Incentives in HMOs Percentage of Payment Withheld from primary Care Physicians

Surpluses in the Reward for Specialist Referral Fund

Other Financial Penalties for Primary Care Physicians Increases in the % payment withheld the following year Liens on future earnings Decreases in the amount of capitation payment the following year Exclusion from the program Reductions in distributions from fund surpluses Require physician to pay amount of deficit

What Can Be Done? Disclosure Informed consent Regulation Consumer protection laws Professional groups

Limitations of the Medical Profession AMA guidelines are voluntary Today's principals contain no statement regarding most conflicts of interest Antitrust laws prevent the AMA from restricting advertising and many commercial practices The AMA has no procedures for monitoring compliance Enforcement is left to state medical societies and professional licensing boards

Large Companies – Express Scripts Enriched itself at the expense of the Empire Plan and its members by inflating the cost of generic drugs; Diverted to itself millions of dollars in manufacturer rebates that belonged to the Empire Plan; Engaged in fraud and deception to induce physicians to switch a patient's prescription from one prescribed drug to another for which Express Scripts received money from the second drug's manufacturer; Sold and licensed data belonging to the Empire Plan to drug manufacturers, data collection services and others without the permission of the Empire Plan and in violation of the State's contract; Induced the State to enter into the contract by misrepresenting the discounts the Empire Plan was receiving for drugs purchased at retail pharmacies.

FDA More than half of the experts hired to advise the government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions, a USA TODAY study found. These experts are hired to advise the Food and Drug Administration on which medicines should be approved for sale, what the warning labels should say and how studies of drugs should be designed.

FDA A USA TODAY analysis of financial conflicts at 159 FDA advisory committee meetings from Jan. 1, 1998, through last June 30 found: At 92% of the meetings, at least one member had a financial conflict of interest. At 55% of meetings, half or more of the FDA advisers had conflicts of interest. Conflicts were most frequent at the 57 meetings when broader issues were discussed: 92% of members had conflicts. At the 102 meetings dealing with the fate of a specific drug, 33% of the experts had a financial conflict.

Journals Large medical journals such as those put out by the AMA and the New England Journal of medicine admit that conflicts of interest have inflated findings published in medical journals. The Journal of Thoracic and Cardiovascular Surgery has threatened to bar authors and their institutions who do not disclose conflicts of interest from publishing in the journal for some period of time.

Drug Company Sponsorship of Clinical Trials One study compiled previously published clinical trials to conclude that patients could both develop a tolerance for beta-agonists and be at increased risk for asthma attacks, compared with those who do not use the drug at all. The second study shows that beta- agonist use increases cardiac risks, such as heart attacks, by more than two-fold, compared with the use of a placebo. Furthermore, the researchers say that their analyses lead them to suspect a conflict of interest among scientists who are supported by pharmaceutical companies that make beta-agonists, among the world's most widely used drugs. This conflict, they say, could be putting 16 million U.S. asthma sufferers in harm's way. Their statement comes as the American Medical Association is voicing its concerns that drug industry sponsorship of clinical tests is affecting the quality of research.

Vioxx: Merck Vs. FDA March 2000: Merck reveals that a new study found Vioxx patients had double the rate of serious cardiovascular problems than those on naproxen, an older nonsteroidal anti-inflammatory drug, or NSAID. November 2000: The New England Journal of Medicine publishes the study, called VIGOR. February 2001: An advisory panel recommends the FDA require a label warning of the possible link to cardiovascular problems. September 2001:The FDA warns Merck to stop misleading doctors about Vioxx's effect on the cardiovascular system. April 2002:The FDA tells Merck to add information about cardiovascular risk to Vioxx's label. Aug. 25, 2004: An FDA researcher presents results of a database analysis of 1.4 million patients; it concludes that Vioxx users are more likely to suffer a heart attack or sudden cardiac death than those taking Celebrex or an older NSAID. Sept. 23, 2004: Merck says it learned this day that patients taking Vioxx in a study were twice as likely to suffer a heart attack or stroke as those on placebo. Sept. 30, 2004:Merck withdraws Vioxx from the U.S. and the more than 80 other countries in which it was marketed.

Paxil The manufacturers of antidepressants continue to market their drugs for children / adolescents even after a causal relation has been scientifically established between antidepressants, such as Paxil / Seroxat and suicide-related behavior. They do so because FDA officials continue to drag their feet about issuing black box warnings on antidepressant labels. Even after an FDA advisory panel urged the agency to require black box warnings about an increased suicide risk--on the labels read by physicians and on the package labels read by consumers--top officials are undecided. The NJ Star Ledger obtained an internal (September 8, 2003) GlaxoSmithKline memo that was distributed to the company's sales representatives. The memo advises them NOT to discuss the suicide-related risk of Paxil / Seroxat with doctors.

Paxil A 2003 memo cites a discredited published report in the Journal of the Academy of Child and Adolescent Psychiatry (2001, pp ) that maintained that Paxil was "safe and effective and well tolerated." It was co-authored by leading US child psychiatrists. However, its claimed findings are refuted by a 1998 internal GSK's memo which states that only "positive data from study 329" would be published. The unpublished data, the memo stated, would not be published or submitted to the FDA because: "It would be commercially unacceptable to include a statement that efficacy had not been demonstrated as this would undermine the profile of paroxetine [Paxil]."

Drugs Adverse prescription drug reactions are the third largest cause of death in the US, topped only by tobacco and alcohol. According to an article in the Journal of the American Medical Association, over 100,000 hospitalized patients died as a result of an adverse drug reaction. The researchers found that over 75% of these ADRs were dose- dependent, which suggests they were due to the inherent toxicity of the drugs rather than to allergic reactions.

FDA Working for the Drug Industry? What makes the issue so controversial is how the FDA has dealt with an internal debate on the matter. Congressional investigators have been examining the agency's decision to block a staffer from revealing this past February his finding of a tie between antidepressants and suicidal tendencies in young people, which drew on many of the same trials. FDA officials said his conclusion was premature, and based on ambiguous data.

FDA Working for the Drug Industry? Instead of protecting the public health, FDA officials have aggressively and improperly invoked FDA's pre-emptive authority by intervening in court cases to shield drug manufacturers who were challenged about their failure to include warnings on drug labels.