Ties between healthcare organizations and drug and device companies are under unprecedented scrutiny. Almost every week, a major news story appears on a glaring conflict of interest that affects patient care. Policymakers are probing the influence of industry marketing on the practice of medicine and healthcare costs. Medical leaders and patient advocates are concerned about the distorting effects of industry ties on research and clinical care.
Companies are taking notice and altering some traditional practices. Eli Lilly and Co., Stryker Corp., Zimmer Holdings and other firms now disclose gifts and payments to providers and healthcare organizations. In January 2009, a new code of ethics from the Pharmaceutical Research and Manufacturers of America, the drug industrys trade group, will take effect. A modest step forward, it discourages some marketing practices (e.g., meals in restaurants) but not others (e.g., meals in physicians offices).
At the same time, several states, including Maine, Minnesota and Vermont are requiring companies to report payments to providers. Sen. Chuck Grassley (R-Iowa), the ranking Republican and former chairman of the Senate Finance Committee, has introduced the Physician Payments Sunshine Act that would bring greater transparency at a national level.
Perhaps the most profound and comprehensive changes come from the medical profession itself. A cadre of medical leaderstypically, hospital chief executive officers and medical school deanshas implemented innovative policies to manage, and often eliminate, conflicts of interest. Over the past two years, we have closely studied their efforts, funded by the Pew Charitable Trusts Prescription Project and the Attorney General Consumer and Prescriber Grant Program. The changes are considerable and include bans on ghostwriting, speakers bureaus and drug samples. Here, we summarize strategies and accomplishments in two key policy areasgifts/meals and vendor accessthat are often the first targets for reform.
Gifts and Meals: A growing number of health systems and medical schools have banned gifts and meals, including Kaiser Permanente of Northern California, the University of Pittsburgh, the University of Pennsylvania, Stanford University, Boston University, the University of Michigan, the University of Wisconsin, the University of Massachusetts at Worcester, and the University of California system. Unqualified bans eliminate policy gray areas, such as modest meals, that lead to enforcement difficulties.
How did organizations prepare for this change? Some budgeted for staff lunches, others expected employees to pay. All notified staff and vendors before implementing the policies, welcoming comments. For example, when residents at the University of Michigan worried about time to purchase lunch before Grand Rounds, the cafeteria opened an express lane.
There were complaints at first about the new policies, but these quickly dissipated. Even staunch critics acknowledged, It was the right thing to do. Vendors did not disagree: Some had always disliked catering; those with smaller marketing budgets welcomed a level playing field. One University of Pennsylvania official described the policies as almost no work to maintain.
Vendor Access: Several organizations have exemplary policies to manage interactions between staff and vendorsthe University of Pittsburgh, the University of Pennsylvania, Henry Ford Health System and Stanford University. They require vendors to register annually and certify that they have read and understood the policy. Visits are then permitted by appointment only.
Representatives sign in at a reception area; personnel verify the appointment and provide identifying badges. Vendors may not wander about in search of staff to detail, nor may they enter clinical care areas. The exception is device representatives in the operating room, for whom some hospitals require special dress, for example, orange hats (University of Pennsylvania) or black scrubs (Henry Ford). Many schools also ban vendor contact with trainees or require a faculty member to be present. Some hospitals do not permit vendors to detail products that are not on formulary.
Vendors have adhered to these policies without much complaint. A few have tested enforcement, but most vendors quickly got the message.
Implementing new policies can be a daunting task. Institutional leaders often are the first to recognize policy gaps, but they may worry that stronger policies will cause disruption. But our findings should lay this fear to rest. In no case have the policies been reversed or weakened.
Changing ingrained attitudes and behaviors is never easy. It can take months for all relevant stakeholders to vet a policy. The process must be transparent and consistent with institutional culture so that everyone understands and accepts the new regulations.
Much progress has already been made, and our findings should encourage more. We have recently launched a new Web site with information on managing conflicts of interest in the key policy areas, including continuing medical education funding, drug samples, ghostwriting, institutional purchasing and speakers bureaus. It can be found at imapny.org/amc_toolkits. The Web site also provides model policy language and a searchable database of relevant policies at medical centers nationwide, imapny.org/coi_data
base/. Organizations tell us these resources are helping them by showing what has worked best in similar institutions.
Although gaps and weakness still exist, we are encouraged by what we are seeing. Five years from now, provider-industry relations will look a lot different than they do today.