Harvard Public Health Review Winter 2007
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Drug Companies at the Crossroads
In recent years, pillars of the pharmaceutical industry have fallen from grace. In a series of high-profile lawsuits, several companies have faced legal trouble over unlawful marketing and promotion practices, kickbacks, and the nondisclosure of drug safety data.

Small wonder that, in a November Harris poll, only 7 percent of Americans said they think drug companies are generally honest and trustworthy.

What measures might be taken to better protect the public's health? Should the government impose new regulations? Or can the industry be encouraged to self-regulate--that is, to change and monitor its practices to meet consumer expectations?

Questions like these have such profound implications for public policy that a young researcher trained in public health, law, and ethics could build a career around them. At the Harvard School of Public Health (HSPH), Michelle Mello has plans to do just that--as the C. Boyden Gray Associate Professor of Health Policy and Law. Recently Mello was appointed to the post, a junior professorship endowed earlier this year by Dean's Council member and Harvard College graduate C. Boyden Gray, AB '64, currently the U.S. ambassador to the European Union.

Michelle Mello
RISING STAR Michelle Mello is the C. Boyden Gray Associate Professor of Public Health Law at HSPH. Her new junior professorship was endowed, and named for, a Harvard College alumnus on the occasion of his class reunion.

Morally complex issues
The annual support provided by endowed chairs like Mello's is highly prized by HSPH faculty members, who typically must raise the better part of their salaries through research grants. Mello, who divides her time between health policy research and teaching at HSPH and Harvard Law School, says the additional funds will allow her to hire a post-doctoral fellow and focus her team's energies on "morally complex" issues important to public health for which research funding is scarce. In one project, she is studying the impact of laws and litigation born of the obesity epidemic on individuals' eating habits and businesses' food-supplying behavior. She has also turned her attention to the pharmaceutical industry, which provides significant benefits to society but may also introduce risks to consumer health in the quest to generate profits.

"As a society, we want to protect companies' for-profit incentive, which spurs innovation," Mello says. "You'd hope for the industry to self-regulate--you'd hope that companies that claim to have a strong corporate conscience would press others to behave better. But when corporate behavior fails to meet public expectations, stronger government regulation may be required."

In the past year, Mello, a Greenwall Foundation Faculty Scholar in Bioethics, has begun plunging into realms where government and drug makers intersect. She has explored the ethical underpinnings of the federal program that provides financial compensation to people injured by vaccines. She has studied a recent legal decision that freed a drug company from the obligation to continue giving clinical-trial participants an investigational drug after the study ended, despite promises made in an informed-consent agreement. And she has examined the FDA's justifications for keeping clinical- trial patient-safety data confidential in the interest of protecting companies' "trade secrets."

One of the complexities of relying on the drug industry to craft and adhere to its own ethical norms, Mello believes, is the absence of what she calls "an ethic of professionalism."

"We trust lawyers and doctors to self-regulate; that trust comes from society's belief that doing good is part of these professions' role," she explains. "But a corporation is a totally different entity; it has a fiduciary responsibility to its stockholders" that can create a conflict of interest as the company also seeks to satisfy public expectations. Mello is now working to understand how drug companies conceive of their ethical obligations, and how their conceptions may differ from how the public perceives them.

For useful parallels, she is looking to for-profit hospitals and health insurers. "They also make special kinds of products that people need for survival," she points out, "yet they're trying to make a profit."

'Win-win' solutions
The choice of Mello as the first C. Boyden Gray Associate Professor delights the man who funded the chair as a way of commemorating his 40th Harvard class reunion. "I was thrilled," says Gray. "They couldn't have picked a better person."

Gray's interest in public health began with his undergraduate thesis, which explored resistance by the British to the smallpox vaccine and the argument for an alternative: quarantine. Having worked as a lawyer at the interface of government and industry, he says he is "fascinated by the challenge of creating market incentives as an alternative to command and control litigation for achieving public policy goals." Prior to his appointment as ambassador to the EU, Gray was White House counsel in the administration of President George H.W. Bush and served as his legal counsel when he was vice president. As a partner in the law firm of Wilmer, Cutler & Pickering in Washington, DC, Gray focused on regulatory matters, with an emphasis on the environment, energy, information technology, and public health.

What intrigues Gray are "win-win" regulatory schemes akin to the U.S. vaccination injury program, which encourages industry to innovate without fear of "crippling" lawsuits by compensating any person accidentally injured by a vaccine. Gray finds promising a model health court system being developed by Mello and her collaborators as an alternative to the expensive and inequitable U.S. medical malpractice system. In a health-court scenario, injured patients could seek redress and compensation from specially trained judges, and medical injuries would be reported and addressed quickly, in the interest of advancing patient safety.

"We don't favor heavy government intervention in this country. That's pretty deeply ingrained," observes Mello. "But there is a public demand that the drug industry isn't meeting." Many commentators have raised questions about current government oversight as well, she says. The FDA must work closely with company representatives throughout the drug approval process; do these relationships compromise the agency's decision-making? Given the FDA's limited power to enforce or monitor patient safety once drugs are approved, might further safeguards be needed?

Questions like these are leading Mello into wide-open territory. With Gray's support, she hopes to settle a new frontier.

Karin Kiewra is the associate director of development communications at HSPH and editor of the Review.

Photo credits: Prescription Drugs, Getty Images-The Image Bank; Michelle Mello, Kent Dayton-HSPH; C. Boyden Gray, Richard A. Bloom/Corbis

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C. Boyden Gray

COMMON GROUND
C. Boyden Gray,
ambassador to the European Union, speaks the same language as HSPH’s Michelle Mello, first incumbent of the C. Boyden Gray Associate Professorship. Gray too was trained as a lawyer. In addition to practicing in Washington, DC, he served as White House counsel to President George H.W. Bush and was director of the Task Force on Regulatory Relief under Ronald Reagan.

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Copyright 2007, President and Fellows of Harvard College