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The Year in Bioethics: The Highs and Lows of 2008

It’s a tradition at The Hastings Center for staff to gather for lunch around the sturdy dining room table in the antique Hudson River mansion and former private school that is our headquarters. Attendance varies, but earlier this month everyone turned out to discuss the biggest news in bioethics over the past year – the highs and lows, the winners and sinners.

These stories struck us as the most important because each one is a first, a turning point, or a tipping point. If we left something out, please let us know by making good use of the comments function at the end.

Conflicts of interest. This might be remembered as the Year of the COI Outing. Congress is investigating several prominent doctors for failing to report large consulting fees or investments in drug companies as required by federal law.

The biggest outings: Joseph Biederman, an internationally renowned psychiatrist at Harvard ($1.4 million) and a leading voice supporting the unapproved use of psychiatric medicine in children with bipolar disorder; Charles Nemeroff of Emory University (at least $2.1 million) who promoted the use of antidepressants; Alan Schatzberg of Stanford and president-elect of the American Psychiatric Association ($4.8 million stock holdings in a drug development company); and Frederick Goodwin, former host of “The Infinite Mind,” a popular NPR show ($1.3 million) who gave reassuring advice on the use of psychotropic medications in children with bipolar disorder. Goodwin defended himself to the New York Times by saying that consulting for many drug companies, as opposed to just one or two, reduced the chance of bias. “These companies compete with each other and cancel each other out,” he said.

A medical charity was also outed. The Foundation for Lung Cancer: Early Detection, Prevention, and Treatment received $3.6 billion from the Vector Group, parent company of Liggett Tobacco. The foundation supported a study by lung cancer researchers at Weill Cornell Medical Center in New York in 2006 that reached the controversial conclusion that 80 percent of lung cancer deaths could be prevented if smokers got regular CT scans. After the news broke in the New York Times, the lead investigator wrote a “clarification of funding” letter inNew England Journal of Medicine, which published the study.

The silver lining: Senator Charles Grassley of Iowa has spearheaded the Congressional investigations of conflict of interest and sponsored The Physician Payment Sunshine Act, which would require industry to disclose to the federal government payments to physicians and their employers. A similar bill is under consideration in the House.

Meanwhile, several medical schools have banned or are considering banning certain financial relationships with industry, including gifts to doctors and support for medical education. Those schools include the University of Pittsburgh, the University of Pennsylvania, and Stanford University. The Cleveland Clinic will disclose all of its staff’s industry ties on its web site, Seeing the writing on the wall, Pfizer stopped supporting continuing medical education programs given by commercial education and communications companies.

Children and psychotropic drugs. The off-label use of psychotropic drugs in children has been growing for years, along with safety concerns, but this year the issue reached a tipping point. An expert panel convened by the Food and Drug Administration found that antipsychotic drugs such as Risperdal, which can cause significant weight gain  and other dangerous side effects and has been associated with 31 deaths in children, are overprescribed. Risperdal prescriptions for children increased 10 percent over the last year. “The growing use of the medicines has been driven partly by the sudden popularity of the diagnosis of pediatric bipolar disorder,” wrote Gardiner Harris in the New York Times. Advocates for the use of these drugs included Joseph Biederman and Frederick Goodwin.

Cloned food. FDA approved cloned animals for food, determining that meat from cloned cows, pigs, and goats is as safe as that from ordinary livestock. The European Food Safety Authority reached the opposite conclusion, citing uncertainties about the risk assessment process. And the European Group on Ethics and Science in New Technologies suggested that cloning animals for food may not be ethical because of “suffering and health problems in surrogate dams and clones.”

Conscience rule. In December, the outgoing Bush administration issued a broad new conscience rule permitting medical facilities, doctors, nurses, pharmacists, and other health care workers to refuse to participate in any procedure they find morally objectionable, including abortion and possibly even artificial insemination and birth control. The Obama administration is expected to undo the regulation, possibly with Congress blocking it or the Department of Health and Human Services issuing a new regulation. In July, Barack Obama was one of 28 senators who wrote to the Health and Human Services Secretary Michael Leavitt urging him to drop the regulation, “which could deny access to critical family planning for women across the country.”

Genetic testing. The federal Genetic Information Nondiscrimination Act (GINA) passed, prohibiting discrimination based on one’s genetic disease risk profile. Meanwhile, the number and variety of commercial genetic testing services grew to include DNA dating services and a genetic test for athletic ability in children, which aims to help parents match their children with the “right” sports. Questions remain about the accuracy of the tests, the usefulness of the information, privacy concerns, and the need for regulation.

Health care reform. The prospect of providing health care for all Americans grew closer than ever, with president-elect Barack Obama making health care reform a priority and proposals to expand coverage and contain health costs issued by Congressmen including Senator Edward Kennedy. Obama’s plan draws on the Massachusetts Health Care Reform Plan, which has expanded coverage to 350,000 residents, more than half of those estimated to be uninsured two years ago when the plan started.

Medical errors. To help reduce medical errors, which cause 44,000 to 98,000 deaths each year in the United States, Aetna, Wellpoint, and other large private insurers are joining Medicare in refusing to pay for “never events,” preventable medical errors that should never happen, including bed sores, patient death or serious disability associated with a medication error, and death or serious disability from a fall in a health care facility. Under the new insurance rules, hospitals can’t bill patients for these charges.

Physician-assisted death. After a decade of relative inactivity, the debate over physician-assisted death resumed. Washington state legalized the practice, becoming the second state after Oregon to do so. And in Montana a judge ruled that physician-assisted death was legal there. The ruling was in a lawsuit brought against the state by a man who is terminally ill with cancer. The plaintiff, Robert Baxter, 75, said in a statement to the Associated Press that he was “glad to know that the court respects my choice to die with dignity if my situation becomes intolerable.”

Sports enhancement. It was a roller coaster year for Oscar Pistorius, the South African double-amputee sprinter who made a bid for the Olympics. First, the International Association of Athletics Federations, the track and field world governing body, banned him from the Olympics on the ground that his carbon fiber prosthetic blades give him an unfair advantage. Then, the Court of Arbitration for Sport overturned the ban because it saw a lack of evidence that the blades were better than ordinary legs. In the end, Pistorius failed to qualify for the 400 meter event. However, he did win three gold medals in the Beijing Paralympics.

Stem cell research: A year after Japanese and American scientists broke new scientific ground by reprogramming adult skin cells to create stem cells, researchers began applying the technique to skin cells from actual patients. Researchers at Harvard and Columbia University created nerve cells from reprogrammed skin cells of two patients with Lou Gehrig’s disease. Another team of Harvard researchers created stem cells from skin cells and bone marrow taken from people with several diseases, including Parkinson disease, Huntington disease, and Down syndrome. The achievements could advance research on the degenerative diseases and eventually lead to stem cell treatments. George Daley of the second Harvard group said that the reprogrammed cells will not eliminate the need to study embryonic stem cells, an issue likely to emerge anew in 2009. During the presidential campaign, Obama supported lifting the ban on federal funding of most embryonic stem cell research.

Published on: December 23, 2008
Published in: Bioethics

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