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New guidelines for ethical conduct
The American Society of Plastic Surgeons (ASPS) recently adopted guidelines concerning ethical conduct for surgeons when dealing with medical device and pharmaceutical manufacturers.
No matter how big or how small, it is no longer permissible for doctors to accept gifts from industry sources that are not directly related to educating healthcare providers or patients. These gifts include but are not limited to dinner, sporting events, tchotchkes, flowers, and the like. This ban also includes take-out meals left in physician's offices and healthcare facilities. The new guidelines permit meals provided for surgeons and their staff during educational presentations, as long as they are not part of an entertainment activity. The guideline also consents to society members accepting educational items as long as they are worth less than $100.
Building on the information presented during a recent Compliance Summit, the ASPS Board of Directors approved guidelines for members' interactions with industry. An all-inclusive document, titled "Considerations for Interactions with Industry," aligns with AdvaMed and PhRMA industry guidelines to ensure ethical relationships between physicians and industry. The document details standards related to the acceptance of gifts, educational products, meals and entertainment from industry; protocols for seeking industry support for educational programs; consulting arrangements; promotional speaking, and the regulations associated with each. A free copy of the new guidelines can be found at http://www.psnextra.org/Articles/Compliance-Guidelines.html.
Cow's blood saves a life
The life of a Melbourne, Australia, woman was spared after a life-saving transfusion was performed using hemoglobin-based oxygen carrier HBOC-201, a product manufactured from cow's blood. Ten units of the blood substitute were flown to Melbourne from the United States, where it is manufactured by the U.S. Navy.
The patient, Tamara Coakley, had been in a medically induced coma since a car accident in October. Because of her Jehovah's Witness faith, 33-year-old Coakley's family refused a conventional blood transfusion but was willing to accept blood substitutes. Jehovah's Witnesses have long been known for their rejection of blood and blood-component transfusion, even when it is necessary to save life. But in a notable change in policy, the Witnesses' governing body announced in the June 15, 2000, issue of its official church publication The Watchtower, that members may now accept fractions of any of the primary components of blood. This includes hemoglobin-based HBOC-201, derived from bovine (cow) blood.
After the ethics committee at Melbourne's Alfred Hospital approved the import, the blood arrived within 48 hours. Doctors at the hospital administered five units of the manufactured blood over two days. The patient did experience complications, including fever and pneumonia, but her hemoglobin levels remained at a healthy level. It was the first case reported in which a synthetic blood product reversed cardiac hypoxia and anemia in a patient.
The blood product does not require cross-matching and can be stored at room temperature for up to three years. Coakley said in an interview that she was overwhelmed by the doctor's efforts to save her life while respecting her personal wishes. Researchers have high hopes that in synthetic products will help the worldwide shortage of donor blood.
Medical center sponsors EOL forum
In honor of National Healthcare Decisions Day on April 16, 2011, Wake Forest Baptist Health in Winston Salem, NC, along with the Bioethics Committee of Lexington (NC) Medical Center, sponsored a forum on end-of-life (EOL) issues.
Although public awareness of the need for advance care planning has increased a great deal over the last few years, studies on the subject indicate that many individuals have not taken advantage of their right to make pre-emptive decisions concerning healthcare, in the event that they cannot speak for themselves. The forum shed light on this initiative and was open to the entire community. The sole purpose to inform participants about relevant healthcare decisions that individuals tend to face at the end of life.
The Rev. Lee Duke III, DMin, chaplain and pastoral counselor at Lexington Medical Center and organizer of the event, said that people are able to live a more meaningful life when they are informed and have made critical decisions about the end of life. The Rev. Jay Foster, DMin, chaplain supervisor at Wake Forest Baptist Medical Center, opened the forum with a short presentation highlighting end-of-life choices. Foster has published an article titled "Clarifying patients' wishes at the end-of-life" in the North Carolina Bar Association Elder Law Newsletter (2006; 11:5-8). Following his presentation, Duke lead a panel discussion about the day's topic. The panelists included Helen Fitzgerald of Hospice of Davidson County, NC, and the following persons from Lexington: Terry Arnold, MD, an internist with Lexington Internal Medicine, Jack Briggs, president and owner of Davidson Funeral Home, the Rev. Ray Howell, DD, of First Baptist Church, David Inabinett of Brinkley-Walser law firm, Dennis Marton, a respiratory therapist at Lexington Medical Center, and Donna Miller, case management coordinator, also with Lexington Medical Center.
NJ surgeons fined for ethics violations
According to published reports, the state Board of Medical Examiners has penalized three orthopedic surgeons for failing to disclose their financial interest in a medical device while participating in clinical trials.
The board reprimanded Richard A. Balderston, MD, of Cherry Hill, NJ, Thomas J. Errico, MD, of Summit, NJ, and Jeffrey A. Goldstein, MD, FACS, of New York, for failing to disclose to their research institutions the financial interests they held in the ProDisc spinal disc device, which was developed to eliminate the need for spinal fusion surgery.
The state board discovered that surgeons Goldstein and Errico indicated they had not received monetary compensation while conducting clinical studies of the spinal disc device at the NYU Langone Medical Center and Hospital for Joint Disease, New York City, and Balderston neglected to reveal his financial interest to the Hospital of the University of Pennsylvania, Philadelphia, while he was the clinical investigator of the device.
According to the published report, Errico was fined $60,000 in civil penalties and $17,500 to reimburse investigative costs, and Goldstein must pay $30,000 in civil penalties and $10,000 in cost reimbursements. Additionally, all three surgeons must complete a refresher ethics course.