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Teaching Hospital Update - November 15-19, 2010

By Allison Cohen and Leah Voigt*

Lawmakers Want More HHS Leadership on Streamlining Doc "Sunshine" Disclosures

Senators Chuck Grassley (R-IA), and Herb Kohl (D-WI), are seeking more leadership from the U.S. Department of Health and Human Services (HHS) to streamline the way that physicians disclose their financial ties with drug and medical device companies. In a November 9, 2010, letter to HHS Secretary Kathleen Sebelius, the lawmakers said some drug and medical device makers are preparing to meet new disclosure requirements, but in the absence of clear guidance from the federal government, the payment data are being prepared in non-uniform ways, causing the material to be difficult for the public to use. Kohl is the chairman of the Senate Special Committee on Aging, and Grassley is a ranking member of the Senate Finance Committee.

Grassley and Kohl have long been proponents of financial disclosures and co-sponsored the Physician Payments Sunshine Act, which was incorporated as part of the Patient Protection and Affordable Care Act. The sunshine provision requires disclosures by pharmaceutical, medical device, biological, and medical supply companies of payments to physicians. Under the law, HHS would begin collecting the information on March 30, 2012, and it would be made available to the public starting September 30, 2013. In the letter, the lawmakers noted that "while we believe" the initial actions of pharmaceutical and device companies toward compliance "are a promising beginning, we are concerned that the variation in individual disclosure policies is creating confusion within the industry and the public."

For example, both academic institutions and manufacturers are releasing data about the same transactions, but with different levels of precision addressing different time periods, the lawmakers wrote. "Prompt federal guidance is urgently needed to ensure the same information is disclosed in the same way, and is meaningful." To ensure a smooth path toward increasing disclosure and eliminating conflicts, the lawmakers urged HHS to designate an agency that will oversee the creation and operation of the reporting database. They also requested that HHS provide a briefing to staff on the Senate Finance Committee as well as the Aging Committee before the end of the year, "allowing them to participate in the Department's decision-making."

Nathaniel Weixel, Lawmakers Want More HHS Leadership On Streamlining Doc "Sunshine" Disclosures, BNA's Health Care Daily Report (Nov. 15, 2010) (note: registration is required to view this content).

FDA Cans Alcoholic Beverages that Contain Caffeine

The U.S. Food and Drug Administration (FDA) has acted to effectively ban the sale of beverages that combine caffeine and alcohol, including Four Loko and Joose, by declaring that caffeine is an unsafe food additive for alcoholic beverages. The agency issued warning letters Wednesday to four makers of caffeinated alcoholic beverages, saying that addition of caffeine to their malt beverages is not "generally recognized as safe (GRAS)," the industry standard. "Several studies have shown that stimulants mask the intoxicating effects of alcohol," Joshua Sharfstein, MD, deputy FDA commissioner, told reporters. This can lead to overconsumption of the beverages and, subsequently, alcohol poisoning, he said.

Most of the drinks contain 12% alcohol by volume and are sold in twenty-four to thirty-two-oz cans. So, one can contains as much alcohol as four or five regular-sized beers. "Young, inexperienced drinkers may not realize just how impaired they are and drink to the point of alcohol poisoning," David Vladeck, director of the bureau of consumer protection at the Federal Trade Commission (FTC), said on the call.

The four manufacturers include Four Loko maker Phusion Projects, Joose maker United Brands Company, Charge Beverages Corp., and New Century Brewing Co. Earlier today, Chicago-based Phusion Products, issued a statement saying it intended "to reformulate its products to remove caffeine, guarana, and taurine nationwide."

Several state attorneys launched their own investigations into the products in 2007 and subsequently brought the issue to FDA's attention, he added. FTC will also notify manufacturers that they are potentially marketing the products illegally, FDA said, and that further action, including seizure of the products, is possible under federal law. FDA action follows a scientific review begun in November 2009 into the safety of the drinks. At that time, the agency sent letters to thirty manufacturers—far more than the four that received warning letters today. Sharfstein said the agency's review is ongoing, and may lead to action against other products.

Kristina Fiore, FDA Cans Alcoholic Beverages that Contain Caffeine, MedPage Today (Nov. 17, 2010).


Commentary—Surrogate Decision-Makers' Dilemma on End-of-Life Care Requires More Input From Doctors

Choosing treatments for patients who cannot do so for themselves puts surrogate decision-makers in an unenviable position. The situation requires that physicians navigate a careful path in offering recommendations while respecting surrogates' and patients' wishes, according to two recent medical journal articles. "Data have shown that the stress of being a surrogate decision-maker is equivalent to the kind of scores people get on psychological instruments when their house just burned down," said one of the co-authors of a recent commentary on surrogate decision-making in The Journal of the American Medical Association (JAMA).

Physicians and hospitals have failed surrogate decision-makers by hewing too closely to a protocol that delegates these life-and-death choices entirely to family members, the author said. Leaving choices in the laps of surrogates is especially problematic because they often do not have an advance directive to help them decide. Only 5% to 25% of patients have such documents, the JAMA article said. Even when advance directives are available, they often fail to cover the precise clinical situation at hand.

"You get these questions like, 'Would the patient have wanted a dopamine infusion at 2 micrograms per minute if they were in a coma and in addition had Alzheimer's disease and pneumonia and were in the ICU?'" said the commentary's co-author. "No one's thought about those things, and trying to guess what the person would have thought is a nearly impossible exercise."

Surrogates may benefit from more input from physicians, but most want to make the final care decisions themselves, according to a study published online October 29, 2010, in the American Journal of Respiratory and Critical Care Medicine. The researchers surveyed 230 surrogate decision-makers for incapacitated patients on ventilators in four intensive care units at the University of California, San Francisco, Medical Center. They were asked who should make the final call about whether to continue intensive treatment for a loved one "with a very small chance" of surviving. Not all patients at the time of the survey were declared to have a small chance of survival.

More than half of surrogate decision-makers said they preferred to "make the final decision," while 40% wanted to "share responsibility" for the decision with a physician. Only 5% said doctors should make the final decision. "What we've unmasked is that surrogates' answer is very different for value-laden decisions," said the study's lead author. "People often don't want to give up control of these decisions to physicians."

Kevin B. O'Reilly, Surrogate Decision-Makers' Dilemma on End-of-Life Care Requires More Input From Doctors, Am. Med. News (Nov. 15, 2010).


New Database From Patient Group Will Track Federally Funded CER Projects

A new tool to identify federally supported comparative effectiveness research (CER) projects will allow easy access for patients and providers to search for research on a specific topic, according to the head of a patient-centered research group. The Partnership to Improve Patient Care (PIPC) this week launched the CER Inventory, an online research tool to give researchers, providers, and patients comprehensive information on federally funded CER. According to PIPC's chairman, the CER Inventory provides a single, comprehensive, easy-to-use database of federally supported CER projects.

The projects in the database include CER studies currently being funded by agencies within the HHS under the American Recovery and Reinvestment Act and other CER studies being funded by the Effective Health Care Program at the Agency for Healthcare Research and Quality (AHRQ). The database contains listings of almost 500 projects. According to the site, projects in the inventory are organized into six categories: medical treatments, items, and services; communication of research results; research methods; data infrastructure; pending awards; and others. PIPC's chairman noted, "We hope it proves to be a valuable resource for researchers, the patient and provider communities, and the Patient-Centered Outcomes Research Institute," or PCORI.

PCORI is an independent, nonprofit entity mandated by the Patient Protection and Affordable Care Act to conduct comparative clinical effectiveness research. The goal of the institute is to assist patients, clinicians, purchasers, and policymakers in making informed health decisions by using evidence-based medicine.

Nathaniel Weixel, New Database From Patient Group Will Track Federally Funded CER Projects, BNA's Health Care Daily Report (Nov. 19, 2010) (note: registration is required to view this content).


Panel Splits Over Skin Cancer Detection Device

An FDA advisory panel has voted eight to seven, with one member abstaining, to recommend approval for an experimental skin cancer detection system called MelaFind. A vote so close generally is not considered an endorsement in the eyes of FDA officials, who have the final say in whether to approve the device. FDA does not have to follow the advice of its advisory committees, but it often does.

Some panelists on the General and Plastic Surgery Devices Committee were concerned that relying on a device to detect melanoma could lead to unnecessary biopsies, or worse: missed skin cancers. Those who voted against the device also were concerned that non-dermatologist physicians might start using it. But other panelists felt that even though the device proved only slightly superior at detecting melanoma in suspicious lesions than a physician alone, having another tool to aid in skin cancer detection would ultimately benefit patients.

The noninvasive device uses a dermascope with near-infrared light to image the skin through a thin layer of alcohol or oil while a digital camera captures images of the lesion. A computer connected to the dermascope displays the image on a screen in the physician's office. Software sorts out various patterns and analyzes lesion color, shape, and consistency to assign a risk that a lesion is a melanoma. MELA Sciences, the device's manufacturer, says MelaFind can visualize lesion structures under the skin. The committee reviewed the company's two main clinical trials of about 1,400 patients with lesions.

Emily P. Walker, Panel Splits Over Skin Cancer Detection Device, MedPage Today (Nov. 18, 2010).

AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting edge issues of interest to teaching hospitals and their counsel. Additional information and more in depth coverage on these topics may be available from AHLA Health Lawyers Weekly and appropriate AHLA practice groups.

*We would like to thank Allison Cohen, Esquire (Washington, DC), and Leah Voigt, Esquire (Squire Sanders & Dempsey LLP, Washington, DC), for providing this week's update.

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