Health Law

CQ (2/10, Carey) reports, "A recent court ruling will hurt the public's ability to assess the quality and efficiency of physician services delivered to Medicare enrollees, according to" Consumers' Checkbook Center for the Study of Services, "the group that filed suit to make that data public." In 2007, the group "won its court case to force the Department of Health and Human Services (HHS) to release Medicare physician claims data. Consumers' Checkbook said it would use the information to create a free resource that would permit the public to check the number and types of major procedures performed by each physician and reimbursed by Medicare, but would not include any information to identify patients." But, on Jan. 30, HHS won an appeal of that decision. In response to the ruling, Consumers' Checkbook "said making the data public could help consumers assess how well the Medicare program is addressing problems."

USA Today (2/10, Rubin) reports, "The Food and Drug Administration [FDA] announced Monday that it was stepping up efforts to reduce unsafe use of 24 narcotics products -- methadone pills, fentanyl patches and extended-release pills containing morphine, oxymorphone and oxycodone, such as OxyContin."

        The "products are classified as Schedule II narcotics and already are restricted according to rules jointly administered by the [FDA] and the Drug Enforcement Agency [DEA]," the New York Times (2/10, A13, Harris) adds. But, according to Dr. John K. Jenkins, director of the FDA's new drug center, "the current restrictions have failed to 'fully meet the goals we want to achieve.'"

        The agency "has issued a number of warnings on prescription pain relievers in recent years and some companies already have plans to manage the drugs' risks," the AP (2/10, Perrone) notes. "Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade," Dr. Jenkins said. "According to [the] FDA, about 3.7 million patients were taking the drugs under scrutiny in 2007. A federal survey conducted that year found 5.2 million people in the U.S. reported using prescription pain drugs inappropriately."

        The Wall Street Journal (2/10, Dooren) reports that "a major part of the new program will be efforts to educate doctors about appropriate prescribing of the products. 'This obviously is going to be the largest risk management program we've undertaken,'" Dr. Jenkins said. Although Dr. Jenkins and other FDA "officials wouldn't speculate about what the final risk-mitigation program would look like, it could have elements of a program designed to limit the use of the acne drug isotretinion (commonly known by the brand name Accutane) by women of child-bearing age because the product causes birth defects. That program requires doctors, pharmacists, and patients to register and meet certain requirements in order to get a new prescription each month." The FDA "sent letters to 16 manufacturers of 24 products. ... The letters told the drugmakers of agency plans to require a risk evaluation and mitigation strategy, or REMS, 'to ensure that the benefits of the drugs continue to outweigh the risks.'"

        Dr. "Jenkins called the new program a multi-pronged and complex effort that will take several months to put in place, after an initial meeting with the drug manufacturers, scheduled for March 3," HealthDay (2/9, Mozes) added.

        "Additional steps will include discussions with other federal agencies -- such as the [DEA] -- patient and consumer advocates, representatives of the pain and addiction treatment communities, and other healthcare professionals," MedPage Today (2/9, Gever) noted. A "public meeting would be held in late spring or early summer to allow for broader public input and participation," according to Dr. Jenkins.

On the front page of its Business section, the New York Times (2/10, B1, Singer) reports that, according to the Food and Drug Administration (FDA), "weight-loss capsules, called StarCaps and promoted as natural dietary supplements using papaya, could be hazardous to your health." The FDA "has found [that] the capsules also contained a potent pharmaceutical drug called bumetanide which can have serious side effects." Furthermore, "in a continuing investigation that has prompted consumer warnings and recalls by some distributors, the FDA has determined that dozens of weight-loss supplements, most of them imported from China, contain hidden and potentially harmful drugs." Michael Levy, the director of the agency's division of New Drugs and Labeling Compliance, said, "A large percentage of these products either contain dangerous undeclared ingredients or they might be outright fraudulent on the ingredients and have no effect at all." The Times adds that "in the coming weeks, the agency plans to issue a longer list of brands to avoid that are spiked with drugs."

The Wall Street Journal (2/10, Winstein) reports, "Disease philanthropy has entered the for-profit world." Previously, "groups like the Juvenile Diabetes Research Foundation and the National Multiple Sclerosis Society spent the money they raised from donors on counseling patients, advocacy in Washington, and funding university researchers in the hopes they would discover cures." Now, "charities, increasingly frustrated with the slow emergence of new disease treatments, are pouring millions of dollars into pharmaceutical start-ups to bring new drugs to market." So far, "about a dozen disease-based charities" are pursuing that avenue, and "most of the charities say they were inspired by the success of the Cystic Fibrosis Foundation." The foundation's chief executive explained that "academics are really not good at taking good understandings of the basic defect and translating it to new therapies," hence there interest in drugmakers. But while this "has become an important new source of capital for small drug companies," it could spark "potential conflicts for charities." For instance, "a patient-advocacy group might be expected to argue for lower prices for pharmaceuticals -- but a group with a royalty stake or equity in a drugmaker has the opposite interest as well." Also, many charities "often give recommendations to doctors, patients, and the FDA," however, an affiliation with a drugmaker may undermine the sense of "impartiality."

The Wall Street Journal (2/10, Sandstrom) reports, "Lundbeck AS agreed to acquire U.S.-based Ovation Pharmaceuticals Inc. for as much as $900 million, a move giving the Danish pharmaceutical company a bigger U.S. presence and strengthening its product pipeline." The company "will pay $600 million to acquire closely held Ovation and as much as an additional $300 million within a year after closing if Ovation achieves certain milestones related to regulatory approval of Sabril [vigabatrin]." The purchase "of Ovation 'definitely goes a long way' to replacing Lexapro [escitalopram oxalate], Lundbeck Chief Executive Ulf Wiinberg said." Wiinberg "said the most valuable asset in the deal is seizure and spasm drug candidate Sabril, which an expert panel recently recommended that the U.S. Food and Drug Administration approve."

        The Chicago Tribune (2/9, Japsen), Bloomberg News (2/9, Cortez, Brogger), the Chicago Sun-Times (2/9, Knowles), MarketWatch (2/9, Turner), Forbes (2/9, LaMotta), and the Copenhagen Post (2/9) also covered the story.

The AP (2/10) delves further into the differences and similarities between the $838 billion Senate version and the $819 billion House version, pointing out that both include "billions for unemployment benefits, food stamps, healthcare and other programs to help victims of the worst recession in decades." In addition, "they also include billions for development of new information technology for the health industry, and billions more to lay the groundwork for a new environmentally friendly industry that would help reduce the nation's dependence on foreign oil." And even though "both houses provide $87 billion in additional funds for the Medicaid program," they "differ on the formula to be used in distributing the money, a dispute that pits states against one another rather than Republicans against Democrats." Among the major differences in the two versions is the fact that "the Senate bill calls for several billion more in spending for research at the National Institutes of Health, the result of an amendment backed last week by Specter."

        Senate, House versions of stimulus plan provide Medicaid support, differ over allocation. USA Today (2/10) reports that both remaining versions of the stimulus bill "provide $87 billion in additional funds for the Medicaid program, which provides healthcare to the low income. But the House and Senate differ on the formula to be used in distributing the money, a dispute that pits states against one another rather than Republicans against Democrats."

        Drug and device industries take aim at $1.1 billion provision to compare medical treatments. The Wall Street Journal (2/10, Mundy) reports, "The drug and medical-device industries are mobilizing to gut a provision in the stimulus bill that would spend $1.1 billion on research comparing medical treatments, portraying it as the first step to government rationing. The fight over the provision is highlighting the tensions behind President Barack Obama's plan to overhaul the healthcare system," which hinges on expanding coverage "while limiting use of treatments that don't work well, but any efforts that might reduce coverage are politically sensitive." The House's stimulus bill "sent shudders through the drug and medical-device industry," while a Senate version "doesn't mention cost as a subject to be studied." Industry lobbyists are pushing to "give industry a seat at the table when federal officials decide what to research with the $1.1 billion." But critics of drug and device-makers note that when AHRQ "suggested in 1995 that there were too many unnecessary back surgeries, doctors and industry groups attacked the conclusion," and eventually Congress "slashed the agency's budget and stripped its authority to make Medicare-payment recommendations."

Modern Physician (2/9, Blesch) reported, "Memorial Hermann Healthcare System in Houston disposed of a two-year antitrust inquiry in a settlement with the Texas attorney general late last month, but much of the same territory will be disputed all over again in a private lawsuit headed for trial as soon as March." In January, "Memorial Hermann entered an agreement with the Texas attorney general resolving antitrust allegations that the system pressured managed-care companies," like Cigna Corp. and Aetna, "to refuse contracts with" Houston Town & Country Hospital, "which opened in 2005 and went out of business in 2007." Now, however, "parties that started on opposite sides of that lawsuit are...united in blaming eight-hospital Memorial Hermann for orchestrating the hospital's demise because it opened a few blocks from its 319-bed Memorial City Hospital." Modern Physician noted that "the judge has yet to rule on a few motions that could end the case before a trial begins."

Life Sciences Law

The U.K.'s Telegraph (2/10, Gammell) reports, "Scientists have worked out a technique where human bone marrow cells are turned into human heart stem cells and then injected into the heart." The technique involves extracting "a patient's own cells" and growing them "in a laboratory." The cells are then transformed into bone marrow cells and "infused into the patient's heart via a catheter in the groin." The procedure "was developed at the Mayo Clinic research centre in Minnesota." Now, "Dr. Jonathan Hill, a consultant cardiologist at London's King's College Hospital, is hoping to perform trials on British patients next year in conjunction with King's College London University." For the trials, "40 millilitres of bone marrow will be taken from a volunteer's hips." Then, "the bone marrow is...grown in a laboratory into human heart stem cells using a special 'growth factor' protein."

The AP (2/10, Blank) reports, "Critics of embryonic stem cell research have accused three top Missouri officials of conspiring to prepare an unfair ballot summary for a proposal to bar use of public funds for abortion and human cloning." Missouri Roundtable for Life has filed a lawsuit in the Cole County Circuit Court, "seeking a new ballot summary and cost estimate for a proposed amendment to the Missouri Constitution that proponents hope to put on the 2010 ballot." The group contends that "the secretary of state, attorney general, and state auditor have not treated stem cell research critics fairly and worked on the ballot summary with stem cell research supporters such as the Missouri Coalition for Lifesaving Cures," according to Steve Clark, an attorney for the group. He stated that the group believes the three officials "are conspiring among themselves and with others to prevent pro-life and anti-cloning groups from ever getting their proposed constitutional amendments before the voters."

        Researchers anticipating end of ban on embryonic stem cell research. HealthDay (2/9, Gardner) reported, "Researchers are rejoicing over President Barack Obama's anticipated lifting of the eight-year ban on embryonic stem cell research imposed by his predecessor, President George W. Bush." In 2001, Bush "limited federal funding for stem cell research only to human embryonic stem cell lines that already existed." But now, "experts are aware that the sobering state of the economy could impose its own restrictions on this type of research." In fact, some are concerned that "any monies redirected to stem cell research could divert funds from other critical avenues of research." Furthermore, "national polls continue to find that the majority of Americans favors embryonic stem cell research, although some surveys have found that that support has declined somewhat in recent years."

The Los Angeles Times (2/10, Oliphant) reports, "When Barack Obama campaigned for president, he promised to enact legislation to prohibit the states from limiting the right to abortion." But early on, there are indications that what abortion foes "dread most and some liberal voters eagerly anticipate...may not come to pass -- at least not yet." This is because "any large-scale effort involving something as polarizing as abortion necessitates spending political capital, something the Obama White House needs in abundance at the moment to ensure the survival of its economic policies." Instead, Democrats are focused on "rolling back Bush administration policies on abortion and contraception. Obama has already acted to revise the 'Mexico City Policy,' which prevented international health organizations receiving U.S. aid from promoting or providing abortion services as a means of family planning."

Bloomberg News (2/10, Harris) reports that a Bayer AG unit reached "a 27-state settlement of claims it misled consumers about the Yaz contraceptive pill," according to Illinois Attorney General Lisa Madigan. The agreement resolves allegations that Bayer Corp. promoted the drug as a treatment for acne "and other conditions for which its use hadn't been approved by the U.S. Food and Drug Administration (FDA)."

        The Boston Herald (2/9) added that under the deal, Bayer is required "to submit all television advertisements to the FDA for pre-approval, and to comply with all changes suggested by the FDA." Bayer must also "disclose in print advertisements what uses the FDA has approved for Yaz." In addition, the company is expected to "conduct a $20 million corrective advertising program to remedy misinformation from the misleading Yaz advertisements."

        The Triangle Business Journal (2/10) adds that the FDA "sent Bayer a warning letter" last year "concerning two of its television advertisements for Yaz." The agency claimed "the ads misled consumers into thinking" Yaz treated premenstrual syndrome (PMS), while also promoting the drug "as a treatment for types of acne that the drug is not approved to treat."

        The new advertisements "point out that while Yaz...also is approved to treat mild acne, it does not treat moderate acne, as indicated in the original ads," the Pittsburgh Business Times (2/10) notes. Furthermore, the "original commercials...also claimed that the drug could lessen the symptoms of" PMS, but "the FDA has only approved the drug to treat the most severe form of PMS, called PMDD, which affects just a small percentage of women."

The Wall Street Journal (2/10, Johnson) reports, "Pfizer Inc. said Monday that it will become the latest drugmaker to publicly disclose the payments it makes to doctors, as the industry has come under fresh fire for its undue influence and could face toughened legislation." The company "follows Eli Lilly & Co., Merck & Co., and GlaxoSmithKline PLC in pledging its commitment to transparency. Pfizer will report all payments to doctors of more than $500 for consulting and speaking arrangements and will also make public the money it pays them to participate in its clinical trials." The piece notes that Congress is considering mandating this type of disclosure, and paints the move on the part of the drug industry as part of an effort to "clean up its image."

        Bloomberg News (2/10, Pettypiece) adds that Pfizer made its announcement "amid criticism from Congress over the ties between the medical profession and drug companies. The payments to practicing physicians and other healthcare providers, as well as to scientists, academic institutions and research centers, will appear on Pfizer's website, the" company said. The AP (2/10, Johnson) also covers the story.

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