APA Backs Same-Sex Marriage
The American Psychiatric Association has filed a brief in support of same-sex marriage in the California case focusing on the state's Proposition 8. The case is an appeal of the August ruling that the proposition's ban on such marriages is unconstitutional. Scientific evidence shows that homosexuality is a normal expression of sexuality and that sexual orientation is not the result of choice, the APA noted, adding that there is no evidence that lesbians and gay men have less stable relationships or that they are less capable parents than heterosexuals. The ban denies homosexuals “the social, psychological and health benefits that are associated with marriage,” Dr. James H. Scully Jr., the association's CEO, said in a statement. In filing the brief, the psychiatrists joined the American Psychological Association, the California Psychological Association, and the American Association for Marriage and Family Therapy.
Institute Urges Oil Spill Study
The Institute of Medicine has urged the Department of Health and Human Services to make the study of the behavioral health effects of the BP oil spill in the Gulf of Mexico a top priority. Researchers should identify factors associated with individuals' vulnerability or resilience during oil spills and other natural disasters, said the institute. It also urged study of the health effects of exposure to oil, dispersants, and other chemicals associated with clean-up, and a thorough assessment of seafood safety.
Ex Pharma Lawyer Is Charged
The U.S. Department of Justice issued a six-count indictment in early November against Lauren Stevens of Durham, N.C., a former pharmaceutical company executive, charging her with obstruction and making false statements. The charge included no company, and the department declined to disclose Ms. Stevens' employer, but GlaxoSmithKline confirmed that she was employed there until her retirement. An industry directory identifies Ms. Stevens as a GlaxoSmithKline vice president and attorney. Ms. Stevens allegedly helped the company promote a drug (reportedly the antidepressant Wellbutrin SR) for unapproved, off-label uses. She also failed to provide the Food and Drug Administration with slide sets that had been used by physicians “who were paid by the company to promote the drug,” according to a Justice Department press release.
Company Pays Huge Fine
GlaxoSmithKline pled guilty to charges that it manufactured and distributed drugs contaminated with microorganisms. The company will pay $750 million to settle federal and state government claims. The Department of Justice announced the agreement in late October. The drugs, manufactured in Puerto Rico between 2001 and 2005, included the antinausea drug Kytril, the antidepressant Paxil CR, the diabetes medication Avandamet, and the anti-infection ointment Bactroban. GlaxoSmithKline will pay the federal government $600 million, and a whistleblower will receive $96 million for having tipped the government to the manufacturing issues. The states are eligible to receive up to $163 million from Glaxo. The complaint alleged that the company knowingly caused false claims to be submitted to state Medicaid programs. “FDA and its law enforcement partners will continue to aggressively pursue those companies that place the public health at risk by distributing products that do not comply with all FDA requirements,” Mark Dragonetti, special agent in charge, FDA New York Field Office, said in a statement.
Top Fraud Cases Involve Health
Pharmaceutical companies paid large fines in 8 of the top 10 fraud cases settled by the Department of Justice in 2010, according to the Taxpayers Against Fraud Education Fund. An insurer and a hospital rounded out the top 10 largest fine payers, making all 10 of the top settlements health care related. Allergan Inc., which in September settled allegations that it had marketed Botox (onabotulinumtoxinA) for off-label uses, accounted for the largest settlement ($600 million). AstraZeneca International came in second with its $520 million payment for illegally marketing the antipsychotic Seroquel (quetiapine). About 80% of all fraud recoveries under the False Claims Act occur in the health care area, the group said.
Drug-Related Hospitalizations Up
Hospitalizations for drug-induced conditions more than doubled between 1997 and 2008 for Americans aged 45 years and older, according to the Agency for Healthcare Research and Quality. Meanwhile, admissions related to prescription- and illicit-drug problems grew by 96% for people aged 65–84 years and by 87% for those older than 85, the agency said. By comparison, the number of drug-related hospital admissions declined by 11% among adults aged 18–44 years. In the older groups, hospitalizations increased most for drug-induced delirium; poisoning or overdose by codeine, meperidine, and other opiate-based pain medicines; and withdrawal from drug addictions, the AHRQ said. Medicare and Medicaid paid 54% of the $1.1 billion tab for these hospitalizations.