Yesterday’s positive vote for Arena Pharmaceuticals’ lorcaserin raises the prospect that patients could soon have the first new drug therapy for weight loss in more than a decade. But as Dow Jones Newswires reports, we’re not quite there yet.

Also: The FDA warns about bone-strengthening drugs; Washington will pay primary-care doctors more; and a patients’ pain group folds hours after senators announce a probe.

Also: The FDA appears open to a preventive HIV treatment, a psychiatric association drops two new diagnoses for lack of evidence, senators probe pain-pill makers’ ties to patients groups, and new retirees should expect to spend $240,000 on health care.

Roche Drug to Raise ‘Good’ Cholesterol Fails (WSJ): The drug’s failure in a large human trial spelled a setback for pharmaceutical companies that see an opportunity in medicines that seek to ward of heart disease by raising so-called “good” cholesterol. Competitors Merck and Eli Lilly said they remain confident in late-stage drugs in their pipelines that work similarly. Study Examines Depression and Aging Brain (WSJ): The onset of depression late in life can be an early warning of Alzheimer’s disease and other dementia later, according to a new study of 13,535 Kaiser Permanente members. A Regime’s Tight Grip on AIDS (New York Times): Cuba’s AIDS rate is only one-sixth that of the U.S., thanks in part to aggressive tactics taken in the early years of the epidemic, such as forced quarantines for people who tested positive for HIV. F.D.A. Staff Raises Concerns About Arthritis Drug (New York Times): Documents released ahead of a Food and Drug Administration review Wednesday show regulators are concerned a new Pfizer treatment for rheumatoid arthritis raised concerns of significant side-effects. Court Dismisses Vets’ Suit on Mental Health Care (San Francisco Chronicle): A San Francisco appeals court dismissed a five-year-old suit by veterans groups accusing the Department of Veterans Affairs of delaying needed mental health services. Drug-Defying Germs from India Speed Post-Antibiotic Era (Bloomberg): The widespread use of antibiotics in India is helping cultivate new breeds of drug-resistant bacteria bred from otherwise benign microorganisms.

Here’s what’s making health news this morning: Court Rejects Patents on Medical Tests: (WSJ) The Supreme Court jolted the biotechnology industry with a unanimous ruling that threw out two medical-testing patents and suggested companies need to do more to prove their discoveries are really new. FDA Panel Rejects Merck Drug for Sarcoma: (WSJ) A federal advisory panel on Tuesday rejected an experimental Merck drug for use in patients with soft-tissue or bone sarcomas—on concerns that it didn’t work well enough to offset potentially serious side effects—while backing a different drug from GlaxoSmithKline. Generic Drugs Prove Resistant to Damage Suits: (NYT) Lawsuits against generic pharmaceutical companies are being dismissed because of a Supreme Court decision last year that said the companies did not have control over what their labels said and therefore could not be sued for failing to alert patients about the risks of taking their drugs. Throat Problems Silence the Biggest Voices: (USAT) A handful of high-profile crooners have been prescribed a break from performing while they deal with throat problems. An Aspirin a Day May Keep Cancer Away Faster: Studies: (Bloomberg) Aspirin, the 3-cent painkiller whose origins can be traced to Hippocrates, reduces the chances of developing or dying from cancer earlier than previously thought and also prevents tumors from spreading, studies reviewed in The Lancet showed.

By Joe Palazzolo A federal rule that requires tobacco companies to display pictures of diseased lungs or other graphic images on cigarette packs is unconstitutional, a judge in Washington ruled Wednesday. Regulations by the U.S. Food and Drug Administration would have required tobacco companies to display the images on the top half of cigarette packs, front and back. It was scheduled to take effect in September. U.S. District Judge Richard Leon said the Obama administration failed “to convey any factual information supported by evidence about the actual health consequences of smoking through its use of these graphic images.” The rule, he said, violates companies’ First Amendment protections against government-compelled speech. Several tobacco companies, including R.J. Reynolds, Lorillard and Liggett Group, filed a lawsuit against the FDA in August, challenging the rule, which stems from the 2009 Family Smoking Prevention and Tobacco Control Act. The government can compel companies to disclose factual, uncontroversial information, to protect consumers from deception or confusion. But the compelled speech can’t be overly burdensome. Other images were of a man exhaling cigarette smoke through a tracheotomy hole in his throat; a plume of cigarette smoke enveloping an infant receiving a kiss from his or her mother; a diseased mouth afflicted with what appears to be cancerous lesions; and a man breathing into an oxygen mask. In his ruling, Leon said that “the graphic images here were neither designed to protect the consumer from confusion or deception, nor to increase consumer awareness of smoking risks; rather, they were crafted to evoke a strong emotional response calculated to provoke the viewer to quit or never start smoking.” Leon said the government could have used far less heavy-handed means in its anti-smoking campaign, such as boosting its own anti-smoking advertisements, requiring companies to place smaller warning labels on their products and changing the images so they convey factual information. “Unfortunately, because Congress did not consider the First Amendment implications of this legislation, it did not concern itself with how the regulations could be narrowly tailored to avoid unintentionally compelling commercial speech,” Leon said. The FDA hasn’t responded to a request for comment. (This post originally appeared on the WSJ’s Law Blog.)

If you developed a seriously painful toothache, would you head to the emergency room to get it taken care of? In an ideal world, probably not. But lacking access to regular care from a dentist, an estimated 830,590 Americans sought help for their dental ailments in the E.R. in 2009, according to a report released yesterday from the Pew Center on the States. That represents a 16% increase from 2006, according to the report, which pulled information on E.R. visits from a database maintained by the Agency for Healthcare Research and Quality. (The estimate is based on an analysis of hospital codes from a weighted sample of 29 million E.R. visits to nearly 1,000 hospitals, Pew says.) So why do people end up in the E.R. for problems that often could have been nipped in the bud through regular checkups, cleanings and fillings? Barriers to accessing care, Pew says. Last year an Institute of Medicine report estimated that a third of the population has difficulty getting dental care. Cost is one stumbling block. Medicaid requires that states provide dental care to kids, but reimbursement is low enough so that many dentists won’t accept the insurance program. And Medicaid dental coverage for adults is optional, which means it is often cut during budgetary hard times (like now), Shelly Gehshan , director of the Pew Children’s Dental campaign, tells the Health Blog. There is also a shortage of dentists in many areas, according to Pew. But shifting dental care to E.R.s is expensive, particularly when problems that would have been easily and cheaply fixed with routine dental visits get bad enough to require surgery and general anesthesia. “Research shows the average costs of a Medicaid enrollee’s inpatient hospital treatment for dental problems is nearly 10 times more expensive than the cost of preventive delivered in a dentist’s office,” the report says. And hospitals generally aren’t equipped to treat toothaches and abscesses effectively, it says. “It’s a waste of money,” says Gehshan. “And it’s inferior care.” The folks at Pew have several recommendations for states, including school-based programs to have dental hygienists apply sealants that can prevent decay, community water fluoridation, expanding the dental workforce by using dental therapists and other alternative practitioners working under dentists’ supervision and higher Medicaid reimbursement rates for dental services. “We advocate that states pay at least as much as it costs to provide the service,” says Gehshan. The American Dental Association says in a statement that it agrees with many of the report’s recommendations. But it says the report “misses the mark on some key points,” notably the question of a dentist shortage. The ADA, citing a projection published in 2009 in the Journal of Dental Education, says the ratio of dentists to population will increase — which means dentists, not dental therapists or other non-dentist providers, should provide needed services. Image: iStockphoto

The second time’s a charm for Vivus’s experimental obesity drug Qnexa, at least when it comes to FDA advisory panel votes. As the WSJ reports , one of the agency’s advisory panels today backed approval of the drug by a decisive 20-2 vote. The FDA — which often but not always follows the advice of its outside panels — is due to make its decision by April 17. If the drug is approved, it would be the first new prescription weight-loss drug in over a decade. Qnexa combines low doses of two existing drugs: phentermine, which cuts appetite, and topiramate, now used to combat seizures and migraines. Back in July 2010, FDA advisors voted against approving Qnexa by a margin of 10-6. The FDA itself nixed the drug later in the year , requesting more safety information. Vivus submitted additional clinical data to the FDA in an attempt to allay its concerns. It’s not clear whether that will be enough to satisfy the agency, though. In briefing documents released ahead of today’s meeting, the FDA raised concerns about possible effects on the heart and about birth defects. But it also noted that Qnexa produced “significant” weight loss in the first year of treatment, with some regain in the second year. Qnexa wasn’t the only obesity drug to stumble with the FDA in recent years. The agency said in October 2010 that Arena’s lorcaserin couldn’t be approved without additional data. And in February 2011 the FDA said that it wouldn’t consider approving Orexigen’s Contrave without another clinical trial. (Contrave, unlike lorcaserin, had actually gotten a thumbs-up vote in its first go-round with the advisory panel.) The Health Blog wondered in September whether some of the rejected drugs might eventually rise from the ashes. Image: iStockphoto

FDA head Margaret Hamburg announces approval of new suppliers for two crucial cancer drugs, easing critical shortages in the U.S.

New supplies of two currently hard-to-find cancer drugs are on the way, according to the FDA. As Dow Jones Newswires reports , the FDA said it would allow the temporary importation of Lipodox, made by Sun Pharma Global FZE and distributed by Caraco Pharmaceutical Laboratories, as a substitute for Johnson & Johnson’s Doxil. The drugs have the same active ingredient. Doxil has been in short supply since about mid-2011. New supplies of Lipodox are “expected to end the shortage and fully meet patient needs in the coming weeks,” the FDA says. The FDA also said it had approved a new manufacturer — APP Pharmaceuticals — of preservative-free methotrexate, a drug that is used to treat a type of children’s leukemia and has also been in short supply . The drug should be available in March, the agency says. Hospira has also “expedited release of additional supplies” of preservative-free methotrexate — 31,000 vials worth, enough to cover a month’s worth of demand, the FDA says. The agency “is actively working with other manufacturers … including Mylan and Sandoz Pharmaceuticals” to meet patient needs, it says. DJN notes that both shortages can be traced back to the closing of a Ben Venue Laboratories plant in Ohio. Ben Venue, a unit of Boehringer Ingelheim, shut down the plant to deal with manufacturing issues. Bonus: GAO Report Blames Drug Shortages on Manufacturing Problems Image: iStockphoto