Pharma Misbehaving

Drug-maker Eli Lilly could pay more than $1 billion to state and federal authorities to settle an investigation into how the company marketed an antipsychotic drug, the New York Times reports. In 2000-03, Lilly pushed doctors to prescribe Zyprexa as a treatment for age-related dementia—though the drug is approved to treat only schizophrenia and bipolar disorder. More »

The problem of drug-name mix-ups is growing in the US, with harmful and sometimes even fatal consequences for patients, USA Today reports. A study undertaken by the group that regulates generic drug names found that the rate of mix-ups has more than doubled since 2004. In one case, a 7-year-old boy ended up in the emergency room after being given schizophrenia drug Zyprexa instead of  the allergy drug Zyrtec. More »

Roughly half of the medical studies involving antidepressants that found little or no effect on patients have gone unpublished or had their findings mischaracterized as positive, a new study reveals. The emphasis on publishing only studies with glowing reviews gives patients and doctors a false sense of the effectiveness of drugs such as Zoloft and Effexor, the Wall Street Journal reports. More »

The first drug approved by the FDA to treat fibromyalgia is raising questions, but not the typical ones about whether the medication works. They're questions about whether the disease even exists. Lyrica sales are up and climbing, but critics say giving a name to the chronic pain that characterizes fibromyalgia lends the diagnosis undeserved legitimacy, the New York Times reports. More »

Actor Dennis Quaid and his wife filed a lawsuit against Baxter International, maker of the blood thinner Heparin, after their newborn twins nearly died of an overdose, the Chicago Tribune reports. The couple said Baxter was negligent because it packaged two different strengths of the drug, one a thousand times more concentrated than the other, in similar vials. More »

A dearth of information on the effects of prescription drugs on children is putting millions of kids at risk, the Washington Post reports. Two-thirds of the medications prescribed to kids haven't been tested on them, and those that have been tested often produce unexpected results: A migraine drug that works on adults causes strokes in kids. And asthma inhaler stunts growth. A pain-killer patch can deliver a fatal overdose to a child. More »

The FDA may change the labels of flu medications Tamiflu and Relenza to warn of serious side effects such as hallucinations, the Wall Street Journal reports. More than 700 so-called neuropsychiatric events—for example, children trying to "flee" by jumping through windows—and 16 deaths may be related to the drugs. Most reports come from Japan, where the drugs are most popular. More »

The FDA has applied its harshest warning to the diabetes drug Avandia, declaring the product potentially increases risk of heart attacks. Now marked with a “black box” warning, GlaxoSmithKline’s drug will stay on the market pending a continuing “safety assessment,” the Wall Street Journal reports; FDA officials say the agency remains split on the wisdom of pulling the drug immediately. More »

China’s massive prescription drug industry has an equally massive flaw: pharmaceuticals made by chemical companies are not held to regulatory standards. Of nearly 500 Chinese companies at a recent drug trade show, 82 were unregulated and uncertified, the New York Times discovered. “This is definitely against the law,” said one drug regulator, who acknowledges that China's food and drug agency doesn't have jurisdiction over chemical companies. More »

More doctors, hospitals, and medical schools are limiting or barring visits from drug-company reps as the calls become more frequent and concerns grow that they may influence prescribing. An organization of doctors who pledge not to welcome pharma reps has only 800 members, but institutional players—including some states—are taking steps to restrict marketing, Newsweek reports. More »

A Nevada jury has tacked on an additional $99 million in punitive damages against the Wyeth pharmaceutical company after ruling in favor of three women who argued that the drug maker's hormone replacement therapy caused their breast cancer. That amount, added to compensatory damages determined last week, makes the total finding against the drug manufacturer $134.1 million. More »

Medtronic is halting sales of a wire that connects defibrillators implanted in the chests of cardiac patients to their hearts. The wires have been shown to fracture and deliver an accidental jolt  to the heart, which can be uncomfortable and may have played a role in five deaths. An estimated 235,000 people worldwide have defibrillators with the lead in question, the Sprint Fidelis line. More »

Several drugmakers have recalled over-the-counter cough and cold products for infants over concerns about fatal overdoses, Reuters reports. Johnson & Johnson Wyeth and Novartis are among those recalling medicines; CVS said it will remove the products and generic equivalents. One professor took the criticism one step further: “There are really no good studies demonstrating that these medications work.” More »

FDA experts have concluded that over-the-counter cough and cold medicines are not safe  for very young children, and they're urging the agency to ban them. In a safety review released yesterday, they conclude that the medicines are not proven effective in children under 6 and have been implicated in more than 100 deaths. Most of the deaths were children under 2, and many were thought to be due to overdoses. More »

Animals used in medical research have more rights and protections than humans who participate in clinical trials, according to a federal investigation. The Food and Drug Administration has only 200 inspectors to monitor 350,000 clinical trials and most of their field reports are ignored, reports the New York Times. More »

Pharmaceutical behemoth Johnson & Johnson has filed a lawsuit in federal court against the American Red Cross over its signature logo, the Wall Street Journal reports. The suit claims the humanitarian organization is violating the Johnson & Johnson trademark by licensing the signature red cross symbol to companies for use on products such as first aid kits. More »

An FDA panel said today that GlaxoSmithKline's diabetes drug Avandia should remain in drugstores, despite earlier evidence the pill ups heart failure risks. Glaxo has defended its drug, countering that the risks associated with the popular Avandia are the same as those of other diabetes drugs. More »

Troubling questions about the diabetes drug Avandia persisted yesterday as an FDA official revealed that she was barred from recommending a critical warning about the medication, the Times reports. In the run-up to congressional hearings that began today, manufacturer GlaxoSmithKline rushed to disseminate interim clinical findings in hopes of blunting the controversy. More »

Glaxo shares pulled out of a tailspin after the pharma giant defended its second biggest selling drug, Avandia, against claims that it triggers heart attacks.  A sharply worded letter from the company's chief medical officer on the website of medical journal The Lancet pointed out that the increased incidence of heart attacks among Avandia patients—0.6%—was still very small. More »

A diabetes doctor warned the FDA of heart risks posed by the diabetes drug Avandia seven years ago, the New York Times reports. The same concerns raised by Dr. John Buse in a 2000 letter were reiterated in a study published by cardiologist Steven Nissen this week. More »