Win some, lose some. Last month, the health care giant succeeded in getting a whistleblower suit filed by two former sales reps tossed. Yesterday, however, Johnson & Johnson couldn’t pull it off again. A federal judge denied its motion to dismiss a suit brought by a former contract sales rep for J&J’s Ortho-McNeil unit. Significantly, the former rep, Ed West, was able to clear a huge hurdle known as rule 9b, a controversial provision of the False Claims Act, which requires a whistleblower to provide specific information about false claims that were submitted to the government for payment.

This is the same rule that prompted a federal judge last month to toss a whistleblower suit filed by two former Ortho-Biotech sales reps - Mark Duxbury and Dean McClellan. The same reasoning was used to bounce a lawsuit brought against Pfizer by whistleblower Peter Rost, but an appeals court reinstated his suit last fall, and Rost more recently filed papers with evidence he hopes will pass muster.

In his suit, West charged that Ortho-McNeil schemed to offer kickbacks and rebates to hospitals to purchase more of its Levaquin antibiotic than a rival med, and encouraged hospitals to divide and re-use single use premix bags of Levaquin in order to create a secret discount and increase hospital profits and Levaquin sales. His suit also accused J&J of paying kickbacks to docs in the form of speaker fees and grants for prescribing more of the antibiotic. J&J denied all the charges and maintained West’s suit should be dismissed because he didn’t offer enough particular evidence - rule 9b - and he actually came across the allegations elsewhere and wasn’t an original source of information.

However, as PharmaFraud notes, US District Court Judge Patti Saris in Boston wrote in her ruling yesterday that West’s “allegations pass muster…The discount, cash bribe, premix bag, and improper fees, grants, and gifts allegations are each sufficiently particular. For example, (West) identifies a particular time (March 2002) when a particular Ortho-McNeil sales representative (Cheryl Janicek) allegedly discounted the price of Levaquin for a specific hospital (Holy Cross Hospital) on the condition that the hospital ‘no longer stock Cipro for MD’s requesting the drug.’ ” (Cipro is a Bayer antibiotic, by the way).

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Eight years ago, Diana Levine entered the emergency room of a Vermont hospital because of a severe migraine. This had happened before and, as on other occasions, she was given a painkiller and another med to treat the nausea brought on by the first drug. One thing, however, was unusual about this visit - the nausea med was administered differently. And the incident eventually caused Levine, a professional musician, to lose her right arm below the elbow. She later filed a lawsuit against Wyeth, which sells the injectable Phenergan nausea med.

Why? At issue is preemption - a legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The court’s decision, therefore, is being closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA. We chatted with Levine, 62, about her plight and the legal battle. This is an excerpt…

Pharmalot: Before this episode, you were a professional musician. What did you do?
Levine: Back in 1989, my husband and I started a label, called Rebop Records, which I did to combine my passion for music and songwriting, and my love for kids. I played bass, guitar and piano. Sometimes, I’d play with my sister, who lives nearby, or my husband in local bands. The label was designed to provide rock and roll that kids and parents could enjoy together.

Pharmalot: But in 2000, you went to the hospital and Phenergan was administered. What happened?
Levine: I have a history of these migraines and, normally, I can manage them, but on occasion, they could be excruciating and debilitating, and I’d get hauled off to the emergency room. Normally, I’d get Demerol for the pain and then Phenergan, because the Demerol would make me nauseous. And it would be intramuscular administration, which was normally a shot in the butt. This time, they gave me a push IV and that’s what caused the problem When I woke up, I was still in pain.

Pharmalot: At what point was your arm in jeopardy?
Levine: This went on for two or three weeks. It’s a bit of blur now. But I was taking bloodthinners and morphine and painkillers. The doctors tried desperately to keep my hand. I’d never been in such pain. There were two procedures, though. The first was to amputate the hand. But it became obvious that the skin (below the elbow) wasn’t going to regenerate and get healthy. The gangrene was still there. So I told them to take as little (of the arm) as you have to. The trauma seemed insurmountable. The best I could say was that I hadn’t died.

Pharmalot: What did this do to your life, and your music?
Levine: Well, it stripped me of my career and my business and my ability to do what mattered most. I had to start from scratch. I’m left-handed and it was my right arm that was affected, so in a way, it was a blessing. Although I tried to do too much and developed over-use syndrome. Anyway, I was eventually outfitted with a prosthesis. And now I can hold a guitar pick and strum and make a chord. I still work with kids, but I can’t tell you how many times they ask what happened. I tell them one is my soft hand and the other is my hard hand.

Pharmalot: What’s your view of Wyeth and its actions?
Levine: They should’ve taken responsibility for changing the label…

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A group of activists and academics have written Thailand’s new health minister, Chaiya Sasomsab, to resist pressure from drugmakers and biotechs to roll back Bangkok’s policy of issuing compulsory licenses. A recent example came when BIO, the biotech trade group, wrote the US Trade Representative, urging that Thailand be placed on the Foreign Priority Country list, which is reserved for the most severe offenders of intellectual property rights. Thailand is already on the rung below, the Priority Watch list.

Thailand’s review of compulsory licenses on three high-priced cancer drugs should not be distorted by groundless threats of potential trade
sanctions from the brand-name pharmaceutical industry…PhRMA says it will push the US Trade Rep to impose trade sanctions if Thailand implements the licenses and imports low-cost generic meds to provide to mainly poor Thais within the public health system, according to the groups signing the letter. And they charge the threat has no basis in law or political reality. A WTO mission recently noted Thailand’s policy is legal.

“The compulsory licenses issued over the past year have shown that developing countries have lawful policy tools available at their disposal to overcome patent barriers to making life-saving medicines accessible. We hope that the government maintains this policy. But whatever it does should be decided on the merits, not influenced by the reprehensible but groundless threats from PhRMA,” the letter states. This is the letter.

Organizations endorsing the letter include Essential Action, American Jewish World Service, the American Medical Student Association, Global AIDS Alliance, Health GAP, Knowledge Ecology International (KEI), Oxfam America, and the Student Global AIDS and Trade Justice Campaigns.

In a closely watched case, the US Supreme Court voted to 8-1 that patients can’t file lawsuits against device makers when their products were approved by the FDA.

The court reviewed a lawsuit that pitted Medtronic against a woman whose now-deceased husband suffered a disabling injury when a balloon catheter burst during angioplasty. Medtronic argued that the Food, Drug, and Cosmetic Act expressly preempts state law claims brought by patients who were hurt by devices that received premarket FDA approval.

In the decision, Justice Antonin Scalia wrote that the FDA’s approval process was “rigorous” and precluded imposition of any additional requirements under state product-liability law (Please see page 4 of the ruling). Justice Ruth Bader Ginsburg was the only dissenter.

The ruling gives device makers an eagerly anticipated defense in product-liability lawsuits. The decision may also gladden drugmakers, which have appealed to the Supreme Court in two separate cases to restrict the ability of patients to file suits in state courts. Unlike medical devices, however, there is no statute providing for preemption for drugs. This separate battle centers on whether decisions by state courts and juries should have the right to trump an FDA rule, which the agency and industry say is the final word on safety and effectiveness.

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The Democrat from Michigan, who chairs the House Energy & Commerce Committee’s Subcommittee on Oversight and Investigations is busier than ever. He’s probing the FDA’s handling of Baxter’s Heparin, the blood thinner linked to hundreds of patient reactions and four deaths; TV ads for Pfizer’s Lipitor; the release of Vytorin clinical-trial data by Schering-Plough and Merck; the marketing of anemia drugs sold by Amgen and Johnson & Johnson; and the review of clinical trial data for Sanofi-Aventis’ Ketek antibiotic.

The common wisdom is that politicians are genetically inclined to beat up on the FDA and pharma, especially Democrats who control Congress and when an election year is under way. But there is more to it than that. In 2000, Stupak’s 17-year-old son, who was using the Accutane acne med, committed suicide. Stupak personally investigated whether the drug could be tied to psychiatric side effects, and went to FDA headquarters in Rockville, Md., to sift through documents. During one hearing, he held up the packaging from the dead teen’s prescription, The Wall Street Journal writes.

Stupak, 55, says his focus on the FDA and pharma doesn’t stem from the tragedy. “It’s a broken agency,” he tells the paper. “It’s not just a Democrat or a Republican in charge. I think that cancer developed in the FDA a long time ago and permeated every administration.” Still, his wife, Laurie, says that had it not been for their son’s death, “maybe he would never have had quite the awareness he has now about how government oversight, or lack of oversight, affects people’s lives. It hits home.”

His outrage last week prompted him to call for FDA commish Andy von Eschenbach to resign, a move that Joe Barton of Texas, the ranking Republican on the Energy and Commerce committee, says was a mistake. Andy, he tells the Journal, is “dedicated public servant,” and “he’s certainly not done anything unethical or illegal.”

Who doesn’t enjoy a good soap opera now and then? And as this clips illustrates, pharma can provide good fodder. Here is a first installment of life at Rx Pharmaceuticals, a drugmaker that knows how to handle its sales reps. Does Nikky, the district sales manager, know what she’s doing when she forces the high-performing Camille to give up the lucrative Bevery Hills territory? Will Camille go to Inglewood quietly or look for another job? And what about Jennifer? Will she ever understand how to sell Paxatram? Can Paul help with her training? Or is she just another cheerleader? Please click on this link to watch.

Hat tip to Pharmagossip

A new survey of 150 internists, general practitioners and cardiologists finds that all three groups expect to prescribe the cholesterol pill less often as a first-line treatment or even as a second-line treatment.

Among general practitions, the use of Vytorin is expected to drop by 20 percent as a first-line treatment; a drop of 9 percent among cardiologists and 7 percent among internists. Meanwhile, usage as a second-line medication is expected to drop across all specialties by 8 to 14 percent of patients. In third-line treatment, however, Vytorin prescriptions received a boost from 20 to 30 percent, according to GfK Market Measures.

Moreover, general practitioners say they will switch more than 40 percent of their patients currently on Vytorin or Zetia to other therapies over the next few months. In comparison, cardiologists and internists participating in the research study anticipate making the switch among a smaller portion of their patients, ranging from 25 percent to 30 percent. (Please click on the chart to make it bigger).

“In light of the Enhance trial result impact, there is obviously an opportunity over the next several months for Lipitor and Crestor to capture additional market share,” says Anna Marie Napolitano, vice president and category business leader, cardiovascular, GfK Market Measures, in a statement. “With physicians counseling patients to wait until their next visit to discuss alternative therapies, Merck and Schering are challenged to provide credible evidence of advantages to maintain existing patients on the drugs, particularly as the FDA’s review and report on the trial are not expected until later this year.”

Glaxo announced what it calls “significant new price reductions” for its HIV drugs that are offered on a not-for-profit basis to the world’s poorest countries. The reductions, the fifth such cut since 1997, apply to all of its HIV medss but the most significant will be on Ziagen syrup which is recommended by the World Health Organisation for use in first-line and second-line regimens within resource-limited settings, particularly for children. The new price per pack was lowered by almost 40 percent to $15.08 (Look here for the chart showing all the price reductions).

The average reduction among the 14 meds is 21 percent and Glaxo says the cuts will take effect immediately for public sector customers and not-for-profit organisations on the United Nations list of ‘Least Developed Countries’ and Sub-Saharan Africa, a total of 64 countriesl. The meds are also available to projects financed by the Global Fund to Fight AIDS, Tuberculosis and Malaria and by President Bush’s Emergency Plan for AIDS Relief, otherwise known as PEPFAR.

In discussing the move, Glaxo says the price cuts reflect “including improvements and efficiencies in manufacturing and supply, and reductions in the costs of active ingredients”