Finished the chores? Curling up with a cup of coffee? Trying to relax? Then the time has come to catch up on events. Here are a few items to enjoy before you head off to pick some apples or talk a walk in the park…

Drugmakers often complain their good deeds go unnoticed, or worse. So Time magazine has run a piece about Merck’s efforts to provide HIV meds in Botswana. The drugmaker wins praise from the government and its partner, the Gates Foundation, although the mag doesn’t bother to ask one of the NGOs, or non-governmental organizations, for a quick comment.

Novartis ceo Dan Vasella, who has felt the sting of rejected drugs more than once lately, complains that the FDA has become politicized. “The FDA has become subject to politics. If they are assailed like they are now, the best thing to do is nothing,” he tells The Financial Times (subscription may be required). “The discussion on what this [drug] brings over and above what’s on the market is a question that’s being asked. The FDA doesn’t seem to trust the physicians any more.” And over in Australia, they don’t trust Novartis.

Another day, another drugmakers pays fines for fraud? Clearly, that’s an exaggeration. But Bristol-Myers Squibb did agree to fork over $515 million last week and sign a corporate integrity agreement. The American Prospect takes a look at the ongoing problem in the industry to avoid such problems amid growing whistleblower activity.

A court case brought by Nigeria against Pfizer resumes on Tuesday, Reuters reminds us. You may recall that Nigeria alleges the drugmaker deceived patients and their families, and caused the death of 11 children in 1996 when it performed clinical trials for Trovan. The northern state of Kano, it is suing the company for $8.5 billion, while Pfizer says it answered a call for help to save the lives of African children during a meningitis epidemic.

The fascination with China continues over at BusinessWeek, which examines manufacturing and intellectual property issues. The conclusion - India and everyone else is getting a run for their money. “If tomorrow the Chinese decide not to supply the world with raw materials, the pharma industry would collapse,” Yusuf Hamied, Cipla’s chairman, tells the mag.

And finally, FDA reviewers are recommending that OTC cough and cold meds that contain decongestants and antihistamines should come with new instructions and shouldn’t be given to very young children. The agency received 54 reports of deaths with decongestants and 69 with antihistamines from 1969 through 2006, mostly in kids younger than 2, Reuters writes. An FDA panel meets on Oct. 18 and 19. Meanwhile, four companies alerted docs to new warnings about side effects of gadolinium, which is used in imaging procedures, because it can raise the risk of a sometimes fatal disease that prompts excessive tissue to grow between internal organs, the Associated Press reports.

(Did we miss something interesting? Write in and tell us.)

That appears to be what Dan is now thinking, according to slightly cryptic remarks he made to reporters in Cambridge, Massachusetts, the other day where he was announcing a new research deal between Novartis and MIT.

“My thoughts on this are that in both models you see successes and failures and it would be a mistake to believe there is only one model for success,” he said. Moreover, he doesn’t plan to step down any time soon, Reuters reports. At one time, he had spoken of 2008 as his departure date and just two months ago, there was a report in a Swiss newspaper that Vasella may propose that Joerg Reinhardt, who is currently head of vaccines and diagnostics, as his successor.

But Dan now says any thoughts of departure were based on a rule the company once had that directors should only serve for 12 years. That rule was implemented because a majority of the board had been elected the same time and therefore would have been required to leave en masse, and it was abandoned a few years ago, Vasella said.

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And so the week comes to an end. We almost hate to say so long, but the dog must be walked. And one of the short people requires some attention, too. But look for us over the weekend. One never knows what will pop up. Meanwhile, please remember to vote in our polls. One is about this week’s study in the New England Journal of Medicine concerning thimerosal and connections to neurological risks. The other concerns possible FDA approval of Zyprexa for teenagers. The polls will remain open throughout the weekend. For now, though, we wish you a pleasant evening…

How so? Variations in a pair of genes my increase the chance of reporting suicidal thoughts after taking Celexa, according to a study in the latest issue of The American Journal of Psychiatry. (Here’s the abstract). Although preliminary, the results may help researchers develop tests to predict who will react badly to the med, and who will do well.

The study focused on reactions only to Forest Labs’ Celexa, and didn’t find any link between the genetic variations and suicide attempts, The New York Times reports. This distinction is critical, because docs don’t know whether people who report suicidal thoughts are at increased risk to act on them. The one patient in the study who attempted suicide denied suicidal thoughts, the paper writes.

The findings are likely to enlarge an ongoing controversy over the safety of antidepressants. Two years ago, the FDA required drugmakers to place Black Box warnings on product labels warning of suicidal behavior and thoughts. The American Psychiatric Association, however, complains the warnings and publicity have scared away some docs and patients, robbing some people of a useful treatment.

“What I would say is that this study is a wake-up call, that we may have the opportunity to use genomic tests to guide personalized care for depression,” said Tom Insel, director of the National Institute of Mental Health, which helped finance the study, tells the paper. But he adds that the genetic test “is not yet ready for prime time.” Indeed, perhaps one antidepressant will one day be proven safer for some people, but not others.

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The drugmaker agreed last December to settle charges of giving kickbacks to docs and overcharging the government, but now the bill has come due. And this includes signing a 5-year corporate integrity agreement (here it is).

The US Attorney in Boston, Mike Sullivan, charged Bristol-Myers with illegally compensating docs to induce them to prescribe oncology meds between 2000 and 2003.. The kickbacks included consulting fees, advisory board payments and travel to “luxurious resorts.” And there’s more: The drugmaker’s Apothecon unit was charged with paying retailers and wholesalers to stock its drugs; there was off-label promotion of the Abilify schizophrenia drug for use in kids for dementia-related psychosis, and Bristol-Myers also misreported its best price for its Serzone antidepressant under provisions in Medicaid..

Bristol-Myers directed its sales force to call on child psychiatrists and other pediatric specialists, and the sales force then urged physicians and others providers to prescribe Abilify for pediatric patients. BMS also created a specialized long term care sales force that called almost exclusively on nursing homes, where dementia-related psychosis is far more prevalent than schizophrenia or bipolar disorder, according to the Justice Department.

“Kickbacks are especially nefarious when they are used as part of a marketing effort to convince physicians to prescribe drugs for uses that the FDA has not determined to be safe and effective,” Sullivan said in a statement.

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File this under premature articulation.

The drugmaker blames some retailers for getting too excited about a new Advil dosage. It so happens, some unnamed chains began advertising that the stronger version would hit store shelves soon, but there was a problem - the FDA hasn’t yet approved Advil Maximum Strength. So Wyeth is in the unenviable position of running newspaper ads saying the product isn’t available yet.

But why did this happen? Wyeth notified some retailers that distribution of the new product was “imminent,” and a few retailers earlier this month promoted it in store flyers, Wyeth spokesman Doug Petkus tells the Associated Press. Here’s the rub - the FDA told Wyeth on Sept. 14 that it must meet certain conditions before the agency can approve sale of the product.

“We have some items to address,” Petkus confesses, although he declines to identify those items or say which retailers ran notices the product would be for sale soon. “We’re optimistic that within a short period of time we’ll get approval.”

Here’s a lesson for the marketing team - be more specific with your customers until you know for certain the FDA has approved the product.

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As the end of the week nears, the opportunity for a quick break presents itself. Go ahead, enjoy yourself. Stretch your legs. Grab something to eat. Catch up on events…

Bristol-Myers Finalizes Deal To Pay $499M For Improper Marketing, Overcharging (Bloomberg News)

Par Pharmaceuticals Sees 2007 Below Wall Street Estimates (Yahoo/Reuters)

Idenix Lays Off 100, Amends Novartis Deal (Yahoo/AP)

Pfizer Says Canadian Court Upholds Viagra Patent (Yahoo/Reuters)

The Wolverine State has the curious distinction of being the only state with a law that bars its citizens from filing product-liability lawsuits against drugmakers. The rationale - the FDA should be the last word on safety and effectiveness. And so a state court judge or jury can’t second-guess the federal regulator. In other words, the agency’s authority trumps, or prempts, a state court action. The FDA also has a rule to this effect, which drugmakers would like to see adopted nationwide.

As you might imagine, consumers groups (and trial lawyers) are fighting this effort, because the implications are enormous. Merck, for instance, has used this reasoning to defend Vioxx lawsuits, with mixed results. So has Wyeth in its Prempro litigation. Now, the Supreme Court may decide the matter.

To gain perspective from someone who lives with this restriction, Pharmalot rang Hank Greenspan, a social ethics lecturer and faculty scholar in integrated medicine at the University of Michigan Medical Center. Two years ago, he helped organize Justice In Michigan, a group of mostly doctors and academics who worked unsuccessfully to repeal the state’s preemption law. Here’s what he had to say….

Pharmalot: What’s it like to live in a state with preemption?
Greenspan: It’s bizarre. If somebody is harmed, or believe they were harmed, or their estate believes harm was done, they don’t have the right to their day in court. Our own law prevents that.

Pharmalot: Why does such a law exist in Michigan, though?
Greenspan: It was passed in 1995 and championed by John Engler, who was the governor at the time. He saw himself as part of the conservative revolution epitomized by Newt Gingrich and favored less government regulation. And Upjohn was a big company here, although it was bought by Pharmacia (which was later acquired by Pfizer).

Pharmalot: Why should anyone not living in Michigan care about this issue?
Greenspan: Because we are your future.

Pharmalot: But preemption already exists for medical devices, on a national basis. Why not extend the same reasoning to prescription drugs?
Greenspan: There’s no logical reason why devices are covered by preemption. So, I’ll put it this way - Why make the same mistake twice?

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The idea is to create a research program aimed at revolutionizing the way drugs are made. And so the goal is to help companies move from making drugs in batches to using a continuous high-tech process that will save time and money, The Boston Globe writes.

The funds, which will be provided over 10 years, should be enough to support research efforts for seven to 10 faculty members, and dozens of graduate students, postdoctoral fellows, and staff scientists. MIT officials believe it will be the largest academic research effort in the world focused on modernizing drug manufacturing.

“There is nothing of this magnitude and this focused,” says Bernhardt Trout, an MIT associate professor of chemical engineering who is running the new Novartis-MIT Center for Continuous Manufacturing. “This is going to be an industry transforming project.”

He says drugmakers currently rely on batch manufacturing simply because they’ve always done so and don’t have the knowledge to make a switch. “We need to develop a whole of new set of technologies that don’t exist,” he says. “We’re the first ones to try to put together all the resources to make it happen.”

MIT and Novartis will jointly share the rights to any research they develop together, and each will control the rights to any technologies they develop alone through the center. They could also generate revenue by licensing technology to other companies.

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And now, a commercial break…