This is promising:

Drugmaker executives whose companies promote unauthorized uses of their medicines may be targeted by U.S. regulators for misdemeanor prosecutions, Food and Drug Administration Deputy Chief for Litigation Eric Blumberg said.

* * * *

‘“It’s clear we’re not getting the job done with large, monetary settlements,” Blumberg said. “Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion.”

Source: Drugmaker CEOs May Be Targets for U.S. FDA in Off-Label Cases, Lawyer Says – Bloomberg

However, I would go one step further.  As a matter of public policy, I would prevent pharmaceuticals from paying for the legal defense of anyone who is charged with criminal off-label promotion.  Let’s face it – the DOJ doesn’t have the best track record in the world in complicated prosecutions.  And the reason the DOJ isn’t winning more cases is because multibillion-dollar companies are able to provide the best defense money can buy.

If pharma executives had to pay the cost of their own defense, two things would happen.  First, executives would be less likely to engage in conduct that might get them criminally prosecuted.  Second, the DOJ wouldn’t be outgunned by multimillion-dollar dream teams.

As I’ve mentioned before, the game plan for most pharmaceutical companies these days seems to be to (a) get a drug approved for a limited indication, and then (b) promote it as a cure for every ailment known to man.  I thought the figures below were interesting:

The Justice Department on Tuesday joined a whistle-blower lawsuit against Pfizer and its subsidiary Wyeth Pharmaceuticals that accuses Wyeth of illegal off-label marketing of Rapamune, a drug used to prevent rejection of kidney transplants.

* * * *

The filing continued a crackdown on drug industry fraud. Over the last three years, the government has also settled false claims suits against Bristol-Myers Squibb for $515 million, AstraZeneca for $520 million, Eli Lilly for $1.4 billion, and last week, a unit of Forest Laboratories for $313 million.

Source: U.S. Joins Whistle-Blower Suit Against Pfizer –

Over the last three years, the government recovered over $2 billion dollars.  If that’s what was actually recovered, one wonders how  much hasn’t yet been recovered.

Drug marketing 101: The FDA approves drugs for specific ailments.  Drug companies may not market the drug to treat any other type of ailment.  If they do, it’s called off-label marketing and it is illegal.

Drug marketing 201: It’s often very profitable to engage in off-label marketing, because the fines you pay are less than the money you make doing it:

Allergan, the maker of Botox, agreed on Wednesday to pay $600 million to settle charges that it illegally promoted and sold the drug through 2005 for unapproved uses like treating headaches.

Source: Maker of Botox Settles Inquiry on Off-Label Marketing –

Now, I don’t know for sure that off-label marketing netted Allergan more than $600 million dollars.  But, I do know that Allergan made several billion dollars selling Botox over the last few years.  $600 million is definitely a large fine, but it’s only effective if it is more money than they made by promoting it off-label.

An analogy I often use: If you only had to give back half of the money you got from robbing a bank, how many banks would you rob?

Some people don’t understand why pharmaceutical companies shouldn’t be allowed to engage in off-label marketing.  Here’s one reason:

Peetz was diagnosed with the autoimmune disorder thrombotic thrombocytopenia purpura in 1995, at age 11. According to the lawsuit, by 2003 Genentech and Biogen Idec were marketing Rituxan as an off-label treatment for Peetz’ condition, meaning the Food and Drug Administration had not approved it for that use.

* * * *

Peetz took Rituxan for two years before developing a near-fatal viral infection that left him "a ventilator-dependent flaccid quadriplegic," the lawsuit said. Peetz’ court filing said the drug puts all users at risk, not just those taking it for off-label conditions

Source: Omaha man sues makers of drug Rituxan – San Jose Mercury News

I haven’t had a chance to take a look at the label for Rituxan, so I can’t comment on whether I think there’s a valid failure-to-warn claim there or not.

I’ll be honest with you. I don’t trust pharmaceutical sales reps.  Few of them are medical doctors, but they tell doctors which drugs should be prescribed for which patients.  Traditionally, their compensation is based in part upon how many drugs the doctors they visit prescribe.  This leads to a gigantic incentive to engage in off-label marketing and other unethical practices.

Perhaps this is going to stop at GSK.

Starting next year, bonuses will be determined “in part, by customer feedback, and by a sales professional’s adherence to the company values of transparency, integrity, respect and patient-focus,” the company said earlier this week. (Here’s the Dow Jones Newswires story.)

Source: Bonuses For GSK Pharma Sales Reps Won’t Be Tied to Sales – Health Blog – WSJ

Time will tell.

I sure hope so.  Because the ability of pharmaceuticals to find out how often doctors prescribe which medications allows those pharmaceuticals to engage in all sorts of shenanigans, like finding doctors open to ghostwriting and pushing for off-label prescription use.

Washington Bureau – When your doctors writes you a prescription, that’s just between you, your doctor, and maybe your health insurance company–right?
Wrong. As things stand now, the pharmaceutical companies that make those prescription drugs are also looking over the doctor’s shoulder, keeping track of how many prescriptions for whose drugs the individual physician is writing.

And that data on the prescribing habits of thousands of doctors has become a powerful sales and marketing tool for the pharmaceutical industry, but also a source of growing concern among some elected officials, healthcare advocates and legal authorities.

Source: States, Consumer Advocates Challenge Rx Data Mining —

Another good article from Duff Wilson at the New York times.

The pharmaceutical company AstraZeneca said Thursday that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel.

One of the investigations related to “selected physicians who participated in clinical trials involving Seroquel,” AstraZeneca disclosed in a government filing. The other case related to off-label promotion of the drug.

Source: AstraZeneca to Pay $520 Million to Settle 4 Seroquel Cases –

I’d love to get my hands on the transcripts for this case.

Oct. 28 (Bloomberg) — A sales representative for Johnson & Johnson’s Janssen Pharmaceutica unit testified that he encouraged doctors to prescribe the antipsychotic drug Risperdal for unapproved uses.

Matthew D. Thompson, testifying today in a trial over claims by a former co-worker, said that in 2002 he pushed doctors to consider prescribing Risperdal in combination with other drugs, so-called augmentation therapy, even though government regulators hadn’t approved this use. Janssen’s training didn’t include any specific prohibitions against promoting the drug that way, he said.

“I’m not saying the company tried to hide it, but we didn’t think about augmentation in the realm of on-label or off- label at that time,” Thompson said. He said he was “probably” aware that promotion of such sales was illegal.

Source: J&J Salesman Says He Sold Drug for Unapproved Uses (Update3) –

If Allergan is successful in challenging this rule, then FDA approval will become meaningless.  Pharmaceuticals will push drugs for any and every ailment under the sun, regardless of whether the drug has been shown to have safety or efficacy for that use.  Some would say that’s the world we already live in…

Oct. 2 (Bloomberg) — Allergan Inc. is challenging a U.S. government rule that prohibits marketing its wrinkle-smoother Botox for unregulated uses, saying the policy restricts information that is needed for patients’ safety.

Doctors should get dosing guidelines and details of injection techniques to reduce risks when giving patients Botox for uses that haven’t been approved, Allergan said today. The drugmaker announced yesterday that it would file a court order enabling the distribution of such information. This is the first lawsuit challenging this aspect of the FDA’s marketing rules, according to the company.

Source: Allergan Sues FDA to Market Off-Label Botox Uses (Update2) –

The AM Law Daily was kind enough to post the transcript of Mark Lanier's opening statement in the Neurontin trial that was called off.  I read this passage and had to share it. 

"Please understand, you're not going to have a lot of documents on  this stuff because you will hear David Franklin explain that the people in his job, he was told, "Do not be putting much of this stuff we're doing in writing." As one of the coworkers said, "It just takes one phone call to turn us all in." They're not allowed to leave the slide, the snake oil salesman slide, they're not allowed to leave those presentations with the doctors.

They go to seminars where they're taught how to do this, and they're handed tablets, and across the tablets it says "Ladies and gentlemen of the jury" to remind them what kind of trouble the company can get in if people write stuff down. So any note that they would take they would take understanding ultimately a jury may get to see it one day. So a lot of what was done was done by phone, it was done face-to-face.

Or there was a time where they were taught how to give a fair and balanced presentation on a videotape. And so the videotape plays, and as the videotape plays, the executives stop the videotape, and they say to everybody, "Okay, now, ignore everything you just heard, and let me tell you how we're going to do it. We were required to show you that."

Now, what Lanier says isn't evidence.  But on the other hand, if those "Ladies and gentlemen of the jury" tablets didn't exist, there would have been a mistrial.

If not for product liability lawsuits, we might never know just how corrupt pharmaceutical companies can be.