Drug Recall Lawyer Blog

Here are the week’s top stories:

• Off-Label Marketing: Jack’s Posterous has a recount of recent off-label marketing fines paid by drug dealers (oops, I mean manufacturers). “As long as off-label promotion is more profitable than the fines for punishing off-label promotion, we will have off-label promotion.”
• Motrin Phantom Recall: Pogust, Braslow & Millrood’s Drug Injury Lawyer Blog has details of Johnson & Johnson’s McNeil Consumer Healthcare and their effort to avoid a Motrin recall.
• Zocor: FDA says it may cause muscle injury (rhabdomyolysis). See our prior Zocor posts.
• Pfizer and Free Samples: Pfizer spends the most doling out free samples--$2.7 billion in a year. Kinda makes you think about those paltry fines, huh?
• Off-Label Marketing, pt. II: Take the poll.
• Drugs and Porn: Can drugs cause porn and gambling addictions? Looks like there are lawsuits in Australia and here in the U.S. I’m highly skeptical of this one.
• Fosamax: Jury selection just ended in the retrial of the Boles case, yesterday.
• Januvia & Janumet: We've been getting a lot of questions about these diabetes drugs lately, so see our website.

Happy Tuesday!

Photo courtesy The Onion

See this article at The Onion.

Is this the ultimate end goal of all pharmaceutical companies?

A kernel of truth in all satire, right? (HT: PharmaGossip).

I saw a link the other day to CNBC's "Pharma's Market" by Mike Huckman titled The Funny Business of Selling Drugs. Unsure if it was truly funny or more simply "funny" in the sense of "something funny is going on, here," I clicked the link.

Turns out it's a little of both. It's a brief article about an HBO Comedy, "The Life and Times of Tim" (which, admittedly, I've never seen nor heard of).

According to the article, one episode has the following premise:

The show is a bawdy, hilarious send-up of doctors' offices that are overrun by so-called "Meals on Heels." That's industry slang for the stereotypical short-skirted, wheely-bag toting, lunch-catering drug sales reps.

As funny as it may (or may not) be, there is usually a little truth behind most jokes. The description of the episode seems to be an indictment of sorts against the way things are done in the Pharm industry--drug companies selling their wares by plying doctors with gifts--little things, like office supplies, stress balls, gadgets, and trips to Hawaii. Is there a better way to keep doctors informed about your products? Well, we're all human, and without a personal incentive, we may not have any interest in learning about these products (I routinely refuse to see vendors who "stop by" the office without an appointment, though some in my office love to spend 30 minutes chatting for some complimentary swag).

Bribery (and that's what it is) doesn't exactly send the right message. I'm sure the drug companies will defend the practice, saying that doctors use their independent judgment, and they are using the gifts as a means to get in the door so they can have a really serious sit-down, but what human wouldn't want to "earn" the free gifts, or at least repay the favor? Surely there is a better way...

The medical journal The Lancet is chiming in on the Avandia debacle. Back in 2009, The Lancet published a paper about the RECORD study (funded by Avandia manufacturer GlaxoSmithKline) which was widely criticized. The major complaint is that the article did not include the drop-out rate—without knowing which patients went off the drug, it is impossible to calculate the risk of Avandia-caused heart attacks.

Now, The Lancet issued an editorial titled “Strengthening the credibility of clinical research.” It describes briefly the Avandia situation, likening the recent Senate Committee on Finance report to a John Grisham novel: “GlaxoSmithKline (GSK), intimidated researchers and manipulated the scientific process for commercial advantage.”

Here are some “talking points” from the editorial:

• at a time when some pharmaceutical firms have received record fines for misconduct, the saga of rosiglitazone [Avandia] tests the limits of tolerance
• such findings damage all who are involved in clinical research, and will likely make funding, ethical approval, and recruitment more onerous for future studies
• trust between doctor and patient, researcher and participant, or author and editor is undermined when the foundations on which evidence is built are treated with such casual contempt
• nothing can completely protect against scientific misconduct

The Lancet reported that it has strived to encourage and use better and more transparent protocols, but that a recent audit of those protocols found that “adherence to protocols was ambiguous and selective.” Like a Tiger Woods apology (or a Jesse James apology, or a Michael Richardson apology, insert your celebrity here), they have vowed to do better, and have spent the past three years working with others on Standard Protocol Items for Randomized Trials (SPIRIT). Heck, just having an acronym makes me feel better.

But seriously—The Lancet is a good publication, and its heart is in the right place, I think. Hopefully they can turn this around and restore confidence in scientific studies and pharmaceuticals.

Interesting developments in online social media and drug companies, in the past week. As you know, the FDA has been soliciting requests about how to manage online social media for drug and device manufacturers. This is clearly a lot for drug companies to deal with, and here are some things they should wrap their minds around:

1. Sanofi-Aventis VOICES Facebook Page: This drug company, maker of the cancer drug Taxotere, learned first-hand the downside of having a Facebook site that allows interaction with customers. That downside is that customers interact. One Taxotere user posted complaints to the FB page about the drug, only to have her post removed. Undeterred, she sent more posts, opened other Facebook accounts, sent more posts, had friends send posts, and just generally assaulted the Sanofi-Aventis stronghold. Finally, Sanofi-Aventis changed their information and stated on the FB page:

   This page is not intended as a forum for discussing sanofi-aventis’ or other companies’ products. As such, Postings that contain product discussions will be removed by sanofi-aventis.

   See John Mack’s Pharma Marketing Blog, which examines whether the complainant’s posts constitute a reportable adverse event that Sanofi-Aventis must share with the FDA.

   This exemplifies some of the problems drug companies will face in creating online social media—how much customer interaction is too much? The value of social media is that it is open to comments and questions and interaction. Otherwise, it becomes simply another mouthpiece for the company, and is bereft of actual benefits (though, to be fair, it would also limit possible damages). But, Sanofi-Aventis now just looks bad for canceling the conversation.

2. Use of hashtags for online social media: Again, John Mack’s blog has a good analysis of this as a possible partial solution to the problem of presenting consumers with a full and balanced view of drug risks and benefits. You can find Novartis’ comments regarding space-saving measures on Twitter here.

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Time to wake up and face the week! Here are the stories we’re following:

• Avandia: The U.K.’s Guardian blogs about GlaxoSmithKline’s potential $6 billion liability. @TomLamb and I are skeptical.
• Vioxx: Australian judge finds for plaintiff in defective drug lawsuit against Merck, though rules that Merck was not negligent. (HT: Pharmalot). Merck’s press release is here.
• FDA: The FDA is going to step up criminal prosecutions of corporate officials.
• Insulin Pump Defects: Insulin pumps have been beset by problems, spanning across the spectrum of manufacturers (HT: Drug Injury Lawyer Blog).
• 510k Approvals in February: See the list here.
• Direct-to-Consumer Advertising: BigPharma’s DTC advertising increased by a “paltry” 1.9% in 2009, but Pfizer leads the pack with $1.1 billion.
• BPA: Wisconsin is added to the list of states banning BPA in baby bottles and cups.
• Nerd Link of the Week: You’ll just have to click to find out…

Happy Monday!

Here are the week’s stories:

• Adverse Events: Our friends at the US Recall News have a link to governmental agencies in charge of adverse event complaints and concerns.
• Avandia: Lots of concern recently about diabetes drug Avandia and heart problems (HT: Nursing Home Abuse Blog).
• Iqbal: The Lewis & Clark law review released its symposium “Pondering Iqbal.” There’s some good topics here—a must read (HT: PrawfsBlog).
• BPA: More on BPA research (HT: Nash & Associates).
• Fentora: This narcotic painkiller is the subject of possible off-label promotion (HT: Drug Injury Lawyer Blog).
• Pharmaceutical Marketing: The title says it all: “A Snarky Look at Sneaky Marketing Tactics Pharma hasn’t Avoided" (HT: Pharma Marketing Blog).
• Gadolinium/Omniscan: A settlement has been reached in the libel suit brought by General Electric (GE) against Danish researcher Henrik Thomsen.

Happy Monday!

In Foster Care Children and Off-Label Drug Use I discussed the use of drugs, particularly psychotropics, to medicate children. In Who Do The Drug Companies Cater To? I talked about doctors (one in particular) who, by all accounts, clearly overprescribed medications, including Seroquel and clozapine.

Now, an article from the Anchorage Daily News reports that the Law Project for Psychiatric Rights filed a federal lawsuit against over a dozen Alaskan psychiatrists, stating that the doctors “unnecessarily drugged children and committed Medicare fraud.”

The article points out that children on Medicare are four times as likely to be put on antipsychotic medication as children who have private insurance. 90% of children seeing psychiatrists are put on medication, while less than 10% of those medications are FDA approved for children.

Assuming these facts are true and that doctors are overmedicating children in Anchorage, some may think that the doctors are to blame. They have the ultimate responsibility, having intimate knowledge (hopefully) of their patients’ conditions, and being able to fully and fairly judge what medication, if any, they should be on. Others may point to the drug companies, who encourage doctors to prescribe drugs to patients, often for off-label uses which have not been safety-tested or FDA-approved. Those same drug companies may use subtle persuasion to enforce these practices—lunches, gifts, and vacations masquerading as medical education seminars.

But one thing is certain—if a drug company sees a physician or group prescribing an inordinate percentage of their drugs, they should spend some time with that physician/group to make sure that the doctor fully understands what the drug is approved for? The drug companies have track these statistics, but something tells me many of them happily look the other way and their profits climb…

Here’s what we’re looking at, this week:

• AstraZeneca sets up a website devoted to its social networking efforts: Twitter, Facebook, YouTube and blogging
• Judge Keenan denies Merck’s motion to dismiss 24 Fosamax lawsuits because a jury may be able to conclude that the drug can cause jaw damage in under 3 years of use
• Increasing use of antipsychotics by pediatric patients
• The Pharma Marketing Blog reports on Big Pharma’s direct to consumer (DTC) advertising trends
• Informative post by Tom Lamb and the Drug Injury Watch on detecting adverse drug reactions and pulmonary embolism

Happy Monday!

Johnson & Johnson’s former sales representative (an employee tasked with selling products to doctors and hospitals) admitted in a New Jersey trial that he encouraged doctors to prescribe the drug for unapproved uses. Risperdal is an antipsychotic medication now approved by the FDA for treatment of schizophrenia, bipolar disorder and irritability in children with autism. It is specifically not indicated for treatment of patients with dementia-related psychosis. Previously, it had only been approved for treatment of schizophrenia.

Continue reading "More On Promoting Drugs for Unapproved Uses: Risperdal" »

Stryker and many of its executives have been indicted on charges of wire fraud, conspiracy to defraud the United States Food and Drug Administration, distribution of a misbranded device, and making false statements to the FDA. The charges were made by the U.S. Attorney’s Office for the District of Massachusetts.

Continue reading "Patterns Of Behavior: Stryker Encourages Off-Label Use" »

Most lawyers do not know how to pronounce qui tam litigation, much less what it is. After this Pfizer settlement, there is going to be a lot more interest.

(Fun etiological note: it is an abbreviation of the Latin phrase “qui tam pro domino rege quam pro si ipso in hac parte sequitur,” meaning “who sues on behalf of the King as well as for himself”).

Black’s Dictionary defines it as “an action brought by an informer, under a statute which establishes a penalty for the commission or omission of a certain act, and provides that the same shall be recoverable in a civil action, part of the penalty to go to any person who will bring such action and the remainder to the state or some other institution.” BLACK’S LAW DICTIONARY 1251 (6th ed. 1990).

The suit was brought by five whistleblowers (who will share $102 million of the settlement). The federal criminal probe and civil qui tam lawsuit alleged that Pfizer improperly marketed 13 drugs, including Viagra, Zoloft, Lipitor and Bextra. New York’s attorney general said that “Pfizer's corrupt practices went so far as sending physicians on exotic junkets as well as wining and dining health care professionals to persuade them to prescribe the company's drugs for patients in taxpayer-funded programs.” These practices including overpromoting the drugs for off-label and unapproved uses, which is oftentimes how the drug companies turn a good drug into a blockbuster drug (see the Seroquel example: Foster Care Children and Off-Label Drug Use; Video on Seroquel).

The $2.3 billion fine is notable for a couple of reasons. First, it is the largest such fine ever levied in a United States criminal case. Second, this is the fourth time in ten years that Pfizer has been found guilty of improperly marketing their drugs. For a drug company to keep taking these hits, in addition to the cost of defending lawsuits and paying settlements and verdicts, it must be making money hand over fist. Something like that should bankrupt a company; however for Pfizer and other members of Big Pharma, this is simply the cost of doing business. The real cost, however, is the untold numbers of people and families who have been devastated by bad drugs. And, guaranteed that Pfizer gets another fine in the next couple of years. Clearly these fines are not big enough to be a significant deterrent.

A nice article from the Washington Post, Probing Doctors’ Ties to Industry, evaluates the recent movement for transparency in the relationships between the pharmaceutical and medical device companies and doctors. We’ve all been to the doctor and have seen pens and pads of paper touting the latest miracle drug, but that is only the tip of the iceberg. The pharmaceutical and medical device industry pays for doctors to attend symposiums (sometimes, these are actually just really fancy vacations with an very small lecture component), dinners, and provides them with gifts of all kinds (from pens to much more valuable objects). It is estimated that Big Pharma spends over $20 billion per year pitching their wares to doctors.

What’s the impact? Like the rest of us, doctors are influenced by marketing (if they weren’t, these industries would not be spending the money). So, a doctor is more likely to prescribe Drug A over Drug B if he just got a nice lunch from Drug A’s sales representative. You’d like to think that all doctors will sit in their library and compare the attributes of the drugs, poring over the Physician’s Desk Reference. But, time is at a premium, and it’s often easier to listen to the sales reps (who are very rarely medically-trained). The question is whether patients receive the proper drug, or the properly marketed drug.

Of course, some donations are for the advancement of science. Doctors frequently receive free samples of drugs or devices for research studies they are performing—this helps pharmaceutical companies and medical device companies to determine the safety and efficacy of their products. Those should be reported as well, but they are less likely to influence a doctor’s prescribing habits.

The article includes statements from a number of doctors who admit to being influenced by these marketing strategies. Many states and the federal government are starting to examine whether doctors should be required to report money and gifts. Some even want to make information available on-line. That way, before your appointment you can see who is paying your doctor. And, you can ask you doctor whether other manufacturers’ drugs might not be better. It’s good to know whether the doctor is prescribing a drug, or whether it’s basically coming straight from industry.

I-Flow, the pain pump manufacturer with the largest market share, has a document on their website that caught my attention today. It is titled “What We Know About Chondrolysis Today.” Sounds like a very informative document, especially now (in 2009) that the company is faced with over 70 lawsuits alleging that they promoted their devices for use after shoulder surgery. Those lawsuits point to the fact that the pumps cause chondrolysis, or the irreplaceable loss of shoulder cartilage.

Scrolling through the document (last revised: 08/2007), though, it is clear that it is outdated and, at this point, blatantly untrue. One wonders if a company that just reported its first-quarter earnings increased 9% this year to a whopping $30.9 million dollars actually has someone in charge of the website, or if they are deliberately avoiding updating the document because the truth makes them look bad. Really bad. There’s been a host of medical literature since 2007 that continues to identify pain pumps as a primary cause of cartilage loss. But, perhaps that’s not worth mentioning to doctors and potential patients?

The issue is this—when corporations like drug companies and pharmaceutical manufacturers have a product to sell, they oftentimes go to the source—doctors. The only way for them to sell products is for doctors to know about them. In an ideal world, a doctor would hear about a product, research the product with the company and in the medical literature, ask colleagues about it, learn the risks, benefits and alternatives, and then decide whether the product is good for his/her patients.

In reality, what happens too often is that a sales rep for the corporation (frequently, with no medical training) will stop by the doctor’s office with lunch or “toys” (stress balls with the corporate logo, calendars with the corporate logo, pens with the corporate logo, stationary with the corporate logo, etc…), and try to convince the doctor to use the product. If I was a doctor, I’d feel a little obligated to return the favor if someone bought me lunch. I’m betting most doctors feel the need to reciprocate a little, by ordering some of the product for patients. However, the conversations doctors have with these sales reps often times are rushed (doctors are busy people); and one-side (and, did I mention that most sales reps don’t have medical training?).

Continue reading "Marketing by Pharmaceutical Companies and Medical Device Manufacturers" »