Off-Label Liability from Media Monitoring

Pharmablogger has a very interesting posting about the potential implications media monitoring that captures information on off-label promotion (see A Question For My New Friends).

I don’t know about Pharmablogger’s company, but I know many pharma companies have policies of not receiving news stories that might hint at off-label usage or adverse events. Some companies believe that even receiving news accounts mean that they had liability. As a way around this, many pharma companies utilize PR agencies to do the media monitoring for them. Normal stories get sent through e-mail, but if something sensitive comes up, it is transmitted by fax or the PR agency would call them.

Pharmablogger states: “We're very aware that this (off-label) is taking place, even if we're not instigating it, and we're not doing anything to stop it. How would you rule?”

I’m not a legal expert, but I don’t believe that receiving media monitoring from social sites would make the company legally responsible. However, moral responsibility is another matter. And what some scum law firm is willing to get an idiot jury to believe in a civil lawsuit is yet another matter.

But even more importantly, what is legal and acceptable today may not be in the future. And when it comes to pharmaceutical companies, the public seems more willing to believe lies than the truth. So while you may still be legally in the right, you may be opening yourself up to civil litigation.

Retail Clinics Stumble

Wal-Mart’s retail clinic operator, CheckUps, is shutting 23 clinics in four states because it is unable to pay the bills. Wal-Mart seems to have expanded the clinic program too quickly and has been unable to drive the traffic necessary to make the clinics profitable. (Source: New York Times)

That sound you hear is the AMA dancing a little jig. The AMA and its allies have been on a state-by-state jihad to block retail clinics at all costs. I’ve been pretty critical of the AMA for being anti-patient, anti-consumer and only in the business of protecting wealthy doctors. However, my own recent experience with a retail clinic may prove illuminating for others.

In a hurry, I popped into a retail clinic for evaluation of a bloodshot eye. At my age, everything out of the ordinary is cause for concern. I thought it might be pink eye and wanted a second opinion. This is the kind of illness that is perfect for retail clinics: common, benign and not time consuming. At thought I’d be in and out in 20 minutes. An hour later, I still had not been able to see the Nurse Practitioner. I called my family physicians’ office and was told pop in. My regular doctor (who I normally have to wait about 25 minutes to see) was able to get me in and out in just under 20 minutes. The lesson for me was clear: don’t believe the hype. Retail clinics have their place, but aren’t perfect and aren’t the panacea for all of the healthcare delivery woes.

FDA Rejects OTC Mevacor

The U.S. FDA has issued a not-approvable letter to Merck for an OTC version of the statin Mevacor. Previously, the FDA had issued an approvable letter, but has been “reviewing” the application since 1999.

The agency wants additional safety and enhanced product labeling before approving the application. In December 2007, the independent FDA advisory committee voted 10-2 to reject OTC Mevacor. In light of the recent brouhaha over statins and Vytorin, the FDA decision was certainly expected.

Back in the 1990’s, “harmonization” was all the rage. Drug standards were going to converge between the U.S. and the EU, enabling cheaper drug approvals for companies and better data for governments. A secondary goal was to also eliminate embarrassing disparities in drug access for governments with socialized medicine.

However, harmonization hasn’t materialized. As evidence, back in May 2004, the UK approved Zocor (simvastatin) for OTC use. The move of statins to OTC was beneficial to the UK budget where the NHS has been able to shift some of the cost burden over to consumers.

But status quo in the United States.

Stallone Advocates OTC Growth Hormones

Sylvester Stallone is a huge fan of human growth hormone (HGH). According to the AP, he used it to bulk up for the latest Rambo movie.

But here’s were it gets weird. Stallone claims HGH is “nothing” and claims it will over the counter within 10 years. No word on when the FDA will consider moving HGH OTC, but Barry Bonds and whole bus full of MLB players can’t wait.

FDA Plans Foreign Inspectors (sort of)

The FDA is going to station food and drug inspectors overseas to stop the flow of dangerous products into the United States. Or at least that’s the plan.

The FDA hasn’t exactly been serious about the problems of counterfeit drugs from China and South America over the last few years. The agency has relied on the heritage of American isolationism from Monroe to Wilson to get us by (and giving new meaning to “water barrier”).

Stationing inspectors overseas is a nice start, but I can’t help but think this is nothing more than a symbolic public relations gesture. Call me jaded, but it looks to be an election year political solution, rather than real overhaul in the way the agency handles imports.

The plan will help, and certainly can’t hurt. But given the explosive problem of counterfeits, I don’t see this announcement having a considerable impact.

Docs Bad at Math; Pharma to Blame

A study shows that physicians have difficulty in titrating the right dose of drugs. This study reminds me of the situation with Dennis Quaid’s kids.

Here’s a summary from Fierce Healthcare:

A new study underscores that simple math errors by physicians can prove deadly when it comes to medications. In the study, which appeared in the Annals of Internal Medicine, researchers asked physician volunteers to give a hypothetical 5-year-old suffering from an allergic reaction 0.12 milligrams dose of epinephrine. Half the 28 volunteer doctors were given a bottle labeled "1 milligram in a 1 milliliter solution," while the others got bottles labeled "1 milliliter of a 1:1000 solution," both of which amount to the same thing. While 11 of the first 14 doctors got the math right, only 2 in the second group did, and one doctor in the second group administered what would have been eight times the correct amount. The study underscores that errors in converting from milligrams per milliliter could lead to errors by factors of 10, which can be very dangerous, researchers noted.

Let’s look at this another way, at best, 20% of doctors got the dosing wrong—1 in 5 physicians can’t properly dose the drug.

Obviously, pharmaceutical companies are to blame (hence Quaid’s lawsuit against Baxter). I propose that all pharmaceutical companies should be required by federal law to dispense a mathematical device with their medications. Drug companies can choose between a slide rule, abacus or calculator and attach it to every bottle or every vial they sell.

Roche’s War of Attrition

Roche finally won its war of attrition for Ventana Medical Systems. The bid process was begining to resemble gestation, but Roche was finally able to get the deal done for $3.4 billion, or about $89.50 per share.

Roche is after PATHWAY, Ventana’s Her-2/neu monoclonal antibody test. PATHWAY will show which patients are likely to receive the greatest benefit from Roche’s breast cancer therapy Herceptin.

The initial offer from Roche last summer was about 20% below the current offer and Ventana announced that it would reject Roche’s move. The tug-of-war that ensued was both entertaining and distracting, but the completion of the deal will enhance Roche’s efforts in personalized medicine.

Alli Gets Creative

The folks at GSK got creative during the holidays. Honing in on their target demographic, they set up booths at malls targeting consumers who have over-indulged in turkey and sweets (pictured below). I snapped a quick picture on the camera phone (sorry for the poor photo quality).

It was a good, catchy idea and a splashy marketing tactic. However, sales of Alli haven’t exactly taken off.

Humira Gets Psoriasis Nod

Late Friday, Abbott’s Humira got the nod for moderate to severe psoriasis. It’s the fifth indication for Humira. Humira has been one of the gems in Abbott’s portfolio over the last year.

Humira is joining other drugs already approved for psoriasis – Enbrel (also for moderate to severe psoriasis) and Remicade (for severe psoriasis).

Source: Abbott press release.

Biogen IDEC Scores with Tysabri Win

The FDA has given the Biogen IDEC/Elan co-market Tysabri the greenlight for Crohn’s disease.

The FDA jerked Tysabri off the market in 2004 because of a handful cases of PML in patients with MS who were treated with the drug. In 2006, the FDA allowed Tysabri back on the market under severely stringent risk management programs.

In many ways, Tysabri’s path should serve as an example to other companies who have had products withdrawn or had FDA approvable letters.

Wellpoint To Launch Doc Rating System

To those who bet the Wellpoint-Zagat partnership to rate doctors wouldn’t get off the ground, its time to face the music. Wellpoint has announced it will launch the system to 35,000 members in the coming weeks. (For background, see Doctor Ratings Business Gets Boost and Ranking Your Doctor)

Physicians have been lukewarm to downright hostile about the idea of patients providing them feedback on their performance. Inevitably, some physician will probably challenge Wellpoint on the system.

I continue to believe a system in which patients can get independent information on their physicians will enhance the patient experience and lead to more effective care.

Thimerosal-Autism Link Disproven…Again

A new study in the Archives of General Psychiatry by researchers in California disproves the causal relationship between the vaccine additive thimerosal and autism. Since the additive has been removed from childhood immunizations, the rates of autism have not declined. In fact, autism rates continue to increase.

This study proves what I wrote back in June 2007 in Thimerosal Goes on Trial that:

Since the government asked manufacturers to reduce/eliminate thimerosal in 1999, we would expect to see significant reductions in autism cases in children born after 1999. We haven’t. In fact, autism incidence continues to increase (particularly in this age group). Autism groups try to sidestep this issue whenever it comes up, but they will have to explain this for people to take their claims seriously.

This is no true scientific evidence linking thimerosal to autism.

Hopefully, we can finally stop wasting resources on this ridiculous myth and start focusing resources on finding the real cause of autism – be it genetic or environmental.

Dingell Goes After Lipitor Spokesman

John Dingell (D-MI), chair of the House Committee on Energy and Commerce is taking aim at Robert Jarvik for his role as Lipitor spokesman.

Evidently, the issue is that since Jarvik only graduated medical school, but has not actually practiced medicine, so he is unqualified to dispense medical advice. Dingell only seems to be going after Jarvik and has not challenged other celebrities (i.e., Tom Cruise) on their legitimacy to dispense medical advice.

The Wall Street Journal Health Blog notes that Robert Bazell, the NBC science correspondent, first pointed out the perceived inadequacies of Jarvik’s academic pedigree. Bazell has reportedly noted that Jarvik is not a physician (neither is Bazell). Bazell has also reportedly noted that Jarvik went to study in Italy (Bazell went to study in England). The good news is that for between $10,001 and $20,000, you can get Robert Bazell to lend his name to your company's initiative (surely Pfizer is paying a lot more for Jarvik). Pfizer could save a truckload of money if they switched from Jarvik to Bazell (NBC might even give discounted air time since Bazell is an NBC personality).

It is unclear how John Dingell, who never graduated from medical school, possesses the strong clinical background to evaluate the subtleties of treating hyperlipidemia. Dingell should stick to what he knows best – big, gas-guzzling automobiles. The Big 3 Detroit Auto Makers give him (and his wife) millions in campaign contributions and other compensation to ensure that real, substantive environmental legislation doesn’t get passed in Congress (although Dingell does a magnificent job throwing table scraps at the environmental lobby to pacify them).

Personally, I find the Jarvik Lipitor ads to be a little annoying. But I’d take medical advice from Jarvik before I’d accept advice from John Dingell (or Tom Cruise).

Back on the Air

Pharm Aid is back on the air.

The Holidays are over. Unfortunately, not enough ice out at the lake for ice fishing this winter (the effects of global warming).