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Category: Drug Companies

Device Company Payouts Mostly Royalties

Regarding, “Device Companies Post How Much They Paid Orthopedic Surgeons” today’s Health Blog revealed that the millions of dollars paid to orthopedic surgeons are mostly in the form of royalty payments (74% of total payouts), at least, for Zimmer:

Zimmer’s CFO broke down his company’s payments during a talk today at a Piper Jaffray health-care conference. According to a slide in the CFO’s presentation, 74% of the outlays were for royalties, 11% for consulting, 10% for “research & clinical” work, 4% for “education & other” and 1% for travel and expenses, Dow Jones reports.

Source: Health Blog

If the docs did indeed own the intellectual property that device companies are licensing to use, then royalty payments make perfect sense. Still, from the blog comments, some remain skeptical of the rationale behind such high payouts.

Bullied by Pharma Co? Fax Senator Grassley

Doctors can now fax Senator Chuck Grassley at 202-228-2131 to report on drug companies that the doctors perceive to “push too far” and are being “bullied” by drug companies. Doctors can remain anonymous and send information by mail or fax. This effort came at the heels of the Avandia investigation earlier this year, where manufacturer GlaxoSmithKline was accused of pressuring Avandia critic John Buse to change his story about Avandia risks. The company said it wanted Buse to correct factual errors Buse made about the drug, while Buse said the company used intimidation tactics.

I wonder if Grassley knows what floodgate he’s opening up by creating a service that allows anonymous tips on what is very much a subjective behavior (i.e. what one perceives to be intimidation or bullying or “hardball tactics”), and whether the senator is actually equipped to conduct investigations into every complaint filed. Source: WSJ Blog.

RLS Anti-Ad Video is as Bad as Drug Company DTC

A Consumer Reports video of the Requip DTC ad (another drug used to treat RLS, manufactured by GlaxoSmithKline) has been published.

cr_rls.jpg

Let me first state that I’ve seen the Requip ad in question many times when I watch TV, and each time I have the same negative reaction to the ad. This means I have some negative personal bias against the ad itself and the way the company is marketing this to consumers en masse. That said, I decided not to go to the drug company’s “defense video”, which may predispose me to additional bias, and I present my analysis of the anti-ad video by Consumer Reports.

A young woman is seen in the ad to go through the drug company’s ads line by line. She comments on the statements made by the drug company ad. She doesn’t really “analyze” the statements as much as comment – and there’s a big difference between an unbiased analysis and editorial/opinion/commentary (example, “Ooh! Sounds Serious” and “Sounds like the side effects are worse than the condition!” and lots of sentences beginning with exclamations like “Ahh!”).

Given that she doesn’t suffer from RLS, her commentary is biased and nothing more than an opinion. I’d like to hear from a member of that 3% population who DOES suffer from RLS and hear whether he or she agrees that the side effects are worse than the condition.

She does mention selectively the 2 people whose compulsive gambling caused them to lose over $100K each as a result of the side effect of Requip. $100K is a lot of money, no question about it. But 2 people – that’s a small “sample size” and in the medical community and the lines of “evidence based medicine” would constitute “case reports” – the weakest type of “evidence” and would be considered anecdotal more than actual evidence. Other types of side effects like nausea and headache probably had more reports, but $100K is more sensational. It seems like the Consumer Reports anti-ad video is using some of the techniques that they’re criticizing the drug company for doing – sensationalizing what is actually a very small percentage of occurrence.

Does the Consumer Report ad make valid points? Sure. Is the anti-ad “ad” video a spin? Yes. A gloating male voice comes at the end to say “This ad is sponsored by – NO ONE!” as a vehicle to suggest that everything it claims in the its video must be unbiased and therefore, credible. However, the video itself contains very little evidence, lots of editorial claims, and does not address symptoms of the actual condition of RLS so that consumers can be “better educated” if Consumer Reports does not believe the GSK’s Requip ad is doing a good job.

This reminds me a bit of smear campaigning that politicians use against each other. What I’d like to see is a curbing of anti-anything from activist groups. For once, I’d like to see someone spend the dollars coming up with the better solution to educating consumers credibly and objectively and setting a positive example for others to follow.

Source: John Mack who has been following the restless leg syndrome (RLS) “phenomenon”.

Stronger Warnings on Heart Failure Risk for Avandia and Actos Type Drugs

Update: “FDA Adds Boxed Warning for Heart Attacks to Anti-Diabetes Drug Avandia. Agency says drug to remain on market, while safety assessment continues”

The US Food and Drug Administration (FDA) is requiring some Type 2 diabetes drugs to change its product label to include a heart failure risk warning. This “boxed” warning emphasizes that the class of thiazolidinedione drugs may cause or worsen heart failure in certain patients. Drugs in this class included Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride). These drugs are currently approved in the US for treating type 2 diabetes in combination with diet and exercise. Postmarketing surveillance of these drugs is required by the FDA as a condition of approving these drugs and making them available on market. Postmarketing reports have shown cases of warning signs of heart failure: significant weight gain and edema (water retention and accumulation in organs). Source: FDA.

Is Restless Leg Syndrome Bullshit?

rls.jpg This past week’s Sunday “Post Secrets” had a postcard that said, “I don’t care what you said, I still think RLS IS BULLSHIT” sent on a postcard made from a Mirapex (prescription drug for restless leg syndrome or RLS) ad. This generated a flurry of comments in the Post Secret discussion forum, where people talked about experiencing RLS or witnessing a loved one who suffers from RLS.

Hence is the dilemma for direct to consumer advertising by drug companies.

On the one hand, there is a grain of truth in the ethics of drug companies to mass market to consumers a condition that affects a very small percentage of the population. One wonders why a drug company would choose huge media outlets like magazines and television to talk about a drug for a condition a very small percentage of the population suffers from. Would this create false diagnoses? Foster hypochondrias in those who do not actually suffer from the condition, but have become suggestive to think they do based on what little they know about the condition in a 30 second TV commercial?

On the other hand, those who do suffer from the rare condition can feel a sense of relief that they were not alone or “crazy”, that the condition is indeed a medical one requiring medical intervention, and that there is medical help. Even if drug companies try to educate doctors on a rare condition, doctors may not always have time to do a detailed workup and uncover the condition unless the patient proactively offers this information.

As cynical as I am of DTC advertising by drug companies, I still choose having the information out there than not having the information available at all.

Device Companies Post How Much They Paid Orthopedic Surgeons

Major device companies that have been investigated by the government and entered into settlement were required to post how much they paid to orthopedic surgeons for consulting services. Wall Street Journal’s Health Blog posted the links to the company websites disclosing payment sums:

Stryker Consulting Payments (check out Richard Harrison Rothman in Philly)

J&J’s DePuy must have deep pockets because several orthos earned almost 3 million dollars in consulting fees (PDF file)

Biomet (check out Adolph V. Lombardi)

Smith & Nephew (check out Richard Laskin)

Many of these surgeons earned tens of thousands of dollars in consulting fees, but some received hundreds of thousands of dollars, and a few earned over a million (there was one ortho who earned almost 3 million dollars in consulting fees). WSJ blogged about the investigation on September 2007.

DTC Advertising: Doctors Still Hate It But Industry Continues to Use It

New England Journal of Medicine recently published a paper looking at “A Decade of Direct-to-Consumer Advertising of Prescription Drugs”, where the study authors looked at pharma company spending on DTC advertising and physician promotion in the past 10 years (1996-2006). The authors also looked at the FDA regulation of drug advertising during this time. While drug companies’ promotional spending went from $11.4 billion (1996) to $29.9 billion (2005) where DTC ad expenditures grew by 330%, this made up “only” 14% of the almost $30 billion in drug companies’ promotional spend.

On the other hand, FDA’s warning letters fell from 142 in 1997 to 21 in 2006. The authors speculate this could either be due to drug companies becoming better behaved and playing by the rules, or due to the FDA being too short-staffed to follow up on all violative behaviors. I’m skeptical whether this reduction in FDA warning letters is mostly due to staff shortage at the FDA given how steep this drop was (142 to 21 per year); while I’d like to think that drug companies are finally being “scared straight” by the various scandals and class action lawsuits in the recent years, I’m also not so much of a pollyanna to believe that no violative behaviors are being produced. Still, it looks like DTC is here to stay, as much as many doctors loathe it with a passion of a thousand suns. (more…)

Backgrounder on Diabetes Drug Avandia Controversy

I’ve been tracking the various developments and commentaries on the controversy surrounding diabetes drug Avandia (rosiglitazone, manufactured by GlaxoSmithKline). For those of you interested in background information and commentaries relating to the use of Avandia and increased risk for heart disease, as well as the affordability of chronic medications like diabetes drugs, I’ve compiled a short reading list including abstracts to the original research articles to help you get started. Please read my conflict of interest disclosure at the end of this article. (more…)

Ladies, Let’s Zap Your Periods

First it’s zapping bad memories (see previous article) and now – monthly periods for women. Gents, you may think of this post as “for ladies only” but keep reading: this has general biological implications for either gender.

Did you know that a small percentage – 8% according to this NYT report – of women have such painful periods that the condition qualifies as a disorder?

Enter Wyeth – a company manufacturing a pill that will zap debilitating periods – “forever”. (more…)

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