Tag Archives: pharmaceutical advertising

Everyone reacts to Avandia roller coaster

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

First, the background: Avandia, also known as rosiglitazone, is an anti-diabetes drug that helps patients control their blood sugar. It made billions of dollars for GlaxoSmithKline until it became associated with higher risks for cardiovascular issues. On Sept. 23, the FDA and European regulators issued their verdicts on the drug. In America, it will still be available, though with much stronger restrictions than before. In the European Union, regulators are looking to stop sales entirely and steer patients toward alternatives.

If you’re looking for the official lines and basic news, start with CardioBrief, where Larry Husten recapped a few of the highlights and then provided each agency’s press release, as well as the official take of Avandia maker GlaxoSmithKline.

Then, it’s time for the reactions. On the NPR health blog, Richard Knox examined the dueling story lines that have emerged since yesterday’s announcements. This larger framework makes all subsequent reactions a little easier to contextualize.

Speaking of other reactions, The Hill‘s health blogger, Julian Pecquet, rounded up the thoughts of some Washington heavy hitters involved in the Avandia debate, from the omnipresent Sen. Max Baucus to the consumer group Public Citizen. Another key player, cardiologist and Avandia critic Steven Nissen, spoke to The Wall Street Journal‘s Alicia Mundy.

In terms of the big regulatory picture, Avandia is the 30th drug which has been restricted under the FDA’s risk evaluation and mitigation strategy provisions since they began in 2007. Merril Goozner says that the FDA has created a new class of drugs. “They are not exactly safe, but not so dangerous that we would deny them to physicians or patients who really want to have them,” he wrote. Five years ago, he said, Avandia would have been pulled from the market. Now, it just gets restricted. It remains to be see how effective those restrictions really are.

Finally, Pharmalot’s Ed Silverman brings us the thoughts of cardiologist and Yale professor Harlan Krumholz, who you might remember from his recent star turn in Forbes. His take emphasized a principle well-known to health journalists: Marketing matters, and often it matters even more than regulation does.

“The company has announced it will no longer promote the drug,” Krumholz wrote, “and the practical result in Europe and the US may be a lot more similar than the decisions at first appear. Usage will stop in Europe and new use should virtually stop here.”

That said, Krumholz raises some interesting questions, any one of which could form the basis of a follow-up story or two. I’ll paraphrase:

  • A long series of fortunate coincidences lined up to produce the evidence that led to Avandia’s delayed near-demise, which begs the question: Why are we relying on luck when it comes to spotting danger in major pharmaceutical products?
  • “Why does the FDA believe that the barriers to prescription in new users should be stronger than those for current users? There are no studies that indicate that the excess risk dissipates over time.”
  • Will the FDA really be able to effectively implement the regulations and guide physician/patient behavior, especially when it comes to a blockbuster such as Avandia?
  • Have we done anything to prevent the next Avandia? How do we even go about doing that?

Update: The European Association for the Study of Diabetes weighs in

Ethics professor takes on clinical trials, marketing

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

Writing for Mother Jones, University of Minnesota medical ethics professor Carl Elliott digs into the Dan Markingson story first covered by St. Paul Pioneer Press reporters Jeremy Olson and Paul Tosto. Elliott works at the same institution as the physicians who who administered a Seroquel trial that the 26-year-old was enrolled in when he committed suicide.

Given his teaching field and institution, it’s not surprising that Elliot couldn’t stay away from the Markingson story.

…the more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported. The danger lies not just in the particular circumstances that led to Dan’s death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them.

Elliot goes after the idea that the new wave of anti-psychotics was any safer than its predecessors, then explains the clinical trial manipulations he says were used to claim they were.

From there, Elliot takes on the use of clinical trials for marketing purposes. Clinical trials can be dangerous, which is theoretically acceptable if they have the potential to advance medical care. But what if patients are just being exposed to those dangers in an effort to sell more drugs?

Pharma starts disclosing sample numbers

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

The health reform law will require drug makers to disclose the amounts of free samples they distribute, a requirement which promises to shed light on a practice whose scope could previously only be estimated. The Wall Street Journal‘s Jared Favole has found some preliminary disclosures; the resulting numbers can be found in the graph below. The numbers should only be treated as the roughest of estimates, as some companies disclosed the market value of the drugs while others gave wholesale numbers. Likewise, some measured the number of samples based on the number of doses, while others counted larger units. samples1 Samples, Favole writes, are a key weapon in pharma’s war against generics as they can be a gateway to brand-name medicines.

A 2008 study in the Southern Medical Journal found that doctors in a clinic were more than three times more likely to prescribe generic medications to uninsured patients after drug samples were removed from that clinic. “Free drug samples may lead to higher costs for uninsured patients by encouraging physicians to write prescriptions for brand-name drugs only,” the study said.

A PDF of that study can be found here.

Feds take aim at off-label marketing

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

The Wall Street Journal‘s Jeanne Whalen writes that a recent string of charges against drug companies, including heavyweights like Pfizer, Eli Lilly, AstraZeneca, Johnson & Johnson and Novartis, shows that a decade of aggressive prosecution hasn’t deterred them from some shady marketing practices. [Article require subscriber access]

Whalen says the promotion of off-label prescriptions is still at the core of the most common offenses, and that, according to says Patrick Burns, director of communications at Taxpayers Against Fraud, problems are most likely to crop up “when drug companies are promoting therapies that are similar to others on the market.”

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Photo by somegeekintn via Flickr.

Whalen reports that the Justice Department, which often relies on corporate whistleblowers to spark investigations in this arena, has made such cases a priority.

“Combating health care fraud is a top priority of the Department of Justice,” said Tony West, Assistant Attorney General of the Justice Department’s Civil Division

Drug companies have apparently taken notice. GlaxoSmithKline recently started “capping its annual payments to U.S. doctors at $150,000 and publishing the figures” while AstraZeneca’s CEO said the crackdown had made pharmaceutical companies “more sensitive than we’ve ever been” when it comes to preventing illegal drug promotion. Whalen writes that these steps may not be enough.

But Shelley Slade, a former Justice Department lawyer who now represents corporate whistleblowers through the firm Vogel, Slade & Goldstein LLP, in Washington, D.C., said large criminal monetary penalties and civil settlements don’t appear to deter companies sufficiently. “It’s not going to stop until the government puts some of these executives in jail,” she said. “Many of these companies view the fines as a small fraction of what they have gained through illegal schemes, and just a cost of doing business.”

How the pharma research ‘sausage’ is made

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

Reporting on Health’s William Heisel has posted the latest installment in his series highlighting the spiciest entries in the Drug Industry Document Archive, this time focusing on the cold mechanics of the drug industry’s research paper assembly line, and its intimate relationship with pharmaceutical marketing.

pills
Photo by somegeekintn via Flickr.

Again, Heisel focuses on the deposition of Wyeth ghostwriter Karen Mittleman and related documents and memorandums. He lists the names of some key ghostwriters to look out for, then details a number of specific cases when production and marketing concerns clearly outweighed science, at least as far as the pharmaceutical manufacturers were concerned.

University’s ties to testosterone therapy questioned

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

When it comes to sketchy medicine, female hormone therapies have company. According to reporter John Fauber of the Milwaukee Journal Sentinel, the fast-growing field of testosterone therapy is “based largely on iffy science, promotion, manipulation and conflicts of interest,” much of which originated at the University of Wisconsin.
andro
Fauber found the questionable ties during an investigation of company-funded UW courses that count as continuing education credits for local physicians. Despite the lack of rigorous research into testosterone therapy’s effects, UW courses (with material created in part by drug company contractors and involving studies authored by doctors with drug company ties) and other like them have helped push testosterone therapies, especially Solvay’s AndroGel, to millions of American males. In his extensively researched piece, Fauber takes on not only local conflicts of interest, but also the male hormone replacement and anti-aging movement.