Showing posts with label Invega. Show all posts
Showing posts with label Invega. Show all posts

Tuesday, January 4, 2011

"Current Psychiatry": Now Binging on Industry Cash for CME

Current Psychiatry is a controlled circulation "throwaway" journal that comes to all psychiatrists free of charge. It's well-written, often useful, but editorially it has unfortunately become a mouthpiece for the promotional aims of its advertisers. Recently a few examples attracted my attention. 

1. This CME Supplement was packaged with the November 2010 issue. It is called “Effective Strategies for Patients With Complex Depression in Psychiatric Practice." It's supported by AstraZeneca, maker of Seroquel, and the supplement's three articles are well-masked ads for the use of Seroquel in treatment-resistant depression. There are lots of subtle promotional strategies here, but check out especially pages 10 and 11. Here, you find a paragraph on atypicals pretending that they all have the same side effects (the crucially hidden point is that Seroquel causes more weight gain and sedation than most other atypicals). On the next page, they are no longer shy about delineating side effects of specific drugs--each of which is a competitor of Seroquel. File under: "Sin of Omission".

2. Another promotional CME Supplement was published in October 2010, and is entitled  "Differential Diagnosis and Therapeutic Management of Schizoaffective Disorder." It is supported by Janssen, the maker of Invega, which was recently the first medication FDA approved for--you guessed it--schizoaffective disorder. I haven't read it yet, but this is a de facto  advertisement simply by virtue of the choice of topic. Janssen makes the only approved product for schizoaffective disorder, and in order to advertise it, they paid off Current Psychiatry to write a huge article about the disorder. It doesn't need to be "biased;" it just needs to be focused on a topic that is of inherent commercial benefit to the supporter. In my opinion, this violates the ACCME Standards of Commercial Support. 

3. Finally, in the current issue, there is this article (not a CME article) introducing Lurasidone (Latuda), the latest FDA approved antipsychotic. The authors have no disclosures, which is surprising, because the article is a glowing endorsement of Latuda. The relentlessly advertorial flavor begins with the opening tag-line ("A new atypical antipsychotic offers once-daily dosing and is well tolerated and considered weight neutral") and reaches a fever pitch at "Table 2", which claims that Latuda stimulates certain brain receptors (true) and therefore improves cognition (false).

I don't know what's going on with Current Psychiatry lately. Each of its CME supplements (and even some of its non-CME articles) are so commercially biased that it would take an army of Carlat clones to keep up with lodging formal complaints with ACCME. Anyone up to the task?  

Monday, August 11, 2008

Can CME be both Biased and Accurate? Of Course!

I enjoy reading Notes from RW, the blog of Robert W. Donnell, MD, a hospitalist in Arkansas who writes frequently for Medscape. While the two of us disagree robustly about the propriety of industry-funded CME, he argues his points rationally. In his current blog entry, he takes me to task for my recent comments slamming Medscape's CME offerings. His main point is that I haven't demonstrated that the industry-funded CME articles in Medscape are inaccurate. To quote Dr. Donnell:

Concerning the
Invega article, cited in his post on Medscape’s “CME corruption”, Carlat wrote "Has Janssen--I mean, Medscape--said anything inaccurate in this puff piece? No." That, we are to believe, is not important. In Carlat’s way of thinking the fact that the CME article is favorable to a product of the sponsor is damning enough without regard to the accuracy of the piece.

It's not that I believe accuracy is "not important." In fact, I believe accuracy is vitally important for CME. Unfortunately, however, accuracy does not protect CME articles from commercial bias.
The clearest argument is to compare drug advertisements with CME. The FDA regulates all industry advertisements for accuracy. Drug ads are required to make accurate claims about both the efficacy and the side effects of the sponsors' products. When ads are inaccurate, the drug companies can count on receiving nasty letters from the FDA such as this one, which scolded Pfizer last year for presenting inaccurate information about their antipsychotic Geodon.

Medscape's CME article on Invega is accurate, but is nonetheless promotional and commercially biased, because it focuses on the one clinical situation in which Invega offers an advantage over its competitors. It does not discuss advantages of other antipsychotics, nor does it discuss the many potential disadvantages of using Invega.

Likewise, Janssen produces advertisements for Invega which are accurate, but commercially biased. For example, here is a link to an advertisement for Invega .

It reads, in part:

"Powerful Efficacy for Many Patients Experiencing Symptoms of Schizophrenia

Including:

Patients who may benefit from a change in therapy

Powerful symptom control
In all 3 pivotal studies, INVEGA demonstrated significant improvements in PANSS total scores at all doses (3 mg, 6 mg, 9 mg, 12 mg ) versus placebo (P<0.001)."

There is nothing inaccurate here. Invega, like all FDA-approved antipsychotics, is efficacious for symptoms of schizophrenia. It does, indeed, demonstrate improvement in PANSS vs. placebo in all 3 pivotal studies. Nonetheless, this accurate medical information is commercially biased, because it is organized around the advantages of the sponsor's product and does not discuss the features of its competitors. For example, the ad does not mention that Invega performed poorly relative to Zyprexa in some of its FDA trials.

This advertisement could not possibly qualify as a CME article, because it breaks the two content rules of the ACCME's Standards for Commercial Support. Rule 5.1 states:
"The content or format of a CME activity or its related materials must promote improvements
or quality in healthcare and not a specific proprietary business interest of a commercial interest." By contrast, advertisements are crafted specifically to serve a company's business interest.

Rule 5.2 states:
"Presentations must give a balanced view of therapeutic options." Again, Janssen's drug ads are accurate but they do not give a balanced view of therapeutic options for schizophrenia. Nobody would expect such a balance--after all, these are ads.

However, the Janssen-funded CME article is supposed to give a balanced view, but it does not. Not only is the entire article organized around Invega's clinical advantages, but it ignores its two most conspicuous disadvantages: hyperprolactinemia and extrapyramidal symptoms (EPS). Instead, the article highlights weight gain and diabetes--side effects of great relevance to Invega's competitor Zyprexa.

(As an aside, Dr. Donnell defends another Medscape CME article which I criticized for an exceedingly gentle description of Zyprexa's side effects. That one, of course, was sponsored by Zyprexa's manufacturer, Eli Lilly. In Janssen's Invega article, by contrast, Zyprexa's side effects are described with vigor: The recent CATIE [study] highlighted the increased risk and incidence of metabolic consequences in patients with schizophrenia, which was associated with the use of a variety of atypical antipsychotic medications as well as specific modifiable risk factors.[10] In particular, the study noted the effects of specific antipsychotic medications on weight gain/obesity and metabolic endpoints. For example, the superior efficacy of olanzapine was tempered by its propensity to cause metabolic problems and greater weight gain than the other treatments, with an average increase of 2 pounds per month, as well as an increased risk for other metabolic effects vs the other agents.[17] In fact, the American Diabetes Association (ADA), American Psychiatric Association (APA), American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity together issued a consensus statement highlighting the relationship between specific atypical antipsychotics and the development of weight gain, diabetes, and hyperlipidemia.)

The bottom line is that accuracy is a minimum requirement of both CME articles and drug ads. In my experience, it is rare for industry-sponsored CME to be blatantly inaccurate. Instead, accurate statements are strung together strategically in order to encourage the use of the sponsor's product--and to discourage use of the competitor's.