The CATIE study has set the cat amongst the pigeons in the antipsychotic market. Older cheaper medicines are just as good as the newer ones!
Will this now lead to health policy changes?
Look at this insight from "Oligopoly Watch" in 2004. (Insiders' comments in italics):
Big Pharma oligopolies are most effective when they not only sit at the table, but when they help legislators in the hard task of writing guidelines and regulations. That's well illustrated in a New York Times article called "Making Drugs, Shaping the Rules" by Melody Peterson (2/1/2004).
Peterson shows that merely marketing drugs is not enough; better yet to "persuade" state health boards to mandate them for patients, making it hard for doctors to prescribe an alternative, even when the alternative is cheaper and equally, or more, effective.
Ten major drug companies, for example, used such tactics to make sure that state mental hospitals and Medicaid adopted their drugs in preference to others, Notable among these were new antipsychotic drugs made by Johnson & Johnson (Risperdal) in preference to generic drugs whose patents have run out. These tactics were recently brought to light by a Pennsylvania lawsuit.
Ten drug companies chipped in to underwrite the initial effort by Texas officials to develop the guidelines. Then, to spread the word, Johnson & Johnson, Pfizer and possibly other companies paid for meetings around the country at which officials from various states were urged to follow the example of Texas.
The companies apparently flew various state commissioners to New Orleans (pre-flood!), wined and dined them, and paid others generous fees for speaking at company-sponsored seminars.
It's still controversial, according to the article, whether the new drugs are that much better than the older, cheaper ones (pre-CATIE!). But one thing is certain: there's a large amount of money in the market for antipsychotic drugs, around $6.5 billion last year.
The Texas guidelines set out the acceptable pharmacology not only for psychosis, but also for schizophrenia, depression, attention deficit disorder, and bipolar disorder. The drug companies involved reply that they are only trying to improve treatments based on the extensive research they have done. They see their task as educational only. But there's a pretty thin line here between education and salesmanship, especially when state and federal governments can't do the extensive testing required, and when the drug companies commission their own tests for efficacy. And there's really no counter-weight, either from neutral researchers or less-wealthy generic competitors.
Influencing government decisions in any health field is becoming more and more critical for drug companies' financial health. As more and more, doctors and hospitals are placed in the position of simply diagnosing a disease and prescribing an "acceptable" drug, the more drug companies will use their money and influence to make sure they are one of the acceptable drugs.
The "persuadability" of underfunded state health commissions makes them easy prey for the drug companies, and when they act in concert, as they did in Texas, they can safely divvy up the pie and jointly unseat generic drugs.
http://www.oligopolywatch.com/2004/02/03.html
Post CATIE, let's see if health policy is evidence driven!
6 comments:
Is it Janssen or J&J who market Risperdal?
Janssen is a wholly owned subsidieary of J&J
The catie trial dosent seem to address the rates of TD associated with the older conventional atypicals. If you ever saw a patient that was suffering from TD caused by the older antipsychotic you would not want yourself or a family member on them. The trial itself also used a subtherapeutic dose of the atypicals and higher dose of the conventionals. The side effects (metabolic effects) of atypicals can be reduced by lowering the dose or switching the medication.
Your point re TD is well made. I'm sure further follow up data from CATIE patients will help answer this issue.
Regarding dosages used. Insider wonders if there might have been an attempt to load the dice in favour of atypicals. All antipsychotics have similar response rates (clozapine excepted). Atypicals always "won" on a better SE profile. What better way to demonstrate this than use modest doses ( but look at the dose of olanzapine!).
That said, the question must still be asked: Are atypicals worth a 10x price premium, based on the CATIE data?
Risperidone [RISPERDAL] is clearly and irrefutable demonstrated, in clinical trials submitted to the FDA or New Drug Application, to provide symptom relief in all five symptom clusters of schizophrenia. These five clusters were hallucinations/delusions, flatt affect/social withdrawal [no results from the conventional antipsychotics in this category], hostility/aggression, thought disorders, and anxiety/depression. The conventional antipsychotics only affect dopamine-related symptoms, which do not include anxiety/depression or flat affect/social withdrawal. Ever see a patient on Thorazine? Blank facial expression? little or no social interaction? Drooling? Tremors? Tongue moving around? Perphenazine [Trilafon], the conventional used in the CATIE trial, is like Thorazine only a bit more potent. Thorazine is a low-potency AP and perphenazine is a mid-potency AP. NONE OF THE CONVENTIONALS HAVE ANY ACTIVITY ON SEROTOIN RECEPTORS, and they saturate dopamine receptors greater than 60-70%, which causes secondary parkinsonism. This trial may set psychopharmacology back 50 years if the Texas algorithm is changed.
AND IT ALL COMES DOWN TO THE DOLLAR. Why should we spend money on the lunatics anyhow?
The New England Journal of Medicine is a peer review journal. Why did they publish this study despite the obvious misleading limitations? Was there pressure or a payoff to publish it just prior to the new Medicare Part D formulary decisions?
Where there's smoke, there's fire.
The only thing this study really proves is...schizophrenic patients don't take their medications, although this study only looks at oral meds, not injections. Many schizophrenics don't comply with meds because of side effects, especially secondary parkinsonism, drooling,and so forth.
Lilly is handing this study out this week. That organization is shooting itself in the foot, because not only do the majority of psychs know that the Lilly drug, Zuprexa, was dose much higher than the other atypicals, they also know Zyprexa is outrageously expensive.
This whole thing is a bunch of hooey and is politically and economically motivated. WHAT ABOUT THE PATIENTS?????!!!!!
It's the Marie Antoinette response: Let them drool.
Not only is there a dosing question but there is also a little selection bias going on. Patients with TD were not allowed to be randomized into the conventional drug group. Patients with TD could arguably also be the more chronic patients.
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