Your 10 Year Antipsychotics Money-Making Forecast

von freakoutcrazy

by Alt_Mentalities

To paraphrase a recently released pharmaceutical industry investment report, your 10 year antipsychotics money-making forecast is as follows: partially cloudy skies in 2011 will give way to full sun by 2021.

In other words, antipsychotic patent expirations will be tempered by the emergence of new BLOCKBUSTER antipsychotic drugs, and investors can expect to make a PILE of money by 2021.

The 208 page report, produced by the market research firm of Decision Resources, goes on to make the following predictions:

  • sales for schizophrenia therapies will drop from $7.4 billion in 2011 to $6.5 billion in 2014 in the developed world, as people switch to newly available generics
  • the launch of new drug therapies will increase profits thereafter to $8 billion by 2021
  • these will include glutamine reuptake inhibitors, which will be marketed as “adjuncts” to antipsychotics which address the so-called “negative” symptoms of schizophrenia (apathy, catatonia, low self-esteem, etc.) and are expected to achieve blockbuster status
  • also included are injectable atypical antipsychotics, sales of which will more than double from $1.4 billion in 2011 to $3 billion in 2021

Well, I’d like to try my hand at a little forecasting myself.  In order for those 8 billion buckaroos (or more!) to find their way into the right pockets, I expect we’ll see:

  • Heavy recruitment of key “opinion leaders” by pharma, supposedly unbiased researchers and clinicians whose endorsements for pharma products are bought and paid for by way of massive bribes (er, I mean funding) for “research” with predetermined outcomes, specifically designed to promote pharma’s commercial interests.
  • A whirlwind of publications promoting the use of long-acting antipsychotic injections, glutamine reuptake inhibitors, the need for polypharmacy in the treatment of schizophrenia, or any combination therein
  • A concerted effort at a.) expanding the members of the population that could be construed as suffering from so-called “schizophrenia” b.) expanding the list of other uses for these drugs, including any and all known or as-yet-unknown “diseases” and “conditions” (even if they must be created out of thin air) and c.) further ingraining the idea that conditions which require the use of these drugs are serious, chronic, and require probably lifelong use of patented medications – no generics, please!
  • If required by the myth-building machine that will lay the foundation for the forthcoming BLOCKBUSTER drugs, paradigm shifts away from currently accepted ideas (perhaps the general public’s abhorrence of forcibly injected, mind-altering drugs?  Or a sly admittance that the whole “dopaminergic” hypothesis regarding the biological cause of schizophrenia was, perhaps, maybe, incorrect?)

The logic behind this forecast is simple: it’s exactly what was done by pharmaceutical companies to promote blockbuster atypical antipsychotics 10 years ago.  And why get creative when the scam worked so well the first time around?

The scam that worked so well

A lot of internal documents never meant for public eyes have come to light in the recent litigation against Johnson & Johnson for Medicaid fraud and the off-label marketing of RISPERDAL.  Two delightful samples will be dissected below:

  1. The full deposition of Alex Gorsky, current CEO of Johnson & Johnson (makers of RISPERDAL), recorded in May, 2012 as part of the national RISPERDAL litigation.
  2. The Annual Report (2002) of The Johnson & Johnson Center for Pediatric Psychopathology at the Massachusetts General Hospital, a research center that presented that was charged by their funders (J&J) to produce specific research outcomes that would support the commercial goals of the company.  This a report from the Center to its funders on their progress towards these goals.

Early in Gorsky’s deposition, we learn that the Johnson & Johnson Center for Pediatric Psychopathology at the Massachusetts General Hospital, headed up by Dr. Joseph Biederman, was established by a grant from J&J and its affiliates for $500,000 in 2001. The center was described in an internal J&J email as “a great way to get the word [about RISPERDAL] out to a big part of the child and adolescent prescribing community.” This was a full 5 years before Risperdal was approved for pediatric use.

And if the name “Joseph Biederman” sounds familiar, that’s because Biederman is commonly acknowledged as the originator of the idea that childhood bipolar disorder is, in fact, a widespread pediatric disease which must be aggressively treated with medications, specifically antipsychotics.  His turn-of-the-millennium publications with Janet Wozniak are credited with jumpstarting the 4000% increase of this diagnosis in children.

More recently, Biederman gained notoriety for some seriously scandalous behavior: he guaranteed J&J company representatives favorable outcomes for a 2005 trial of RISPERDAL in preschoolers.  This did tarnish his reputation a little, but by no means did it motivate any of the institutions for which he works (Harvard Medical School, Massachusetts General Hospital) to dismiss him.

Interesting aside: As Bob Fiddaman reports on his blog, here’s an excerpt from an earlier (Feb, 2009) deposition from Dr. Biederman: when asked what rank he held at Harvard, he answered “Full professor.”  “What’s after that?” asked a lawyer, Fletch Trammell.
“God,” Dr. Biederman responded.
“Did you say God?” Mr. Trammell asked.
“Yeah,” Dr. Biederman said.

What you’ll see in the documents below is that 2005 was not the beginning of Biederman’s agreement with J&J to produce favorable results validating the research conclusions they specified in advance; that’s been going on at least since 2001, and perhaps earlier.

And what exactly did Johnson & Johnson want him to prove?  That there is such a thing as childhood bipolar disorder.  It’s a brain disease, likely chronic, that requires lifelong medication adherence.  And most importantly: kids need to be taking RISPERDAL.

From the  Annual Report (2002) of The Johnson & Johnson Center for Pediatric Psychopathology at the Massachusetts General Hospital

An essential feature of the Center is its ability to conduct research satisfying… [certain] criteria…. [including that] it will move forward the commercial goals of J&J.

Considering that nearly all psychiatric medication use in children is off label, studies of safety and efficacy in children are essential for clinicians, parents, and patients to feel comfortable using these medications in children… Equally important to effective use of medications is the demonstration of the validity of disorders.  Because parents, patients, and clinicians are exposed to a media that frequently questions the validity of childhood disorders, genetic and brain imaging studies are needed to show the validity of these disorders as brain disorders that respond to medication.  Epidemiologic studies are needed to show that childhood disorders are frequently chronic and severely debilitating.  Without such data, many clinicians question the wisdom of aggressively treating children with medications, especially those like neuroleptics, which expose children to potentially serious adverse events….

Through the funding provided by J&J, we [the J&J Center for Pediatric Psychopathology] are creating a team of investigators focusing on the following issues:

We will generate and publish data on the efficacy and safety of medications for improving currently available treatment options for child psychopathology.  This work is an essential precursor to the … widespread use of medications given that most must be used off-label.

(emphasis added)

From the deposition of Alex Gorsky, CEO of Johnson & Johnson (makers of RISPERDAL)

[by the way, Gorsky is positively the most skilled waffler I have ever encountered!  Twice in the deposition he admits to having given the opening address at a meeting (it was, unfortunately for him, noted in the agenda), but can’t recall having been there or any of the other things said, and even goes so far to suggest that he may have given the opening address but then, somehow… left.  Maybe he was the guy they sent to pick up lunch…]

Gorsky, is that you??

Scientific “research” to further Johnson & Johnson’s commercial aims

Q. You see this document is called “Annual Report 2002: The Johnson & Johnson Center for Pediatric Psychopathology at the Massachusetts General Hospital“?… And the director is Joseph Biederman, M.D., whom we’ve spoken about a couple times today, right?
A. Yes.
Q. Let’s turn to page 861, please, Mr. Gorsky, which is it is executive summary of the annual report. The first sentence of the overview says that “The mission of the Center is…a strategic collaboration between Johnson & Johnson and the Pediatric Psychopharmacology Research Program at the Massachusetts General Hospital.” Is that correct?
A. Yes, that’s what it says.
Q. Let’s turn to the next paragraph, Mr. Gorsky. It says, “An essential feature of the Center is its ability to conduct research satisfying three criteria. . .” Did I read that right?A. Yes.
Q. And if we look at the third criteria, it says “it will move forward the commercial goals of J&J.” Is that correct?
[…Gorsky tries and fails to avoid answering this question. Finally…] A. Yes.
Q. So, this annual report from the Johnson & Johnson Center For Pediatric Psychopathology from 2002 admits that information and research from this supposedly unbiased research center is to benefit the business of sales for Johnson & Johnson. Is that correct? … And commercial goals would include sales of pharmaceuticals. Is that right?
A. Yes, it would.

Promoting the widespread use of medication, specifically RISPERDAL, in children

Q. Okay. And then if we look at the next sentence from the annual report, it says “We strongly believe that the Center’s systematic scientific inquiry will enhance the clinical and research foundation of child psychiatry and lead to the safer, more appropriate and more widespread use of medications in children.” Did I read that correctly?
A. Yes, you did.
Q. So…one of the goals of this center’s inquiry is to lead to the more widespread use of medications in children. Is that right?
A. […extensive verbage from Gorsky, followed by…] yes.
Q. … Mr. Gorsky, let’s look at the next sentence, where it says “Considering that nearly all psychiatric medication use in children is off label. . .”
Q. Do you see that?
A. Yes, I do.
Q. And that would include Risperdal because in 2002, I think we’ve already agreed, Risperdal was not approved for use in children and adolescents. Is that right?
A. Based upon our earlier conversation, it did not have the specific indication at that time, that’s correct.

Producing lifelong RISPERDAL customers

Q. And it [the J&J Research Center’s 2002 Annual Report] says — and this is interesting — “Showing how pediatric mania evolves into what some have called mixed or atypical mania in adulthood will provide further support for the chronic use of RISPERDAL from childhood through adulthood.”
Do you see that?
A. Yes, I do.
Q. So, one of the specific goals of the center is to show that pediatric mania will evolve into mania in adulthood, which will then require the chronic use of Risperdal from childhood to adulthood. Is that right?
A. […much waffling, and then…] I think if that was the goal as outlined, that was a reasonable research objective.
Q. And the continuation of Risperdal from childhood to adulthood would be one of those –remember back in the beginning of this document we saw the word there were commercial goals of Johnson & Johnson, right?
A. Yes, I did see that.
Q. All right. And the continuation of a Risperdal prescription from a young man or young boy through adulthood would be a commercial goal of Risperdal, right? Or of Johnson & Johnson, I’m sorry.
A. Successful treatment of patients, if they were responsive on the medication, for them to stay compliant on the medication would be one of our goals, but only if the drug was working and the patient was living better.
Q. So, the way I interpret this is that Johnson & Johnson and Massachusetts General Hospital and Dr. Biederman are collaborating to validate a lifetime use and treatment with Risperdal. Is that correct?
A.[…further waffling…]

(emphasis added)