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Risperdal® in its many forms

some background

For a compendium of previous Etopia Medical News coverage of prescription drug-related news stories, click on: Rx Wars, Volume 1.

For a possibly-comparable case of a major drug company (Pfizer, the world’s largest) forced to pay $430 million dollars in damages for overly-enthusiastically promoting off-label sales of one of their biggest moneymakers, go to: “Pfizer settles multi-state Neurontin® "off-label" marketing suit for $430 million,” first published on Etopia Medical News on June 7, 2004, where you’ll find a plea to change the drug regulation regime to require the specific approval by the FDA for the prescribing of any pharmaceutical product for any particular condition, a suggestion that has not, as of this time, been implemented.

For additional background, and coverage of early efforts to discover how much Risperdal is being prescribed off-label, click on: “Is the U.S. Department of Justice investigating abuses of “off-label“ sales of Risperdal by Johnson & Johnson subsidiary Janssen, L.P.?”

For an in-depth discussion of various aspects of Alzheimer’s Disease between this reporter and Dr. Piero Antuono, recorded on November 29, 2004, click on: “Piero Antuono, M.D., leading Alzheimer's researcher, discusses causes and treatment of this disease.”

After reading a report from the U.K. entitled “Shocking new research: Alzheimer's patients are dying early because of controversial drugs,” this reporter set out to see find out how much Risperdal (Johnson & Johnson’s patent-protected brand of risperidone) was being given to Alzheimer’s patients in the U.S.

A conversation on Monday, April 9th, with Sri Ramaswami, J&J’s pointperson on the drug, yielded only a refusal to comment on the study until it was officially published, even though the company’s official Risperdal page prominently displays this warning (bolding in original):

“IMPORTANT SAFETY INFORMATION

“Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL (risperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.”

If Johnson & Johnson was already publishing such a strong warning about how dementia patients given Risperdal were “at an increased risk of death compared to placebo,” why wouldn’t their spokesman be willing to comment about a study from the U.K. claiming that an assortment of neuroleptic drugs including Risperdal “were linked with a significant increase in long-term mortality - with patients dying on average six months earlier,” telling Etopia Medical News, as he said he’d already told Bloomberg News: “Until I see the full data, I’m not in a position to comment”?

asking the government about Risperdal use in California and the U.S.

Calls to the State of California’s Department of Health Services (DHS) were not particularly fruitful. On April 8, 2007, DHS spokesperson Lea Brooks told Etopia Medical News that the State of California had no information about the level at which Risperdal was being used in the state’s nursing homes, only that “unusual incidents,” but not aggregate statistics about how patients were being medicated, existed in state records.

She suggested inquiring at the State Board of Pharmacy, the Centers for Medicare & Medicaid Services, and the agency responsible for regulating the operations of skilled nursing facilities (“nursing homes”).

An inquiry to the New England Journal of Medicine, where the U.K. study commissioned by the Alzheimer’s Research Trust and carried out by Professor Clive Ballard at Kings College London is scheduled to be published in a few months on the same day revealed that the NEJM does not reveal the content of the studies it publishes prior to releasing them, under embargo, to the media one week in advance of their publication.

No information about Risperdal use in Los Angeles County nursing homes was available from the County’s Health Facilities Division.

On April 10th, DHS spokesperson Ken August said he would be able to provide statistics about the number of prescriptions for Risperdal paid for under the state’s Medi-Cal program. The data, compiled by the Pharmacy Contracting and Policy Section of the California Department of Health Services, arrived on April 12, 2007, and, according to Mr. August‘s e-mail, “are for the Medi-Cal fee-for-service program and do not cover expenditures for beneficiaries enrolled in the Medi-Cal managed care program,” and are reproduced below:

five million Medi-Cal-financed prescriptions for Risperdal costing a billion dollars plus, 1995-2006
(from California Department of Health Services)

According to DHS, “The significant drop in expenditures and claims in 2006 from 2005 is due to the impact of Part D drugs for the Medicare population no longer being paid for by Medi-Cal.”

an expression of concern from J&J

On Wednesday, April 11th, Etopia Medical News called Sri Ramaswami at Johnson & Johnson and asked him for whatever information he might have about the off-label use of Risperdal.

“We don’t promote our products for off-label use,” he said, adding that he was “concerned about where this is going.”

Mr. Ramaswami suggested contacting pharmaceutical industry analysts for information about off-label use.

information about Risperdal from the quest for equity analysts in the field

As of this writing (April 15th), no pharmaceutical industry analyst contacted by Etopia Medical News for information about off-label use of Risperdal has replied to these inquiries, but research in this direction has revealed some new facts about the financial significance of this powerful atypical anti-psychotic.

In an April 3, 2007, article entitled “Analysts, investors aloof about J&J stock,” by New Jersey Star-Ledger staff reporter Jeff May writes:

“Johnson & Johnson hasn't slashed its work force or suffered through regulatory setbacks this year, as several of its rivals have. But investors have been noticeably cool on the drugmaker's stock.

“Several analysts recently cut their 2007 earnings estimates for the company, and shares are down 12 percent since last October as concerns mount about J&J's growth prospects. Johnson & Johnson is under pressure on three main franchises: drug-coated stents; its anemia treatment, Procrit: and its lineup of antipsychotic drugs.

“Those three categories made up 19 percent of the New Brunswick company's sales last year, and al most 40 percent of its profit, according to Catherine Arnold, an analyst with Credit Suisse. But by 2011, those figures could slip to 8.4 percent and 18 percent, respectively, she said. "‘The next five years for Johnson and Johnson will be very different and much more challenging than the past five years,’ Arnold, who has an ‘underperform’ rating on the company, wrote in a note to clients last week….

“J&J's No. 1 drug is the schizophrenia treatment Risperdal, but it loses patent protection in 2008. A new antipsychotic, Invega, hit the market in January and is supposed to help replace the Risperdal franchise and its $4.2 billion in sales. So far, however, the results have been disappointing.

"‘Based on the early prescription and promotion data, Invega is off to a slow start,’ Prudential Equity analyst Larry Biegelsen wrote in a report yesterday.”

California Board of Pharmacy knows nothing about Risperdal use

On Wednesday, April 11th, Virginia Herold, spokesperson for the California Board of Pharmacy, responsible for the regulation of pharmacies in the state, told Etopia Medical News that that agency had no information about the amount of Risperdal being prescribed in the state.

Food and Drug Administration has nothing to say about off-label use of Risperdal

A call to the U.S. Food and Drug Administration asking about off-label use of Risperdal resulting in a request for an e-mail on the subject, which, as of this time, has not been responded to by the federal agency responsible for protecting the American public from harm caused by prescription drugs.

pre-mature death warning mystery solved and further leads provided by official at the Alzheimer‘s Association

Finally doing what he should have done in the first place, on Friday, April 13th, this reporter contacted the ‘black box warning,” which would explain why Johnson & Johnson had put a warning about pre-mature death from Risperdal on its web site, this being a requirement under federal law in the case of drugs for which such caveats were required as part of their labeling.

Subsequent online research revealed this to indeed have been the case.

a plethora of information about Risperdal

Specifically, on May 6, 2005, in Psychiatric News, in an article entitled “FDA Orders New Warning On Atypical Antipsychotics,” it’s reported that:

“The FDA has linked off-label prescribing of antipsychotic drugs to an increased risk of death in the elderly, adding yet more text to the black-box warnings on the drugs' labels.

“The U.S. Food and Drug Administration (FDA) has ordered manufacturers of atypical, or second-generation, antipsychotic medications to add a new warning to already existing black-box warnings noting that the drugs are associated with an increased risk of death related to psychosis and behavioral problems in elderly patients with dementia.

“Although none of the newer antipsychotic medications is approved to treat behavioral disturbances associated with dementia, the use of the drugs in the elderly has been widely studied. Both industry executives and regulators acknowledge that the popular medications are commonly prescribed off-label for older patients—particularly those with Alzheimer's disease—who exhibit aggressive or agitated behaviors.

“The FDA said last month that an agency review of placebo-controlled trials involving the use of four of the drugs in elderly patients with dementia-related behavioral problems found numerical increases in the rate of death in patients taking the medications compared with patients taking placebo. Of the studies included in the agency analysis, 15 of the 17 trials showed increased death rates associated with olanzapine (Zyprexa), aripiprazole (Abilify), risperidone (Risperdal), and quetiapine (Seroquel).”

An entry on the web site of RxList (“The Internet Drug Index”) here provides this information:

“Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10 week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. RISPERDAL®. (risperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.”

The personal injury law firm of Brown & Crouppen, on their Risperdal page, point out that:

“After reviewing 17 studies on four drugs in the class, the FDA found that the death rate for elderly patients on the medication was 1.6 to 1.7 times greater than those on a placebo. Most of the deaths were either heart related or from infections.

“This action follows the warning letters sent by Johnson & Johnson in April 2003, alerting physicians about Risperdal’s link to an elevated risk of stroke in elderly patients. At the time, the company had received 37 reports of stroke or stroke-like events, including 16 deaths, among Risperdal patients.”

a possibly ironic connection between Risperdal and Alzheimer‘s

According to information provided on the Brown & Crouppen web site linked to above, “Risperdal has also been linked to the development of diabetes.” According to an April 23, 2006, article entitled “Latest Issue Of Alzheimer's & Dementia Explores New Ideas For Cause, Screening And Risk Factors”:

“The researchers propose that changes in the way brain cells use sugar to generate energy eventually lead to impaired brain cell function and cell death, and that these are the key elements that lead to the development of plaques, tangles, and brain atrophy seen in Alzheimer's. Diabetes is a known risk factor for dementia, and diabetes in midlife has been linked to the subsequent development of dementia decades later.

“A commentary points out the exciting possibility that decades of research and drug development for diabetes may now be relevant to our understanding of Alzheimer's.”

If this new hypothesis linking diabetes to Alzheimer’s proves true, then giving Alzheimer’s patients a drug, Risperdal, that could itself encourage the development of diabetes, a possible precursor of Alzheimer’s, can’t be doing them much good on that account, either.

more attacks on Risperdal by lawyers

In a June 7, 2006, posting on the Lawyers and Settlements web site (“Imagine Winning”), in an article entitled “Drug Companies Still Peddling Risperdal and Zyprexa For Off-Label Use,” Evelyn Pringle writes:

“Data unveiled March 2006 by investment firm CIBC World Markets verifies the massive amount of spending going for these drugs. CIBC found that in the previous 12 months, of the top 20 drugs by managed care spending, psychotropic drugs accounted for nearly 20%, or $13 billion. The drugs that made the list were Zyprexa ($2.6 billion), Seroquel ($2.5 billion), Risperdal ($2.2 billion).

“Atypicals were approved by the FDA for treatment of adult schizophrenia and bipolar disorder. None of the 6 drugs including Clozaril, Risperdal, Zyprexa, Seroquel, Abilify and Geodon are approved for the treatment of any other disorder in children or the elderly. [Risperdal has since been approved for the treatment of “irritability associated with autistic disorder.”]

“But nonetheless, they are being routinely prescribed to patients of all ages, in most cases off-label for uses not approved by the FDA and people are dying from their side effects at alarming rates….

“Six months later, on October 18, 2005, the Associated Press reported a study that showed atypicals used to treat elderly patients with dementia-related aggression and delusions can raise their risk of death.

“The researchers in the study pooled the results of 15 previous studies on atypicals Zyprexa, Risperdal, Seroquel and Abilify. Among more than 5,000 elderly dementia patients, those taking any of the 4 drugs faced a 54% increased risk of dying within 12 weeks of starting the drugs, compared to patients taking placebos.

“According to the AP article, there were 118 deaths among the 3,353 atypical users versus 40 in the 1,757 patients receiving a placebo and the risks were similar for each atypical.

“And yet, research shows that nursing home residents are being fed antipsychotics in record numbers. A study published in the June 13, 2005 Archives of Internal Medicine examined the quality of antipsychotic prescriptions in about 2.5 million Medicaid patients in nursing homes and found that "over half (58.2%)," received antipsychotics that exceeded the maximum recommended dosage, received duplicate therapy, or under the guidelines, had inappropriate indications for the medications to begin with.

“The study determined that more than 200,000 nursing home residents received antipsychotic therapy but had ‘no appropriate indications for use.’“

This article also includes additional claims about the efforts of drug companies to, in its view, inappropriately encourage the dosing of additional classes of people with atypical anti-psychotic medications. According to one observer cited in the article, Kelly O'Meara, author of the newly released book, Psyched Out:

"Sharing one's feelings with a doctor," she warns, "more often than not is all it takes to be diagnosed with a psychiatric disorder and prescribed a mind-altering drug to ‘treat’ the disorder."

more attacks on Risperdal

You can find more information about the perils of taking Risperdal at “The Basic Facts about RISPERDAL”

In a article on his web site entitled “Off-Label Dementia Drug Use Can Be Deadly,” Dr. Joseph Mercola writes:

“Here's a good example why drugs -- especially new ones merely pumped out to keep the coffers of the mega-drug manufacturers flush with cash -- so often cause harm: Medications used to treat elderly patients greatly raise their risk of death.

“Based on an analysis of 15 studies encompassing more than 5,000 elderly dementia patients, those who took an atypical psychotic drug -- Zyprexa, Risperdal, Seroquel and Abilify -- increased their chances of death by 54 percent within 12 weeks of first taking it! Three times as many patients died after taking those atypical psychotic drugs versus the placebo group.

“These needless deaths merely add to the body of evidence that shows more off-label use and abuse allowed by the FDA,,,,

“And, if you thought this kind of abuse was confined to the elderly, guess again: A study I posted last year found Risperdal to be a safe and effective long-term solution for below-average children with disruptive behaviors.

“Nonsense like this makes my blood boil, and fuels my passion to transform the existing conventional medical paradigm from one addicted to pharmaceuticals, surgeries and other methods that only conceal or remove specific symptoms to one focused on treating and preventing the underlying causes.

More recently, in a January 21, 2007, article on the Medical News Today web site entitled “No Evidence To Support Many Off-label Uses Of Atypical Antipsychotics,” it says:

“Some newer antipsychotic medications approved to treat schizophrenia and bipolar disorder are being prescribed to millions of Americans for depression, dementia, and other psychiatric disorders without strong evidence that such off-label uses are effective, according to a new analysis by HHS' Agency for Healthcare Research and Quality.

“The federally funded comparative effectiveness review of these drugs called atypical antipsychotics identified the medications' potential for serious side effects while pointing to an "urgent need" for more research into new treatments for the growing population of dementia patients who display severe agitation.

“’This report emphasizes the importance of understanding the risks and benefits of different medicines,’ said AHRQ Director Carolyn M. Clancy, M.D. ‘Caution is necessary in the off-label use of atypical antipsychotics, especially when used in the elderly and when the evidence for effectiveness is not good.’”

Perhaps the most succinct statement about the down-side to Risperdal use can be found on the Crazy Meds web site (“Nobody on this site is a doctor, therapist, or a pharmacist”), which, in addition to saying that Risperdal “is the bomb when dealing with the combination of Asperger's and bipolar, or just Asperger's and other forms of autism alone,” also says that:

“Although frequently given to treat Alzheimer's, the latest reports have it that all atypical antipsychotics are pretty much a bust. Especially that bit about their dropping dead and all.”

listen to an in-depth interview with Dr. Piero Antuono, recorded on November 29, 2004, discussing basic questions about Alzheimer‘s

You can listen to an in-depth interview with Dr. Piero Antuono, recorded on November 29, 2004, discussing basic questions about Alzheimer‘s, by clicking on the appropriate button in the Medical Interview Channel