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An April 2, 2007, press release from the Alzheimer’s Research Trust (“the leading UK research charity for dementia”) reported that:

“Many Alzheimer's patients are dying earlier because of sedatives they are being prescribed, according to new research from King's College London.

“Results from a five-year project, funded by the Alzheimer's Research Trust and presented at the charity's conference in Edinburgh, found that the drugs were linked with a significant increase in long-term mortality - with patients dying on average six months earlier.

“The investigation, led by Professor Clive Ballard, found that the sedatives, known as neuroleptics, were associated with a significant deterioration in verbal fluency and cognitive function, and that neuroleptic treatment had no benefit to patients with the mildest symptoms.”

Included in the press release were these details:

“-The neuroleptics in the study were thioridazine (Melleril), chlorpromazine (Largactil), haloperidol (Serenace), trifluoperazine (Stelazine) and risperidone (Risperdal) [bolding added]. Patients continued to take their prescribed neuroleptic drug for 12 months or took a matched placebo

“-Neuroleptics are sedative drugs, also known as major tranquilisers or anti-psychotics. They are not licensed for the treatment of dementia, but are prescribed to some people with dementia to control agitation, delusions, anxiety, hallucinations, sleep disturbance, and aggressive behaviour

“-Originally used to treat schizophrenia, neuroleptics are prescribed to up to 45 per cent of people with Alzheimer's living in residential or nursing homes (Reference: McGrath AM, Jackson GA. Survey of prescribing in residents of nursing homes in Glasgow. BMJ 1996;314:611-2)”

The results of this study had already been reported in a March 29, 2007, article from Reuters entitled “Dementia patients dying early on sedatives: study.”

On April 3, 2007, the day after this press release was issued, Etopia Medical News contacted the makers of Risperdal, Janssen, L.P. (“Exclusively Dedicated to Mental Health”), a wholly-owned subsidiary of Johnson & Johnson, to get their comments on this study.

Johnson & Johnson’s Risperdal media relations pointperson Sri Ramaswami told Etopia Medical News that neither he or any of the many other reporters who’d called seeking comment on the findings reported in the Alzheimer’s Research Trust/Kings College London press release had yet seen a copy of the actual study upon which the press release was based and that, therefore, he couldn’t comment about the alleged contribution of his company’s product to “patients dying on average six months earlier” than those on placebo.

The Etopia Medical News reporter told Mr. Ramaswami that he’d do what he could to get him a copy of the actual report as soon as possible so he could get the company’s reaction to the data alleged to be contained within it.

Etopia Medical News immediately sent e-mails requesting a copy of the underlying report to the Alzheimer’s Research Trust, which sponsored the study, and to Kings College London, where it was conducted.

Overnight, Claire Jagot, Senior Account Manager at Munro & Forster, the Alzheimer’s Research Trust’s PR agency, and Maria Hampton, at the Trust itself, replied to these e-mails.

Referring to the Alzheimer’s Research Trust/Kings College London study, Ms. Jagot wrote, “We hope it will be published within the next few months,” while Ms. Hampton indicated more precisely that “Prof Ballard's study is currently being prepared for journal release but it is likely to be at least another two to three months before it is published.”

Immediately after receiving these e-mails from the U.K., the Etopia Medical News reporter sent copies of them to Mr. Ramaswami and asked, again, for comment about the allegations of accelerated mortality from the use of Risperdal by Alzheimer’s patients, saying:

“I've forwarded to you the results of my inquiries in the U.K. regarding the publication of the study about Risperdal. I hope we can arrange for an audio or video interview on Thursday or Friday in which you can set out Johnson & Johnson's reaction to the findings as reported in the press release and expected to be included in the final publication of the study.”

This he followed up in a cellular phone conversation from the San Diego-bound California Amtrak “Surfrider” with Mr. Ramaswami’s colleague Ambre Morley, in which he recounted the chronology of his efforts to elicit a response to the study in question from Johnson & Johnson and re-iterated his interest in getting the pharmaceutical giant’s point of view on the issue of its blockbuster drug’s effect on Alzheimer’s patients being given it.

Having not heard back from Mr. Ramaswami by Friday, April 6th, the Etopia Medical News reporter searched the Johnson & Johnson web site for other possible sources of comment and discovered, a press release, dated March 12, 2007, entitled “Johnson & Johnson Receives Subpoenas,” which said, here reproduced in its entirety, that:

“Johnson & Johnson (NYSE: JNJ) today announced that it has received separate subpoenas from the U.S. Attorney's Office in Philadelphia, the U.S. Attorney's Office in Boston and the U.S. Attorney's Office in San Francisco. The subpoenas relate to investigations by those three offices previously disclosed in SEC filings and directed, respectively, to sales and marketing of RISPERDAL [bolding added] by Janssen, TOPAMAX by Ortho-McNeil and NATRECOR by Scios -- each subsidiaries of Johnson & Johnson.

“The subpoenas request information regarding Johnson & Johnson's corporate supervision and oversight of these three subsidiaries, including their sales and marketing of these drugs.

“Johnson & Johnson will cooperate in responding to these requests.”

Listed as a media contact on the press release was the name of Jeffrey J. Leebaw. The Etopia Medical News reporter asked Mr. Leebaw if he could facilitate the generation of an audio, video, or text -based response from Johnson & Johnson about the allegations against Risperdal included in the press release about the as-yet-unpublished Alzheimer’s Research Trust/Kings College London study or, failing that, a statement that the company wouldn’t be commenting until the actual study was published. Mr. Leebaw said he’d look into the matter.

In light of the news about the subpoenas from the U.S. Attorney’s requesting information “regarding Johnson & Johnson's corporate supervision and oversight of these three subsidiaries, including their sales and marketing of these drugs,” including Risperdal, the Etopia Medical News reporter asked Johnson &Johnson’s corporate spokesperson for any additional information he might have to offer about whatever the Department of Justice was looking into in this case. He declined to do so.

Immediately after this conversation with the Johnson & Johnson spokesperson, a nameless Federal government spokesperson at the office of the U.S. Attorney in San Francisco similarly declined to provide any information whatsoever regarding whatever was involved in its use of a subpoena to access information about the sales and marketing of Risperdal by Janssen/Johnson &Johnson.

The subpoenas from multiple U.S. Attorneys about which neither Johnson & Johnson nor the San Francisco U.S. Attorney will comment are not the first delivered to the New Jersey-based drug company in regard to Risperdal.

According to a January 24, 2004, article in the New York Times entitled “Johnson & Johnson gets subpoena on schizophrenia drug“:

“Johnson & Johnson said that it had received a federal subpoena for documents related to Risperdal, the most-prescribed schizophrenia medication in the nation. The subpoena, which was sent to the company's Janssen Pharmaceutica division, came from investigators for the Office of Personnel Management, Johnson & Johnson said. Risperdal has been at the center of lawsuits filed by Johnson & Johnson, which is trying to block other companies from making generic copies of the medicine. A patent on the drug is set to expire in 2007. A spokesman for Janssen, Doug Arbesfeld, said that the company was cooperating with the inquiry. Rusty Asher, a spokesman for the Office of Personnel Management, which oversees health benefits for federal employees, said the agency did not comment on active investigations. Johnson & Johnson is based in New Brunswick, N.J.”

Risperdal is Janssen/Johnson & Johnson‘s brand name for risperidone,“a very strong dopamine blocker (antagonist); i.e., it inhibits functioning of postsynaptic dopamine receptors.

Among the side effects of Risperdal listed by Johnson & Johnson in its March 1, 2007, press release announcing “FDA Grants Pediatric Exclusivity For RISPERDAL® (Risperidone)” are “tremor [and] muscle stiffness.”

This is not surprising, given that the dopamine blocked by Risperdal is essential for proper muscle control and that Parkinson's disease, which is characterized by “muscle rigidity, tremor, a slowing of physical movement (bradykenesia) and, in extreme cases, a loss of physical movement (akinesia)” is caused by “the loss of pigmented dopamine-secreting (dopaminergic) cells” in the brain.

In essence, Risperdal treats psychosis by inducing artificial Parkinson's disease.

Specific risk factors affecting geriatric patients being given Risperdal are not unknown to Johnson & Johnson. The press release linked to above, trumpeting a six-month extension of J&J’s exclusive right to sell Risperdal due to its receipt of “pediatric exclusivity” from the FDA, includes this warning, among many others:

“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.”

Johnson & Johnson’s PR department might not be willing to comment on an unpublished study linking Risperdal administration to pre-mature death, but its legal department is certainly conversant with this relationship, and is clearly trying to establish the company’s good faith by having prominently displayed a warning in that regard on its own web site a month before the official press release announcing the unpublished study was posted in the U.K.

Even before the announcement on April 2, 2007, of the findings of the Alzheimer’s Research Trust/Kings College London study linking Risperdal and pre-mature death, litigation against Johnson & Johnson for allegedly-deleterious effects of the drug Risperdal was already a high priority among trial lawyers.

According to the resource4risperdalinfo.com home page, maintained by the San Diego-based law firm of Steigerwalt & Associates, which offers a “free case review“ for those who think they may have been harmed by taking Risperdal:

“Risperdal is the most popular antipsychotic medication in the United States today. Since its FDA approval to treat schizophrenia in 1993, Risperdal has been prescribed to over 10 million people, generating over 2.1 billion in sales annually for its manufacturer Janssen Pharmaceutica and its parent company Johnson and Johnson. A decade later, the FDA approved Risperdal to treat bipolar disorder, and a new market for an already-successful drug was born….

“Unfortunately news outlets and medical agencies began to report on the serious and unexpected side effects of reckless Risperdal prescriptions. Risperdal was suspected in 37 incidents of stroke-like events in elderly patients undergoing treatment for senile dementia, and tragically, 16 of these innocent people died. Because Risperdal was not yet tested on the aged population and the potential side effects could not be properly anticipated, Janssen Pharmaceutica sent a letter to Canadian doctors in 2002 warning them of this risk. Strangely however they waited until 2003 to warn American doctors of the same danger….

“When powerful pharmaceutical companies like Risperdal manufacturer Janssen Pharmaceutica neglect to inform users about potentially dangerous complications from their prescription medications in a timely manner, consumer safety as a whole is jeopardized. Successful lawsuits can send a clear message to the industry about accountability and corporate responsibility, as well as ensure that innocent victims are compensated for their physical and emotional anguish.”

Parker Waichman Alonso Mark LLP (“a diverse law firm handling a wide array of plaintiff litigation matters“) maintains an Injured by Risperdal? page on its web site, where, after recounting a bit of the history and downside of taking the powerful dopamine antagonist, it posts this invitation:

“If you or a loved one took Risperdal and suffered side effects, please fill out the form at the right for a free lawsuit case evaluation by a qualified drug side effects attorney.”

As reported by Etopia Medical News on June 7, 2004, in “Pfizer settles multi-state Neurontin® ‘off-label’ marketing suit for $430 million,” drug companies can often incur liability by inappropriately encouraging the “off-label” use of their FDA-approved drugs for diseases that the drug has not been specifically been approved to treat.

As reported at that time by Etopia Medical News:

“Off-label prescribing” is the practice by which pharmaceutical drugs approved for one use by the Food and Drug Administration (FDA) are prescribed to patients for use in connection with other diagnoses.

“Obviously, the more conditions a drug is prescribed for, the more of it will be sold and the more money its manufacturer will make. FDA rules require that a drug be proven to be "safe" and "effective" in the treatment of the condition for which it was approved. It doesn't need to be proven to be either safe or effective when used to treat other conditions, however.”

When Risperdal is prescribed for the treatment of Alzheimer’s, whether out of sincere concern and after a thorough evaluation of its overall potential to help the person receiving it, or as an expedient to make the management of nursing home patients more convenient for their administrators, it’s being used “off-label.”

As reported above, in the as-yet-unpublished Alzheimer‘s Research Trust/Kings College London study in the U.K., “neuroleptics are prescribed to up to 45 per cent of people with Alzheimer's living in residential or nursing homes.” Is that the case in the U.S. as well?

Are hundreds of thousands of U.S. Alzheimer’s patients, who possibly don’t benefit and possibly are being harmed by the administration of Johnson & Johnson’s Risperdal as the clock runs out on its recently-extended to June, 2008, monopoly on this drug, receiving it “off-label” for the sake of corporate profit and nursing home administrators convenience rather than in their own best medical interests?

Evidence from another, previous study of dementia patient management (“Effect of enhanced psychosocial care on antipsychotic use in nursing home residents with severe dementia: cluster randomised trial”) co-authored by the Alzheimer’s Research Trust/Kings College London study’s principal investigator, Clive Ballard, led to the conclusion that:

“Good practice guidelines recommend that psychological or environmental management options should be the first line approach and that drugs should be stopped after symptoms have been absent or minimal for three months.”

Evidence that priorities other than “good practice” are, or are not, driving Johnson & Johnson’s “sales and marketing” of Risperdal will need to wait on further announcements from the offices of the U.S. Attorneys who are now possibly looking into this question.