AstraZeneca & Novartis Paid Chicago Doctor of Death to Illegally promote Seroquel & Trileptal
The Doctor of Death is back in the news @BNET http://bit.ly/c2DMnS today. So I though I would bring an disturbing old post back to the top, & add in this important article by Jim Edwards @ BNET as more confirmation of how criminal and corrupt the pharmaceutical industry has become with absolutely no substantive oversight or accountability being brought by our government, the DOJ, or FDA regulators.
Novartis Paid Doc Who Urged Use of Seizure Meds on Bipolar Kids
By Jim Edwards October 11, 2010 -http://bit.ly/c2DMnS
Novartis (NVS) gave research funds to a doctor who advocated using the anti-seizure drug Trileptal as an anti-bipolar depression treatment in children — an unapproved use of that drug — the company confirmed to BNET. The doctor, Michael Jay Reinstein, once told a newsletter for parents with bipolar children that “high enough” doses of Trileptal were useful in quelling aggression in bipolar children. Novartis spokesperson Anna Fradle said: "He has done clinical studies on Trileptal on our behalf.
She declined to detail how much money Novartis had paid Reinstein over the years. The use of antidepressants and other pyschiatric drugs in children is controversial. It is not well-established that conditions such as depression, bipolar disorder or mania exist in children, or that if they do the appropriate treatment is a seizure medicine like Trileptal. Yet Johnson & Johnson (JNJ), Shire (SHPGY) and AstraZeneca (AZN) have all funded research by doctors who advocate antidepressants for kids, and so didForest Labs(FRX).
The admission illustrates how a small group of doctors can end up on the payroll of multiple drug companies, triggering illegal “off-label” sales.
Novartis agreed to pay $422 million to end Department of Justice allegations that the company promoted Trileptal for unapproved uses and paid kickbacks to health care providers to induce them to prescribe the drug.
Novartis also instructed its sales representatives to carry “Medical Request Forms” on their sales calls to psychiatrists and use them to “prompt” the psychiatrists to “ask” for information on Trileptal’s off-label uses. While a physician is free to inquire about off-label uses of a drug, a sales representative may not initiate that communication or use a Medical Request Form for such a purpose
…In many cases, the Novartis sales representative even filled out the Medical Request Form in advance of the sales call. They then explained to the psychiatrist that in response to the doctor’s “request,” the company would provide him or her with all the medical data and studies regarding the off-label use. As it turns out, decision-makers at Novartis’ corporate headquarters decided to select out certain positive information in response to the purported requests (consisting mostly of “chart reviews” and single patient or small group studies) and to conceal the negative data and studies suggesting Trileptal is neither safe, nor effective in the treatment of bipolar.
One of the responses Novartis provided to such requests was a summary of research into the use of Trileptal for mania, bipolar and aggression disorders. It mentions a study by “Reinstein et al” in 2002 of patients aged “11-83 years” and another study by Reinstein et al from 2001 in 47 adults. At about that time, Reinstein published a third study of 57 patients on Trileptal vs. patients taking divalproex sodium. And, according to The Bipolar Child, a medical newsletter, Reinstein presented a fourth set of data in 2001 on Trileptal vs. Depakote to the American Psychiatric Association Conference in New Orleans. The Bipolar Child newsletter asked Reinstein about using Trileptal in children. He replied:When the dose gets high enough, the aggression tends to subside.
Reinstein is a controversial figure in psychiatry. He was the subject of Propublica investigation that found he received nearly $500,000 from AstraZeneca (AZN) and became one of the company’s top prescribers of Seroquel, an antipsychotic drug that’s associated with weight gain: “If he is in fact worth half a billion dollars to (AstraZeneca),” the company’s U.S. sales chief wrote in 2001, “we need to put him in a different category.” To avoid scaring Reinstein away, he said, the firm should answer “his every query and satisfy any of his quirky behaviors.”Putting aside its concerns, AstraZeneca would continue its relationship with Reinstein, paying him $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of mentally ill residents in Chicago-area nursing homes.Reinstein has been criticized for writing prescriptions for an improbably large number of patients.
In 2007 he prescribed various medications to 4,141 Medicaid patients, including more prescriptions for clozapine than were written by all the doctors in Texas put together, Medicaid records show.
Reinstein did not return three messages left for comment at two phone numbers or an email address associated with him.
This is a another story about old disturbing news, becoming even more disturbing new news.
This, as with other deeply disturbing stories of profiteering, fraud, and medical malpractice which have become far too numerous to even fathom for most average citizens; that do not follow the antics of this modality and industry regularly.
This should be highlighted on every national network news outlet with the Headline "AZ sponsors Doctors of Death in the drugging of America"
This doctor has ties to that big scandal of the AZ sex and corporate espionage fame Wayne McFadden "AZ chief of deception", who worked covering up the side effects of seroquel through ghost writers and burying studies.
This Chicago psychiatrist was featured on advertising pamphlets and spoke to countless doctors as a paid promoter for AZ.
From the Chicago Tribune:
Doctor-drugmaker ties: Psychiatrist Dr. Michael Reinstein received nearly $500,000 from antipsychotic drug's manufacturer--Chicago Tribune:
the Chicago Tribune article, here.
Doctor gives risky drugs at high rate"In 2007 he prescribed various medications to 4,141 Medicaid patients, including more prescriptions for clozapine than were written by all the doctors in Texas put together, Medicaid records show."
"Records also show he is getting government reimbursement for seeing an improbably large number of patients. Documents filled out by Reinstein suggest that if each of his patient visits lasts 10 minutes, he would have to work 21 hours a day, seven days a week. Reinstein sees 60 patients each day, he wrote in an audit report in 2007."
"Working from a strip-mall office in Uptown, Reinstein says he is psychiatric medical director at 13 nursing facilities, seeing patients with chronic mental illness whom few doctors will accept. Those include people with schizophrenia, who make up the bulk of his practice."
"In written statements to ProPublica and the Tribune, Reinstein said he works long hours seven days a week, as do his four partners, who separately also prescribe clozapine. State records overstate his workload"
"The most gratifying part of my day," he wrote, "(is) when patients reach this level and come to the office!!!"
"Autopsy and court records show that three patients under Reinstein's care died of clozapine intoxication. Alvin Essary died at age 50 at the Somerset Place nursing home on the North Side in 1999. Medical records show that when he died his blood contained five times the toxic level of clozapine."
"Essary's sister, Shirley Palmer, said she can't believe he is still practicing."
"There's nothing that's been done to this doctor who's caused all these problems," Palmer said. "It makes me mad that this keeps going on."
"Reinstein's troubles were perhaps most dramatic at Maxwell Manor, a South Side nursing home. The Illinois State Police and the U.S. Postal Service began investigating Reinstein in 2000 amid accusations of billing fraud, according to documents obtained through public records requests.
Included in those documents is the account of a Maxwell Manor psychiatric supervisor who said Reinstein heavily promoted Clozaril, the original brand name for clozapine. Deborah Grier told state police investigators that Reinstein had handed out glossy fliers to staff and prescribed the drug to nearly all of his patients.
Grier, who has since died, said Reinstein persuaded some patients to take Clozaril by offering passes to leave the home."
"Another Maxwell Manor worker, Engoyama Fela, told investigators that Reinstein "would not spend more than one minute" with a patient during his rounds, according to a summary of the interview. "Many patients became agitated and rebellious because they knew they needed care and they wanted to talk to Reinstein but were not allowed to," he said.
Fela said Maxwell Manor security staffers were assigned to guard Reinstein when he came to update medical records."
"Barry Miller, the prosecutor overseeing the criminal inquiry, declined to comment. Case records say the matter was referred to Medicare to recover any overpayments. Agency officials declined to comment. Reinstein said he was not sanctioned by Medicare and did not have to reimburse the agency.
Retired state investigator Ray Lewis was unhappy to see the criminal case closed. In a recent interview, he said that if there were one Medicaid fraud case he could revisit, Reinstein's would be it. "I'd investigate it for free," Lewis said.
The agency responsible for investigating physician conduct, the Illinois Department of Financial and Professional Regulation, does not reveal to the public the number of complaints filed against doctors"
Doctor-drugmaker ties: Psychiatrist Dr. Michael Reinstein received nearly $500,000 from antipsychotic drug's manufacturer"Executives inside pharmaceutical giant AstraZeneca faced a high-stakes dilemma.
On one hand, Chicago psychiatrist Dr. Michael Reinstein was bringing the company a small fortune in sales and was conducting research that made one of its most promising drugs look spectacular.
On the other, some worried that his research findings might be too good to be true.
As Reinstein grew irritated with what he perceived as the company's slights, a top executive outlined the scenario in an e-mail to colleagues.
"If he is in fact worth half a billion dollars to (AstraZeneca)," the company's U.S. sales chief wrote in 2001, "we need to put him in a different category." To avoid scaring Reinstein away, he said, the firm should answer "his every query and satisfy any of his quirky behaviors."
Putting aside its concerns, AstraZeneca would continue its relationship with Reinstein, paying him $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of mentally ill residents in Chicago-area nursing homes.
During that period, Reinstein also faced accusations that he overmedicated and neglected patients who took a variety of drugs. But his research and promotional work went on, including studies and presentations examining many of the antipsychotics he prescribed on his daily rounds.
The AstraZeneca payments, filed as exhibits in a federal lawsuit, highlight the extent to which a leading drug company helped sustain one of the busiest psychiatrists working in local nursing facilities."
Health professionals who have encountered Reinstein have had similar concerns. When he gave promotional presentations about various medications at Grasmere Place nursing home in Chicago, case manager Staci Burton recalled that she was pleased to get free lunches. But she said she wondered why Reinstein put his patients on twice as many drugs as other psychiatrists who treated residents.
"I was thinking, 'Why are you using so many medications?' " Burton, who worked at the facility from 2004 to 2006, said in an interview. "(His patients) would have symptoms, they'd have all these side effects, and their doctor was not listening."
Psychotropics to lose weight?Chanile Hayes, a South Side resident, says she came under Reinstein's care at a psychiatric hospital after she suffered a nervous breakdown nearly 10 years ago. She found it odd, she said, when Reinstein told her that taking Seroquel would help her lose weight.
"I couldn't understand why he wasn't taking it because he was a plus-sized man himself," said Hayes, now 37. She is one of thousands of people nationwide suing AstraZeneca on allegations it concealed Seroquel's links to weight gain and diabetes.
While she is a plaintiff in New York state, a federal suit is playing out in Orlando, Fla. Reinstein is not a defendant in either case, but Orlando plaintiffs have cast him as a key figure: an influential promoter of Seroquel who was financially backed by AstraZeneca. They allege that Reinstein has claimed that the antipsychotic drug helps patients lose weight.
Hayes said she went from 140 pounds to nearly 300 within two years of taking the drug and later developed diabetes.
Reinstein has done studies, funded by AstraZeneca and two other drugmakers, that found that various medications, including Seroquel, carry an unexpected yet welcome side effect: They help some patients shed pounds.
That claim runs counter to established research that links so-called atypical antipsychotic drugs, such as Seroquel, to considerable weight gain. Drugs in this class, approved for schizophrenia and bipolar disorder, can have other serious side effects that include spastic movement disorders and seizures and can cause premature death among the elderly.
A Seroquel flier dated 1999 features a photograph of Reinstein on the cover. Inside, Reinstein describes one patient losing weight and no longer needing insulin shots because his diabetes had improved so much.
In a 2001 promotional telecast to 5,000 physicians nationwide, Reinstein said he had "jokingly kind of suggested to AstraZeneca" that the drug could be used for "taking away excessive appetite."
"There's actually some nurses in some of our facilities who have actually requested (Seroquel) because they noticed it really did suppress the appetite, and they wanted to lose weight themselves," Reinstein said, according to a transcript of the speech, sponsored by AstraZeneca and broadcast from Somerset Place, a Chicago nursing home.
Two years after the speech, the Food and Drug Administration, armed with mounting research, asked AstraZeneca to warn patients of Seroquel's diabetes risk. The drug's label now cautions that the medication is linked to diabetes and weight gain -- with nearly four times more patients gaining weight on Seroquel than on a placebo.
In his response to reporters, Reinstein characterized Seroquel as "generally weight neutral, although some patients gain weight and others lose weight."
"I would never recommend" that patients take antipsychotics "to lose weight," he wrote.
AstraZeneca spokesman Tony Jewell said plaintiffs have not proved that Seroquel was responsible for their injuries. He said the company, based in London, provided appropriate safety data about Seroquel to the FDA.
Chanile Hayes, who said she saw Reinstein during visits to his office, questioned why he prescribed her the drug: "How could you tell me that it would help me lose weight if it doesn't help (people) lose weight?"
At AstraZeneca, early doubtsIn the corporate halls of AstraZeneca, the company's scientific staff also questioned Reinstein's work.
clozapine/seroquel 1999 abstract
March 2, 2009, Furious Seasons"Seroquel Documents: "Buried" Studies And A Psychiatrist Who Claimed Patients Lost Weight On The Drug"
Saturday, October 10, 2009, Study 15, silence was not golden: Seroquel: you got fat for a reason.
Abstract,Clozaril-Seroquel 1999-Dr. Michael Reinstein. -November 11, 2009
AstraZeneca's Internal Documents at Furious Seasons-March 2009