Thursday, January 5, 2012

AstraZeneca Seroquel - NEW DEAR DOCTOR WARNING LETTER - Dec. 2011 - but wasn't their litigation defense based on their claim that Seroquel doesn't cause diabetes?

AstraZeneca Seroquel - NEW DEAR DOCTOR WARNING LETTER - Dec. 2011 - but wasn't AstraZeneca's litigation defense based on their dubious claim that Seroquel doesn't cause diabetes?

 From the MHRA

 Seroquel (quietapine) - 23 December 2011
 Information on weight gain, hyperglycaemia, and metabolic riskPDF file (opens in new window) (208Kb)

Dear Doctor

Re: quetiapine and quetiapine prolonged release Summary Product Characteristics update
We are continuously monitoring the safety of our products and the Summary of Product Characteristics (SmPC) is updated frequently to accommodate the most up to date information regarding our products. Section 4.4 Special Warnings and Precautions of the quetiapine and quetiapine prolonged release SmPCs was updated recently to reflect the most up to date information on weight gain, hyperglycaemia and metabolic risk.

In agreement with the MHRA, AstraZeneca is providing the following information to prescribers to highlight the labelling text relating to metabolic parameters. We have also added a citation for guidelines on how to monitor patients that are taking atypical antipsychotics in line with good practice as recommended by MHRA.

Update to information in the “Special warnings and precautions” section of the label on weight gain, hyperglycaemia and metabolic risk:

Weight gain has been reported in patients who have been treated with quetiapine, and should be monitored and managed as clinically appropriate as in accordance with utilised antipsychotic guidelines*.

Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases (see section 4.8). In some cases, a prior increase in body weight has been reported which may be a predisposing factor. Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines. Patients treated with any antipsychotic agent including quetiapine, should be observed for signs and symptoms of hyperglycaemia, (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control. Weight should be monitored regularly.

Metabolic Risk:
Given the observed changes in weight, blood glucose (see hyperglycemia) and lipids seen in clinical studies, there may be possible worsening of the metabolic risk profile in individual patients, which should be managed as clinically appropriate.

Reg Office AstraZeneca UK Limited,
2 Kingdom Street, London, W2 6BD,
Reg No 03674842
AstraZeneca UK Limited is a subsidiary
company of AstraZeneca PLC
DOP: November 2011 545607 - 1551204

Existing information on other metabolic parameters include the following:

Increases in triglycerides, LDL and total cholesterol, and decreases in HDL cholesterol have been observed in clinical trials with quetiapine. Lipid changes should be managed as clinically appropriate.
Please see Section 4.4 of the SmPC “Special warnings and precaution for use” for further details.
*Antipsychotic guidelines relevant to UK include the following. Prescribers are encouraged to check for updates to relevant guidelines on a regular basis.

National Institute for Health and Clinical Excellence. Core intervention in the treatment and management of schizophrenia in primary and secondary care (update). Clinical guideline 82. 2009
Should you have any questions regarding the above information please contact our Medical Information Department on 01582 836836.

Yours faithfully,
Catriona McMahon BSc MBChB FRCA MFPM
Medical & Regulatory Affairs Director
AstraZeneca UK Marketing Company

Somehow this newest dear doctor warning letter doesn't quite jive with what AstraZeneca was actually doing & claiming while feverishly promoting the drug Seroquel

 From the highly regarded 1boringoldman blog

Drugmaker Paid Psychiatrist Nearly $500,000 to Promote Antipsychotic, Despite Doubts About Research
Propublica and Chicago Tribune
by Christina Jewett, ProPublica, and Sam Roe
Nov. 11, 2009
Dr. Michael ReinsteinChanile Hayes came under Dr. Michael Reinstein’s care after suffering a nervous breakdown. Hayes went from 140 pounds to nearly 300 in two years after taking Seroquel, a drug that Reinstein was paid to promote by its manufacturer, AstraZeneca. 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.
In an e-mail, an AstraZeneca executive says Reinstein should get careful treatment because of his potential worth to the company.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 indigent, mentally ill residents in Chicago-area nursing homes. During this 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. In an interview and in response to written questions, Reinstein said industry payments he has received for speeches and other engagements have had no bearing on his research results or patient care. He said he does not "accept any money from corporations to study their medications. This eliminates any possible conflicts of interest."
But he does receive money from the Uptown Research Institute, a for-profit business that conducts industry and federally funded studies on psychotropic drugs to help mentally ill patients. Reinstein’s office in Uptown is adjacent to the research institute, which is owned by John Sonnenberg, a clinical psychologist who describes Reinstein as "a mentor of mine" and "brilliant." Sonnenberg said drugmakers and others pay his institute to do research, and the group, in turn, pays Reinstein a consulting fee "under $2,000 a month" and has for many years…
This next clip about Reinstein’s use of Clozaril is much worse and should be read in toto [In Chicago’s Nursing Homes, a Psychiatrist Delivers High-Risk Meds, Cut-Rate Care]. There are plenty of other equally disturbing reports about Reinstein and Sonnenberg. Just google michael reinstein md. And in spite of Sonnenberg’s denials, this is clearly a shared enterprise with a fabricated separation to deflect conflict of interest charges. It’s kind of hard to see how John Sonnenberg can run a 52 site multinational clinical trial from a Chicago store-front, but this is the very Agency in charge of the Lurasidone D1050231 Trial that I’ve been discussing – the one that Drs. Meltzer and Potkin are so excited about.

Back to the Main Event:
So, looking back to the table of changes for the clinical trial of Latuda® [D1050231], it should make sense. John Sonnenberg and his Uptown Research Institute conducted the clinical trial for Dainippon Sumitomo Pharma. In 2009 Dainippon Sumitomo Pharma acquired Sepracor and created Sunovion in early 2010. In the meantime, Dr. Reinstein and Uptown Research were the focus of a lot of negative and embarrassing attention, being included in suits against AstraZeneca’s Seroquel. Here, I’m back to guessing again, but I suspect that Sunovion needed to sanitize D1050231 and distance themselves from Reinstein and Sonnenberg, so they brought in Quintiles to clean things up and help them with their FDA process and other things. So Dr. Herbert Y. Meltzer was not the Principal Investigator of the clinical trial like he said in the video. He was a Principle Investigator of the Vanderbilt site, one of fifty-two sites. The Study Principal Investigator was John Sonnenberg PhD operating out of that Chicago store-front next to and affiliated with a major dangerous pill mill operated by Dr. Michael Reinstein [that needs shutting down yesterday]. I doubt that anyone reading the article in the American Journal of Psychiatry pictured that store-front as the research facility behind the article [or Dr. Reinstein as a psychiatric consultant]…

Addendum: Perhaps you recall Dr. Reinstein’s Seroquel Pamphlet on Diabetes from long ago:

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