Tuesday, June 07, 2011
Thursday, June 02, 2011
Saturday, May 28, 2011
Thursday, April 28, 2011
Wednesday, April 27, 2011
Friday, February 11, 2011
What were AstraZeneca's senior management telling Wall Street about Seroquel ten years ago?
Sunday, December 19, 2010
AZ's Brennan speaks! Pass me the bucket (of money)
Bucket story
The Seroquel story
Question 1. How much did Dave Brennan know about "The Seroquel Issue" at the time?
http://pharmagossip.blogspot.com/2009/10/astrazeneca-to-pay-520-million-to.html
The pharmaceutical company AstraZeneca said Thursday (29/Oct/09) that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel.
One of the investigations related to “selected physicians who participated in clinical trials involving Seroquel,” AstraZeneca disclosed in a government filing. The other case related to off-label promotion of the drug.
H. Waxman's letter:
http://oversight.house.gov/Documents/20070305175741-03469.pdf
The Zoladex issue:
http://www.justice.gov/opa/pr/2003/June/03_civ_371.htm
Question 2
What do you think Corporate Integrity Agreements are?
http://oig.hhs.gov/fraud/cia/agreements/AstraZeneca06042003.PDF
This might help.
http://peterrost.blogspot.com/2007/04/secret-astrazeneca-audio-tapes.html
http://peterrost.blogspot.com/2007/04/open-letter-to-oig-from-astrazeneca.html
Question 3
Is Dr Michael Reinstein one of the Seroquel investigators under investigation by the DoJ?
http://pharmagossip.blogspot.com/2009/11/dr-michael-reinstein-clozaril-king-is.html
Today's question (4):
Was Geoff Birkett the "man behind the curtain" in the Seroquel Scandal?
Someone has to take the fall Dave!
http://www.chicagotribune.com/health/chi-drugs-seroquel-reinsteinnov11,0,6067737.story
Tuesday, June 15, 2010
Wednesday, May 05, 2010
Saturday, May 01, 2010
AstraZeneca - Crestor: the diabetes connection
The statin drug Crestor, made by AstraZeneca, recently received an expanded label indication from the FDA to include patients with normal cholesterol levels. At the same time, new studies indicate that statins increase the risk of diabetes by 9%. For low-heart-risk patients, the risk-benefit analysis might not support statins.
Naveed Sattar, MD PhD, author of the Lancet paper highlighting the diabetes risk, spoke with The HCC. He reviewed his findings and posed some possible biological mechanisms of action to explain how statins could causes diabetes. Other drugs, such as antipsychotics, are well known to cause diabetes.
Login to view the story. Register on http://thehcc.tv/
The Healthcare Channel on http://thehcc.tv/
Friday, April 30, 2010
Jay Byrne - V-Fluence and the AstraZeneca Seroquel connection
Jay Byrne
From SpinProfiles
Jay Byrne is Monsanto's former Director of Public Affairs and former Internet Outreach Programs Director. Prior to Monsanto, Byrne worked for USAID. Since leaving Monsanto, Byrne has become president of Internet PR company V-Fluence[1], whose vice-president, Richard Levine, was formerly part of the Monsanto team for Monsanto's Internet PR firm Bivings Group. V-Fluence is based, like Monsanto, in St. Louis. Monsanto is one of its clients.[2]
Covert Monsanto-Bivings campaign
Byrne is believed to have been the chief architect of the covert Monsanto-Bivings PR campaign which involved attacks on the company's critics via front e-mails, such as those of Andura Smetacek and Mary Murphy, and material posted on the website of a fake agricultural institute, the Center For Food and Agricultural Research (CFFAR). CFFAR material, attacking Monsanto's critics, was also faxed to journalists and planted at a conference.
The campaign is believed to have been a response to the growing role of the Internet in Monsanto's marketing problems in the late 1990s. As Bill Lambrecht pointed out in a September 1999 article in the St. Louis Post-Dispatch:
- The Internet is enabling mobilization like never before and, in the process, giving biotechnology companies fits. In recent months, St. Louis-based Monsanto Co. and its rivals in the new science of genetically engineering food have watched in dismay as pockets of protest have mushroomed... perhaps no single factor looms larger in biotechnology's tumble than the role of the Internet' [emphasis added].[3]
Byrne led Monsanto's counter attack. He is reported to have spent "a quarter of his time monitoring the Web for rogue and activist sites. He finds everything from activist sites to sites that provide even-sided discussions and debates about industry issues to those that paint Monsanto black."[4] Some of these he attempted to shut down. He gave advice to other PR professionals on the best ways to achieve this: "Anonymous sites often can be shut down by contacting the site's hosting company. To avoid any possible liability, hosting companies will shut down a site if they can't identify the owner, Byrne says."[5]
In February 2001 the owners of the monsanto.org site received a letter from Monsanto's lawyers telling them, "The information contained on your web site is defamatory, inaccurate and misleading". The letter also said, "if you do not immediately cease and desist from your conduct, as demanded by this letter, Monsanto will institute the appropriate proceedings against you without delay." Monsanto took legal action against the site in order to gain possession of the monsanto.org domain.[6]
Besides attacking critical sites, a significant part of Byrne's focus as an Internet strategist appears to have been on how to make Monsanto's case beyond the company's own websites and listservs. CS Prakash's campaign launched in January 2000 seems to have been of particular interest. According to one PR article:
- The site's listserv (AgBioWorld) generates more than 2,000 subscribers. Byrne subscribes and offers advice and information when relevant and ensures his company gets proper play.[7]
Byrne's exact role in the Prakash campaign's emergence can only be guessed at but there is evidence that the AgBioWorld site was designed by Monsanto's PR company Bivings Group and its original e-mail archive was covertly hosted on Bivings' main apollo server. The AgBioView list prominently circulated emails from Andura Smetacek and Mary Murphy attacking Monsanto's critics. Murphy's mails have been Bivings and Smetacek's to Monsanto, as is detailed in Andrew Rowell's book, Don't Worry, It's Safe to Eat.
At the end of 2001 Byrne ran a PR industry workshop in Chicago which was billed by its organisers, Ragan Communications, as showing how Monsanto 'brilliantly outwits its opponents at their own game of guerilla PR.' Byrne's presentation was accompanied by a PowerPoint display.[8] One of Byrne's slides, headed, "Take action/Take control", illustrated Monsanto's work on a particular search engine. Listed are the top search results for "GM food" before and after Monsanto took action. All the "before" sites are critical of GM; the "after" sites were mostly created by Bivings and include the Center For Food and Agricultural Research - the fake agricultural institute promoted by Smetacek.
Another of Byrne's slides is headed "Listservs: Directed & opt-in". It contains a single image: a thread of messages on the AgBioView list. The implication would seem to be that Monsanto uses this list for strategic PR purposes.
The content of Byrne's concluding slide is a quote: "Think of the Internet as a weapon on the table. Either you pick it up or your competitor does - but somebody is going to get killed."
Graydon Forrer and Philip Angell were colleagues of Byrne's at Monsanto.
What is the AstraZeneca Seroquel connection, you ask?
It looks like Byrne's company have a contract with AZ to monitor what is being said about Seroquel on the blogosphere.
But their system has a fault and one of those being watched got into the watchers system!
LOL
Explain that to your client Jay!
Thursday, April 15, 2010
Wednesday, April 14, 2010
Sunday, March 21, 2010
Thursday, March 11, 2010
J&J - Risperdal; Did J&J Plan to Break Rules?
Documents from a lawsuit by the state of Louisiana accusing J&J of off-label marketing shed fresh light on the company's long-standing desire to broaden the market for Risperdal beyond the ailments listed initially on the label—psychotic disorders linked to schizophrenia. J&J disclosed the documents from the suit, filed in the Opelousas district court in September 2004, after Bloomberg News asked the court to unseal them. The case is scheduled to go to trial in September.
As early as 1994, the filings show, the FDA ordered J&J's Janssen Pharmaceuticals unit, which developed Risperdal, to stop making false and misleading marketing claims about the drug's superiority to competing medicines. In 1999 the FDA warned J&J in a letter that its marketing materials for geriatric patients, including brochures, journal ads, and letters, overstated Risperdal's benefits while minimizing its risks. The letter said J&J misleadingly implied that Risperdal had been found effective for illnesses such as bipolar disorder and elderly psychosis. Months later J&J drew up a business plan that called for increasing Risperdal's market share in treatments for elderly dementia, aiming at $302 million in sales, the filings show.
"Egregious Examples"
Louisiana cited dozens of internal J&J files in its lawsuit claiming the company marketed Risperdal to the elderly and to children for unapproved, off-label uses. Professor Jerry Avorn of Harvard Medical School, who isn't involved in the case, says the papers add up to "one of the more egregious examples" of marketing drugs to vulnerable patients. Medical professionals know "that drug companies resort to unsavory practices to promote drugs," he says, but seeing the details of this campaign "is still pretty upsetting."More at BusinessWeek
Friday, February 05, 2010
Saturday, January 30, 2010
"Drug marketing is a very sophisticated system which corrupts every part of the scientific and medical network,"
A FLINDERS University study has exposed "corrupt" drug company marketing practices including covering up adverse side effects and pushing patients on to new, more expensive drugs even when they are less effective.
Psychiatrist Peter Parry and American colleague Glen Spielmans studied 400 internal emails and research documents unearthed mainly through court cases.
"Drug marketing is a very sophisticated system which corrupts every part of the scientific and medical network," Dr Parry said.
Dr Parry said one disturbing finding was that, regardless of the health benefits, drug companies were pushing patients towards their own patented drugs because they could make bigger profits. Such products were called "blockbuster drugs" in the industry because they could make more than $1 billion in profits.
The documents, sourced from US and European companies which also market and sell their products in Australia, indicate:
INSTRUCTIONS to sales representatives not to mention weight gain side effects of the drug Zyprexa.
HIDING the weight-gain side effects of anti-psychotic drug Seroquel.
EXAGGERATING the benefits of Seroquel over an existing medication.
DISTORTION of research trials by excluding the results of some patients, not publishing the findings or making up statistical reasons to exclude some "bad apple" results.
GHOST writing of medical journal articles by marketers with the names of doctors used as "honorary" authors.
All of the drug companies involved rejected the conclusions of the study, published in the journal Bioethical Inquiry, arguing the documents on which it is based are taken out of context as evidence in court cases.
Dr Parry said while he supported the use of drugs in psychiatry, all results of research should be made available to prescribing doctors.Source
Wednesday, January 27, 2010
Tuesday, January 26, 2010
This is a "must read"! - Marketing Based Medicine
Abstract: While much excitement has been generated surrounding evidence-based medicine, internal documents from the pharmaceutical industry suggest that the publicly available evidence base may not accurately represent the underlying data regarding its products. The industry and its associated medical communication firms state that publications in the medical literature primarily serve marketing interests. Suppression and spinning of negative data and ghostwriting have emerged as tools to help manage medical journal publications to best suit product sales, while disease mongering and market segmentation of physicians are also used to efficiently maximize profits. We propose that while evidence-based medicine is a noble ideal, marketing-based medicine is the current reality.