http://www.pharmamarketingblog.com/blogpost368.htm
Also see Pharma Marketing News OpEd Pieces
Group of 7 (code name "whiskey") Reports Unethical AZ Behavior to OIGPosted: April 12, 2007
This just in from Peter Rost (personal communication):
"We are a group of 7 honest AstraZeneca employees scattered around headquarters and field sales.
Our goal is for AstraZeneca to once again become an ethical pharmaceutical company.
We have been reporting unethical behavior to the Code of Conduct hotline 888 244-1769) for years. However, the company continues to violate policies developed under the HHS OIG Corporate Integrity Agreement. We are afraid that AZ is not properly notifying OIG
For more on this, see today's post
http://www.pharmalot.com/2007/04/the_astrazeneca_scandal_market/?akst_action=share-this
The AstraZeneca Scandal: Secret Memo Make a comment
By Ed Silverman // April 20th, 2007 // 3:52 pm
As the ‘Zubillaga newsletter affair’ unfolds, various memos are surfacing. The latest example was purportedly distributed in January to sales reps and makes comparisons between AstraZeneca’s Arimidex breast-cancer treatment and a Novartis rival called Femara. Such comparisons violate company policy, since there was no head-to-head study of these drugs.
For those who haven’t kept up, anonymous employees calling themselves the Gang of Seven have circulated the memos to various blogs, including Pharmalot. To date, the allegations in each of the memos remain unfounded, although a spokesman for the HHS Office of Inspector General confirms the agency is “aware” of this ongoing drama, but wouldn’t confirm or deny any probe. The drugmaker signed a Corporate Integrity Agreement with the OIG in 2003.
In any event, an attempt was made earlier today to contact the brand manager who allegedly authored this particular memo, but there was no reply. Since then, the memo has appeared on two other blogs, which chose to identify this person. The document, which was received today, is not on any letterhead, so the AstraZeneca employee shall remain nameless for now.
The complete memo discusses a medical journal article comparing two drugs other than Arimidex. Here are some excerpts:
“This reprint is being provided to you for YOUR BACKGROUND INFORMATION ONLY and is not for proactive distribution or discussion outside of AstraZeneca…
Happy New Year! …Our friends at Novartis have just poured gasoline on that fire that we all stoked…..IMAGINE THAT!…
…To be clear, the paper is for background use only and we don’t advocate anyone using this publication to sell Arimidex but attached are a couple thoughts on how this paper relates to our Arimidex messaging…
(At this point, the memo refers to data in a study comparing Femara, or letrozole, with a third drug, tamoxifen. The comparisons include the rate of discontinuation due to adverse events, the actual rate of any type of adverse event and life-threatening or fatal adverse events. By pointing to such data, the implication is that Arimidex would supposedly look better than Femara).
..Arimidex – The only AI with a 5-year consistent, and well established safety profile…Although the overall incidence of cardiac adverse events did not differ significantly between the two treatments, a trend for higher grade cardiac events on letrozole compared with tamoxifen was seen…
…While there is no single comment overtly called out in this paper I would put under this message, I would remind you to be proud of all the things we do to support women with breast cancer and the doctors who care for these people. We do it in a way that is not deceiving and in a way that puts patient’s health first…
…Ladies and gentlemen, this is the time to capitalize on what may very well be the biggest opportunity in 2007 for Arimidex…It is our job to behave like the market leader we are because ARIMIDEX has nothing to hide, and in fact, has answers to the questions people will want to ask. Patients and providers alike deserve to know just how good ARIMIDEX is at times like this!
For those interested in reading the brief, two-page memo, go here or here.[tags]Arimidex, AstraZeneca, Mike Zubillaga[/tags]
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Hepatotoxicity (from hepatic toxicity) implies chemical-driven liver damage. The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents. Certain medicinal agents when taken in overdoses and sometimes even when introduced within therapeutic ranges may injure the organ. Other chemical agents such as those used in laboratories and industries, natural chemicals (e.g. microcystins) and herbal remedies can also induce hepatotoxicity. Chemicals that cause liver injury are called hepatotoxins.
More than 900 drugs have been implicated in causing liver injury[1] and it is the most common reason for a drug to be withdrawn from the market. Chemicals often cause subclinical injury to liver which manifests only as abnormal liver enzyme tests. Drug induced liver injury is responsible for 5% of all hospital admissions and 50% of all acute liver failures.[2][3]
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Hydrocodone or dihydrocodeinone is a semi-synthetic opioid derived from two of the naturally occurring opiates, codeine and thebaine. Hydrocodone is an orally active narcotic analgesic and antitussive. It is commonly available in tablet, capsule, and syrup form and is often compounded with other analgesics like paracetomol or ibuprofen. It is marketed, in its varying forms, under a number of trademarks, including Vicodin, Symtan, Anexsia, Dicodid, Hycodan (or generically Hydromet), Hycomine, Hycet, Lorcet, Lortab, Norco, Novahistex, Hydrovo, Duodin, Kolikodol, Orthoxycol, Mercodinone, Synkonin, Norgan, and Hydrokon. Hydrocodone was first synthesized in Germany in 1920[1] and was approved by the FDA on 23 March 1943 for sale in the United States under the brand name Hycodan.[2][3]
The particular niches in which hydrocodone is most commonly used is as an intermediate-strength centrally-acting analgesic and strong cough suppressant, especially in those for whom histamine release and attendant itching from codeine is a problem. For the latter indication, at the 5-10 mg dose range hydrocodone is more powerful than most cough suppressants, being roughly equal to its derivative thebacon and with the top of the list being hydromorphone (Dilaudid Cough Syrup) and methadone (Methadone linctus, about 33 per cent the concentration of the liquid used for opioid physical dependence maintainence or detoxification).
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« Despite Indictments and Guilty Pleas, the HGH Industry Rolls On Main Bucket of Money Scandal: Reps Complaining as Early as March 4; Abraxis Linked? »
http://www.brandweeknrx.com/2007/04/at_az_a_potenti.html
April 16, 2007
At AZ, a Potential Smoking Gun Emerges in the Bucket of Money Scandal
Peter Rost this morning posted what appears to be an inexplicable set of PowerPoint slides from the AZ Group of 7 whistleblowers. The entire slideshow (see download below) is a comparison of AZ's Arimidex anti-cancer drug vs. Novartis' Femara drug. I hope I don't have to remind you at this stage that it is against AZ's internal policy (which in turn is controlled by its corporate integrity agreement with the government over the Zoldex scandal), to market Arimidex in comparison to Femara. Especially as the two drugs have never, according to Rost and his sources, gone head-to-head in proper study.
The icing on the cake? AZ reps' performance review forms included a section where supervisors are asked to rate reps on: "Product Initiatives- Arimidex (1) Grow at expense of Femara (2)." See second download below.
In the journalism world, we call these "Smoking Guns."
Ed from Pharmalot points out that the mainstream media has had its lunch eaten by Rost et al on this story. Given that it involves breast cancer, breaking the law, and greed ... it's a matter of time before the big boys wade in.
One last thought: Take a look at AZ's full press statement from Friday (see third download). It's a lengthy explanation of AZ's official position, the fact that it is responding by investigating the allegations, and an explanation of how it frowns upon this type of wrongdoing. This is what good crisis PR looks like. They're not ducking it, spinning it or pretending it doesn't exist. Yes, it is going to suck at AZ for a while, but if the company can be seen to be doing the right thing and not trying to persuade us all that this is somehow 'not a story,' then it will be over faster and with less lasting damage.
The proof now will be in the pudding: Will AZ tell the public the results of their probe? Or will we have to get that from the OIG and the Group of 7 six months from now? I would recommend AZ be first out of the gate on that one.<>
Download ATACvsBIG1-98-1.ppt
Download 2007bscpsstemplate1.doc>
Download oncology_newsletter_az_highest_ethics_statement_4.13.07 final v2.doc
Posted on April 16, 2007 Permalink
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http://azgroupof7.blogspot.com/
Wednesday, May 30, 2007
AZ Seven release Memo That Forbids Reps Handing Out Cupcakes to Patients
As seen on Question Authority:From: Paskman, AndreaSent: Tuesday, May 01, 2007 4:49 PMTo: Danhoffer, Ronald E; Hardesty, Edward L: Russel, Joseph; Cioll Richard E (ONC DSM); Karcewski, Thomas M; Call, TeresaCc: Kelly, Shawn; Hagelbarger, Jeff ASubject: FW: MUMs ProgramsImportance: HighFor those who have been asking about the MUMs program:Recently, questions have been raised to both legal and compliance personnel regarding the sales force’s ability to distribute patient educational materials for the MUMs programs. During the month of May 2007, the sales force will be permitted to conduct such in-office MUMs programs, however the following provisions apply:1. Approved patient education materials may be distributed to patients in the office on behalf of, and with the permission of , the HCPs2. PSS may display patient education materials on a small table in the office waiting room3. The provision of food, snacks, beverages, and/or flowers to patients is not permitted.The future of the MUMs program and similar in-office programs is currently being evaluated. You will be notified once the evaluation is complete.
Posted by John Mack at 11:20 AM 0 comments Links to this post
Labels: cupcakes
Tuesday, May 29, 2007
AZ Group of 7 Believe OIG Probe of Arimidex Marketing Is Stalled
Source: BandweekNRXJim Edwards over at BrandweekNRX just finished having a nice chat with one of the Group of 7 whistleblowers at AZ. He had several updates, including:1. That this is not the first time that AZ has indulged in an improper promotional campaign in which reps were encouraged to compare Arimidex to Femara even though there was no data supporting such a comparison. An earlier campaign took place in 2000 and 2001 (see download at the end of this post). Internal sales slides show: "During 2000 and 2001 we talked about Femara on 61% of our sales calls." In fact, according to the slides, the company regretted not spending more time talking about the opposition.Why is this a big deal? AZ's agreement with the OIG not to engage in comparison selling was not enacted until 2003. The Group of 7 believe this is a big deal because even though such an agreement was absent, such comparisons—when there is no data backing them—are still generally frowned upon by the FDA."The FDA would say there's no way in hell you can do that," the whistleblower told me. "For 2 years they campaigned off-label and then they turned around and did it again."2. The OIG has not contacted the group even though "I've offered to give them any information they want" regarding AZ's violations of the corporate intergrity agreement that the company has signed with the OIG back in 2003.3. He alleges that the salesforce trainer whose voice is on the roleplay tapes in which Armidex is compared to Femara (even though there is no data comparing the two) is the same AZ exec who hosted a phone conference with AZ sales reps earlier in May in which reps were given guidance on what they can and cannot do to promote Arimidex.4. He gives "credit" to AZ management for not attempting to find the Group of 7 or retaliate against them. "There has not been a witchhunt...there seems to be an effort to clean this up."5. He gave me another presentation slide which looks very much like a comparison of Arimedex vs. Letrozole (see second download at the end of this post.)Bottom line: Now that AZ has fired two execs on this issue, the OIG's credibility is on the line. If it becomes known that the OIG doesn't bother to investigate violations of its own corporate integrity agreements, then there will be no incentive to follow them...and drug compoanies will stop bothering to fire execs who break them.Get more documents here.
Posted by John Mack at 1:23 PM 0 comments Links to this post
Labels: OIG
Wednesday, May 2, 2007
“ZubeGate Story” Leads to Congressional Letter and Inquiry
One month ago Whistle Blower extraordinaire Peter Rost wrote the article AstraZeneca: "There is a big bucket of money sitting in every [doctor's] office.This post led to the termination of one sales director, comments by AstraZeneca's CEO, OIG involvement, many newspaper articles, a CNBC segment, and now, a letter from Congressman Pete Stark, Chairman, Ways & Means Subcommittee on Health to Daniel Levinson, Inspector General, Department of Health and Human Services.Read more about this here...
Posted by John Mack at 3:51 AM 1 comments Links to this post
Labels: OIG
Tuesday, April 24, 2007
Secret AstraZeneca Audio Tapes
Secret AstraZeneca Audio Tapes: Violation of Corporate Integrity Agreement?Question Authority has just obtained internal AstraZeneca training tapes (download below), which appear to confirm that AstraZeneca may be in violation of its Corporate Integrity Agreement with the Office of Inspector General of the United States Department of Health and Human Services. If such a violation is confirmed, it could in a worst case scenario result in exclusion of AstraZeneca from selling drugs to the Federal Government.Here's the background...
Posted by John Mack at 2:30 PM 0 comments Links to this post
Labels: Secret tapes
Saturday, April 21, 2007
New Whistle Blowers: The Abraxis 300
Source: Question Authority ("Quote of the day: Abraxis BioScience")AstraZeneca's "Zubegate" is moving over to Abraxis BioScience's message board on CafePharma.This appears to be a comment by an Abraxis BioScience sales rep. If so it supports what AstraZeneca's "Fantastic 7" have claimed:"If I were a MSL or DSM, I will be very concerned because they are all complicit in off-label promotions. I have been told many times by my manager to use MSL to promote off-label and NEVER to put anything on email or in writing.AZ counterpart received the same instruction. It is time we unite and do what the Gang of Seven at AZ has done. We should be policing our MSL, DSM, BF, CM, JH, RAMs, and make sure that we document and report all illegal activities. I still don't know the basis for my ridiculously high sales target!Today the Abraxis 300 is born to fight corruption, illegal marketing, offlabel promotions, sex discrimination and incompetent incompetence of the ABBI management."To the "Abraxis 300" sales reps: Write rostpeter@hotmail.com with more tips and information. If credible, it will be published.
Posted by John Mack at 4:15 AM 0 comments Links to this post
Labels: Abraxis 300
Friday, April 20, 2007
New Memo Surfaces
Hat Tip to Peter Rost (see "Another secret AstraZeneca document revealed!")
Date: January 9, 2007
From: Matt Lehman, Brand Director Arimidex
Department and Location: Breast Cancer Brand Team
Subject: BIG 1-98 51 month analysis publication
This reprint is being provided to you for YOUR BACKGROUND INFORMATION ONLY and is not for proactive distribution or discussion outside of AstraZeneca
Happy New Year!
We provided the sales organization with more aggressive HCP messaging and established some good momentum closing out 2006. We are conducting training as we speak on new material to support those messages to re-ignite that energy here in January. Continuing to kick off 2007 with that same energy is vital to our success. Our friends at Novartis have just poured gasoline on that fire that we all stoked…..IMAGINE THAT!
BIG 1-98 Update
Please see attached the publication of the 51-month data analysis we first heard about at ESMO last year. It was just published in JCO and is below for your background information. The areas of differentiation, which the team has been focusing on, are supported or reinforced in this paper. There is scheduled training through the end of the week where this information will be included so each and every PSS and DSM is aware of the publication.
AstraZeneca thoughts reflections on the publication
To be clear, the paper is for background use only and we don’t advocate anyone using this publication to sell Arimidex but attached are a couple thoughts on how this paper relates to our Arimidex messaging.
Arimidex delivers the proven efficacy benefit she needs..whatever her risk of recurrence
Remember Letrozole was highlighting the efficacy they have in node positive disease and patients previously receiving chemotherapy? Please see the author’s commentary under results/efficacy on page 4…”We explored various protocol-defined subgroups to identify whether there was any apparent difference in the relative efficacy of letrozole on DFS compared with the overall benefit observed. NO SUBGROUPS SHOWED SIGNIFICANLY DIFFERENT RELATIVE EFFICACY; IN PARTICULAR NO SIGNIFICANT HETEROGENEITY WAS OBSERVED BY NODAL INVOLVEMENT STATUS OR PROGESTERONE RECEPTOR STATUS.”
ARIMIDEX – The only AI with a 5-year consistent, and well established safety profile
Also on page 4 under results: “More patients in the letrozole group discontinued trial treatment early as a result of an adverse event (12.3% of patients on letrozole and 11.1% of patients on tamoxifen.) On the top of page 5 they go on to say: “More patients receiving letrozole compared with patients receiving tamoxifen, reported at least one adverse event of any grade (2,292 patients v 2,165 patients respectively) and at least one life-threatening or fatal adverse event (113 of 2,2448 patients [4.6%] v 92 of 2,447 patients [3.8] respectively.”
ARIMIDEX – No significantly increased risk of CV morbidity or mortality vs. tamoxifen
Further down on page 5 the authors commented “Although the overall incidence of cardiac adverse events did not differ significantly between the two treatments, a trend for higher grade cardiac events on letrozole compared with tamoxifen was seen.” This is drawn out in table 2 just below the comments.
AstraZeneca is committed to helping you support her everyday
While there is no single comment overtly called out in this paper I would put under this message, I would remind you to be proud of all the things we do to support women with breast cancer and the doctors who care for these people. We do it in a way that is not deceiving and in a way that puts patient’s health first.
Is there more?
This paper goes on to mention several other very important observations/conclusions that support the need for mature safety and efficacy data. It is acknowledged there are higher event numbers seen early on during treatment (What You Do First Matters Most), and they normalize DFS definitions and then compare the efficacy results to what was seen with ATAC. The potency they have claimed to possess doesn’t seem to translate to more efficacies. The question really is: Does it translate into something being seen on the safety of letrozole?
Onward!
Ladies and gentlemen, this is the time to capitalize on what may very well be the biggest opportunity in 2007 for Arimidex. Questions will arise after the oncology community takes a moment to learn about this new information. It is our job to behave like the market leader we are because ARIMIDEX has nothing to hide, and in fact, has answers to the questions people will want to ask. Patients and providers alike deserve to know just how good ARIMIDEX is at times like this!
Posted by John Mack at 2:09 PM 0 comments Links to this post
Labels: Head-to-head comparison, Memo, More dirt
Monday, April 16, 2007
More Dirt, I Mean Proof of Questionable Practices
This just in from Peter Rost at Question Authority:
The AstraZeneca “Group of Seven” has just provided Question Authority with additional proof of questionable promotional practices in connection with selling of AstraZeneca’s cancer drug ARIMIDEX ® (anastrozole), used for postmenopausal women with hormone receptor-positive early breast cancer, against Novartis' FEMARA® (letrozole), used for treatment for postmenopausal women suffering from female hormone imbalance with early stage breast cancer.For the details see "The AstraZeneca Controversy Increases with More Proof of Questionable Practices"Rost Credibility an Issue?Make sure you read the comments, such as:
You have got to be kidding me!!!First off....Arimidex is not an injectable drug. It is a daily oral medication and has no similarity to Zoladex!!Second of all, how can you question why a representative should know about the compitition. You are clearly on a witch hunt with this as this slide deck appears as background information and is anything but "proof" of improper marketing practices.I commended your efforts initially on this subject, but now you have goine beyond following the truth and jumped in to "Jerry Springer" type hype!!Jim Edwards over at BrandweekNRX had this to say:
Peter Rost—who has been leading the charge on this in a way that is most irritating for us professional journalists who, you know, would like to be able to check the facts ‘n’ stuff before writing—has shared with me some more email he got from the Group of 7. (see "AZ 'Bucket of Money' Whistleblowers Allege Off-Label Campaign Occured; AZ Switches Global Marketing Execs").
Posted by John Mack at 7:53 AM 5 comments Links to this post
Labels: More dirt
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AstraZeneca Internal Probe Over for Now
Senate OKs Reimportation, Safety Delayed
J&J Stent Fails in Test, Opening Door for Rivals
Schering-Plough Could Reprise Claritin in Combo
WSJ Opinion: Thai Flu Moves South
Some doctors say DTC ads create informed patients
The Advertising Coalition Calls for Campaign Against Kennedy-Enzi drug-safety bill
Former FDA Chief Says Agency Is “Broken”
Drug-Import Window Opens
TV continues to attract pharma’s media spend: Nielsen
More firms say they will divulge CME grants
Clinton deal to lower AIDS drug costs
DTC Moratorium Yanked From PDUFA
Mandatory HPV vaccine push ends in Texas
Pharma's Med Ed Gets Low Grade From Congress
Senate Passes Drug-Safety Reforms
Medical Journal Questions Gardasil Efficacy
Purdue Guilty in Oxycontin Case, to Pay $634 Million
Oral Sex Might Lead to Throat Cancer
Lawsuit papers show J&J push for doctors to prescribe Procrit
In Guilty Plea, OxyContin Maker to Pay $600 Million
Concern Rises Over Anemia Drugs
Bristol admits lies in Plavix probe
The Danger in Drug Kickbacks
Physician Blogs Spark Concerns About Privacy, Accuracy of Information
Pharma Makers Find New Flavors for 'Yucky' Drugs
Washington Whistleblower Week
Black Wednesday at the FDA
Editorial Calls on House to improve Senate FDA bill
Pfizer in court clash with British drug authority
No ED Gel in GSK's Futura
Medicare May Limit Anemia-Drug Money
Study: Diabetes drug use spikes in girls
Weinstein braces for SICKO backlash
Senate Panel Discusses Ways To Limit Online Drug Companies
Our Lawless FDA
Cell phones as medical devices?
Pharma Shopping Channel?
SiCKO Triumphant at Cannes!
Pfizer Shifts Leadership
WSJ Advises on How to Purchase Drugs Abroad
Sequel for Vioxx Critic: Attack on Avandia (part 1)
Doctors, Legislators Resist Drugmakers' Prying Eyes
GSK Touts Over-The-Counter Diet Pill
Avandia Concerns Reopen a Wider Debate
Regulators Sought Avandia Warning, U.S. Lawmaker Says
FDA Data on Gardasil May Fuel Controversy
Years Ago, Agency Was Warned of a Avandia’s Risks
For Drug Makers, a Downside to Full Disclosure
FDA Study Said to Show Avandia Risk
Glaxo Courts Doctor Support of Avandia
Grassley, Baucus bill would enhance research on pharmaceutical safety and effectivene
Avandia case similar to Vioxx failings
Clinton Sees $120 Billion In Health-Care Savings
Avandia Heart Safety Trial in Jeopardy
Is Big Pharma Shifty as Well as Greedy/
Ketek: Drug's chilling path to market
Effective, Yes, but Is It Safe? A Drug’s Risks
How Far Will Avandia Fall?
Glaxo Shares Rise After Company Questions Report on Avandia
Pfizer Charged in Nigeria With Using Children as Test Subjects
States: Beware of Pharma Lobbyists Bearing Gifts
Jazz to Sell Shares
F.D.A. Still Unsettled in Wake of New Questions
Avandia Critic Claims FDA Smear Campaign
Glaxo, Top Ad Spender, Didn't Publicize Diabetes Drug's Risks
Viagra May Kill Your Sperm
GSK: “Why would you publicize it?”
Zheng Xiaoyu Meet Lester Crawford
Pfizer Faces New Charges Over Nigerian Drug Test
After Sanctions, Doctors Get Drug Company Pay
Lynch 'Em -- FDA Asleep on Drug Safety
Big Pharma Doesn't Like How It Looks on YouTube
Avadia puts FDA in spotlight
Give FDA More Authority to Monitor Drugs After Approval
LyonHeart Challenges Conventional Ad Agency Thinking
DTC Advertising Improvements Observed In Two New Reports
Glaxo's Avandia Fuels Arguments for Tougher Drug Laws
A positive attitude may not solve all your problems, but it will annoy enough people to make it worth the effort.~Herm Albright~
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