Exposure Is A Good Thing…..
Australian class action against Merck in the federal court began 3-30-2009 in Melbourne. Merck is fighting this class action- risking the copious amounts of dirty laundry of theirs being exposed to the world. Their confidence and ego as an entity are clearly inflated.
Plaintiffs are led by Graeme and Peterson law firm. The judge is Chris Jessup.
Trial is expected to take a critical look at the autonomy, behavior, and marketing tactics of Merck. Reports and articles from this trial since it has started follows:
3-31: Merck employee David Loker had both his parents die while on Vioxx. David considers Merck’s defense regarding Vioxx rightfully a bit too much to swallow. Merck is being accused of ignoring clinical tests, which they did if the tests did not favor Vioxx. Just because something is ignored or is not discussed certainly does not mean it does not exist.
Vioxx linked to CV events was acknowledged in 1998. Merck employee and laboratory head Ed Scholnick was troubled and worried about research results recently linking Vioxx to CV events in the year 2000. Yet no action was taken by this man high up the corporate ladder of Merck, and action should have been taken to save the lives of others.
4-1: Merck made a hit list of doctors who had to be neutralized and discredited due to criticizing Vioxx, and recommended a course of action, which included intimidation tactics as damage control. The doctors were primarily researchers and academics, as Merck was seeking KOLs. Key Opinion Leaders are coerced by Merck to present Vioxx with intentional bias, as Merck is paying them for this role with their company.
Merck’s culture is illustrated that seriously impinges on academic freedom. Mr. Peterson is accused by Merck of not taking Vioxx months before his myocardial infarction, based on filling of a prescription of Vioxx. Not taken into account is the samples of Vioxx Mr. Peterson likely took in the months before his MI.
4-2: Dr. Paul Anderson was unaware of the cardiovascular risk associated with Vioxx, and would not have prescribed this drug had he known this association existed. This overtly exposes Merck’s unbalanced representation of the qualities of Vioxx.
4-9: Merck hires guest authors, such as scientists, doctors, and academics, for research constructed by Merck, as well as Merck constructing entire journals that are deceptive to others intentionally. All data presented to others from such bastardization of the scientific method is likely harmful to both health care providers and the patients who may take Vioxx as a result.
4-15: Dr. John Dickman states that over the course of 3 years, the multiple visits by Vioxx sales representatives never disclosed the risks of Vioxx and cardiovascular events. This is not unusual, as pharmaceutical representatives are only concerned with increasing the number of prescriptions of products they promote to doctors. Balancing their conversations with doctors regarding their promoted products provides no benefit to the representative, and would be against their monetary goal.
4-16: Aggressive sales strategies shared with the court implemented by Merck and the marketing of Vioxx. Sales representatives with Merck were directed to utilize objection handling cards if anything negative about Vioxx was brought up by a prescriber. This, apparently, was felt necessary by Merck so that the sales representative would not engage or research any negative qualities associated with Vioxx.
Merck implemented a highly sophisticated and well-resourced marketing campaign that was able to minimize the awareness of safety risks that exist with Vioxx. This included telling Vioxx sales representatives that cardiovascular risks being associated with Vioxx is outright lies generated by competitors of Vioxx. This seemed to comfort the Vioxx sales representatives, and sedate any concerns they may have had about this very serious issue.
4-17: Merck implements quid pro quo with bribing targeted doctors so they will prescribe more Vioxx. This in itself is illegal in the United States at times, as it violates the federal Anti-Kickback statute.
Merck gives its sales representatives a ‘budget spend’, and requires them to exhaust the budget within a certain time frame. So obviously Merck representative are anxious to bribe doctors for this reason alone.
They determine such doctors by the prescribing data they have on each doctor due to the AMA selling prescribing data to the pharmaceutical industry in the United states that makes the American Medical Association about 50 million dollars a year.
4-18: Merck intends to bring a Vioxx human commercial to Australia to increase market share of Vioxx at this location, which actually is Merck attempting to acquire a new host for their damaging virus. Also, again it is stated the obvious- that Merck insists on minimizing potential adverse publicity while maintaining credibility of both Merck and Vioxx. With this trial, Merck is maximizing adverse publicity and disintegrating the credibility of the organization.
4-20: Merck creates an Arthritis Advisory board with the intent to mask this board as a front group to gain support for Vioxx both in Australia in Asia. This, they believed, would have more credibility than Merck attempting to accomplish this goal alone as a company.
One objective of this board, who was paid 2000 dollars each member at every meeting by Merck, was to publically state that Vioxx was superior to similar drugs, as well as offering positive advice about Vioxx to regulatory agencies. The board’s members at times were used by Merck without their knowledge to facilitate the profitable efforts of Merck regarding Vioxx.
While stating that this board was to educate others, it clearly was created to promote Vioxx. Front groups similar in nature to this one are often created by big pharmaceutical companies to expand the diagnostic boundaries of a specific disease state to increase the growth of their promoted product. What they call brand conditioning really is disease mongering.
4-22: Merck scientist and senior VP of Merck’s research laboratories Alise Reicin expressed concern about the CV issues associated with Vioxx in the year 1997. Dr. Briggs Morrison, a colleague of this scientist, was aware through this email of the Vioxx concerns 2 years before the drug got FDA approval in the United States.
4.24: Merck attempts to encourage their Vioxx sales representatives with ridiculous songs. This is nothing short of cult-like behavior. Merck wants their sales representatives to be passionate about a tangible object- Vioxx. Merck wants them to be void of objectivity, as this will to be to the benefit of Merck. The whole subculture of Merck seems to think that their vocations are some sort of TV show or movie. Fictional. Not illustrating the importance of what they should know and do.
4-24: Merck has hired a crisis management team and media relations firm to supplement their own litigation communications team for this trial to save face. This team and firm are largely failing, it seems. At this point, Merck is not going to be able to offer interpretations of what is being presented in this trial about a month old at this point.
4-28: Documents illustrate that Merck Vioxx sales representatives are extrinsically motivated primarily by money, and this is what Merck wants their primary motivation to be working for them. Helping the rich get richer can be deadly for others.
Merck representatives, as with other pharmaceutical representatives in the United States, rarely have a medical background or knowledge. Merck knows this, so their training mainly consists of how to manipulate prescribers and bribe them to grow the market share of products these representatives will promote for them. It is unlikely that these representatives understand cox II inhibition, the inflammatory process, the disease state of osteoarthritis, or the fact that if something is a drug, it has side effects. If a drug does not have side effects, it is not a drug.
4-29: Additional remuneration via dinners and nice hotels paid for by Merck for selected and target doctors potentially or actually core to the growth of Vioxx. It’s likely that Merck would not engage in such activities with doctors that are catalysts for their monetary growth if such activities were not effective.
5-5: Merck makes the claim that clinical studies involving Vioxx are contradictory often, and therefore Vioxx cannot be labeled a cardiovascular risk for patients. Yet Merck proved beyond material extent that the evidence from these clinical trials clearly showed that Vioxx did in fact increase the risk of heart attacks for those who take the drug. Yet if Vioxx is making over 2 billion dollars a year for Merck, such concerns are of little importance to the company.
5-6: Merck hired a heart expert in the United States to go to the Australian trial to praise Vioxx and its benefits and safety. Dr. Douglas Vaughan. Vioxx was promoted the safety of Vioxx through its sales representatives on every dialogue with a prescriber, as well as superior efficacy that did not exist compared with other cox II inhibitors and NSAIDS.
5-7: Elsevier in collusion with Merck’s deceptive marketing ploy by faking an independent medical journal for the benefit of Merck’s Vioxx, and others. Elsevier’s admission in this cronyism only happened when it was forced to do so due to various factors that were going to become transparent. Elsevier’s business model largely is directed at facilitating the marketing efforts for companies like Merck. Normally this business model of theirs is quietly implemented. This case is rare here.
5-7: Merck accused of making scientifically unsound claims generated from corrupted and invalid studies created by Merck, as claimed by Vioxx critic and Rheumatologist, Les Cleland. It appears the accusations are indeed with merit, as the evidence is overwhelming.
5-12: Merck convinces regulators, such as the FDA, to soften the warnings they insist on putting on the Vioxx label now three years after the drug has been on the market. The FDA considers such companies as Merck ‘clients’, due in large part to what is known as the PDUFA (Prescription Drug Users Fee Act). Created to speed drug approvals and have drug companies pay the FDA to do so, this act now accounts for over 50 percent of the FDA’s entire budget. The FDA is supposed to strictly regulate, and not serve those entities that may harm others.
5-14: Merck attempts to stall safety and pricing probes about Vioxx. The reasons are obvious.
5-23: The money spent by Merck for promotional tactics is illustrated. Merck, as with other large pharmaceutical companies, spends more money on marketing than they do on research. The plans involving these tactics are approved by various marketing leadership of Merck. Their strategies involving their tactics created with deliberate intent and reckless disregard were implemented with complete autonomy.
6-8: Merck planned to set up patient loyalty programs to assure greater compliance regarding such patients taking Vioxx. This was developed by Merck simply so patients would take Vioxx for a longer period of time. Think of it as a superior version of direct to consumer advertising.
Merck, I believe, is relying on the apathy of others as information continues to be shared from this trial. Thank you Milanda Rout at “The Australian” for your dedication in sharing with the world what is happening with this trial:
I just wanted to say a belated thank you for your lovely comments about my coverage of the Vioxx trial – much appreciated!
I also note with interest that you were once a Merck sales representative – I would love to have a chat with you (off the record if you prefer it) about your experiences at Merck with Vioxx if that would suit you. I am interested in doing a more in-depth piece about the issues that the trial raised after the court process has finished.
Level 2, West IBM Centre,
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From: Robyn Clothier [mailto:firstname.lastname@example.org]
Sent: Monday, 25 May 2009 10:12 AM
To: Rout, Milanda
Subject: FW: Check out vioxx - The Australian Search
I thought you might be interested in these comments from one of our members – a former pharmaceutical representative in the US.
May I add my congratulations on your excellent work, which we have been following closely.
Healthy Skepticism Inc
34 Methodist St
Willunga SA 5172
Ph/Fax: +61 8 8557 1040
From: Diohdan@aol.com [mailto:Diohdan@aol.com]
Sent: Wednesday, 20 May 2009 1:05 PM
Subject: Check out vioxx - The Australian Search
Click here: vioxx - The Australian Search
The Australian has done a wonderful job exposing what were tacit tactics utilized by Merck to promote Vioxx. This would not have happened in the U.S., I'm sad to say, this kind of exposure.
I launched Vioxx as a representative with Merck back in 1999.
Aside from looming patent experations from two of Merck’s ACE Inhibitor hypertension drugs, Vasotec and Prinival, as well as their first statin drug, Mevacor, this drug was very important to Merck for two other more concerning reasons: One is that Lipitor, which was approved in 1997, rapidly acquired the lion's share of the statin market (Merck has the lion's share of this class of medications with Zocor before this happened). Merck was not prepared for this rapid uptake of Lipitor, and this vexed Merck greatly.
Secondly, Vioxx got approved 6 months after Celebrex, and this concerned Merck. Historically, the drug that is first in class that gains approval first will capture the lion's share of the market, and maintain the lead over the competitors- in this case, the Cox II class of medications.
Celebrex getting approval before Vioxx concerned Merck as well. So the plans implement read almost daily in The Australian are plans that were implemented in the United States as well. Merck was desperate, and clearly was willing to cross ethical lines to assure Vioxx would be the success that Merck needed it to be due to competition.
What we read about this trial that continues is accurate, even though merck is saying in defense that most of we read is 'mis-statements', or embellishents. What we read is true, and the ethically if not legally corrupt plans of actions implemented by Merck were with deliberate intent and reckless disregard as they continued to strive to gain additional market share with an unsafe drug of theirs.