UCSF Drug Industry Document Archive: More on Doctors and Big Pharma
The University of California at San Francisco has created a fascinating archive of documents concerning the marketing drug industry. Among them are the public records of several law suits as well as Congressional hearings. These include suits against Parke-Davis for the marketing of gabapentin (Neurontin), against Merck for the sale of Vioxx (Cona et al vs. Merck, Humeston v. Merck & Co, Hermans et. al v. Merck & Co., Ernst et. al. v. Merck & Co) as well as the Grassy and Waxman Congressional Hearings. The site contains links to external documents (press reports, academic articles, government documents) which provide further context.
Among the many fascinating documents is a list of physicians that Merck sought to “neutralize/discredit” because they were not favorable enough to Vioxx. Some of these names come with an ominous all-caps and bolded “NEUTRALIZED” under their names. Each physician has noted down their contact information, affiliations, a detailed description of why they are problematic, and a recommended plan of action.
Dr. John J. Condemi, a speaker for Searle (a Merck competitor) was someone targeted for neutralization. According to the documents Dr. Condemi had the following background: “Thought leader in the community and Upstate NY; speaking on behalf of Searle as an advocate and investigator; recently enrolled him in a clinical trial (RA) after many months of promises and hard effort; not entirely certain this wasn’t too little, too late; speaking to community physicians at programs sponsored by Rochester Blue Cross Blue Shield (80% market share in a 90% managed care market); have not been in attendance at these meetings, but can imagine that VIOXX has not been mentioned nearly as often as Celebrex; has trained many of the RHU in the Upstate area and is considered the expert by many (thus, the reason BC/BS has used him as a speaker); has done studies on FOSAMAX and SINGULAIR but for some reason was slighted by us for VIOXX; wants to be involved with VIOXX.” As this document shows one of the ways to win physicians is to enroll them in “clinical trials.”
The plan for Dr. Condemi is as follows: “Provide scientific information; research; interested in NSAID-induced asthma; provide investigator slides to balance presentations; personal visit by a “heavyweight” from MRL or CDP (Greg Bell or Greg Geba) to discuss where we want to go with VIOXX; could work with him to develop a clinical pathway for COX-2 inhibitors in a managed care setting; panel with Dr. Singh of Stanford and some others to focus on pharmacoeconomic studies which verify reductions in PPI or H2 blocker use. – He is in a clinical trial; – He is attending a program given by Dr. Geba – Speaker – doing a good job”
Dr. Max Hamburger, President of a large, private Rheumatology practice in Long Island (New York) is listed as having become an ADVOCATE. Here the hook was not a clinical trial but rather financial support. Hamburger’s practice was important to Merck because it included “high volume prescribers” who were users of Celebrex (an anti-inflammatory drug that competed with Vioxx). Here is how Merck characterized the situation presented by the practice: “companies that provide funding will receive preferred status with its members and those that do not will have trouble accessing the IPA members; first endeavor is to put together a “Standards of Care” retreat meeting to develop a document that will serve as their manifesto (to include a drug formulary and how the members will treat certain diseases, preferred medications); price tag is $25,000 to support this meeting and to have access during it.” In its recommendation the document concludes: “Financial support of private practice rheumatology IPA – (has taken place). Has been turned around.” Such horse-trading is worthy of a grade B movie. It is important to remember that we are talking about highly expensive and dangerous medicines. And patients who trusted their physicians to provide the best-possible clinical advice, not suggestions based on which drug company was willing to finance their practice.
This types of relationships form part of the context for a recent JAMA article recommending that professional medical associations sharply curtail their reliance on drug companies for financing (Rothman et. al. Professional Medical Associations and Their Relationships With Industry: A Proposal for Controlling Conflict of Interest, JAMA 2009;301:1367). The document offers a number of specific recommendations and concludes: “PMAs should work toward a goal of $0 contributions from industry; they should not collaborate in or profit from industry marketing activities; PMA leaders and executive staff should be free of conflict of interest and, in time, so should the entirety of the board and the members of the practice guideline committees.“ Since so many of the “leaders” in organized and academic medicine have close financial ties to industry, this is essentially a call for revolution.
How much such a revolution come about? It would seem to us that the only way would be in the context of a universal, publicly funded and administered health care system which is measured by its ability of efficiently protect and promote the health of the populace. Is that a revolutionary idea?
posted by Matt Anderson, MD
The Atrophy Of Objectivity
If I were to rate the corruptive tactics performed by big pharmaceutical companies during my intimate experience with them , the frequent and intentional strategy of implementing fabricated and unreliable results of clinical trials performed by others possibly tops the list of corruptive tactics by the pharmaceutical industry that sponsors such trials.
By this atrophy of the scientific method absent of authenticity that has been known to occur, harm and damage is possibly done to the health of the public.
The marketing protocol for pharmaceutical clinical trials includes designing the clinical trial protocol and having the ability to oversee this trial. Also, they select targeted investigators and the clinical trial sites. The sponsor runs investigator meetings, as well as select and control contract research organizations (CROs). The sponsor also performs data assessment, as well as completes the clinical trial so it can be published in a journal chosen by the sponsor.
Most would agree that the science of research should be sound and as aseptic as possible- completely free of deliberate and reckless interference. However, it appears, money and increased profits can be a catalyst for disregard for human health with the clinical trial process that is largely unregulated.
This is particularly a factor on post-marketing studies of various pharmaceutical companies, as some pharmaceutical corporations seem to be deliberately conducting nothing less than seeding trials- with about a 50 percent tax credit for these trial sponsors. Trials that are in fact pointless and void of scientific benefit.
Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of drugs and devices to benefit mankind. Then, in 1980, the Bayh-Dole Act, Public Law 96-517,was created, which allowed for such places with their researchers can profit off of their discoveries that were performed for pharmaceutical companies and others in the past.
Furthermore, such academic institutions were coerced to license patented inventions to those pharmaceutical companies that will then commercialize these discoveries paid for in large part by the taxpayers who funded this research to a degree.
This resulted in the creation of for-profit research trial sites without any academic affiliation that are called Contract Research Organizations. CROS utilize primarily community patient care clinics whose staff are absent of any research training compared with the former researchers that existed decades ago.
Because of this structure, the clinical trial investigators of these pharmaceutical sponsored trials are likely novice compared with academic researchers.
This, of course, happens with intent by the sponsor who can and does control all aspects of the clinical trial protocol at the site locations of a clinical trial that the pharmaceutical company structures and even gives the trial the title they want for their marketing purposes.
These quite numerous CROS are in fact for- profit, with some CROs making billions of dollars a year, and this market continues to grow.
The trials conducted at such places again are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their particular drug chosen to be studied.
Etiology for their deception regarding this manipulation is because the pharmaceutical company that sponsors such a trial is basically creating a marketing tool for this drug of theirs to be studied in this manner. This coercion is done by various methods of deception in subtle and tacit methods.
As a result, research in this protocol of the sponsor ensures favorable results of the sponsor’s medication that is involved in the clinical trial they clearly own.
These activities are again believed to be absent of true or applied regulation to any degree, and therefore have the autonomy to create whatever they want to benefit the pharmaceutical sponsor.
There likely is a collusive relationship between the sites, the CRO, and the sponsor, as this whole system is planned beforehand by the pharmaceutical sponsor of their clinical trial to again be utilized to increase the market share of the drug studied that they promote.
Guest authorship has been known to be aggressively recruited by sponsors by paying a known opinion leader to sign off on the completed clinical trial. The author’s duty includes making noted cognitive contributions to a published clinical trial, as well as revising and drafting the clinical trial.
Furthermore, the pharmaceutical sponsor recruits investigators to be used for this function of what ultimately is a fabricated clinical trial protocol. The trial manuscript and protocol design is prepared by those employed by the drug company sponsor upon specific direction of this sponsor on how this should be prepared.
The medical program coordinator of a particular sponsored trial is an actual employee of the sponsoring drug company and also may act as the publisher, manuscript version reviewer, and the clinical trial director who works with the drug company’s hired CRO editors whose objectives are to benefit the sponsor.
Typical and ultimate cost of the final manuscript of the trial to the sponsor created by the hired CRO and the recruited ghostwriters exceeds 1000 dollars per page, some have said.
Merck engages in this behavior, which shocked many, as they were always viewed as an ethical pharmaceutical company that always placed patients over profits.
Apparently, this is no longer the case. There are other well known and large pharmaceutical corporations that consider this plan of action standard operating procedures to ensure growth of their drugs.
Further disturbing is that once the creation of the trials is completed, the research paper is often composed with specific directions by the sponsor to writers known again as ghostwriters. These people are usually not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers.
One does not need research training or certification in order to perform this function. Rarely do clinical trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the pharmaceutical sponsor. Also, these hired mystery writers are known to make about 100 grand a year performing this deception full time.
This activity removes accountability and authenticity of the fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring again a known thought leader as an author to have their name be placed on the trial, while this hired author likely had absolutely no involvement with the trial, or even reviewing the trial is not asked or required by the hired author, others have said.
To have the trial published, the sponsor has been known to pay an obscure journal, and the sponsor bribes the journal in a few ways, such as the sponsor purchasing from a selected journal thousands of reprints of their study from the journal, for example.
Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers mentioned earlier and progressively growing research sites to receive the support the pharmaceutical industry.
So benefits of pharmaceuticals that are studied in such a malicious way potentially can harm patients and their treatment options along with clear safety risks as a result of this process.
The purchased reprints of the fabricated clinical trial are then bought by the sponsor of the study from the medical journal they hired to publish this trial. The reprints are eventually distributed to the sponsor’s sales force to share the content with prescribers, with the sales force completely unaware about this manipulation that has happened with such a trial that benefits the drug they promote for their employer.
As a bonus, the sponsor may agree to pay the chosen medical journal to advertise their products to be placed in this journal as well.
Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns, as stated previously. If so, our health care treatment options with drugs that are claimed to have benefits that are absent have now become unreliable in large part due to such corruptive situations. Not to mention the absence of objectivity that has been intentionally eliminated with trials produced in this way.
More now than ever, meds are removed from the market or are given black box warnings due to the damaging effects of drugs approved by the FDA. We as citizens need to dig deep and ask why this is happening.
Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method.
More importantly, research should be conducted in a way that the sponsor cannot in any way interfere in such ways described in this article, which would require independent clinical trial sites with no involvement from the maker of the drug studied in a clinical trial.
And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters. Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course. We can no longer be dependent on others for our optimal health.
Commercial sponsors of clinical studies have the potential to manipulate the structure, implementation, and assessment of the clinical trial results to further their monetary interests.
This, of course, is detrimental for patients because clinical trial results supposed to be based on the best information from clinical trials possibly may be restructured by others, and is done so with deliberate intent and reckless disregard. Pharmaceutical Marketing uses science this way as a host to infect it, and bastardize the scientific method.
Knowledge is power, and is also possibly a lifesaver.
“Ethics and Science need to shake hands.” ……. Richard Cabot
Dan Abshear
Author’s note: What has been written was based upon information and belief.
Published on: http://www.brainblogger.com
There are more internal documents that remain sealed by the DOJ that are likely just as revealing and shocking.
How big pharma targets prescribers:
Pharmacies sell prescribing data, also known as prescriber-identifiable data, to the pharmaceutical industry’s providers of this data. This is known as, ‘data mining.’
The two largest data mining companies are IMS and Verispan in this 2 billion dollar a year data mining industry.
The data on individual prescribers is purchased from the American Medical Association. As a result, this association receives between 40 and 50 billion dollars a year, which is nearly 20 percent of the AMA’s budget.
Over 1 billion prescriptions are monitored every year due to this process.
Advocates of the pharmaceutical industry have continuously told the public that this prescriber data is to facilitate the care the prescriber gives the patient.
Nothing could be further from the truth. In 10 years, I worked as a drug representative for 3 of the largest pharmaceutical companies in the world.
With each employer, the prescribing data that we had on the prescribers was used entirely to increase the market share of the drugs promoted with these companies by manipulating the prescribers targeted for financial gain of these pharmaceutical corporations.
Also, data mining is utilized by drug companies to target those who need to be gifted, and those who will not,
Dan Abshear
In my opinion, it is not Americans special way of being that is the problem but American politicians’ deep pockets, and the corrupt political process, including a corrupt corporate media that fails to do its watchdog job, both of which allow special interests to override the will of the people.
The vast majority of Americans would be best served by systems like the Canada’s or Great Britain’s. And they would chose those systems, as many do already, where it not for the politics of obfuscation deliberately silencing a publicly financed system (e.g. single payer) option.
Thanks Matt for bringing this important issue to our attention.
Not a revolutionary idea at all – look at Canada and the UK. The challenge lies in the American soul which is swollen with the premise that the rights of the individual supersede those of the community. This makes agreement around a “universal best idea or practice” almost impossible. Community requires tolerance and compromise, much of which we lack as a society.
Not only that, but how do we “measure a system by its ability of efficiently protect and promote the health of the populace”?
The URL for UCSF’s Drug Industry Document Archive is http://dida.library.ucsf.edu. You can find the documents mentioned in this post and many more.