Pfizer Losing Battle Against Scientific Journals

I wanted to follow up on the post the other day about Pfizer's (PFE) attempts to open up the editorial files in various scientific journals. The decision on the New England Journal of Medicine motion hasn't come down yet, but two others have.

And Pfizer's lost both of them. The district court in Chicago rejected the company's arguments to compel JAMA and the Archives of Internal Medicine to open up their records on papers concerning Celebrex or Bexxtra. The ruling held (correctly, in my opinion) that the possible value of these documents to Pfizer's case was more than outweighed by the harm that would be done to the journals by allowing access.

And as this story at the Science web site mentions, the NEJM case may well be about to go the same way. According to the journal's attorneys, Pfizer narrowed its request to just the peer-review comments returned to the authors of the manuscripts. That seems, at least to me, to weaken the argument that these documents are of such great value to their legal case, while leaving the problem of breaching confidential peer review.

At least I think it does - I assume that Pfizer wants names attached to these things, unless they can use them in their case without attribution. Even so, that still doesn't sound like something that'll make people enthusiastic about reviewing such papers - the prospect of having their comments read off in open court. No, I think that argument that sank Pfizer's requests in Illinois still obtains, and that the Massachusetts court will rule the same way.

So if this whole issue goes away, we can relax until the next legal inspiration hits. In the interim, I still think that Pfizer should at least be vaguely ashamed of having taken this road. A confidential poll of the company's own scientists would surely find that a solid majority of them would be opposed to the whole idea of legal discovery of peer review documents (I say that because I've hardly talked to a single chemist or biologist who didn't think the same way). That said, there aren't many companies that size whose business decisions would all survive after polls among the scientific staff...

Comments

[BJC]

Although I can appreciate the opinions expressed like those in the article, I cannot bring myself to accept that complete transparancy isn't always good in scientific discovery. The public and scientific communities will always be better served with scientific feedback to other's findings are open and defendable....unless the authors of the comments don't believe they are defendable. Maybe that's the problem...

Signed,

Brian Cluff - A chemist you apparently never talked to.

[Dana Cole]

Who knows what the motives of "scientists" are? When there's a lot of money involved, anything could happen.

[notsosmart]

how many "clean & neutral" people are around today that will give an honest unbiased opinion on anything.the bottom line rules & everybody has an agenda.good luck.

[chriscql]

I see slim reason for peer reviews to be secret. If the opinion is valid, the reviewer and the publication should not hesitate to be forthright about it.

[User 167450]

I'm not an attorney, but in the third paragraph above, I think it's interesting how the writer of the article refers to one side as "the journals" (people!) but refers to the other side, the pharmaceutical company as "Pfizer's case" (an intangible entity). I agree with the Commenters above that more transparency is in order. That seems consistent to our constitutional right of the accused to be faced by his or her accuser, otherwise, it's a lot easier for people to make accusations without having to substantiate them. The pharmaceutical companies that actually discover products and try to make them safe have found it more difficult to do their work recently due to unfair patent infringement, counterfeiting, etc., and if they go downhill further (financially), don't be surprised if medicines that would otherwise help our families and friends become even harder to come by.

[Quiact]

Published on brainblogger.com

The Human Injury of Lost Objectivity

If I were to rate the corruptive tactics performed by big pharmaceutical companies during my intimate experience with them , the intentional strategy of implementing fabricated and unreliable results of clinical trials performed by others possibly top the list, as they often were sponsored by a pharmaceutical company. By this atrophy of the scientific method absent of authenticity, harm and damage is possibly done to the health of the public. Most would agree that the science of research should be sound and as sterile and aseptic as possible- completely free of interference. However, it appears, money and increased profits can be a catalyst for reckless disregard for human health that is largely unregulated. This is particularly a factor on post-marketing studies of various pharmaceutical companies because others seem to be deliberately ignorant.
Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of meds and devices to benefit mankind. Then, in 1980, the Bayh-Dole Act was created, which allowed for such places with their researchers to profit off of their discoveries that were performed for pharmaceutical companies and others in the past. This resulted in the creation of for-profit research trial sites, called Contract Research Organizations that are often composed of primarily community patient care clinics absent of any research training compared with the former. Because of this structure, investigators of these pharmaceutical sponsored trials are likely void by sponsor design of necessary research experience or quality regarding their research purpose and ability to ensure its sterility, yet benefit it’s supporter. These quite numerous CROS are in fact for- profit, with some CROs making billions of dollars a year.
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 med being studied in the trial. 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 studied drug of theirs. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner ensures favorable results of the sponsor’s medication after the trial is complete. Their activities are again believed to be absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit what may be a collusive relationship between the site and the sponsor; as such sites are largely unregulated.
Guest authorship has been known to be aggressively recruited by sponsors and usually the sponsors seek investigators to be recruited for this function in addition to being the lead investigator of their fabricated clinical trial. The trial manuscript and protocol design is prepared by those employed by the pharma sponsor upon specific direction of this pharma sponsor. The medical program coordinator of a particular sponsored trial is an actual employee of the sponsoring pharma company and also acts as the publisher, manuscript version reviewer and trial director who works with their pharma 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 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 not.
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 as ghostwriters. These people are not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers, as one does not need research training or certification in order to perform this function. Rarely do trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the sponsor. Also, these hired mystery writers are known to make about 100 grand a year. This activity removes accountability and authenticity of the possibly fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring 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 by the hired author.
To have the trial published, the sponsor has been known to pay a 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 meds studied in such a malicious way potentially can harm patients and their treatment options along with clear safety risks. The purchased reprints bought by the sponsor of the study are distributed to the sponsor’s sales force to share the content with prescribers, with the sales force completely unaware about this manipulation. As a bonus, the sponsor may pay this 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 meds are now undetermined in large part due to such corruptive situations, as well as the absence of objectivity that has been intentionally eliminated with trials produced in this way. Trust in the scientific method in this type of activity illustrated in this article is absent and replaced with what could be harmful to others.
More now than ever, meds are removed from the market or are given black box warnings, which is basically eliminating future growth of the black box drug. Now I understand why this may be occurring.
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 not 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 of the drug maker. 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. 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.