Wednesday, July 16, 2008

It's Not the Answers That Are Biased, It's the Questions

...which is the title of this incredible article just published by David Michaels in the Washington Post. Read it. Now.


Anonymous said...

Wow, so the idea is that the scientists are not dishonest, it's just humanely impossible to be objective. Sounds like an area for a psychological study, but I guess the psychologists would design the study based on what they expected the outcome to be whether they were aware of it or not. What does this tell you about the interpretation of the MMPI and Rorschach?

Or is it that there's nothing wrong with only finding what is good about the product that earns you your paycheck?

Seems like it would be about as hard for a government "watch-dog" group to be objective if this is true, seeing as how government agencies almost always have some stake in the outcome of the research. Maybe companies should hire law firms to identify future areas of possible legal exposure and superivse teams of scientists to see if the exposure really exists. But then I could be biased towards lawyers. Guess what I do for a living?

Meanwhile I'm trying to find a publisher for my rigorous scientific paper in which I publish my discovery that my dog actually is better than other dogs, it's not just that I'm some how biased because he's my best friend. He provided no funding for this study.

Anonymous said...

Nice link. I still do not understand how and why you want to be on this APA committee and do this kind of reporting on your blog. They seem to be diametrically opposed in endpoint.

Money corrupts, we all know this. And yet so many fall victim to it. And, in our line of work, people's lives depend on the oath we take to be a provider of health care. MAybe my eternal comment that there should never be profit in health care arenas needs to be reconsidered.

Like the Steve Martin medieval doctor character in early Saturday Night Live skits:

Anonymous said...

it took the editor of the BMJ 25 years to realize what could be understood by an undergraduate with some background in experiment design could have told you? Just like statistics can be massaged to support almost any point without necessarily being false, scientific studies can be manipulated to produce accurate data supporting almost any position. To paraphrase my best friend's mom- "That's embarrassing for him."

Just look at the language used in the article- references to studies "more than a third concluded that secondhand smoke was not harmful." I could come up with an experiment that could show secondhand smoke as harmless- just look at the effects of secondhand smoke on something not very related to secondhand smoke exposure, and BAM! we have a study showing that secondhand smoke is harmless. I'm surprised that people so involved in scientific research forget that studies tend to focus on such narrow topics that this can happen.

James M. La Rossa Jr. said...

Ironically, I find myself stuck in our Nation's capital this morning, waiting for a connecting west-bound flight, when I spy in today's Wall Street journal the headline, "CONGRESS RELAXES NEW RULES ON LOBBYIST DISCLOSURES." (Elizabeth Williamson, WSJ, July 18, Page A2)

Even with Jack Abramoff behind bars and democrats in control of both houses, "Congress has relaxed rules that would have required public disclosure of contributions and parties paid by lobbyists, narrowing the scope of new ethics rules intended to draw back the veil on Washington's influence game."

Now perhaps just being at Reagan National has heightened my irony radar a bit, but this article begs the question that if the Congress can't clean up its act, why should they expect (compel) that the medical community can? Whatever your take is on the ongoing debate on this blog, we can all agree that the relationship between industry and medicine is critically important to the development of new drugs. One cannot make that same claim about the relationship between legislators and lobbyists. Lobbyists do not advance "progress," but only the interests of their clients. The Congress' job is to represent the interests of their constituents -- the people -- and they don't need lobbyists to tell them what the people that voted them in want!

Yes, the bar in medicine should be set high, as TF and many others have written. But it's upsetting that the medical community is being held to a standard that our own Congress thumbs its nose at. While Senators are still allowed to use the corporate jets of lobbyists, physicians are painted as pariahs for accepting free CME. Enough already!

Anonymous said...

In response to James L's above comments:

In the comic Spiderman, the catch phrase is: with great power comes greater responsibility.

Physicians have great power in the position we eventually take with the patient; they (patients)turn to us for help, guidance, support, trust, and care. I don't really care at this point in my life and career how anyone will twist and modify to their advantage that medical care is different now and the hippocratic principles do not apply or are archiac. I just say this in response: if you want to make money, invest in oil, not blood. Another way I put it in a letter to the editor about 12 years ago in my local paper: take the F O R out of profit in health care.

We should hold our alleged political representatives to the same standards: if you want to resent us instead of represent us, get the hell out of office.

But, as George Carlin so wisely put it in his 1996 routine in "Back in Town": the public sucks, ---- hope! I leave it to the reader to fill in the blank.

It is time for psychiatrists with a conscience and dedication to stop selling the quick fix by just writing scripts. Until we as a sizeable, collective majority accept that, we aid and abet the enemy--insurance companies, pharma, and politicians, as a start.

Just my opinion. One of 15 years as a provider.

Anonymous said...

The sentence that stands out for me is this: "The information presented in the ISS must provide participants with an objective viewpoint." In particular, the word "objective" because everything that follows seems to belie any possibility of being truly objective. This is all about money and who has the money? The drug companies and they have one agenda -- to sell their drugs -- not to improve the welfare of patients.

Anonymous said...

I sympathize with Mr. La Rossa and wish we could clean up Congress too. But if I am ill (mentally or physically), I want to be treated by an ethical and informed physician and most certainly not by a politician. I might survive with the former; but surely would die with the later! So let's clean up Medicine first.

Anonymous said...

Published on

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.