The Human Injury of Lost Objectivity: An Insider’s Look into the Corruption of Clinical Trials




Drugs_Clinical_Trials2.jpgIf I were to rate the corruptive tactics performed by big pharmaceutical companies, the intentional corruption of implementing fabricated and unreliable results of clinical trials would be at the top of the list. Pharmaceutical companies manipulate the trials they sponsor because of their power to control others involved in the process largely absent of regulation. This is a matter of requiring authenticity and, more importantly, assuring the safety of the public health.

Research instituteDecades ago, clinical trials were conducted in academic settings that focused on the acquisition of knowledge and the completely objective discovery of novel medicine. Then, in 1980, the Bayh-Dole Act was created, which allowed for such places to profit off of their discoveries that were performed for pharmaceutical companies in the past. This resulted in the creation of for-profit sites, called Contract Research Organizations (CROs), which are composed of community research sites with questionable investigators void of necessary experience or quality regarding their research purpose and ability. Since they are for-profit, the trials conducted at CROs are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner has been transformed into a method of marketing, which includes altered results of the trial to favor the sponsor’s medication. Their activities are absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit the collusive relationship between the site and the sponsor.

MoneyFurther disturbing is that once the trials are completed, the medical articles are then written by ghostwriters, who are not identified and acknowledged by the sponsor, and are not trained in clinical research overall, as they are simply freelance writers. How often ghostwriters are utilized by pharmaceutical companies remains a mystery. This activity removes accountability and authenticity of the fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring an author to be placed on the trial that likely had no involvement with the trial, and, along with others, was paid by the sponsor. To have the trial published, the sponsor pays a journal, along with the promise of purchasing thousands of reprints of the study from the journal. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers and research sites to support the industry. So benefits of medicine studied in such a malicious way can potentially harm patients and their treatment options. The purchased reprints are distributed to the sponsor’s sales force to share the content with prescribers — your doctor.

Such misconduct impedes research and the scientific method with frightening ethical and harmful concerns. Our health care treatment with medications is now undetermined in large part in such situations, as well as the objectivity that has been intentionally eliminated regarding the trust in the scientific method in this type of activity illustrated in this article. More now than ever, meds that are removed from the market are given black box warnings. Now I understand why this is occurring.

The pharmaceutical industry needs transparency and disclosure in order to correct what we have historically relied upon for conclusive proof — the scientific method. More importantly, research should not be conducted in a manner that the sponsor can interfere in the ways I described in this article. We should call for independent sites with absolutely no involvement with the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion. 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

  • Stuart

    I don’t know where to begin! You’re obviously an angry man, but you’re also seriously misinformed. Virtually your entire article is incorrect, from your characterization of CROs and the investigators to your misunderstanding of how medical writing and publishing works. But after 20 years in the business, I’m resigned to the misinformation, half-truths, and the ugly rants.

    I will make one point: the thousands and thousands of people employed in the pharmaceutical industry – from large pharma to CROs to small biotechs – care about science, care about safety, and care about the patients. We do important work, under highly regulated circumstances, and with great attention paid to detail. We’re not getting rich, we’re not interested in conning anyone, and we’re not involved in some great conspiracy to manipulate data for our financial reward. I currently manage a team of 35 people. Do you think I could get all of them to agree to manipulate poor data? I can’t even get them to agree on a day when we can all have a teleconference!

    I suggest the next time you want to vent about how much drugs cost, ask yourself, “Compared to what?” Lost quality of life? Hospitalization? Lost work? Surgery? Death? The 10 cents or so out of your health dollar is the best spend you could make.

  • Tania

    Yes it is an angry man’s rant. I will concede that the entire health industry including the physicians they serve needs transparency and disclosure. But a few bad apples should not make the entire harvest bad.

    Furthermore, your blanket statements, e.g. “ghostwriters, who are not identified and acknowledged by the sponsor, and are not trained in clinical research overall, as they are simply freelance writers” shows poor thought. 1) many of these CRO / “freelance” writers are trained in clinical research. A large proportion (30-50%) are mobile, highly trained medical doctors,pharmacists, nurses, and PhDs who chose to move and have a family in a country they are not licensed and therefore, need to make a living by writing. I personally know about 30 people who fit in this category. There is a push and mandate by journals and Medical Writer’s organizations to require acknowledgment of external writers.

    Short of having the raw data produced by the pharma/med device industry available to the public, ranters like you will never be satisfied. Going back to the “good old days” of pure academic research will also mean lost time, lost lives. If one needs to compare, we should compare how “good” academic research was in terms of the same metrics. Acquisition of knowledge sure sounds much better than improving human lives.

  • Casper

    If Ghostwriters are so qualified, then why are thier names not on the papers? Why hire an author to sign off on such studies described in this article? Is this not deception?

    Think before you pass judgement.

  • Tania

    Because they did not participate in the creation, design of the study or experiment, or collection of raw data.

    Several external writers (MD, PhDs) I know are acknowledged, but this is the vast minority. I agree, to not at least acknowledge that someone else helped write the paper is deception and more transparency is required. The pressure is on from both sides, the writers and journals, so it is just up to the damn pharma companies that pay out to agree to it.

  • Pingback: A Failed Attempt to Improve Perceived Greatness: The ENHANCE Trial | Brain Blogger()

  • Pingback:   The Human Injury of Lost Objectivity: An Insider’s Look into the Corruption of Clinical Trials — An Inconvenient Woman()

  • Duncan

    Stuart and Tania take umbrage at the criticism in the article without really acknowledging the seriousness of the issues raised.

    I find Tania’s view of “ghostwriting” to be shocking. Any college students would be kicked out of school for such behavior: both the writers and the “authors of signature”.

    Stuart’s claim that most of the people in his industry are “good” therefore “don’t criticize” is not a argument, it is simply a complaint. I sympathize to the extent that taking Stuart at his word that he is honorable, it must be quite painful to have a constant stream of well researched criticisms levied against his industry.
    (And yes, of course, there are also a lot of off-the-wall critics as well

    Stuart may lead an impeccable team solely dedicated to science and truth but even a casual exploration of the flood of criticisms of the pharmaceutical industry by researchers, medical journals and the regulatory agencies and courts opens many doors on questionable activities. Dan Abshear is just one of the many writers exploring this area.

    I would suggest that Stuart and Tania get involved in forming groups within the pharma industry to weed out the scoundrels so the reputation of the industry can be improved. The criticisms are not going to stop until the shady practices are corrected.

    Tania’s suggestion of providing the raw data to the public is excellent. To have third party access and analysis of the data and research would go a long way to improving everyone’s behavior: industry insiders, regulators and critics alike.

    The histories of Vioxx, Celebrex, Avandia, Seroquel, Neurontin etc, etc, are not deniable.

  • Anonymous

    If your interested in a recycled rubber playground then you should use this company they’re great.

  • onergk69

    I agree w/ Dan’s essential premise about Big Pharma & the push for profits over patient/client safety. Due to their huge conflict of interests, their studies are more subjective than impirical,& they have experienced record amounts of criminal fines in the past few years due to illegal marketing tactics.

    The US is only 1 of 2 core developed countries that allows DTC marketing!

    I posses over 40 yrs. of clinical experience in behavioral health, esp. re: psychotropics.

    I suggest that any skeptics do a search on Big Pharma placebo washout strategies; and keep in mind that BP is not required to submit studies where the active agent does not beat placebo. And they are only required to submit 2 studies that demonstrate that the active agent is superior to placebo. And BTW, placebo effects can be as high as 35% in double-blind, controlled research.

    I’ve seen marketing materials on psychostimulants that are only 3 or 4 weeks in duration!!

    Rich

Dan Abshear

Dan Abshear recently divorced himself from "big pharma" after working for three of the largest pharmaceutical companies in the world for over a decade. He continues to write primarily opinion pieces regarding what may be little known facts about the health care system- particularly the pharmaceutical industry, and his writings also include responses to the related writings of others as well on various internet sites. Before his pharmaceutical career, he was a patient caregiver for over a decade, which included being a medic (hospital corpsman) in the U.S. Navy and Marine Corps.
See All Posts By The Author

Do not miss out ever again. Subscribe and get latest Brain Blogger articles straight to your inbox.