Saturday, February 11, 2012

David Gorski’s Financial Pharma Ties: What He Didn’t Tell You

David Gorski’s Financial Pharma Ties: What He Didn’t Tell You

Gorski Beer By Jake Crosby

 His motto is “A statement of fact cannot be insolent,” yet the title of his blog reads “Respectful Insolence.” In other words, even he admits there are no facts on his blog.

He has become the online spokesperson for the vaccine industry, a member of the highly trafficked, drug-industry-sponsored “Science”Blogs where he heavily promotes the tobacco science obscuring causes of autism. Posting under the science fiction name “Orac,” David Gorski has become the most outspoken, self-styled “skeptic” in defense of mercury that exceeds EPA limits in vaccines. Another example of a cause of autism he vehemently denies is the MMR - the triple, combined live-virus vaccine implicated in measles virus infection in the ileum, peripheral blood mononuclear cells, and cerebrospinal fluid of children who have autistic enterocolitis.

 In case anybody’s wondering what David Gorski’s connection is to the autism debate, he has undisclosed financial ties to the vaccine industry. He has made no mention of these connections, despite stating in one of his many defenses of millionaire vaccine industrialist Paul Offit, “A general principle is that undisclosed potential conflicts of interest (COIs) are of far more concern and potentially far more damaging to the scientific process than disclosed COIs.” However, Gorski has steadfastly denied possessing any conflicts, having once told me online without my even accusing him, “You are wrong. I receive no money from pharmaceutical companies and haven’t for 14 years.”

Sanofi-Gorski

Well, it so happens Sanofi-Aventis – the world’s largest vaccine maker - is involved in several partnerships under which the company may be required to pay a total of €31 million ($39 million USD) from 2008 to 2013. Gorski’s employer, Wayne State University, is one of the partners, and he is conducting a clinical trial of one of the company’s drugs. Therefore, like Offit (who concealed the millions he received in Merck royalty payments because Merck paid the royalties to a third party, not Offit directly) Gorski has a reasonable expectation to receive money from a vaccine maker, even if it is through a third party. A look at the summary description of the Gorski Lab reveals that his research focus is drug discovery and development. However, he is not developing a new drug, but rather, developing new uses for an existing one. Such a process is far more profitable to the drug manufacturer as it eliminates the costs of developing a new substance from scratch, thereby maximizing profits for the company.


The potentially profitable drug Gorski is in the process of conducting a clinical trial for is the ALS drug Riluzole, made by Sanofi-Aventis and marketed as Rilutek. Amplifying the conflict further is that the same drug is also being studied for the treatment of autism. At Autism One, the National Institute of Mental Health was handing out recruitment pamphlets for children ages 7-17 to take part as subjects in a clinical trial of Riluzole for its effectiveness in the treatment of autism spectrum disorders, and repetitive and stereotypical behaviors in particular. Apparently, David Gorski has had his eye on that drug for a long time, but as a possible treatment for breast cancer. As suggested by a 2008-2009 webpage of a breast cancer website:

“Three years ago in another cancer (melanoma), Dr. Gorski's collaborators found that glutamate might have a role in promoting the transformation of the pigmented cells in the skin (melanocytes) into the deadly skin cancer melanoma. More importantly for therapy, it was found that this protein can be blocked with drugs, and, specifically, in melanoma cell lines and tumor models of melanoma using a drug originally designed to treat ALS and already FDA-approved for that indication (Riluzole) can inhibit the growth of melanoma.” HERE

Subtract three years from 2008-2009 and you get 2005-2006 – when David Gorski started blogging heavily about vaccines. Currently, the Barbara Anne Karmanos Cancer Institute of Wayne State University is sponsoring the trial for Riluzole, and Wayne State is the only university listed in the Yahoo! Finance stock summary of Sanofi-Aventis as being in a financial partnership with the company. Sanofi-Aventis owns Sanofi-Pasteur, the second largest manufacturer of vaccines in the world, including both thimerosal-preserved vaccines, and MMR vaccines. (Its first MMR vaccine, Immravax, was banned for causing viral meningitis in children.) David Gorski, while up front about the direct funding he received from drug companies 14 years ago for a patent as well as the funding he has received from the various institutions with which he has been affiliated, has not been up front about funding from drug companies received through his institution. According to the drug company’s website in 2008, “Sanofi-Aventis has entered into various other collaboration agreements with partners including Immunogen, Coley, Wayne State University, Innogenetics and Inserm, under which Sanofi-Aventis may be required to make total contingent payments of approximately €31 million over the next five years.” This is the same year it was announced that David Gorski would carry out a series of clinical trials for the company and its drug, Riluzole. HERE  In fact, one of the two primary interests of the Gorski lab is this Sanofi-Aventis drug. In the Wayne state description, the lab’s two interests are described, “First, we are interested in the transcriptional regulation of vascular endothelial cell phenotype.” Worth noting is that a patent relating to this was issued listing David Gorski as an inventor. In his blog bio, Gorski admits receiving money for the patent in 1994 from a drug company, but that was only during the provisional filing before the patent was issued. Whatever the compensation was, its timing does not suggest any licensing of the intellectual property rights.

Also, according to the Gorski lab, “Our second area of interest is the role of metabotropic glutamate receptors (mGluRs) in breast cancer,” which relates directly to the therapy linking the use of Riluzole to breast cancer treatment. However, the description concludes, “In addition, we have noted that mGluR1 is expressed on vascular endothelial cells and have preliminary evidence that its inhibition is also antiangiogenic, thus linking our laboratory’s two interests and suggesting a broader application for metabotropic glutamate receptor targeting in cancer therapy.” In other words, David Gorski’s entire research focus, including a patent still listed in his name for which he admits receiving drug company money, ties into finding new uses for a drug made by Sanofi-Aventis, while the university housing his lab is in partnership with the company. HERE

In spite of this easily-accessible information about his drug industry ties, Gorski’s denial of being in the pocket of the drug industry stretches so far beyond what he is even regularly accused of, that he will from time to time actually post a handful of links to the few token, laughably transparent posts out of the thousands he’s written which are at all critical of the drug industry. None concerned ongoing, unresolved controversies such as those surrounding autism, and none are critical of Sanofi. To David Gorski, Sanofi-Aventis is apparently untouchable. When a fellow blogger wrote a post entitled “Placing a vaccine order with crooks and liars” - questioning the government’s reliance on Sanofi-Aventis developing a swine flu vaccine just after the company was forced to pay nearly $100 million in compensation for cheating Medicaid, David Gorski was not amused. “Jumpin' Jesus on a pogo stick. The antivaccine nuts will have a field day with this,” he yelped.

The blogger responded, “orac: Meaning we shouldn't call them on it?” David Gorski chastised even his fellow blogger: “I would have hoped that you would realize that that's not what I meant at all to the point where you wouldn't have even asked a question like that, but apparently I was wrong. I didn't realize your opinion of me was so low.” Apparently, the public image of Sanofi-Aventis is more important to Gorski than the fact that disabled people, including those with autism, were cheated out of millions of dollars.

His actual profession may have nothing to do with the disorder, but Sanofi-Aventis certainly plays a major role in the autism epidemic. So blogging like the kind Gorski has been engaged in would undoubtedly win him some major brownie points with the pharmaceutical company. This could be very beneficial to a researcher like him, given that he is conducting a clinical trial of Sanofi-Aventis’ drug while his employer is in a Sanofi-Aventis partnership that could be worth millions. Meanwhile, he is trashing alternative therapies for autism when the drug he is conducting a clinical trial on may become a treatment for autism. How none of this could be considered undisclosed COIs to David Gorski--while Dr. Andrew Wakefield’s connection to lawyers in relation to the retracted case report from the Lancet is a “fatal” COI--is absolutely bizarre. Gorski makes no mention of his current connections to the drug industry on his blog, including the possible application the drug he is focused on may have to autism. 

Yet a number of years back, David Gorski wrote on his blog as “Orac,” “Yes, in the case of a true ‘shill’ who does not reveal that he works for a pharmaceutical company and pretends to be ‘objective,’ it is quite appropriate to ‘out’ that person.” From reading this, one would think David Gorski would be happy to know that his undisclosed connections to Sanofi-Aventis – one of the largest vaccine makers in the world - have just been outed.

So I e-mailed him:

Dr. Gorski,
This is Jake Crosby. I am doing a piece about your acknowledgment that disclosure of conflicts of interest is important, yet your lab at Wayne State University stands to benefit from Sanofi Aventis money for the breast cancer research you are conducting on a drug the company manufactures and markets, Riluzole, which is also being studied for the treatment of autism. Why isn't any of this disclosed on your blogs? I await your reply.
Sincerely,
Jake Crosby
Age of Autism
Contributing Editor with Autism
http://www.ageofautism.com/jake-crosby/

Dr. Gorski Responds
David Gorski, a.k.a. “Orac,” of “Science”Blogs/-BasedMedicine replied the next morning with a short, excuse-filled response:

“A more comprehensive answer will be forthcoming when I have more time, probably by tomorrow. (I have to go to work now, and because we have house guests, I will be busy when I get back.) In the meantime, suffice it to say that I receive no money from Sanofi-Aventis, nor am I likely to. 
David”
He did not address my question at all; perhaps he was too busy cooking breakfast for his house guests. I never said he received any money from Sanofi-Aventis, only that his lab stood to benefit from such money since the company is in a partnership with his lab’s university, Wayne State, which is sponsoring Gorski’s clinical trial of Riluzole.

Two days later came his “more comprehensive answer.” If Dr. Jekyll wrote his previous email, Mr. Hyde wrote:

“My answer is here:
http://www.sciencebasedmedicine.org/?p=5627
Since you were obviously preparing to do to me what you've done in the past with, for example, Adam Bly, Gardiner Harris, and Chris Mooney, I decided that the best defense is a good offense and that a public preemptive response was demanded.
When you write your piece, link to it if you dare. If there's one thing about AoA that I find despicable and cowardly, it's that they refuse to link to me when they slime me. J.B. is particularly guilty of this. I link to AoA because I'm not afraid of my readers going to the primary source. Are you?
David”
I’ll let the editors at Age of Autism decide whether they want to include the link or not. Age of Autism is comprised of original material that Gorski is heavily dependent on for his fits; he’s a scavenger. Plus, all our readers are perfectly capable of accessing his tantrums anyway.

Moving on to his post, it is essentially a huge rant divided up into five sections, the first of which can be summed up by this sentence: “It’s far easier for [quacks and pseudoscientists] just to put their fingers in their ears and scream ‘Conflict of interest! Conflict of interest!’ and then use that to dismiss completely their opponent’s argument.”

In fact, that’s basically the whole point of the first three sections. I have never advocated this in any of my articles, and I invite him to point out a specific example of where I have either in his case or in another example of my posts. He even lied that I accused Seed Media founder Adam Bly of being influenced by Sanofi-Aventis while he was studying at the Canadian National Research Council – I never alleged any such thing.

I do agree with him, however, that this is the proper way to take into account conflicts of interest: “…if a study is funded by big pharma, he decreases the strength of the evidence in his mind by a set amount.” That said, I do believe that conflicts of interest whenever present should be brought up, like that of Gardiner Harris, who violated the ethical guidelines of The New York Times by failing to disclose that his brother sells lab equipment to pharmaceutical companies. David Gorski does not seem to think so, despite agreeing with me that pharmaceutical funding does decrease the strength of evidence. My question for him: Which is it?

In the fourth section, Gorski congratulates himself for the research that is related to his Sanofi-Aventis connections. He brags, “If it passes clinical trials, it may well be a very useful drug for potentiating the effects of other cancer therapies, such as chemotherapy and radiation.” Beyond Gorski’s blogging about autism and his undisclosed COI, as J.B. Handley put it, “I could care less about Mr. Gorski or his career.”

 Moving on to the final section, he sums up his basis for denying he has a conflict of interest:
“First, I would have to be receiving money from Sanofi-Aventis. I am not.”
I never said he was, only that Sanofi-Aventis is in a partnership with his university, which in turn is sponsoring his clinical trial of Sanofi’s drug, Riluzole.

“Second, I would have to have the reasonable expectation to receive money from Sanofi-Aventis. I do not.”

Though he may not expect to receive money from Sanofi-Aventis directly, he can expect to receive money that Sanofi has paid to his employer, Wayne State.

 “I’m not even angling for money from Sanofi-Aventis to run my lab.”
He doesn’t have to; his university does the angling for him.

“Third, I would have to know that Riluzole is being tested as a treatment for autistic children.”
It does not matter if he did not know Riluzole was being studied to treat autism, he would still have a COI.

“In any case, even if I had known [of Riluzole as a possible treatment for ASD], it still wouldn’t have been a COI. I’m not a neurologist, and I don’t treat ASD or OCD. I’m never going to be doing research with Riluzole in children with ASD, OCD, or both.” Even though he does not treat autism, and even though he is not a neurologist, he still has a conflict of interest because of his Sanofi ties and the fact that he blogs about autism causes and treatments all the time.

What ultimately matters is that David Gorski is conducting a clinical trial of a Sanofi-Aventis drug (undisclosed to his readers), sponsored by his Sanofi-Aventis-partnered university (also undisclosed to his readers), and he constantly writes blog posts that are favorable to Sanofi-Aventis. To show just how important Sanofi is to Gorski, he even said in the comments section that if the drug fails his clinical trial for breast cancer, it would be a “major setback” for his research. Yet, instead of conceding that he is conflicted in this way, he attempts to talk his way out of the points I raised in the 84-word e-mail I sent to him with a 4,562-word smokescreen, followed by another 20,915 words from his loyal commenters.

Jake Crosby is a college student at Brandeis University who is double majoring in History and Health: Science, Society and Policy, and is a contributing editor to Age of Autism.

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