Tag Archives: Fda

David Gorski’s Cancelled Drug Trial Tainted By Institutional Conflict of Interest

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Wayne State University oncology professor and “Science”Blogger David Gorski is a hypocritical and crooked “doctor” who should be fired, de-licensed and not allowed anywhere near patients. He should also be investigated for his social media role in the US Centers for Disease Control and Prevention’s cover up of vaccine injury, a topic he squirms over when questioned about his lies publicly. And now, it is clear he had a conflict of interest in human subjects research at his university according to academic policy despite his denials.

Unfortunately, he has yet to get what he deserves as he continues to misrepresent his conflict of interest with Sanofi and the pharmaceutical industry while both smearing the parents of severely disabled children who were never the same again following vaccination and lying for the federal government that covers up that harm. Just recently, he spoke on the Skeptics Guide to the Universe – a podcast hosted by front group advisor Steven Novella – apparently upset at some recent critical coverage Gorski has been getting from NaturalNews. In the podcast, he complained of having talks with his supervisor at his job as a result of the NaturalNews reports.

Among the unflattering facts NaturalNews cited about Gorski is the six year old discovery by Autism Investigated’s editor that he has been conducting a since-withdrawn trial of Sanofi drug Riluzole, sponsored by his employer that was in a partnership with Sanofi. The finding led to a letter-writing campaign by concerned readers to Gorski’s employer informing them of the conflict, an event Gorski has complained about ever since. Yet despite his university apparently letting him off the hook and his repeat claims that he was not conflicted in any way, the Institutional Review Board policies of his employer say otherwise:

Institutional Conflict of Interest consist of two major types: (1) l Conflict of Interest involving University equity holdings or a royalty arrangement related to sponsored programs

The principal investigator Gorski is a professor at Wayne State. The trial sponsor Barbara Anne Karmanos Cancer Institute is affiliated with Wayne State, which was partnered with Sanofi. Whereas before Gorski did not disclose this conflict in human subjects research, he now misrepresents it as not being a conflict on his bio at “ScienceBasedMedicine” – a blog he edits.

On the clinicaltrials.gov website, the following is stated about Gorski’s now-defunct trial: “This study has been withdrawn prior to enrollment. (Funding ended)”. According to the website, Gorski failed to enroll patients into his trial after two-and-a-half years of patient recruitment. Perhaps his reputation has something to do with it. A simple Google search of Gorski yields the following title on the first page: “David Gorski’s Financial Pharma Ties: What He Didn’t Tell You”. Any patient being recruited for Gorski’s trial who is curious about its principal investigator would no doubt see that headline and have concerns, and Gorski himself is undoubtedly aware of the potential for patients to find his blog.

The trial’s cancellation is remarkable in light of Gorski’s expressed hopes for it, suggesting Riluzole may prove to be as effective a treatment for breast cancer as surgery, radiation or chemo. That would certainly not be something a drug company would lack any interest in funding as Gorski had claimed about his research.

But even more remarkable is the hypocrisy as it relates to the ethical standards with which Gorski holds other doctors. He was a huge online cheerleader for the ruin of absolved British doctor Andrew Wakefield’s career, even though medical disciplinary findings against him that included conflict of interest and unethical research allegations were disproved.

Yet here we have Gorski not being up front about his own conflicts of interest with the pharmaceutical industry in human subjects research on blogs that he knows could be written by the very patients he was trying to recruit for his Sanofi drug trial. Not only did he possess an undisclosed conflict of interest according to his own university’s IRB, but also according to the very medical disciplinary panel in the UK that yanked Dr. Wakefield’s license. Those guidelines make very clear that doctors should be up front to patients about potential conflicts of interest, including those of their employer. Gorski’s employer Wayne State was in a partnership with Sanofi that was probably worth millions while he was actively trying to recruit patients for his trial, yet nowhere was that mentioned on his public blog.

But these connections do not just conflict Gorski’s role in medicine and human subjects research, but also in medical education. On his academic bio, Gorski reveals that he encourages students to contribute to his online blog: 

As the managing editor of Science-Based Medicine (SBM), a weblog devoted to discussing the science of medicine, Dr. Gorski is very interested in science communication and critical thinking, and interested students are welcome to publish in SBM under Dr. Gorski’s guidance to hone their writing skills for lay audiences.

Little would his students know that his since-cancelled drug trial was tainted by an institutional conflict of interest that connected his employer Wayne State to the drug company Sanofi, the maker of Riluzole that Gorski was recruiting patients to a breast cancer trial on. While being misled into thinking they are honing their writing skills, they are merely providing content free-of-charge to an agenda-driven, corporatist blog edited by a doctor who was not upfront about his conflicts on his blog.

By not including his connections on his blog and continuing to misrepresent them, he continually misleads both students and patients about his competing interests. It is hardly surprising that such a dishonest hypocrite would help expand the CDC’s vaccine-autism cover-up to social media.

Relatives of Dr. Jeff Bradstreet Speak Out On Untimely Death

Brother and sister-in-law Thomas Bradstreet and Candice Lee-Bradstreet have spoken out on the recent and untimely passing of their relative: noted autism doctor, researcher and parent Dr. Jeff Bradstreet. In particular, they dispel a number of myths that have arisen following his death. Please support the Bradstreet Family’s fundraising effort to support an ongoing investigation into this tragedy.

From the description:

I am honored that the Bradstreet family sat down to talk with me about the beloved late MD; Dr. Jeffrey Bradstreet.

I didn’t know how they felt when I wrote the first story about his tragic death when he was found  in a river, with a gunshot wound to his chest, 7 weeks ago.  Shortly thereafter, more holistic doctors were found dead, mostly here in Florida and mostly holistic, some of whom we knew well.  I wrote the stories as tough as it was and we’re still waiting for answers.

I’ve been fortunate to talk with Bradstreets for a while now and they are nothing but an honest, sincere caring family and I cannot imagine how they must feel. I cannot even begin to understand the depth of their pain.  I am just honored that they trust me and opened up to me for this first interview ever.  Here we talk about Dr. Bradstreet and the man they knew as Jeff.  We also discuss GcMAF and many other topics. Please click on the youtube video above to listen.

This is Erin Elizabeth on Weds. Aug 12, 2015

Doctor Who Shined Light on Vaccine Injury Dies at 60

Dr. Jeff Bradstreet

By Jake Crosby

It comes with great sadness to announce the untimely passing of Dr. Jeff Bradstreet, a medical doctor and parent of a child who developed autism after vaccination. Having once stated at a conference that “autism taught me more about medicine than medical school did,” he has contributed heavily to the body of peer reviewed science implicating the vaccine schedule in autism’s etiology. He had produced research suggesting children with autism have a higher body burden of mercury as well as research detecting measles in a subset of children with regressive autism who received the live-virus measles, mumps and rubella vaccination. As such, he believed children who presented with these types of findings should be treated for them.

Dr. Bradstreet faced considerable scorn as a result of his research, practice and views. In 2004 his work was dismissed by the Institute of Medicine, which was paid by the Centers for Disease Control and Prevention to produce a report rejecting any association between autism and vaccination. He was also ridiculed for mercury detoxification treatment by a special master in vaccine court, where email evidence has since shown that petitioners’ attorneys advised by SafeMinds threw the case for the mercury-based vaccine preservative thimerosal causing the autism epidemic.

Then shortly after an FDA raid on his clinic in Buford, Georgia, Dr. Bradstreet was suddenly found dead. The FDA – which continues to maintain that thimerosal is safe despite contrary evidence produced by him and other researchers – would not comment on why its agents visited his clinic. An investigation is ongoing and a fundraising effort has been set up by his brother “To find the answers to the many questions leading up to the death of Dr Bradstreet, including an exhaustive investigation into the possibility of foul play.”

In the meantime, his brother requested that people not spread rumors or gossip about Dr. Bradstreet’s untimely death out of respect for his family. Autism Investigated will honor those wishes and will not approve any comments through moderation that do. May the circumstances surrounding Dr. Bradstreet’s passing be revealed soon, and may Dr. Bradstreet’s scientific contributions help lead to the end of the harm being done to so many children.

See on The Epoch Times.

How Dan Olmsted and David Kirby Helped Kill A Landmark Autism Lawsuit

Justice-Denied-IPI

By Jake Crosby

It may sound bizarre, but that is exactly what happened when journalists Dan Olmsted and David Kirby interfered with Coalition for Mercury-Free Drugs’ Reverend Lisa Sykes’ 2008 personal injury lawsuit against drug companies Bayer, Wyeth and GlaxoSmithKline. Incredibly, Olmsted and Kirby were persuaded to co-write a letter that took the side of the drug companies against Sykes’ case. Even more bizarre was who successfully appealed to Olmsted and Kirby to support Bayer: vaccine industry mainstay blogger Dr. David Gorski, via an open letter on “Science”Blogs. (He would later accept direct funding from Bayer: a 30,000-euro grant according to Gorski himself.)

It all began when “neurodiversity” blogger Kathleen Seidel of the now-defunct neurodiversity.com website was subpoenaed by attorney Cliff Shoemaker, who was representing Reverend Sykes in her case against Bayer and other pharmaceutical companies for injuries her son sustained from mercury exposure through vaccination and Rh-immunoglobulins. Seidel had quite a track record of pro-pharma activities. She had complained against scientists to their state medical board and to the FDA, and had also written in support of the CDC freezing outside researchers from accessing a federal database. These complaints by her would eventually culminate in a scientist being coerced by FDA into voluntarily withdrawing a product from the market, even though it met FDA’s safety standards. Seidel’s complaints would also lead to a scientist losing his medical license and his son being fined $10,000 by a medical board known for flouting fairness statutes meant to protect doctors. According to millionaire vaccine industrialist Paul Offit, Seidel falsely claimed to him that Generation Rescue co-founder JB Handley threatened her with a lawsuit which in turn led to Handley being libeled in Offit’s 2008 book. He would be forced to change the text in his book. Not surprisingly, Seidel had also attacked Rev. Sykes’ case.

So what is wrong with Sykes’ lawyer, Clifford Shoemaker, subpoenaing Kathleen Seidel in order to try and find out possible connections she may have to pharma? Well, according to the vaccine industry blogger David Gorski’s letter to Kirby and Olmsted: ”freedom of speech” and the “First Amendment.” Gorski also insisted Seidel was not connected to the pharmaceutical industry (as if he would admit that she was if he was privy to this information) and noted that she is not a defendant in the case, despite her persistence in helping those defendants by targeting their critics. Gorski did make one point to Olmsted and Kirby that was correct, however:

If both of you, who so strongly disagree with Kathleen’s conclusions, were to speak out, it would shame Shoemaker and his clients, the Sykes, beyond any condemnation that I or the rest of the blogosphere can provide.

Indeed, Olmsted and Kirby were in a unique position to undermine Reverend Sykes’ case against Bayer and other pharmaceutical companies given that both journalists are well known to be on the same side of the debate as Sykes. That is the real reason Gorski wrote them his letter as he stated himself. He even hilariously tried to make them feel sympathetic towards Seidel by saying that they wouldn’t like being subpoenaed by vaccine manufacturers, and ended his email with the following plea:

If a lawyer representing a plaintiff suing vaccine companies can get away with this, just imagine what abuses lawyer [sic] with the resources of a big pharmaceutical company or the government could perpetrate to silence blogospheric critics. Imagine what mischief they could cause by demanding the correspondence, e-mails, financial records, and contacts with religious groups from their critics. That would be you, Mr. Kirby and Mr. Olmsted.

Just think about it.

Sincerely,

Orac

And yet, Orac, (blogging pseudonym for Dr. David Gorski) supports that very “mischief.” After Dr. Andrew Wakefield sued Brian Deer, Dr. Fiona Godlee and the British Medical Journal for libel in 2012, Gorski wrote Dr. Wakefield’s lawsuit:

…would allow them [Deer and Godlee’s lawyers] to subpoena all sorts of information…It might also, as I’ve pointed out, allow the defendants’ lawyers to depose all manner of Wakefield’s connections relevant to this libel suit, possibly even some of Generation Rescue’s luminaries and bloggers at AoA, given that it appears very much to me as though GR (Generation Rescue) and AoA coordinate their attacks on Deer and Godlee with Wakefield.

When Dr. Wakefield first filed his lawsuit, Gorski wrote that:

Communications between Wakefield and any AoA blogger might be subject to discovery.

That would include “Mr. Kirby and Mr. Olmsted,” not to mention me and potentially anyone else who has ever contributed to Age of Autism and corresponded with Dr. Wakefield. Obviously, Gorski would support the Merck and GSK-funded British Medical Journal, its editor Fiona Godlee and writer-for-hire Brian Deer serving Olmsted and Kirby with a subpoena. Gorski’s ploy is not surprising at all, given his complicity in the CDC’s thimerosal-autism cover-up and IOM’s subsequent whitewash.

What is devastatingly surprising, however, is Kirby and Olmsted’s response that came just three days after Gorski’s letter that blatantly stated: “I am appealing to both of you to use your influence and position in the autism biomedical movement to protest this shameless action by Mr. Shoemaker.”

In a complete betrayal to the autism community, Olmsted and Kirby did use their influence to protest Shoemaker’s subpoena, but they only sent their letter of protest to David Gorski. It appeared on his blog and nowhere else:

We both take this matter very seriously, and strongly oppose any effort to subpoena the records of Ms. Kathleen Seidel. We have also clearly expressed our feelings to Mr. Shoemaker. While we may not agree with her opinions, we consider Ms. Seidel to be a colleague. Rights to privacy, and to free speech as guaranteed by the First Amendment, must be upheld for all. We urge Mr. Shoemaker to reconsider, and drop this action against Ms. Seidel.

David Kirby

Dan Olmsted

Perhaps the most shocking part of the letter is their reference to Seidel as their “colleague” – a colleague who has no journalism credentials, who complains against scientists to their state’s medical board, the FDA and medical journals while advocating for outside researchers to be frozen out of accessing a taxpayer-funded, federal database. That is the “colleague” Kirby and Olmsted profess to support on the basis of “free speech” – a “colleague” whom by Gorski’s own standards as applied to Dr. Wakefield’s case – would be more than appropriate to subpoena.

It gets worse, however, much worse.

Less than two weeks after Kirby and Olmsted’s signed letter of support for their “colleague” Kathleen Seidel invoking the first amendment, Seidel gained free legal support from a Washington, DC-based consumer advocacy group called “Public Citizen.” More specifically, she was receiving support from Public Citizen’s “First Amendment Team.”

Dan Olmsted is connected to Public Citizen through its Health Research Center director/cofounder Dr. Sidney Wolfe. Dr. Wolfe’s involvement in Public Citizen spanned nearly four decades. Did Dan Olmsted provide Kathleen Seidel with free legal support? Whether directly or indirectly, the letter of support for Seidel he cosigned with Kirby could have only helped.

Within a day of David Gorski boasting about Public Citizen’s support for Seidel on “Science”Blogs, Shoemaker’s motion to subpoena was quashed. Less than two weeks after that, the Sykes dropped their case against Bayer and other pharmaceutical companies. The following month, the Sykes’ lawyer Clifford Shoemaker was professionally sanctioned.

As this was all happening, Olmsted and Kirby’s support for Seidel drew the ire of one notoriously cantankerous Age of Autism reader – autism father and Hating Autism blogger John Best. He tried to complain about Olmsted and Kirby’s support for Seidel – and by extension Bayer – in the comments of Age of Autism, only to be censored. Eventually, Best was banned from commenting on Age of Autism altogether. Apparently, Seidel’s right to free speech is more important to Age of Autism than that of its own readers as well as the scientists whose reputations she worked to destroy and whose research she worked to stifle.

John Best is not the only person who did not receive a satisfactory explanation from Kirby and Olmsted regarding their support of Seidel. David Kirby did not respond to my inquiry for this article. (I merely asked him if anyone other than Gorski had pressured him to write the letter.) Age of Autism editor Dan Olmsted has informed me that he refuses to communicate with me altogether. When we were still communicating, however, he figuratively claimed:

John Best wants to shoot me, and I’m a good guy!”

At that time, I had no idea that this “good guy” helped quash a thimerosal lawsuit against Bayer – much less that that was what Best had been complaining about and been censored from Age of Autism over. Then in 2011, David Gorski disclosed taking research funds directly from Bayer. I would love to know what role Olmsted and Kirby’s letter invoking “free speech” may have played in helping secure direct pharmaceutical funding to Gorski – a blogger who ironically considers them worthy of subpoena by vaccine industry-backed litigants.

Jake Crosby is editor of Autism Investigated and is diagnosed with an autism spectrum disorder. He is a 2011 graduate of Brandeis University with a BA in both History and Health: Science, Society and Policy, He is completing his candidacy for an MPH in epidemiology from The George Washington University School of Public Health and Health Services.