David Gorski’s cancelled drug trial tainted by institutional conflict of interest

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Source: Autisminvestigated.com
Jake Crosby
September 1, 2016

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cited about Gorski is the six year old discovery by Autism Investigated’s editor that he has been conducting a since-withdrawn trial of Sanofi drug Riluzole, sponsored by his employer that was in a partnership with Sanofi.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.

Read More At: Autisminvestigated.com

Harvard Study Finally Admits Drug Prices are High Because Govt Grants Big Pharma a Monopoly

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via: GreyEnigma.wordpress.com
via: SentinalBlog.com
Source: ActivistPost.com
Matt Agorist
August 27, 2016

In what can only be described as paradigm-shattering research on drug prices, the Journal of the American Medical Association has officially recognized why drug prices skyrocket in America. Big pharma is granted a monopoly by the State which effectively eliminates their competition and allows them to charge any price they want — so they do.

The new paper, published on August 23,  “The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform,” set out to  “review the origins and effects of high drug prices in the US market and to consider policy options that could contain the cost of prescription drugs.”

What the paper’s authors, Harvard Medical School doctors Aaron Kesselheim and Jerry Avorn, and jurist Ameet Sarpatwari, found and subsequently admitted, shatters the very assertion that government regulation in the market is needed to keep medical care costs low. In fact, their findings were quite to the contrary.

According to the paper:

The most important factor that allows manufacturers to set high drug prices is market exclusivity, protected by monopoly rights awarded upon Food and Drug Administration approval and by patents.

Imagine that.

The costs associated with studying, testing, and getting new drugs approved can be staggering, and the money made from selling the new drug is often used to pay for future drugs as well as paying back investments made to produce the current ones. Unfortunately, the people involved in creating life-saving drugs cannot work for free.

Nothing is wrong with making a drug that saves lives and profiting from it. However, when the profits are a direct result of government involvement, it no longer becomes an issue of innovation and the market, but rather an issue of a State-granted monopoly.

According to the paper:

Although prices are often justified by the high cost of drug development, there is no evidence of an association between research and development costs and prices; rather, prescription drugs are priced in the United States primarily on the basis of what the market will bear.

Increasing the market price of an item to the maximum profit per unit is a natural function of the free market. And, contrary to what the pro-government regulation sect asserts, this increase in price in relation to supply coupled with competition, happens to work toward keeping prices down — unless these prices are protected by a government-granted monopoly. 

As the paper points out:

The most important factor that allows manufacturers to set high drug prices for brand-name drugs is market exclusivity, which arises from 2 forms of legal protection against competition. Together, these factors generate government-granted monopoly rights for a defined period. Initial regulatory exclusivity is awarded at FDA approval.

While the Journal of the American Medical Association is finally admitting the reason for skyrocketing drug prices, Austrian economists have been pointing this out for decades.

Ludwig von Mises correctly explains the situation in the statement below:

As has been pointed out already, there is no such tendency toward monopolization. It is a fact that with many commodities in many countries monopoly prices prevail, and moreover, some articles are sold at monopoly prices on the world market. However, almost all of these instances of monopoly prices are the outgrowth of government interference with business. They were not created by the interplay of the factors operating on a free market. They are not products of capitalism, but precisely of the endeavors to counteract the forces determining the height of the market prices. It is a distortion of fact to speak of monopoly capitalism. It would be more appropriate to speak of monopoly interventionism or of monopoly statism.

A glaring example of the staggering discrepancies in American drug prices can be seen in the remarkable drug for Hep C, sofosbuvir. Sofosbuvir boasts a near miraculous cure rate of 84-96% for Hep C. 

However, the American version of the drug Solvaldi by Gilead, which has an FDA-granted monopoly protecting it, will cost patients a mountainous $84,000. 

In India, however, Gilead has to compete in a free market. Competitors, of which there a many, using the older, much cheaper, and equally effective drug, have driven the price down to a mere $4 a pill. This makes the total cost of curing Hepatitis C in India’s free market — $336.

Because the FDA has become little more than a revolving door for the pharmaceutical industry to continually grant itself special privilege, the natural checks and balances of the market do not apply and we see seemingly insane price differences when compared to other markets.

One example of this revolving door is FDA member, Milton Packer, who chairs the Cardiovascular and Renal Drugs Advisory Committee. Packer, who reviews applications for drugs submitted for FDA approval, is financed by Novartis and actually spoke on their behalf to the advisory board that he chaired.

According to the Wall Street Journal, Packer also appeared before the Cardiovascular and Renal Drugs Advisory Committee involved speaking on behalf of Bristol-Myers Squibb in 2002; acted as a consultant and speaker for GlaxoSmithKline in 2003; appeared as a speaker for NitroMed in 2005; appeared as a speaker for Sanofi in 2009 and acted as a consultant on behalf of Pfizer in 2010.

And Packer is only one example, the list goes on.

The timing of this paper is impeccable given the recent hoopla in the news on the absurd price hike of EpiPens. Mylan CEO, Heather Bresch – daughter of Senator Joe Manchin (D-West Virginia) — is on the receiving end of the FDA’s power to monopolize drugs. As a result of her monopoly, no one can compete with Mylan which has grown Bresch’s annual salary from $2.4 million in 2007 to $18.9 million in 2015.

Again, there is nothing wrong with making money. But, when that money is made at the expense of everyone else — freedom loses.

While the mainstream media often acknowledges that these drug companies charge exorbitant prices for their medications, they conveniently leave out the reason they can do so is because they have the full support of Uncle Sam.

Instead of looking at the corrupt government, who has the unique ability to create and sustain monopolies, the evil market is blamed, and people ironically call for more government – thus creating a vicious cycle of corporatism.

Hopefully, this admonition in JAMA, by these doctors from the Harvard Medical School, opens the eyes of those who continuously cry for more regulation to control prices. We’ve seen where that’s gotten us.

Here at the Free Thought Project we agree with the authors when they say:

High drug prices are the result of the approach the United States has taken to granting government-protected monopolies to drug manufacturers, combined with coverage requirements imposed on government-funded drug benefits. The most realistic short-term strategies to address high prices include enforcing more stringent requirements for the award and extension of exclusivity rights; enhancing competition by ensuring timely generic drug availability.

Matt Agorist is the co-founder of TheFreeThoughtProject.com, where this article first appeared. He is an honorably discharged veteran of the USMC and former intelligence operator directly tasked by the NSA. This prior experience gives him unique insight into the world of government corruption and the American police state. Agorist has been an independent journalist for over a decade and has been featured on mainstream networks around the world.

Read More At: GreyEnigma.com