Medical Whistleblower Advocacy Network

Human Rights Defenders

“All human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood.”

 Universal Declaration of Human Rights

Article 1



Misbranding, False & Misleading Information

The Corporations and Big Pharmaceutical Companies now use the off-label clinical use to market and promote very dangerous drugs. The Citizens United vs FEC opened the doorway to even greater amounts of money being used to influence elections - promote Pharmaceutical Industry legislation objectives and to control governmental regulation of prescription drugs.The Commercial Free Speech Constitutional argument is being used to protect the right of corporations to promote and market a dangerous drug which is controlled by the Food and Drug Administration for only limited clinical trials.

Xyrem is essentially the sodium salt of the date rape drug GHB - it metabolizes to the same active neuro-metabolite in the brain and Xyrem at the right dosage can be used as a date rape drug. The company is hiding the fact that out of the 9,000 people in this limited trial of Xyrem (GHB) 103 people died while taking the experimental drug. The company under-reported the deaths that occurred in order to keep marketing the drug.

The clinical trial of Xyrem is supposed to only distribute the prescription drug Xyrem to only the participants of the clinical study. These human subjects have been approved by the strict standards of the National Institutes of Health.  This is a process which demands informed consent of any human person who is involved in a scientific experiment or behavioral study.  Thus no one but the legally approved human subjects should be getting access to the experimental drug prior to it's approval by the Food and Drug Administration.

United States v Caronia

The extra-label use of GHB - Xprem which is extremely dangerous.  This drug has very narrow safety limitations for clinical use.   Xyrem is essentially the sodium salt of the date rape drug GHB -

In a 2-1 decision, the Second Circuit Court of Appeals recently vacated the criminal conviction of a pharmaceutical sales representative who marketed a narcolepsy drug for "off-label" uses, or uses of the drug that had not been approved by the Food and Drug Administration ("FDA"). The court held that the conviction violated the sales representative's First Amendment right to free speech.   New York, Connecticut, and Vermont, which comprise the Second Circuit.  It seems certain that the government will move for reargument and seek en banc review, and, failing that, will petition the Supreme Court for certiorari and that the Supreme Court will possibly be reviewing Caronia.

In March 2005 Orphan hired Alfred Caronia as a Specialty Sales Consultant to promote Xyrem.  In July 2005, Caronia instituted a speaker’s program for Xyrem.  Through the speaker’s program, Orphan paid physicians to speak to other physicians about Xyrem’s approved uses.  In the Spring of 2005 the government began to investigate Caronia and Dr. Peter Gleason, a speaker hired by Caronia, regarding alleged off-label marketing of Xyrem.  Caronia was heard on two consensual tape recordings promoting Xyrem to physicians for unapproved uses.  On July 25, 2007, Caronia was indicted, and on August 18, 2008, the government filed a superseding information.  The superseding information consisted of two misdemeanor counts.  Count One accused Caronia of conspiring to introduce a misbranded drug into interstate commerce in violation of 21 U.S.C. §§ 331(a) and 333(a)(2).  Count Two accused him of introducing a misbranded drug into interstate commerce, in violation of 21 U.S.C. §§ 331(a) and 333(a)(2). After trial, the jury found Caronia guilty of Count One, specifically with respect to the first object, the conspiracy to introduce Xyrem into interstate commerce when it was misbranded.  The jury acquitted Caronia of the second prong of Count One, and also of Count Two. 

On appeal, Caronia argued that the FDCA’s misbranding provisions prohibit off-label promotion and thus violate the First Amendment’s free speech protections.  The Second Circuit agreed, albeit on somewhat narrower grounds.  It found that the FDCA did not criminalize off-label promotion itself, but rather, viewed off-label promotion as evidence of misbranding.  However, the Court found that the government had, indeed, prosecuted Caronia for off-label promotion and that the District Court had instructed the jury that it could convict on that theory.  Under those circumstances, the Second Circuit held, Caronia’s conviction must be vacated.  Having found that the government had prosecuted Caronia for commercial speech, Judge Chin then addressed the level of scrutiny to be used in determining whether that speech was protected under the First Amendment.  Judge Chin looked chiefly to two Supreme Court decisions: Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011), and  Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n of N.Y., 447 U.S. 557 (1980).   Under that heightened scrutiny, the Court concluded, the Vermont law failed to pass constitutional muster.

This is the use of Commercial Free Speech Constitutional argument to protect the right of corporations to promote and market a dangerous drug which is controlled by the Food and Drug Administration for only limited clinical trials. 


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― Leo Buscaglia

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"Never impose on others what you would not choose for yourself."  Confucius

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Theodore Roosevelt- Excerpt from the speech "Citizenship In A Republic", delivered at the Sorbonne, in Paris, France on 23 April, 1910