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There are a number of issues to unpack in the case of Jeffrey Pearlman, an ex-pharmaceutical sales representative for Insys Therapeutics Inc, who is accused of paying kickbacks to induce doctors to write prescriptions for an opioid drug.

 

Pearlman was charged criminally in September 2016 for allegedly arranging sham speaker programs designed to encourage physicians and other prescribers to write prescriptions for a fentanyl sublingual spray, Subsys.1

 

The drug is manufactured by Insys and approved by the FDA in January 2012 "for the management of breakthrough pain in adult cancer patients who are already receiving and who are tolerant to around-the-clock therapy for their underlying persistent cancer pain."2

 

And the case goes beyond Pearlman: Insys, based in Arizona, is being investigated for its sales tactics and an alleged kickback scheme.3 At least one former executive for the company has been criminally charged: Elizabeth Gurrieri, former manager of reimbursement services for the company, was charged with wire fraud conspiracy in US District Court in Boston.3

 

And at least one prescriber, Connecticut nurse Heather Alfonso, pleaded guilty in June 2015 to receiving $83,000 in kickbacks from the company from January 2013 to March 2015, while she was employed at the Comprehensive Pain and Headache Treatment Center in Derby, Connecticut.3

 

According to the Hartford Courant, Alfonso is cooperating in the federal investigation. She said in court that Insys paid her through a sham "speakers program," supposedly to give presentations to other prescribers about Subsys. Instead, court documents say that Insys paid her about $1000 per event for going out to dinner with friends and coworkers, or with just an Insys sales rep. At the same time, she wrote out Subsys prescriptions at what prosecutors called "an alarming rate."

 

Court documents in her case say that some of the patients who were given Subsys did not have cancer, but that "prior authorizations" submitted on their behalf falsely represented that they did, the Courant reported.

 

Back to Pearlman: He faces trial in US District court in Connecticut. He made news a few months after he was charged, when his lawyers filed a request to modify his bail conditions so that he can continue to use medical marijuana prescribed to him by a New Jersey physician.

 

The Reuters news service reported that Pearlman's lawyers say the medical marijuana was prescribed to him to help him kick his opioid addiction, and is necessary for the defendant to participate fully in his defense.2 They say he became addicted to opioids used to treat severe back and leg pain and the drugs made him "foggy" and unable to think clearly. After being prescribed marijuana in August, they said, his pain has subsided and he is able to "think more clearly," Reuters reported.

 

Although some states have passed laws allowing physicians to prescribe marijuana in certain cases, marijuana remains illegal in federal court. There have been challenges to this in the past, mostly during President George W. Bush's administration. President Barack Obama's administration has not prosecuted medical marijuana cases that do not violate the state laws where they exist.

 

For the cases that came to the US Supreme Court during the Bush years, the court ruled against any attempts to legalize medical marijuana. Under federal law, there is no such thing as medical marijuana-there is only marijuana. The drug is classified as a Schedule I substance, meaning it is addictive and serves no medical purpose. Many prescription opioids, in contrast, fall under Schedule II-addictive, but having medical uses.

 

Yet Pearlman argues that it is his constitutional right to continue to smoke the illegal drug in order to avoid addiction to the legal one.

 

"Forcing him off the medical marijuana and forcing him to return to addictive opioids would impair his Sixth Amendment right to participate fully in his defense and his Fifth [Amendment] right to due process," wrote his attorneys Michael Rosensaft and Scott Resnik of Katten Muchin Rosenman LLP.2

 

According to the Reuters article, Pearlman's request is unusual and possibly the only motion of its kind to assert a Sixth Amendment constitutional right to use it in order to be able to participate fully in his defense, with a clear head. The defense claims that the failure to permit medical marijuana use could retrigger Pearlman's opioid addiction, which undermines his full participation in his own trial.

 

"It is a very creative defense," Keith Stroup, the legal counsel and founder of NORML, a nonprofit that advocates for the legalization of pot, told Reuters. "But I can assure you there has never been a federal judge that has granted such a motion."

 

Whether the judge will grant Pearlman's request remains to be seen.

 

Two defendants in other federal courts previously lost their bids to continue using medical marijuana, though the facts and circumstances in those cases were different.

 

In this case, the US Attorney's Office has not opposed the request, Reuters reported, and a spokesman for the office declined to elaborate further.

 

References

 

1. Lynch SN. Defendant in U.S. opioid kickback case claims constitutional right to smoke pot. http://Reuters.com. Published October 31, 2016. Accessed November 2, 2016. [Context Link]

 

2. US FDA Center for Drug Evaluation and Research. Approval Letter for Subsys. http://www.accessdata.fda.gov. Published January 2, 2012. Accessed at November 2, 2016. [Context Link]

 

3. Chedekel L. Drug company falsely claimed patients had cancer, feds allege. Hartford Courant, October 18, 2016, reported under a partnership with the Connecticut Health I-Team (http://www.c-hit.org). Accessed November 2, 2016. [Context Link]