Health Letter, July 2016
By Michael Carome, M.D.
If you’re not outraged,
you’re not paying attention!
Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.
On June 9, FBI agents arrested two former drug company employees for allegedly running a brazen scheme to bribe doctors to prescribe millions of dollars’ worth of a powerful synthetic opioid. Complaints filed in federal court by the FBI paint a disturbing picture of doctors succumbing to greed and violating their duty to act only in the best interests of their patients.
Defendants Jonathan Roper and Fernando Serrano formerly worked at Insys Therapeutics as a district sales manager and a sales representative, respectively. Insys markets only one product: fentanyl spray (Subsys), a rapidly acting, highly potent, dangerous opioid sprayed under the tongue. Subsys is approved solely for treating breakthrough pain in cancer patients who are not responding adequately to other opioids.
The government alleges that from 2013 to 2015, Roper and Serrano paid speaking fees to doctors, purportedly to educate other health care providers about Subsys. But many of the educational programs were phony, involving social gatherings and no education. Emails written by Roper to his sales team explicitly signaled that in exchange for receiving speaking fees for the sham educational programs, as well as for being wined and dined at expensive restaurants, doctors were expected to prescribe Subsys.
For example, in one particularly incriminating email from late March 2014, Roper wrote:
Good luck today, biggest Friday of the quarter is here!! Still 4 days including today to get [prescriptions] filled, put more $$ in your pockets and for those of you who haven’t met your baseline yet, there’s still time left! You have all heard it before, LIVE WITH YOUR TOP DOCS, and even more importantly ASK for their business.
We all benefit from having the best ROO [Rapid-Onset Opioid] in its class, that being said, there is no excuse for any of your docs to not take care of you at this crucial time of the quarter. For the first time as a company, we are facing the challenge of meeting our quarterly goal. That being said, its time for all of your … top prescribers (esp. SPEAKERS) to give back for all of the hard work, long days and late nights you have spoiled them with.
In a subsequent May 2014 email quoted by government investigators, an apparently outraged Roper asked his sales staff:
Where is the ROI [Return on Investment]??!!! All prescribers from this team that are on this list are [Pharma Company-1] speakers. We invest a lot of time, $, blood, sweat, and tears on ‘our guys.’ … We hire only the best of the best to be apart [sic] of our speaker bureau and dropping script counts is what we get in return?
. . .
This is a slap in the face to all of you and is a good indication as to why NONE of you are climbing in the rankings this quarter. DO NOT be afraid to set your expectations and make them crystal clear as to what they are before, during, and after HIRING these priviliged [sic] set of docs who are fortunate enough to be a part of the best speaker bureau in the market in the world of BTCP [breakthrough cancer pain]. Please handle this immediately as funding will not be given out to anymore [sic] ‘let downs’ in the future.
Likewise, Serrano allegedly told one unidentified doctor, who was invited to be a company-paid speaker and is now a government witness, that the doctor needed to help Serrano out by writing prescriptions for Subsys.
Unfortunately, the defendants found several doctors who were more than willing to play ball at the expense of their patients. For example, two Manhattan-based doctors recruited by the defendants — identified by the government only as “Doctor-1” and “Doctor-2” — were two of the top recipients of Insys speaking fees in the U.S. in 2014, receiving $147,000 and $112,000, respectively.
The company’s investment in these doctors appears to have paid handsome dividends: Together they accounted for approximately $2.6 million worth of Subsys prescriptions reimbursed by Medicare and more than $5 million worth of prescriptions reimbursed by private insurance, making them among the top Subsys prescribers in the U.S. in 2014. The prolific prescribing of Subsys by Doctor-1 is even more troubling given that the doctor is not a cancer specialist, suggesting that many prescriptions were for patients with noncancer pain.
The alleged conduct of Doctors-1 and -2, if true, was reprehensible. By prescribing a dangerous and highly restricted opioid like fentanyl in exchange for bribes from Insys employees, they not only violated federal kickback laws but also potentially endangered patients’ lives. Hopefully, the Justice Department will identify and file charges against Doctors-1 and -2, and if they are found guilty, the New York state medical board will permanently revoke their medical licenses.
 Thomas K. Drug maker’s former employees accused of shady dealings with doctors. June 10, 2016. New York Times. http://www.nytimes.com/2016/06/11/business/drug-makers-former-employees-accused-of-shady-dealings-with-doctors.html?_r=0. Accessed June 26, 2016.