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Why Our Prescribing of Transcutaneous Immediate Release Fentanyl (TIRF) Were for Patients’ Best Interests, Not for Self Interests
Xiulu Ruan, MD; October 21, 2021
Government’s Assertions
The Government’s entire case against Dr. Couch and myself hinged on the presumption that we prescribed TIRF medicines for self-interests, namely for money, not for patients’ best interests. Specifically, it asserted that we overprescribed Abstral in order to boost Galena stock price because we owned a large number of Galena stocks (the company that marked Abstral) (Tr.1/5/2017, p. 30-31). At the same time, the Government asserted that we overprescribed Subsys because we were speakers for lnsys Therapeutics (the company that manufactured Subsys) in order to receive its speaking fees. (Id., p. 31) Here I will demonstrate that when rationally examining our TIRF prescribing data, one can only come to the conclusion that our TIRF prescribing was for our patients’ best interests, not at all for self interests.
Only A Small Fraction of PPSA Patients Actually Received TIRF Medicines.
Most patients at PPSA did not receive any TIRF medicine. Although the FDA approved TIRF drugs for breakthrough cancer pain, many of my cancer patients did not receive any TIRF medicine because I made the clinical decision that their pain was not severe enough to justify a TIRF prescription. On the other hand, many non-cancer patients did receive TIRF medications when their breakthrough pain was severe enough and did not respond to other non-TIRF opioids. For example, my patient J.B. (Count 12) who had seen me for about four years, had a history of colon cancer and partial colon resection (Tr. 1/13/2017, p. 870), did not receive any TIRF medicine because I decided he did not need a TIRF prescription.
Three Government witnesses testified that about 15% of the patients at PPSA were cancer patients. (Tr. 1/31/2017, p. 2525; Tr. 2/1/2017, p. 3768; Tr. 1/26/2017, p. 2878) The percentage of my patients who has tried Subsys or Abstral were only 8.2% and 7.8%, respectively. (Tr. 5/26/2017, p. 49) Had I simply prescribed Subsys or Abstral to every patient with a cancer diagnosis, at least 15% of my patients would have been prescribed Subsys or Abstraf. These data are contrary to Mr. Bodnar’s misstatement in his closing argument: “This was about going out and farming through your patients…could put on Abstral, that you’ve got a financial self interest in.” (Tr. 2/16/2017, p. 6042)
My TIRF Prescriptions Were Selective and My Specific Instructions Resulted in Significant Cost Saving
In those patients to whom I did prescribe TIRF medications, I always instructed them to use TIRF only for very severe breakthrough pain. As a result, each of their TIRF prescriptions lasted a lot longer, which translated into cost saving. At trial I testified twice to this. (Tr. 2/14/2017, p. 5675) (“When I prescribed it, I put it for very severe breakthrough pain. I don’t just write p.r.n for pain.”); Id., p. 5691) (“Use it only for very severe breakthrough pain.”)
My patients followed my instructions well. For example, Government witness S—— B—– (a patient of mine from 2008 to 2015, who had been under my care for her lower back pain and leg pain due to lumbar spinal stenosis and failed back surgery syndromes) testified that she only used her Subsys for “tight situations. (Tr. 2/2/2017, p. 4152) (“If I was to go shopping and my leg was to go out where I could not move it, then I would take it to get me back to my automobile.”)
Ms. B—– received only one box of Subsys 600 mcg (0.6 mg), 30 units, as a free voucher medication on October 31, 2013. (Id., p. 4173) By March 24, 2014, about five months later, she still had 10 units left. (Id., p. 4152)
The significant cost saving can be seen from the following comparison: In his opening statement, Mr. Bodnar repeatedly told the jury how expensive such TIRF medicines were, e.g.: “Prescriptions for Subsys and Abstral range from $5,000 to over
$24,000 EVERY MONTH” (Tr. 1/5/2017, p. 29, emphasis added) In his closing argument, he again told the jury: “this is big-time money…there is no fooling around with $150 in cash when you can prescribe $18,000 A MONTH Subsys and Abstral and have insurance pay for it.” (Tr. 2/16/2017, p. 6017) (emphasis added)!
At trial the BC/BS record showed that from January 1, 2011 to May 20, 2015, I prescribed 353 Subsys prescriptions to 179 BC/BS patients, and BC/BS paid $1,515,369 (Tr.1/25/2017, p. 2549) Thus, on the average, each BC/BS patient received less than two Subsys prescriptions, at the total cost of $8,483 for their entire treatment course, not “$18,000 a month.” My use of free voucher TIRF drugs along with my specific instructions to my patients resulted in significant cost saving. (see below)
Our use of Free Voucher Abstral Program Negatively Affected Galena, the Company We Owned Large Share of Its Stocks
At trial a handful of Government witnesses testified about the free voucher TIRF medications. (Tr. 1/26/2017, p. 2878), (Tr. 1/17/2017, p. 1183), Tr. 1/18/2017, p. 1315), Tr. 1/31/2017, p. 3525), (Tr. 1/19/2017, p. 49) I took advantage of manufacturer’s free medication program to benefit my patients at PPSA. Of the small fractions (i.e. 8.2% and 7.8%) of patients who had ever tried Subsys or Abstral, most of them were actually one time free-voucher medication recipients. As a matter of fact, as high as 90% of the Abstral recipients were free voucher Abstral recipients. (Tr. 2/14/2017, p. 5690)
Government witness, Galena National Sales Director, D—- C—–, testified to the free voucher Abstral program: “The voucher program where a patient could get up to three prescriptions of Abstral at 32 tablets a piece, so up to 96 tablets of Abstral free of charge.”(Tr. 1/19/2017, p. 49) (Notice C—- said although Galena allowed up to total 96 units of Abstral free of charge, they had to be written on three prescriptions, rather than one prescription for 96 units.)
At my sentencing hearing I testified that in order for patients to use manufacturers’ free voucher program, I had to write multiple small prescriptions: “You cannot write one prescription for 120 pills. You have to write, 30, 30, 30, 10, 10, 10, or 7, 7, 7 [units on each prescription].” I also explained that when a tracking system was based on the number of prescriptions written, my way of prescribing while taking advantage of the free voucher program to benefit our patients, would easily be construed as an outlier, simply because the number of prescriptions was higher.
David Corin also testified that our use of Abstral at PPSA and C&R Pharmacy hurt Galena financially: “It affected us negatively because Galena paid for all products in the voucher program…because we were losing money on the voucher program…” (Tr. 1/19/2017, p. 53-54) He also confirmed that Galena’s financial loss was tied to our free voucher medications at PPSA. (Id.) This fact alone contradicted the Government’s assertion that we prescribed Abstral for self interests — to boost Galena stock price simply because we were significant Galena stock owners.
TIRF “Victims” Testified at Trial for Government Were Actually TIRF Beneficiaries Who Received Only Free Subsys and Abstral
At trial two Government witnesses, S—– B—- and A—– D—– B—– testified, as the “victims” of TIRF recipients. Both of them had lower back pain and leg pain for years, due to degenerative lumbar disc disease, lumbar spinal stenosis, and failed back surgery syndromes. E.g., B—– had undergone five lumbar spinal surgeries prior to her being referred to PPSA to see me. (Tr. 1/31/2017, p. 3671) Even though both testified as if they were TIRF “victims,” their testimony actually sounded like success stories.
S— B—- testified that she only used her TIRF medication for “tight situation” as she stated previously; A—- B—- told the jury that the Abstral and Subsys prescribed helped her pain tremendously: “I could clean my house, wash my car.:” (Id.,
- 3666); “I feel wonderful. l didn’t feel (any) pain in the world.” (Id.; p. 3667)
- Remarkably, both B—- and B—- received only Subsys and Abstral fr e voucher medications, only once for each, without spending a penny of their insurance companies’ or their own money. B—- received her Subsys 600 mcg (30 units) on October 31, 2013 (Tr. 2/2/2017, p. 4173); she received her Abstral 600 mcg (three boxes, 96 units written on three separate prescriptions, 32 units on each prescription) on March 24, 2014 (Id., p. 4174), (Tr. 2/14/2017, p. 5797).
- B—– received Abstral 200 mcg (three boxes, 96 units written on three prescriptions, 32 units on each prescription) in September 2014 (Tr. 2/14/2017, p. 5774) and one box of Subsys 200 mcg (30 units) in October 2014. (Id., p. 5775)
Rationally Analyzing Our Subsys and Abstral Prescribing Data Showed That We Prescribed TIRFs Based on Patients’ Needs,
Not Our Own Interests
According to Government Exhibit 10-22, the total dose of Subsys and Abstral received by B—- was 0.076 grams. Notably, her total dose ranked #143 among 637 Subsys and Abstral recipients (prescribed by me). Since B—- was one-time recipient who received only free voucher Subsys and Abstral as discussed above, and her total dose ranked #143 out of 637, those recipients following B—– in their rankings (namely those ranked from #144 to #637) were most likely one-time, free sample users, just like B—–. In other words, 494 out of 637 recipients, or about 78% Subsys and Abstral recipients were likely one-time voucher users. This percentage is consistent with my testimony at trial that up to 90% of Abstral filled at C&R Pharmacy were through the free voucher program from October, 2013 to March, 2014. (Tr. 2/14/2017, p. 5690)
Again, Government witness, D—- C—– testified that our free voucher uses of Abstral significantly hurt Galena financially, necessitating the change of its voucher program at the end of March, 2014. (Tr. 1/19/2017, p. 53) Yet, both Dr. Couch and I owned large shares of Galena stocks.
A handful of Government witnesses testified that there were four TIRF products, namely Subsys, Abstral, Fentora, Lazanda, and the companies owning these products were mutual competitors. (Tr. 1/17/2017, p. 1129), (Tr. 1/9/2017, p. 466), (Tr. 1/18/2017, p. 1257), (Tr. 1/19/2017, p. 123) The jury had heard that Dr. Couch and I each invested about $800K in Galena (the company that marketed Abstral). (Tr. 1/9/2017, p. 498), (Tr. 2/14/2017, p. 5698) Had Dr. Couch and I conspired with each other and wanted to enrich ourselves by overprescribing Abstral to presumably help Galena stocks (as asserted by the Government), we would have switched all or most of our patients from other TIRF medicines to Abstral because all these were mutual competitors. This, however, was not what the trial record showed.
The trial record showed that both Dr. Couch and I prescribed much more Subsys than Abstral. For example, in 2014, the top 6 of monthly Subsys prescribed by Dr. Couch (rn grams) were 6.5, 6.1, 6.0, 5.4, 5.1, 5.0, In September, May, October, April, July, and January, respectively. [Government Exhibit 10-18(a)]; meanwhile, in the same year (2014), the top 6 of prescribed Abstral by Dr. Couch (in grams) were 2.1, 1 8, 1.8, 1.5, 1.5, 1.3, in November, May, February, April, December, and October, respectively. [Government Exhibit 10-19(a)]
My counsel Mr. Dennis Knizley showed that, when comparing the total amount of Subsys and Abstral having been prescribed by me from November 2013 to May 2015, 64.5% was Subsys and 35.2% was Abstral. (Tr. 1/12/2017, p. 530-31)
In addition, the trial record showed that I prescribed more Fentora (another competitor TIRF drug) than I prescribed Abstral in the Indictment period. Specifically, according to Government Exhibit 12-2, I prescribed total of 93,034 units of Fentora and 67,892 units of Abstral. Yet, the jury heard very little about Fentora because such data would have contradicted the prosecutors’ argument that I over-prescribed Abstral to boost Galena stock.
A separate note on our Galena stock investment Dr. Couch and I invested heavily in Galena stocks because of its pipeline product, Neuvax, a vaccine for recurrent breast cancer. (Tr. 2/1412017. p. 5694) Several of my family members and friends had passed away because of breast cancer; I knew such a vaccine was highly needed. (Id.) Dr. Couch testified that Neuvax was initially funded by the Department of Defense of the U.S. Government. (Tr. 2/13/2017, p. 5513) When its phase Ill clinical trial failed in 2016 (one year after our arrest), Dr. Couch lost $487,000. (Tr. 1/9/2017, p. 498); I lost at least as much.
On the other hand, the prosecutors insisted that Dr. Couch and I over-prescribed Subsys for its speaking fees. The Eleventh Circuit illogically argued that there was “abundant evidence that the appellants prescribed millions of doses of TIRF for their own financial gain (i.e. their Investments in Galena stock and their payments as lnsys speakers) [United States v. Ruan, 966 F.3d 1101, 1175(11th Cir. 2020), but the prescribing data shown above directly contradicted its conclusion.
- The prosecutors argued that we continued to prescribe Subsys for self interests, namely the speaking fees; however, both Dr. Couch and I each had invested about $BOOK into a company stock at a rate of $2-$3 per share, the speaking fees for its competitor’s drug (namely Subsys) at a rate of $2K-$3K per talk become insignificant compared to the potential yield from the stock investment had we stopped prescribing all other competitor TIRF drugs.
- Further, had we prescribed Abstral for self interests, we would not have used free Abstral vouchers at all because we knew free voucher medications did not generate any revenue for Galena. The trial evidence showed that we used Abstral free vouchers liberally in selected patients to the point of hurting Galena financially, causing Galena to change the free voucher program.
In sum, all of the above prescribing data strongly support only one logical conclusion: We prescribed TIRF medicines to benefit our patients, not for self interests as was asserted, and that was the fact.
