It’s movie awards season, and that reminds us that filmmakers are at work on new projects that might snag an award or two next year. And ever since the film Love and Other Drugs turned Jake Gyllenhaal into a Viagra sales rep, and director Steven Soderbergh‘s film Contagion made a vaccine researcher into a hero, Big Pharma’s a hot theme in the movie biz.
For example, a recent Reuters report says that Kathleen Sharp‘s book Blood Medicine (formerly Blood Feud) has just been optioned by the film production company, New Regency. This book is the true story of Mark Duxbury, a Johnson & Johnson drug rep-turned-corporate whistleblower. Duxbury repped for J&J’s biotech division Ortho, and was one of its top salespeople for its anemia drug Procrit – until he was fired, allegedly for warning that the drug could actually be harmful.
Here’s why this real-life script has suspense thriller written all over it. Procrit (epoetin alfa, or EPO) seemed to be a miraculous blood booster, stimulating the bone marrow to make red blood cells. This anti-anemia medication was one of the first biotech wonder drugs, developed in the 1980s by a start-up company called Applied Molecular Genetics, or Amgen.
As the story opens, Amgen knows it has a potential blockbuster on its hands. The AIDS epidemic is sweeping the U.S. At this time, there is no way to detect HIV-tainted blood, and any new drug which can reduce the need for blood transfusions has the potential to save countless lives. But Amgen needs capital to develop their new drug, and they enter into a partnership with pharmaceutical drug industry giant Johnson & Johnson to sell the drug under the brand names Procrit, Epogen, and Aranesp.
J&J sales rep Mark Duxbury champions this new product and believes in the technology behind it. Described by Sharp as “always at the ready with a joke and a smile”, his knowledge and passionate pitches set sales records and help him win company performance awards.
J&J allegedly provides Duxbury with a playbook of tactics known to convince physicians to write more Procrit prescriptions and at higher, more dangerous doses, all the while assuring them the drug is “as safe as mother’s milk.”
Doctors, as Sharp describes, are easily manipulated into prescribing more of this drug through J&J’s offers of rebates, speaking and consulting fees, research stipends, grants, rebates, free meals, secret discounts, honoraria, “continuing medical education” seminars at luxury resorts, and other kickbacks.
Procrit is heavily promoted as an instant cure for chemotherapy-related fatigue as well as for anemia in kidney dialysis patients. J & J starts running ads for Procrit. This ad campaign, which runs between 1998 and 2005, features the tagline “Strength for Living.” An FDA letter to J&J, however, warns that the ad is “misleading because it implies that Procrit improves strength and may improve survival, when the outcomes have not been demonstrated by adequate and well-controlled clinical trials.”
J&J also finances “The Fatigue Coalition” – a patient-advocacy group that promotes off-label (unapproved) uses of the drug for cancer patients, despite studies* concluding: “these agents are effective in the management of cancer-related fatigue but also raises serious concerns about safety data and adverse outcomes associated with these agents. The review concludes that these agents should not be used for the treatment of fatigue in patients with cancer.” *
Kickbacks to doctors and hospitals buying Procrit become an integral part of the marketing strategy. For example, an internal company memo calculates that a physician who orders $1 million of Procrit over 15 months would personally receive a kickback of $237,885 in return, or a 24% cash rebate.
The drugmaker also:
- monitors doctors’ prescribing habits to determine the marketing strategies that will work best
- violates patient confidentiality laws by encouraging sales reps to troll medical records for the best drug-testing candidates
- uses study participation to get doctors to prescribe Procrit for dangerous off-label purposes.
Then the plot thickens. The deaths of about a dozen high-profile European cyclists from a deadly condition called pure red cell aplasia (a total shutdown of the body’s red blood cell production) are linked to high dosing with the blood booster EPO (accessed via the black market).**
EPO has already been linked to illegal doping among elite athletes, and is banned as a performance-enhancing drug that claims to increase an athlete’s aerobic capacity and muscle endurance. (It also made headlines last year when U.S. cyclists Tyler Hamilton and Floyd Landis each claimed first-hand knowledge of disgraced seven-time Tour de France champion Lance Armstrong‘s use of the banned drug).***
Sharp writes that drug safety tests have not been conducted for Procrit, though such testing is required by the FDA contingent on approval. Astonishingly, the FDA had decided that safety studies could be done after the drug was brought to market. She writes:
“Scientists knew that boosting red blood cells also thickened the blood, which increased the risk of clotting. Blood clots lead to strokes, heart attacks, and brain aneurisms. No one could be sure that Procrit was safe at even recommended doses, according to several sources.”
Eventually, Mark Duxbury comes to the horrifying conclusion that up to half a million people may have died as a result of this drug. He tries to stop some of the ruthless marketing practices, but is fired by J&J. Then he attempts to warn the public about the drug’s dangers in any way he can: by testifying in a secret arbitration, joining a class action effort, and, finally, filing a whistleblower lawsuit.
In the spring of 2007, the Food and Drug Administration slaps a black box warning on the label of the drug (sold as Procrit, Epogen and Aranesp), and the U.S. Congress calls a hearing about the illegal promotion of these anti-anemia drugs.
The drug’s packaging insert now includes this ominous warning:
“INCREASED MORTALITY, SERIOUS CARDIOVASCULAR EVENTS, THROMBOEMBOLIC EVENTS, STROKE and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE.”
Physicians are still prescribing Procrit. As of June 2011, the FDA’s warning to patients now simply reads:
“Using PROCRIT can lead to death or other serious side effects.”
Stay tuned for release date information as the Blood Medicine film production begins.
Meanwhile, watch this interview with Kathleen Sharp about what convinced her to write her book, Blood Medicine.
* Minton O, Richardson A, Sharpe M, et al: Drug therapy for the management of cancer-related fatigue. Cochrane Database Syst Rev 7: CD006704, 2010.
** Nicole Casadevall. Pure Red-Cell Aplasia and Antierythropoietin Antibodies in Patients Treated with Recombinant Erythropoietin. N Engl J Med 2002; 346:469-475 February 14, 2002
*** U.S. Anti-Doping Agency official charges, June 12, 2012: “Erythropoietin (EPO), also known as E, Po, Edgar or Edgar Allen Poe, among other names. EPO is used by athletes to increase the number of red blood cells in their circulatory system which are available to carry oxygen. … Even after the EPO urine test was developed and implemented in sport in late 2000 EPO was difficult to detect and the Respondents [Lance Armstrong, a team director, team captain and team doctors] implemented a number of means to avoid detection of EPO use, including: micro-dosing (i.e., using smaller amounts of EPO to reduce the clearance time of the drug), intravenous injections (i.e., injecting the drug directly into the vein rather than subcutaneously to reduce clearance time), saline, plasma or glycerol infusions (described below) and various effort to avoid testing by drug testers at times that EPO might still be detectable in the riders’ urine. … Multiple riders with firsthand knowledge will testify that between 1998 and 2005 Armstrong personally used EPO and on multiple occasions distributed EPO to other riders.”