Lupron Crimes Betrayed Patient Trust
by JACQUELINE STRAX
New York, NY, February 27, 2001. In 1998 prostate cancer advocates mounted a campaign against US government Medicare's surcharge on the testosterone-blocking castration drug Lupron. Medicare was not covering the cost of prescription drugs taken at home. But because Lupron and its rival Zoladex are usually injected in the doctor's office, by a nurse, these drugs were (and to date still are) covered by Medicare as well as by many private insurance plans.
The story on the surcharge was this: both drugs, Lupron and Zoladex, have always been sold at a high price.Lupron (made by TAP) costs slightly more than Zoladex (made by Astra-Zeneca). In most other respects the two drugs are virtually interchangeable in their effect (bringing about clinical castration) even though the pharacological routes differ soemwhat. Medicare decided to save tax-payer money by refusing to pay the extra cost asked by pharmacies filling Lupron prescriptions. Medicare decided to favor the "least costly alternative."
So in 1998 Medicare began to take action against the higher price of Lupron. In several states, Medicare extended its Least Costly Alternative policy to prescription drugs and withheld full reimbursement from prostate cancer patients who took Lupron. Medicare continued to pay in full for Zoladex, which for a monthly shot costs about $125 per month less.
Since patients were taking Lupron on the advice of their doctors, many patients when told this story felt Medicare's move was outrageously unfair. "Medicare is putting its own cost-cutting ahead of the well-being of the patient," patient-activist Harry Pinchot said in November 1998 in helping to launch a campaign against Medicare's policy.
Both of these monthly or three-monthly depot drugs are delivered by large-needle injection. Lupron is injected in muscle in the buttock; Zoladex uses a bigger needle into in a more sensitive spot, the abdomen. The drugs have similar efficacy profiles, but normally, if one injection hurts more than the other, that would be enough to justify a patient preference. Men with a notoriously painful cancer, many patients said, should not be forced to pay a surcharge to avoid this extra, almost cruel and unnecessary pain and discomfort from a bigger needle in a more sneisitive spot.
Medicare officials at inquiry meetings were unsympathetic. Pinchot addressed a California Medicare panel. He said afterwards that when he brought up the bigger needle, his remarks met with smirks and eye-rolling.
All this sounded like an outrage to us. But while activist patients championed patients' choice and attacked what they took as a Medicare assault on the doctor-patient relationship, something quite different was happening behind the scenes. Federal prosecutors, in an undercover criminal investigation, were gathering evidence to prove that the manufacurers of Lupron (TAP pharmaceuticals) and hundreds of doctors recruited by TAP--were ripping off taxpayers and patients alike.
Urologists in Indiana, Florida and Connecticut have been charged by federal prosecutors with conspiring with a drug company to gain excess payments from Medicare for prescriptions of Lupron used to treat prostate cancer.
Melody Peterson reported February 20 in the New York Times that the drug company is identified in court papers as Company X. Everyone knows, though, Lupron is made by TAP Pharmaceutical Products. TAP, short for for Takeda Abbott Pharmaceuticals, is a joint venture of Abbott Laboratories in Illinois and Takeda Chemical Industries in Japan.
On February 13 this year a company spokesman in Japan said "We cannot comment about TAP which is still under investigation by the Justice Department which began its investigation into TAP in December 1997."
Federal prosecutors charge that in the summer of 1995 the company offered Bristol, CT urologist Joseph A. Spinella a deal. If he would switch all his prostate-cancer patients from Zoladex to Lupron, he could extract as much as $7,000 extra a year from Medicare. Prosecutors say the company set up Spinella with free samples. He charged these samples to Medicare also.
Dr. Spinella has been charged with taking a bribe by conspiring to receive kickbacks. Hartford Courant reporter Matthew Kauffman wrote February 21,"'Dr. Spinella switched the drug he injected into his prostate-cancer patients so that he could make more money,' said Donald K. Stern, U.S. Attorney for the District of Massachusetts, where the indictment was issued on Dec. 8. 'He did this by getting free samples as kickbacks and then billing his patients and third-party payers, such as Medicare.'"
Another urologist, Dr. Jacob Zamstein of Bloomfield, CT, is accused of accepting more than 100 free samples of Lupron and then billing patients and insurers as much as $550 for each dose, netting a profit of more than $30,000.
In addition to offering doctors "billable" free sample handouts, prosecutors say, the company gave the federal government an inflated wholesale price for Lupron, then sold the drug to hundreds of doctors at a much lower price. On billing Medicare, the doctors could expect to get $100 or more in extra profits on every shot.
Some patient advocates worry and even stoke fears that managed care and Medicare might try to push prostate cancer patients off these drugs back to surgical castration (orchiectomy). Patient concern about this issue is stark. The surgery is irreversible except by applying testosterone patches or injections.
It's quite well known that for years TAP has played a role in leveraging the full range of genuine patient concerns and anxieties. TAP has sponsored startups of prostate cancer patient organizations like National Prostate Cancer Coalition and its state branches. TAP also sponsors a New York City road race against prostate cancer.
Now, however, patients can see -- while their activists were fighting Medicare on behalf of Lupron and the patient-doctor relationship, Company X was bribing urologists so as to grab market share. Company X encouraged doctors to taint and betray the patient-doctor relationship.
The fraud investigation found evidence that TAP pitched Lupron to urologists as a money-maker. According to the Chicago Tribune, in May 1999 salespeople for TAP told doctors that ultimately they would make more off each patient by trading surgery for the Lupron shot, each of which pulls in a profit of $100 plus per month.
TAP representatives "'would lay it all out,'" urologist Dr. P.W. Kinder, a South Carolina urologist, told the Chicago Tribune. "'They had it all documented, how much money it would mean to your practice,' Kinder said. 'Their point was, why make $500 or something like that on [surgery] when you could be making $1,200 a year. ... It means a very significant adjunct to somebody's income.'"
The company is negotiating a settlement of hundreds of millions of dollars.
Reuters says that the amount is "close to $840 million, which was the record settlement that hospital chain HCA (NYSE:HCA - news) paid last year in a health-care fraud investigation."
Conspiracy to Get Men On To Lupron Alleged April 2000
AstraZeneca Pleads Guilty in Cancer Medicine Scheme
22 JUNE 2003 "AstraZeneca , the large pharmaceutical company, pleaded guilty today to a felony charge of health care fraud and agreed to pay $355 million to settle criminal and civil accusations that it engaged in a nationwide scheme to illegally market a prostate cancer drug."
HOW PATIENTS HELPED TAP TO FIGHT MEDICARE
Medicare's Lupron Surcharge Goes Ahead in California Harry Pinchot April-May 1998
Medicare Aims to Make Patients Quit Lupron, Switch to Zoladex or Pay Extra Harry Pinchot, November 1, 1998
Medicare Jeopardizes Trust Over Cost of Lupron by Harry Pinchot Nov. 24 1998.
This archived article dates from February 7, 2001. This article does not claim to represent the latest information on this topic.