Oncologist countersues government in unregulated medicine case

Apr 8, 2017 – Joplinglobe

Robert L. Carter, a Joplin oncologist who was ordered by a federal court to pay $2.2 million after he treated patients with unregulated cancer drugs, wants some of his money back. He is suing, saying that federal prosecutors overstated the amount his practice paid for the unregulated medicines.

The judgment against Carter included drug purchases he supposedly made in June of 2011, one month after his practice was destroyed in the May 22 Joplin tornado, according to the lawsuit.

Carter, 76, was one of several doctors targeted by federal prosecutors as part of a nationwide crackdown on the importation of unregulated medicines. The charges were a byproduct of a counterfeit drug scandal that led the U.S. Food and Drug Administration to investigate dozens of physicians who ordered drugs from a network of companies that brought fake cancer drugs into the U.S. Carter was never accused of selling fake drugs

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Three years later, federal prosecutors followed up, charging doctors around the nation with selling drugs that hadn’t been approved by the FDA.

Many made purchases from Quality Specialty Products, the Canadian company that sold chemotherapy and other drugs to Carter. Ali Ben-Jacob, a Utah cancer doctor, was forced to pay the $975,000 he made from selling misbranded drugs. D. Anda Norbergs, a Florida oncologist, relinquished roughly $867,000 for the same reason.

Prosecutors said Carter’s practice made $1.2 million by selling the drugs and that it received about $972,000 from government insurance programs, court records show. In 2015, a judge ordered him to pay back both sums, serve a five-year probation and stop practicing medicine.

Carter says he was surprised by the charges. By the time the FDA sent a letter in 2012 warning him that he had purchased drugs from an unreliable and illegal supplier, his practice at 1617 W. 26th St. had been swept away.

Carter’s lawsuit targets Stephen J. De Zeeuw, an investigator for the FDA, saying he provided prosecutors with false information that led them to inflate those figures by a total of $600,000. Carter is also requesting a jury trial, which he views as a chance to publicly restate the innocence he has maintained since 2015.

He says high drug prices had made it barely profitable to operate his private cancer practice in 2010, when, at the suggestion of another doctor, he began buying drugs from QSP, which was selling chemotherapy drugs for less than U.S. prices. He says he checked to be sure that the drugs, which would be injected into his patients, were identical to the ones already in use, then began ordering from the company in April 2010, never suspecting the practice was illegal.

He insists above all that no patients were harmed.

“I never saw that stuff,” he said of the medications. “I took care of sick people. Did any patient suffer? The answer is no.”

Patients did not know that they were receiving foreign drugs because Carter himself did not keep track of which drugs were supplied by QSP, he says. By his account, office staff handled and purchased the drugs, which they obtained from many different suppliers..

Doing so was illegal because the FDA had not approved the drugs for distribution in the U.S. and because some were “misbranded” with instructions for use in a language other than English, according to a statement from the Western District of the federal court in Missouri.

Carter’s lawsuit does not dispute this but points to a report that De Zeeuw submitted to prosecutors saying Carter purchased drugs from QSP after the practice was destroyed and purchases had stopped. That report is not public record and could not be obtained by the Globe. In other court filings, prosecutors said Carter stopped purchasing unregulated drugs in May of 2011.

Bill Fleischaker, Carter’s attorney, declined to comment because the lawsuit is in its early stages. No response has been filed in the case. Fleischaker previously said Carter was being forced to pay twice for some of his drug purchases.

The Western District did not respond to Globe requests for comment.

Carter has not completed payments on the original $2.2 million judgment.

The drug purchases were business decisions, he says, and he believed them to be legal.

<\z186667>”I was astounded that they would do something like this,” he said of receiving the federal charges.

An article published in the Journal of the American Medical Association has estimated that U.S. citizens pay more than twice as much for drugs than the average resident of other developed countries. Carter was saving between 10 and 20 percent on cancer drugs bought from QSP, and he says the drugs helped patients.

<\z186667>Shabbir Safdar, executive director of the Partnership for Safe Medicine, a think tank funded by health care and pharmaceutical trade groups, said high prices do not warrant the use of unregulated medicines.

<\z186667>“The solution to (high prices) is not to endanger your patients with a drug that (may be) real or not,” he said.

Among the 14 different medicines shipped to Carter’s practice was Avastin, the chemotherapy drug that made headlines in 2012 when counterfeit versions of it were discovered in the U.S. Documents submitted by prosecutors acknowledge that no fake drugs were found in Carter’s possession.

The fakes traced back to Canada Drugs, the Winnipeg, Manitoba, online drug retailer that controlled QSP and other unregulated U.S. retailers, the Wall Street Journal reported in 2012. Founded in an attempt to undercut rising drug prices, the company reportedly met with sharp opposition from big drug makers. Whenthe company was shut out of the Canadian drug market, it sought to buy drugs overseas, eventually losing control of parts of its supply chain. Fake drugs entered the U.S. market through Canada Drugs subsidiaries such as QSP, leading to an FDA crackdown.

Federal prosecutors looked beyond doctors to Canada Drugs itself, serving it with an indictment accusing it of bringing $78 million of unregulated drugs to the United States.

Canada Drugs is still a licensed as a pharmacy by the Manitoba government, though Canadian authorities revoked its right to sell drugs wholesale. American consumers are still able to order drugs from the company online, though the practice is not legal.

For his part, Carter is still dedicated to the vocation he chose as a child. Although fallout from the indictment has haunted him professionally — he officially withdrew from medical practice earlier this year rather than face disciplinary action from the Missouri medical licensing board — Carter has participated in medical missions, delivering supplies and basic care to poor communities.

“When I can walk in there and see somebody and save a life, it’s like I’m alive again.”

— Dr. Robert Carter in reference to a trip with others from Grace Episcopal Church in Carthage in February to Haitian communities impacted by Hurricane Matthew, which struck the country this past fall.