CLEVELAND: Seven cancer specialists in northern Ohio have been put on probation based on their guilty pleas to importing unapproved cancer drugs from Canada, the U.S. government said Wednesday.
The government said the seven must pay a total of $2.6 million in fines, penalties and restitution to Medicare.
The doctors pleaded guilty to violating the Food, Drug and Cosmetic Act. The charges were filed last August, and the doctors were sentenced over the past four months.
The seventh defendant, Dr. Hassan Tahsildar, 55, of nearby Euclid, was put on probation for a year on Tuesday by a magistrate judge in U.S. District Court. He was ordered to pay $179,316 in fines and restitution.
Tahsildar pleaded guilty Sept. 27 to importing misbranded drugs from Canada from 2006 to 2009.
His attorney, Anthony Vegh, said Wednesday the case was never about the efficacy of the drugs prescribed by Tahsildar.
“He has always provided his patients the highest quality of care and continues to do so today,” Vegh said.
Colleagues who have practiced with Tahsildar in Green Bay, Wis., wrote character letters to the court to express their respect for him and his work. One said he believed the drug importing was meant to help his patients, not benefit himself.
A pre-sentence report for a co-defendant, Dr. David Fishman, 62, also of Euclid, said he began using lower-cost but identical drugs from Canada after Medicare cut drug reimbursements to 85 percent of the average cost for office-based oncologists.
A single chemotherapy treatment can cost $10,000, so the reimbursement created a financial burden, Fishman’s attorney told the court.
All seven drug importing cases were handled through a criminal information filing with the court, indicating they had cooperated with investigators.
“These doctors used drugs that had not been approved by the FDA,” U.S. Attorney Steven Dettelbach said in announcing the wrap-up of the cases.
The doctors were charged with importing unapproved drugs, including Zometa, Kytril, Taxotere, Gemzar, Eloxatin and others. The drugs are used to treat a variety of cancer types or side effects of cancer chemotherapy.
A drug may be considered misbranded even if it is identical in composition to an approved drug. The misbranding wasn’t specified.
The misbranding rule applies even if the drug was produced by the same manufacturer and in the same facility as the approved version.
There was no estimate from prosecutors on how many patients may have used the drugs or if any were harmed.
An investigator said patient safety had been put at risk.
“This conduct is potentially harmful to patients as it circumvents the laws that were enacted to ensure medications are safe for use,” said Lamont Pugh III with the Department of Health & Human Services’ regional Office of Inspector General.