FDA: Hard to prove if foreign meds harmed any cancer patients

Copyright © 2014 Albuquerque Journal

A U.S. Food and Drug Administration agent testified Monday that there is no way to tell whether cancer patients of a Deming oncologist who were treated with foreign drugs for two years were actually harmed – in part because many are now dead.

“I know a lot of patients treated during this time period are now deceased,” special agent Todd Blair testified during a state Medical Board hearing on allegations against Dr. Mohamed Aswad. “That’s the mystery.”

Blair said the U.S. Attorney’s Office, which successfully prosecuted Aswad in November for buying the non-approved drugs, has been fielding numerous calls from concerned patients and their families now that the case has been publicized.

Medical board prosecutor Dan Rubin said in opening arguments that the Medical Board considers the standard of care and the risk to patients’ health and safety.

“It doesn’t matter if he (Aswad) rolled the dice and came up OK,” Rubin argued.

The Medical Board on Nov. 14 ordered an emergency suspension of Aswad’s license to practice medicine pending Monday’s hearing. No immediate decision was issued.

The board’s suspension was triggered in part because Aswad pleaded guilty in November to a federal misdemeanor charge related to his purchase of the foreign drugs from July 2010 to April 2012.

The cost of at least one of the drugs was about 20 percent lower than the FDA-approved version, Blair testified. Aswad is alleged to have billed Medicare and Medicaid for the higher-priced FDA-approved versions.

Under the federal plea agreement, he must repay $1.3 million in restitution. He also faces three years of probation and must forfeit $750,000.

Federal agents who executed a search warrant on Aswad’s Deming medical office on April 10, 2010, seized more than 10 different foreign-made cancer treatment drugs, Blair testified.

Aswad testified Monday that he didn’t know until the FDA agents told him during the search that the cancer drugs weren’t approved by the FDA.

“I take excellent care of my patients. I never plan to take risks. I never thought I was doing anything illegal,” said Aswad, who has been practicing oncology, hematology and internal medicine in southern New Mexico since 2007.

One of his attorneys, Molly Schmidt-Nowara, told the hearing officer that Aswad didn’t knowingly buy or use the illegal drugs and never tried to conceal the fact he was buying them. She said other physicians in the United States caught with such drugs are still practicing medicine.

Blair testified that the investigation showed Aswad purchased one drug, Altizan, more than 20 times, with the labels almost entirely in Turkish. Most of the vials discovered were empty, but those that were tested did contain the active ingredient of the FDA-approved version of the drug, he testified.

The FDA in other cases elsewhere found diluted and counterfeit versions of Altizan, but Blair testified there wasn’t enough of the drug left in the vials at Aswad’s office for the FDA to ascertain the purity of the drug and its ingredients.

Aswad, who graduated from the University of Aleppo medical school in Syria in 1991, said he never looked at the Turkish packaging because he already knew how to administer the drugs.

Aswad said he began buying the drugs via a toll-free phone number after being contacted by a drug representative who said the company was based in Canada.