Friday, November 30, 2018

Doctor Says Prescriptions Were Faked


By Walter F. Roche Jr.


Boston-The former chief medical officer at a Boston hospital testified that he never issued the prescription that a drug compounding company provided to a state board showing him as the prescribing physician.
Dr. Sunil Eappen also told jurors in U.S. District Court today that the patients listed on some 300 fake prescriptions never even got the drug listed although they were patients at the Massachusetts Eye and Ear Infirmary.
Prosecutors say the fake prescriptions were part of an attempt by the now defunct New England Compounding Center to hide the fact that it was breaking a state law requiring individual patient specific prescriptions for every dose of drug it sold.
The testimony came as the prosecution started to wind up its case against six former employees of NECC, the company blamed for a deadly 2012 fungal meningitis outbreak. The jury is expected to begin deliberations next week.
Eappen, who is now the chief medical officer at Boston's Brigham and Women's Hospital, said the drugs provided by NECC were supposed to numb patients eyes before undergoing eye surgery, but they discovered the so-called eye block did not contain the required amount of lidocaine.
"We learned that the lidocaine was only 10 or 20 percent. The block wouldn't work," Eappen said, adding that not only would patients feel pain but the eye itself would not be immobilized as required during surgery.
He said both patients and doctors had complained, prompting an inquiry that led to the discovery that the NECC drugs were sub-potent.
"I had never seen that before," Eappen said.
Under questioning by Assistant U.S. Attorney George Varghese, Eappen said the names listed on the prescriptions came from a roster of patients who had undergone laser treatments at the hospital and they would not have been treated with the eye block.
Other doctors names on fake prescriptions included physicians, like a plastic surgeon, who would never have use for an eye block, Eappen said.
Asked if the use of the patient names was proper, Eappen said it was not.
He said the hospital considered the problem with the sub-potent eye block to be serious and reported the matter to the state Board of Pharmacy. In fact it was that report which triggered an inquiry by the state board and the subsequent response from NECC, including the 300 fake prescriptions.
In other testimony Eric Kastango, a licensed pharmacist and expert in the compounding of sterile drugs, said NECC was "gaming the system," when it changed the beyond use dates on drugs.
He said that was especially true when the company shipped doses of methotrexate, a cancer treatment drug that had expired years earlier.
He said that natural degradation of that drug could produce toxic chemicals harming patients.
Kastango, who has served as a consultant to federal prosecutors, said NECC failed to take action even when its own monitoring tests showed the presence of mold and bacteria in a clean room where sterile drugs were being prepared.
He said matters only worsened when the company turned off the air conditioning in the building at night.
"It's like saying,'Come on and grow," Kastango said referring to the effect of heat and humidity on bacteria and mold.
Under cross examination by Mark Pearlstein, Kastango was confronted with articles he had co-authored which indicated problems in clean rooms, especially in hospitals, were widespread.
Pearlstein, who represents defendant Joseph Evanosky, also questioned Kastango about a presentation before a group of health officials which concluded that the root cause of calamities like the fungal meningitis outbreak was a lack of leadership.
Kastango said he never made that presentation, but the person who did had used his slides.
Asked if it wasn't NECC President Barry Cadden who, as the pharmacist-in-charge, was ultimately responsible for what went on at the company, Kastango said it was. But, he added, that pharmacists who witnessed unsanitary conditions in the workplace, had "a responsibility" to do something.
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