Thursday, March 9, 2017

Physician Says Prescriptions Are Fake

By Walter F. Roche Jr.

BOSTON Mass.-The chief medical officer at a major local hospital testified today that he never signed or approved several prescriptions that the head of a drug compounding firm submitted to state regulators in response to a 2012 complaint.
Testifying in in U.S. District Court in the second degree murder trial of Barry J. Cadden, Dr. Sunil Eappen also said that several other prescriptions submitted by the New England Compounding Center could not have been written by the doctors named on the forms because they would not be using the drug being dispensed.
Eappen,  an anesthesiologist from the Massachusetts Eye and Ear Infirmary (MEEI) was the final prosecution witness in a trial that began nearly two months ago. Lawyers for Cadden later introduced their first witness and there were indications the case could finally go to the jury next week after two additional days of testimony.
Cadden has been charged with defrauding the U.S. Food and Drug Administration, racketeering and 25 counts of second degree murder.
 Shown prescriptions for a large volume of an eye numbing agent, Eappen said they weren't his and he never approved them despite the fact that his name was listed on the forms as the prescribing physician.
Shown prescriptions signed by other MEEI physcians, Eappen said the doctors named would never have had a need for an eye numbing agent because of their specialties. One of them does nose jobs, while another is a plastic surgeon, Eappen said. A third doctor, whose name was on an NECC prescription, does cochlear implants.
Under questioning by Assistant U.S. Attorney George Varghese, Eappen recounted how MEEI filed a formal complaint against NECC with Massachusetts Pharmacy Board in 2012 after doses of that same eye numbing drug proved ineffective, with both patients and their doctors registering complaints.
"We just wanted to make sure it wasn't a trend" Eappen said when asked why it was reported to the state.
Eappen said doses of the eye numbing drug were eventually found to have only 25 percent of the prescribed key ingredient, lidocaine.
His testimony about the false prescriptions follows Wednesday's statements by a former employee of NECC's sales arm. Beth Reynolds related how she and another employee, under Cadden's direction, created some 300 prescriptions to make it appear that NECC had complied with a state law mandating the use of patient specific prescriptions.
Eappen said the numbing agent is used for eye surgeries. In addition to blocking pain, it keeps the eyeball still. He said it is injected into the tissue beneath the eyeball. At MEEI, he said,  those injections are administered between 6,000 and 7,000 times a year.
He said MEEI initially had the numbing agent prepared daily by staff anesthesiologists, but then shifted the duty to the in-house pharmacy. He said they eventually turned to NECC because the Framingham company offered a version with fewer risks of infection and a 30 day shelf life.
Also testifying about the eye blocking incident was William E. Frisch Jr., an investigator for the state Pharmacy Board, who was assigned to look into the MEEI complaint.
He said he sent a letter to Cadden with a series of specific questions about the preparation of the drug and general information on NECC's operations including a list of licensed pharmacists and registered pharmacy technicians.
Among the items requested were copies of the patient specific prescriptions for the eye numbing drug from the lot which triggered the complaint.
"We wanted to make sure there were prescriptions," he said.
He said the response including the prescription copies were sent to the board on June 14, 2012 in a letter signed by Cadden.
After Assistant U.S. Attorney Amanda Strachan announced the prosecution had completed its case, Stephen O'Neill, the head of an Ashland environmental monitoring company, was called as Cadden's first witness.
Under questioning by Bruce Singal, O'Neill said his firm, Scientific Air Analysis had been doing testing twice a year for NECC since the compounding firm opened in the late 90s. The company specializes in clean room inspection and monitoring, according to its web site.
Shown the results of the last test conducted on June 22, 2012, O'Neill said the sampling for particulates in the primary clean room showed it exceeded the requirements set by the U.S. Pharmacopeia and the International Standards Association.
His testimony will resume Friday.

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