NECC Drugs Verified Before Sterilization

By Walter F. Roche Jr.,

BOSTON- A U.S. Food and Drug Administration official said today the company responsible for a nationwide outbreak certified its drugs were sterile before they had been sterilized.
Testifying in U.S. District Court as a prosecution witness Stacey Degarmo, the lead FDA investigator in the probe of the 2012 outbreak said Glenn Chin's verification of the steroid blamed for the outbreak was dated a day before records show the drug was placed in an autoclave to ensure sterility.
The statement came in the 14th day of the trial of Chin, who was a supervising pharmacist at the now defunct New England Compounding Center. Chin is facing racketeering, second degree murder and mail fraud charges.
U.S. District Judge Richard G. Stearns disclosed at the end of the Friday session that the trial was running some three weeks ahead of schedule and the case could be going to the jury the week after next. That would be in sharp contrast to the 10-week trial of co-defendant Barry J. Cadden, who already is serving a nine year prison sentence,
Cadden, who was NECC's president and part owner, was convicted of racketeering and mail fraud, but cleared of second degree murder charges.
Degarmo also testified at length about NECC's use of an autoclave, in violation of its own standard operating procedures. She said Chin, who was in charge of the clean room where the methylprednisolone acetate was compounded, told her the drug was sterilized in large beakers for only 15 minutes instead of the 20 minutes listed in the company records.
She said Chin told her NECC changed to 15 minutes after the purchase of a new autoclave. Degarmo said that changing the autoclave would not justify a reduced treatment time.
In addition she said NECC failed to include the time needed to being the large beakers of steroid to the the desired temperature. She estimated that as a result the beakers may only have been sterilized at the proper temperature for four minutes.
She also said Chin acknowledged NECC was not using biological indicators to assure sterilization had been achieved
In other testimony, Samuel Penta of the Massachusetts Board of Pharmacy described how surprised he was to see the size and scope of NECC's operations. He said it was nothing like anything he had seen at any drug compounder licensed by the state.
Stating that they knew they would need help, Penta said the state board turned to the FDA and agents for both agencies began a series of visits to the Framingham, Mass. facility.
Penta acknowledged there was confusion as the outbreak developed in late September 2012 over whether state or federal officials had jurisdiction.
The 2012 outbreak sickened some 778 patients in 20 states. Seventy-six died.
Testimony continues Tuesday.
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Prosecution Witness Hammered at Chin Trial

By Walter F. Roche Jr.

BOSTON-The head of quality control at a defunct drug compounding firm said that the company president sent a completely falsified report to state regulators even as a deadly fungal meningitis outbreak caused by the company was unfolding.
Testifying at the racketeering and second degree murder trial of supervising pharmacist Glenn A. Chin, the witness, Annette Robinson, said the report purporting to show nearly perfect scores on environmental tests was falsified and that despite her position she was never even shown the document before it was sent the Massachusetts Board of Pharmacy.
During questioning by Assistant U.S. Attorney Amanda Strachan, Robinson said she was warned by a fellow worker at the New England Compounding Center not to tell Chin that she had inadvertently touched something she shouldn't have in a clean or sterile room where injectable drugs were being prepared.
"He'll throw you under the bus," Robinson said she was told.
Robinson subsequently underwent more than an hour of cross examination by one of Chin's lawyers, who asked if she didn't have a personal grudge against Chin. Robinson said she didn't know, couldn't remember or didn't understand many of Robert L. Sheketoff's questions.
Robinson's testimony, which spanned two days, comes in the racketeering, conspiracy and second degree murder trial of Chin, 49. He was one of 14 charged following a two-year probe of the 2012 fungal meningitis outbreak, which took the lives of 76 patients in 20 states. Co-defendant Barry Cadden already is serving a nine-year prison sentence following his March conviction on racketeering, conspiracy and mail fraud charges.
It was Cadden, Robinson testified, who sent the false report to the Massachusetts board on the results of environmental testing at NECC's facilities.
Under cross examination Sheketoff zeroed in on Robinson's earlier testimony that Chin was present when Cadden said that there was a test that the company should have been performing all along but hadn't"
When Robinson said Chin was "probably there," Sheketoff asked what probably means.
"I don't know if he was there or not," she responded.
He also questioned her about the fact that she was testifying under a grant of immunity and that she had a lawyer representing her when she was first questioned by federal prosecutors.
Robinson later stated that the lawyer was provided by NECC and Cadden.
As she did at Cadden's trial, Robinson wept while testifying that she feared that she might have caused the outbreak because she had inadvertently touched a piece of equipment in the clean room where sterile drugs were prepared.
"Why didn't you just clean it? Why didn't you tell anyone?" he asked.
Sheketoff also questioned why Cadden would have ever hired her for the quality control position when she had no background or training for the job.
"He thought that I could do it," she responded.
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NECC Official Told F-Off on Tests

By Walter F. Roche Jr.

BOSTON- The woman who was the sole quality control official at a now defunct drug company said she was told to F-off when she raised questions about the failure to conduct periodic tests on the competency of employees compounding sterile drugs intended for human injection.
Annette Robinson, testifying today at the racketeering and second degree murder trial of Glenn Chin, said it was Chin who sent her an e-mail with that message not once but twice in the weeks and months leading up to a deadly fungal meningitis outbreak caused by drugs produced at the New England Compounding Center.
She said she had emailed Chin, NECC's supervising pharmacist, expressing concerns that the staffers had not even read the mandated procedures for conducting the tests known as media fills.
Another email entered into the record by federal prosecutors was a message Chin sent to an official of a sterilizing device manufacturer showing that he was unsure of how long drugs had to be placed in an autoclave to assure sterility.
The email, sent from Chin's personal computer, was dated Oct. 12, 2012, over a week after the outbreak had become public and even as victim deaths were mounting. Prosecutors have charged that Chin failed to place steroid drugs in an autoclave long enough to kill any contaminants.
Robinson was also a witness against NECC's president and part owner, Barry J. Cadden, who is now serving a nine-year sentence following conviction on racketeering, conspiracy and mail fraud charges. He was acquitted on the 25 second degree murder charges that Chin still faces.
Chin, Cadden and 12 others were indicted in 2014 following a two year federal probe of the deadly fungal meningitis outbreak caused by fungus loaded steroids shipped from NECC to health facilities across the country. The outbreak sickened 778 patients, killing 76 of them.
Robinson, who said she had no formal training or previous experience in environmental monitoring, said she was given the quality control job when another employee left. She said her predecessor described the duties including conducting environmental monitoring in NECC's clean rooms, sending products out for testing and making sure staffers read the Standard Operating Procedures for compounding various drugs.
She said that when her environmental tests showed evidence of fungus or bacteria, nothing was done about it. One hot spot, she said, was in the area where methylprednisolone acetate was being prepared. That drug, federal regulators have concluded, caused the outbreak
Robinson said she also learned that employees were apparently not performing daily and monthly cleaning assignments. In fact she said she found out workers waited till the end of the month and affixed their initials to a cleaning log sheet.
She said she did have a conversation  with Chin because the forms were not being filled out on a daily basis.
"They weren't being done," she said.
She said she saw insects in the clean rooms and other locations in the Framingham, Mass. facility. She also said hair was frequently found in the same two rooms.
When Cadden raised concerns about the hair droppings, Chin replied in an email, "Yes there are a lot of hairy zoo animals in the room."
Robinson said that she only sent out two samples of drug batches for testing at an outside laboratory though she later learned that more samples were required for a valid result. She said that when she raised the issue with Chin, he told her her he didn't want to waste the vials.
She said some drugs were also sent out before sterility test results were received and in some cases the tests were never performed.
As for her relationship with Chin, Robinson said, "Sometimes he was nice" but he also could be hurtful. The hurtful "happened more and more" as NECC raced to an October 2012 shutdown, she said.
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Judge Pleased With Pace of Chin Trial

By Walter F. Roche Jr.

BOSTON - The federal judge presiding over the racketeering and second degree murder trial of the former supervising pharmacist at a company blamed for a deadly meningitis outbreak said Tuesday that he was pleased with the pace of the trial and it might end sooner than he had predicted.
U.S. District Judge Richard G. Stearns told jurors just before he dismissed them for the day that he was pleased with the way the trial was proceeding.
He praised lawyers for moving the case along and told jurors that his original estimate - that the trial would last six to seven weeks - might be revised.
Under his original prediction the trial could go into early November but a revised estimate could bring the case to an end late this month.
Stearns comments to the 12 jurors and three alternates followed by a day comments he made to the attorneys on the case after the jurors had gone home. On Monday he praised the attorneys, particularly prosecutors, for the way they have been presenting the case.
In the earlier trial of co-defendant Barry J. Cadden, Stearns, during a bench conference was critical of the way the case was being presented. He told the attorneys both he and jurors were frustrated by the repetitious presentation, according to a transcript released after the 10 week trial had ended.
Prior to opening arguments in the Chin case, Stearns imposed time limits on both the prosecution and defense teams.
Cadden and Chin were among 14 indicted in late 2014 following a two year federal probe of the 2012 fungal meningitis outbreak. Cadden was given a nine-year prison sentence following his conviction of racketeering and mail fraud charges.
Cadden was the president and part owner of the New England Compounding Center, while Chin was a supervising pharmacist. NECC shipped thousands of vials of contaminated drugs to health facilities across the country sickening 778 patients, including 76 who died.
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NC Witness Details Mother's Outbreak Death

 

By Walter F. Roche Jr.

BOSTON-The daughter of an outbreak victim whose death first alerted health officials to the fact that a growing public health tragedy was not limited to Tennessee, says her mother hoped her death would help others to survive.
 Anna Allred testified for the prosecution in the racketeering and 2nd degree murder trial of Glenn Chin, who was a supervising pharmacist at the company blamed for the outbreak.
Alfred's mother, Elwina Shaw, was the first outbreak victim to be stricken who had not been injected with a fungus laden steroid  at a Nashville clinic. Until her death in October of 2012, all the victims had been treated at the Saint Thomas Outpatient Neurosurgical Center.
Allred said her mother knew she would not survive but agreed to forego any treatment with pain or other medications which might make it more difficult for health professionals to figure out exactly what was sickening and killing a growing number of victims.
She said her mother became the 11th outbreak victim to die. That total would eventually climb to 76. They were among 778 patients sickened after being injected with methylprednisolone acetate from the now defunct New England Compounding Center.
"She insisted  they do a spinal tap," Allred said, adding that her mother "became sick almost immediately" after getting the third in a series of injections at a High Point, N.C. pain clinic.
While the third shot made her sick, the first two provided no relief, Allred said.
She said the spinal tap showed a "very milky" spinal fluid, an indication of a severe infection.
One of her mother's last requests, Allred said,  was that an autopsy be performed in hopes that the results would help the other victims.
In other testimony Tuesday, a Michigan Medical Examiner, Dr. Jeffrey Jentzen, provided details on the autopsies performed on 11 victims who were injected at a local pain clinic. He described how the fungus, exserohelium rostratum, penetrated a protective layer of the spine and then traveled to the brains of victims.
Once in the brain, he said the fungus, which "likes blood vessels," attacked them, rupturing some and blocking others. The results were strokes and other brain damage. In some cases the spinal chord itself was damaged.
Jentzen walked jurors through the cases his office handled including Donna Kruzich, Karina Baxter and Lyn LaPerriere. Chin has been charged with second degree murder in theirs and 22 other outbreak deaths.
Also testifying was a former NECC clean room worker, Derek Carvalho, who said that one of his fellow workers was acting as a registered pharmacy technician even though his registration had been revoked. He said the technician used the name and password of then NECC President Barry Cadden to sign into the company computer system.
Cadden is serving a nine year prison sentence following his conviction on racketeering and mail fraud charges.
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Cadden Email Warned: "People Can Die"

By Walter F. Roche Jr.

BOSTON -Just months before a deadly outbreak swept across the country, the head of a drug compounding firm warned his supervising pharmacist that practices at their company were "a disaster waiting to happen. People can die."
The 2012 email from Barry J. Cadden to Glenn A. Chin was introduced into evidence today as Chin's federal trial on racketeering and second degree murder charges entered its third week.
U.S. Department of Defense Special Agent Sara Albert testified that the June 21 email along with more than a dozen others had been recovered from the records of the New England Compounding Center, where Cadden served as president. Some were also recovered from Chin's personal email.
She testified that other emails covered such topics as shipping drugs before testing, relabeling drugs to make it appear they had been tested, using expired ingredients and and shipping drugs that had never been tested at all.
Both Cadden and Chin were indicted along with a dozen others following a two year probe of the fungal meningitis outbreak which sickened 778 patients in more than 20 states. Seventy six of them died.
Cadden whose 10-week trial on similar racketeering and fraud charges ended in late March, already is serving a nine year prison sentence. He was acquitted on the second degree murder charges.
Albert also testified about a Chin resume retrieved during the investigation in which he claimed to be a supervising pharmacist at NECC since at least 2009. Chin's lawyers had challenged the assertion that he held that title.
In one email exchange Albert read to the jury, Chin informed Cadden that it was too late to give an employee another chance because he already had fired him.
 "Too late. I just canned his ass," Chin wrote.
In a July 25, 2012 email, Cadden stated that there were tests that "we are not currently doing, but should be doing."
In the June 21 email and others Cadden expressed concerns about practices in NECC's two clean rooms where sterile injectable drugs were prepared under Chin's supervision.
In a 2011 email, which also was introduced in Cadden's trial, Cadden warned, "We can't get caught with our pants around our ankles...Ever."
"We can't do what you are currently doing any more. No exceptions," Cadden wrote in another email to Chin.
In other testimony a Michigan pain doctor described how the outbreak unfolded at the clinics where he had administered injections of NECC's methylprednisolone acetate into the spines and joints of patients.
 Dr. Edward Washabaugh of Michigan Pain Specialists described how one victim was stricken just after arriving in London and had to be sent back home. By the time she arrived she had suffered a devastating stroke Washabaugh said.
Even worse were the side effects of powerful antifungal medications victims were forced to take, he said. He said the overall impact caused patients to die from heart attacks and other seemingly unrelated ailments.
He said 19 of the clinics patiens died. Five of them were his.
Anita Baxter, the daughter of a Michigan victim, said her mother suffered a massive stroke and doctors said she was clinically dead.
"It was horrible" she said recalling the scene in her mother's last hours.
Her mother had told her, "I don't want to be a vegetable," so she agreed to end life support. She said her mother had also directed that her body be donated for medical research and, as a result, the cause of her death was eventually determined.
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Some NECC Drugs Super-Potent, Im-Potent

By Walter F. Roche Jr.

BOSTON--Tests on one New England Compounding Center drug showed it had more than 6,000 percent of one ingredient while analysis of another drug showed it had no traceable amount of the primary component.
That's what an official of an Oklahoma drug testing firm told jurors last week as the second week of testimony came to a close in the trial of Glenn Chin, who is facing charges of racketeering and second degree murder.
Chin, 49, who was a supervising pharmacist for NECC, has paid close attention to the testimony, often taking detailed notes and conversing with his attorneys. He has displayed virtually no emotion.
The test results on NECC products were detailed by Tommy Means from Analytic Research Laboratories, the company NECC hired to run tests on samples of its drugs.
Chin was charged in late 2014 following a two year federal probe of the deadly 2012 fungal meningitis outbreak caused by fungus ridden drugs shipped from NECC's Framingham offices to health providers across the country.
Means' Friday testimony was similar though briefer than he gave in the trial of co-defendant Barry J. Cadden, who is serving a nine-year prison sentence following his conviction on racketeering and mail fraud charges. He was acquitted of the second degree murder charges.
Cadden was the president and part owner of NECC. While Cadden's lawyers continually sought to pin the blame on Chin, Chin's lawyers are now returning the favor by continually referring to Cadden, even noting the comments by prosecutors in the Cadden case who repeatedly told jurors NECC was "Cadden's baby." Those same Assistant U.S. Attorneys, Amanda Strachan and George Varghese, are handling the Chin case.
Though there are numerous parallels in the Cadden and Chin cases, there are differences, one imposed by the presiding judge.
 At one point in the Cadden case, U.S. District Judge Richard G. Stearns, in a bench conference out of the hearing of jurors, expressed his frustration with the pace and direction of the trial. The transcript of that bench conference was not made public until weeks after it took place.
In contrast, in a brief session last week, also out of the hearing of jurors,  Stearns expressed satisfaction with the way the prosecution has been presenting the case.
Under his orders, time limits have been placed on both the prosecution and defense in the case. Stearns imposed the limits in midst of the Cadden trial, which started in January and ended in late March.
In other testimony last week, hospital administrators from Massachusetts, Virginia and Illinois stated that they were assured that NECC met the highest standards for drug compounders and said they never would have purchased the company's drugs had they known otherwise.
This week's testimony will begin with Philip Sliney, the lead FBI investigator in the NECC investigation.
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