LOWELL -- The Massachusetts U.S. Attorney's Office reports that the New England Compounding Center scandal is still actively under investigation. NECC reportedly shipped more than 17,600 doses of tainted steroid injections to 23 states more than a year ago before inspectors said they found mold, standing water and other unsterile conditions at the NECC facility. More than 750 people were infected, and 64 of them have died, according to federal investigators. The scandal prompted Congress to approve legislation calling for more federal oversight of similar pharmacies. President Barack Obama signed it into law just before Thanksgiving. The law requires NECC and other large-scale compounding pharmacies to register with the Food and Drug Administration, and to submit to federal inspections and quality standards, much like other drug manufacturers. A state bill is also in the works. The Joint Committee on Public Health hopes to have a law in place by January, according to the office of the committee's chairman, state Sen. John Keenan, a Quincy Democrat. The House and Senate have passed their own versions of a bill so far. A state law would aim for more transparency within the industry, along with strict licensure standards, required training and education, and strict standards for reporting and accountability. The state Department of Public Health in recent months also launched unannounced inspections of compounding pharmacies across the state. Gov. Deval Patrick put into effect authorization for the Board of Pharmacy to fine pharmacies in violation of existing policies, as well. Keenan said he hopes the new state law will prevent compounding facilities like NECC from "taking advantage" of the lack of state and federal regulations and oversight that existed previously. "NECC's egregious actions brought to light a serious issue -- an industry that once had an important public health function grew well beyond its justifiable boundaries ..." he wrote in an email. "The compounding industry operated in the shadows, and in my opinion, put corporate profits before patient safety." When asked about what efforts are in place to help patients like Kelly Papaleo, a 46-year-old Lowell woman who falls under the Centers for Disease Control and Prevention guidelines as being a probable victim in the case, Keenan said he hopes the U.S. attorney's investigation brings justice to those affected. "From the perspective of the joint committee, we can best remember those who passed and those who continue to suffer by ensuring that we have the legal and regulatory framework in place to prevent another tragedy like this from ever happening again," he said. In November, U.S. Attorney Carmen Ortiz announced there is new coordination of continuing independent state and federal criminal investigations. In addition, The Boston Globe reported that grand juries in both Boston and Michigan are investigating any criminal wrongdoing. Michigan, where 19 of the 64 reported deaths have occurred, is the hardest-hit state in the nation from the NECC case, according to the U.S. Attorney's Office. Hundreds of NECC victims have filed civil lawsuits seeking compensation. Papaleo, who moved in with her aunt in the Belvidere section of Lowell when she could no longer care for herself, has joined a class-action lawsuit filed in Missouri. But she is doubtful any money will come out of it for her or other patients. Attorney Frederic Ellis, of Boston-based Ellis and Ripacki, LLP, represents a handful of victims. He said he is trying to remain optimistic for his clients. He said pain clinics that administered the drugs to unknowing patients are being considered as targets in the case, too, to help contribute to compensation for victims. NECC has already filed for bankruptcy, which Ellis said further complicates the case. "We are reaching out and trying to get a lot of the different players that may have played a contributing part in this to contribute to the pot so there will be some amount distributed to victims," Ellis said. "Is it likely ever going to be enough to satisfy all the victims? Probably not, unfortunately, but that's certainly what our goal is." NECC representatives have remained quiet since going out of business following the scandal in the fall of 2012. However, earlier this year, ABC News reported that NECC officials said a cleaning company hired to service the Framingham facility should be held responsible for the site's unsterile conditions. NECC representatives have also claimed the state was invited to perform more inspections at their location before the outbreak. According to an October 2012 report by CBS News, House Republicans claimed the FDA failed to act on numerous complaints concerning problematic drugs and practices at the NECC site for years. A message left at the now-defunct NECC site went unreturned, and executives could not be reached for comment. An official from the N.H. Department of Health and Human Services said she does not believe PainCare, LLC, had been fined in this case so far. The Boston Globe reported that PainCare has been subpoenaed by plaintiffs' lawyers, along with about 80 other businesses that administered the injections. Representatives for PainCare, a Merrimack, N.H., facility where Papaleo received steroid injections, did not return a request for comment. However, the company's CEO, Dr. Michael O'Connell, posted to his blog account in March that a 60 Minutes report on the NECC case was "a mix of fact and total fiction." O'Connell claimed in his blog post that purchasers of the tainted products were not motivated by greed in this outbreak. Some leaders in the pharmaceutical industry have publicly alleged NECC executives were acting greedily by their actions, however, as reported by other news outlets. "NECC should be crucified for their negligence, but other compounding pharmacies should not be painted with the same brush," O'Connell wrote. "By the way, if you REALLY are interested in investigating medical related deaths, Google up 'hospital medical errors' or 'deaths, pharmaceutical companies.' You will be blown away." A deadline for victims of the NECC outbreak is set for Jan. 15 to file a proof of claim in the incident as NECC goes through its bankruptcy process. The FBI is also requesting victim-impact statements. The Associated Press contributed to this report.
Read more: http://www.lowellsun.com/todaysheadlines/ci_24728414/pharmacy-scandal-prompts-new-federal-state-oversight#ixzz2neXkCtc0
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