Congress Hears Testimony Regarding ESI Linked Meningitis Outbreak

Medicare Set-Aside Blog on November 14, 2012 | Posted by


On November 14, 2012, the House Energy & Commerce Oversight & Investigations Committee held a hearing to examine the facts surrounding the recent outbreak of fungal meningitis and other infections linked to contaminated injectable products made and distributed by the New England Compounding Center (NECC) in Framingham, Massachusetts. Chairman Stearns opened the session by providing the atrocious history of NECC, pretty much endangering the public since its inception in 1998. The background information provided notes that less than a year after the company’s formation, the Massachusetts Board filed a complaint against the owner, Barry Caden, for providing practitioners with blank prescription pads referring to NECC in violation of MBP regulations and clearly indicating where his head was in this endeavor. Additional marketing complaints started in 2001 and the complaints appear to have continued consistently throughout the years. States such as Colorado, Nevada, Texas, South Dakota, Iowa and Wisconsin all took action to address NECC’s actions within their states, yet the MBP issued advisory letters that did not constitute disciplinary actions. Even prior to the recent outbreak, Congressman Markey noted that 23 deaths and 86 injuries had been attributed to NECC. So because NECC was so well known to regulators at both the state and federal level, the consensus is that this crisis could have been avoided.

To further compound the pathetic manner in which NECC was handled throughout the years, the initial handling of notifying the family of the first reported victim of the outbreak was even more atrocious. The first panel consisted of the widow of the Honorable Eddie Lovelace, a Tennessee circuit court judge who sustained a lumbar injury during a motor vehicle accident in March 2012. Following PT and other conservative modalities, he was referred to a neurosurgical outpatient facility for epidural steroid injections. He received the last of a series of three on August 31st, started suffering headaches and other symptoms on September 11th, was admitted to the hospital on September 12th, immediately transferred to Vanderbilt, died on September 17th with the cause of death reported as stroke and was buried on September 21st. On September 25th, the clinic called the widow to ask how the patient was doing following the last ESI, at which time they were advised of Judge Lovelace’s death. The next day, another individual from the clinic called asking about the symptoms he developed and inquired about whether an autopsy had been conducted. On October 3rd, the family became aware of the outbreak through the press and didn’t think anything of it until a reporter called on the 5th asking about her husband’s death. The reporter told her that Vanderbilt released a statement that a 78 year old male who died there on September 17th was the first death associated with the fungal injections as a result of epidural steroid injections. The family received no calls from the CDC, FDA, either hospital, the clinic nor the State of Tennessee notifying them of the true nature of Judge Lovelace’s death.

The second panel consisted of Barry Cadden, president, co-owner and director of pharmacy of the New England Compounding Center. There is nothing said about whether Mr. Cadden showed any remorse for the deaths that he is responsible for given that he did nothing but invoke the 5th Amendment and was ultimately dismissed with a warning that he may be recalled by the committee.

The thing that was most interesting (disturbing?) to me about the pharmacy’s egregious practices, yet of the least concern to the committee, was the fact that it distributed large batches of compound sterile products to facilities for general use rather than requiring a prescription for an individual patient as is required under Massachusetts state law, not to mention the laws of many of the states where these products were distributed. While the focus of the hearing kept returning to the pharmacy’s sterility practices and how it continued to put the public at risk despite numerous warnings and promises to improve their ways, there was no discussion about the over utilization of the procedure itself as a general proposition. 17,676 contaminated doses were shipped to clinics in 23 states and by the time the contamination had been identified, more than 14,000 had already been used. One of the early articles back in September referenced a comment by one of the affected clinics stating that the reason they turned to NECC for product was because supply was extremely hard to obtain from traditional sources. So how could the outbreak have been prevented? Perhaps we should be looking at the sheer volume and effectiveness of ESIs in general and question why they are prescribed so freely.

As of November 9, 2012, 32 people have died and 438 been sickened across 19 states.

Hearing may still be viewed here.