WASHINGTON — The co-owner of the Framingham pharmacy blamed for the fungal meningitis outbreak that has killed 32 people strode grimly into a congressional hearing Wednesday overflowing with politicians, patient advocates, and media awaiting an explanation for one of the worst public health crises in decades.
But Barry Cadden immediately made clear he would provide no answers in his first public appearance since New England Compounding Center was tied to the illnesses. "Mr. Chairman, on the advice of counsel, I respectfully decline to answer," he said repeatedly in response to questions, exercising his constitutional right not to incriminate himself. Cadden appeared to be reading from an index card.
The four-hour hearing was marked by sharp confrontations between members of the House Energy and Commerce subcommittee on Oversight and Investigations and the Food and Drug Administration commissioner, Dr. Margaret Hamburg. Many of the House members said their constituents included some of the 461 people sickened in the outbreak.
Hamburg insisted that her agency did not have the authority it needed to properly oversee compounding pharmacies, which are supposed to custom-make drugs for patients who cannot use manufactured medications. That is why New England Compounding was able to keep making drugs, she said, despite a dozen complaints about its practices and several investigations by FDA and state officials dating to 1999. Several Republican committee members disputed her assertions, saying the agency simply chose not to act.
Democrats said they want to pass legislation by the end of the year authorizing the FDA to inspect compounding pharmacies and obtain their records. Republicans said they are open to giving the agency more authority — if the FDA proves it needs it by providing hundreds of internal e-mails discussing its dealings with New England Compounding, which the agency so far has failed to do.
At a separate hearing at the State House in Boston on Wednesday, Massachusetts lawmakers grilled public health administrators about their oversight of compounding pharmacies, saying more accountability and transparency are needed.
"The public needs to be reassured . . . that if they are receiving pharmaceuticals, that they are safe, and they won't become sicker by the drugs they are receiving," said Representative Harold Naughton, chairman of the Joint Committee on Public Safety and Homeland Security.
State Health and Human Services Secretary Dr. JudyAnn Bigby testified that the Patrick administration would be scrutinizing the structure of state boards that oversee health professions. The pharmacy board is made up primarily of pharmacists, including seven of the current 10 members. There is one vacancy.
"While it is important that professional expertise be represented, there needs to be a better balance of oversight to include members who are free of conflict," Bigby said.
In Washington, Joyce Lovelace of Kentucky told lawmakers that New England Compounding killed her husband, Judge Eddie Lovelace, one of the first patients to die in the outbreak. He got injections of the pharmacy's contaminated steroid for back pain resulting from a car accident. Weeks later, he died of a stroke. "Why did so many medical providers purchase this product from unregulated or poorly regulated sources," Joyce Lovelace asked from a wheelchair.
Cadden then came in, under a subpoena to appear. His attorney, Bruce Singal of Boston, had delivered a letter to subcommittee members explaining that Cadden had "strong desires'' to answer the committee's questions, but given state and federal investigations, Singal had advised him to exercise his Fifth Amendment privilege. He said Cadden had cooperated with investigators to quickly recall 17,676 doses of the contaminated steroid so no one else would get sick.
After Cadden was seated, Representative Clifford Stearns, a Florida Republican and committee chairman, said the loved ones of those who died and patients who are sick "deserve some answers today. Mr. Cadden, I ask you to reconsider and tell this committee how this tragedy happened.''
Cadden, who was also chief pharmacist of New England Compounding, declined. Stearns and Representative Diana DeGette, a Colorado Democrat, tried to prod Cadden into answering questions, but eventually Stearns dismissed him. As Cadden walked outside, he was followed for two blocks by television crews shouting questions. He looked straight ahead and did not say a word, before getting into a waiting black sport utility vehicle.
Afterward, Representative Edward Markey, a Massachusetts Democrat, said he was "very disappointed. This was his opportunity to explain to the American people.'' But Markey added, "He is going to be charged with very serious violations of law, so I understand why he pled the Fifth.''
When her turn came, Hamburg called federal and state regulations of compounding pharmacies a "crazy quilt'' of confusing rules. She said the FDA can routinely inspect and demand documents from manufacturers, but not from compounders. But committee members said New England Compounding was acting as a manufacturer, shipping thousands of doses to dozens of states, and the agency could have stepped in.
They pointed to a 2006 warning letter from the FDA, which threatened New England Compounding with "seizure or injunction" if it did not improve its practices.
"Are you saying that letter was an empty threat?'' Stearns asked.
Congressional investigators were also highly critical of the Massachusetts pharmacy board. "It seems to me the ball was dropped and dropped in a big way,'' DeGette said.
Dr. Lauren Smith, interim commissioner of the state Department of Public Health, who also testified before the committee, agreed. "There were certainly missed opportunities and lapses of judgment,'' she said.
Representative Janice Schakowsky, an Illinois Democrat, asked whether the board failed to take strict action against New England Compounding, including weakening a 2006 consent agreement with the company, because it was too close to the pharmacy. Board member Sophia Pasedis worked for New England Compounding and later for its sister company Ameridose. The state has since asked her to resign from the board.
"It seems like the board was more interested in protecting pharmacists than in protecting consumers,'' Schakowsky said.
At the Massachusetts hearing, state pharmacy board president James DeVita testified that the 2006 consent agreement was loosened by Nancy Dolberg, a Department of Public Health attorney. The board had initially approved a reprimand and three years of probation for Cadden and New England Compounding, but the discipline was dropped and the probation scrapped.
DeVita said he felt the final agreement was a "better result" because it included requirements that the company improve its operations.
A Patrick administration spokesman, Alec Loftus, released a statement Wednesday night saying Dolberg had indicated to state investigators that "the documents were drafted and redrafted under guidance of board of pharmacy staff. These same staff members have already been removed from their jobs for failing to act on warning signs at NECC."
Bigby, the health secretary, told Massachusetts lawmakers that more money is needed to adequately monitor the state's compounding pharmacies. The state health department has shouldered steep budget cuts in recent years.
"If there were more resources, it would be possible to do more unannounced inspections," Bigby said, referring to the five additional inspectors the agency recently hired temporarily to conduct surprise inspections of the state's 25 compounding pharmacies that produce sterile injectable medicines similar to the now-closed New England Compounding Center.
If the agency needs more money, David Linsky, chairman of the House Committee on Post Audit and Oversight, told her, "get us a request for more resources."