SALON

Tuesday, Oct 30, 2012 11:45 AM UTC

Romney’s lax regulation may have fueled meningitis outbreak

A meningitis epidemic that has killed 25 is linked to a Mass. company Romney's administration failed to regulate

By

Topics: Mitt Romney, Massachusetts, meningitis, Deregulation, ,

Romney's lax regulation may have fueled meningitis outbreakMassachusetts Gov.-elect Mitt Romney at the Statehouse in Boston, Nov. 7, 2002. (Credit: AP/Steven Senne)

The fatal meningitis epidemic sweeping the United States can now be traced to the failure of then-Gov. Mitt Romney to adequately regulate the Massachusetts pharmaceutical company that is being blamed for the deaths.

At least 344 people in 18 states have been infected by the growing public health crisis and 25 have died so far.

But the epidemic may also play a role in the presidential campaign, now that state records reveal that a Massachusetts regulatory agency found that the New England Compounding Co., the pharmaceutical company tied to the epidemic, repeatedly failed to meet accepted standards in 2004 — but a reprimand was withdrawn by the Romney administration in apparent deference to the company’s business interests.

“It goes all the way up to Mitt Romney,” said Alyson Oliver, a Michigan attorney representing victims of the outbreak. According to Oliver, on at least six occasions, NECC was cited by authorities for failure to meet regulatory standards and almost subjected to a three-year probation. “It goes directly to the heart of what Romney says about regulation, ‘Hands off. Let the companies do their thing.’”

“When the person who is supposed to be in charge of oversight does not believe oversight is necessary, this is what happens,” Oliver added.

“The philosophy of the Romney administration was to have lax regulations across the board,” Philip Johnston, a former secretary of health and human services in Massachusetts before the Romney administration, told Salon. “It speaks volumes about the tragic outcome of Romney’s view on regulatory issues. There are two dozen people who died needlessly. It was clearly the responsibility of the company to protect them, but it was also the responsibility of the government at various levels, and, as far as I’m concerned, they failed.”

On Oct. 28, Rep. Ed Markey, D-Mass., called for “a full investigation” into the regulatory issues that led to the epidemic. “There’s a regulatory black hole here,” he said, “but the full assessment of responsibility, state to federal, is ongoing. We need to know everything.”

The owners of NECC have made campaign donations both to Romney and to Massachusetts Republican senatorial candidate Scott Brown, Salon has learned.

The victims in the epidemic all received shots of methylprednisolone acetate, a steroid compound often used to alleviate back pain, but which was tainted with a fungus that caused meningitis, an inflammation of the protective membranes covering the brain and spinal cord.

According to CBS News, federal authorities announced they had matched a fungus responsible for the epidemic with more than 50 unopened vials of the drug sent out by New England Compounding Center, a Framingham, Mass., pharmaceutical company that has been identified as the source of contaminated drugs. Over 17,000 vials of the tainted drugs linked to the epidemic have been shipped to 76 different facilities throughout the country.

On Tuesday, Oct. 23, state authorities said they would open a criminal investigation and move to revoke NECC’s license after finding that the pharmaceutical firm did not test lab equipment properly, failed to sterilize medications and repeatedly shipped orders for the drug without confirming that the lots had been sterilized.

Meanwhile, the Massachusetts Department of Health released documents dating back more than a decade that revealed a series of regulatory citations involving NECC.

In 2002, the Food and Drug Administration filed a confidential report alleging that two patients had suffered “adverse effects” after injections of an NECC compounded betamethasone repository, a steroid that is different from the one under scrutiny in the current epidemic. A few months earlier, New York resident William Koch became ill with bacterial meningitis after receiving injections of the steroid. According to an AP report, NECC settled a lawsuit in the case after he died in 2004.

In all, Massachusetts state records revealed that between 2003 and 2006, there were six complaints regarding NECC and its co-owner, Barry Cadden. At least one of these complaints alleged that NECC’s methylprednisolone acetate failed to comply with pharmaceutical standards. This is the same drug involved in the current epidemic.

In October 2004, the Massachusetts Board of Registration in Pharmacy, a state regulatory agency reporting to Gov. Romney, offered to let NECC enter into a consent agreement that would have acknowledged professional misconduct by NECC warranting disciplinary action, a public reprimand and three years probation.

But in a letter dated Nov. 11, 2004, Paul Cirel, an attorney for NECC, argued that such disciplinary action would be “potentially fatal” to NECC’s business. In a footnote, he asserted, “Once disclosed, the reprimand will surely result in investigations/inquiries/investigations in those other jurisdictions. Regardless of the derivative actions taken, the attendant legal and administrative costs will be devastating.”

The letter added that instead of having the state monitor the company, NECC would be willing to “bear the burden of cost and monitoring and reporting compliance” in exchange for a non-disciplinary resolution.

The Board of Registration subsequently dropped the reprimand. Meanwhile, in 2005, NECC was the subject of another complaint. Nevertheless, the Board of Registration went forward with a Consent Agreement that was, according to Oliver, “even more advantageous to the company than was requested by NECC.”

The term of the “probation” would be one year, not three, and it was to be a non-disciplinary agreement that would not be reported to the National Association of State Boards of Pharmacy or other outside agencies.

Subsequently, in 2006, NECC was effectively permitted to monitor itself simply by assuring the board it was in compliance with all procedures. In a May 22, 2006, letter obtained by Salon, NECC co-owner Barry Cadden wrote the board a short letter saying, “I am pleased to report that the following actions have been completed” regarding several safety precautions.

“Romney was responsible for these agencies,” said Oliver, who is the lead attorney attempting to consolidate the meningitis cases. “They reported to him.” She added that under Chapter 13, Section 22 of the General Laws of Massachusetts, members of the Board of Registration in Pharmacy are appointed by the governor.

In October, NECC issued a statement saying, “We have voluntarily suspended operations while we assist authorities in this investigation. The fatalities and illnesses confirmed today by the CDC and FDA are tragic. The thoughts and prayers of everyone employed by NECC are with those who have been affected.”

Three of its facilities have subsequently been shut down by authorities.

WCVB-TV in Boston has reported that NEC president Greg Coniglario hosted a fundraiser for Sen. Scott Brown, bringing in $37,000 for the Brown campaign against Elizabeth Warren. Conigliaro and members of his family have reportedly given $10,000 of their own money to Brown.

In July, Brown was one of 10 senators to sign a letter to the Drug Enforcement Agency arguing that regulations on the compounding industry should be loosened.

Conigliaro also contributed $2,500 to the Romney for president campaign.

Craig Unger is the author of 'Boss Rove: Inside Karl Rove's Secret Kingdom of Power' (Scribner, September 2012). He is also a contributing editor of Vanity Fair, and wrote the New York Times bestseller, 'House of Bush, House of Saud.' For more about Boss Rove, and to buy the book, go to www.bossrove.com. More Craig Unger.

Next Article

Related Stories

More Related Stories

Featured Slide Shows

The week in 10 pics

close X
  • Share on Twitter
  • Share on Facebook
  • Thumbnails
  • Fullscreen
  • 1 of 11
  • Lisa Montgomery embraces her nephew Thursday after a tornado tore apart her home in Cleburne, Texas. The twister killed six people and destroyed entire swaths of the North Texas town.
    Credit: AP/LM Otero

  • Jack McMahon, the defense attorney for abortion doctor Kermit Gosnell, speaks outside the Criminal Justice Center Philadelphia Tuesday. His client was convicted of killing three babies in his clinic, and will serve multiple life sentences.
    Credit: AP/Matt Rourke

  • A photo taken Monday captures Vice President Joe Biden's response to a Milwaukee second-grader's innovative proposal to end America's epidemic of gun violence. This guy!
    Credit: AP/Jenny Aicher

  • Sen. Rand Paul, R-Ky., flanked by a grouper-eyed Michele Bachmann, addresses the IRS' admission that it targeted Tea Party groups in advance of the 2012 election. In an op-ed for CNN Thursday, the Kentucky senator slammed the president for his faux outrage.
    Credit: AP/Molly Riley

  • Ousted IRS chief Steven Miller is sworn in on Capitol Hill Friday. Miller testified before the House Ways and Means Committee on the extra scrutiny the agency gave conservative groups applying for tax-exempt status.
    Credit: AP/J. Scott Applewhite

  • Attorney General Eric Holder pauses as he testifies on Capitol Hill before the House Judiciary Committee Wednesday. Holder is under fire, among other things, for the Justice Department's gathering of phone records at the Associated Press.
    Credit: AP/Carolyn Kaster

  • O.J. Simpson sits during an evidentiary hearing at Clark County District Court in Las Vegas, Nev., Thursday. Simpson, who is currently serving a nine-to-33-year sentence in state prison for armed robbery and kidnapping, is using a writ of habeas corpus to seek a new trial.
    Credit: AP/Las Vegas Review-Journal/Jeff Scheid

  • Major Tom to ground control: On Sunday astronaut Chris Hadfield recorded the first music video from space, a cover of David Bowie's "Space Oddity."
    Credit: AP/NASA/Chris Hadfield

  • When it rains it pours. President Barack Obama speaks during a news conference Thursday with Turkish Prime Minister Recep Tayyip Erdogan, inexplicably inspiring an #umbrellagate Twitter meme.
    Credit: AP/Jacquelyn Martin

  • A smoke plume rises high above a road block at the intersection of County A and Ross Road east of Solon Springs, Wis., Tuesday. No injuries were reported, but the the wildfire caused evacuations across northwestern Wisconsin.
    Credit: AP/The Duluth News-Tribune/Clint Austin

  • Recent Slide Shows

  • Share on Twitter
  • Share on Facebook
  • Thumbnails
  • Fullscreen
  • 1 of 11

Related Videos

Comments

 85 Comments

Comment Preview

Your name will appear as username

You may use these HTML tags and attributes: <a href=""> <b> <em> <strong> <i> <blockquote>

follow salon

Most Read

Popular on Reddit

links from salon.com

vote
New Yorker launches tool by Aaron Swartz to protect leaks: Strongbox, co-created by the late technologist, is an open-source drop box for leaked documents
219 points220 points | 7 comments
vote
New Yorker launches tool by Aaron Swartz to protect leaks: Strongbox, co-created by the persecuted late technologist, is an open-source drop box for leaked documents
160 points161 points | comment
vote
Loaded terminology like "entitlements" and "welfare" skews the debate and alters America. How right-wingers use semantic tricks to kill government.
112 points113 points | 30 comments
vote
Obstruction will ruin the GOP: Playing politics and abusing the system can excite the extremes, but it's a recipe for long-term political disaster
50 points51 points | 8 comments
vote
With the help of Photoshop, artist Yao Lu has made shanshui — traditional ink paintings — of China's landfills
26 points27 points | 1 comment

From Around the Web

Presented by Scribol
listener_new_rect The Listener: So long, Sookie Stackhouse

Recommendations