Skip to main content

Deadly meningitis outbreak was completely avoidable

By Michael Carome, Special to CNN
updated 4:07 PM EDT, Tue October 16, 2012
The steroid linked to a fungal meningitis outbreak was produced and distributed by the New England Compounding Center.
The steroid linked to a fungal meningitis outbreak was produced and distributed by the New England Compounding Center.
STORY HIGHLIGHTS
  • Michael Carome: The current deadly meningitis outbreak was completely avoidable
  • The outbreak has sickened at least 214 people and killed 15 across 15 states
  • The FDA allows compounding pharmacies to produce drugs without regulation, he says
  • Americans should demand that all responsible parties be held accountable, Carome says

Editor's note: Dr. Michael Carome is deputy director of the Public Citizen's Health Research Group.

(CNN) -- The ever-expanding outbreak of life-threatening fungal meningitis in back pain patients linked to steroid injections prepared by a compounding pharmacy, which so far has sickened at least 214 people and killed 15 in 15 states, is a public health catastrophe. What is particularly tragic for those who have been sickened or killed by the tainted drug and for their loved ones is that this situation was completely avoidable.

Since federal laws were enacted in 1938 and 1962 giving the Food and Drug Administration the authority to ensure that all brand name and generic drugs were both safe and effective, compounding pharmacies have traditionally filled a very narrow health care niche in which they prepared, in response to physicians' prescriptions, individually tailored preparations of drugs for patients having unique medical needs that could not be met by a commercially available standard drug manufactured by a pharmaceutical company.

While the FDA has long considered the compounding of drugs to be subject to FDA regulations, the agency has recognized the important health care role for such compounded medications. Therefore, it has used "enforcement discretion" to allow compounding pharmacies to produce these drugs without complying with FDA regulations, generally deferring regulatory oversight to state pharmacy boards.

Dr. Michael Carome
Dr. Michael Carome

News: What is a compounding pharmacy?

However over the past two decades, many so-called compounding pharmacies began large-scale production of drugs and moved from the traditionally narrow role filled by such pharmacies into a realm that clearly involved drug manufacturing and distribution of standardized drugs. In many cases, the drugs have been sold in multiple states, thus involving interstate commerce.

The steroid medication linked to the current fungal meningitis outbreak was produced and widely distributed by the New England Compounding Center in Framingham, Massachusetts, one of many compounding pharmacies across the country that has crossed the line between traditional compounding and large-scale drug production. The injectable steroid medication produced at the center was never approved by the FDA and was not manufactured in accordance with the FDA's rigorous manufacturing standards designed to ensure that drugs are sterile and uncontaminated with such germs as bacteria or fungi before being sold and distributed.

Two new drugs linked to meningitis
Kin: Meningitis victim didn't have to die
Family mourns meningitis victim

As a result, as many as 14,000 patients in 23 states were exposed to potentially contaminated steroids and need to be monitored for signs of fungal meningitis or other infections.

Many people rightly are asking how the disastrous outbreak could happen in the United States and who is to blame.

While numerous probes and investigations are just getting under way and litigation targeting the producer of the tainted drug and health care providers who used it will certainly take years to resolve, blame for this disaster will undoubtedly rest with many parties. Among them are the compounding pharmacy that produced the contaminated steroid drugs, health care facilities and providers who chose to use a dangerous drug lacking approval by the FDA and evidence that the products were sterile, trade associations and professional groups representing compounding pharmacies that have vigorously resisted federal regulatory oversight of their members, state and federal regulators, and Congress.

A key player at the federal level deserving a significant amount of blame is the FDA.

Loud alarm bells were sounded on December 4, 2006, when the FDA issued warning letters to the New England Compounding Center and four other compounding pharmacies, directing them to stop producing standardized versions of medications that, according to the agency, were being "marketed for general distribution rather than responding to the unique medical needs of individual patients." the center was cited for violations of FDA regulations in marketing four different drugs, including repackaged doses of the cancer drug Avastin into syringes for treatment of macular degeneration.

News: Injectable drugs from Mass. facility suspect

Clearly, the FDA considered the center and the other compounding pharmacies to be engaged in drug manufacturing. The pharmacies, like any other drug manufacturer, were therefore subject to the safety and effectiveness standards required for approval of new drugs, as well as the rigorous manufacturing standards designed to ensure that drugs are sterile and uncontaminated with such germs as bacteria or fungi before being sold and distributed.

However, following its warning letter, the FDA subsequently dropped the ball and failed to take the actions necessary to ensure the center adhered to these drug standards, which are essential for protecting the health of patients. For whatever reason, whether inattentiveness or lack of compliance and legal resources, by not aggressively enforcing the regulations related to large-scale drug manufacturing and interstate commerce, the FDA allowed the company to shift its wide-scale manufacturing and interstate distribution operation to injectable steroids.

On Thursday, the FDA attempted to deflect criticism for its failures by asserting that it lacked authority to take action earlier. This flies in the face of the agency's long-stated position that it had legal authority over such activities and its prior enforcement activities against the New England center and multiple other compounding pharmacies. While no one wants to be viewed as being responsible for a preventable public health catastrophe, American citizens should express their outrage and demand that all parties responsible for this tragedy -- including the FDA -- be held accountable.

Otherwise history will repeat itself.

Follow @CNNOpinion on Twitter

Join us at Facebook/CNNOpinion

The opinions expressed in this commentary are solely those of Michael Carome.

ADVERTISEMENT
Part of complete coverage on
updated 7:34 PM EDT, Fri October 17, 2014
The world's response to Ebola is its own sort of tragedy, writes John Sutter
updated 4:33 PM EDT, Fri October 17, 2014
Hidden away in Russian orphanages are thousands of children with disabilities who aren't orphans, whose harmful treatment has long been hidden from public view, writes Andrea Mazzarino
updated 1:22 PM EDT, Sat October 18, 2014
When you hear "trick or treat" this year, think "nudge," writes John Bare
updated 12:42 AM EDT, Sat October 18, 2014
The more than 200 kidnapped Nigerian schoolgirls have become pawns in a larger drama, writes Richard Joseph.
updated 9:45 AM EDT, Fri October 17, 2014
Peggy Drexler said Amal Alamuddin was accused of buying into the patriarchy when she changed her name to Clooney. But that was her choice.
updated 4:43 PM EDT, Thu October 16, 2014
Ford Vox says the CDC's Thomas Frieden is a good man with a stellar resume who has shown he lacks the unique talents and vision needed to confront the Ebola crisis
updated 4:58 AM EDT, Sat October 18, 2014
How can such a numerically small force as ISIS take control of vast swathes of Syria and Iraq?
updated 9:42 AM EDT, Fri October 17, 2014
How big a threat do foreign fighters in Syria and Iraq pose to the West? It's a question that has been much on the mind of policymakers and commentators.
updated 8:21 AM EDT, Fri October 17, 2014
More than a quarter-million American women served honorably in the Iraq and Afghanistan wars. Now they are home, we have an obligation to help them transition back to civilian life.
updated 4:27 PM EDT, Thu October 16, 2014
Paul Begala says Rick Scott's deeply weird refusal to begin a debate because rival Charlie Crist had a fan under his podium spells disaster for the Florida governor--delighting Crist
updated 12:07 AM EDT, Thu October 16, 2014
The longer we wait to engage on Ebola, the more limited our options will become, says Marco Rubio.
updated 7:53 AM EDT, Wed October 15, 2014
Democratic candidates who run from President Obama in red states where he is unpopular are making a big mistake, says Donna Brazile
updated 12:29 AM EDT, Thu October 16, 2014
At some 7 billion people, the world can sometimes seem like a crowded place. But if the latest estimates are to be believed, then in less than a century it is going to feel even more so -- about 50% more crowded, says Evan Fraser
updated 3:38 PM EDT, Thu October 16, 2014
Paul Callan says the Ebola situation is pointing up the need for better leadership
updated 6:45 PM EDT, Wed October 15, 2014
Nurses are the unsung heroes of the Ebola outbreak. Yet, there are troubling signs we're failing them, says John Sutter
updated 1:00 PM EDT, Wed October 15, 2014
Dean Obeidallah says it's a mistake to give up a business name you've invested energy in, just because of a new terrorist group
updated 7:01 PM EDT, Wed October 15, 2014
Fear of Ebola is contagious, writes Mel Robbins; but it's time to put the disease in perspective
updated 1:44 PM EDT, Tue October 14, 2014
Oliver Kershaw says that if Big Tobacco is given monopoly of e-cigarette products, public health will suffer.
updated 9:35 AM EDT, Sat October 18, 2014
Stop thinking your job will make you happy.
updated 10:08 PM EDT, Tue October 14, 2014
Ruben Navarrette says it's time to deal with another scandal involving the Secret Service — one that leads directly into the White House.
updated 7:25 AM EDT, Tue October 14, 2014
Americans who choose to fight for militant groups or support them are young and likely to be active in jihadist social media, says Peter Bergen
updated 9:03 AM EDT, Mon October 13, 2014
Stephanie Coontz says 11 years ago only one state allowed same sex marriage. Soon, some 60% of Americans will live where gays can marry. How did attitudes change so quickly?
updated 4:04 PM EDT, Tue October 14, 2014
Legalizing assisted suicide seems acceptable when focusing on individuals. But such laws would put many at risk of immense harm, writes Marilyn Golden.
updated 9:07 AM EDT, Mon October 13, 2014
Julian Zelizer says the issues are huge, but both parties are wrestling with problems that alienate voters
updated 6:50 PM EDT, Mon October 13, 2014
Mel Robbins says the town's school chief was right to cancel the season, but that's just the beginning of what needs to be done
updated 11:43 AM EDT, Sat October 11, 2014
He didn't discover that the world was round, David Perry writes. So what did he do?
ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT