Calls for more US oversight after tainted drug outbreak

October 11, 2012 by Mira Oberman

A deadly meningitis outbreak in the United States blamed on a tainted drug has triggered outrage and calls for tighter regulation of the loosely controlled pharmaceutical compounding industry.

At least a dozen people have died and the number of fungal meningitis cases rose to 138 Wednesday after a contaminated drug was shipped to clinics and hospitals in 23 states.

Investigators say as many as 13,000 people may have received contaminated doses of the steroid, which is injected into the spine to treat back pain.

Critics said have found a way to sidestep costly and strict oversight by classifying themselves as pharmacies, which are given freer rein to mix for patients.

"People are just playing Russian roulette when they use one of these compounded drugs," said Sheldon Bradshaw, a Washington lawyer who was chief counsel for the from 2005 to 2007.

"They don't have to follow good manufacturing practices which, if followed, guarantee that a product isn't going to be contaminated. They don't have to spend hundreds of millions on clinical trials to show their drugs are safe," he told AFP.

Problems could be far more widespread than feared because, unlike manufacturers of FDA-approved drugs, pharmacies are not required to report or injuries.

And many doctors don't realize the drugs they are prescribing are not produced at facilities that have received the FDA's seal of approval.

"Our loss and that of others should be a wake-up call to our country," George Cary told reporters after a memorial for his wife Lillian, 67, in Michigan Tuesday.

"The apparent lack of suitable inspections should not have happened."

Several lawmakers have already announced plans to introduce legislation that would strengthen oversight and others are asking the FDA for more immediate action.

"The recent outbreak of dangerous, potentially indicates a clear and present need for stronger accountability and oversight," Senator Richard Blumenthal said in a letter to the FDA.

The looser regulations were intended to allow pharmacists to fulfill their traditional role of tailoring a drug to suit a particular patient—say by mixing a lower dose of medicine with flavored syrup to make it suitable for a child—without having to deal with onerous requirements like clinical trials.

Yet they have created a "grey area in the law," allowing a growing number of companies to produce compounds at an industrial scale, said Kevin Outterson, a professor of health law at the Boston University School of Law.

"It's just a classic gap in the regulatory structure that companies have used to build this business over the past few decades," Outterson said.

As a result, the FDA has more power to regulate drug companies in China than large-scale compounding pharmacies in the United States, he said in a telephone interview.

State agencies are charged with regulating pharmacies, although the FDA typically steps in to investigate if a "significant violation" is reported.

The company that distributed thousands of vials of the tainted steroids—the New England Compounding Center—has been investigated by the state of Massachusetts and the FDA on at least two occasions in the past decade. It is also not accredited by a professional board.

It is not yet clear how the drugs were contaminated or why it took so long to discover the problem. Health officials are urging patients who received a dose as far back as May 21 to contact their doctors.

But the New England Compounding Center has recalled all of its products from the market and ceased operations.

The FDA declined to comment on whether an oversight failure or the loose regulation of compounds contributed to the outbreak.

But an industry spokeswoman said it is clear the New England Compounding Center was not following the rules.

"There is regulation in place. Unfortunately, it looks like it just did not work in this particular situation," said Dagmar Climo, a spokeswoman for the International Academy of Compounding Pharmacists.

"When the system is working, we should not be seeing these types of problems. Unfortunately, this was just a major oversight of an organization that was essentially manufacturing."

Representatives from the academy will be meeting with lawmakers on Thursday to discuss ways "to make sure this never happens again," Climo said.

However, she declined to comment on whether the group believes large-scale producers of compounds need to be better regulated.

Explore further: Tainted drug death toll rises to 14 in US

Related Stories

Tainted drug death toll rises to 14 in US

October 11, 2012
The death toll from a deadly meningitis outbreak in the United States blamed on a tainted drug rose to 14 Thursday as the number of cases jumped to 172 in 11 states, health officials said.

US clinics rush to warn of tainted steroid; 5 dead

October 5, 2012
(AP)—Health providers scrambled to notify patients in nearly two dozen U.S. states that the steroid injections they received for back pain may have been contaminated with a deadly fungal meningitis. Five people have died.

US: Avoid drugs from company tied to meningitis (Update)

October 4, 2012
U.S. health officials ramped up warnings Thursday about a specialty pharmacy linked to a widening outbreak of a rare kind of meningitis, urging doctors and hospitals not to use any products from the company.

FDA warning public of risks of online pharmacies

September 28, 2012
The Food and Drug Administration is warning the public that most Internet pharmacies are fraudulent, selling drugs that likely are counterfeit and could harm or even kill people.

Steroid-related meningitis cases rise to 47

October 5, 2012
(AP)—As the tally from a deadly meningitis outbreak rose Friday, health officials identified the medical clinics across the country that received steroid shots for back pain now linked to the illnesses.

13,000 got suspect steroid shots; risk uncertain

October 8, 2012
(AP)—As many as 13,000 people received steroid shots suspected in a U.S. meningitis outbreak, health officials said Monday. But it's not clear how many are in danger.

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.