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

Cholesterol-lowering drugs may fight infectious disease

August 21, 2017
That statin you've been taking to lower your risk of heart attack or stroke may one day pull double duty, providing protection against a whole host of infectious diseases, including typhoid fever, chlamydia, and malaria.

Data revealed under FOI shows benefits of multiple sclerosis drug currently blocked by regulators

August 17, 2017
A drug that is blocked by the EU regulatory system has now been found to improve the quality of life of people with multiple sclerosis (MS), according to a study by Queen Mary University of London (QMUL).

Opioids overused in migraine treatment, regardless of race, study finds

August 17, 2017
African-Americans are more likely to experience debilitating migraine headaches than whites, but a new study probing the issue found no evidence of racial disparities in treatment practices.

Finding better ways to reduce serious drug side effects

August 14, 2017
Many of the medicines we depend on to treat disease—and even to save our lives—pose potentially serious risks along with their benefits. Data from the U.S. Centers for Disease Control and Prevention indicate that about ...

Ultrasound-triggered liposomes for on-demand, local anesthesia

August 10, 2017
Researchers at Boston Children's Hospital have found a new way to non-invasively relieve pain at local sites in the body; such systems could one day improve pain management by replacing addictive opioids and short-lasting ...

Independent pharmacies and online coupons help patients save money on drugs

August 8, 2017
Uninsured patients or those with limited prescription drug coverage can save significant money by buying their drugs at independent pharmacies instead of big box, grocery or chain drug stores and by using discount coupons, ...

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.