Tuesday, September 10, 2013

Dangers From Compounding Pharmacies Persist

Nearly a year after a nationwide outbreak of fungal meningitis erupted, new cases of the disease are still emerging, and efforts to tighten regulation of the type of pharmacy behind the outbreak are moving slowly.

The Food and Drug Administration has reported 14 multistate or national voluntary recalls so far this year of products made by so-called compounding pharmacies, which custom-mix large batches of medications not available from pharmaceutical companies. The FDA reported only two recalls of products from such pharmacies in 2012, including the recall of the injection behind the fungal-meningitis cases. There were none in the four years before that.

The medicines recalled this year by their makers include cataract drops, testosterone pellets and an injection like the one behind the meningitis outbreak.image
Tim Gruber for The Wall Street Journal
Traci Maccoux takes several pills daily.

Meanwhile, doctors say they are struggling to cure patients because very little is known about a condition that normally affects plants, not people. More than 700 out of 14,000 people who received tainted injections have fallen ill since the outbreak began in September 2012, according to data released this month from the Centers for Disease Control and Prevention. That includes 86 cases diagnosed since the beginning of this year. Hundreds are still in treatment. Of those who have gotten sick, 63 have died, including 24 this year, the CDC said.

And while the total number of cases hasn't risen in the past two months, more could still fall ill. "There's no way this is over for several years," said Tom Chiller, deputy chief of the CDC's mycotic-diseases branch, one of the divisions that oversaw the federal government's response to the fungal-meningitis outbreak last year. Fungal diseases affecting bones or soft tissue can take months to develop, he said. The CDC has launched a two-year study of approximately 500 fungal-meningitis patients to learn more about the long-term health effects of their infections and to monitor the effectiveness of their treatments.

The slow pace of moves to tighten oversight and mounting case count underscores how long the effects of a deadly outbreak are lingering. The delayed response also illustrates how difficult it is to create a system meant to mitigate widespread compounding errors.

A Senate bill that would give the FDA oversight of many large compounding pharmacies—which operate like manufacturers and sell drugs all over the country—is one of only a few pieces of legislation that may make it to the Senate floor this fall, according to Senate Democratic aides. Even if successful, it would be months, if not years, before enforcement took effect.

The fungal-meningitis illnesses thus far have all been traced to a single source: the New England Compounding Center, of Framingham, Mass. NECC, through its court-appointed bankruptcy trustee, declined to comment.

Bob Pinkstaff, of Elberfeld, Ind., thought he had escaped harm last October when he showed no symptoms of fungal meningitis despite having received one of the tainted NECC steroid injections at an Evansville, Ind., pain clinic to relieve back pain from injuries in a car accident.
But about five months after a spinal tap showed he was okay, a series of symptoms were unrelenting. Headaches wouldn't go away; his eyes were ultrasensitive to light. On March 7, a test confirmed the 59-year-old's worst fears: his blood sample had the mold found in the contaminated steroids.

The medications he is on make him sweat profusely, requiring him to change T-shirts several times a day. His eyes are so sensitive to light that he has to watch TV with sunglasses. He said his doctors tell him they don't know when he will be cured.

A spokeswoman for St. Mary's Health, the multifacility health system in Evansville, Ind., where Mr. Pinkstaff received his steroid injections and was initially treated, declined to comment, citing privacy concerns.

"I wish I could just go back and have my old pain, deal just with the back issues," said Mr. Pinkstaff, who has been on disability since the car accident.

Doctors have had little experience to go on, as the type of fungus that contaminated most of the injections—exserohilum rostratum—is typically found on plants rather than in humans.

"We're unable to say whether a patient who is doing well is really in the clear or not," said Lakshmi Halasyamani, chief medical officer for St. Joseph Mercy Hospital in Ann Arbor, Mich., which has treated 195 people for fungal meningitis since October.

Traci Maccoux has spent 40 nights in the hospital since she was diagnosed with fungal meningitis last October. Her medical bills alone total more than $430,000, which her insurer has so far covered. After halting treatment in April, she immediately began having searing headaches, so she went back on treatment. Side effects from the drugs have blurred her vision, leaving her unable to drive for long distances and house-bound. The 23-year-old from Brooklyn Park, Minn., could enroll in only one class for her junior year of college this fall, said her mother, Cathy Maccoux. "Her biggest fear is if she'll ever be able to get her life going again—and nobody knows," she said.

The proposed Senate legislation would give the FDA oversight of big compounding pharmacies and subject them to regulations like those required of pharmaceutical manufacturers. Now they are regulated by state pharmacy boards, but regulation differs from state to state.

Under the bill, which Senate Democratic aides say could come up for a vote this month, large compounding pharmacies that make sterile products, such as steroid injections, would be reclassified as "compounding manufacturers." Those with more than $1 million in annual revenue would pay a $15,000 fee every year and be placed on a national registry. Inspections would occur every three years.

The Senate bill "provides the agency with the authorities needed for more effective and appropriate oversight of the pharmacy compounding industry," said Erica Jefferson, an FDA spokeswoman. "If we don't, we will continue to see tragedies that may have been prevented in the future."
The International Academy of Compounding Pharmacists, an industry group, opposes the Senate bill. It "will not assure Americans of safety and will limit the ability of pharmacists to provide vitally needed medication to patients," an IACP spokesman said. The Senate bill too aggressively limits the types of compounding allowed at an individual pharmacy, the spokesman added.

Meanwhile, the number of recalls of productsat compounding pharmacies has mushroomed. Most recently, on Aug. 11, Specialty Compounding LLC of Cedar Park, Texas, voluntarily recalled all of its sterilized products after 15 people developed bloodstream infections caused by Rhodococcus equi, a bacteria, following injection with a mineral supplement used to treat conditions associated with low-calcium levels or for cardiac arrest.

Specialty Compounding's independent laboratory testing "has not yet proven an association between the medication compounded by Specialty Compounding and the infected patients," said a spokesman.
Some patients like Angel Farthing of Abingdon, Md., a Baltimore suburb, say that due to broader skepticism about prescribing opioid painkillers, they are having trouble getting physicians to treat their ongoing pain—intensified by meningitis-related issues like abscesses near the injection or arachnidits, a clumping up of the nerves.She finally found someone willing to treat her pain: the same doctor at the clinic that gave her the NECC injection.

It isn't clear how many more people will develop fungal meningitis, health officials say. Thousands of those who received injections have never been tested for the disease. "There remains a currently impossible to quantify risk for a currently impossible to specify number of exposed patients," said John Dreyzehner, commissioner of the Tennessee Department of Health. Tennessee was an epicenter of last fall's outbreak.


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