WRAL Investigates

Meningitis survivor: 'We're killing our own people'

Posted November 5, 2012

— Ginny Rauch thought she was going to die. The pain in her legs and back was so excruciating that she could hardly breathe at times. A steroid shot that was supposed to ease her back pain had instead left her with a near-fatal case of fungal meningitis.

That was 2002. Now, 10 years later, Rauch has flashbacks to her ordeal and says she is angry that a new meningitis outbreak has killed 29 people and sickened 377 across the U.S., including in North Carolina.

“When I heard what happened to all these people, I could just not believe that this had happened, because it’s cleanliness,” Rauch said. “If they had done what they said they were going to do, this would’ve never happened.”

Ginny Rauch talks about surviving fungal meningitis Woman talks about surviving fungal meningitis

Rauch was one of the lucky ones 10 years ago. She survived, while two other North Carolinians died. The 71-year-old former Raeford music teacher, who now lives in Virginia, says she is on a mission to hold the Food and Drug Administration accountable for the tainted medicine, even if that means speaking before Congress.

“I just don’t feel that we should ever have to have this conversation again. To me, it’s ridiculous. It’s absolutely ridiculous,” Rauch said. “We’re killing our own people in the United States from filth.”

A Spartanburg, S.C., pharmacy manufactured the tainted medicine that sickened Rauch and killed two others. The current meningitis cases stem from a specialty pharmacy in Framingham, Mass.

In both cases, the shots came from compounding pharmacies. Compounding, which involves making a special order for an existing drug, is something all pharmacies do. Pharmacy experts say special orders aren’t the problem. The problem is when pharmacies start mass producing those special orders for the public, instead of just for one patient.

“It’s hard not to attribute this to greed, simple greed,” said Jay Campbell, executive director of the North Carolina Board of Pharmacy, which inspects pharmacies. “The issue is where is the line between legitimate compounding pharmacies and full-blown manufacturing?”

Campbell says big compounding companies can sell drugs for less. They need FDA inspection but often operate in a gray area and avoid the type of oversight Campbell thinks they need.

The FDA released a statement to WRAL Investigates, saying that its "regulatory authority over compounding pharmacies is more limited by statute than it is for typical drug manufacturers."

Ginny Rauch talks about surviving fungal meningitis Meningitis survivor: 'We're killing our own people'

"Compounding pharmacies and pharmacists are responsible for the quality and safety of the drugs they produce for patients. The FDA will continue to act within its existing authorities to protect public health and help ensure the safety of medical products," the FDA's statement continued.

"Once the immediate crisis is contained, the FDA is committed to working with Congress, compounders, the states, and all other stakeholders to strengthen the system to prevent tragedies like this from happening again."

Inspectors struggle to visit clinics regularly

In North Carolina, eight state inspectors cover 1,600 pharmacies across the state, 40 to 50 of which specialize in compounding. At that rate, it takes two to three years to do routine visits for each.

Compounding pharmacies are regulated by state boards of pharmacy and are exempt from FDA regulations. The FDA regulates only the ingredients.

No meningitis outbreaks have been tied to North Carolina pharmacies, but in 2005, large drug orders from Triangle Compounding Pharmacy were called into question after a woman died using the company's numbing gel for hair removal. The company was issued an Order of Reprimand, which is a form of public discipline that goes to the National Practitioner Data Bank. No problems have been reported since.

The WRAL Investigates team examined two years of state inspections for all North Carolina pharmacies and found no major problems. However, inspectors noted several times that compounding areas needed to be cleaned better to avoid cross contamination of drugs. Inspectors also found a lot of expired drugs still on shelves.

FDA inspectors struggle with resources for routine inspections as well. 

In 2008, pre-filled syringes of saline from an Angier company – under FDA inspection – were linked to a bacterial infection outbreak that killed five people and infected at least 288. Two managers of the company, AM2PAT, pleaded guilty to fraud and allowing tainted drugs into the marketplace and were serving four-year sentences in federal prison.

Federal authorities are still searching for Dushyant Patel, the company’s former president and chief executive, who was indicted on 10 federal charges, including fraud and selling adulterated medical devices. Authorities said in 2010 that he might have fled to his native India.

After a 2005 warning letter to AM2PAT, inspectors found no major safety violations in annual visits.

Rauch: ‘I could barely walk’

Fungal meningitis is dangerous, experts say, because symptoms can develop slowly, sometimes taking up to six weeks to appear after a patient receives a contaminated steroid injection.

Meningitis is the swelling of the protective membranes, or meninges, covering the brain and spinal cord. The swelling is usually caused by an infection with a bacteria or virus, but meningitis can also be caused by a fungus, according to the Centers for Disease Control and Prevention.

Someone with fungal meningitis may experience a few mild symptoms at first, such as a headache, some nausea and light sensitivity. The pain can then increase to a worsening headache, stiff neck, weakness or numbness in parts of the body, slurred speech and increased pain, redness or swelling at the injection site.

Rauch says she experienced some of those symptoms after receiving a contaminated injection in her spine at a Pinehurst clinic in 2002. She received the shot to help ease her back pain from a 1993 fall on the ice.

Ginny Rauch 11/14/2002: Raeford teacher says she received contaminated painkiller

“It’s an elective thing when you get the shot, but they helped immensely,” Rauch said. “They help a lot of people, and I wouldn’t want people to never get those shots again.”

The shot, which Rauch says is similar to getting an epidural, is inserted into the spine and numbs the area. Instead of feeling relief, the then 61-year-old felt something different.

“I could feel my neck stiffen, and I could barely walk. The next week, they diagnosed me with meningitis,” she said. “If I’d waited another week, I wouldn’t have made it.”

Ten years later, Rauch says she still has side effects, such as not being able to control her hands like she used to, making it nearly impossible for her to play her beloved piano. Despite her medical struggles, the former music teacher remains optimistic and says she can’t stop thinking about the people struggling in the latest meningitis outbreak.

“I know what these people are feeling,” she said. “Of those who have it now, just don’t give up. Just don’t give up.”

18 Comments

This story is closed for comments. Comments on WRAL.com news stories are accepted and moderated between the hours of 8 a.m. and 8 p.m. Monday through Friday.

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  • WageSlave Nov 8, 1:19 p.m.

    I thought private companies could regulate themselves just fine. No need for large government bureaucracies to get in their way. Right, republicans?
    scientistjo

    Not with this population, the free market argument would be that this company would be sued and everyone would avoid their service bc they participate in unsafe practices. However, this population won't even remember this company next week, let along ask for details when the doctor is giving them shots.

  • scientistjo Nov 8, 12:12 p.m.

    I thought private companies could regulate themselves just fine. No need for large government bureaucracies to get in their way. Right, republicans?

  • commonsense4 Nov 6, 4:17 p.m.

    The FDA is supposed to be there to protect Americans, but it really just insures that manufacturers products are out in the market before determining the risks to the public.

    More than 221 organizations hired 77 lobbying firms to fight over details in the US Food and Drug Administration's (FDA) Food Safety Modernization Act recently passed by the US Senate.

    Americans can't compete with lobbyists - a giant flaw in our government, and the reason why unnecessary legislation (lobbyists for the rich) gets passed over necessary legislation. Under Romney, agencies like the FDA will kill way more Americans as they side even more with the rich and their corps.

  • tran Nov 6, 1:21 p.m.

    "Well, being a free market, the public can sue these folks out of existence ..."

    Good luck with that.

  • Reformed Liberal Nov 6, 12:09 p.m.

    "You people have no one to blame but yourselves. Stay away from doctors, if you listen to tv every drug advertized on it there carry the same warnings as cigarettes, They WILL kill you! This week, it's ask your doctor if blank blank is right for you. Next week its , if you or a family has used blank blank and has suffered thus and thus as a result call the law offices of WE and THEM!"

    Huh? If someone keeps suffering from severe back pain what do you want them to do? Sit there and collect government benefits?

  • Reformed Liberal Nov 6, 12:07 p.m.

    Let businesses regulate themselves? What do you think will happen? A lot more of this.

  • Frank Downtown Nov 6, 11:41 a.m.

    This happens when people do not follow rules and regulations. Standards are set for a reason- safety.

  • WageSlave Nov 6, 11:15 a.m.

    "Were Killing out Own people"

    Wait till we see what 20 years of eating GMO's looks like. And with the FDA being in bed with Monsanto what could go wrong?

  • CestLaVie Nov 6, 10:54 a.m.

    "The FDA will continue to act within its existing authorities to protect public health and help ensure the safety of medical products,"

    Baloney.

    The FDA is in bed with the pharma companies. There's a revolving door between the people on their boards. First, a director with a drug company; then, a director with FDA. Back & forth. Profits, like everything else in this country, has really become the name of the game.

    I wouldn't trust the FDA or USDA or DHS or any other Fed agency any farther than I could throw them. Public health or safety or serving US citizens is NOT their main concern. That goes for our Prez & reps in Congress too. Funny how new laws are now protecting these drug companies from lawsuits about such matters, the public be damned.

    Mrs. Rauch: You are right to fight them. It's what citizens have to do all the time, it seems. I'm sorry your hard lesson continues on for others.

  • piene2 Nov 6, 10:31 a.m.

    "We're killing our own people"

    You are correct and it's called Obamacare!
    Nuff z Nuff"

    how totally irrelevant and absurd.

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