Centers for Disease Control and Prevention

The two molds that have caused meningitis in 203 people and killed 15 of them. Left is Aspergillus; on the right is Exserohilum

More than 200 people in 14 states have either died or shown symptoms in an outbreak of rare fungal meningitis linked to contaminated pain injections, federal health officials said Sunday. Fifteen people have died.

The Centers for Disease Control and Prevention said 203 people had meningitis, while two had infections in their joints.

The CDC has also published its first case report of the outbreak, which began when a Tennessee doctor diagnosed a patient with fungal meningitis on Sept. 18, nearly six weeks after getting a steroid injection for back pain.

The CDC says 26 of the patients have a confirmed fungal infection, and all but one are infected with a type of black mold called Exserohilum. It’s never been known to cause meningitis before, although it’s common in the environment and can cause sinus and eye infections. One patient has Aspergillus, another fungus that occasionally can cause meningitis if injected into the spine, as well as other infections.

Both grow slowly and don’t cause the classic symptoms of meningitis. “Early in this outbreak, many patients with meningitis had only a few mild symptoms,” the CDC and state health offficials say in their report.

Worse, treatment can last months and requires infusions of two strong antifungal drugs, the CDC says. Right now, no one knows how long patients will have to be treated, and the drugs themselves can cause severe side effects such as kidney damage. As many as 14,000 patients may have been given the tainted steroids.

“Early identification and treatment of patients with fungal infections might reduce the risk for serious complications, such as stroke or death,” CDC says.

Meningitis is an inflammation of the spinal cord or the membrane surrounding the brain. It's extremely serious when caused by bacteria; viruses can also cause meningitis. Fungi and parasites cause it more rarely. Most of the patients in this outbreak have complained of headaches.

"FDA urges patients who believe they received an injection or other product compounded by NECC to remain vigilant for the signs and symptoms of infection, including meningitis. The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status," the Food and Drug Administration said in a statement.

State and federal health officials are trying to find out how and why a Massachusetts pharmacy, the New England Compounding Center, managed to distribute so many vials of the steroid, called methylprednisolone. It can be injected into the spine or joints such as the knee or ankle to treat pain.

Massachusetts state health authorities say it appears NECC broke regulations in distributing the high volume of drugs. All of the cases so far have been linked to three affected batches of the steroid, although all of NECC’s products have been recalled.

A sister company, Ameridose, is also being investigated. "Based on the business relationship between NECC and Ameridose, FDA and the Massachusetts Board of Pharmacy launched a joint inspection at the Ameridose facility in Westborough, Massachusetts on October 10, 2012," the FDA said in a statement.

"As part of our efforts to protect the public health, FDA is investigating whether certain aspects of compounding practices and facility conditions observed at NECC may be present at the Ameridose facility. FDA will review whether Ameridose has procedures and facilities necessary to safely produce and provide sterile drug products. At this time, there is no known contamination of products produced by Ameridose."

Related stories:

• Regulators say they had no clear power to stop outbreak
• Compounding pharmacies - heroes or outlaws?
• One man worries after getting tainted injection

At least 91 people have been infected with an unusual type of meningitis caused by contaminated steroid injections, federal health officials said Sunday, with seven deaths. The drugs were given starting May 21, much earlier than previously suspected, officials with the Centers for Disease Control and Prevention said.

They are urging anyone who has had an injection for lower back pain to watch for symptoms of meningitis, which include a stiff neck and balance problems.

Cases have been identified in nine states and health officials fear the numbers will rise as doctors check patients for the symptoms. Doctors and patients alike may not know to look for the unusual infection, which can take weeks to develop after an injection.

"Several of these patients have had strokes related to the meningitis," the CDC said in a statement posted on its website. "In several patients, the meningitis was found to be caused by a fungus that is common in the environment but rarely causes meningitis. This form of meningitis is not contagious. The source of the fungus has not yet been identified, and the cause of infections in the other patients is still being assessed."

The drug in question is called methylprednisone and is used mostly to treat older patients for lower back pain.

The contaminated drugs have been traced to a single pharmacy in Massachusetts, the New England Compounding Center. The pharmacy has closed voluntarily and recalled its products, which include steroids, painkillers and dozens of other drugs. At least one sealed vial of drug has been found to have fungus growing in it, the Food and Drug Administration said. The FDA does not regulate pharmacies like the one in Massachusetts but can be called in when contamination is suspected.

Compounding pharmacies usually make drugs to order, and the steroids suspected of causing the infections did not contain preservatives that can keep fungi and bacteria from growing.

The pharmacy sent products to clinics in California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas, and West Virginia, the CDC says.

In this case, the patients appear to have had contaminated drugs injected directly into their spinal fluid. CDC says the clinics do not appear to be to blame. The CDC said it has found fungus, including Aspergillus and Exserohilum, in specimens from nine patients.

Meningitis is an inflammation of the protective membranes covering the brain and spinal cord. Bacteria or viruses are the usual cause, but meningitis can also be caused by fungi and parasites. "In addition to typical meningitis symptoms, like headache, fever, nausea, and stiffness of the neck, people with fungal meningitis may also experience confusion, dizziness, and discomfort from bright lights. Patients might just have one or two of these symptoms," CDC said.

Related stories:

Seven dead in meningitis outbreak

Officials widen recall in meningitis outbreak

Meningitis outbreak points to pharmacy problem

It sounds like a fine idea: "Good Laboratory Practice." But critics say that reliance on this standard of scientific test by the U.S. Food and Drug Administration has allowed dangerous chemicals to be used in foods and food packaging.

The nonprofit group 100 Reporters has this interesting story, Good Practice v. Good Science, researched and written by Clare Howard.

An excerpt:

In a recent decision to permit continued use of a chemical in food packaging that research has tied to cancer, diabetes, miscarriages and developmental delays in children, the U.S. Food and Drug Administration has favored two industry-funded studies over more than 1,000 independent analyses finding the chemical poses serious risks to human health.

The FDA’s decision on bisphenol A was not an isolated, or even unusual, call. For more than 30 years, U.S. regulatory agencies have relied on an arcane rule for approving chemicals used in everything from food packaging and drugs to pesticides and electronics, one that favors industry-funded reports over independent academic research.

That process exalts studies that follow design standards known as “Good Laboratory Practice,” and discounts research that may be confirmed through peer review, but do not follow the GLP protocols. Favoring GLP has given a green light to hundreds of chemicals and products from nicotine to atrazine linked to human disease and chronic health conditions.

Critics contend that the protocols, defended by the chemical industry, have become an arbitrary barrier, shutting out important independent research. In the case of BPA, a common chemical used in food packaging, adherence to the protocol largely overrode studies linking BPA to breast cancer, prostate abnormalities, low sperm count, developmental disorders, heart disease, obesity and diabetes.

Read the full story at 100 Reporters.

Truckloads of medical products, tankers of bulk liquids and cartons of chemicals have been hauled to secure landfills and waste disposal centers as a Wisconsin supplier works to recover from a year-long contamination scandal blamed for illness and death.

By one account, H&P Industries and the Triad Group of Hartland, Wis., had enough potentially tainted medical prep wipes to fill a football field.

The sister firms have either destroyed or reconditioned more than $6 million of suspect products seized by federal regulators last spring, bringing them in compliance with a court order, new government documents show.

The firm’s $4 million penal bond has been canceled and the seized products have been returned to H&P’s jurisdiction for disposal, possible steps toward reopening, according to new Food and Drug Administration documents obtained through an msnbc.com open records request and appeal.

The discarded products included 50 truckloads of finished goods, 13 truckloads of raw chemicals and five bulk tank-trailers of in-process materials, according to Shelly Burgess, an FDA spokeswoman.

"The firm will not be permitted to resume operations until FDA is satisfied that it can do so with full compliance with the decree and the law," Burgess said.

It took H&P Industries three tries to gain FDA approval of a reconditioning plan that outlines an overhaul of manufacturing, monitoring, inspection and reporting procedures to correct problems with contamination and sterilization. Previous plans were not detailed enough to satisfy FDA’s concerns, the documents posted online late Tuesday showed.

“Because of both micro- and cross-contamination concerns, FDA has no [good manufacturing process] assurance and is uncomfortable with introducing any potential risk back into the market,” said Tamara Ely, an FDA compliance officer, according to an account of a November 21, 2011 meeting.

Only unopened, factory-sealed raw chemicals will be allowed to be “reconditioned” so that they’re safe for use either by H&P Industries or by a vendor who agrees to accept returned product, the documents showed. The reconditioning procedure requires sampling, testing and approval to verify that no microbial contamination exists.

Everything else — finished products, in-process products, materials in tanks and drums, raw chemicals, bulk chemicals and other open, used components  — was destroyed. The firm is still prohibited from manufacturing drugs or devices, Burgess noted.

H&P’s compliance comes more than a year after FDA officials urged the company to issue the first of several global recalls of alcohol and iodine prep products potentially contaminated with at least two kinds of bacteria because of inadequate manufacturing and sterilization procedures.

FDA officials had known for years about problems with the Wisconsin plant, but had failed to adequately enforce regulations, an msnbc.com investigation found.

The move also comes nearly a year after parents of a 2-year-old Houston boy first filed a lawsuit claiming that contaminated alcohol pads made by H&P Industries were responsible for the bacterial infection that killed their son.

Since then, at least a dozen lawsuits have been filed by patients and their families in several states who claim that tainted prep wipes led to infections, illnesses and, in some cases, deaths.

H&P Industries officials did not respond to msnbc.com requests for comment, but the firm consistently has denied that its products could be directly tied to those events.

Burgess, the FDA spokeswoman, confirmed the number of truckloads of finished medical products, tanker trucks of bulk liquids and containers of chemicals that the company was forced to destroy.

But by another estimate, the volume of returned alcohol and iodine prep products alone would have filled an area “the size of a football field,” according to a lawyer representing the Triad Group.

“There are billions of these pads produced a year, millions in a day, believe it or not, so it is massive what has been returned,” lawyer Alana Bassin told U.S. District Court Judge Lynn Hughes during a July briefing, a court transcript shows.

The medical products have been transferred to secure landfill and destruction sites that operate under regulatory jurisdiction. Some of the material may have to be processed as hazardous waste, the documents noted.

H&P Industries' plans for the future remain unclear. The firm’s 285,000-square-foot plant at 700 W. North Shore Drive , Hartland, Wis., is for sale for $14.2 million, real estate listings show.

Related: Tracking tainted wipes: an msnbc.com special investigation

A 36-year-old California computer specialist says he has fathered 14 children -- and is still a virgin.

Trent Arsenault confirmed to CNN’s Anderson Cooper on his syndicated television show that he has never had sex. He said he “committed 100 percent of my sexual energy for producing sperm for childless couples to have babies. So I don't have other activity outside of that.”

The Food and Drug Administration, however, wants to put an end to Arsenault’s activity.

FDA cracks down on sperm donor

Through his own website, Arsenault connects with Bay Area couples looking to conceive. The website is extensive and lists his medical records, including a list of sexually transmitted diseases he has been tested for, his diet, sperm count, and personality traits.

The federal government is not happy he sells his sperm directly, but Arsenault believes he is helping couples start families.

"It is helping people in need," Arsenault told NBC News affiliate KNTV in San Francisco in December. "I don't make any money, I don't charge people anything. And it's just helping childless couples have children."

The FDA has challenged Arsenault in court, and the battle has raged on for over a year. Now he is awaiting a formal hearing from the FDA.

Until the hearing, Arsenault will continue to donate his sperm.

He has received 20,000 emails since 2004 requesting his service.

More content from msnbc.com and NBC News

• Homeless numbers down, but risks rise
• Syria's 'Big Brother' looms over a tense capital
• Teen girls' medical mystery: mass hysteria? 
• New weapon aimed at Occupy: lynching charge
• US survivors recount panic aboard Italy cruise liner

Featurepics.com

Chocolate ice cream is a frequent catch-all for botched batches of other flavors, which are doled out in small amounts and mixed with the dark, rich treat in order to avoid waste and expense. Reworking food is a common practice, industry experts say.

When a school lunch supplier repackaged moldy applesauce into canned goods and fruit cups, it drew a sharp warning from federal health regulators last month -- and general disgust from almost everyone else.

“I was appalled that there were actually human beings that were OK with this,” said Kantha Shelke, a food scientist and spokeswoman for the Institute of Food Technologists. “This is a case of unsafe food. They are trying to salvage that to make a buck.”

But even as Food and Drug Administration officials prepare to re-inspect Snokist Growers of Yakima, Wash., to ensure that the applesauce maker keeps toxin-tainted fruit off store shelves, federal officials and industry experts acknowledge that Snokist is not alone in “reworking” faulty food.

Turning imperfect, mislabeled or outright contaminated foods into edible -- and profitable -- goods is so common that virtually all producers do it, at least to some extent, sources say.

“Any food can be reconditioned,” said Jay Cole, a former federal inspector who now works as a senior consultant with The FDA Group, a firm that specializes in helping manufacturers comply with industry regulations.

“It’s how people do their business,” added Shelke, founder of Corvus Blue, a Chicago-based packaged goods consulting firm.

It may be something benign, such as misshapen pieces of pasta that are re-ground into semolina, or something unexpected, like a batch of mislabeled blueberry ice cream mixed in with chocolate to avoid waste.

It might be something unappetizing, such as insect parts sifted out of cocoa beans or live bugs irradiated -- and left behind -- in dried fruits like dates and figs.

Or it could be something alarming, such as the salmonella Tennessee bacteria detected last year in huge lots of hydrolyzed vegetable protein, or HVP, a flavor enhancer used in foods from gravy mix and snack foods to dairy products, spices and soups. 

Some 177 products were recalled in 2010, but bulk HVP products from Basic Food Flavors Inc. of Las Vegas, Nev., were allowed to be reconditioned by heat-treating the foods to kill the salmonella, according to the FDA. The reprocessed foods were then distributed and sold.

No question, FDA regulations do permit foods to be reconditioned, said William Correll, the agency’s acting director of compliance.  That leeway can avoid both waste and expense, he explained.

“Some things can be adulterated and fixed, and you’re not throwing out food that would otherwise be OK,” Correll said.

That’s why chocolate ice cream becomes the catch-all when other flavors aren’t quite right, said Shelke. If a producer accidentally botches a batch of blueberry, small amounts of the mistaken treat can be mixed into future bins of chocolate, where the dark color and rich flavor mask any error.  

The key, however, is that the process must render the food safe for consumption. 

That’s why Snokist Growers drew such a strong warning. In the case of the moldy applesauce, there are a couple of problems, Correll said. Mold is tricky because when contamination is extensive, it’s not enough to simply remove the obviously tainted parts and then zap the food with heat.

Snokist officials claim that their heat process kills patulin, the most common toxin produced by mold in apples, and renders the food commercially sterile. But FDA officials counter that the firm’s thermal process is not adequate to ensure that other heat-stable mycotoxins are eradicated from the food.

“Mold is not an easily reconditionable product,” Correll said. “It’s not OK to take moldy tomatoes and make them into tomato paste.”

Not that some food firms don’t try. It’s no secret that the FDA allows certain levels of expected contaminants to remain in foods, simply because a zero-tolerance standard would be impossible to meet, officials said.

The agency’s “defect action levels” are used to define the point at which food becomes adulterated and subject to enforcement. Below that level, however, some unappetizing substances make it through.

The FDA allows, for instance, an average of 225 insect fragments or 4.5 rodent hairs per 8 ounces of macaroni or noodle products. An average of 20 or more maggots of any size is permitted per 3.5 ounces of drained canned mushrooms, or per half-ounce of dried mushrooms. When it comes to mold, an average count of 15 percent is OK for canned cranberry sauce.

Because such levels are permitted, some food producers propose to combine faulty and sound products to lower the overall level. An apple-juice maker might ask to mix juice with high counts of mold with a batch with low counts, for instance. But, Correll said, that’s not allowed.

“Dilution is not the solution,” he said.

Similarly, companies that propose to eliminate a serious contaminant without addressing the source are turned down. He recalled a seafood firm with faulty bathroom practices that led to canned crab contaminated with fecal E. coli bacteria. Heat-treating would have eradicated the bugs -- but not the problem, Correll said.

“If food is adulterated in an unacceptable way, reconditioning won’t fix it,” he said. “You can’t cook the poop out of it.”

FDA officials couldn’t provide an estimate of the number of reconditioning requests received from food firms each year. But in 2009, the agency started a new Reportable Food Registry, which requires notification of hazards to human health. At least 2,240 reports were logged in the registry’s first year, including the salmonella-tainted vegetable protein.

Many producers faced with faulty food simply want to minimize their losses without harming public health, said Peter Quinter and Jennifer Diaz, lawyers with the Florida firm Becker & Poliakoff, which represents importers of foreign food.

Such firms want to avoid having product refused, so they go to great expense to salvage products such as insect-infested rice for future consumption, Diaz said. Grain products can be sifted, re-inspected, repackaged – and sent on to grocery stores.

“Taking the ick factor away is that the product is no longer contaminated,” she added.

Related stories:

FDA: Moldy applesauce repackaged by school lunch supplier
Chicken livers sicken 179 with salmonella
Six new E. coli strains banned from beef supply