It's about to get faster and easier to diagnose food poisoning, but that progress for individual patients comes with a downside: It could hurt the nation's ability to spot and solve dangerous outbreaks.

Next-generation tests that promise to shave a few days off the time needed to tell whether E. coli, salmonella or other foodborne bacteria caused a patient's illness could reach medical laboratories as early as next year. That could allow doctors to treat sometimes deadly diseases much more quickly — an exciting development.

The problem: These new tests can't detect crucial differences among different subtypes of bacteria, as current tests can. And that fingerprint is what states and the federal government use to match sick people to a contaminated food. The older tests might be replaced by the new, more efficient ones.

"It's like a forensics lab. If somebody says a shot was fired, without the bullet you don't know where it came from," explained E. coli expert Dr. Phillip Tarr of Washington University School of Medicine in St. Louis.

The federal Centers for Disease Control and Prevention warns that losing the ability to take a germ's fingerprint could hamper efforts to keep food safe, and the agency is searching for solutions. According to CDC estimates, 1 in 6 Americans gets sick from foodborne illnesses each year, and 3,000 die.

"These improved tests for diagnosing patients could have the unintended consequence of reducing our ability to detect and investigate outbreaks, ultimately causing more people to become sick," said Dr. John Besser of the CDC.

That means outbreaks like the salmonella illnesses linked this fall to a variety of Trader Joe's peanut butter might not be identified that quickly — or at all.

It all comes down to what's called a bacterial culture — whether labs grow a sample of a patient's bacteria in an old-fashioned petri dish, or skip that step because the new tests don't require it.

Here's the way it works now: Someone with serious diarrhea visits the doctor, who gets a stool sample and sends it to a private testing laboratory. The lab cultures the sample, growing larger batches of any lurking bacteria to identify what's there. If disease-causing germs such as E. coli O157 or salmonella are found, they may be sent on to a public health laboratory for more sophisticated analysis to uncover their unique DNA patterns — their fingerprints.

Those fingerprints are posted to a national database, called PulseNet, that the CDC and state health officials use to look for food poisoning trends.

There are lots of garden-variety cases of salmonella every year, from runny eggs to a picnic lunch that sat out too long. But if a few people in, say, Baltimore have salmonella with the same molecular signature as some sick people in Cleveland, it's time to investigate, because scientists might be able narrow the outbreak to a particular food or company.

But culture-based testing takes time — as long as two to four days after the sample reaches the lab, which makes for a long wait if you're a sick patient.

What's in the pipeline? Tests that could detect many kinds of germs simultaneously instead of hunting one at a time — and within hours of reaching the lab — without first having to grow a culture. Those tests are expected to be approved as early as next year.

This isn't just a science debate, said Shari Shea, food safety director at the Association of Public Health Laboratories. If you were the patient, "you'd want to know how you got sick," she said.

PulseNet has greatly improved the ability of regulators and the food industry to solve those mysteries since it was launched in the mid-1990s, helping to spot major outbreaks in ground beef, spinach, eggs and cantaloupe in recent years. Just this fall, PulseNet matched 42 different salmonella illnesses in 20 different states that were eventually traced to a variety of Trader Joe's peanut butter.

Food and Drug Administration officials who visited the plant where the peanut butter was made found salmonella contamination all over the facility, with several of the plant samples matching the fingerprint of the salmonella that made people sick. A New Mexico-based company, Sunland Inc., recalled hundreds of products that were shipped to large retailers all over the country, including Target, Safeway and other large grocery chains.

The source of those illnesses probably would have remained a mystery without the national database, since there weren't very many illnesses in any individual state.

To ensure that kind of crucial detective work isn't lost, the CDC is asking the medical community to send samples to labs to be cultured even when they perform a new, non-culture test.

But it's not clear who would pay for that extra step. Private labs only can perform the tests that a doctor orders, noted Dr. Jay M. Lieberman of Quest Diagnostics, one of the country's largest testing labs.

A few first-generation non-culture tests are already available. When private labs in Wisconsin use them, they frequently ship leftover samples to the state lab, which grows the bacteria itself. But as more private labs switch over after the next-generation rapid tests arrive, the Wisconsin State Laboratory of Hygiene will be hard-pressed to keep up with that extra work before it can do its main job — fingerprinting the bugs, said deputy director Dr. Dave Warshauer.

Stay tuned: Research is beginning to look for solutions that one day might allow rapid and in-depth looks at food poisoning causes in the same test.

"As molecular techniques evolve, you may be able to get the information you want from non-culture techniques," Lieberman said.

Related stories:

• Peanut plant closed after feds find more salmonella
• Trader Joe's peanut butter recalled
• Nine types of salmonella at one peanut plant

Susan Walsh / AP

Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg testifies Wednesday, Nov. 14, 2012, before the House Energy subcommittee on Oversight and Investigations hearing on the fungal meningitis outbreak. Without better legislation, Hamburg says, more such outbreaks could happen.

Food and Drug Administration officials know little about compounding pharmacies in the U.S., including who all is making drugs and medical supplies, how much they are making and where they are sending it, the agency's commissioner said Thursday. 

And, says FDA's Dr. Margaret Hamburg, it’s entirely likely there could be another outbreak of infections like the spread of fungal meningitis caused by contaminated pain injections that has killed 32 people and sickened more than 460.

Even while repeated inspections showed the pharmacy blamed for making and distributing the contaminated drugs was operating with dirty conditions and wasn’t following the rules, regulators at FDA were arguing about how much they could actually do to shut them down, Hamburg told a Senate hearing.

Hamburg and Dr. Lauren Smith, interim commissioner of the Massachusetts Department of Public Health, faced a second day of questioning in Congress about the outbreak. Reports by the House and Senate subcommittees holding the hearings paint a picture of a mixed record, with some states, such as Tennessee and Colorado, acting promptly and others, such as Massachusetts, doing little. And they also point a finger at the FDA.

“While the quick work of the public health community has led to early identification and treatment of many cases of meningitis, and reduced the fatalities resulting from the administration of the contaminated methylprednisolone, the committee’s investigation demonstrates that this crisis should have, and could have, been avoided entirely,” the Senate Health, Education, Labor and Pensions (HELP) committee report reads.

At issue is how the New England Compounding Center could have continued to make and distribute contaminated drugs that were given to at least 14,000 unsuspecting patients, even while regulators had their eyes on the company.

"It was obvious they were acting illegally," said said David Miller, chief executive of the International Academy of Compounding Pharmacy in Missouri City, Tex. "The Massachusetts Board of Pharmacy knew this was going on, FDA knew they were doing this 10 years ago and still did nothing to stop it."

Hamburg said it could happen again.

“For more than a decade there have been problems in this area and there will be more problems unless we really work together,” she told the subcommittee’s hearing. “I just think we can do better.”

Hamburg has been pressing for federal legislation to make clear what the FDA can do to regulate pharmacies. Some members of Congress have said at two days of hearings that they are not sure FDA needs more power but rather needs to use the powers it already has.

Sen. Pat Roberts, R-Kan., read out a list of state and federal actions against the New England Compounding Center dating back to 2002, none of which closed it down. Regulators say NECC was acting as a large-scale manufacturer, distributing tens of thousands of medical products to 45 states, while it was licensed to be a compounding pharmacy. Compounding pharmacies are supposed to mix products to order on the basis of individual prescriptions.

“In March 2002, a prescribing doctor reported to the FDA that as many as five patients became ill following an epidural injection of NECC-produced betamethasone repositories,” the Senate HELP committee report reads. Betamethasone is a steroid that can be used to treat pain like methylprednisolone, the main drug involved in the current outbreak.

“He reported the illnesses to the FDA, alerted NECC about the issue, and returned unused doses to NECC without taking samples. However, when the FDA arrived to inspect NECC on April 9, 2002, there were no records for the drugs in question.” No disciplinary action followed.

Two more patients got sick in August with meningitis-like symptoms, linked to methylprednisolone made by NECC, again reported to FDA.

The strongest action FDA ever took against NECC, before it raided the facility in October of this year, was a warning letter in 2006 over a different issue. “Finally, in 2006, a warning letter!” Roberts shouted. “Finally, we get something done!”

But FDA never acted on that warning, either. “Holy mackerel,” Roberts said. “What am I missing here?”

“I wasn’t at the agency at the time,” Hamburg said. “I know there was a lot of internal debate about whether and how to proceed. That’s why it was slow, because there was ambiguity in the law. I think that we all wish we had done more.”

Hamburg said she is trying to find out how many companies like NECC there are, making products in mass quantities.

“We do not know the universe of compounding pharmacies,” she told the hearing. “I do think that we should know,” she added. “We are beginning to reach out to our colleagues on the state level.”

Currently, the FDA regulates drug manufacturers, while state boards regulate pharmacies, including compounding pharmacies. FDA has mixed authority in different parts of the country, and another problem is the changing nature of the industry, Hamburg said.

“The problem is that it is not a clear distinction between what is a compounder and what is a manufacturer, either in law or in practice, and the industry is evolving,” she said. “We have tried to use the authority that we have, but it’s reactive.”

And FDA doesn’t even know where to begin looking harder. “We think there are about 7,500 pharmacies doing so-called advanced compounding, then about 3,000 doing sterile processing,” Hamburg said.

Hamburg said there is a need for federal regulations that set a framework for states to follow. “Some states are very strong in terms of their boards of pharmacy, others are weaker,” she said. “We have authority but it is limited and unclear and contested.”

Miller disputed this. “The difference between NECC and a compounding pharmacy is they weren’t filling prescriptions. They were bulk manufacturing and selling,” Miller told the committee. “By all current indications, the operations of NECC were clearly outside the scope of the state’s licensure requirements and their license should have been pulled long ago.”

Sen. Tom Harkin, D-Iowa, who chairs the panel, said the committee was sending a letter to every state board of pharmacy asking them to detail companies acting as compounding pharmacies.

“This committee will forge ahead in developing legislation,” Harkin said. He said he hoped a draft could be ready by early next year.

Harkin also said agencies like FDA and the Centers for Disease Control and Prevention need to be funded and staffed well so they can protect public health.  “This comes down to resources,” Harkin added. “We continually ask the Food and Drug Administration to do more and more and more.”

One person who could have answered questions wasn't there. Barry Cadden, president of NECC, did not accept the committee's invitation to appear. On Wednesday he refused to testify to a House panel, involking his Fifth Amendment right not to speak.

Related stories:

Pharmacy owner escapes testifying about fungal meningitis outbreak

Fungal meningitis victim: "It's tortuous"

State pharmacy board chief fired

Cj Gunther / EPA

A Food and Drug Administration agent enters the New England Compounding Center, a pharmaceutical company in Framingham, Massachusetts, linked to an outbreak of fungal meningitis.

Nine more people have been diagnosed with fungal disease linked to contaminated pain injections, federal health officials said Wednesday. They said 317 people had been sickened and 24 have died from the mold-contaminated drugs.

Of these, 312 had a rare form of meningitis that is not infectious to others but that causes very subtle symptoms and is hard to treat. They were infected by steroid shots into the spine. Five have been infected by injections to the ankle, knee, shoulder or elsewhere, the Centers for Disease Control and Prevention said.

As many as 14,000 people may have been given injections from three lots of steroid prepared by the New England Compounding Center in Framingham, Mass. State officials have revoked the company’s license and federal officials raided it earlier this month. Both state and federal officials say they found non-sterile conditions at the pharmacy and say it appears to have made and sold drugs far beyond what its license allowed.

CDC says 97 percent of the people who may have been affected have been told of the risk. They said the greatest risk of meningitis comes in the first six weeks after treatment; no one should have received any contaminated injections after Sept. 26, when the pharmacy’s drugs were recalled and officials first raised the alarm.

At least one consumer group says the Food and Drug Administration failed to act even though it knew of problems at the NECC. FDA and Massachusetts officials have both said they lacked the authority to move against the pharmacy and said Congress needs to pass clear legislation giving the FDA authority to regulate so-called compounding pharmacies.

Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, called it an attempt to deflect criticism.

"The claims by agency officials that the FDA lacks authority to properly regulate compounding pharmacies is contradicted by a long history of remarkably consistent statements and enforcement actions asserting the agency’s legal authority over such pharmacies," Carome said in a statement.

The FDA regulates drug manufacturers, and can inspect compounding pharmacies, which are supposed to make drugs for specific patients who need specific formulations on a prescription-by-prescription basis. NECC was one such compounding pharmacy.

"Prior warning letters from the FDA to the NECC and other compounding pharmacies appear to indicate that the agency considered these pharmacies to be engaged in drug manufacturing. The pharmacies were therefore considered subject to the safety and effectiveness standards required for approval of new drugs, as well as the rigorous manufacturing standards designed to ensure that drugs are sterile and uncontaminated with such germs as bacteria or fungi before being sold and distributed," Public Citizen said.

NECC also says regulators were familiar with its operations.

"NECC has had a long standing practice of working closely and cooperatively with the Massachusetts Board of Registration in Pharmacy and the Massachusetts Department of Public Health," the company's lawyer, Paul Cirel, said in a statement.

"It has always been the company’s practice to provide the Board with full and complete access to its facility and its records.  As is standard practice in the health care industry, the Board had numerous opportunities, including as recently as last summer,  to make first-hand observations of the NECC’s facilities and operations. Based on that history, it is hard to imagine that the Board has not been fully apprised of both the manner and scale of the company’s operations."

 Related links:

• Filthy conditions found at NECC
• Massachusetts to revoke license of pharmacy tied to fungal meningitis
• Fungal meningitis destroyed Maryland woman's brain

AP Photo/Minnesota Department of Health

Vials of the injectable steroid made by New England Compounding Center implicated in a fungal meningitis outbreak. About 17,700 single-dose vials of the steroid sent to 23 states have been recalled.

Federal health officials had good news Wednesday for some of the people injected with fungus-contaminated steroids: They don’t have an open-ended wait to find out if they are infected.

The greatest risk for fungal meningitis comes in the first six weeks -- 42 days -- after injection, the Centers for Disease Control and Prevention says. After that, doctors and patients still need to watch but they may not need to worry quite as much, the CDC said in updated guidance.

"This is the light at the end of the tunnel," Dr. John Dreyzehner, the commissioner of the Tennessee Department of Health, said at a press conference Wednesday about the new guidelines. "By Nov. 8, patients exposed in Tennessee will have passed the 42-day mark."

In Tennessee, 70 patients have been sickened and nine died -- the most in the nation -- after receiving tainted steroid injections. 

The outbreak of fungal disease has made 308 people sick in 17 states so far, and 23 of them have died, the CDC says. The New England Compounding Center in Framingham, Mass., the pharmacy that distributed the contaminated steroids, has been closed and its license has been permanently revoked.  State officials say they have found dirty conditions there. 

By Jay Lindsay, Associated Press

Water from a leaking boiler collected just outside a room that was supposed to be sterile. Floor mats used by technicians were filled with dirt and debris. Drugs were shipped out before the company even confirmed they were sterile.

State officials said Tuesday that they found these and other problems at the New England Compounding Center during a preliminary investigation into the company, linked to a deadly outbreak of meningitis.

The probe can't yet conclusively prove what caused the outbreak, a top health official said. In the meantime, Massachusetts Gov. Deval Patrick said he wants to tighten oversight at similar companies, including with surprise inspections — the first of which happened Tuesday.

The state has also moved to permanently revoke the pharmacy's operating license, as well as the licenses of its top three pharmacists.

"Those whose laboratory practices caused this outbreak should never practice pharmacy or manufacture in Massachusetts again," Patrick said.

The outbreak of fungal disease including meningitis, an inflammation of the lining of the brain and spinal cord, has sickened 308 people, including 23 who have died, in 17 states. The outbreak has been traced back to a steroid made by the NECC and given mainly for back pain. Compounding pharmacies like NECC custom-mix solutions in doses or forms generally not commercially available.

The federal government is conducting a criminal investigation.

The state said Tuesday that its preliminary investigation, which began last month after the company was first suspected in the growing outbreak, found batches of drugs ready for general distribution but not labeled for specific patients.

Its state license permits the company to fill out only specific prescriptions for specific patients, and distributing drugs in batches like a manufacturer would violate that, said Dr. Madeleine Biondolillo, director of the state Department of Public Health's Bureau of Healthcare Safety.

But company attorney Paul Cirel said it's "hard to imagine" state regulators weren't previously aware of the scale of its operations because they've worked so closely together. The state Board of Registration in Pharmacy has always had complete access to the facility, and board members were there as recently as last summer, he said.

"NECC's transparency in dealing with the board since inception in 1998 demonstrates its good-faith intention to operate in compliance with the requirements of its license," Cirel said.

Besides possible state license violations, Biondolillo said the inspections also revealed "several health and safety deficiencies" at the NECC facility in Framingham, just west of Boston.

Three lots of steroids produced by the company are suspected in the outbreak, and the company shipped orders from those lots 13 times before receiving the results of its own tests to confirm those lots were sterile, Biondolillo said. Some medication was shipped as long as 11 days before the company received test results, she said.

Biondolillo also detailed signs of flawed sterilization procedures, including black specks of fungus in sealed vials of the steroids, which were returned to the company during a recall.

Investigators found the company didn't sterilize its products long enough and didn't adequately test whether its sterilization equipment was working, she said.

In addition, mats on which people wiped their shoes to remove contamination before entering a sterile environment were "visibly dirty and soiled with assorted debris," she said. And a leaking boiler adjacent to a pharmacy clean room left an unsanitary pool of water around it and the adjacent walls, she said.

As the investigation continues, Patrick's moves to increase oversight at the state's 25 compounding pharmacies have started.

The first of the unannounced inspections, to take place at least annually, was done on Tuesday, health department spokesman Alec Loftus said. He wouldn't give the inspected facility's name and said the results are being reviewed.

Patrick also said compounding pharmacies will now be required to file annual compliance reports that could help regulators determine if they are acting as manufacturers.

 Related stories:

• Massachusetts to revoke license of pharmacy tied to fungal meningitis
• Fungal meningitis destroyed Maryland woman's brain
• Clues predict who will get sick from fungal infection

AP

Vials of the injectable steroid product made by New England Compounding Center.

By Mike Stobbe
The Associated Press

The fungus found in tainted steroid shots matches the one behind the national meningitis outbreak that has killed 20 people, federal health officials said Thursday.

The match confirms the link between the outbreak and the maker of the steroids, New England Compounding Center of Framingham, Mass. Officials previously said they found fungus in more than 50 unopened vials from the company, but needed more tests to determine the kind of fungus.

The specialty pharmacy has been at the center of a federal and state investigation into more than 250 fungal meningitis cases. The death toll rose Thursday to 20.

The victims in the outbreak had all received steroid shots made by the pharmacy, mostly to treat back pain. The company last month recalled three lots of the steroid made since May. It later shut down operations and recalled all the medicines it makes.

The fungus was confirmed in one steroid batch made in August, according to the Food and Drug Administration and the Centers for Disease Control and Prevention. The CDC has linked outbreak illnesses to all three lots; tests are continuing on the other two lots.

The initial recall involved about 17,700 single-dose vials of the steroid sent to clinics in 23 states. As many as 14,000 people got shots from the three lots.

The company released a statement Thursday afternoon that said, in part; "We are eager to review these findings as part of our continued cooperation with the CDC and FDA to identify the cause of this contamination."

The fungus in the vials — Exserohilum rostratum — is the same as that found in at least 45 people sickened with fungal meningitis.

"We were able to link the organism in these vials to the organism in the patients," said the CDC's Mary Brandt, whose lab did the testing.

The FDA-CDC announcement did not say how many tested vials had that kind of fungus.

Exserohilum is common in dirt and grasses, but it rarely causes illness and has never before been identified as a cause of meningitis, CDC officials have said.

Meningitis is caused by the inflammation of protective membranes covering the brain and spinal cord. Tainted spinal injections would directly put germs into that part of the body.

Also on Thursday, the CDC said New York has reported a fungal illness, making it the 16th state with outbreak cases. The others are Florida, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.

Officials say 254 of the cases are meningitis related to shots for back pain. Three others are infections in the joints, including the New York case.

The new death reported was in Michigan, bringing its total to four.

More coverage of meningitis outbreak:

• Fungal meningitis can destroy brain fast, first case history shows
• Fungal meningitis outbreak isn't the first
• FDA: Check all who got suspect pharmacy drugs

Dominick Reuter / Reuters

A Framingham police officer (in doorway) keeps watch as federal agents search the New England Compounding Center company in Framingham, Massachusetts October 16, 2012.

By The Associated Press

Two members of Congress have asked the U.S. Department of Justice to investigate whether a specialty pharmacy linked to a nationwide meningitis outbreak violated any federal laws or regulations.

The number of illnesses associated with contaminated steroid shots distributed by New England Compounding Center climbed to 233 in 15 states, the Centers for Disease Control and Prevention reported Tuesday. Fifteen people have died.

Criminal investigators from the Food and Drug Administration were at the Framingham company on Tuesday. FDA spokesman Steven Immergut said the investigators were there as part of a broad investigation by several state and federal agencies into the outbreak.

Company attorney Paul Cirel said it was "difficult to understand the purpose" of the FDA search. He said the company has made clear it would provide, and has provided, anything requested by investigators.

"We've been clear that warrants weren't needed; asking would have produced the same result," he said. "Nevertheless, we continue to offer our cooperation."

Boston U.S. Attorney Carmen Ortiz confirmed that her office is part of the investigation.

Rep. Edward Markey, D-Massachusetts, wrote in a letter to the Department of Justice that the list of products recalled by the company appears to include controlled substances that fall under the jurisdiction of the Drug Enforcement Agency.

The DEA requires pharmacies that sell or compound controlled substances to be registered with the agency, which NECC was not, Markey wrote. He added that the rules only allow pharmacies to sell controlled substances directly to patients with specific prescriptions unless the pharmacies register with the DEA as manufacturers or suppliers.

"This is a matter that I believe requires further investigation by the DEA to ensure that this facility, already believed to have broken Massachusetts state law, has not also skirted federal law related to controlled substances," said Markey, a member of the Energy and Commerce Committee in whose district the company is located.

Gov. Deval Patrick said last week that NECC might have misled regulators and done work beyond the scope of its state license. Federal and state investigators have said they have found fungus in more than 50 vials from the company, but they have not said whether they have pinpointed the source of the contamination.

In a recent letter to U.S. Attorney General Eric Holder, Sen. Richard Blumenthal, a Connecticut Democrat, also called for a criminal investigation of the company, its officers and employees, pointing to reports that NECC may have "flagrantly and blatantly violated" state and federal laws.

The Department of Justice had no immediate comment on the letters.

NECC, in a statement, did not directly respond to the legislators but said it was cooperating with ongoing probes by other agencies.

The CDC said Tuesday that 231 of the reported illnesses were cases of fungal meningitis linked to shots for back pain and two others were nonfatal joint infections.

Related stories:

All patients who got NECC products need check, FDA says

How did the drugs get contaminated? 

Jared Wickerham / Getty Images

The New England Compounding Center is shown here on October 5, 2012 in Framingham, Mass. The pharmacy is currently being investigated for producing a contaminated steroid injection, and possibly other contaminated drugs.

Federal health officials have expanded their investigation of an outbreak of fungal meningitis, asking doctors to follow up with all patients treated with any products from a Massachusetts pharmacy. They said 233 people have been diagnosed with infections, and 15 of them have died, and federal agents raided the center on Tuesday.

Food and Drug Administration officials said an inspection of the New England Compounding Center raises concerns about its cleanliness procedures, and doctors need to reach out and make sure patients are all right. They want doctors to check not only people who got injections of steroids into their spines to treat pain, but patients treated with any product, from nipple cream to painkillers and steroids.

“We have looked at practices of the firm and we are concerned that we cannot provide assurances of sterility,” said the FDA’s Dr. Janet Woodcock. Woodcock said confidentiality concerns prevented her from giving details about what those practices might be.

“We are asking that clinicians who administered these products since the end of May actively contact their patients in some way,” Woodcock told doctors on a conference call. “We cannot assure right now that these products that were administered were sterile.” She says doctor's offices and clinics should call or write patients to ask about any symptoms they may have.

At first the outbreak only involved people treated with a steroid called methylprednisolone and only three specific lots of that drug made by NECC.

On Monday the FDA raised concerns about two more drugs -- a steroid called triamcinolone acetonide and another a product called cardioplegia used during heart surgery. At least three patients treated with those products have infections, although it's not certain they have fungal infections.

Woodcock said the FDA wasn’t sure how many patients might need follow-up from their doctors. Nearly 14,000 people got injections from three suspect lots of methylprednisolone, but the company shipped dozens of different drugs, many of them injectibles.

"We would like clinicians to report to us. We would like them to follow up with the patients and if there are any infections, we would like to hear about it," Woodcock said. "We know that NECC shipped large volumes of various products. We do not know how many."

A third mold called Cladosporium has now been found in a patient as well, said Dr. Tom Chiller of the Centers for Disease Control and Prevention. It is similar to Exserohilum, the mold most commonly found in patients with meningitis affected in the outbreak. CDC experts said it was possible other contaminants may be found, as well.

But the CDC still advises that only patients with clear signs of inflammation be treated with antifungal drugs. Patients who do need treatment likely face a minimum of three months of therapy, experts said.

Dr. Peter Pappas of the University of Alabama at Birmingham said doctors have never had to deal with anything like the current outbreak, and he said they are learning as they go along.  "It’s not clear to me at all what is going to occur," he said on the conference call. Fungal infections can grow very slowly, and it could take a long time for infected patients to have any symptoms.

Two patients who were injected with steroid from NECC in the ankle have some kind of infection, CDC officials said. They are being counted among the 233 total victims because the infections are bacterial or viral in origin, so are presumed to be fungal. They're not in immediate danger in the same way meningitis patients are, but could also have to undergo months of antifungal therapy.

Some of NECC's products are creams or eye drops and the experts were reassuring about patients who may have used those, even if they turn out to have been contaminated. All three molds that have been identified are fairly common in the outdoors. "These are things we are exposed to every day in nature," he said. Most healthy patients who get them on the skin, in the eye or even who inhale them are not likely to become infected, he said. The biggest risk is to patients who had contaminated drugs injected into the spinal fluid.

The FDA and state regulators are checking to see how and why NECC shipped so many drugs to so many different places when it was supposed to be a compounding pharmacy -- one that makes drugs to order for individual patients. FDA had warned NECC several times both about sterility procedures and about doing business beyond its licensed permission.

Members of Congress say they are investigating the matter, as well. The House Energy and Commerce Committee has asked FDA, CDC and NECC officials to appear before a hearing by the end of the week. Members have also asked the Justice Department to investigate whether the NECC broke Drug Enforcement Administration regulations by selling morphine and other controlled substances.

Related stories:

• Fungal meningitis outbreak has docs thinking about where they get drugs
• More drugs implicated in fungal meningitis outbreak
• Regulators say they had no clear power to stop outbreak

By Joyce Ho
NBC News

Whooping cough has resurfaced this year at an alarming rate. In Washington State alone 640 cases have been reported and confirmed as of March 31st compared to 94 cases in the same period of time. Other cases have been reported in Oregon, Vermont, and certain areas of California.

Experts warn that lack of vaccinations and booster shots are behind this new epidemic. Here’s what you need to know to protect yourself from this nasty infection.

What is whooping cough?

Whooping cough is an airway infection caused by the Bordetella pertussis bacteria that results in significant illness and risk of death in children, especially those younger than one year old. The World Health Organization estimates that there are 20 to 40 million cases of whooping cough in the world per year, with 90 percent of those cases occurring in developing countries. In 2010, there were 27,550 reported cases of pertussis in the United States, according to the Centers for Disease Control.

What are the complications associated with whooping cough?

Infants less than six months of age are at highest risk for developing severe complications from pertussis. Pneumonia, rib fracture or hernias from violent coughing, seizures, and fainting can all arise from whooping cough. Because infants have less developed immune systems, these complications from pertussis can be life-threatening.

How is whooping cough spread?

Whooping cough is spread through droplets in the air during coughing or sneezing. The bacteria is breathed in through the nose and then travels throughout the airways. This disease is highly contagious.

What are the symptoms of whooping cough?

The word “pertussis” means “violent cough,” and that is the most striking symptom of this infection. The uncontrollable coughing spasms produce a distinctive “whooping” sound when patients try to breathe, and can lead to vomiting, loss of consciousness, and choking. Whooping cough begins with symptoms similar to the common cold – fever and runny nose. About a week later, patients start experiencing deep and violent coughing spells that make it hard to breathe. This cough usually lasts one to six weeks, but may persist up to 10 weeks.  

Click here to hear what whooping cough sounds like.

How do I protect myself against whooping cough?

The DTaP vaccine is a recommended childhood immunization that is given to children at 2 months, 4 months, 6 months, 15-18 months, and 4-6 years. The vaccine combination not only protects against whooping cough but also diphtheria and tetanus, which are other bacterial infections with severe health risks for patients. Because immunity against this bug goes down over time, booster shots are recommended in people ages 11-64. For more information visit the CDC's website.

What do I do if I have it?

Treatment includes antibiotics such as erythromycin if the infection is caught early enough. Babies with whooping cough are usually treated in the hospital because they are at higher risk for severe complications.

To prevent yourself from spreading whooping cough to others, wear a face mask or cover your mouth when coughing. Do not go near babies and young children because they are very susceptible to the disease. Make sure everyone in your household is vaccinated and protected against pertussis.

For more information, visit:

NIH: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002528/

CDC: http://www.cdc.gov/pertussis/