The Food and Drug Administration failed to act on warnings about contaminated drugs produced by a Massachusetts company linked to last year’s meningitis outbreak that killed 53 people and sickened hundreds more, a congressional committee report said on Tuesday.

The House Energy and Commerce Committee report concluded that the tragedy might have been prevented if the FDA had taken tougher enforcement action against the New England Compounding Center (NECC) and ordered state inspections of drug-producing facilities.

“Going into this investigation, we knew NECC and its sister company, Ameridose, were bad actors. But what makes this tragedy even more heartbreaking for these families is that this could have been prevented,” Chairman Fred Upton (R-MI) and Oversight and Investigations Subcommittee Chairman Timothy Murphy (R-PA) said in a joint statement.

The committee’s majority staff report cited internal FDA documents chronicling the agency's opportunities over the years to address warning signs about NECC that produced and distributed the contaminated drugs that led to the deadly meningitis outbreak.

Compounding pharmacies, which mix customized medications, have usually been overseen by state pharmacy boards. But the growth of larger operations like NECC which mass produce thousands of drugs across the United States, has prompted calls for more federal oversight.

Last October, the Oversight and Investigations Subcommittee launched an investigation to examine the deadly outbreak in which 53 died and over 700 were sickened, and to determine whether the tragedy could have been prevented.

Tuesday’s report revealed that FDA Commissioner Margaret Hamburg did not disclose some key information during a November  hearing.  She did not say that the agency had received a litany of complaints about NECC and Ameridose, right up until the outbreak. A number of these complaints were associated with issues different in nature and scope than those addressed in a 2006 warning letter sent to NECC, the report said.

These complaints were related to the safety and potency of NECC and Ameridose products, issues that the FDA failed to routinely, if ever, inform the state about, it said. Finally, FDA also considered - but never conducted - several additional inspections of the companies and related enforcement actions that, had they happened, may have adverted the tragedy.

FDA spokesman Steven Immergut said the rapid growth of the pharmacy compounding industry had been a challenge for the agency's limited resources. "For years, FDA has been working with a limited set of authorities and tools to regulate the rapidly growing and evolving pharmacy compounding industry."

"We all need to urgently work together to fix this, and our hope is that the House Energy and Commerce Committee will work with FDA to put the appropriate laws and resources together," Immergut said.

However, a review of more than 27,000 documents presented a different picture of the FDA's actions than portrayed in the intial November hearing, Upton and Murphy said.

 “We now know that doctors, patients, providers, and whistleblowers tried to warn FDA for years that NECC and Ameridose were operating as manufacturers and marketing their products nationwide without patient prescriptions, the statement said. “The FDA was also warned about sterility and safety issues with the companies' products. Rather than do its job and protect the patients who were taking NECC and Ameridose drugs, FDA chose not to act,” they said.

“We found that FDA focused on perfecting their legal reasons for inaction instead of protecting families. Even the FDA staff wanted to go back and inspect these unsanitary manufacturers. And the FDA hierarchy said ‘no,’ the committee chairmen said.

"We owe it to the families who lost loved ones and the 730 individuals still suffering to get answers from the FDA on why they failed to protect patients and how they will assure this never happens again,” said Upton and Murphy.

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More bacteria fungi in drugs from mass pharmacy

FDA wanted to close Mass. pharmacy in 2002, report says

The Food and Drug Administration is stepping up pressure on firms that make drugs for specific individuals, known as compounding pharmacies, as it seeks greater regulatory authority following a deadly meningitis outbreak traced to one such pharmacy. 

On Thursday, the agency posted reports on its web site for 28 of 31 compounding pharmacies it inspected between February and April listing a raft of violations ranging from inappropriate clothing for sterile drug processing to insufficient testing for contaminants.

In two cases the FDA said its inspections were delayed because investigators were forced to obtain search warrants. Several other pharmacies attempted to block access to records. The agency said it is reviewing the information obtained during the inspections and will take enforcement action "as appropriate."

But the agency reiterated its position that it does not have enough authority to always take enforcement action following inspections unless specific violations have taken place, such as the distribution of a contaminated drug -- a claim some Republican lawmakers question.

Compounding pharmacies are supposed to provide individually mixed drugs for specific patients who might not be able to get a product elsewhere or in the right format. Over the past decade some of these firms have burst out of that limited role and now ship large volumes of product to hospitals and doctors across the country, taking on, in the process, some of the characteristics of a traditional, regulated pharmaceutical company.

The release of the inspection reports comes five days before a congressional hearing into the meningitis outbreak traced to the Framingham, Massachusetts-based New England Compounding Center (NECC) that killed more than 50 people and sickened hundreds. The hearing, by the House Committee on Energy and Commerce, will be the second held on the matter.

In November, the FDA's commissioner, Dr. Margaret Hamburg, testified before the same committee that ambiguities in the law had inhibited its ability to take aggressive enforcement action against compounding pharmacies, which are mostly regulated by the states. Republican lawmakers argued that the agency has plenty of authority but failed to use it in a way that could have prevented the meningitis outbreak.

The FDA issued a warning letter to NECC in 2006 following an inspection four years earlier that had revealed problems. Yet it failed to follow up on the warning. Hamburg told the committee in November that NECC repeatedly challenged the agency's authority.

On Thursday a group of Democratic lawmakers urged the Committee in a letter to invite the head of the International Academy of Compounding Pharmacists (IACP), an industry association, to testify at Tuesday's hearing.

"The hearing will focus on why FDA has not acted more forcefully to protect the public from the risks of improperly compounded drugs," the letter said. "Internal IACP documents provided to the Committee reveal that for almost two decades, the organization lobbied aggressively and successfully to restrict FDA authority over compounding pharmacies, even when top IACP leaders were aware of significant public health risks from compounding."

Last month the IACP wrote to members of the Senate Committee on Health, Education, Labor and Pensions in a bid to head off any attempt to allow the FDA to determine whether a firm should be classed as a compounding pharmacy and which pharmaceuticals company. That authority, the letter said, "should and must remain exclusively" with the states. 

Related stories: 

• After fungal meningitis outbreak, agencies do battle with pharmacies
• FDA ponders new rules after deadly outbreak
• Nurse spotted mold-tainted drugs right away, hospital says

A Georgia compounding pharmacy that recalled eye injections earlier this week because of possible contamination is recalling everything it made now.

The Food and Drug Administration says Clinical Specialties of Augusta, Ga., is voluntarily recalling all lots of all sterile products it repackaged and distributed because it cannot assure they are sterile. The agency has cracked down on compounding pharmacies after an outbreak of fungal meningitis and other fungal infections that has affected 722 people and killed 50.

“This expanded recall follows the firm’s initial recall of Avastin on March 18, 2013, due to reports of five patients who have been diagnosed with serious eye infections associated with the use of the product,” the FDA said in a statement.

“The Centers for Disease Control and Prevention (CDC) notified the FDA of these endophthalmitis infections, which occur inside the eyeball. Endophthalmitis after intravitreal injection is a serious complication that can lead to permanent loss of vision. Clinical Specialties Compounding sterile products covered under this recall were distributed nationwide between October 19, 2012 and March 19, 2013.”

The firm was repackaging the cancer drug Avastin for use in treating a degenerative eye condition called macular degeneration. The drug has been shown to help stop progression of the disease.

The drug company Roche, which makes Avastin, makes a version called Lucentis specifically for use in the eye. But Lucentis costs as much as $2,000 per dose, compared to $150 a dose for Avastin when reformulated by a compounding  pharmacist. Roche has complained that repackaging Avastin in this way can lead to contamination and infections.

The FDA says Clinical Specialties isn’t able to ensure that its practices are keeping its products sterile. Inspections at the New England Compounding Center, which caused the fungal meningitis outbreak, showed widespread contamination and poor hygiene.

“Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company,” the FDA says.

Related:

• Eye infections prompt Avastin recall
• Nurse spotted mold-tainted drugs right away, hospital says
• Visible mold forces recall of N.J. pharmacy injection drugs
• FDA warns of new batch of fake cancer drug Avastin

A sharp-eyed nurse at Yale-New Haven Hospital in Connecticut is being credited with raising a warning last week about floating mold in vital intravenous drugs, prompting a mass recall -- and possibly averting serious infections in patients in at least four states.

The nurse spotted the debris in a bag of magnesium sulfate IV solution as part of a routine safety check, according to spokesman Rob Hutchison.

“This nurse pulled it and immediately called the pharmacy,” said Hutchison, who didn’t identify the employee.

The hospital quickly quarantined about 40 different types of drugs produced by Med Prep Consulting Inc., a Tinton Falls, N.J., compounding pharmacy that has recalled all lots of all drugs and temporarily ceased operations under a consent order imposed by the state pharmacy board.

Five bags with floating mold were found at Yale-New Haven Hospital; tests showed the debris was a still-unidentified fungus. Eighty-eight orders of the magnesium sulfate solution -- in shipments ranging from 10 to 20 bags up to 500 bags -- were sent to 13 hospitals including Yale-New Haven, according to Angelo J. Cifaldi, a lawyer for Med Prep.

Hospital officials are reaching out to doctors and patients who may have received the contaminated drugs, Hutchison said. Health officials in Connecticut, New Jersey, Pennsylvania and Delaware all said they are working with federal investigators to determine what steps to take next. The drugs were produced and delivered between Feb. 18 and March 13.

The worry is that patients may have been injected with tainted 50-millileter doses of magnesium sulfate 2 gram in dextrose 5 percent solution in water.

“Giving a patient a contaminated injectable drug could result in a life-threatening infection,” Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research for the Food and Drug Administration, said in a statement.

So far, no infections or other problems have been reported, FDA officials said.

But it’s a worrisome -- and very real -- possibility six months after an outbreak of fungal meningitis tied to contaminated pain shots that have been tied to 722 illnesses and 50 deaths.  The now-bankrupt compounding pharmacy blamed in that outbreak, New England Compounding Center of Framingham, Mass., had serious problems with contamination and sterility, investigations showed.

In addition to the magnesium sulfate solution -- which is used to replace electrolytes in hospitalized patients -- Med Prep also makes a wide variety of sterile drugs, including antibiotics, anesthetics, cardiac, labor and delivery and pain management medications, according to the FDA.

The firm received FDA warnings about its sterility practices in 2001 and 2010, agency records showed.

The 1,541-bed Yale-New Haven hospital has used drugs from compounding pharmacies in order to meet the demand for the volume of vital medications, Hutchison said. Drug shortages in recent years -- particularly shortages of sterile injectables -- have sent many hospitals to compounding pharmacies, experts say.

Of the 86 drugs affected by the Med Prep recall, 53 are in short supply, according to Erin Fox, manager of the Drug Information Service at the University of Utah, which tracks drug shortages. 

After pulling the Med Prep products, the hospital is trying to find ways to replace the drugs -- and mixing many of the specialized products themselves.

“We’re working very hard to source products from other vendors,” Hutchison said.

Many of the drugs will be unavailable, however, Fox said. And it can be very hard for a hospital to ramp up its own sterile drug production quickly. 

"I think it's concerning anytime a hospital is completely starting from scratch in a day or two."

Related stories: 

• Visible mold forces recall of N.J. pharmacy injection drugs
• Six months after fungal meningitis outbreak, patients still getting infections

AP

Nearly six months after injectable steroids made by the New England Compounding Center were implicated in an outbreak of fungal meningitis and other infections, more people are turning up ill, including those who previously tested clear of infection.

Nearly six months after the start of a deadly fungal meningitis outbreak blamed on tainted pain shots, patients who originally tested clear are showing up sick, raising worries that the incubation period for illness may be longer than anyone thought.

Though the flood of patients has slowed dramatically, two or three people each week are still reporting infections caused by contaminated steroids in the outbreak that has killed 48 and sickened more than 700, officials with the Centers for Disease Control and Prevention said.

Among those new patients are people who received mold-tainted doses of the drug methylprednisolone, but who previously got MRIs or lumbar punctures that showed they were free of infection. These slow-growing infections aren't as severe as meningitis, but worrying nonetheless.

“If you had an MRI in October, I don’t know that you’re out of the woods,” said Dr. Anurag Malani, an infectious disease expert at St. Joseph Mercy Hospital in Ann Arbor, Mich., the state that has seen the most cases -- 253 -- in the outbreak.

CDC officials issued a health alert this week urging clinicians to remain vigilant for new infections, even in people who show subtle symptoms -- or none at all.

“We are seeing some patients with very long incubation periods,” said Dr. Tom Chiller, associate director for epidemiological science in the CDC’s division of foodborne, waterborne and environmental diseases. “We expect to see people getting infections months after their injections.”

Nearly 14,000 people in 23 states were exposed to the contaminated drugs produced by the now-shuttered New England Compounding Center of Framingham, Mass. An estimated 11,000 actually received shots for back or neck pain, the CDC says. So far, 720 people in 20 states have fallen ill.

Most of the seriously ill people – those with fungal meningitis infections that caused strokes, for instance – showed up within several weeks or one to two months starting in late September.

Back then, CDC officials told worried patients that the greatest risk for meningitis was likely in the first 42 days -- six weeks -- after the shots, suggesting that they could breathe easy after the first week in November.

But patients have continued to become ill, most often not with meningitis, but with infections at the injection site, with epidural abscesses or with a condition called arachnoiditis, an inflammation of the nerves near the spine.

Though doctors have little experience with such fungal infections, the incubation period appears to be stretching longer than a previous outbreak in 2002, when a patient became ill 152 days – five months – after getting a steroid shot.

“I don’t think at this time we know how long the incubation period is,” Malani said.

That’s worrisome for people like John Horrell, 54, of Nashville, Tenn., who received a steroid shot for back pain from one of three tainted lots in September. He says he’s feeling “remarkably well” these days, with no signs of infection. Health officials told him the biggest worry was after 90 days or so, but now he’s not so sure.

“There’s people still having problems,” said Horrell, who owns a sound system firm. “We just keep our fingers crossed. I try not to worry about it.”

CDC officials want health workers to continue to monitor patients who got shots, particularly those whose have pain that is worse or different from the initial symptoms. But even patients who previously tested negative for infections and those with no apparent symptoms are at risk.

“These infections may be unrecognized because some patients have not continued to receive close clinical follow-up or because they have not recognized symptoms suggestive of a localized infection,” the new alert says.

CDC recommends that health workers have a low threshold for considering MRIs, or magnetic resonance imaging, to detect unseen infections.

Even patients who initially resisted MRIs because they didn’t want them or didn’t think they needed them have turned up with infections, said Malani.

The danger of not detecting the infections is that they only will get worse, Chiller said.

“Any untreated infection can sit there and smolder and spread,” he said, noting it can move beyond soft tissue to bone and the central nervous system, with devastating, even deadly, effects.

That, however, raises the next question in the ongoing meningitis puzzle: How long should infected patients be treated? Some patients say they’ve been told three months, then nine months -- then a year.

The primary drugs used to treat the fungus -- voriconazole and amphotericin B -- are both expensive and toxic, with a host of side effects ranging from hair loss and hallucinations to liver problems. 

Margaret Snopkowski, 51, of Fowlerville, Mich., has been on the drugs since early October, when she developed meningitis -- and later, arachnoiditis -- after getting a contaminated shot.

She's back home, but life is hardly back to normal, especially with the high doses of antifungal drugs necessary to keep her infection in check.

“She walks around like a zombie,” said her husband, Tom Snopkowski. “It just knocks her on her butt.”

Family members had hoped she’d be better by now, or at least looking to wean herself from the drugs. But that’s not happening, her husband said. Another MRI is scheduled for next week to see whether the infection has gotten worse.

“Now, they don’t even have an end date for that treatment," he added.

Related: 

Pharmacy tied to fungal outbreak files for bankruptcy

Fungal meningitis risk greatest first six weeks after shots, CDC says

Fungal meningitis victim hopes Congress hears: 'It's torturous'

Courtesy Minnesota Department of Health via AP

Vials of injectable steroid drugs made by the New England Compounding Center in Framingham, Mass., have been blamed for fungal meningitis and other infections that have caused 45 deaths and nearly 700 illnesses. Now, a new survey says that 13 percent of pharmacists and others polled said they found contamination in their sterile drugs last year.

As deaths continue to climb in the ongoing outbreak of fungal meningitis infections caused by contaminated pain shots, a new survey of hospital pharmacists shows that they believe it could happen again.

About 13 percent of pharmacists, pharmacy technicians and others who responded to a poll from the Institute for Safe Medication Practices said that they believed contamination had occurred in the compounded sterile drugs made by their shops last year.

Those are the same types of drugs now blamed for 45 deaths and nearly 700 infections in people who received tainted injectable steroids made by the shuttered New England Compounding Center of Framingham, Mass., according to the Centers for Disease Control and Prevention.

Only about half of staff pharmacists in the ISMP poll were confident that contamination had not occurred at their site in the past year. And nearly three-quarters of the 412 health care practitioners who responded said that contamination certainly could occur in drugs from their sites that were supposed to be sterile.

“We’ve known that this is a risk and a hazard for a long, long time,” said Mike Cohen, president of the ISMP, which monitors medication safety. “Consumers are still at risk. And they need to know.”

The fungal meningitis outbreak, which has left hundreds of people facing months or years of treatment, is among the “worst public health disasters related to medication in my lifetime,” Cohen said.

ISMP officials wanted to understand if the problems of properly managing high-risk compounded sterile preparations -- known as CSPs -- were as widespread as they thought.

It appears that the answer is yes.

The poll, which included mostly pharmacists, but also pharmacy techs, doctors and nurses, was conducted last November and December, at the height of the meningitis investigation, which was first detected in September.

It focused on how hospitals are managing CSPs, which are either made on-site by trained staff, or purchased from external compounding pharmacies, which includes companies such as NECC.

Sterile injectable drugs are particularly difficult to produce because they require mixing non-sterile drugs and other ingredients, which must be then terminally sterilized to ensure that no contamination such as bacteria, mold or fungi get into the final products.

In the case of NECC, federal inspectors found significant contamination throughout the site, including in the company’s so-called clean room.

But the new poll shows that problems may be present in other places, too. Eleven percent of the pharmacists and 29 percent of pharmacy techs in the study reported they believed there had been contamination of CSPs on site in the previous year. It’s not clear from the poll whether the contamination was detected before distribution, or whether the drugs made it to patients. Nor is it clear whether they reported the problems to hospital authorities or others.

Those are important questions, said Bona Benjamin, director of medication use quality improvement at the American Society for Health-System Pharmacists. If techs responsible for enforcing sterilization requirements under the strict USP 797 guidelines detected contamination as a result of careful testing, then it's a good sign. If the drugs were dispensed, then it's not. 

"Contamination is a well-known risk of compounding sterile products," Benjamin said. "I think the results are very interesting and I think it would bear a little bit of a deeper dive."

The poll also showed that half of the pharmacists were confident that contamination had not occurred on their watch, but that dropped to 38 percent when the pharmacy techs were asked.

Of the quarter of respondents who said that contamination could not occur in their facility, most noted that it was because high-risk CSPs were not prepared in their hospital pharmacies.

Ryan Forrey, associate pharmacy director at The Ohio State University Medical Center, said the ISMP poll underscores that hospitals should use high-risk CSPs only when they're necessary -- and that they should follow strict guidelines. 

"It highlights the need for work practices that are followed consistently and that are effective for reducing contamination," said Forrey, who is affiliated with the James Cancer Hospital and the Solove Research Institute.

The recent poll is only one more indication of the potentially serious problems involving sterile drug contamination, Cohen said. Food and Drug Administration Commissioner Margaret Hamburg faced harsh questioning by Congress in November about the agency’s handling of the fungal outbreak. In December, FDA officials recommended changing the way compounding pharmacies are regulated, in part to keep a closer eye on high-output pharmacies like NECC.

In the meantime, consumers should understand that sterile injectable drugs -- including back pain shots -- may be riskier than even the doctor acknowledges, Cohen said.

“If they’re going to get an epidural injection -- or have concerns about any injection, they should ask,” he said.

Related stories: 

• Lucky phone call alerted CDC to meningitis outbreak
• Fungal meningitis victim hopes Congress hears: 'It's torturous'
• Fallout from fungal meningitis mess: more drug shortages

The compounding pharmacy at the center of an ongoing outbreak of fungal meningitis and other infections says the cleaning company it hired is also at fault for unsanitary conditions linked to more than 650 infections and 39 deaths in the U.S.

The New England Compounding Center sent a letter Dec. 31 to UniFirst Corp., asking UniFirst officials to indemnify NECC against claims stemming from the compounding and sale of tainted steroid injection drugs, according to a filing with the Securities and Exchange Commission.

“This demand relates to the limited, once-a-month cleaning services the Company provided to portions of NECC’s cleanroom facilities,” UniFirst, of Wilmington, Mass., explained in required filings.

“Based on its preliminary review of this matter, the Company believed that NECC’s claims are without merit.”

Federal health regulators found fungi in three lots of tainted steroids linked to infections and deaths and more fungi and bacteria in other drugs made by NECC.

In addition, Food and Drug Administration inspectors found evidence of contamination documented throughout the NECC facility and dating from January 2012 through September. In some cases, surfaces were overgrown with visible mold, inspectors said.

UniFirst provided services through its UniClean business as specified by NECC and using NECC’s own “defined cleansing solutions,” UniFirst spokesman Adam Soreff told NBC News in a statement. UniClean technicians cleaned approximately 1½ hours each month.

“UniClean was not in any way responsible for NECC’s day-to-day operations, its overall facility cleanliness, or the integrity of the products they produced,” Soreff said.

NECC filed for Chapter 11 bankruptcy protection on Dec. 21, with officials pledging to establish a fund for victims. NECC faces more than 400 lawsuits from patients who received epidural steroid injections later found to be contaminated with fungus linked to the serious and deadly infections. Some 14,000 people in 23 states received the injections before the problem was discovered in September.

Related stories: 

• Pharmacy tied to fungal meningitis outbreak files for bankruptcy 
• FDA ponders new pharmacy rules after deadly outbreak
• Fungal meningitis victim hopes Congress hears: 'It's torturous'

Poor Larry isn't looking too good. He's pale and clammy and he's been projectile vomiting over and over again while his carers just stand by and watch.

Yet their lack of concern for Larry is made up for by their intense interest in how far splashes of his vomit can fly, and how effectively they evade attempts to clean them up.

Larry is a "humanoid simulated vomiting system" designed to help scientists analyze contagion. And like millions around the world right now, he's struggling with norovirus - a disease one British expert describes as "the Ferrari of the virus world".

"Norovirus is one of the most infectious viruses of man," said Ian Goodfellow, a professor of virology at the department of pathology at Britain's University of Cambridge, who has been studying noroviruses for 10 years.

"It takes fewer than 20 virus particles to infect someone. So each droplet of vomit or gram of feces from an infected person can contain enough virus to infect more than 100,000 people."

Norovirus is hitting hard this year - and earlier too.

In Britain so far this season, more than a million people are thought to have suffered the violent vomiting and diarrhea it can bring. The Health Protection Agency (HPA) said this high rate of infection relatively early in the winter mirrors trends seen in Japan and Europe.

"In Australia the norovirus season also peaks during the winter, but this season it has gone on longer than usual and they are seeing cases into their summer," it said in a statement.

In the United States, the Centers for Disease Control and Prevention (CDC) say norovirus causes 21 million illnesses annually. Of those who get the virus, some 70,000 require hospitalization and around 800 die each year. 

Profuse and projectile 

Norovirus dates back more than 40 years and takes its name from the U.S. city of Norwalk, Ohio, where there was an outbreak of acute gastroenteritis in school children in November 1968.

Symptoms include a sudden onset of vomiting, which can be projectile, and diarrhea, which may be profuse and watery. Some victims also suffer fevers, headaches and stomach cramps.

John Harris, an expert on the virus at Britain's HPA, puts it simply: "Norovirus is very contagious and very unpleasant."

What makes this such a formidable enemy is its ability to evade death from cleaning and to survive long periods outside a human host. Scientists have found norovirus can remain alive and well for 12 hours on hard surfaces and up to 12 days on contaminated fabrics such as carpets and upholstery. In still water, it can survive for months, maybe even years.

At the Health and Safety Laboratory in Derbyshire, northern England, where researcher Catherine Makison developed the humanoid simulated vomiting system and nicknamed him "Vomiting Larry", scientists analyzing his reach found that small droplets of sick can spread over three meters.

"The dramatic nature of the vomiting episodes produces a lot of aerosolized vomit, much of which is invisible to the naked eye," Goodfellow told Reuters.

Larry's projections were easy to spot because he had been primed with a "vomitus substitute", scientists explain, which included a fluorescent marker to help distinguish even small splashes - but they would not be at all easily visible under standard white hospital lighting.

Add the fact that norovirus is particularly resistant to normal household disinfectants and even alcohol hand gels, and it's little wonder the sickness wreaks such havoc in hospitals, schools, nursing homes, cruise ships and hotels.

During the two weeks up to December 23, there were 70 hospital outbreaks of norovirus reported in Britain, and last week a cruise ship that sails between New York and Britain's Southampton docked in the Caribbean with about 200 people on board suffering suspected norovirus.

Moving target

The good news, for some, is that not everyone appears to be equally susceptible to norovirus infection. According to Goodfellow, around 20 percent of Europeans have a mutation in a gene called FUT2 that makes them resistant.

For the rest the only likely good news will have to wait for the results of trials of a potential norovirus vaccine developed by U.S. drugmaker LigoCyte Pharmaceuticals Inc, or from one of several research teams around the world working on possible new antiviral drugs to treat the infection.

Early tests in 2011 indicated that around half of people vaccinated with the experimental shot, now owned by Japan's Takeda Pharmaceutical Co, were protected from symptomatic norovirus infection.

The bad news, virologists say, is that the virus changes constantly, making it a moving target for drug developers. There is also evidence that humans' immune response to infection is short-lived, so people can become re-infected by the same virus within just a year or two.

"There are many strains, and the virus changes very rapidly - it undergoes something virologists call genetic drift," Harris said in a telephone interview. "When it makes copies of itself, it makes mistakes in those copies - so each time you encounter the virus you may be encountering a slightly different one."

This means that even if a vaccine were to be fully developed - still a big 'if' - it would probably need to be tweaked and repeated in a slightly different formula each year to prevent people getting sick.

Until any effective drugs or vaccines are developed, experts reckon that like the common cold, norovirus will be an unwelcome guest for many winters to come. Their advice is to stay away from anyone with the virus, and use soap and water liberally.

"One of the reasons norovirus spreads so fast is that the majority of people don't wash their hands for long enough," said Goodfellow. "We'd suggest people count to 15 while washing their hands and ensure their hands are dried completely."

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Fungal meningitis: Michigan hospital leads fight against deadly outbreak

CHICAGO (Reuters) - After his first day working at St Joseph Mercy Ann Arbor hospital's newly created Fungal Outbreak Clinic, Dr David Vandenberg struggled to describe to his boss the enormity of what lay ahead. He settled on a line from the movie Jaws.

Rebecca Cook / REUTERS

Bonita Robbins, a patient suffering with arachnoiditis due to a contaminated steroid injection, sits on her hospital bed as she and her husband Ed listen to Infectious diseases Dr. Anurag Malani at St. Joseph Mercy Ann Arbor hospital in Ypsilanti, Mich.

"We're going to need a bigger boat," Vandenberg told Dr Lakshmi Halasyamani, chief medical officer of the Michigan hospital, echoing the film's local police chief after he first eyes a 25-foot (7.5-metre) killer shark.

The St Joseph Mercy clinic has been at the front line of the fight against one of the biggest ever U.S. outbreaks of fungal meningitis, a killer infection that has been traced to tainted steroid shots from a Massachusetts pharmacy.

So far, 620 Americans have developed serious infections related to the outbreak, including 367 cases of deadly meningitis, and 39 people have died. Of the 19 U.S. states affected, Michigan has been worst hit, handling more than one third of the total cases in the outbreak.

St Joseph Mercy - a 537-bed Catholic hospital located in Ypsilanti, on the doorstep of the University of Michigan - has treated 169 of the state's 223 cases of infections that can cause meningitis, including 7 people who died.

At one point it was so overrun that 87 of its 537 beds, which are usually occupied by patients with cancer or heart ailments and the like, were occupied by patients with fungal meningitis and related infections.

Dr Tom Chiller, the fungal disease expert at the U.S. Centers for Disease Control and Prevention, who has been overseeing the outbreak, praised the work of the hospital in helping to limit deaths from the outbreak.

"They have been incredibly creative in dealing with these complicated patients," he said.

In all, almost 14,000 people seeking relief from back and joint pain received injections from moldy steroid shots made at the now-bankrupt New England Compounding Center in Massachusetts before they were recalled in late September.

CDC experts initially feared death rates in the 40 to 50 percent range; instead, only about 6 percent of those infected have died, and the CDC credits the creative and dogged efforts of state and local health officials for keeping the death rates so low.

The first wave of the outbreak involved the most severe cases of meningitis - an inflammation of the membranes that cover the brain and spinal cord. But starting in mid-October, patients who had been recovering from meningitis were developing potentially fatal localized infections near the site where contaminated drug was injected to treat back or neck pain.

As they started seeing more cases of these local, secondary infections, the staff at St Joseph's devised a bold plan to screen all patients in their database looking for potential new infections that might have been missed in the first wave.

On December 20, the CDC issued an alert to doctors incorporating some of lessons learned by the efforts of doctors at St Joseph's and other hospitals, calling for increased screening of patients who may be harboring localized infections.

A bewildering fungi

Among the patients who developed secondary infections was Bonita Robbins, a 72-year-old retired nurse from Pinckney, Michigan, who received doses of the tainted drug at the Michigan Pain Specialists clinic in the nearby town of Brighton while seeking relief for lower-back pain.

The first shot brought some relief, the second did little to ease her aches, and the third was contaminated. In October, Robbins went to St Joseph's with a severe headache, back pain and pain in her thighs.

She spent 37 days in the hospital taking two kinds of antifungal drugs.

Dr Anurag Malani, an infectious disease specialist treating Robbins, said the challenge with the outbreak was that there was no medical literature to fall back on.

"No one has ever seen anything of this magnitude related to fungal infections, ever," he said.

Chiller said U.S. doctors had never treated meningitis caused by Exserohilum rostratum, the environmental mold causing most of the infections.

"It's just a rare, rare cause of infection." Seeing that mold in the meninges - membranes covering the brain and spinal cord - is "completely new."

Initially, St Joseph's Fungal Outbreak Clinic was started in order to coordinate the care of patients after their discharge, which included overseeing the administration of a complex regime of anti-fungal drugs.

It morphed into something bigger when some of its 53 patients with meningitis started returning with infections near the site in their back or neck where the contaminated drug was injected.

Then came a wave of patients like Robbins, who had been ruled out for meningitis with a spinal tap, but were still complaining of pain near their injection site.

Getting the "bigger boat"

"When it became obvious that the number of patients would be a much higher percentage than anticipated by the CDC, we expanded our clinic and started enlisting the help of several other hospitals," Vandenberg said.

Many of the patients had spinal abscesses, an infection in the space between the outside covering of the spinal cord and the bones of the spine. Others developed arachnoiditis, an infection of nerves within the spinal canal.

The decision to screen all patients in the hospital database who might have received tainted injections was not taken at the recommendation of the CDC.

"That was our own decision," said Vandenberg, a specialist in internal medicine overseeing the screening effort.

He admitted that the strategy was aggressive, but said that, especially early on, doctors feared the local infections might be precursors to meningitis, making catching them early a potentially life-saving move.

Excluding patients who had already been screened and those who had injections in areas other than the spine, the hospital targeted about 500 patients for MRI scans.

Most so far have had private insurance that covers the screening. For the uninsured, the hospital's Patient Financial Services department has been helping them to apply for financial support.

"We did over 400 MRIs in about a 4-week period," Vandenberg said. The hospital screened so many patients, in fact, that the state of Michigan sent in an emergency mobile MRI unit to help.

Vandenberg got the task of reading stacks of MRI reports, sometimes as many as 30 a day.

So far, about 20 percent of the MRIs have shown up as abnormal, meaning that patients have to come back for surgery and treatment.

Vandenberg makes all of those calls personally. Not all of them go smoothly. He likens the gravity of the conversation - learning you have a potentially deadly new disease that requires months of treatment with risky drugs - to telling someone they have cancer.

After one especially tough call, in which a heart patient feared he would not survive the surgery he would need to clear his infection, Vandenberg cracked.

"I started crying. I probably haven't cried for 15 years."

Signs outbreak is easing

But at last, after months of onslaught, there are signs the outbreak is easing.

Attendance at the hospital's daily support group has begun to taper off. And since the beginning of December, more than 50 patients with fungal infections have been discharged, while only 20 have been admitted, bringing the total number of fungus-related inpatient to 30.

Vandenberg nevertheless cautions that the outbreak is still far from over.

"Every single day of this screening program, we're finding one or two cases that are abnormal and need to be admitted," he said.

Vandenberg gave the CDC access to the clinic's database so the agency could see how the effort turned out, and this month, the CDC issued the alert to doctors incorporating some of the results of the MRI screening program.

The alert warned that some patients who got tainted injections but did not develop meningitis may still be at risk of localized infections.

And it urged doctors to consider ordering an MRI for all patients who still have pain, even if the pain is similar to what sent them in for treatment in the first place.

Chiller said the United States had not yet reached the end of the outbreak.

"Unfortunately, with fungi, the incubation periods are so long and they can remain indolent. I'm definitely concerned that we're going to continue to see more cases."

(Reporting by Julie Steenhuysen; Editing by Jilian Mincer, Mary Milliken and David Brunnstrom)

The year started in the United States with a mild flu season but ended up being marked by deadly outbreaks of fungal meningitis, West Nile virus and Hantavirus.

Tainted steroid medication has been cited as the cause of the meningitis outbreak that killed 39 people.

Weather contributed to the worst outbreak of West Nile virus since 2003 and an unusual outbreak of Hantavirus in California's Yosemite National Park.

Transmitted by infected mice, Hantavirus is a severe, sometimes fatal syndrome that affects the lungs. West Nile can cause encephalitis or meningitis, infection of the brain and spinal cord or their protective covering.

As of December 11, 5,387 cases of West Nile virus had been reported in 48 states, resulting in 243 deaths, the CDC said in its final 2012 update on the outbreak. The 2003 outbreak left 264 dead from among nearly 10,000 reported cases.

A large number of cases this year occurred in Texas, Louisiana and Mississippi where there are large mosquito populations.

CDC and state officials have said that rainfall in the spring and record high summer temperatures contributed to the severity of the outbreak by affecting mosquito populations, which transmit the disease by biting humans and animals.

Health officials said that only a small percentage of cases of West Nile virus are reported because most people have no symptoms and about 20 percent have mild symptoms such as aches and fever. One in 150 people with West Nile virus develop other illnesses such as meningitis and encephalitis.

The biggest outbreak in nearly two decades of Hantavirus, which emerges in dry and dusty environments, cropped up during the summer in 1,200-square-mile (3,100-square-km) Yosemite National Park, killing three of 10 infected visitors.

The National Park issued warnings to 22,000 people who may have been exposed to the rare disease, and 91 Curry Village cabins in the park were closed in late August.

In early September, a 78-year-old judge named Eddie Lovelace was rushed to a hospital in Nashville, Tennessee. Thought to have had a stroke, he died a few days later.

After a large outbreak of fungal meningitis was linked to tainted steroid injections, Lovelace's cause of death was revised. He became the first documented death in a meningitis outbreak that has infected 620 people and killed 39 in 19 states.

The New England Compounding Center in Framingham, Massachusetts, was closed after investigators found that it had shipped thousands of fungus-tainted vials of methylprednisolone acetate to medical facilities around the United States. The steroid was typically used to ease back pain.

More than 14,000 people were warned that they may have had an injection of the tainted steroid. Doctors continue to see new cases of spinal infections related to the steroid, and cases of achnoiditis, an inflammation of nerve roots in the spine.

The outbreak led two Democratic lawmakers in the U.S. House of representatives to introduce legislation to increase government oversight of compounded drugs.

And what lies ahead in 2013?

"While there are some trends we can predict, the most reliable trend is that the next threat will be unpredictable," said Centers for Disease Control and Prevention (CDC) Director Thomas Frieden.

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A Food and Drug Administration agent enters the offices of New England Compounding Center in Framingham, Mass. on Oct. 16. The FDA has proposed a new way to regulate pharmacies responsible for a deadly outbreak that has killed 39 people.

The Food and Drug Administration is recommending a new way to regulate so-called compounding pharmacies after an outbreak of fungal meningitis that has infected 620 people and killed 39 of them.

The FDA recommends dividing these pharmacies into two categories: typical compounding pharmacies, which make medicines to order based on individual prescriptions, and high-output pharmacies that would be regulated differently. A consumer group says this is a recipe for disaster.

The outbreak, first confirmed in September, has been traced to the New England Compounding Center in Framingham, Mass. It was licensed as a compounding pharmacy, which means it was supposed to mix and distribute drugs only on an individual, prescription-by-prescription basis.

However, investigations have shown NECC worked on a much, much larger scale, and somehow wiggled out of several run-ins with both the FDA and state regulators over the scale of its operation and also previous cases of contamination.

FDA investigators have found vials of steroids used for back and joint pain injections were contaminated with at least two species of fungus, as well as bacteria. Patients being treated for back pain had these contaminated drugs injected right into their spines, where the fungus grew slowly, eventually spreading into spinal fluid and causing vague symptoms such as headache and fever.

So far, 33 of the victims have had strokes, and patients all face weeks and months of therapy with strong antifungal drugs that themselves can have severe side effects, the Centers for Disease Control and Prevention says.

FDA officials are holding a meeting later on Wednesday with representative of states to discuss how to better regulate pharmacies, especially since more and more super-compounders like NECC are operating.

“A category of ‘nontraditional’compounding has evolved in the last decade that FDA believes requires additional oversight. The Agency is working with Congress to consider new authorities regarding ‘non-traditional’ compounding pharmacies,” the  FDA said in a statement issued ahead of the meeting.

“Historically, regulation of pharmacy compounding has focused on drawing a line between traditional pharmacy compounding and other manufacturing.” States have regulated the small compounding pharmacies, while FDA has regulated the big manufacturers.

“Going forward, FDA believes the focus should be shifted from attempting to draw a bright line between traditional pharmacy compounding and other manufacturing to clearly defining traditional pharmacy compounding that should be primarily overseen by the states and higher risk non-traditional pharmacy compounding that would require compliance with federal standards,” the FDA says.

The consumer group Public Citizen says the FDA is trying to give up some of its responsibility for regulating pharmacies.

“The FDA’s proposal for oversight of ‘non-traditional’ compounding, if implemented, would decriminalize what is now illegal drug manufacturing conducted under the guise of pharmacy compounding, and ensure the continuing occurrence of serious disease outbreaks caused by tainted drugs in the future,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “The proposal would legitimize current abuses to the system and put the public at risk.”

Carome suspects Hamburg wants to pass much of its responsibility for regulating even the big compounders to the states. And, he says, many of the drugs that would be made by the new class of compounding pharmacies would be sterile drugs meant to be injected. “This is a high-risk class of drugs, no matter how many doses you make” Carome said in a telephone interview.

Carome’s group wrote a letter to Health and Human Services Secretary Kathleen Sebelius urging her to reject any such proposal.

“We have expressed concern all along, since the fungal meningitis outbreak became known, that this represents a significant regulatory failure on the part of the FDA, that at the highest levels the agency sought to dodge criticism,” Carome said in a telephone interview.

“There needs to be an independent investigation of this.” Carome suggests the Office of Inspector General could undertake such an investigation.

Neither the FDA nor officials with the department of Health and Human Services have responded to questions about Public Citizen's concerns. 

Carome’s not alone in accusing the FDA of of dodging questions. Several senators and representatives, even some Democrats friendly to the administration, accused FDA Commissioner Dr. Margaret Hamburg of avoiding giving straight answers to their questions at hearings in November.

"This is a complete and utter failure on the part of your agency," Rep. Cliff Stearns, the Florida Republican who chairs the House Energy and Commerce oversight subcommittee, told Hamburg at a Nov. 14 hearing.

Hamburg told Congress the FDA needs stronger authority to regulate the pharmacies. Congress passed a bill in 1999 that would do that, but part of it was thrown out by the Supreme Court and Congress and the FDA never decided how to proceed.

“Under current law, FDA can act and needs to act. They can’t wait for new legislation,” Carome contends. But he also supports a bill offered by Connecticut Democratic Rep. Rosa DeLauro that would strengthen FDA’s authority.

Republicans who control the House say they aren’t sure the FDA needs any more powers, and it’s not clear if or when Congress could come up with a bill.

And FDA has noted that compounding pharmacies play an important role in filling needs during drug shortages.

Related stories:

• FDA to Congress: Fungal meningitis could happen again
• We didn't have the power to stop NECC, regulators say
• Compounding pharmacies - heroes or outlaws?

Regulators repeatedly passed up opportunities to crack down on a Massachusetts pharmacy blamed for an outbreak of fungal meningitis that has killed 36 people and made 541 sick, the Boston Globe reported Monday.

Barry Cadden, the pharmacist who started up the New England Compounding Center, boasted about taking the pharmacy national even as he promised state regulators that he wanted to supply only locally, the newspaper reported. And the Food and Drug Administration handed over responsibility for monitoring NECC to the state pharmacy board even as Cadden made good his promise to expand beyond his license.

Compounding pharmacies like NECC are supposed to supply drugs on an individual, prescription-by-prescription basis. But NECC was mass-producing and mass-distributing drugs, state and federal regulators have found.

“By 2002, the year the FDA started investigating the firm, it was clear that New England Compounding’s strategy went far beyond the local focus Cadden had promised. Yet state and federal regulators did next to nothing to slow its growth,” the Globe reports.

Cadden set up an exhibit at a 2003 meeting of eye doctors, aggressively marketed NECC’s products and co-sponsored the Eastern Pain Association meeting in New York in 2005.

NECC is now closed and both the FDA and state regulators are trying to figure out how things went so badly wrong.

Related links:

• More bacteria, fungi found in NECC's drugs
• FDA says another fungal meningitis outbreak could happen
• Cadden refuses to testify about outbreak