Madrid to apply one-euro charge on drug prescriptions

MADRID (Reuters) – The region of Madrid said on Wednesday it would introduce an unpopular one-euro surcharge for medical prescriptions next year as pressure mounts on Spain‘s cash-strapped regions to curb deficits.

The plan is part of Madrid‘s efforts to save some 2.7 billion euros ($ 3.5 billion) in next year’s budget, Madrid regional president Ignacio Gonzalez told a news conference.

Opponents to the surcharge say the reform will mean the most vulnerable, especially the elderly who are often dependent on several prescriptions, will avoid basic care to save costs.

Madrid, which surrounds and includes Spain’s capital and accounts for almost a fifth of Spain’s economy, will be the second of the 17 regions to introduce the payment, after Catalonia in June.

The regions are under pressure to cut their deficits to 0.7 percent of output in 2013 from a target of 1.5 percent this year as part of the country’s drive to balance its accounts.

Spain is the latest weak link in the euro zone debt crisis amid investor concerns the conservative government cannot control its finances in the midst of a prolonged recession.

The regions control over a third of total Spanish spending and are responsible for their own health and education costs.

Madrid missed its deficit target last year, hitting 2.2 percent of its GDP compared with the official target of 1.3 percent. While the region’s finances are generally better than many of its counterparts, sour market conditions forced it postpone a planned bond issue on October 23.

Gonzalez also said he would outsource non-health-related hospital services and the health services of six recently-built clinics, fuelling criticism the conservative government was working toward privatization.

Spain’s public health care system until last year provided free medications for pensioners and low-cost prescriptions for everyone else. The government says the system encourages over-prescription and inefficient use of state resources.

A co-payment system for prescription medicine, linked to income and economic status of the patient, was introduced earlier this year.

The one-euro surcharge will apply to most prescriptions.

(Reporting by Inmaculada Sanz; Writing by Paul Day; Editing by Andrew Roche)

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After Sandy’s Pain, There Will Be Gain

In terms of sheer size (1,100 miles from end to end) and the number of people in its path (some 60 million), Hurricane Sandy was the biggest storm ever to hit the East Coast of the U.S. Estimates of its devastation range from $ 30 billion in destroyed property and lost business activity to as much as $ 50 billion. Whatever Sandy’s ultimate price tag, it’s a huge number. But as devastating as it was, Sandy’s impact to the national economy will likely be negligible: The short-term loss to economic output should be made up by long-term spending to rebuild.

Photographs by AP PhotoThe bad news: Your town is damaged. The good news: Construction is up

Whether it’s recovering from a war or cleaning up after a natural disaster, periods of severe destruction are usually followed by sharp bursts of economic activity. Money pours in from government and insurers to repair infrastructure. Homes get rebuilt, debris cleared. As a result, the overall economic growth that follows a natural disaster can often outweigh the wealth it destroyed. Economists call this the broken window effect. “To an economist, breaking a window always boosts GDP,” says Michael Englund, chief economist at Action Economics. Englund thinks that Sandy could end up boosting fourth-quarter gross domestic product by as much as two-tenths of a percentage point. “The backfill activity will probably be bigger,” he says. “By the time the rebuild is over, I think we’ll see this as a net positive [for GDP].”

While the full extent of that rebuilding will take months to show up in the economy, the short-term hit to output could be severe. The 12 states in Sandy’s path, from Virginia to Maine, account for about 23 percent of national GDP. Throwing a giant “Superstorm” at one-quarter of the country’s economic engine will have a major impact on businesses over the next few weeks. In particular, holiday spending on items like clothes and toys could take a hit.

That spending won’t vanish, though; it will merely be delayed and redirected. People may cut back on holiday shopping but end up buying a new car to replace the one that got damaged by a tree. Much of the wealth lost in disasters is assumed by global insurance companies, which make good on policies and pump money into the local economy afterwards. That lost wealth doesn’t get reflected in GDP, while the increase in spending does.

There’s also the question of job creation. While a worker probably won’t lose his job as a result of Hurricane Sandy, there’s a chance he might gain one afterwards, particularly if he’s in the construction industry. “We definitely see stronger job gains in response to natural disasters, particularly when economies are coming out of recession,” says Gus Faucher, senior economist at PNC Financial, who has researched the economic effects of natural disasters. He cites two examples: After Hurricane Andrew hit the southeast coast of Florida in August 1992, job growth in Miami went from just under 1 percent a year to more than 5 percent by mid-1993, as more than 1,700 construction jobs were added. In the year after a 6.7 magnitude earthquake hit Northridge, Calif., outside Los Angeles, in January 1994, 16,000 construction jobs were added.

There are exceptions. Hurricane Katrina, the most expensive natural disaster in the U.S. at $ 150 billion in total economic losses, slowed annual growth in the second half of 2005 from 3.3 percent to 2.8 percent, according to an analysis by the Congressional Budget Office. Katrina knocked out about 20 percent of the country’s refining capacity and damaged more than 100 oil and gas rigs along the Gulf Coast. Within a week, national gasoline prices had jumped 13 percent.

While a number of refineries shut down along the East Coast as Sandy approached, their suspension of operations likely won’t have the same impact because the East Coast facilities handle a far smaller share of refined products. There’s another crucial difference between Sandy and Katrina that could dampen the overall economic impact of the recent hurricane. The East Coast economy is more knowledge-based, with a higher-skilled, better-educated workforce, which makes it more resilient than the blue-collar Gulf Coast economy.

The bottom line: Hurricane Sandy could cost the economy as much as $ 50 billion, but the payback from rebuilding could end up larger.

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Storm knocks down some web sites, but most stay online

SAN FRANCISCO (Reuters) – Despite outages at a few well-known web sites and ripple effects that occasionally slowed communications around the country, the Internet came through the massive storm that swamped New York and New Jersey with relatively minor problems.

Built for resiliency and buttressed by the adoption of cloud computing, the Internet functioned largely as it was supposed to, industry experts said, routing around major disruptions in one of its central network locations, New York City.

“You don’t hear about big content providers going offline anymore,” said Jeffrey Young, a spokesman for major delivery network Akamai Technologies Inc, which has servers spread among some 1,100 communications set-ups. “We can route around issues that are occurring.”

New York has two major exchange centers where U.S. backbone telecommunication providers meet data from undersea cables, said Doug Madory, senior analyst at Renesys Corp, which monitors Internet response times. A number of network addresses were inaccessible on Tuesday afternoon, including many in the New York area, and connection times for others were slower than normal, he said, but the disruptions were limited.

Still, a handful of popular web sites, including Google‘s YouTube, AOL Inc’s Huffington Post, and the network of sites owned by Gawker Media, did experience outages.

Social news site BuzzFeed and News Corp’s financial site MarketWatch were also reduced to bare-bones versions as they regrouped on Tuesday.

At least some of the problems were the direct result of data centers losing power and being unable to fuel their own generators because of flooding.

Most web sites use commercial data centers rather than running their own computer servers, in part to ensure security and stability in emergencies. Many of those data centers offer back-up services elsewhere.

But New York data centers, including Internap and Datagram, went down due to the power and flooding problems. BuzzFeed, Huffington Post and Gawker all crashed because of Datagram.

“How dumb to locate datacenter in a flood zone. And how dumb to host Gawker servers there,” Gawker founder Nick Denton wrote on Twitter. The company moved to blog platform Tumblr for a while, one of a number of creative workarounds made easier by more advanced web offerings. BuzzFeed moved everything onto Akamai and Amazon’s web services arm.

An AOL spokeswoman said after Huffington Post’s main data center went under that it had shifted to a backup data system in Newark. That worked until all three telecom firms serving that location went down.

“At approximately 3:30 a.m., network connectivity failed at the backup datacenter when all three of its providers each separately failed,” said AOL’s Erin Kurtz.

Huffington Post switched to a skeletal blog platform until it recovered at eight hours later.

Dow Jones and Datagram could not be reached immediately for comment. YouTube refused to say why it became unavailable, but Google’s New York headquarters was closed by the storm. The company said the video site was available, if slow, for most users by Tuesday evening.

Many large and mid-sized companies adopted disaster planning for data after the September 11, 2001, attacks, making sure to have duplicates of core data in different locations. Smaller firms have taken the same route by moving to cloud computing, which generally spreads data across multiple facilities.

“The whole point of the cloud is that companies are insulated from outages really of any sort, absent a giant nuclear disaster,” said Bernard Golden, vice president at enStratus Networks, a cloud software company. “You want your provider to have facilities in disparate-enough locations so that even if you have problems in a particular region, your service is still available.”

(Additional reporting by Alexei Oreskovic and Alistair Barr in SAN FRANCISCO and Jennifer Saba in NEW YORK; Editing by Jonathan Weber and Paul Tait)

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‘Homeland’ hits series high, Showtime sets record

LOS ANGELES, Oct 30 (TheWrap.com) – Showtime‘s “Homeland” hit a series high with its Sunday episode — and it helped to deliver a first-time honor for the network, Showtime said Tuesday.

With “Dexter,” in its seventh season, inching up 5 percent from last week to score 2.28 million total viewers, Sunday marked the first time that Showtime has aired two back-to-back episodes of original series that have drawn more than 2 million viewers each in a single night.

“Homeland” drew 2.07 million viewers with its 10 p.m. airing Sunday, jumping 19 percent from the previous week and delivering the highest viewership to date for the series, which cleaned up at the Emmy Awards earlier this year.

Between its 10 p.m. airing and an encore showing, “Homeland” brought in a total of 2.29 million viewers, making for the highest-rated night of the series, now in its second season.

Meanwhile, “Dexter” delivered its highest viewership since the seventh-season premiere with its 9 p.m. airing. Along with an encore airing, it drew a total of 2.81 million viewers.

(Editing By Zorianna Kit)

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Sensitive New Sensor Detects Prostate Cancer in Early Stages

British scientists have designed a prototype of a highly sensitive scanner that can detect diseases such as prostate cancer and HIV in very early stages. They consider their discovery extremely useful in countries where high-tech detection equipment is scarce.

The researchers, from Imperial College London, reported that their new visual sensor technology is 10 times more sensitive than traditional disease detectors that measure biomarkers in the body, according to Medical News Today.

The team tested the sensor’s accuracy in looking for a biomarker known as p24 that’s associated with HIV in human blood samples. They tested other samples for the Prostate Specific Antigen (PSA) marker, one indicator of prostate cancer.

The National Cancer Institute predicts that more than 240,000 men in the United States will be diagnosed with prostate cancer in 2012 and that more than 28,000 of them will die. A male newborn has a one in six chance of developing this disease.

The two standard ways of detecting this cancer are a digital rectal exam and a PSA test. In early stages, many cases have no symptoms. According to the Mayo Clinic, use of the PSA test is debatable because studies have never proven that the blood test saves lives. It can yield suspicious results even when the patient merely has an infection.

The new sensor detects prostate cancer by looking for PSA in a blood sample. With a positive result, irregular clumps of nanoparticles form and emit a specific blue shade inside the disposable container. For a negative test, the nanoparticles separate and form shapes that resemble a ball. The process creates a red hue. Both colors are visible to the naked eye.

The ultra-sensitive sensor could detect certain diseases at much earlier stages than current technology can find. It found miniscule levels of p24 in samples from patients with low HIV viral loads, a result impossible with standard tests like the Enzyme-Linked Immunosorbent Assay (ELISA).

The next step toward implementation is finding a sponsor among not-for-profit global health organizations to oversee the strategy for development, funding, and distribution of the technology.

While use of the sensor in the United States might be years away, the device is of special interest to my family. After years of lower-than-average PSA results, the numbers for my husband, who has a family history of prostate cancer, shot up last year. A test six months later showed even higher numbers.

The urologist performed prostate biopsies that caused bleeding and discomfort for weeks. The results showed no sign of malignancy, calling into question the validity of the two tests. A year later, the numbers mysteriously returned to the low end of the normal range. It would be reassuring to have access to this sensitive new sensor, knowing that it has the capacity to detect prostate cancer in very early stages.

Vonda J. Sines has published thousands of print and online health and medical articles. She specializes in diseases and other conditions that affect the quality of life.

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NYC Rats: Stronger Than Sandy

Unprecedented flooding throughout low-lying portions of New York City over the past two days undoubtedly left hundreds—if not thousands—of rats scrambling for their dear lives. According to experts, most of them likely survived. “They’re a jack of all trades when it comes to locomotion,” says Rick Ostfeld of the Cary Institute of Ecosystem Studies in Millbrook, N.Y. “They can’t sprint, but they run well; they’re not Michael Phelps, but they’re strong swimmers; and even though they don’t have prehensile tails, they climb well. They do it all.”

Ostfeld notes that rats can easily swim a couple hundred yards. In fact, he says, “one of the ways that rats have dispersed around the world is by jumping off of ships and swimming to shore—the proverbial ‘rats leaving a sinking ship’ is actually based on reality.”

No one knows exactly how many rats live in New York City, but Ostfeld suspects that there are at least as many rats as humans. The city’s population is dominated by the Norway rat (Rattus norvegicus), an invader from Europe, and the Black rat (Rattus rattus), which originated in Asia. These highly resilient rats can be found throughout New York City, but they usually don’t travel far within those limits.

The displacement of rats caused by Hurricane Sandy—a dispersal of rats that is likely unprecedented for the city in terms of numbers—has Ostfeld concerned about a possible increased spread of rat-borne diseases. “You get infected individuals mixing with uninfected individuals and that’s a recipe for an outbreak,” says Ostfeld. “It spreads like the flu, from rat to rat.”

Urban rats are known to carry infectious diseases including leptospirosis, typhus, salmonella, hantavirus, and even the plague. The incubation period for these diseases in humans is usually a couple of weeks or months, and symptoms are often similar to those of a common flu. According to Ostfeld, “In the coming weeks and months, health-care providers should have rat-borne diseases on their radars and potentially test for them.”

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Hurricane’s death toll rises to 65 in Caribbean

PORT-AU-PRINCE, Haiti (AP) — As Americans braced Sunday for Hurricane Sandy, Haiti was still suffering.

Officials raised the storm-related death toll across the Caribbean to 65, with 51 of those coming in Haiti, which was pelted by three days of constant rains that ended only on Friday.

As the rains stopped and rivers began to recede, authorities were getting a fuller idea of how much damage Sandy brought on Haiti. Bridges collapsed. Banana crops were ruined. Homes were underwater. Officials said the death toll might still rise.

“This is a disaster of major proportions,” Prime Minister Laurent Lamothe told The Associated Press, adding with a touch of hyperbole, “The whole south is under water.”

The country’s ramshackle housing and denuded hillsides are especially vulnerable to flooding. The bulk of the deaths were in the southern part of the country and the area around Port-au-Prince, the capital, which holds most of the 370,000 Haitians who are still living in flimsy shelters as a result of the devastating 2010 earthquake.

Santos Alexis, mayor of the southern city of Leogane, said Sunday that the rivers were receding and that people were beginning to dry their belongings in the sun.

“Things are back to being a little quiet,” Alexis said by telephone. “We have seen the end.”

Sandy also killed 11 in Cuba, where officials said it destroyed or damaged tens of thousands of houses. Deaths were also reported in Jamaica, the Bahamas and Puerto Rico. Authorities in the Dominican Republic said the storm destroyed several bridges and isolated at least 130 communities while damaging an estimated 3,500 homes.

Jamaica’s emergency management office on Sunday was airlifting supplies to marooned communities in remote areas of four badly impacted parishes.

In the Bahamas, Wolf Seyfert, operations director at local airline Western Air, said the domestic terminal of Grand Bahamas‘ airport received “substantial damage” from Sandy’s battering storm surge and would need to be rebuilt.

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Steve Jobs’s Secret Yacht Looks Like a Giant iPhone

RELATED: Should You Buy an iPad 2?

Just over a year after Steve Jobs’s death, shipbuilders in Aalsmeer, Holland have finally finished the yacht that the Apple visionary spent years designing — stealthily, of course. Boy, does it look like an Apple product. Her name is Venus.

RELATED: A Guide to the Reactions and Tributes to Steve Jobs

Built entirely out of aluminum, the yacht was designed by Jobs personally along with some help from French designer Phillipe Stack. It’s a big one, too. The ship measures between 70 and 80 meters, but because of the aluminum construction, it’s lighter than your typical yacht, giving it a bit of an edge when it comes to speed. It doesn’t lack amenities, either. The front of the ship is equipped with a uniquely large sun deck with a jacuzzi built in. Behind that comes an all glass cabin that’s topped with a bridge equipped with seven 27-inch iMacs that handle the ship’s navigation and controls. When you take a step back, squint a little and turn your head to the left, it sort of looks like an iPhone 4 with the strip of windows around the middle and the clean lines.

RELATED: The Motherlode of iPhone Rumors: Apple Will Release Two This Fall

Jobs’s yacht project might seem a little out of character at first. After all, the billionaire was famously humble about many aspects of his lifestyle. He lived in a normal house on a normal suburban street in Palo Alto, California, not some massive mansion out in the mountains. He wore jeans, a black turtleneck sweater and New Balance tennis shoes, a basically thrifty choice for a man who could afford his own cashmere farm. He also drove a very nice car, but it wasn’t rapper nice. That is, it wasn’t a Bentley or an Aston Martin or a Maybach — just a Mercedes. (Ok, now we’re stretching the humble thing, but you get the point.)

RELATED: Listen to Steve Jobs Describe the iPad in 1983

We now know that Steve Jobs was not a stranger to the finer aspects of being filthy rich, luxuries like chrome-coated yachts and custom-built private jets. But hey, the guy wanted to retire one day, and so what if he wanted to live like a king after building the world’s most valuable technology company. Walter Isaacson wrote about the yacht in his biography of Steve Jobs, who had evidently been working on the project alone for six years:

After our omelets at the café, we went back to his house and he showed me all of the models and architectural drawings. As expected, the planned yacht was sleek and minimalist. The teak decks were perfectly flat and unblemished by any accoutrements. As at an Apple store, the cabin windows were large panes, almost floor to ceiling, and the main living area was designed to have walls of glass that were forty feet long and ten feet high. He had gotten the chief engineer of the Apple stores to design a special glass that was able to provide structural support. By then the boat was under construction by the Dutch custom yacht builders Feadship, but Jobs was still fiddling with the design. “I know that it’s possible I will die and leave Laurene with a half-built boat,” he said. “But I have to keep going on it. If I don’t, it’s an admission that I’m about to die.”

Sadly, Jobs did die before the yacht was finished, but the folks at Feadship finished the job. Evidently, the Jobs family recently had a little christening party with the shipbuilders, who all got an iPod Shuffle with “Venus” engraved on the back as a token of thanks. Now that we said all that stuff about Jobs and conspicuous consumption, you’d think they could have at least splurged for the iPod Touch.

RELATED: Steve Jobs Resigns as Apple CEO, Staying on as Chairman

Check out the chrome plates on the stern. The sleek windows that wrap around the middle of the ship is where the Jobs family quarters are. The crew gets the little portholes underneath.

You can see the row of iMacs in the bridge.

End-to-end, it’s a pretty impressive vessel.

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“Argo” rises above “Cloud Atlas” as Sandy spooks

LOS ANGELES (Reuters) – Acclaimed Iran hostage thriller “Argo” brought home its first box-office win over a quiet weekend, leading movie charts with $ 12.4 million in U.S. and Canadian ticket sales as would-be moviegoers hunkered down for Hurricane Sandy.

The tally for “Argo,” directed by and starring Ben Affleck, topped the $ 9.4 million for new sci-fi drama “Cloud Atlas“. Halloween-themed animated film “Hotel Transylvania” scared up $ 9.5 million from Friday through Sunday, narrowly edging “Cloud Atlas“, studio estimates showed.

After two weeks in the No. 2 spot, “Argo” moved into the lead and lifted its domestic sales to $ 60.8 million through three weekends.

The movie, produced by Warner Bros. and GK Films for $ 44 million, tells the story of a mission to rescue U.S. government employees from Iran in 1979. The film has earned Oscar buzz after stellar reviews from critics and an “A+” grade from audiences polled by CinemaScore.

Dan Fellman, president of theatrical distribution for Warner Bros., a unit of Time Warner Inc, attributed the film’s jump to “great word-of-mouth”, which he called “the best form of advertising”.

“Cloud Atlas“, also from Warner Bros., fell short of industry forecasts for a $ 13 million debut at North American (U.S. and Canadian) theaters. Fellman said the film did better in larger cities, but struggled in the South and Midwest.

The film, starring Tom Hanks and Halle Berry, cost $ 100 million to make. Many in Hollywood thought the story, based on a philosophical novel by David Mitchell, was too complex to bring to the big screen.

The nearly three-hour film with six interweaving stories divided critics, with the harshest reviewers saying it would try audiences’ patience with multiple storylines and century-hopping plots. The film’s stars also shift characters. Hanks, for example, is a shady doctor in the 1840s, a nuclear scientist in the 1970s and a simple valley-dweller in the distant future.

But “Cloud Atlas” also drew praise as an ambitious and well-acted epic. Sixty-one percent of reviews on the Rotten Tomatoes website recommended the film.

“Hotel Transylvania” set a record for a September film opening in North America when it opened on September 28, and has performed solidly since then.

In the family comedy, Frankenstein, the Invisible Man and other monsters gather for a party at a high-end resort operated by Dracula. Their celebration is disrupted when a boy discovers the hotel and falls in love with Dracula’s daughter but must deal with her overprotective father.

The president of worldwide distribution for Sony Corp‘s Sony Pictures studio, Rory Bruer, wasn’t entirely surprised that the weeks-old movie beat “Cloud Atlas“, despite the latter movie’s buzz.

“Anything at this point doesn’t surprise me,” Bruer said. “It’s like an annuity that keeps on giving and giving.”

Paul Dergarabedian, box office analyst at Hollywood.com, said the Halloween weekend gave the film a boost, and is “still the number one choice for families” among the spooky seasonal films currently playing.

This weekend was fairly quiet at the box office in North America, which Dergarabedian attributed to Hurricane Sandy, a storm menacing the East Coast of the United States.

However, the new James Bond movie “Skyfall” whipped up a storm of its own overseas, taking $ 77.7 million in 25 countries. The latest installment of the British spy saga took the top spot in all 25 countries, broke the all-time Saturday attendance record in the United Kingdom, and was the biggest film opening there of 2012. It will open in the United States on November 9.

Rounding out the weekend’s top five, low-budget horror sequel “Paranormal Activity 4″ grossed $ 8.7 million at domestic theaters. “Silent Hill: Revelation 3D” and “Taken 2″ tied for fifth place, each pulling in $ 8 million.

Two other new films failed to crack the top five.

New Halloween-themed comedy “Fun Size” brought in $ 4.1 million at domestic theaters, landing in tenth place. The $ 14 million production tells the story of a boy who goes missing among trick-or-treaters, sparking his teen sister’s frantic search to find him before her mother comes home.

Sports drama “Chasing Mavericks” disappointed, failing to break the top ten. The movie stars Gerard Butler in the story of a surfer who tries to conquer one of the biggest waves on Earth.

“Silent Hill: Revelation 3D” was released by Open Road Films, a joint venture between theater owners Regal Entertainment Group and AMC Entertainment Inc. Paramount Pictures, a unit of Viacom Inc, released “Fun Size” and “Paranormal Activity 4″.

“Chasing Mavericks” was distributed by News Corp’s 20th Century Fox studio. Sony Corp’s movie division released “Hotel Transylvania“.

(Reporting by Lisa Richwine and Andrea Burzynski; Editing by Will Dunham and Dale Hudson)

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U.S. regulator needs new authority over compounding pharmacies: report

WASHINGTON (Reuters) – The U.S. Food and Drug Administration‘s power to regulate compounded drugs similar to those linked to a deadly meningitis outbreak is legally nonbinding and lacks the authority of stringent standards imposed on drug manufacturers, according to a congressional report released on Sunday.

The report, compiled by the staff of U.S. Representative Edward Markey, a Massachusetts Democrat, drew an immediate response from FDA Commissioner Margaret Hamburg, who said the agency is committed to working with Congress and others to garner “the authority we need to help prevent tragedies like this from happening again.”

“Over the years, there has been substantial debate within Congress about the appropriate amount of FDA oversight and regulation of compounding pharmacies. But unfortunately, there has been a lack of consensus and many challenges from industry,” Hamburg said in a statement emailed to Reuters.

“As pointed out in the report from Congressman Markey, FDA’s authority over compounding pharmacies is more limited by statute than with drug manufacturers,” she added.

The Markey report and Hamburg’s comments surfaced as Congress has begun preliminary discussions that could give the FDA new powers to oversee compounding pharmacies like the New England Compounding Center, which is at the heart of a fungal meningitis outbreak that has sickened 337 people, including 25 who have died, in 18 states.

But the public health crisis has also stirred debate about how much authority the FDA actually needs. Last week, the advocacy group Public Citizen called on the Department of Health and Human Services to investigate the agency on grounds that it failed to exercise its existing authority to prevent the meningitis outbreak.

The FDA issued a warning letter to NECC in 2006 describing potential health risks including microbial contamination. But there has been little evidence of a follow-up. Congressional investigators also say there is evidence that the FDA and state regulators knew of potential problems at NECC in 2002.

Hamburg has had little to say publicly about the regulatory issue. “FDA’s primary focus right now is containing the immediate crisis, protecting patients and their families from any further harm and completing our investigation,” she said.

Compounding is a traditional pharmacy practice in which a pharmacist alters, mixes or recombines ingredients to make a drug that meets the special needs of a patient with a physician’s prescription. But in recent decades, officials say some compounding operations have grown to resemble full-scale manufacturing without meeting FDA standards.

DOZENS OF WARNING LETTERS

The congressman’s report, based partly on documents gathered by investigators in the House of Representatives, says state governments that are now the chief regulators of pharmacy compounding cannot perform the kind of safety oversight necessary to prevent more drug-related outbreaks from occurring.

The FDA has issued dozens of warning letters against compounding pharmacies since 2001. But the report said the agency has based its enforcement actions on relatively weak, nonbinding guidance documents since a 1997 law granting it oversight of “new drugs” was struck down in U.S. courts more than a decade ago in cases brought by compounders.

“Guidance documents do not establish legally enforceable rights or responsibilities and do not legally bind the public or the FDA,” said a Congressional Research Services report cited by Markey’s staff.

That gives the agency far less power over compounding operations than it has over conventional drug manufacturers, which must submit to stringent safety and efficacy standards.

“Absent clear new authority, FDA’s efforts will ultimately be constrained by gaps in regulatory authority and thwarted by an industry that has historically resisted a federal role for the oversight of its activities,” said Markey.

An aide to Markey, who is on the House Energy and Commerce Committee which is conducting one of two congressional investigations into the outbreak, said the report was compiled from staff research. The aide acknowledged that some of the documents also form part of the House panel’s probe.

Markey has said he will propose legislation to enhance FDA oversight when Congress returns after the November 6 election. The committee is expected to hold hearings by the end of the year.

The report cites FDA documents as saying that compounded drugs may have been responsible for at least 23 deaths and 86 other cases of disease or injury before the current outbreak, related to injectable steroid treatments for back and joint pain first drew public attention last month.

FDA records described by the report also show that 10 of 29 compounded products tested by the FDA in 2003 failed at least one of the regulatory agency’s safety or efficacy tests. Three years later, in 2006, one-third of 36 compounded drug samples failed FDA analytical testing.

“The risks of allowing the safety of compounding pharmacies to go largely unregulated have been recognized for years, and the devastating tragedies of this outbreak will be felt well beyond it,” Markey said.

(Editing by Christopher Wilson)

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