Showing posts with label Health. Show all posts
Showing posts with label Health. Show all posts

AP PHOTOS: Simple surgery heals blind Indonesians

PADANG SIDEMPUAN, Indonesia (AP) — They came from the remotest parts of Indonesia, taking crowded overnight ferries and riding for hours in cars or buses — all in the hope that a simple, and free, surgical procedure would restore their eyesight.

Many patients were elderly and needed help to reach two hospitals in Sumatra where mass eye camps were held earlier this month by Nepalese surgeon Dr. Sanduk Ruit. During eight days, more than 1,400 cataracts were removed.

The patients camped out, sleeping side-by-side on military cots, eating donated food while fire trucks supplied water for showers and toilets. Many who had given up hope of seeing again left smiling after their bandages were removed.

"I've been blind for three years, and it's really bad," said Arlita Tobing, 65, whose sight was restored after the surgery. "I worked on someone's farm, but I couldn't work anymore."

Indonesia has one of the highest rates of blindness in the world, making it a target country for Ruit who travels throughout the developing world holding free mass eye camps while training doctors to perform the simple, stitch-free procedure he pioneered. He often visits hard-to-reach remote areas where health care is scarce and patients are poor. He believes that by teaching doctors how to perform his method of cataract removal, the rate of blindness can be reduced worldwide.

Cataracts are the leading cause of blindness globally, affecting about 20 million people who mostly live in poor countries, according to the World Health Organization.

"We get only one life, and that life is very short. I am blessed by God to have this opportunity," said Ruit, who runs the Tilganga Eye Center in Katmandu, Nepal. "The most important of that is training, taking the idea to other people."

During the recent camps, Ruit trained six doctors from Indonesia, Thailand and Singapore.

Here, in images, are scenes from the mobile eye camps:

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Study finds mammograms lead to unneeded treatment

Mammograms have done surprisingly little to catch deadly breast cancers before they spread, a big U.S. study finds. At the same time, more than a million women have been treated for cancers that never would have threatened their lives, researchers estimate.

Up to one-third of breast cancers, or 50,000 to 70,000 cases a year, don't need treatment, the study suggests.

It's the most detailed look yet at overtreatment of breast cancer, and it adds fresh evidence that screening is not as helpful as many women believe. Mammograms are still worthwhile, because they do catch some deadly cancers and save lives, doctors stress. And some of them disagree with conclusions the new study reached.

But it spotlights a reality that is tough for many Americans to accept: Some abnormalities that doctors call "cancer" are not a health threat or truly malignant. There is no good way to tell which ones are, so many women wind up getting treatments like surgery and chemotherapy that they don't really need.

Men have heard a similar message about PSA tests to screen for slow-growing prostate cancer, but it's relatively new to the debate over breast cancer screening.

"We're coming to learn that some cancers — many cancers, depending on the organ — weren't destined to cause death," said Dr. Barnett Kramer, a National Cancer Institute screening expert. However, "once a woman is diagnosed, it's hard to say treatment is not necessary."

He had no role in the study, which was led by Dr. H. Gilbert Welch of Dartmouth Medical School and Dr. Archie Bleyer of St. Charles Health System and Oregon Health & Science University. Results are in Thursday's New England Journal of Medicine.

Breast cancer is the leading type of cancer and cause of cancer deaths in women worldwide. Nearly 1.4 million new cases are diagnosed each year. Other countries screen less aggressively than the U.S. does. In Britain, for example, mammograms are usually offered only every three years and a recent review there found similar signs of overtreatment.

The dogma has been that screening finds cancer early, when it's most curable. But screening is only worthwhile if it finds cancers destined to cause death, and if treating them early improves survival versus treating when or if they cause symptoms.

Mammograms also are an imperfect screening tool — they often give false alarms, spurring biopsies and other tests that ultimately show no cancer was present. The new study looks at a different risk: Overdiagnosis, or finding cancer that is present but does not need treatment.

Researchers used federal surveys on mammography and cancer registry statistics from 1976 through 2008 to track how many cancers were found early, while still confined to the breast, versus later, when they had spread to lymph nodes or more widely.

The scientists assumed that the actual amount of disease — how many true cases exist — did not change or grew only a little during those three decades. Yet they found a big difference in the number and stage of cases discovered over time, as mammograms came into wide use.

Mammograms more than doubled the number of early-stage cancers detected — from 112 to 234 cases per 100,000 women. But late-stage cancers dropped just 8 percent, from 102 to 94 cases per 100,000 women.

The imbalance suggests a lot of overdiagnosis from mammograms, which now account for 60 percent of cases that are found, Bleyer said. If screening were working, there should be one less patient diagnosed with late-stage cancer for every additional patient whose cancer was found at an earlier stage, he explained.

"Instead, we're diagnosing a lot of something else — not cancer" in that early stage, Bleyer said. "And the worst cancer is still going on, just like it always was."

Researchers also looked at death rates for breast cancer, which declined 28 percent during that time in women 40 and older — the group targeted for screening. Mortality dropped even more — 41 percent — in women under 40, who presumably were not getting mammograms.

"We are left to conclude, as others have, that the good news in breast cancer — decreasing mortality — must largely be the result of improved treatment, not screening," the authors write.

The study was paid for by the study authors' universities.

"This study is important because what it really highlights is that the biology of the cancer is what we need to understand" in order to know which ones to treat and how, said Dr. Julia A. Smith, director of breast cancer screening at NYU Langone Medical Center in New York. Doctors already are debating whether DCIS, a type of early tumor confined to a milk duct, should even be called cancer, she said.

Another expert, Dr. Linda Vahdat, director of the breast cancer research program at Weill Cornell Medical College in New York, said the study's leaders made many assumptions to reach a conclusion about overdiagnosis that "may or may not be correct."

"I don't think it will change how we view screening mammography," she said.

A government-appointed task force that gives screening advice calls for mammograms every other year starting at age 50 and stopping at 75. The American Cancer Society recommends them every year starting at age 40.

Dr. Len Lichtenfeld, the cancer society's deputy chief medical officer, said the study should not be taken as "a referendum on mammography," and noted that other high-quality studies have affirmed its value. Still, he said overdiagnosis is a problem, and it's not possible to tell an individual woman whether her cancer needs treated.

"Our technology has brought us to the place where we can find a lot of cancer. Our science has to bring us to the point where we can define what treatment people really need," he said.

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Online:

Study: http://www.nejm.org/doi/full/10.1056/NEJMoa1206809

Screening advice: http://www.uspreventiveservicestaskforce.org/uspstf/uspsbrca.htm

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Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP

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OB/GYNs back over-the-counter birth control pills

WASHINGTON (AP) — No prescription or doctor's exam needed: The nation's largest group of obstetricians and gynecologists says birth control pills should be sold over the counter, like condoms.

Tuesday's surprise opinion from these gatekeepers of contraception could boost longtime efforts by women's advocates to make the pill more accessible.

But no one expects the pill to be sold without a prescription any time soon: A company would have to seek government permission first, and it's not clear if any are considering it. Plus there are big questions about what such a move would mean for many women's wallets if it were no longer covered by insurance.

Still, momentum may be building.

Already, anyone 17 or older doesn't need to see a doctor before buying the morning-after pill — a higher-dose version of regular birth control that can prevent pregnancy if taken shortly after unprotected sex. Earlier this year, the Food and Drug Administration held a meeting to gather ideas about how to sell regular oral contraceptives without a prescription, too.

Now the influential American College of Obstetricians and Gynecologists is declaring it's safe to sell the pill that way.

Wait, why would doctors who make money from women's yearly visits for a birth-control prescription advocate giving that up?

Half of the nation's pregnancies every year are unintended, a rate that hasn't changed in 20 years — and easier access to birth control pills could help, said Dr. Kavita Nanda, an OB/GYN who co-authored the opinion for the doctors group.

"It's unfortunate that in this country where we have all these contraceptive methods available, unintended pregnancy is still a major public health problem," said Nanda, a scientist with the North Carolina nonprofit FHI 360, formerly known as Family Health International.

Many women have trouble affording a doctor's visit, or getting an appointment in time when their pills are running low — which can lead to skipped doses, Nanda added.

If the pill didn't require a prescription, women could "pick it up in the middle of the night if they run out," she said. "It removes those types of barriers."

Tuesday, the FDA said it was willing to meet with any company interested in making the pill nonprescription, to discuss what if any studies would be needed.

Then there's the price question. The Obama administration's new health care law requires FDA-approved contraceptives to be available without copays for women enrolled in most workplace health plans.

If the pill were sold without a prescription, it wouldn't be covered under that provision, just as condoms aren't, said Health and Human Services spokesman Tait Sye.

ACOG's opinion, published in the journal Obstetrics & Gynecology, says any move toward making the pill nonprescription should address that cost issue. Not all women are eligible for the free birth control provision, it noted, citing a recent survey that found young women and the uninsured pay an average of $16 per month's supply.

The doctors group made clear that:

—Birth control pills are very safe. Blood clots, the main serious side effect, happen very rarely, and are a bigger threat during pregnancy and right after giving birth.

—Women can easily tell if they have risk factors, such as smoking or having a previous clot, and should avoid the pill.

—Other over-the-counter drugs are sold despite rare but serious side effects, such as stomach bleeding from aspirin and liver damage from acetaminophen.

—And there's no need for a Pap smear or pelvic exam before using birth control pills. But women should be told to continue getting check-ups as needed, or if they'd like to discuss other forms of birth control such as implantable contraceptives that do require a physician's involvement.

The group didn't address teen use of contraception. Despite protests from reproductive health specialists, current U.S. policy requires girls younger than 17 to produce a prescription for the morning-after pill, meaning pharmacists must check customers' ages. Presumably regular birth control pills would be treated the same way.

Prescription-only oral contraceptives have long been the rule in the U.S., Canada, Western Europe, Australia and a few other places, but many countries don't require a prescription.

Switching isn't a new idea. In Washington state a few years ago, a pilot project concluded that pharmacists successfully supplied women with a variety of hormonal contraceptives, including birth control pills, without a doctor's involvement. The question was how to pay for it.

Some pharmacies in parts of London have a similar project under way, and a recent report from that country's health officials concluded the program is working well enough that it should be expanded.

And in El Paso, Texas, researchers studied 500 women who regularly crossed the border into Mexico to buy birth control pills, where some U.S. brands sell over the counter for a few dollars a pack. Over nine months, the women who bought in Mexico stuck with their contraception better than another 500 women who received the pill from public clinics in El Paso, possibly because the clinic users had to wait for appointments, said Dr. Dan Grossman of the University of California, San Francisco, and the nonprofit research group Ibis Reproductive Health.

"Being able to easily get the pill when you need it makes a difference," he said.

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Online:

OB/GYN group: http://www.acog.org

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New push for most in US to get at least 1 HIV test

WASHINGTON (AP) — There's a new push to make testing for the AIDS virus as common as cholesterol checks.

Americans ages 15 to 64 should get an HIV test at least once — not just people considered at high risk for the virus, an independent panel that sets screening guidelines proposed Monday.

The draft guidelines from the U.S. Preventive Services Task Force are the latest recommendations that aim to make HIV screening simply a routine part of a check-up, something a doctor can order with as little fuss as a cholesterol test or a mammogram. Since 2006, the Centers for Disease Control and Prevention also has pushed for widespread, routine HIV screening.

Yet not nearly enough people have heeded that call: Of the more than 1.1 million Americans living with HIV, nearly 1 in 5 — almost 240,000 people — don't know it. Not only is their own health at risk without treatment, they could unwittingly be spreading the virus to others.

The updated guidelines will bring this long-simmering issue before doctors and their patients again — emphasizing that public health experts agree on how important it is to test even people who don't think they're at risk, because they could be.

"It allows you to say, 'This is a recommended test that we believe everybody should have. We're not singling you out in any way,'" said task force member Dr. Douglas Owens, of Stanford University and the Veterans Affairs Palo Alto Health Care System.

And if finalized, the task force guidelines could extend the number of people eligible for an HIV screening without a copay in their doctor's office, as part of free preventive care under the Obama administration's health care law. Under the task force's previous guidelines, only people at increased risk for HIV — which includes gay and bisexual men and injecting drug users — were eligible for that no-copay screening.

There are a number of ways to get tested. If you're having blood drawn for other exams, the doctor can merely add HIV to the list, no extra pokes or swabs needed. Today's rapid tests can cost less than $20 and require just rubbing a swab over the gums, with results ready in as little as 20 minutes. Last summer, the government approved a do-it-yourself at-home version that's selling for about $40.

Free testing is available through various community programs around the country, including a CDC pilot program in drugstores in 24 cities and rural sites.

Monday's proposal also recommends:

—Testing people older and younger than 15-64 if they are at increased risk of HIV infection,

—People at very high risk for HIV infection should be tested at least annually.

—It's not clear how often to retest people at somewhat increased risk, but perhaps every three to five years.

—Women should be tested during each pregnancy, something the task force has long recommended.

The draft guidelines are open for public comment through Dec. 17.

Most of the 50,000 new HIV infections in the U.S. every year are among gay and bisexual men, followed by heterosexual black women.

"We are not doing as well in America with HIV testing as we would like," Dr. Jonathan Mermin, CDC's HIV prevention chief, said Monday.

The CDC recommends at least one routine test for everyone ages 13 to 64, starting two years younger than the task force recommended. That small difference aside, CDC data suggests fewer than half of adults under 65 have been tested.

"It can sometimes be awkward to ask your doctor for an HIV test," Mermin said — the reason making it routine during any health care encounter could help.

But even though nearly three-fourths of gay and bisexual men with undiagnosed HIV had visited some sort of health provider in the previous year, 48 percent weren't tested for HIV, a recent CDC survey found. Emergency rooms are considered a good spot to catch the undiagnosed, after their illnesses and injuries have been treated, but Mermin said only about 2 percent of ER patients known to be at increased risk were tested while there.

Mermin calls that "a tragedy. It's a missed opportunity."

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Online:

Task force recommendation: http://www.uspreventiveservicestaskforce.org

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EU drug regulator OKs Novartis' meningitis B shot

LONDON (AP) — Europe's top drug regulator has recommended approval for the first vaccine against meningitis B, made by Novartis AG.

There are five types of bacterial meningitis. While vaccines exist to protect against the other four, none has previously been licensed for type B meningitis. In Europe, type B is the most common, causing 3,000 to 5,000 cases every year.

Meningitis mainly affects infants and children. It kills about 8 percent of patients and leaves others with lifelong consequences such as brain damage.

In a statement on Friday, Andrin Oswald of Novartis said he is "proud of the major advance" the company has made in developing its vaccine Bexsero. It is aimed at children over two months of age, and Novartis is hoping countries will include the shot among the routine ones for childhood diseases such as measles.

Novartis said the immunization has had side effects such as fever and redness at the injection site.

Recommendations from the European Medicines Agency are usually adopted by the European Commission. Novartis also is seeking to test the vaccine in the U.S.

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EU drug regulator OKs Novartis' meningitis B shot

LONDON (AP) — Europe's top drug regulator has recommended approval for the first vaccine against meningitis B, made by Novartis AG.

There are five types of bacterial meningitis. While vaccines exist to protect against the other four, none has previously been licensed for type B meningitis. In Europe, type B is the most common, causing 3,000 to 5,000 cases every year.

Meningitis mainly affects infants and children. It kills about 8 percent of patients and leaves others with lifelong consequences such as brain damage.

In a statement on Friday, Andrin Oswald of Novartis said he is "proud of the major advance" the company has made in developing its vaccine Bexsero. It is aimed at children over two months of age, and Novartis is hoping countries will include the shot among the routine ones for childhood diseases such as measles.

Novartis said the immunization has had side effects such as fever and redness at the injection site.

Recommendations from the European Medicines Agency are usually adopted by the European Commission. Novartis also is seeking to test the vaccine in the U.S.

Read More..

EU drug regulator OKs Novartis' meningitis B shot

LONDON (AP) — Europe's top drug regulator has recommended approval for the first vaccine against meningitis B, made by Novartis AG.

There are five types of bacterial meningitis. While vaccines exist to protect against the other four, none has previously been licensed for type B meningitis. In Europe, type B is the most common, causing 3,000 to 5,000 cases every year.

Meningitis mainly affects infants and children. It kills about 8 percent of patients and leaves others with lifelong consequences such as brain damage.

In a statement on Friday, Andrin Oswald of Novartis said he is "proud of the major advance" the company has made in developing its vaccine Bexsero. It is aimed at children over two months of age, and Novartis is hoping countries will include the shot among the routine ones for childhood diseases such as measles.

Novartis said the immunization has had side effects such as fever and redness at the injection site.

Recommendations from the European Medicines Agency are usually adopted by the European Commission. Novartis also is seeking to test the vaccine in the U.S.

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Diabetes rates rocket in Oklahoma, South

NEW YORK (AP) — The nation's diabetes problem is getting worse, and the biggest jump over 15 years was in Oklahoma, according to a new federal report issued Thursday.

The diabetes rate in Oklahoma more than tripled, and Kentucky, Georgia and Alabama also saw dramatic increases since 1995, the study showed.

The South's growing weight problem is the main explanation, said Linda Geiss, lead author of the report by the Centers for Disease Control and Prevention study.

"The rise in diabetes has really gone hand in hand with the rise in obesity," she said.

Bolstering the numbers is the fact that more people with diabetes are living longer because better treatments are available.

The disease exploded in the United States in the last 50 years, with the vast majority from obesity-related Type 2 diabetes. In 1958, fewer than 1 in 100 Americans had been diagnosed with diabetes. In 2010, it was about 1 in 14.

Most of the increase has happened since 1990.

Diabetes is a disease in which the body has trouble processing sugar; it's the nation's seventh leading cause of death. Complications include poor circulation, heart and kidney problems and nerve damage.

The new study is the CDC's first in more than a decade to look at how the nationwide boom has played out in different states.

It's based on telephone surveys of at least 1,000 adults in each state in 1995 and 2010. Participants were asked if a doctor had ever told them they have diabetes.

Not surprisingly, Mississippi — the state with the largest proportion of residents who are obese — has the highest diabetes rate. Nearly 12 percent of Mississippians say they have diabetes, compared to the national average of 7 percent.

But the most dramatic increases in diabetes occurred largely elsewhere in the South and in the Southwest, where rates tripled or more than doubled. Oklahoma's rate rose to about 10 percent, Kentucky went to more than 9 percent, Georgia to 10 percent and Alabama surpassed 11 percent.

An official with Oklahoma State Department of Health said the solution is healthier eating, more exercise and no smoking.

"And that's it in a nutshell," said Rita Reeves, diabetes prevention coordinator.

Several Northern states saw rates more than double, too, including Washington, Idaho, Montana, Wyoming, South Dakota, Minnesota, Missouri, Ohio and Maine.

The study was published in CDC's Morbidity and Mortality Weekly Report.

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Associated Press writer Ken Miller in Oklahoma City contributed to this report.

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Online:

CDC report: http://tinyurl.com/cdcdiabetesreport

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Booze calories nearly equal soda's for US adults

NEW YORK (AP) — Americans get too many calories from soda. But what about alcohol? It turns out adults get almost as many empty calories from booze as from soft drinks, a government study found.

Soda and other sweetened drinks — the focus of obesity-fighting public health campaigns — are the source of about 6 percent of the calories adults consume, on average. Alcoholic beverages account for about 5 percent, the new study found.

"We've been focusing on sugar-sweetened beverages. This is something new," said Cynthia Ogden, one of the study's authors. She's an epidemiologist with the Centers for Disease Control and Prevention which released its findings Thursday.

The government researchers say the findings deserve attention because, like soda, alcohol contains few nutrients but plenty of calories.

The study is based on interviews with more than 11,000 U.S. adults from 2007 through 2010. Participants were asked extensive questions about what they ate and drank over the previous 24 hours.

The study found:

—On any given day, about one-third of men and one-fifth of women consumed calories from beer, wine or liquor.

—Averaged out to all adults, the average guy drinks 150 calories from alcohol each day, or the equivalent of a can of Budweiser.

—The average woman drinks about 50 calories, or roughly half a glass of wine.

—Men drink mostly beer. For women, there was no clear favorite among alcoholic beverages.

—There was no racial or ethnic difference in average calories consumed from alcoholic beverages. But there was an age difference, with younger adults putting more of it away.

For reference, a 12-ounce can of regular Coca-Cola has 140 calories, slightly less than a same-sized can of regular Bud. A 5-ounce glass of wine is around 100 calories.

In September, New York City approved an unprecedented measure cracking down on giant sodas, those bigger than 16 ounces, or half a liter. It will take effect in March and bans sales of drinks that large at restaurants, cafeterias and concession stands.

Should New York officials now start cracking down on tall-boy beers and monster margaritas?

There are no plans for that, city health department officials said, adding in a statement that while studies show that sugary drinks are "a key driver of the obesity epidemic," alcohol is not.

Health officials should think about enacting policies to limit alcoholic intake, but New York's focus on sodas is appropriate, said Margo Wootan, director of nutrition policy for the Center for Science in the Public Interest, a public health advocacy group.

Soda and sweetened beverages are the bigger problem, especially when it comes to kids — the No. 1 source of calories in the U.S. diet, she said.

"In New York City, it was smart to start with sugary drinks. Let's see how it goes and then think about next steps," she said.

However, she lamented that the Obama administration is planning to exempt alcoholic beverages from proposed federal regulations requiring calorie labeling on restaurant menus.

It could set up a confusing scenario in which, say, a raspberry iced tea may have a calorie count listed, while an alcohol-laden Long Island Iced Tea — with more than four times as many calories — doesn't. "It could give people the wrong idea," she said.

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Online:

CDC report: http://www.cdc.gov/nchs/

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Report: FDA wanted to close Mass pharmacy in 2003

WASHINGTON (AP) — Nearly a decade ago, federal health inspectors wanted to shut down the pharmacy linked to a recent deadly meningitis outbreak until it cleaned up its operations, according to congressional investigators.

About 440 people have been sickened by contaminated steroid shots distributed by New England Compounding Center, and more than 32 deaths have been reported since the outbreak began in September, according to the Centers for Disease Control and Prevention. That has put the Framingham, Mass.-based pharmacy at the center of congressional scrutiny and calls for greater regulation of compounding pharmacies, which make individualized medications for patients and have long operated in a legal gray area between state and federal laws.

The House Energy and Commerce Committee released a detailed history of NECC's regulatory troubles on Monday, ahead of a meeting Wednesday meeting to examine how the outbreak could have been prevented. The 25-page report summarizes and quotes from FDA and state inspection memos, though the committee declined to release the original documents.

The report shows that after several problematic incidents, Food and Drug Administration officials in 2003 suggested that the compounding pharmacy be "prohibited from manufacturing" until it improved its operations. But FDA regulators deferred to their counterparts in Massachusetts, who ultimately reached an agreement with the pharmacy to settle concerns about the quality of its prescription injections.

The congressional report also shows that in 2003 the FDA considered the company a pharmacy. That's significant because in recent weeks public health officials have charged that NECC was operating more as a manufacturer than a pharmacy, shipping thousands of doses of drugs to all 50 states instead of small batches of drugs to individual patients. Manufacturers are regulated by the FDA and are subject to stricter quality standards than pharmacies.

The report offers the most detailed account yet of the numerous regulatory complaints against the pharmacy, which nearly date back to its founding in 1998. Less than a year later, the company was cited by the state pharmacy board for providing doctors with blank prescription pads with NECC's information. Such promotional items are illegal in Massachusetts and the pharmacy's owner and director, Barry Cadden, received an informal reprimand, according to documents summarized by the committee.

Cadden was subject to several other complaints involving unprofessional conduct in coming years, but first came to the FDA's attention in 2002. Here are some key events from the report highlighting the company's early troubles with state and federal authorities:

__ In March of 2002 the FDA began investigating reports that five patients had become dizzy and short of breath after receiving NECC's compounded betamethasone repository injection, a steroid used to treat joint pain and arthritis that's different from the one linked to the current meningitis outbreak.

FDA inspectors visited NECC on April 9 and said Cadden was initially cooperative in turning over records about production of the drug. But during a second day of inspections, Cadden told officials "that he was no longer willing to provide us with any additional records," according to an FDA report cited by congressional investigators. The inspectors ultimately issued a report citing NECC for poor sterility and record-keeping practices but said that "this FDA investigation could not proceed to any definitive resolution," because of "problems/barriers that were encountered throughout the inspection."

__ In October of 2002, the FDA received new reports that two patients at a Rochester, N.Y., hospital came down with symptoms of bacterial meningitis after receiving a different NECC injection. The steroid, methylprednisolone acetate, is the same injectable linked to the current outbreak and is typically is used to treat back pain. Both patients were treated with antibiotics and eventually recovered, according to FDA documents cited by the committee.

When officials from the FDA and Massachusetts Board of Pharmacy visited NECC later in the month, Cadden said vials of the steroid returned by the hospital had tested negative for bacterial contamination. But when FDA scientists tested samples of the drug collected in New York they found bacterial contamination in four out of 14 vials sampled. It is not entirely clear whether FDA tested the same lot shipped to the Rochester hospital.

__ At a February 2003 meeting between state and federal officials, FDA staff emphasized "the potential for serious public consequences if NECC's compounding practices, in particular those relating to sterile products, are not improved." The agency issued a list of problems uncovered in its inspection to NECC, including a failure to verify if sterile drugs met safety standards.

But the agency decided to let Massachusetts officials take the lead in regulating the company, since pharmacies are typically regulated at the state level. It was decided that "the state would be in a better position to gain compliance or take regulatory action against NECC as necessary," according to a summary of the meeting quoted by investigators.

The FDA recommended the state subject NECC to a consent agreement, which would require the company to pass certain quality tests to continue operating. But congressional investigators say Massachusetts Board of Pharmacy did not take any action until "well over a year later."

__ In October 2004, the board sent a proposed consent agreement to Cadden, which would have included a formal reprimand and a three-year probationary period for the company's registration. The case ended without disciplinary action in 2006, when NECC agreed to a less severe consent decree with the state.

Massachusetts officials indicated Tuesday they are still investigating why NECC escaped the more severe penalty.

"I will not be satisfied until we know the full story behind this decision," the state's interim health commissioner Lauren Smith said in a transcript of her prepared testimony released a day ahead of delivery. Smith is one of several witnesses scheduled to testify Wednesday, including FDA Commissioner Margaret Hamburg.

The committee will also hear from the widow of 78-year-old Eddie C. Lovelace, a longtime circuit court judge in southern Kentucky. Autopsy results confirmed Lovelace received fungus-contaminated steroid injections that led to his death Sept. 17.

Joyce Lovelace will urge lawmakers to work together on legislation to stop future outbreaks caused by compounded drugs, according to a draft of her testimony.

"We now know that New England Compounding Pharmacy, Inc. killed Eddie. I have lost my soulmate and life's partner with whom I worked side by side, day after day for more than fifty years," Lovelace states.

Barry Cadden is also scheduled to appear at the hearing, after lawmakers issued a subpoena to compel him to attend.

The NECC has been closed since early last month, and Massachusetts officials have taken steps to permanently revoke its license. The pharmacy has recalled all the products it makes, including 17,700 single-dose vials of a steroid that tested positive for the fungus tied to the outbreak.

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British medical journal slams Roche on Tamiflu

LONDON (AP) — A leading British medical journal is asking the drug maker Roche to release all its data on Tamiflu, claiming there is no evidence the drug can actually stop the flu.

The drug has been stockpiled by dozens of governments worldwide in case of a global flu outbreak and was widely used during the 2009 swine flu pandemic.

On Monday, one of the researchers linked to the BMJ journal called for European governments to sue Roche.

"I suggest we boycott Roche's products until they publish missing Tamiflu data," wrote Peter Gotzsche, leader of the Nordic Cochrane Centre in Copenhagen. He said governments should take legal action against Roche to get the money back that was "needlessly" spent on stockpiling Tamiflu.

Last year, Tamiflu was included in a list of "essential medicines" by the World Health Organization, a list that often prompts governments or donor agencies to buy the drug.

Tamiflu is used to treat both seasonal flu and new flu viruses like bird flu or swine flu. WHO spokesman Gregory Hartl said the agency had enough proof to warrant its use for unusual influenza viruses, like bird flu.

"We do have substantive evidence it can stop or hinder progression to severe disease like pneumonia," he said.

In the U.S., the Centers for Disease Control and Prevention recommends Tamiflu as one of two medications for treating regular flu. The other is GlaxoSmithKline's Relenza. The CDC says such antivirals can shorten the duration of symptoms and reduce the risk of complications and hospitalization.

In 2009, the BMJ and researchers at the Nordic Cochrane Centre asked Roche to make all its Tamiflu data available. At the time, Cochrane Centre scientists were commissioned by Britain to evaluate flu drugs. They found no proof that Tamiflu reduced the number of complications in people with influenza.

"Despite a public promise to release (internal company reports) for each (Tamiflu) trial...Roche has stonewalled," BMJ editor Fiona Godlee wrote in an editorial last month.

In a statement, Roche said it had complied with all legal requirements on publishing data and provided Gotzsche and his colleagues with 3,200 pages of information to answer their questions.

"Roche has made full clinical study data ... available to national health authorities according to their various requirements, so they can conduct their own analyses," the company said.

Roche says it doesn't usually release patient-level data available due to legal or confidentiality constraints. It said it did not provide the requested data to the scientists because they refused to sign a confidentiality agreement.

Roche is also being investigated by the European Medicines Agency for not properly reporting side effects, including possible deaths, for 19 drugs including Tamiflu that were used in about 80,000 patients in the U.S.

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Online:

www.bmj.com.tamiflu/

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