By Anna Yukhananov

WASHINGTON |
Fri Jan 27, 2012 7:19pm EST

WASHINGTON (Reuters) – Health regulators on Friday detained nine shipments of orange juice from Brazil and Canada that contained traces of an illegal fungicide, and rejected industry calls to overhaul the way they test for the banned substance.

WASHINGTON (Reuters) – Health regulators on Friday detained nine shipments of orange juice from Brazil and Canada that contained traces of an illegal fungicide, and rejected industry calls to overhaul the way they test for the banned substance.

The Food and Drug Administration said carbendazim would remain illegal for citrus in any amount in the United States. Brazil and U.S. industry groups asked the FDA to reconsider its stance on the fungicide, widely used in Brazil to combat blight blossom and black spot, a type of mold that grows on orange trees.

The FDA started testing for the fungicide on January 4, after an alert from Coca-Cola, roiling orange juice futures to record highs as traders feared a prolonged disruption to supply.

Orange juice futures jumped almost 3 percent on Friday after the FDA announcement.

Traders also fretted that the fungicide testing would further dent demand if it translated into higher prices for consumers, or sparked fears of a health risk.

Brazilian orange juice makes up about half of all U.S. imports, and meets more than a tenth of domestic demand.

The U.S. Juice Products Association and Brazil’s CitrusBR urged the FDA to raise the amount of the fungicide, carbendazim, it will allow into the country by raising the legal limit for frozen concentrated juice.

“If this were considered, the whole problem would have been already resolved,” CitrusBR’s Christian Lohbauer told reporters on Friday.

These were the first public efforts by the two countries’ industries to persuade the FDA to restore juice imports into the United States since testing began almost a month ago.

FROZEN JUICE EXCEPTION

The industry groups called on the FDA to differentiate between ready-to-drink juice and frozen concentrate.

Since the concentrate is diluted before drinking, the level could be close to 60 parts per billion (ppb) without exceeding the FDA’s legal limit for drinkable juice, industry groups said.

The FDA said any imports with detectable levels of fungicide, which means above 10 ppb, would not be allowed in the country.

The European Union allows 200 ppb, and the FDA has said any level of fungicide below 80 ppb poses no health risk. The agency did not recall any juice already on store shelves in the United States.

Ready-to-drink juice, which makes up about 65 percent of Brazil’s juice shipments to the United States, does not seem to have a problem with traces of the fungicide.

Only frozen juice spikes above the limit because it is in concentrate form and would be diluted for drinking, Lohbauer said.

“The agency is using this lower maximum level … because the letter of the law requires the agency to do so,” the U.S. Juice Products Association said in a statement, and said a higher tolerance level would be the logical choice to protect consumers.

But the FDA did not budge on its testing policies.

“We’ve stated before that we would test imports on an ‘as is’ basis, and that’s still our policy,” FDA spokeswoman Siobhan DeLancey said in an email.

Brazil juice imports will continue to falter unless the FDA raises its tolerance level for fungicide, or Brazilian growers find an alternative way to keep trees free from mold, growers said. However, U.S. consumers still have plenty of juice to drink for now because of a large crop this season, analysts said.

The Brazilian juice industry said it would study alternatives if the United States continues to reject its juice shipments.

POSITIVE RESULTS

The industry’s pressure on the FDA came after the agency announced on Friday that it had blocked three shipments of Brazilian orange juice and six from Canada that tested positive for carbendazim.

Canada, which makes up less than 1 percent of U.S. imports, does not grow its own oranges, and traders assumed the Canadian juice was grown in Brazil. The South American country often ships juice to Toronto, to get it to consumers in Chicago.

Of the six shipments detained from Canada, none had levels of fungicide higher than 31 ppb, and most were below 20 ppb. The Brazilian shipments that tested positive had carbendazim levels between 20 ppb and 52 ppb.

Two other Brazilian concentrate shipments tested positive for the fungicide, but the companies decided not to import the juice into the country, the FDA said.

The FDA said 29 of the 80 orange juice samples it had taken since testing began on January 4 had no traces of carbendazim, including two from Brazil and seven from Canada. Importers will have 90 days to export or destroy the product, the agency said.

The FDA said it would test all shipments twice, and detain any that tested positive for carbendazim at least once.

In the United States, trace amounts of the fungicide are still allowed in 31 food types including grains, nuts and some non-citrus fruits. The fungicide had been allowed for citrus until 2009 as a temporary measure, regulators said.

(Reporting by Anna Yukhananov in Washington, additional reporting by Rene Pastor in New York, Reese Ewing in Sao Paulo and Lisa Baertlein in Los Angeles; Editing by Lisa Von Ahn, Marguerita Choy, Dale Hudson and Josephine Mason)

Reuters: Health News

A proposed change to the definition of depression could pathologize normal grieving and greatly expand the number of people treated for the mood disorder, researchers contend in a new report, the latest salvo in a bitter skirmish over the diagnosis that has gone on largely under the public radar.

The criteria for depression are being reviewed by the American Psychiatry Association, which is finishing work on the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders, or D.S.M., the first since 1994. The manual is the standard reference for the field, shaping treatment and insurance decisions, and its revisions will affect the lives of millions of people for years to come.

In coming months, as the manual is finalized, outside experts will intensify scrutiny of its finer points, many of which are deeply contentious in the field. A controversy erupted last week over the proposed tightening in the definition of autism, possibly sharply reducing the number of people who receive the diagnosis. Psychiatrists say current efforts to revise the manual are shaping up as the most contentious ever.

The new report, by psychiatric researchers from Columbia and New York universities, argues that the current definition of depression — which excludes bereavement, the usual grieving after the loss of a loved one — is far more accurate. If the “bereavement exclusion” is eliminated, they say, “there is the potential for considerable false-positive diagnosis and unnecessary treatment of grief-stricken persons.” Drugs for depression can have side effects, including low sex drive and sleeping problems.

But experts who support the new definition say sometimes grieving people need help. “Depression can and does occur in the wake of bereavement, it can be severe and debilitating, and calling it by any other name is doing a disservice to people who may require more careful attention,” said Dr. Sidney Zisook, a psychiatrist at the University of California, San Diego.

In blogs, letters, and editorials, experts and advocates have been busy dissecting the implications of this and scores of other proposed revisions, now available online, including new diagnoses that include “binge eating disorder,” “premenstrual dysphoric disorder” and “attenuated psychosis syndrome.” The clashes typically revolve around subtle distinctions that are often not readily apparent to those unfamiliar with the revision process. If a person does not meet precise criteria, then the diagnosis does not apply, and treatment is not covered, so the stakes are high.

“The world has changed” since the last revision, in 1993, said Dr. James H. Scully Jr., chief executive of the psychiatric association. “We’ve got electronic media around the clock, and we’ve made drafts of the proposed changes public online, for one thing. So anybody and everybody can comment on them, at any time, without any editors.”

Many doctors and therapists approve of efforts to eliminate vague, catch-all diagnostic labels like “eating disorder-not otherwise specified” and “pervasive development disorder-not otherwise specified,” which is related to autism. But a swarm of critics, including two psychiatrists who oversaw revisions of earlier editions, has descended on many other proposals.

“What I worry about most is that the revisions will medicalize normality and that millions of people will get psychiatric labels unnecessarily,” said Dr. Allen Frances, who was chairman of the task force that revised the last edition.

Dr. Frances, now an emeritus professor at Duke University, has been criticizing the current process relentlessly in blog posts and e-mails. Dr. Robert L. Spitzer, who oversaw revision of the third manual in 1980, has also voiced concerns, as have the American Counseling Association, the British Psychological Society and a division of the American Psychological Association. Some of the concerns have to do with important technical matters, like the statistical reliability of diagnostic questionnaires. Others are focused on proposed changes to the most familiar diagnoses.

Under the current criteria, a depression diagnosis requires that a person have five of nine symptoms — which include sleeping problems, a feeling of worthlessness and a loss of concentration — for two weeks or more. The criteria make an explicit exception for normal grieving, which can look like depression.

But the proposed diagnosis of depression has no such exclusion, and in the new study, Jerome C . Wakefield of New York University and Dr. Michael First of Columbia concluded that the evidence was not strong enough to support the change. “An estimated 8 to 10 million people lose a loved one every year, and something like a third to a half of them suffer depressive symptoms for up to month afterward,” said Dr. Wakefield, author of “The Loss of Sadness.” “This would pathologize them for behavior previously thought to be normal.”

But Dr. David J. Kupfer, a professor of psychiatry at the University of Pittsburgh School of Medicine and the chairman of the task force making revisions, disagreed, saying, “If someone is suffering from severe depression symptoms one or two months after a loss or a death, and I can’t make a diagnosis of depression — well, that is not being clinically proactive. That person may then not get the treatment they need.”

Another point of growing contention is a proposed new diagnosis, “attenuated psychosis syndrome,” which would be given to people who experience delusional thinking and hallucinations and sometimes say things that do not make sense. Psychosis is the signature symptom of schizophrenia, typically a lifelong, disabling mental disorder. Psychiatrists have long hoped for a way to catch it early, before it turns into full-blown schizophrenia.

But critics say these symptoms are poor predictors of the disorder. In studies, 70 percent to 80 percent of young people who report these strange experiences do not ever qualify for a full-blown schizophrenia diagnosis, yet the label increases the risk of being “treated” with powerful anti-psychosis drugs.

“There’s already overuse of these drugs in children and adolescents, and having this vague diagnosis, regardless of its intent, will only increase misuse in this vulnerable population,” said Dr. Peter J. Weiden, director of the psychosis treatment program at the University of Illinois at Chicago.

Some outside experts say the same is true of other proposed additions, like premenstrual dysphoric disorder (lethargy and other depressive symptoms in the week before menses, among other things) and binge-eating disorder (out-of-control bingeing, complete with self-loathing). Getting the diagnosis increases the likelihood of being treated for what is normal behavior, or close enough.

Task force members argue differently: If a person is in distress and seeking help, then treatment ought to be offered — and covered by insurance.

For now, these revisions are still in play; the completed manuscript is due to the printer in December. In the longer term, the politicking is likely to have a corrosive effect on the process, some experts said. Recent findings in genetics show that nature does not respect psychiatric categories — many different disorders seem linked to some of the same genetic glitches.

Already a federal agency, the National Institute of Mental Health, has set up its own independent effort to classify mental disorders, called Research Domain Criteria, based on research findings rather than existing categories.

In time, said Dr. Steven E. Hyman, a resident scholar at the Broad Institute of M.I.T. and Harvard, this kind of approach should ground the field more in nature and less in expert opinion. Until then, there is and will be the diagnostic manual.

NYT > Health

The entrance to the Eleven West wing at Mount Sinai Medical Center, where Jasmine Williams is a guest services attendant.

The feverish patient had spent hours in a crowded emergency room. When she opened her eyes in her Manhattan hospital room last winter, she recalled later, she wondered if she could be hallucinating: “This is like the Four Seasons — where am I?”

Connect with @NYTMetro on Twitter for New York breaking news and headlines.

A menu available to patients in Greenberg 14 South, the luxury wing of NewYork-Presbyterian/Weill Cornell hospital.

The bed linens were by Frette, Italian purveyors of high-thread-count sheets to popes and princes. The bathroom gleamed with polished marble. Huge windows displayed panoramic East River views. And in the hush of her ,400 suite, a man in a black vest and tie proffered an elaborate menu and told her, “I’ll be your butler.”

It was Greenberg 14 South, the elite wing on the new penthouse floor of NewYork-Presbyterian/Weill Cornell hospital. Pampering and décor to rival a grand hotel, if not a Downton Abbey, have long been the hallmark of such “amenities units,” often hidden behind closed doors at New York’s premier hospitals. But the phenomenon is escalating here and around the country, health care design specialists say, part of an international competition for wealthy patients willing to pay extra, even as the federal government cuts back hospital reimbursement in pursuit of a more universal and affordable American medical system.

“It’s not just competing on medical grounds and specialties, but competing for customers who can go just about anywhere,” said Helen K. Cohen, a specialist in health facilities at the international architectural firm HOK, which recently designed luxury hospital floors in Singapore and London and renovated NewYork-Presbyterian’s elite offerings in the McKeen Pavilion in Washington Heights. “These kinds of patients, they’re paying cash — they’re the best kind of patient to have,” she added. “Theoretically, it trickles down.”

A waterfall, a grand piano and the image of a giant orchid grace the soaring ninth floor atrium of McKeen, leading to refurbished rooms that, like those in the hospital’s East 68th Street penthouse, cost patients ,000 to ,500 a day, and can be combined. That fee is on top of whatever base rate insurance pays to the hospital, or the roughly ,500 a day that foreigners are charged, according to the hospital’s international services department.

But in the age of Occupy Wall Street, catering to the rich can be trickier than ever, noted Avani Parikh, who worked for NewYork-Presbyterian as in-house project leader when the 14th floor was undertaken. She pointed to the recent ruckus at Lenox Hill Hospital, where parents with newborns in the intensive-care unit complained that security guards had restricted their movements and papered over hospital security cameras in their zeal to please Jay-Z (real name Shawn Carter) and Beyoncé Knowles, whose daughter was born on Jan. 7 in a new “executive suite.”

Many American hospitals offer a V.I.P. amenities floor with a dedicated chef and lavish services, from Johns Hopkins Hospital in Baltimore to Cedars-Sinai Medical Center in Los Angeles, which promises “the ultimate in pampering” in its ,784 maternity suites. The rise of medical tourism to glittering hospitals in places like Singapore and Thailand has turned coddling and elegance into marketing necessities, designers say.

The spotlight on luxury accommodations comes at an awkward time for many urban hospitals, now lobbying against cuts in Washington and highlighting their role as nonprofit teaching institutions that serve the poor. Indeed, NewYork-Presbyterian, which once opposed amenities units, would not answer questions about its shift, and declined a reporter’s request for a tour.

In Greenberg, where the visitors’ lounge seems to hang over the East River in a glass prow and Ciao Bella gelato is available on demand, the patient who likened her suite to the Four Seasons was not paying for it. She did not want to be identified because her wealthy boss, who picked up the bill, would not want publicity.

During a reporter’s unofficial visits to both units this month, however, some people enjoying the perks expressed uneasiness about those priced out. In space-starved New York, many regular hospital rooms are still double-occupancy, though singles are now the national standard for infection control and quicker recovery.

NYT > Health

Bone loss and osteoporosis develop so slowly in most women whose bones test normal at age 65 that many can safely wait as long as 15 years before having a second bone density test, researchers report in a new study.

Dr. Ethel S. Siris, director of the Toni Stabile Osteoporosis Center, stands in front of a bone density scanner at the Columbia University Medical Center New York-Presbyterian Hospital.

The study, published in Thursday’s issue of The New England Journal of Medicine, is part of a broad rethinking of how to diagnose and treat the potentially debilitating bone disease that can lead to broken hips and collapsing spines.

A class of drugs, bisphosphonates, which includes Fosamax, have been found to prevent fractures in people with osteoporosis. But medical experts no longer recommend the medicines to prevent osteoporosis itself. They no longer want women to take them indefinitely, and they no longer consider bone density measurements the single defining factor in deciding if a woman needs to be treated.

Now, with the new study, researchers are asking whether frequent bone density measurements even make sense for the majority of older women whose bone density is not close to a danger zone on an initial test.

“Bone density testing has been oversold,” said Steven Cummings, the study’s principal investigator and an emeritus professor of medical epidemiology and biostatistics at the University of California, San Francisco.

The study followed nearly 5,000 women aged 67 and older for more than a decade. The women had a bone density test when they entered the study and did not have osteoporosis. (In a separate national study by the Centers for Disease Control and Prevention, about 70 percent of women over age 65 did not have osteoporosis.)

The researchers report that less than 1 percent of women with normal bone density when they entered the study, and less than 5 percent with mildly low bone density, developed osteoporosis in the ensuing 15 years. But of those with substantially low bone density at the study’s start, close to the cut off point for osteoporosis of less than 2.5 standard deviations from the reference level, 10 percent progressed to osteoporosis in about a year.

Dr. Margaret Gourlay, the study’s lead author and a family practice specialist and osteoporosis researcher at the University of North Carolina, said she and her colleagues were surprised by how slowly women progressed to osteoporosis.

Medicare pays for a bone density test every two years and many doctors have assumed that this is the ideal interval, although national guidelines say only that screening should be done at “regular intervals.”

“I think this will change the way doctors think about screening,” Dr. Gourlay said.

The results, says Joan McGowan, director of the division of musculoskeletal diseases at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, “provide telling evidence that you are not going to fall off a cliff if you have normal bone density in your 60s or early 70s, that you are not going to have osteoporosis in the next five years unless something else happens.”

Dr. McGowan, who was not involved in the study, said a woman who had to take high doses of corticosteroids for another medical condition would lose bone rapidly. But the findings “cover most normal women,” she said.

Bone density screening took off after Fosamax, the first bisphosphonate, was approved at the end of 1995. For the first time, doctors had a specific treatment that had been shown to prevent fractures in people with osteoporosis.

For years doctors were overly enthusiastic, prescribing it for women whose bone density was lower than normal but not in a danger zone, keeping women on the drug indefinitely. They even gave a name, osteopenia, to lower than normal bone density, although it was not clear it had real clinical significance.

Now, osteoporosis experts consider osteopenia to be a risk factor, not a disease, and its importance varies depending on a patient’s age, said Dr. Ethel Siris, an osteoporosis researcher at Columbia University who was not involved in the study.

Doctors are more likely to prescribe bisphosphonates for older patients and recommend against them for most younger postmenopausal women with osteopenia.

The experts also generally recommend that most people on bisphosphonates take them for just five years at a time, followed by a drug holiday of undetermined length. The idea is to reduce the risk of rare but serious side effects, including unusual thighbone fractures and loss of bone in the jaw.

A risk calculator, FRAX, can help determine whether treatment is recommended. It assesses a combination of risk factors: whether a parent had a hip fracture, the age of the patient, steroid use, bone density at the hip, and whether the person has broken a bone after age 50, an especially important indicator. Nearly half who break a hip already had already broken another bone, Dr. Siris said.

“If you are an older individual, a man or a woman, who already broke a major bone — spine, hip, shoulder, or pelvis or wrist — take it very seriously and get treated,” she said. “If you have relatively good bone density then you are not at risk now.”

NYT > Health

By Dorene Internicola

NEW YORK |
Mon Jan 16, 2012 5:05am EST

NEW YORK (Reuters) – The short days, the weak sun, and the warm beds of winter can wreak havoc on your fitness routine.

NEW YORK (Reuters) – The short days, the weak sun, and the warm beds of winter can wreak havoc on your fitness routine.

As the outside temperature plummets, so too can the will to brave the elements for outdoor exercise. Experts say as long as you layer up, drink up and tune into how cold is just too cold it shouldn’t impact your fitness.

“Come with a different game plan for the winter,” advises Jessica Matthews, an exercise physiologist with the American Council on Exercise (ACE).

“Motivation tends to wane a bit, so explore different activities, including things you can do in your own home. Have a flexible approach to your fitness routine as the weather changes.”

If you’re keen to exercise outside in all seasons, says Matthews, learn to dress for workout success.

“Wear layers. That’s really important when it’s cold outside and make sure you’re not becoming wet. Heavy cotton soaks up sweat, so you might want to stick with wool or polyester: something water repellent.”

Matthews suggests a first layer of lightweight synthetic.

“The second can be a little heavier, but still avoid heavy cotton,” she said.

And don’t leave home without hat and gloves. Heat loss from the head alone is about 50 percent at the freezing mark, according to ACE’s safety tips for cold weather.

Keeping hands and feet warm is crucial because in cold the body shunts blood away from the extremities to warm internal organs at the center.

“In temperatures below zero, consider a scarf or face mask, kept loosely over mouth, to warm the air a little bit before it gets into your body,” Matthews said.

Sometimes it’s just too cold outside.

“Check the air temperature and wind chill factor before exercising in the cold,” Matthews said. “Data from the National Safety Council suggest that when the wind chill factor falls below -20 degrees Fahrenheit (-29 Celsius), a danger zone exists.”

Hypothermia is a potentially fatal condition. Warning signs include light-headedness, dizziness and lethargy.

“Those are the beginning stages,” Matthews said.

Most people are not likely to forget to layer up in the cold, but they will more easily neglect to hydrate.

“It’s too easy to forget to hydrate in the cold, and it’s so important to stay hydrated in winter,” said Matthews. “You are going to sweat.”

She suggests drinking up to 20 ounces (0.59 liters) of water two or three hours before working out.

Deborah Plitt is a trainer with the Illinois-based equipment company Life Fitness, which recently broke down the calorie burn of 30 minutes of winter activities, such as sledding (250 calories), ice skating (230 calories), shoveling snow (230 calories).

“Of course there’s a lot of wiggle room (in the calculations). It’s based on an average woman of 145 pounds,” said Plitt. “And sledding and snow shoveling depends on whether the snow is wet or fluffy.”

Plitt said the point is to stay physically active, regardless of the weather, even if that means just taking the dog for a walk (125 calories).

“They’re mixing things up; they’re enjoying what they’re doing,” she said. “And believe it or not you burn more calories when you’re shivering.”

Reuters: Health News

Surgeons in Sweden have replaced the cancerous windpipe of a Maryland man with one fabricated in a laboratory and seeded with his own cells.

The windpipe, or trachea, made from minuscule plastic fibers and covered in stem cells taken from the man’s bone marrow, was transplanted successfully in November. The patient, Christopher Lyles, who had a type of tracheal cancer that is normally considered inoperable, arrived back home in Baltimore on Wednesday. It was the second procedure of its kind and the first in an American.

“He went home in very good shape,” said Dr. Paolo Macchiarini, director of the Advanced Center for Translational Regenerative Medicine at the Karolinska Institute in Stockholm.

Dr. Macchiarini is a leader in the field of tissue engineering, in which the goal is to produce replacement tissues and organs outside the body. Research in the field has undergone a resurgence in recent years because of advances in the study of stem cells, undifferentiated cells that can proliferate and be induced to become cells of a specific type of tissue.

“What we did is surgically removed this malignant tumor,” Dr. Macchiarini said. “Then we replaced the trachea with this tissue-engineered scaffold.”

The scaffold, made from nano-sized fibers of a type of plastic called PET that is commonly used in soda bottles and tailor made to match his existing windpipe, was seeded with stem cells from Mr. Lyles’s bone marrow. It was then placed in a bioreactor — basically, a warm and wet container — for several days to allow the cells to proliferate. Special compounds are added to help force the stem cells to become trachea cells. Then it was transplanted into Mr. Lyles.

Because Mr. Lyles’s own cells were used, there is no need for drugs to prevent his body from rejecting the new organ, a common problem in transplants.

Dr. Macchiarini said that the cells are continuing to grow and differentiate now that the windpipe is implanted. “We’re using the human body as a bioreactor to promote regeneration,” he said.

NYT > Health

By Tom Hals

WILMINGTON, Delaware |
Tue Jan 10, 2012 8:18am EST

WILMINGTON, Delaware (Reuters) – When the French firm at the center of a breast implant scandal sought to expand its U.S. business a decade ago, it turned to Donald McGhan, a pioneer in the implant industry with a history of legal troubles.

WILMINGTON, Delaware (Reuters) – When the French firm at the center of a breast implant scandal sought to expand its U.S. business a decade ago, it turned to Donald McGhan, a pioneer in the implant industry with a history of legal troubles.

McGhan’s career traces back to the laboratory at Dow Corning where the first breast implants were made in the early 1960s. By the time he partnered with France’s Jean-Claude Mas, founder of Poly Implant Prothese (PIP), in 1999, he had been sued by shareholders who accused him of stealing money, was being investigated by the Securities and Exchange Commission for false accounting and had been replaced from his position as chief executive at one of the world’s leading implant makers.

Separately, a Reuters review of securities filings, U.S. product liability lawsuits and interviews with doctors and patients found that saline implants made by PIP and distributed by its U.S. partner MediCor Ltd, founded by McGhan, continued to be used – dodging certain constraints imposed by the FDA – for at least two years after health regulators said they were adulterated and rejected them for sale in the United States.

McGhan has since been jailed for wire fraud for illegally using money from clients in a real estate company in an attempt to build yet another implant business.

The now-defunct PIP was recently found to have sold implants made with industrial-grade silicone to some 300,000 women worldwide, sparking a global health scare. France’s government instructed 30,000 French women to have their implants replaced due to a high rupture rate, and the country’s health minister has called for Mas to answer for the actions of a “shady business.

In the United States, where the FDA had banned all silicone implants from 1992-2006, PIP sold a line of saline-filled implants starting in 1996. The business accounted for up to 40 percent of its revenue, according to company securities filings. McGhan’s MediCor signed on to distribute the products in 1999, but a year later the Food and Drug Administration (FDA) conducted a new review of the devices and decided there wasn’t enough data to show they were safe.

The agency then sent an inspector to PIP’s plant in France, who found multiple violations of accepted manufacturing practices and determined the products to be “adulterated,” Reuters has reported.

Despite that, MediCor continued to book sales of the implants until 2002, according to a MediCor prospectus for a sale of its stock. Reuters interviews with three surgeons and two patients found cases in which women received implants after the 2000 rejection.

Several doctors told Reuters that while PIP had informed them about the FDA rejection, it was their understanding that they could use devices they had in stock to replace implants that ruptured or deflated.

“If you had three in the closet, you could use them. That sort of thing,” said Patrick Hudson, a New Mexico plastic surgeon. Hudson said he used PIP implants to replace deflated devices for one of his patients after the FDA rejection. “I don’t think even the replacement lasted very long.”

Hudson said that nearly all of the 15 or 20 PIP devices that he used in patients eventually failed, which he attributed to the implant’s thin membrane.

The FDA confirmed that PIP received a “compassionate use” exception to allow doctors to implant the devices in women whose PIP implants had ruptured or deflated, but only for up to 300 women.

“For women who were suffering from a ruptured implant of this type, it was felt that there were not other implants on the market that would give a satisfactory cosmetic appearance,” said Dr. William Maisel, the deputy director and chief scientist of the FDA’s devices division, in an interview. For example, if a woman needed to replace only one of two PIP implants, and wanted her body to look symmetrical.

Only women who had previously gotten PIP implants could get a new one under this program, and the FDA asked PIP to remove all other implants from the market in 2000, when the company withdrew its application.

However, it turns out the company did not fully comply with the FDA’s requirement.

The FDA said it found out there were still PIP saline implants in the United States in 2002. The agency does not have the exact figures of how many implants were still not collected. But they asked the company to send out letters in 2002 and 2003 to more than 1,000 surgeons, asking them to send back all unused implants to PIP.

Only about 10 to 20 percent responded to the first letter, but more than half responded that they received the second letter, Maisel said.

“It’s very unusual (that a company not withdraw its products),” Maisel said. “Our expectation certainly was that the company would remove their product from the market.”

The FDA said it is now generally confident PIP’s implants are off the U.S. market, as it received reports about 1,810 problems with PIP’s saline implants through the end of 2000, and only 48 reports between 2001 and 2009.

FROM LAB TO JAIL CELL

McGhan, who is serving a 10-year sentence in Texas federal prison, turned down a request for an interview on his ties to PIP, delivered through a prison official. Lawyers who have represented him declined to comment.

Mas’s lawyer Yves Haddad said his client declined to comment on any ties to McGhan. Mas, who is recuperating from a December surgery in the Var region in southern France, is the subject of an Interpol arrest warrant for a drunk driving incident in Costa Rica. French authorities are considering whether to press charges against any PIP executives.

People who have encountered McGhan describe him as a persuasive salesman who succeeded in spreading his vision for the implant industry among doctors and investors.

“McGhan is the actual architect of the breast implant industry as we know it today,” said Pierre Blais, a former advisor to Canada’s health regulator. Blais now runs a program that gathers data on implant removals, and offers the information up to government agencies, health insurers and litigators. “He is the true father of all this, with all its sins and glory.”

* McGhan got his start in the Dow Corning lab that created the first implants from silicone in 1963 in Hemlock, Michigan, according to Blais. By the mid 1970s, he and several Dow colleagues launched a new implants company, McGhan Medical Corp.

* McGhan sold McGhan Medical to manufacturing giant 3M Corp, bought it back in 1984 and merged it two years later with Inamed Corp, which grew to be one of the largest breast implant makers worldwide along with Johnson & Johnson’s Mentor unit. Inamed is now part of Allergan.

* In 1998, McGhan was replaced as Inamed’s chairman and chief executive, according to Inamed’s securities filings.

* A year later, looking to build yet another implants business, McGhan founded MediCor and signed a deal to become PIP’s distributor in the United States.

While McGhan created, sold, bought and merged implants businesses, the industry was rocked by a series of health scares through the 1980s and early 1990s. The devices were found to rupture and leak, and women brought thousands of product liability lawsuits against manufacturers including Dow Corning and 3M. The FDA banned silicone implants for most women from 1992 to 2006 pending additional safety data.

Most of the lawsuits were resolved in a billion class action settlement in 1994. 3M ended up contributing 5 million. Dow Corning ended up bankrupt. Inamed, which estimated it held 40 percent of the global 5 million breast implant market in the mid 1990s, contributed about million shortly after it replaced McGhan.

Among Inamed’s many problems under McGhan’s tenure was a cash shortage so dire it risked breaking the law by not paying payroll tax on time, according to securities disclosures by its auditors Coopers & Lybrand, who resigned. That prompted regulators to investigate, and Inamed said at the time it was fully cooperating.

To prop up Inamed, McGhan began diverting money from Medical Device Alliance Inc, a liposuction company that he had founded in 1995, according to a lawsuit filed in Nevada state court by company shareholders in 1999. McGhan and his partners raised million from investors to finance research and testing by Medical Device Alliance, the lawsuit said.

“He would run around in a private jet that MDA financed, naturally, and try to impress people with his wealth and try to get doctors and others to put in a lot of money,” said Kathryn Tschopik, an attorney who represented MDA shareholders whose money was allegedly diverted by McGhan.

As soon as investors wired money to MDA, McGhan diverted it to Inamed, she alleged. McGhan had argued the money was loaned by MDA to Inamed and was a permitted use of MDA’s funds, according to securities disclosures by Inamed.

A receiver was appointed to replace McGhan at MDA, according to Nevada state court records. MDA’s shareholders were eventually repaid by McGhan and other defendants, who were able to fund the settlement in part thanks to a sharp rise in Inamed’s stock price, Tschopik said.

McGhan also paid a ,000 fine in 2000 to the Securities and Exchange Commission to settle claims he filed false financial reports for Inamed in 1996 and 1997. He neither admitted nor denied the SEC’s claims.

MCGHAN AND MAS “FIT TOGETHER”

As Mas was looking to turn the his implants into a global export, McGhan offered Mas his skill as a respected technician and salesman, but also business acumen and a familiarity with doctors in the United States, Blais said.

“The two fit together. Mas made something McGhan could use. McGhan took the initiative to import Mas implants,” Blais said.

Even though the FDA rejected PIP’s implants in 2000, PIP and McGhan’s MediCor aimed to eventually win approval, according to MediCor securities filings. In anticipation of returning to the United States, PIP merged with a shell corporation called Heritage Worldwide Inc in 2003, giving it a U.S.-listed stock.

MediCor soon became its second-largest shareholder, behind an entity owned by Jean-Claude Mas, with a stake of about 7 percent, according to a securities disclosure from Heritage.

McGhan also provided support in other ways. MediCor paid .66 million in claims owed by PIP to U.S. women with deflated implants, according to securities disclosures. In 2004, MediCor also forgave some of the .4 million PIP owed to it in return for transferring to MediCor PIP’s application for FDA approval of its saline implants. At the time, PIP’s total revenues for 2003 were .4 million and the company booked a net loss of .8 million, according to securities disclosures.

Despite the FDA’s decision in May 2000 to withhold approval, surgeons continued to use PIP’s saline implants in at least a dozen women in California, Michigan, Nevada, New Mexico, Texas and Utah for more than a year afterward, according to lawsuits brought by patients who suffered deflated implants. Only half of them received the implants as replacements.

Doctors were beginning to notice high rupture rates for the products. Grant Stevens of Marina Del Rey, California began to track data on 500 PIP devices implanted between 1996 and 2000 and compare them with 500 implants from Mentor from the same period.

Stevens found the PIP products deflated at a rate that was 3.5 times higher than the Mentor implants. The study was published in the journal Plastic and Reconstructive Surgery in 2006.

Blais, who tracks implants that are removed, also estimated the failure rate after five years at 70 percent, which he attributed to the implants’ thin walls, one of the features that made it popular. “The simple act of walking is very abrasive and the shells (of the PIP implants) are not capable of withstanding this vigor and will fail very quickly,” he said.

Laine Wich, a Texas dental hygienist and mother of two, had PIP’s saline product implanted more than six months after the FDA rejection. While doctors said they operated under the assumption they could use PIP implants as replacements, Wich said they were her first implants from the company. In 2006, they deflated.

“I chose them because they felt more natural,” Wich said. She said she followed the advice of her plastic surgeon, Neil Saretsky of Dallas, about the product choices. “I just trusted what he said.”

By the time Wich had completed additional surgery to fix the problem, she had spent ,000 out of pocket. PIP and MediCor offered warranties for up to 10 years, but Wich said it was never honored.

Messages left with the office of Saretsky, who was also listed as a MediCor shareholder in the company’s securities disclosures, were not returned.

Nancy Ewert of Bakersfield, California, received PIP replacement implants after the FDA withdrew its approval. She said her doctor told her the PIP products were the only choice, unless she wanted to pay for another brand. “I didn’t know they were pulled off the market.”

LAST GAMBIT

By the time it became clear that PIP’s implants would not drive business for MediCor, McGhan was scrambling for cash to buy yet another breast implant maker.

In May 2004, MediCor signed an agreement to buy Eurosilicone SA, a breast implant maker, for million, according to McGhan’s guilty plea for wire fraud. But McGhan was turned down for financing after meeting with various potential lenders, according to his plea agreement. He had until June 30, 2004 to find the cash.

Within weeks, he agreed to buy yet another company called Southwest Exchange Inc, which acted as an intermediary for real estate transactions and was sitting on 0 million of client escrow accounts, more than enough to buy Eurosilicone.

McGhan bought Southwest Exchange on June 28 for million and within two days began sweeping out client money to buy the French implant maker, according to a lawsuit brought by Southwest Exchange clients in Nevada in 2007.

“They had to buy a company, steal the money, launder the money and get it out of the U.S.” in a matter of days, said Robert Brace, an attorney who sued McGhan over McGhan’s management of Southwest Exchange. “It was an amazing feat, really.”

For two years, while the real estate bubble continued to inflate, Southwest Exchange’s escrow accounts overflowed with readily available cash to prop up MediCor and, according to the lawsuit, fund a lavish lifestyle. The lawsuit by Southwest Exchange’s clients alleges that McGhan diverted their money to buy a 19-seat jet, ,000 dinners and private schooling for children of the McGhan family. Brace said McGhan even bought a golf course.

When the U.S. real estate market began to founder in the middle of 2006, the net client inflows into Southwest Exchange became severe outflows. McGhan was unable to meet the client cash demands and within a year the Southwest Exchange had collapsed, according to his guilty plea.

By the end of 2007, MediCor was also bankrupt, and McGhan would eventually plead guilty to wire fraud in 2009, according to his guilty plea and bankruptcy court filings. PIP said MediCor’s bankruptcy left it with an unpaid debt of million, which represented the sales MediCor had promised but failed to deliver in the U.S. market. The claim was never paid. In 2009, PIP also filed for bankruptcy.

(Additional reporting by Anna Yukhananov in Washington; Editing by Michele Gershberg and Claudia Parsons)

Reuters: Health News

By Brian Rohan

BERLIN |
Fri Jan 6, 2012 6:01pm EST

BERLIN (Reuters) – German and British health officials issued conflicting messages on Friday about the health risk posed by breast implants made by a French company at the heart of a global health scare and whether they should be removed.

BERLIN (Reuters) – German and British health officials issued conflicting messages on Friday about the health risk posed by breast implants made by a French company at the heart of a global health scare and whether they should be removed.

Germany’s Federal Office for Pharmaceuticals and Medical Devices advised women with implants made by Poly Implant Prothese (PIP) to have them taken out, saying reports from doctors had shown they might constitute a health risk.

However, following a review by its experts, Britain’s Department of Health said it had found no evidence to warrant the routine removal of the implants.

The conflicting government advice reflects a wider lack of international agreement over the regulation of medical devices, like implants, and the risks they pose.

The new head of Europe’s drugs watchdog told Reuters on Friday there was an acute need to tighten controls on medical devices. Guido Rasi, executive director of the European Medicines Agency (EMA) they needed the same level of regulation as medicines.

The scandal erupted when the French government advised 30,000 women to have PIP implants removed because of reports that the implants were more prone to rupturing than standard medical implants.

Concern focused on the death from cancer last year of a French woman with PIP implants.

About 300,000 PIP implants were sold worldwide before the firm went out of business in 2010 after an official investigation revealed it was using a cheaper unapproved industrial-grade silicone in some of its products.

Germany had advised women with implants to have them examined last month but it upped its warning after reports showed silicone could seep out without signs of tearing.

“The Office thus recommends that the implants in question be removed as a precautionary measure,” Walter Schwerdtfeger, President of the Federal Office for Pharmaceuticals and Medical Devices, said in a statement.

“The urgency for removal in each case depends mainly on how long the patients have had the implants.”

“NO CANCER LINK”

The UK expert review said it had found no link between the implants and cancer, but had not been able to establish if the PIP implants were more likely to rupture than others, saying information from the industry to the regulator was patchy.

“The data available to the experts has not been good enough to enable them to give a clear recommendation of the risk posed by PIP implants,” Health Secretary Andrew Lansley said in a statement.

But while Britain said there was no reason for the implants to be routinely removed, Lansley said patients who had received implants through the state-funded National Health Service (NHS) could have these removed and replaced by the NHS.

He added private health clinics were expected to provide the same service and Britain’s two largest private hospital providers, BMI Healthcare and Spire Healthcare, both said they would offer their patients free implant removal and replacement.

Anger with PIP was further fuelled on Friday when a police document was leaked to media which showed the company’s boss had admitted willfully lying about the implants’ poor quality and had accused women of filing complaints in return for money.

“I knew the gel was not standard but I did it consciously because the PIP gel was cheaper,” Jean-Claude Mas, the founder and chief executive of PIP is quoted as saying in a transcript of an interview with police in late 2010.

“This formula is perfect, it is better than the one used to make standard gel,” he said according to the document leaked in the French media and obtained by Reuters.

Lawyers representing women with PIP implants said Mas was treating their clients with disdain.

“Jean-Claude Mas is showing complete cynicism with regard to the victims,” said lawyer Laurent Gaudon, whose clients accuse PIP and surgeons who used the firm’s implants of fraud.

(Additional reporting by Michael Holden in London and Francois Revilla in Marseille; Writing by Michael Holden; Editing by Andrew Heavens)

Reuters: Health News

Wed Jan 4, 2012 12:47am EST

(Reuters) – Children who get more exercise also tend to do better in school, whether the exercise comes as recess, physical education classes or getting exercise on the way to school, according to an international study.

(Reuters) – Children who get more exercise also tend to do better in school, whether the exercise comes as recess, physical education classes or getting exercise on the way to school, according to an international study.

The findings, published in the Archives of Pediatrics & Adolescent Medicine, come as U.S. schools in general cut physical activity time in favor of more academic test preparation.

Amika Singh, who worked on the study, said the findings meant that schools should prioritize both academics and exercise and that families could have the same attitude at home.

“Maybe it’s an activity break, stand up every half an hour in class and do something,” said Singh, from VU University Medical Center in Amsterdam.

“It might mean going to school by bike … Any kind of physical activity you can think of. It doesn’t mean only the physical education standard class.”

Singh and her colleagues reviewed 14 studies that compared kids’ physical activity with their grades or scores on math, language and general thinking and memory tests.

Those included two types of reports, such as 10 so-called “observational studies” in which researchers asked parents, teachers or students themselves how active they were, then followed them for a few months to a few years to track their academic performance.

In the four other studies, one group of kids was given extra time for physical education classes and other health and fitness exercises, and their test scores were later compared against a group of kids who didn’t get extra exercise.

When researchers asked students how much time they spent exercising, they found that those with higher rates of physical activity did better in the classroom.

Three of the four studies involving an exercise intervention found that students given more exercise time scored higher on measures of academic performance.

In one report from the United States, second and third graders who got an extra 90 minutes of physical activity per week did better on a test of spelling, reading and math, along with gaining less weight over the next three years.

That may be because children are better behaved and can concentrate better when they get enough exercise, or because physical activity improves blood flow to the brain and boosts mood, the researchers wrote.

“There’s obviously the long-term links between physical activity and health,” said Sandy Slater, who has studied recess and physical education at the University of Illinois at Chicago but wasn’t involved in the latest study.

“But this is another reason to try to continue to keep some dedicated amount of time for physical education or recess or some other types of physical activity in the school day.”

Recent research has suggested that many U.S. children are not getting the recommended amount of physical education and recess endorsed by the American Heart Association, which includes two and a half hours of physical education a week and 20 minutes of recess every day.

SOURCE: bit.ly/rMXkHY

(Reporting from New York by Genevra Pittman at Reuters Health; Editing by Elaine Lies and Yoko Nishikawa)

Reuters: Health News

BEIJING |
Sat Dec 31, 2011 5:52am EST

BEIJING (Reuters) – A man in southern China’s Guangdong province died of bird flu Saturday a week after being admitted to hospital with a fever, state media reported.

BEIJING (Reuters) – A man in southern China’s Guangdong province died of bird flu Saturday a week after being admitted to hospital with a fever, state media reported.

The 39-year-old bus driver living in Shenzhen, just across the border from Hong Kong, developed symptoms on December 21 and was admitted to a hospital on December 25 because of severe pneumonia, the official Xinhua news agency said.

He died in the early afternoon, having tested positive for the H5N1 virus, the brief report added.

Guangdong’s official newspaper, the Southern Daily, said separately that 120 people who had contact with the man had developed no signs of sickness.

About 10 days ago Hong Kong culled 17,000 chickens at a wholesale poultry market and suspended all imports of live chickens from mainland China for 21 days after a dead chicken there tested positive for the H5N1 virus.

The virus is normally found in birds but can jump to people who do not have immunity to it. Researchers worry it could mutate into a form that would spread around the world and kill millions.

In recent years, the virus has become active in various parts of the world, mainly in east Asia, during the cooler months.

Authorities in China are worried about the spread of infectious diseases around this time when millions of Chinese travel in crowded buses and trains across the country to go home to celebrate the Lunar New Year.

The current strain of H5N1 is highly pathogenic, kills most species of birds and up to 60 percent of the people it infects.

Since 2003, it has infected 573 people around the world, killing 336.

The virus also kills migratory birds but species that manage to survive can carry and disperse the virus to new, uninfected locations.

It transmits less easily between people but there have been clusters of infections in people in Indonesia and Thailand in the past.

(Reporting by Ben Blanchard; Editing by Ed Lane)

Reuters: Health News