Initial reports said that the 13 workers on the rig were accounted for but were floating in the water near the rig. Twelve of the workers are reportedly wearing immersion suits, and one worker is reportedly injured.

According to the U.S. Coast Guard, the rig platform was fixed in 340 feet of water and the rig was in production at the time of the fire. Workers have told authorities that they had started emergency shutdown procedures before evacuating.

The platform does not have a standard blow-out preventer, according to the U.S. Coast Guard.

White House spokesman Robert Gibbs addressed the rig explosion in his daily briefing saying, “We obviously have response assets ready for deployment, should we receive reports of pollution in the water.”

The U.S. Coast Guard has seven helicopters, two fixed-wing planes and a number of watercraft on the way to the scene. The vidtims are expected to be taken directly to area hospitals, according to ABC affiliate KATC.

The rig, positioned 80 miles south of Vermillion Bay in Louisiana, is owned by Mariner Energy. It was not immediately known what caused the explosion, but the rig reportedly remained on fire after the explosion.

Phone messages left for Mariner Energy were not immediately returned.

It is unclear whether oil is leaking into the water.

According to the authors of the trial, which was funded by Meridia’s maker, Abbott, the findings are generally in line with what has been known about the drug and shouldn’t change how it is used.

“The only time you’ve got an increase in heart attacks or strokes were in those patients who had had previous heart disease or strokes, in other words, the people who should never have received the drug in the first place,” said Dr. Philip T. James, a professor at the London School of Hygiene and Tropical Medicine in England, and first author on the paper, which appears in the Sept. 2 issue of the New England Journal of Medicine.

Since January, Meridia (sibutramine) has carried a label warning that it should not be used by people with preexisting heart disease, so “the current prescription is entirely appropriate,” James said.

However, not everyone agrees. The FDA is slated to meet in September to decide if more regulatory action perhaps a tougher “black-box” warning or even removing Meridia from the market should be taken.

According to Dr. Greg Curfman, executive editor of the NEJM and co-author of an accompanying editorial, the FDA’s January warning was based on preliminary information only. The new study results represent the first hard data, “the first outcomes trial,” he said.

Based on the findings, he and others wonder if the drug is worth keeping around.

The drug did not seem to make people healthier, Curfman said. “Some people were actually made worse,” he said. “All this taken together results in an unfavorable risk-benefit profile and, based on that, we don’t see a rationale for keeping this on the market.”

Also, he said, “the efficacy of producing weight loss with the drug is very unimpressive. In this trial, patients lost on average less than 4 kilograms [about 9 pounds] and we know that that’s not going to translate into a real health benefit over time. It’s not enough weight loss. The FDA has a benchmark of about 5 percent loss of baseline body weight to consider a weight loss drug [effective].”

A University of Rochester expert concurs.

“I have never really found that people taking Meridia had obtained a real substantive weight loss,” said Dr. J. Chad Teeters, assistant professor of clinical medicine, cardiology division at the University of Rochester Medical Center. “It seems that a lot of these ‘quick fix’ weight loss drugs don’t really live up to the hype and they come with risks. I think there’s probably going to be a significant downturn in the use of the drug given the low efficacy and increased risk of side effects.”

This trial involved almost 11,000 older overweight or obese adults with type 2 diabetes or heart disease or both who were randomized either to take Meridia or a placebo and followed for about 3.4 years.

In the group taking Meridia, 11.4 percent had a heart attack, stroke or died as the result of a heart problem, versus 10 percent in the control group, a 16 percent increase.

People taking Meridia also had a 28 percent higher risk for nonfatal heart attack and a 36 percent raised risk for nonfatal stroke, compared to those taking placebo, the authors found.

All trial participants were also engaged in a diet-and-exercise program to lose weight, whether they were taking the drug or not, said study author James. “Meridia is not a wonder drug that guarantees people lose weight but it is a major additional help for people who change their diet and increase their physical activity,” he said.

But Teeters narrowed the prescription. “Good old-fashioned diet and exercise is the only substantive sustained therapy that’s shown to be helpful,” he said. “There’s no quick-fix pill.”

Wright County Egg of Galt, Iowa, whose chicken-feed samples tested positive for salmonella, has suggested the contamination might have come from a feed ingredient, bone meal, supplied by another company. That company, Central Bi-Products of Redwood Falls, Minn., strongly disagreed and said its heat-processed bone meal was untainted when it was shipped.

The FDA said it still didn’t know where the contamination found by its inspectors originated. It issued a report on August 30, 2010 citing many sanitation problems at Wright’s facilities, such as flies, frogs, pigeons, piles of chicken manure, and bird droppings.

The tainted eggs haven’t been tied to any deaths, according to the U.S. government. The strain of bacteria linked to the illnesses was found in feed made by Wright’s parent company, Quality Egg LLC, which also supplies the other major egg producer in the recall, Hillandale Farms of Iowa.

Wright raised the issue of its supplier last week when the FDA said the feed and bone meal showed traces of salmonella. Wright spokeswoman Hinda Mitchell said the company kept bone meal in an overhead bin and the ingredient was tested separately by FDA officials.

“This finding obviously is of great concern to us,” Wright said in a statement, adding that the company provided the FDA with information about its supplier and immediately notified that company of the testing results.

Central Bi-Products’s president, Don Davis, said in an interview that he was “shocked and surprised” that anyone was suggesting his bone-meal ingredients were tainted, in light of recent FDA reports on Wright County Egg farms.

He said Central Bi-Products heats its meat and bone meal to temperatures of up to 260 degrees to kill any bacteria, including salmonella, and hires a company to test its products regularly. The ingredients are later added to the chicken feed as a protein supplement. It appears “obvious” that any contamination occurred after the meal left Central’s plant, Mr. Davis said.

If that is so, the question remains as to when the salmonella got into the feed, which the FDA has said is a likely source of infection in the chickens and their eggs.

The sanitary conditions in the Quality Egg feed mill, where feed and feed ingredients are stored, showed multiple points of possible contamination, according to the FDA.

Storage bins containing ingredients including the meat and bone meal were rusted, porous and exposed to live birds and avian feces, FDA investigators said. They also said rodents, a major source of salmonella, appeared to have access to many parts of the barn.

Quality Egg mixes the bone meal with corn and soy meal to make the feed that is given to chickens. An FDA official said individual ingredients were usually heat-treated but the final feed wasn’t processed again.

Central Bi-Products’s Mr. Davis said his company didn’t sell directly to Wright or Quality Egg but went through a middleman. He said Central Bi-Products, which is part of Farmers Union Industries LLC, supplies many farms and feed distributors. According to FDA officials, only two egg farms: Wright and Hillandale appear to be linked to the contamination.

U.S. researchers revealed that black patients are at increased risk of developing life-threatening blood clots after receiving a drug-coated stent to prop open narrowed arteries, according to a recent HealthDay News report.

The new study included more than 7,200 patients who had stents coated with clot-prevention drugs implanted between mid-2003 and the end of 2008. The researchers found that black patients were nearly three times more likely to develop a clot compared to patients of other races. In fact, being black was the strongest predictor that clotting would occur more than one month after implantation of a drug-coated stent, the study authors noted.

When the researchers took into account other known risk factors for clotting including diabetes, high blood pressure and kidney problems; black patients still had a higher rate of developing a blood clot, according to the study results.

The clotting rates for blacks compared to non-blacks were:

• 1.71 percent versus 0.59 percent after 30 days.
• 2.25 percent versus 0.79 percent after one year.
• 2.78 percent versus 1.09 percent after two years.
• 3.67 percent versus 1.25 percent after three years.

The findings held true even though black patients took their prescribed anti-clotting medication at a higher rate than other races, the study authors pointed out. Possible genetic differences in the way the patients’ bodies react to the anti-clotting medication may be one potential cause that needs further study, the researchers suggested in a news release from the American Heart Association.

The study also found that the rate of death from all causes after three years was almost 25 percent for black patients compared to about 13 percent for patients of other races.

The higher death rates among black patients are “not just because this population is sicker or less compliant, but there is something else there that needs to be explored,” lead author Dr. Ron Waksman, associate director of the cardiology division at Washington Hospital Center and a professor of medicine and cardiology at Georgetown University, said in the news release.

The study was released online in advance of publication in an upcoming print issue of the journal Circulation.

DePuy Orthopaedics Inc. said it is recalling two hip replacement products because new data, about to be released, show higher-than-expected rates of patients needing a second hip replacement procedure. Within five years, one in eight patients needed a revision surgery. That’s required when an artificial joint doesn’t fit perfectly, causing pain and difficulty walking. The products are the ASR Hip Resurfacing System and the ASR XL Acetabular System.

Each of the metal systems is used to replace a worn or weakened part of the hip, which consists of a socket at the outer edge of the pelvis and a rounded bone atop the thigh bone that fits into that socket like a ball. Total hip replacement involves replacing both parts at once.

The ASR Hip Resurfacing System replaces the ball portion of the hip and has a metal stem that fits into the top of the hip bone, or femur. The ASR XL Acetabular System is a concave metal piece used to provide a smooth lining for the acetabulum, the bowl-shaped socket in the pelvis.

DePuy, part of Johnson & Johnson of New Brunswick, N.J., said data it received from the National Joint Registry of England and Wales shows that within five years, about 12 percent of people getting the hip resurfacing system and about 13 percent of those getting the acetabular system needed corrective surgery. Women were more likely to need a second surgery than men.

DePuy said previous data “had shown lower revision rates and that the ASR hip was performing in line with other devices in its class.”

The acetabular system, launched in 2004, has been sold worldwide. The resurfacing system, introduced in 2003, is only sold outside the U.S.

DePuy decided last fall to discontinue both, Gawreluk said. The company is working on developing a new generation of both products.

On August 24, 2010, the FDA told DePuy to stop selling its Corail Hip System for two unapproved uses. It also ordered the company to provide information needed to review another product the agency said DePuy has been selling even though it was never approved. It’s called the TruMatch Personalized Solution System, and uses software and high-tech CT scanning technology to create a 3-D view of a patient’s knee to help a surgeon position a knee implant.

Additionally, on August 23, 2010, Johnson & Johnson recalled millions of 1 Day Acuvue TruEye contact lenses sold in Asia and Europe because some users complained of stinging or pain when they inserted the lenses.

Johnson & Johnson remains under scrutiny by the FDA, Congress and federal prosecutors over eight previous U.S. recalls of nonprescription medicines since last September. Those included millions of bottles of Tylenol, other pain relievers and cold medicines for children and adults, for problems including bacterial contamination and tiny metal savings found in some bottles.

The huge recall Toyota’s 15th in 2010 came just two days after the National Highway Traffic Safety Administration announced it was ratcheting up its investigation of the stalling problem. NHTSA said it has received 163 complaints. Toyota blamed the faulty computer, called an electronic control module or ECM for the stalling and said it will replace them in the recalled vehicles. The company said it has three unconfirmed reports of crashes, including one involving an injury.

Owners will be informed of the recall by mail in September and then will get a second letter when dealers have the parts for the repair.

Of all of the 5.8 million cars that Toyota has recalled since January 1, this is the first that involves a problem with the engine computer. Toyota continues to defend the ECM against allegations that it might be at fault in some sudden-acceleration incidents, which have already prompted two huge Toyota recalls for mats that can jam the gas pedal and pedals that can stick open.

Some auto-safety advocates say it raises new doubts about the ECMs.

“If you can get it wrong on stalling, you can get it wrong on unintended acceleration,” says Clarence Ditlow, executive director of the Center for Auto Safety in Washington, D.C.

And Sean Kane of Safety Research & Strategies said the stalling problem is similar to runaway car problems in that the computers don’t always create diagnostic trouble codes that let mechanics or investigators figure out what went wrong. “The heart of the problem is really their inability to detect the problem.”

Toyota has known about the stalling problem for years. It issued four technical service bulletins, the most recent in 2007, telling mechanics about the problem and instructing them to replace the module. But it did not deem the problem to be a safety risk needing a recall.

It was only after extreme temperature tests in which four of 32 units malfunctioned that Toyota decided to voluntarily proceed with the recall, Hanson said. It was found stalling could be due to faulty coating on the module’s circuit boards or a crack in the surface of a glass coating.

The move came after three people, two in Maine and one in New York, were identified as becoming ill from a strain of E. coli, the government said. The USDA says it believes certain BJ’s Wholesale Club stores in Connecticut, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York and Virginia received the products.

The recalled ground beef was shipped June 11 to distribution centers, where it was repackaged into consumer-size packages and sold under different retail brand names. The USDA did not identify the brands.

The recalled beef bears the USDA establishment number “EST. 9400,” a product code of “W69032″ and a “use/freeze by” date of July 1.

The USDA’s Food Safety and Inspection Services, which said it became aware of the problem on August 5, “determined that there is an association between the ground beef products subject to recall and the cluster of illnesses in the states of Maine and New York.”

Saturday’s statement identified the strain as E. coli 026, which can cause bloody diarrhea, dehydration and, in severe cases, kidney failure.

The government “strongly encourages consumers to check their freezers and immediately discard any product subject to this recall.”

The government lists the recall as Class 1, meaning “there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.”

Consumers with questions regarding the recall should contact the Cargill consumer line at (877) 788-4953.

Each year, tens of millions of people in the United States are sickened and millions are killed or injured as a result of complications caused by food poisoning each year.

On July 9, 2010, a medical reviewer for the FDA announced that drug maker GlaxoSmithKline misinterpreted crucial details of a study finding that Avandia, its blockbuster diabetes drug, is safe, according to a recent New York Times news story.

On August 19, 2010, federal drug regulators ordered GlaxoSmithKline to send a letter to key doctors describing a July expert advisory panel that discussed the risks of Avandia, the company’s controversial diabetes medicine. But the company’s letter is misleading and could endanger patients, a federal official and some members of the panel said. (Text of the letter.)

The dispute comes as the FDA is expected in the coming weeks to announce either new warnings for Avandia’s label, a program to restrict its sales or the drug’s complete withdrawal from the market.

Doctors who received the letter are investigators in a study called the Tide trial, which is intended to compare the heart risks of Avandia with a similar drug made by Takeda, Actos. The ethics of the Tide trial were a point of contention during the advisory committee hearing, and the F.D.A. ordered GlaxoSmithKline to stop recruiting new patients into the study, although patients already in the study could continue.

Dr. David Graham, an F.D.A. medical officer, gave an impassioned presentation at the advisory meeting arguing that the study should be stopped because patients in the trial are being exploited. None of
these arguments were referenced or described in GlaxoSmithKline’s letter.

“This summary is biased, misleading and not truthful,” Dr. Graham said in an interview. “The whole purpose of this letter is so that they can reassess whether this is an ethical trial going forward, but the step-by-step ethical flaws and problems with the Tide trial are not even referenced.”

Several members of the advisory committee complained that the company’s letter was biased. “This letter is really deceptive,” said Dr. Clifford Rosen, a panel member. Dr. Rosen said that the letter made no reference to a presentation by members of an Institute of Medicine study panel about the usefulness of observational studies.

Dr. Curt D. Furberg, a panel member, described the company’s letter as “very Avandia friendly” that ignored much of the discussion criticizing the validity of the company’s studies. Other panel members expressed similar reservations but Dr. Sanjay Kaul, a panel member, disagreed and said the company’s letter “faithfully reflects the deliberations of the Avandia advisory meeting.”

Erica Jefferson, an F.D.A. spokeswoman, said that after ordering GlaxoSmithKline to send a meeting summary to the Tide investigators, the agency relied on the company to provide a balanced account.

“F.D.A. did not pre-clear or approve the content,” she said. Mary Anne Rhyne, a GlaxoSmithKline spokeswoman, said that the company had only one week to write the summary, which was necessarily brief.

But the company and the leader of the Tide trial agreed that the letter “reflected the science and data discussed at the advisory committee meeting,” she said.

Dr. Steven Nissen, a Cleveland Clinic cardiologist who made a presentation before the committee arguing for Avandia’s withdrawal, said that GlaxoSmithKline’s letter failed to mention that the committee concluded that Avandia carries a higher risk of heart attack than Actos.

“Since the Tide trial compares these two alternative therapies, this omission does not meet any reasonable ethical standards,” Dr. Nissen said.

The dispute is part of a continuing battle over what the committee actually decided in July. The committee’s most important vote was whether Avandia should remain on the market and, if so, how. Five different options were offered. Three panel members voted for no change; 7 voted to add more warnings to the drug’s label; 10 voted to severely restrict the drug’s marketing; and 12 voted that the drug should be withdrawn. One abstained.

Some commentators emphasized that a majority of the panel voted to keep the drug on the market. Others noted that a majority voted to withdraw or severely restrict the drug’s sales. The former group interpreted the meeting as largely positive for GlaxoSmithKline; the latter said it was a blow.

This argument has now spilled into a dispute about a letter attempting to explain the committee’s discussion. If the drug is withdrawn, this latest dispute will disappear since the Tide trial itself would likely end.

Teens from around the world who regularly take acetaminophen, best known as Tylenol, were more than twice as likely to have asthma as teens who never take the over-the-counter pain and fever reducer, new research finds. Taking acetaminophen was also linked to an increased chance of eczema and rhinoconjunctivitis, or allergic nasal congestion, in adolescents.

Because the study was epidemiological meaning researchers asked teens to report after-the-fact how often they took acetaminophen researchers said they can’t prove that acetaminophen helps cause asthma. But the study is one of several in recent years that has linked acetaminophen usage during pregnancy or childhood to an increased risk of developing asthma.

“We cannot assume causation, but the association was found in widely different communities, with widely different patterns of illness and lifestyles,” said study author Dr. Richard Beasley, a professor of medicine at the Medical Research Institute of New Zealand. “When you put it together with all of the other studies, clearly there is [cause for concern].”

Nearly 323,000 children between the ages of 13 and 14 who were participating in the International Study of Asthma and Allergies in Childhood answered questionnaires about their use of acetaminophen and history of wheezing, nasal congestion and recurrent, itchy rashes.

“Medium” users of acetaminophen were those who had taken the drug at least once during the prior year; “high” users were those who reported taking acetaminophen at least once a month for the past year.

The risk of having asthma was nearly 2.5 times higher among frequent users, and 43 percent higher among medium users than those who never took acetaminophen.

Frequent users of acetaminophen were also more than twice as likely to have rhinoconjunctivitis as kids who never took the drug, while medium users had a 38 percent greater risk. For eczema, frequent users had a 99 percent increased risk, while medium users had a 31 percent increased risk.

The study also found an association with frequency of use and severity of asthma symptoms. Frequent users of acetaminophen were 2.75 times as likely to say their wheezing was so bad it disturbed their sleep and limited their ability to speak, Beasley said.

The study will be published Aug. 13 on the American Thoracic Society’s Web site and will later appear in the American Journal of Respiratory and Critical Care Medicine.

Marc Boston, a spokesman for McNeil Consumer HealthCare, which makes Tylenol, said in a statement that “there are no prospective, randomized controlled studies that show a causal link between acetaminophen and asthma.”

He also noted that “the authors of this [new] study also published data in the September 2008 edition of The Lancet. In the press release that accompanied that data, they stated that, ‘international asthma guidelines recommend that for both children and adults with asthma, [acetaminophen] is the preferred drug to relieve pain or fever.’”

A second study in the American Journal of Respiratory and Critical Care Medicine, conducted among children in Ethiopia, also found a link between acetaminophen use and asthma, but not eczema.

Researchers followed some 1,065 women during pregnancy and for three years after their children were born. Between ages 1 and 3, about 7.7 percent of children had experienced wheezing.

Children who had taken one to three tablets of acetaminophen in the past month were 88 percent more likely to have asthma, while children who had taken four tablets were more than seven times more likely to have asthma.

“These two studies further contribute to what appears to be mounting evidence of an association between acetaminophen and asthma and potentially other allergic diseases,” said Matthew Perzanowski, an associate professor of environmental health sciences at Columbia University’s Mailman School of Public Health.

So what should parents do?

Experts said a link between ibuprofen, another over-the-counter pain and fever reducer, and asthma has not been reported. Yet experts continue to recommend acetaminophen for asthmatic children, Beasley said, because in some asthmatics, ibuprofen may bring on or worsen asthma symptoms.

“Acetaminophen is still the preferred drug for children to take who have asthma. Its safety profile is better than ibuprofen, and our findings don’t change that,” Beasley said.

Yet limiting the use of acetaminophen is probably a wise idea, said Dr. Andy Nish, an allergist at the Allergy and Asthma Care Center in Gainesville, Ga.

“My personal opinion is it would be reasonable, particularly in families that had the tendency toward allergic diseases such as asthma, hay fever and eczema, to use acetaminophen judiciously, and perhaps consider the use of an alternative,” Nish said.

Young children should not be given aspirin, he noted.

Researchers believe acetaminophen may impact the development of asthma by altering the body’s immune response. Previous studies have suggested that acetaminophen may lower levels of glutathione in the lungs, which is involved in detoxifying the body, Perzanowski said. Other research has found that children with asthma have lower levels of glutathione in the lungs than those without asthma.

Asthma rates have been climbing in developed nations over the last 30 years, leading researchers to wonder what about the modern Western world could be contributing. Previous research found using acetaminophen during the first year of life increased the chances of having asthma at age 6 or 7.

Beasley, Perzanowski and other experts said the next step is conducting a randomized, controlled trial the gold standard of medical studies to see if acetaminophen really is the cause.

But there remain other possible explanations for the asthma-acetaminophen link. Children who have asthma or who will go on to receive an asthma diagnosis may develop more colds and respiratory illnesses, or may seem to have worse colds, than other kids, Perzanowski said. Colds can cause fever, which may prompt parents to give acetaminophen.

Frequency of acetaminophen use varied among countries, with only 2 percent of children in Taiwan taking it more than once a month, while 68 percent of kids in Nigeria did.

One company, drug repackager Advantage Dose, accounted for more than 1,000 of those recalls. Even excluding Advantage Dose, which has shut down, recalls jumped 50% last year.

“We’ve seen a trend where the last four years are among the top five for the most number of drug recalls since we began tallying recalls in 1988,” said Bowman Cox, managing editor of the Gold Sheet. “That’s a meaningful development.”

The fast pace of drug recalls seems to be continuing in 2010. Drug recalls totaled 296 from January through June of this year, said Cox. “If we continue at this same rate, we could get 600 or more recalls by the end of the year,” he said. “That’s still a very high rate of recalls.”

High-profile recalls of Tylenol and other products by McNeil Consumer Healthcare, a unit of Johnson & Johnson, have drawn attention to quality concerns in manufacturing.

The growing problems over recalls have also drawn attention from lawmakers. Two bills introduced this year would impose stricter regulations on the industry and give the FDA authority to mandate recalls.

The spike in recalls, especially of generic and over-the-counter drugs, is being driven by manufacturing lapses, experts say. Some of the biggest culprits: the quality of raw materials, faulty labeling and packaging and contamination.

Cause for concern

A number of factors are fueling the recall surge. The stampede by drug makers to be first to bring generic versions to market, after drugs lose patent protection, is one of them.

“The first applicant typically gets the lion’s share of the business for the new drug,” said Cox.

Generic drugs account for about three quarters of all prescription drug sales, according to industry group PhRMA.

In their hurry, drug makers sometimes fail to spend enough time time learning how best to make the drug.

For example, Detroit-based Caraco Pharmaceutical Laboratories issued four “tablet-thickness” recalls on March 31, 2009, an additional one on June 8 and yet another recall on April 17 for products that might have been contaminated, said Cox.

“So they get the application. They make and market the drug, but they could still have problems down the road if they haven’t really understood the optimum way to make that drug,” said Cox.

Caraco could not be reached for comment.

Drug makers aren’t the only ones that have run into problems. Repackagers that relabel drugs into smaller units for resale or distribution to health care facilities have also had serious lapses.

Advantage Dose, which led last year’s recalls by far, is one such company. It issued 1,106 recalls last year following the FDA’s inspection of its facility in late 2008. According to the Gold Sheet report, the FDA’s inspection listed a wide range of manufacturing problems.

Cost pressures

Another reason for the recalls: Cost cutting that goes too close to the bone.

Drug makers, facing intense competition, are trimming manufacturing investment or outsourcing production, said Prabir Basu, executive director of the National Institute for Pharmaceutical Technology and Education, a nonprofit scientific and research organization.

“It is very expensive to make drugs. It also costs a lot of money to maintain adequate quality controls,” Basu said. “You have to invest a lot.”

And since generic and over the counter drugs aren’t as lucrative for drug makers as prescription drugs, companies may not be investing enough resources to make high-quality, safe products.