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Archive for the ‘FDA’ Category

I recently picked up a book titled ” The China Study”, which was published in 2006.  After having read it from cover to cover, I was flabbergasted – to say the least – and hope anyone who reads this post will read it as well. It’s an eye opener.

During the past two to three decades, we have acquired substantial evidence that most chronic diseases in America can be partially attributed to bad nutrition. Expert government panels have said it, the surgeon general has said it and academic scientists have said it. More people die because of the way they eat than by tobacco use, accidents or any other lifestyle or environmental factor. We know that the incidence of obesity and diabetes is skyrocketing and that the Americas’ health is slipping away, and we know what is to blame: diet. So shouldn’t the government be leading us to better nutrition? There is nothing better the government could do that would prevent more pain and suffering in the country than telling Americans unequivocally to east least animal products, less highly-refined plant products and more whole, plant-based foods. It is a message soundly based on the breadth and depth of scientific evidence, and the government could make this clear, as it did wit cigarettes. Cigarettes kill, and so do these bad foods. But instead of doing this, the government is saying that animal products, dairy and meat, refined sugar and fat in your diet are good for you.

The government is turning a blind eye to the evidence as well as to the millions of Americans who suffer from nutrition-related illness. The covenant of trust between the U.S. government and the American citizen has been broken. The Untied States government is not only failing to put out our fires, it is actively fanning the flames.

Dietary Ranges: The Latest Assault

The Food and Nutrition Board (FNB), as part of the Institute of Medicine (IOM) of the National Academy of Sciences, has the responsibility every five years or so to review and update the recommended consumption of individual nutrients. The FNB has been making nutrient recommendations since 1943 when it was established a plan for the U.S. Armed Forces wherein it recommended daily allowances (RDAs) for each individual nutrient.

In the most recent FNB report, published in 2002, nutrient recommendations are presented as rangers instead of single numbers, as was the practice until 2002. For good health, we are now advised to consume 45% to 65% of our calories as carbohydrates. There are ranges for fat and protein as well.

A few quotes from the news release announcing this massive 900+ page report say it all. Here is the first sentence in the news release.

To meet the body’s daily energy and nutritional needs while minimizing risk for chronic disease, adults should get should get 45% to 65% of their calories from carbohydrates, 20% to 35% from fat and 10% to 35% from protein …

Further on, we find:

… added sugars should comprise no more that the 25% of total calories consumed … added sugars are those incorporated into foods and beverages during production and major sources include candy, soft drinks, fruit drinks, pastries and other sweets.

Let’s take a closer look. What are these recommendations really saying? Remember, the news release starts off by stating the report’s objective of  “minimizing the risk for chronic disease.” This report says that we can consume a diet contaning up to 35% of calories as fat; this is up from the 30% limit of previous reports. It also recommends that we can consume up to 35% of calories as protein; this number is far higher that the suggestion of any other responsible authority.

The last recommendations puts the frosting on the cake, so to speak. We can consume up to 25% of calories as added sugars. Remember, sugars are the most refined type of carbohydrates. In effect, although the report advises that we need a minimum of 45% calories as carbohydrates, more than half of this amount (i.e., 25%) can be the sugars present in candies, soft drinks and pastries. The critical assumption of this report is this:  the American diet is not only the best there is, , but you should now feel free to eat an even richer diet and still be confident that you are “minimizing risk for chronic disease.” Forget any words of caution you may find in this report – with such a range of possibilites, virtually any diet can be advocated as minimizing disease risk.

You may have trouble getting your mind around what these figures mean in everyday terms, so I have prepared the following menu plan that supplies nutrients in accordance with these guidelines.

Chart 16.1 – Sample Menu That Fits Into The Acceptable Nutrient Ranges

Meal                                                                                                    Foods

Breakfast                                                                                            1 cup Froot Loops

                                                                                                               1 cup skim milk

                                                                                                               1 package M&M milk chocolate candies

                                                                                                               Fiber and vitamin supplements

Lunch                                                                                                  Grilled cheddar cheeseburger

Dinner                                                                                                 3 slices pepperoni pizza, 1-160z. soda

                                                                                                                1 serving Archway sugar cookies

Chart 16.2 – Nutrient Profile Of Sample Menu And Report Recommedations

Nutrient                                                                          Sample Menu Content                                              Recommended

Total Calories                                                                          1800                                                                    Varies by height/weight

Protein (% of total calories)                                               18%                                                                               10-35%

Fat (% of total calories)                                                        31%                                                                               20-35%

Carbohydrates (% of total calories)                                 51%                                                                              45-65%

Sugars in Sweets, or Added Sugars                                  23%                                                                               Up to 25%                                     (% of total calories)

I’m not kidding – This disastrous menu plan fits the recommendations of the report and is supposedly consistent with “minimizing chronic disease.”

What’s amazing is that I could put together a variety of menus, all drenched in animal foods and added sugars, that conform to the recommended daily allowances. At this point in the book, I don’t need to you that when we eat a diet like this day in and day out, we will be not just marching , but sprinting into the arms of chronic disease. In sad fact, this is what a large portion o f our population already does.

Protein

Perhaps the most shocking figure is the upper limit on protein intake. Relative to total calorie intake, only 5-6% dietary protein is required to replace the protein regularly excreted by the the body (as amino acids). About 9-10% protein, however, is the amount that has been recommended for the past 50 years to be assured that most people at least get their 5-6% “requirement.”  This 9-10% recommendation is equivalent to the well-known recommended daily allowance, or RDA.

Almost all Americans exceed this 9-105 recommendation; we consume protein within the range of about 11-21%, within an average of about 15-16%. The relatively few people consuming more than 21% protein mostly are those who “pump iron,” recently joined by those on high-protein diets.

It is extremely puzzling that these new government-sponsored 2002 FNB recommendation now say that we should be able to consume protein up to the extraordinary level of 35% as means of minimizing chronic diseases like cancer and heart disease. This is an unbelievable travesty, considering the scientific evidence. The evidence presented in this book shows that increasing dietary protein within the range of about 10-20% is associated with a broad array of health problems, especially when most of the protein is from animal sources.

Furthermore, the FNB panel had the audacity to say that this 10-35% recommendation range is the same as previous reports. Their press release clearly states, “protein intake recommendations are the same as previous reports.” I know of no report that has even remotely suggested a level as high as this.

When I initially saw this protein recommendation, I honestly though that it was a printing error. I know several of the people on the panel who wrote this report and decided to give them a ring. The first panel member, a long-time acquaintance, said this was the first time he had even heard about the 35% protein limit! He suggested that this protein recommendation might have been drafted in the last days of preparing the report. He also told me that there was little discussion of the evidence on protein, for or against a high consumption level, although he recollected there being some pro-Atkins sympathy on the committee. He had not worked in the protein area, so he did not know the literature. In any event, this important recommendation slipped through the panel without much notice and made the first sentence of the FNB release!

The second panel member, a long-time friend and colleague, was a subcommittee chair during the latter part of the panel’s existence. He is not a nutritional scientist and also was surprised to hear my concerns about the upper limit for protein. He did not recall much discussion on the topic either. When I reminded him of some of the evidence linking high-animal protein diets to chronic disease, he initially was a little defensive. But with a little mor persistence on my part about the evidence, he finally said, “Colin, you know that I really don’t know anything about nutrition.” How, the, was he a member – let alone the char – of this important subcommittee? And it gets worse. The chair of the standing committee on the evaluation of these recommendations left the panel shortly before its completion for a senior executive position in a very large food company – a company that will salivate over these new recommendations.

All of the above comes The China Study – except for my brief introduction.

Thank the author – T. Colin Campbell, PhD and Thomas M. Campbell II – for all of their work – and I hope that you get this book and read it word by word.

Wishing all of you the best of health.

 

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(WSJ) – In a bid to save costs and stem a rising tide of medical waste, hospitals are recycling a growing number of medical devices labeled as single-use, from scissors and scrubs to the sharp blades surgeons use to saw through bones.

Recycling medical devices labeled for single use is legal as long as certain Food and Drug Administration guidelines are followed. But the practice, which involves shipping devices to reprocessing facilities to be cleaned, sterilized and tested for reuse, has raised concerns about safety. Medical device makers say their single-use products are just that, and pose a higher risk of failure and harm when recycled. Reprocessing companies, hospital associations and environmental groups counter that the devices they reprocess are as safe as new thanks to modern sterilization methods, cost 40% to 60% less, and can eliminate thousands of tons of waste from landfills.

In January, after reviewing eight years of FDA data, the Government Accountability Office weighed in with a report concluding there is no evidence that reprocessed single-use devices create an elevated health risk for patients. About 100 devices — just 2% of all devices labeled for single use — are now reprocessed.

But while the GAO report tilts the debate strongly in favor of reprocessing and opens the door to more widespread use, device makers are sticking to their guns. They are lobbying in several states for legislation that would require health-care providers to obtain “informed consent” from a patient before using a reprocessed device during a procedure. Utah already has approved liability protections for original equipment makers, and other state bills include measures that would free original manufacturers from liability if a reprocessed device fails and causes injury or death.

Device makers maintain that their products labeled for single use aren’t designed to hold up to harsh sterilization chemicals and processes. Even when the devices are sterilized, blood, tissue or other bodily fluids on porous surfaces and in tiny crevices could allow transmission of viral and bacterial infections, they say. In general, “single-use devices present an increased safety risk to patients because they are designed for optimal performance and safety in a single patient,” says Tara Federici, vice president of technology and regulatory affairs at AdvaMed, a trade group that represents leading device makers.

For example, heart stabilizers, the devices used to position a beating heart during surgery, have hollow tubes and other parts that device manufacturers say could harbor blood and tissue and become weakened during reprocessing in ways that might not be evident during inspection. A study by the University of Minnesota of stabilizers made by Medtronic Inc. found that while new devices showed little or no manufacturing debris, a majority of reprocessed devices had corroded parts and traces of human hair and protein, bringing into question the effectiveness of the reprocessing efforts.

Last year, the FDA began requiring that reprocessed heart stabilizers undergo more rigorous premarket clearance reviews, and a Medtronic spokesman says the company plans to repeat the tests to see if the more stringent requirements improve performance. Until then, he says, the company stands by its position that the devices can’t safely be reprocessed.

The Association of Medical Device Reprocessors, a trade group whose members reprocess the majority of devices, counters that it recycles only products made from rigid, hard metals or durable polymers and plastics that can safely be reused between two and five times, depending on the device. The group has petitioned the FDA to require new heart stabilizers to undergo the same premarket review as reprocessed ones, because the device itself is high-risk. Since 2001, the group notes, there have been 73 adverse events reported to the FDA involving devices used to stabilize the heart, including incidents in which pieces have broken off and fallen into the chest cavity.

Dan Vukelich, president of the group, says reprocessed devices can be safer in some cases because each must be inspected before reuse, while original manufacturers test new devices only in batches. He also contends that device makers label many products as single-use merely to be able to sell more new devices to hospitals and thwart competition — a contention that medical device makers dismiss.

About $31.5 billion of single-use medical devices are sold annually in U.S. hospitals and surgery centers, of which around $150 million are recycled, according to Ascent Healthcare Solutions, a leading reprocessing company. John Grotting, Ascent’s chief executive, estimates that about $3.6 billion of single-use devices are safe for reprocessing, which could save the health-care industry about $1.8 billion a year. Ascent hospital customers eliminated about 1,684 tons of waste from their local landfills last year, a 31% increase over 2006, by using reprocessed devices, Ascent says.

Mr. Grotting says reprocessed devices are as safe as new ones. Of 65 events reported to the FDA from October 2003 to July 2006 involving or suspected to involve reprocessed devices, the device was just one of several possible causes of harm, and the adverse events were of the same type reported for new, nonreprocessed devices, the FDA found.

Manufacturers began labeling more products as single use starting in the 1980s, partly in response to concern about the spread of infectious diseases like AIDS. Single-use items such as tongue depressors, bandages, adhesive tape, urinary catheters and breathing tubes are discarded after one use. FDA-approved reprocessing, with sterilization methods that would result in only a one-in-a-million chance of a contaminant surviving the process, is very different from cases such as a recent outbreak of hepatitis C in Nevada traced to the reuse of unreprocessed syringes.

But hospital administrators and other experts say many products such as saw blades that were historically designated as reusable now carry single-use labels, with no obvious difference in the product.

“Single-use labeling is a real scam for a lot of devices, and by not using reprocessed devices where possible it is wasteful and not environmentally responsive, since these items have to be disposed of as biomedical waste,” says Kenneth Kizer, a consultant and former undersecretary for health at the U.S. Department of Veterans Affairs. “The reuse of medical devices that are labeled for single-use only is a well-established and safe practice regulated by the FDA and utilized by most of the top-ranked hospitals in the country.”

Dr. Kizer testified last year at a congressional hearing that the VA could save up to $30 million in 2008 by using reprocessed medical devices. The VA, with 153 hospitals, has had a longstanding policy against the use of reprocessed devices on the grounds that it can’t determine if they are safe, noting that manufacturers didn’t design them to be used more than once and don’t provide instructions on cleaning and sterilizing the devices. A spokesman says the VA reviews the policy from time to time but has no plans to change it at present.

The FDA has stepped up its oversight of reprocessing, including more plant inspections, after new legislation in 2002 began requiring devices to be labeled if they are reprocessed. The FDA says it is working on a new strategy for monitoring and communicating information about reprocessed devices, and conducting research on “acceptable” single-use device-cleaning criteria.

AMDR, the reprocessing group, is fighting efforts to require that patients go through formal informed-consent processes. Mr. Vukelich says informed consent is meant for experimental treatments and clinical trials, and not for devices that are legally marketed and approved by the FDA. For patients, however, it may be reassuring to ask physicians whether a reprocessed single-use device will be used during an invasive procedure and what steps have been taken to ensure it carries no additional risk

Oakland, Calif.-based health-care giant Kaiser Permanente started working with Ascent to reprocess single-use devices more than a decade ago, and sharply increased its use of reprocessed devices in 2006. Dean Edwards, vice president and chief procurement officer, says Kaiser shaved about $3.5 million from its device costs in 2007, and eliminated about 45.7 tons of medical waste.

At Catholic Healthcare West, the nation’s eighth-largest hospital system, a wide range of medical devices labeled as “single use” are reprocessed each year. Last year, the San Francisco-based concern figures it reduced waste volume by 41 tons and saved $1.8 million.

“The safe use of these reprocessed devices helps us conserve resources so we can be more cost-effective in delivering care” says Sister Susan Vickers, vice president of community health. “And we are diverting significant amounts of medical waste, which definitely benefits our planet.”

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Don’t think you’re seeing double – I posted this identical article over on ‘MorganRants’ – just to make sure everyone would hopefully read it.  What a bunch of hogwash. 

WASHINGTON – (NYT) –  In a case with huge implications for the health care-technology industry, the Supreme Court ruled on Wednesday that the manufacturer of a federally approved medical device cannot be sued under state law if the device causes an injury.

The 8-to-1 ruling in favor of Medtronic, the Minneapolis-based maker of cardiovascular devices, made it much more difficult for patients and their families to sue makers of medical devices that have been granted federal approval.

In 1996, a balloon catheter burst and severely injured Charles R. Riegel while he was undergoing an angioplasty. Mr. Riegel and his wife, Donna, sued the company in federal court, contending that the catheter had been designed, labeled and manufactured in a way that violated New York state law, and that those defects had caused severe and permanent injuries to Mr. Riegel.

But a federal district court and the United States Court of Appeals for the Second Circuit, in Manhattan, dismissed the Riegels’s suit on the ground that the catheter had been given pre-market approval by the Food and Drug Administration, thus protecting the manufacturer from liability under state law. (The case of Riegel v. Medtronic was tried in federal court because the plaintiffs and defendant were based in different states.)

The Supreme Court upheld the lower federal courts on Wednesday, with Justice Antonin Scalia writing for the majority that Medtronic and other manufacturers were protected under the Medical Device Amendments of 1976, which in its section on pre-emption bars states from imposing on medical devices “any requirement which is different from, or in addition to, any requirement applicable under this chapter.”

But the justices’ ruling was hardly the last word on when F.D.A. approval bars patients from suing. They are already considering at least three cases involving drugs and drug-labeling.

In 1996, when there was a different lineup of justices, the Supreme Court ruled that medical devices approved by the F.D.A. under a different, more expedited process were not shielded from state liability. At the time, the federal government took that position.

But in 2004, the Bush administration reversed the government’s position and began to take the side of manufacturers. In the Medtronic case, the administration argued that there would be “serious undermining of F.D.A.’s approval authority and its balancing of the risks and benefits” if juries could second-guess the agency.

Justice Scalia wrote that the F.D.A. spends an average of 1,200 hours reviewing each device application and grants pre-market approval only if it finds there is a “reasonable assurance” of its “safety and effectiveness.”

“It may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives,” Justice Scalia wrote, noting that the F.D.A. approved a ventricular assist device for children with failing hearts “even though the survival rate of children using the device was less than 50 percent.”

Justice Scalia said jurors would probably not be in a position to weigh the benefits and dangers of medical devices as well as agency experts. A jury, he wrote, “sees only the cost of a more dangerous designed, and is not concerned with its benefits; the patient who reaped those benefits are not represented in court.”

The majority was apparently persuaded by Theodore B. Olson, the lawyer for Medtronic, who argued before the justices on Dec. 4 that the F.D.A. and not the courts was the right forum for imposing requirements on cutting-edge medical devices. Arguing that “nothing is perfectly safe,” Mr. Olson said it would harm patients and future patients to “discourage the marketing of products that might save our lives.”

Medtronic, which makes a wide variety of medical products and is one of the world’s largest manufacturers of cardiovascular devices, no longer makes the type of catheter used on Mr. Riegel, who died several years after the operation. As part of its defense, the company maintained that the doctor involved failed to heed a warning not to use the device on a patient who had calcified arteries, as Mr. Riegel did. Founded in 1949, Medtronic has more than 37,000 employees and had revenues of $12.3 billion in its last fiscal year, according to the company’s Web site.

Justice Ruth Bader Ginsburg was the lone dissenter on Wednesday, asserting that the majority had adopted an unnecessary “constriction of state authority.” Justice Ginsburg said she did not believe that Congress had intended to bring about “a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.”

Allison M. Zieve, the lawyer for Donna Riegel, expressed her disappointment to Bloomberg News. “Pretty bad for patients, pretty good for industry profits,” she said.

Leading Congressional Democrats criticized the high court’s decision and issued statements vowing to enact legislation to allow lawsuits against medical device makers.

“The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” said Representative Henry A. Waxman of California, the chairman of the House Committee on Oversight and Government Reform. “This isn’t what Congress intended and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”

Senator Edward M. Kennedy of Massachusetts, the chairman of the Senate Health, Education, Labor and Pensions Committee, agreed, saying: “Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices. Congress obviously needs to correct the court’s decision. Otherwise, F.D.A. approval will become a green light for shoddy practices by manufacturers.”

Just so you know, Henry Waxman is the same guy who helped enact The Drug Price Competition and Patient Term Restoration Act of 1984otherwise known as the Hatch-Waxman Act.


  

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SAN JUAN, Puerto Rico – (AFP) The first warning sign came when a sharp-eyed worker sorting pills noticed that the odd blue flecks dotting the finished drug capsules matched the paint on the factory doors.

glax0smithcline-factory-in-san-jaun-puerto-rico.jpg

GlaxoSmithKline factory in San Juan, Puerto Rico.

After the flecks were spotted again on the capsules, a blood-pressure medication called Diltiazem, the plant began placing covers over drugs in carts in its manufacturing areas.But the factory owner, Canadian drug maker Biovail Corp., never tried to find out whether past shipments of the drug were contaminated — or prevent future contamination, according to U.S. regulators.

Thirteen of the 20 best-selling drugs in the United States come from plants on this island. But an investigation by The Associated Press has found dozens of examples over four years of lapses in quality control in the Puerto Rican pharmaceutical industry, which churns out $35 billion of drugs each year, most of it for sale as part of the $300 billion market in the U.S.

An AP review of 100 pages of Food and Drug Administration reports shows even modern drug plants here under the watch of U.S. regulators have failed to keep laboratories sterile and have exported tainted pills.

“People would be shocked to find this whole variety of contamination,” said Dr. Sidney Wolfe of the Washington watchdog group Public Citizen. “The common denominator of all these is there’s really poor quality control.”

FDA officials say the problems in Puerto Rico are proportionate with the large number of pharmaceutical plants here and generally no worse than those on the U.S. mainland.

Consumer advocates say they demonstrate the regulatory agency does not sufficiently monitor the industry across Puerto Rico and in the mainland.

The FDA issued a warning letter to Wyeth in May 2006, after consumers reported finding machinery pins inside bottles of Effexor, a leading depression treatment, and the heartburn drug Protonix. The letter expressed concern that the plant was not “able to detect that the affected equipment was missing some of its parts.” The Madison, N.J.-based company faulted mistakes by workers who packaged the drugs.

In another case cited in a June 2006 FDA inspection report, a plant owned by Teva Pharmaceutical Industries exported drugs — including the diabetes treatment Metformin — even though they were known to contain small amounts of metal particles. The company had also received at least six consumer complaints of dark residue inside bottles or foreign material embedded in tablets, according to the report.

Teva’s quality-control unit said the presence of some metallic material was to be expected because the manufacturing equipment is made of metal, according to the report.

Teva recalled 21 different drugs as a result of the inspection, according to FDA officials, and the Israeli drugmaker announced two months later it was closing the plant, citing a restructuring.

Denise Bradley, a Teva spokeswoman, insisted the medicine from the now-closed plant was safe and effective despite the contamination.

The reports obtained by AP were produced by FDA inspections from 2003 to 2007 of 13 pharmaceutical plants — roughly half the total in this U.S. territory, a Caribbean island with one of the world’s highest concentrations of drug makers.

Several are closing or downsizing as the expense of updating decades-old plants to meet regulations adds to struggles with rising energy costs and tightening tax breaks.

The FDA often hesitates to crack down at the first sign of problems because manufacturers can chalk them up to isolated mishaps, said John Scharmann, a former FDA administrator for the Denver district now associated with a watchdog group.

That appeared to be the case at the Biovail-owned factory in the San Juan suburb of Carolina where the sharp-eyed worker noticed the foreign specks of blue.

“Incident was considered an isolated event … even when the employee reported having observed the same particles before,” the report said.

David Elder, director of enforcement in FDA’s regulatory affairs office, said pharmaceutical companies generally fix problems on their own and issue recalls if necessary once notified.

“They’re making products that save or support lives, so it’s not in their interest to make products that are unsafe or ineffective,” he said. “I think they’re good corporate citizens by and large and want to do right by their patients.”

Four of the plants described in the reports closed or announced plans to do so after the discovery of significant quality-control problems, but none of them cited the discoveries as a reason for closing.

One of those four, GlaxoSmithKline PLC, produced tablets of the popular antidepressant Paxil CR that split apart, potentially causing patients to take incorrect dosages.

When the company would not recall all the affected pills, U.S. marshals raided the plant in March 2005 in the largest drug seizure in FDA history and also collected tablets of the diabetes treatment Avandamet after some were found not to have accurate doses of the active ingredient.

Some plants in Puerto Rico are three decades old, built when the territory’s pharmaceutical industry took off thanks to tax incentives aimed at developing more high-tech manufacturing.

The industry here has faded somewhat. Companies have shed more than 3,000 jobs in the last 18 months and closed several plants for a variety of reasons, including the loss of federal tax breaks and cost-cutting.

Still, this island turns out some top-selling drugs on the U.S. market, including cholesterol drugs Lipitor and Zocor, the blood-thinner Plavix, anemia drugs Aranesp and Epogen and the antidepressant Zoloft.

The FDA’s San Juan office has 22 inspectors who devote about a quarter of their time to pharmaceutical plants. They typically visit the factories once every two years, more often if there are consumer complaints or the company has repeated infractions.

Factories confronted with violations often make extensive changes. The Biovail plant invested $5 million in equipment upgrades and addressed problems including errant metal particles from cleaning spatulas. A follow-up FDA inspection found no problems, said Gilbert Godin, executive vice president of the Ontario-based company.

Scharmann, a consulting editor for the watchdog publication Dickinson’s FDA Review, said the FDA is concerned by anything that affects drug quality but considers the likelihood that the companies may file legal challenges to enforcement actions.

“There’s a fairly broad latitude that is allowed,” Scharmann said.

Elder contends inspections are rigorous.

“The folks doing this work aren’t just regulators. That’s our job, but we’re also consumers of these products,” he said. “It’s personal to us to make sure these products are in compliance.”

Now doesn’t that put a warm feeling in your heart!

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BEIJING  (NYT)— A huge state-owned Chinese pharmaceutical company that exports to dozens of countries, including the United States, is at the center of a nationwide drug scandal after nearly 200 Chinese cancer patients were paralyzed or otherwise harmed last summer by contaminated leukemia drugs.

Chinese drug regulators have accused the manufacturer of the tainted drugs of a cover-up and have closed the factory that produced them. In December, China’s Food and Drug Administration said that the Shanghai police had begun a criminal investigation and that two officials, including the head of the plant, had been detained.

The drug maker, Shanghai Hualian, is the sole supplier to the United States of the abortion pill, mifepristone, known as RU-486. It is made at a factory different from the one that produced the tainted cancer drugs, about an hour’s drive away.

The United States Food and Drug Administration declined to answer questions about Shanghai Hualian, because of security concerns stemming from the sometimes violent opposition to abortion. But in a statement, the agency said the RU-486 plant had passed an F.D.A. inspection in May. “F.D.A. is not aware of any evidence to suggest the issue that occurred at the leukemia drug facility is linked in any way with the facility that manufactures the mifepristone,” the statement said.

When told of Shanghai Hualian’s troubles, Dr. Sidney M. Wolfe, a leading consumer advocate and frequent F.D.A. critic, said American regulators ought to be concerned because of accusations that serious health risks had been covered up there. “Every one of these plants should be immediately inspected,” he said.

The director of the Chinese F.D.A.’s drug safety control unit in Shanghai, Zhou Qun, said her agency had inspected the factory that produced mifepristone three times in recent months and found it in compliance. “It is natural to worry,” Ms. Zhou said, “but these two plants are in two different places and have different quality-assurance people.”

The investigation of the contaminated cancer drugs comes as China is trying to restore confidence in its tattered regulatory system. In the last two years, scores of people around the world have died after ingesting contaminated drugs and drug ingredients produced in China. Last year, China executed its top drug safety official for accepting bribes to approve drugs.

Shanghai Hualian is a division of one of China’s largest pharmaceutical companies, the Shanghai Pharmaceutical Group, which owns dozens of factories. Neither Shanghai Hualian nor its parent company would comment on the tainted medicine.

Last week, The New York Times asked the F.D.A. whether the Shanghai Pharmaceutical Group exported to the United States any drugs or pharmaceutical ingredients other than the abortion pill. But after repeated requests, the agency declined to provide that information; it did not cite a reason.

On at least two occasions in 2002, Shanghai Hualian had shipments of drugs stopped at the United States border, F.D.A. records show. One shipment was an unapproved antibiotic and the other a diuretic that had “false or misleading labeling.” Records also show that another unit of Shanghai Pharmaceutical Group has filed papers declaring its intention to sell at least five active pharmaceutical ingredients to manufacturers for sale in the United States.

One major pharmaceutical company, Pfizer, declined to buy drug ingredients from Shanghai Pharmaceutical Group because of quality-related issues, said Christopher Loder, a Pfizer spokesman. In 2006, Pfizer agreed to evaluate Shanghai Pharmaceutical Group’s “capabilities” as an ingredient supplier, but so far the company “has not met the standards required by Pfizer,” Mr. Loder said in a statement.

Because of opposition from the anti-abortion movement, the F.D.A. has never publicly identified the maker of the abortion pill for the American market. The pill was first manufactured in France, and since its approval by the F.D.A. in 2000 it has been distributed in the United States by Danco Laboratories. Danco, which does not list a street address on its Web site, did not return two telephone calls seeking comment.

Problems with the cancer drugs first surfaced last summer after leukemia patients received injections of one cancer drug, methotrexate. Afterward, patients experienced leg pain and, in some cases, paralysis. At the People’s Liberation Army No. 307 Hospital in Beijing, a 26-year-old patient, Miao Yuguang, was unable to stand up five days after being injected in the spine with the drug. “We were already unlucky to have this illness,” her father, Miao Futian, said of the leukemia. “Then we ran into this fake drug.”

The authorities recalled two batches of the drug, but issued only mild warnings because the cause of the problem was unclear. Officials with Shanghai Pharmaceutical Group stood by their products, saying that drug regulators investigating the plant had found no problems. But when another cancer drug made in the same factory — cytarabin hydrochloride — also began causing adverse reactions, investigators suspected contamination.

In September, health and drug officials announced that they had found that the two drugs were contaminated with vincristine sulfate, a third cancer drug, during production. After issuing a nationwide alert, the government announced a wider recall, and Shanghai’s drug agency sealed manufacturing units at the plant.

“Many people thought there was a problem with the hospitals,” said Zheng Qiang, director of the Center for Pharmaceutical Information and Engineering Research at Peking University. “It wasn’t until later that they discovered the problem was with the medicine.”

Chinese media attention on the case has surged, after a terse statement by China’s drug agency in December, accusing Hualian company officials of a systematic cover-up of violations at the facility that made the drugs.

Family members at the No. 307 hospital have counted 53 victims in Beijing, and say they were told that there were least 193 victims nationwide. It is unclear how many were paralyzed, because the authorities have not released an official figure. Relatives have joined to share information and advocate for the victims. Based on interviews with several families in Beijing and Shanghai, it appears that about half of those injected still cannot walk.

Wu Jianhua said his daughter, Wu Xi, 15, collapsed on her way to school after an injection in August. “We thought she was tired,” Mr. Wu said. Doctors now say she may never walk without a cane, he said.

Last week, on a window near the gate of the closed plant was a notice from the Shanghai Food and Drug Administration, dated Sept. 8, accusing the plant of “producing substandard medicine that poses major risks of causing serious harm to human health.” It identified a company official, Gu Yaoming, as the “person responsible” for the plant.

Records show Mr. Gu also met with the United States F.D.A. inspectors last May as part of the routine inspection of the plant that makes RU-486.

Reached by telephone, Mr. Gu declined to describe his role at the two plants. “I cannot answer your questions,” he said.

A spokeswoman for China’s Food and Drug Administration, Yan Jiangying, said that Shanghai Hualian had been stripped of its license to produce antitumor drugs, but that this action did not affect RU-486.

Hualian is the latest in a string of tainted medicine cases that have undermined confidence in the safety of drugs here. In 2006, at least 18 Chinese died after an intravenous drug used to treat liver disease, Armillarisin A, was laced with diethylene glycol, a toxic chemical used in some antifreeze. Also in 2006, at least 14 Chinese died after taking a Chinese antibiotic, Xinfu, which was not properly sterilized during production. And more than a hundred people died in Panama after taking cold medicine containing a mislabeled and toxic chemical from China.

In each of these cases, the manufacturer failed to follow good manufacturing practices to ensure the final product was safe.

Describing the cover-up at the factory, Ms. Zhou, the regulator who led the investigation, said workers did not tell investigators that vincristine sulfate — a drug too toxic for use in spinal injections — had been stored in a refrigerator with materials for other drugs.

“At the time, we didn’t think they had lied to us,” Ms. Zhou said. The deception sent investigators on a two-month hunt for other possible causes of the adverse reactions. “If they had been open about the vincristine sulfate in the beginning, maybe fewer people would have been harmed,” she added.

While regulators have accused factory employees of a systematic cover-up of violations in production, they have not said whether superiors at Shanghai Pharmaceutical were aware of it. “We’ll have to wait until the police investigation is finished” to make more details public, said Ms. Yan, the drug agency spokeswoman.

Mr. Zheng at Peking University said that producing multiple drugs in a single workshop was risky, but that some Chinese companies saw it as a way to save money. “It was an accident,” he said of the Hualian case. “But it was bound to happen.”

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Recent laboratory tests found so much mercury in tuna sushi from 20 Manhattan stores and restaurants that at most of them, a regular diet of six pieces a week would exceed the levels considered acceptable by the Environmental Protection Agency.

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Tuna sushi

Sushi from 5 of the 20 places had mercury levels so high that the Food and Drug Administration could take legal action to remove the fish from the market. The sushi was bought by The New York Times in October.

“No one should eat a meal of tuna with mercury levels like those found in the restaurant samples more than about once every three weeks,” said Dr. Michael Gochfeld, professor of environmental and occupational medicine at the Robert Wood Johnson Medical School in Piscataway, N.J.

Dr. Gochfeld analyzed the sushi for The Times with Dr. Joanna Burger, professor of life sciences at Rutgers University. He is a former chairman of the New Jersey Mercury Task Force and also treats patients with mercury poisoning.

The owner of a restaurant whose tuna sushi had particularly high mercury concentrations said he was shocked by the findings. “I’m startled by this,” said the owner, Drew Nieporent, a managing partner of Nobu Next Door. “Anything that might endanger any customer of ours, we’d be inclined to take off the menu immediately and get to the bottom of it.”

Although the samples were gathered in New York City, experts believe similar results would be observed elsewhere.

“Mercury levels in bluefin are likely to be very high regardless of location,” said Tim Fitzgerald, a marine scientist for Environmental Defense, an advocacy group that works to protect the environment and improve human health.

Most of the restaurants in the survey said the tuna The Times had sampled was bluefin.

In 2004 the Food and Drug Administration joined with the Environmental Protection Agency to warn women who might become pregnant and children to limit their consumption of certain varieties of canned tuna because the mercury it contained might damage the developing nervous system. Fresh tuna was not included in the advisory. Most of the tuna sushi in the Times samples contained far more mercury than is typically found in canned tuna.

Over the past several years, studies have suggested that mercury may also cause health problems for adults, including an increased risk of cardiovascular disease and neurological symptoms.

Dr. P. Michael Bolger, a toxicologist who is head of the chemical hazard assessment team at the Food and Drug Administration, did not comment on the findings in the Times sample but said the agency was reviewing its seafood mercury warnings. Because it has been four years since the advisory was issued, Dr. Bolger said, “we have had a study under way to take a fresh look at it.”

No government agency regularly tests seafood for mercury.

Tuna samples from the Manhattan restaurants Nobu Next Door, Sushi Seki, Sushi of Gari and Blue Ribbon Sushi and the food store Gourmet Garage all had mercury above one part per million, the “action level” at which the F.D.A. can take food off the market. (The F.D.A. has rarely, if ever, taken any tuna off the market.) The highest mercury concentration, 1.4 parts per million, was found in tuna from Blue Ribbon Sushi. The lowest, 0.10, was bought at Fairway.

When told of the newspaper’s findings, Andy Arons, an owner of Gourmet Garage, said: “We’ll look for lower-level-mercury fish. Maybe we won’t sell tuna sushi for a while, until we get to the bottom of this.” Mr. Arons said his stores stocked yellowfin, albacore and bluefin tuna, depending on the available quality and the price.

At Blue Ribbon Sushi, Eric Bromberg, an owner, said he was aware that bluefin tuna had higher mercury concentrations. For that reason, Mr. Bromberg said, the restaurant typically told parents with small children not to let them eat “more than one or two pieces.”

Koji Oneda, a spokesman for Sushi Seki, said the restaurant would talk to its fish supplier about the issue. A manager at Sushi of Gari, Tomi Tomono, said it warned pregnant women and regular customers who “love to eat tuna” about mercury levels. Mr. Tomono also said the restaurant would put warning labels on the menu “very soon.”

Scientists who performed the analysis for The Times ran the tests several times to be sure there was no mistake in the levels of methylmercury, the form of mercury found in fish tied to health problems.

The work was done at the Environmental and Occupational Health Sciences Institute, in Piscataway, a partnership between Rutgers and the Robert Wood Johnson Medical School.

Six pieces of sushi from most of the restaurants and stores would contain more than 49 micrograms of mercury. That is the amount the Environmental Protection Agency deems acceptable for weekly consumption over a period of several months by an adult of average weight, which the agency defines as 154 pounds. People weighing less are advised to consume even less mercury. The weight of the fish in the tuna pieces sampled by The Times were 0.18 ounces to 1.26 ounces.

In general, tuna sushi from food stores was much lower in mercury. These findings reinforce results in other studies showing that more expensive tuna usually contains more mercury because it is more likely to come from a larger species, which accumulates mercury from the fish it eats. Mercury enters the environment as an industrial pollutant.

In the Times survey, 10 of the 13 restaurants said at least one of the two tuna samples bought was bluefin. (It is hard for anyone but experts to tell whether a piece of tuna sushi is bluefin by looking at it.)

By contrast, other species, like yellowfin and albacore, generally have much less mercury. Several of the stores in the Times sample said the tuna in their sushi was yellowfin.

“It is very likely bluefin will be included in next year’s testing,” Dr. Bolger of the F.D.A. said. “A couple of months ago F.D.A. became aware of bluefin tuna as a species Americans are eating.”

A number of studies have found high blood mercury levels in people eating a diet rich in seafood. According to a 2007 survey by the New York City Department of Health and Mental Hygiene, the average level of mercury in New Yorkers’ blood is three times higher than the national average. The report found especially high levels among Asian New Yorkers, especially foreign-born Chinese, and people with high incomes. The report noted that Asians tend to eat more seafood, and it speculated that wealthier people favored fish, like swordfish and bluefin tuna, that happen to have higher mercury levels.

The city has warned women who are pregnant or breast-feeding and children not to eat fresh tuna, Chilean sea bass, swordfish, shark, grouper and other kinds of fish it describes as “too high in mercury.” (Cooking fish has no effect on the mercury level.)

Dr. Kate Mahaffey, a senior research scientist in the office of science coordination and policy at the E.P.A. who studies mercury in fish, said she was not surprised by reports of high concentrations.

“We have seen exposures occurring now in the United States that have produced blood mercury a lot higher than anything we would have expected to see,” Dr. Mahaffey said. “And this appears to be related to consumption of larger amounts of fish that are higher in mercury than we had anticipated.”

Many experts believe the government’s warnings on mercury in seafood do not go far enough.

“The current advice from the F.D.A. is insufficient,” said Dr. Philippe Grandjean, adjunct professor of environmental health at the Harvard School of Public Health and chairman of the department of environmental medicine at the University of Southern Denmark. “In order to maintain reasonably low mercury exposure, you have to eat fish low in the food chain, the smaller fish, and they are not saying that.”

Some environmental groups have sounded the alarm. Environmental Defense, the advocacy group, says no one, no matter his or her age, should eat bluefin tuna. Dr. Gochfeld said: “I like to think of tuna sushi as an occasional treat. A steady diet is certainly problematic. There are a lot of other sushi choices.”

Okay, how many of you remember that years ago there were screaming headlines in the newspaper, reporters foaming at the mouth, politicians demanding that we warn the people, about a jillion advocacy groups, on both sides of the fence,  whining either for or against installing regulations,  grocery stores with warning labels about the possible/probable contamination of fish of whatever stripe?  Oh how soon we forget – the case of history repeating itself , ja?

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FRIDAY, Jan. 25 (HealthDay News) — The controversy surrounding the highly promoted cholesterol-lowering drug Vytorin continued Friday when U.S. health officials said they would review the medication’s effectiveness, but only after final trial results were completed.The debate began earlier this month when preliminary results of the so-called Enhance trial showed that Vytorin — a combination of two cholesterol drugs — had little medical benefit.

“We have not yet received a final study report and can’t explain why Vytorin didn’t lead to lesser amounts of plaque compared to patients treated with simvastatin alone,” Dr. John Jenkins, director of the FDA’s Office of New Drugs, Center for Drug Evaluation and Research, said during an afternoon teleconference.

A study released Jan. 14 by the makers of Vytorin found that the drug — a combination of the Zocor (simvastatin) and Zetia (ezetimibe) — may be no more effective at reducing the build-up of plaque in the arteries than Zocor alone. About 60 percent of U.S. patients who are taking Zetia now receive the drug as part of Vytorin.

The FDA expects to receive the final report on Vytorin in the next several months, Jenkins said.

“Once we receive the final study report, we estimate it will take as long as six months for us to fully evaluate the results of the Enhance study,” he said. “And we will be considering whether any further action is warranted in regard to Zetia or Vytorin, and also whether this study has any impact on our approach to the approval of lipid-lowering drugs.”

The Enhance trial found that although cholesterol was lowered, the pace at which artery-clogging plaques formed within vessels almost doubled in patients taking Vytorin, compared to those taking Zocor alone.

The FDA noted the trial was not designed to detect any difference in risk of heart attack or stroke between the two treatments.

Jenkins said another ongoing trial will evaluate the effect of Vytorin compared with Zocor on heart disease and stroke. Results from this trial will be available in 2011, he said.

Merck/Schering-Plough Pharmaceuticals, the makers of Zetia and Vytorin, have been criticized for not releasing the Enhance test results earlier.

“While the Enhance trial was time-consuming and took longer than originally anticipated to complete, our companies acted with integrity and good faith in connection with the trial,” Thomas Koestler, president of the Schering-Plough Research Institute, said in a prepared statement released Friday.

Dr. Harlan M. Krumholz, a professor of medicine at Yale University School of Medicine, said the FDA is right to wait until all the results from the Enhance trial are in. But in the meantime, he said, Vytorin and Zetia should be limited to patients who can’t tolerate cholesterol-lowering drugs called statins, such as Lipitor.

“We have enough information from Enhance to say it is not providing much evidence that this drug is delaying the progression of atherosclerosis,” he said. “It raises uncertainty whether this drug produces benefits for actual patients.”

“This [Vytorin] is really a second-line drug,” Krumholz said. “We really should be guided by evidence, not marketing, and the evidence is really strong for statins. If lifestyles aren’t sufficient to lower cholesterol, the next place they should go is statins. Only after those have failed should you go to the next step,” he added, referring to Vytorin.

More information

For more information on lowering cholesterol, visit the American Heart Association.

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