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Hadcorp News: February 23, 2008

In this edition of our newsletter:

Macrolane VRF is now available for breast augmentation in the EU (USA) �Visit the Hadcorp website for updated information.

Supreme Court Backs Medical-Device Manufacturers (USA) �Yet another defeat for the victims of medical device companies. The Supreme Court today ruled that patients could not sue medical-device manufacturers in state court over harm from a device that has approval from federal regulators.

Breast implants in man's leg go belly-up (Australia) � Canadian Lane Jensen had the 'implants' surgically inserted in early December last year, but by Christmas Eve the sutures had split, and large amounts of lymphatic fluid were draining out of his leg.

Consumers may not be able to avoid cloned food (USA)� An ethics board advising the European Food Safety Authority concluded in January that cloning for food production cannot be justified at this point because of the suffering of both deformed clones and their surrogate mothers. A significant segment of consumers have rejected other foods the FDA deemed safe, such as milk from hormone-treated cows and genetically modified corn.

County nixes crematorium move (Fort Collins, CO, USA) �Commissioner Randy Eubanks said mercury build up in the environment is cumulative and needs to be taken seriously, even if crematorium emissions are not regulated in other Northern Colorado communities. Adding a $500,000 scrubber to the facility's smokestack, as recommended by county staff members, was apparently too expensive and a recommendation that teeth with fillings be removed from bodies before cremation was not acceptable.

Amalgam ban causes a stir (UK) � Denmark�s ban on the use of amalgam in dental procedures will come into place on 1 April 2008, while the Norwegian and Swedish legislation has been in effect since 1 January. An online petition to the UK government calling for the ban of mercury in dental amalgam attracted nearly 1000 signatures.

Man getting clout for Gulf War veterans (USA) � Kirt Love is a man on a mission, and for the first time in a long time, he is getting some political muscle to back him up.

Supreme Court Backs Medical-Device Manufacturers

By Anna Boyd

USA

11:03, February 21st 2008

The Supreme Court today ruled that patients could not sue medical-device manufacturers in state court over harm from a device that has approval from federal regulators.

The Supreme Court Case involved a specific lawsuit from a patient, named Charles Riegel, who suffered serious injuries when a Medtronic Inc. catheter burst during a medical procedure. Riegel used the catheter to unclog an artery and was left disabled before dying in 2004. He argued that the catheter was not designed properly and sued the manufacturer. Medtronic no longer manufactures the catheter.

However, the court ruled that because the device received final approval from the Food and Drug Administration, Medtronic could not be sued over the catheter�s design flaws. The court ruled 8 to 1 in favor of a law that was established back in 1976 that protects medical device manufacturers from legal action being taken against them by patients, who are hurt or otherwise injured from using approved medical devices.

Justice Antonin Scalia noted for the court majority that the FDA spends an average of 1,200 hours (nearly a year) reviewing each device application and grants approval only if it finds there is a �reasonable assurance� of the device�s �safety and effectiveness,� the New York Times reported.

The ruling is �a victory for a national system designed to maximize the benefits to patients� from exhaustive review by government experts, Theodore Olson, lawyer for Medtronic said. He argued no product is perfectly safe, and suggested a reasonable risk should be accepted while the majority of patients have received benefits from the medical device.

Medtronic Chief Executive Bill Hawkins said, in a statement, that the ruling was �a very important decision, which ensures that patients continue to have appropriate access to innovative, life-saving medical devices,� Reuters reported.

Allison Zieve of the Public Citizen Litigation Group, Riegel�s lawyer said the decision was �potentially dangerous for patients,� because the prospect of damages against manufacturers is an incentive for safety.

The ruling was one of three yesterday in which the justices affirmed the supremacy of federal laws or regulations over often-tougher state laws aimed at protecting consumers.

Breast implants in man's leg go belly-up

LIVENEWS.com.au

Sydney, NSW, Australia

Jesse Perez

20/02/2008 5:59:00 PM.

LIVENEWS.com.au covered the story late last year about a man who had silicone surgically implanted in his leg to make his tattoo of a buxom beauty appear to be more anatomically correct. Unfortunately, not everything has worked out for our busty ink-job heroine.

Canadian Lane Jensen had the 'implants' surgically inserted in early December last year, but by Christmas Eve the sutures had split, and large amounts of lymphatic fluid were draining out of his leg.

"There was so much fluid in there. I went back to the studio and pushed on it gently - the implant shot right out,' he told the Edmonson Sun.

My body just rejected it. I guess my girl wasn't meant to have 3D breasts".

Doctors gave Jensen a course of antibiotics, and later advised him that his love affair with his leg-lady was now over.

Off the wall says: Not to speculate, but we think the problem was caused simply because he couldn't stop playing with them.

GENETICALLY MODIFIED FOODS

Consumers may not be able to avoid cloned food

Bernadette Tansey, Chronicle Staff Writer

Monday, February 18, 2008

Less than a dozen years after Dolly the sheep became the world's first cloned mammal, grocers and restaurateurs are digesting the fact that milk and meat from cloned animals could soon filter into their supply chains.

The government took major steps toward easing cloned livestock and their offspring into the food supply in mid-January, when the Food and Drug Administration concluded they're safe to eat.

The question is, will consumers swallow the new technology? And how will food businesses cope if their customers balk?

Many food merchants are still framing their policies while they warily monitor public opinion. The historic commercial debut of cloning comes in an era when a significant segment of consumers have rejected other foods the FDA deemed safe, such as milk from hormone-treated cows and genetically modified corn.

Cloning is an attempt to create a new animal using the DNA from an existing adult animal. The FDA, while noting that livestock cloning produces many malformed or ill newborn animals, said cloned animals that survive for several months after birth can be healthy. They can reproduce normally and produce healthy young, the FDA said. The agency said it found no signs that food from healthy clones is harmful to humans, and predicted that sickly clones would be excluded from the food supply.

Consumer groups, however, have called FDA's positive safety assessment hasty and ill-founded. The Center for Food Safety said the FDA based many conclusions on small or limited studies, many of them financed by cloning companies. Clones that appear healthy can have infections, or abnormalities that could affect food quality such as unusual proteins or imbalances between protein and fats, the group said. Further studies should be done to evaluate clones and their offspring, the organization said.

Such groups are urging consumers to press their supermarkets and restaurants to refuse food from clones. And those businesses are being peppered with inquiries like "Will my hamburger meat come from a cloned cow?" and "Are clones kosher?"

Independent grocer Sam Mogannam said he didn't need any calls from his customers to know if they'd accept food from cloned lineages. He's sure they won't. And he has no intention of stocking any at Bi-Rite Market, which he bills as a mecca for organic, sustainable and non-artificial foods in San Francisco's Mission District.

"We believe in allowing nature to take its due course," he said. "I know our customers wouldn't support us if they knew we were knowingly accepting products from clones or their offspring."

But food merchants, from small shop owners to national supermarket chains, could face formidable challenges if they want to guarantee customers the option of avoiding all products linked to cloning.

No public system is in place to alert food sellers when products from animal lines that include clones could reach their shelves - whether in the form of a rib-eye steak, a quart of low-fat milk, a can of beef minestrone or a wedge of sharp cheddar.

Consumer groups such as the Center for Food Safety and Consumers Union support mandatory labeling of all products linked to cloning, from raw meat to meatball sandwiches. They're backing bills proposed in Congress and by a few state legislators, including state Sen. Carole Migden, D-San Francisco. Without labeling, they argue, any food safety problems that did arise from cloning would never be linked to the technology.

Some retailers, after hearing from customers, are also calling for some form of government action. Two supermarket chains with a significant presence in Northern California, Safeway and Whole Foods Market, say the government should oversee a system to track clones through the food supply. It should also consider other means, such as food labeling, to ensure that consumers can make informed choices about products of cloning, the companies said.

"The lack of effective governmental oversight and tracking could mean consumers will lose the ability to choose clone-free products," Whole Foods spokeswoman Margaret Wittenberg said.

The FDA maintains that no labeling or disclosure requirements are necessary to protect public health. The agency, after years of study, issued a lengthy report Jan. 15 concluding that milk and meat from cloned cattle, pigs and goats are safe for consumption. The FDA said it had too little information to assess cloned sheep, but it found no food safety problems connected with the progeny of clones.

The offspring of all cloned livestock were immediately cleared as food sources by the U.S. Department of Agriculture, based on the FDA's findings. Clones themselves - cattle, pigs and goats - will also enter the food supply. But when, and under what regulatory scheme, if any, has not yet been decided.

The USDA is inviting industry input as it develops a plan to usher cloned animals into the market. In the meantime, the agency is asking companies that have created or purchased clones to honor a voluntary ban on selling their meat or milk for food.

This means that Ditto, a cloned cow created by a UC Davis researcher, can't be a food source just yet because the university honors the temporary ban. But UC Davis is now free to sell milk or meat from Ditto's daughter, an unnamed Holstein cow conceived by sexual reproduction.

Even before the FDA's favorable report, a few clone owners admitted in various news reports that they had already sold milk or meat from the animals as food.

As the rules stand now, livestock breeders and milk or meat suppliers have no legal obligation to disclose to either food manufacturers or consumers that a product came from a cloned animal line. Some vendors plan to keep their products clear of cloned lineages, but the FDA may not permit packages to bear a voluntary label such as "clone free."

Safeway Inc. of Pleasanton, one of the nation's largest food retailers, said its customers are demanding more information. The company acknowledged that the government conducted important studies on food from clones. But to help shoppers make informed choices about products tied to cloning, Safeway supports additional studies "that would help ensure changes to federal policy are done in a manner that maintains consumer confidence and informed decision making."

The Pleasanton chain, which has 269 stores in Northern California, is asking its suppliers to deliver no products from cloned animals while the government mulls its options. "Meanwhile, the federal government should exercise its authority and expertise to determine an appropriate regulatory framework, including traceability and labeling," Safeway said in response to a Chronicle inquiry. Safeway declined to say whether it will accept foods from the offspring of clones.

Trader Joe's, a Monrovia (Los Angeles County) grocery chain that carries many organic product lines, did not respond to The Chronicle's query.

Bruce Knight, USDA undersecretary for marketing, said the agency is willing to help industry members create a tracking and certification program if they request it. The USDA already administers standards and certification of organic products. Knight said the USDA would work with companies that want to set up voluntary labeling of food from clones.

Few food businesses have actively sought to sell products from cloned animal lines, but all could be affected by the few U.S. cloning companies in business. Their customers are farmers who want replicas of valuable breeding animals - clones of a prize bull, for example, whose semen fetches high prices for artificial insemination. As breeders, cloned animals could quickly influence the gene pool of U.S. livestock. The preserved semen of one bull can be sent throughout the country to produce thousands of descendants.

One healthy cloned calf can cost as much as $20,000. But these expensive animals may enter the meat supply when their reproductive lives wane. Their milk will also be sold for dairy products.

At this point, retailers that want to avoid food from clones are relying on private agreements with their suppliers, who in turn have to trust their own sources. Meat packers may be able to exclude some clones by consulting an industry database of cloned animals whose owners volunteer to register them. The two major livestock cloning companies, ViaGen Inc. and Trans Ova Genetics, are developing the registry with the certification company AgInfoLink. Meatpackers would be able to scan or read an animal's ear tag to identify clones, said AgInfoLink executive Glenn Smith.

At this point, AgInfoLink doesn't plan to track the milk, semen or offspring of clones. But Smith said that could change if retailers request such services.

Most food outlets that have taken a stand on cloning have said they will exclude clones themselves, but not necessarily food from their progeny.

Natural foods retailer Whole Foods Market of Austin, Texas, which has 24 stores in Northern California, said its products will remain free of both clones and their descendants.

"We are working with our supplier community to develop a chain of custody records that trace product breeding stock through multiple generations," said Edmund LaMacchia, vice president of purchasing for perishables.

It's not clear, however, that all USDA-certified organic operations will be completely "clone free." Some organic producers say they're not sure yet how they can guarantee that their animals have no ties to cloning. That includes Albert Straus, president of Straus Family Creamery in Marin County, which supplies all the dairy products for Sam Mogannam's Mission District market and nearby ice cream store.

Like most dairy operators, Straus relies on artificial insemination to reproduce his herd. Straus wants the government to require semen suppliers to reveal whether their products come from a cloned bull or its young. Without such certainty, Straus said, dairies might lose their organic certification from the USDA.

USDA's organic standards do rule out clones, but the agency may permit the use of a clone's descendants, Knight said. Therefore, consumers who want to avoid food from both clones and their offspring may not be able to rely solely on the organic label.

Buying only kosher foods won't insulate consumers from products of cloning at all. Rabbi Menachem Genack of the Orthodox Union, which certifies food items as kosher, said cloned animals would qualify as long as they belong to a single kosher species, such as cattle, sheep and goats.

At this point, consumer choice rests on a patchwork chain of voluntary agreements among suppliers and retailers.

The first time many Americans take a bite of food from a cloned animal or its offspring, they may never know it.

Cloning's imperfections at center of debate
Twenty years from now, the eating public may blithely accept food from cloned animals. But at this point, consumer groups are aghast at government actions to usher cloned livestock and their offspring into the U.S. food supply. To a large extent, the resistance stems from the fact that livestock cloning is still an imperfect art.

The Food and Drug Administration found in January that food from healthy clones and their progeny is safe. But in the same lengthy report, the FDA also detailed snags in the current art of animal cloning that reduce its rate of producing healthy clones to less than 10 percent. Many cloned embryos die or develop into sickly newborns.

Among consumer groups, those technical snags have raised questions not only about food safety, but also about animal welfare and ethics. They contend that further study may reveal health dangers the FDA didn't discover, as new testing methods emerge. In the FDA's view, future research will not only confirm the safety of food from clones, but will also improve methods of creating them.

Clones are made by coaxing a single adult cell from the original animal - call it a bull named George - to form an embryo that will become George2. The nucleus containing George's DNA is swapped into an egg cell from a cow, after the egg's nucleus is removed. The hope is that the resulting embryo, implanted in a surrogate mother, will be an exact copy of George. But about 90 percent of the time, that doesn't happen.

Clones can be born grossly malformed, and many die within six months. The fetuses can grow too large, causing difficult, extended pregnancies ending with delivery by cesarean section, the FDA found in a review of scientific studies.

But the FDA said clones that survive past six months are often healthy and fertile. Their offspring have even fewer health problems, the agency said. No significant differences appeared in milk or meat from cloned animal lines and their non-cloned counterparts, FDA reported.

The FDA acknowledged that newborn clones are often sick or dying, but said those animals would never pass inspection for entry into the food supply.

Consumer groups aren't convinced that cloning raises no safety concerns. For example, they suspect that many young clones will survive only through treatment with antibiotics and other drugs. Such animals could enter the food supply and affect human health, they contend.

An ethics board advising the European Food Safety Authority concluded in January that cloning for food production cannot be justified at this point because of the suffering of both deformed clones and their surrogate mothers, or dams, in animal breeding terms.

On the question of food safety, however, the European Food Safety Authority agreed with the FDA. The FDA, whose purview is limited to food safety, did not evaluate the ethics of cloning.

Online resources

Read the FDA's risk
assessment of cloning: www.fda.gov/cvm/
cloning.htm

Read the Center for Food Safety's critique of FDA's report: www.centerforfood safety.org/Policy.cfm

MERCURY

County nixes crematorium move

Commissioners say mercury emissions need to be addressed

The Coloradoan

Fort Collins, CO, USA

BY KEVIN DUGGAN

A proposal to place crematorium facilities at Resthaven Memorial Gardens near Loveland received a cold shoulder Monday from the Larimer County commissioners, who said the facility would not fit in with the residential area.

The commissioners said concerns about potential pollution from the facility - particularly mercury emitted through the cremation process - made the proposal inappropriate for the surrounding neighborhood, which includes schools and churches. The mercury would come from silver amalgam fillings in the teeth of the deceased.

Commissioner Randy Eubanks said mercury build up in the environment is cumulative and needs to be taken seriously, even if crematorium emissions are not regulated in other Northern Colorado communities.

"If we want to take the lead on this, if we want to err on the side of caution, I believe it's our right to do so," he said.

A carefully orchestrated presentation by opponents drove home concerns about the facility and how mercury would affect neighborhood residents, especially children. Neighbors also said the facility would drive down local property values and did not fit in with long-term land-use plans.

Linda Kaiser, a registered nurse, said mercury contamination from crematoriums is becoming a concern in other states and countries.

"We should not be placed in harm's way for the convenience of a business," Kaiser said.

Rick Allnutt, owner of Allnutt Funeral Services, had proposed moving two crematorium machines called retorts from a building on Riverside Avenue in Fort Collins to Resthaven, which sits in unincorporated Larimer County between Loveland and Fort Collins off U.S. Highway 287.

Acknowledging stiff neighborhood opposition to the proposal, Allnutt asked the commissioners to separate "facts from emotions" in making their decision.

Adding a $500,000 scrubber to the facility's smokestack, as recommended by county staff members, was too expensive, he said, and a recommendation that teeth with fillings be removed from bodies before cremation was not acceptable.

Allnutt proposed counting the number of fillings in bodies designated for cremation. If more than 10 fillings were found, the funeral service would work with family members to find an alternative location for cremation, he said.

But Dennis Lynch, an outspoken opponent to the crematorium, said the exact number of fillings would be impossible to determine since many could be hidden under dental crowns.

Following the unanimous decision, Allnutt said he was disappointed but glad he went through the process. He might continue operating the crematorium from the Riverside Avenue building, which is for sale, or move it to an industrial location such as the Fort Collins-Loveland Municipal Airport, he said.

"I just wonder what they are going to do with the other crematoriums in Larimer County," he said.

Amalgam ban causes a stir

14th February 2008

Dentistry.co.uk

London, UK

Denmark has announced plans to ban the use of amalgam in dental procedures, echoing a similar move by Norway and Sweden earlier this year.

The Danish ban will come into place on 1 April 2008, while the Norwegian and Swedish legislation has been in effect since 1 January.

Swedish officials cite both health and environmental reasons behind the move. Danish spokespeople also indicate the material has been banned because composites have improved to the point that they are now a viable alternative to amalgam.

Jakob Axel Nielsen, Danish Minister for Health, said: �Composite fillings have now become so strong that� we can expand the ban to also include amalgam fillings.�

Norwegian legislation bans the material by imposing restrictions on mercury itself, citing primarily environmental reasons.

In an official statement, Erik Solheim, Norwegian Minister of the Environment and International Development, said: �Mercury is among the most dangerous environmental toxins. Satisfactory alternatives to mercury in products are available, and it is therefore fitting to introduce a ban.'He also hailed the move as �an important signal' to the EU, which plans to start restricting mercury's use and exports from 2009, but has not yet acknowledged any problem in its use as a filling material. A report by an EU scientific committee published earlier this year failed to find any link between mercury use in amalgam and health problems.

This report has not deterred the opposition lobby, which claims that the health risks of mercury as a substance are well-documented, regardless of whether the method of delivery has an effect.

Some dentists point to a general unwillingness on the part of European governments to open themselves up to litigation by admitting the risk, an attitude that has faced heavy criticism.

One comment posted on our online forum, said: �In 25 years I've not had one patient who accepts a product that warns of systemic poisoning or neurological damage. We are fools to continue to place a toxic poison in people just because the government wants to avoid a litigation tidal wave.

'The move has prompted renewed calls from pressure groups for a similar ban to be introduced in the UK. An online petition to the government calling for the ban of mercury in dental amalgam attracted nearly 1000 signatures.

The pro-amalgam lobby is just as vocal.

Derek Jones, Professor Emeritus of Biomaterials at Dalhousie University in Canada, and chair of the International Standards Organisation's Technical Committee on Dentistry, has denounced the ban.

He said: �For the past 20 years, the public has been bombarded by sensational, confusing and misleading media reports about health issues related to dental amalgam. The public opinion on this issue has been modified by minority, non-scientific views driven and supported by media sensationalism.'

Jones went on to suggest that the real reasoning behind the Norwegian ban was an attempt to divert attention away from its poor handling of mercury pollution caused by a German submarine wrecked during World War II.

Mercury is not biodegradable, and quickly turns into methylmercury � its most toxic form � once in the environment.

� A new study adds to evidence that mercury-containing dental fillings do not harm children's brain development.

In the new study, researchers in Portugal and the U.S. followed 507 children who had received either amalgam or resin-based fillings when they were between 8 and 12 years old.

Over seven years, the two groups showed no differences in their rates of neurological symptoms, such as tremors, vision or hearing deficits, or coordination problems.Dr. Martin Lauterbach, a neurologist at the University of Lisbon in Portugal, led the study. The findings are published in The Journal of the American Dental Association.

The results add to evidence from two recent studies - including one of this same group of children � that found no evidence that amalgam fillings harmed children's intellectual or behavioural development.

An advisory panel to the US government recently said that while existing evidence suggests the fillings are generally safe, more study is needed into certain unanswered questions � such as how amalgam fillings in pregnant women might affect foetal development.

GULF WAR SYNDROME

Man getting clout for Gulf War veterans

Temple Daily Telegram

Temple,TX,USA

by Bryan Kirk - Telegram Staff Writer

Published February 13, 2008

Kirt Love is a man on a mission, and for the first time in a long time, he is getting some political muscle to back him up.

With the help of U.S. Rep. Chet Edwards, D-Waco, Love is hoping to help those who served during the first Gulf War to get more access to resources through the Department of Veterans Affairs.

Last month, Edwards wrote a letter to Dr. James Peak, Secretary of Veterans Affairs, and asked him to form an advisory committee.

On Feb. 5, Dr. Peak responded to Edwards� appeal and agreed to form the Gulf War Veteran�s Advisory Committee to address issues related to treatment, benefits and family support.

�My staff is drafting a proposed charter for my review within the next 10 days,� Peak wrote.

In the corner of the memo sent back to Edwards, Peak wrote that he appreciated the suggestion made by Edwards.

�My motivation was to see that Gulf War veterans have adequate input into VA decisions,� Edwards said.

There have been a number of committees born as a result of the specter of Gulf War illness.

In January 2002 a presidential advisory committee, known as the Research Advisory Committee on Gulf War Veterans� Illnesses was formed to determine what causes the illness known as Gulf War Syndrome.

However, those questions were never answered.

�There is still a question about exposure to chemical agents in the first Gulf War. There are still a lot of concerns that have not yet been fully answered.�

Love couldn�t agree more.

The Crawford resident and Bell County native has been fighting for answers from the U.S. government about the ailment commonly referred to as Gulf War Syndrome for more than a decade.

Love mounted his campaign in 1997, six years after the war ended and four years after he nearly succumbed to what he still believes were chemical agents used by Iraqi forces against U.S. troops during Operation Desert Shield/Desert Storm.

The changes in Love, however, were gradual.

When he and other members of his unit returned from Iraq, they began to experience substantial weight gain. Two years later, Love found himself substantially thinner and near the point of dying.

�I spent two years on my death bed. I was not supposed to make it,� Love recalled.

He was unable to eat or drink unless he ingested a teaspoon of powdered sulfur.

Still, no one knew what he had, and they still don�t know, Love said.

When he recovered sufficiently, Love went to Washington to try to get something done for Gulf War veterans who suffer from ailments that may have resulted from chemical agents.

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