Tuesday, April 18, 2006

NYC Wrong on WTC Rescue and Recovery Worker Injuries

From Newsinferno

Date Published: Sunday, April 16th, 2006
By Steven DiJoseph

When it comes to human tragedies, there is always a big difference between what people know and what they will admit to. The facts determine the former while money, as in all other aspects of life, often determines the latter.

Consider the following examples of this rather insincere view of reality:


Everyone knew safer cars could be designed and built but, for decades, the auto industry was able to delay the implementation of such things as seat belts, air bags, and emission systems because of the added expense involved. In the meantime, hundreds of thousands of people died needlessly.
Cigarettes kill people, period. No secret there, right? Yet for decades, big tobacco hid and denied that fact while it continued to market its products without warnings and in a way that enticed people to smoke rather than to avoid it at all costs. Unnecessary death toll? Millions, at the very least – and continuing.
Agent Orange, the defoliant, that the U.S. saturated Viet Nam with from the air up until 1971, was loaded with powerful chemical agents that really had no business being dropped on civilians and military personnel. The dioxins Agent Orange (as well as Agents Purple, Pink, Blue, and Green) contained are carcinogens as well as teratogens. Once responsible scientists and doctors began linking cancers and other serious diseases in thousands of servicemen and their offspring directly to their exposure to those chemicals, the U.S. government, Dow Chemical and Monsanto refused to admit any such connection because it would have meant paying out damages to victims and additional benefits to veterans. Only decades of litigation have managed to coerce the government and the chemical companies into settlements with Americans, Australians, South Koreans, New Zealanders, and Canadians. The Vietnamese, however, remain uncompensated for the carnage the chemicals caused.
Every day, insurance companies that maintain they have their policyholders’ wellbeing in mind and advertise their willingness to pay quickly and fully on claims made by those policyholders, deny benefits whenever possible for a variety of bogus or highly questionable reasons. Many companies have been sued and found liable for such conduct. Of course, none of this ever stopped an insurance company from collecting its premiums.
In the case of many dangerous prescription drugs, pharmaceutical companies have repeatedly refused to admit having known and withheld data concerning adverse reactions and side-effects that appeared during clinical trials. Manipulation and deletion of information has also been proven in many cases where approved drugs have had to be pulled from the market after injuring and killing hundreds or thousands of people.
So, is it any wonder that the City of New York, through its Health Commissioner, Dr. Thomas Frieden, has taken the rather questionable position that he would be “surprised” if anyone could conclusively link the death of someone like NYPD Detective James Zadroga to the hundreds of hours he spent breathing in the toxic air at ground Zero as he helped in the rescue and recovery efforts.

The Commissioner stated: “An autopsy can determine whether there was damage to the lungs and it can determine whether that damage might have been related to foreign bodies. But whether that was related to [the World Trade Center], I don’t think that would be easy to say definitively.”

Of course, there is a very good reason why the Frieden has taken this position. Any admission by the City or the NYPD would have far reaching effects since it would potentially force the re-classification of disability pensions and death benefits due to the injured police officers or their survivors.

It would also seriously affect the ongoing litigation against the City and other defendants that focuses on the negligent handling of the cleanup efforts that exposed thousands of city and private-sector workers and volunteers to the toxic hazards that were produced when the twin towers collapsed.

While the City often heaps additional benefits and posthumous promotions on police officers and firefighters killed in the “line of duty.” It has refused to acknowledge any such heroism on the part of the men and women who toiled without rest or regard for their own safety at the WTC site.

Speeches, plaques, and monuments are apparently one thing; conferring monetary benefits and admitting potential liability are something else.

Besides the anger and frustration expressed by Det. Zadroga’s parents, who now care for his orphaned 4-year-old daughter Tylerann, there is the medical and scientific evidence that 9/11 was not only a tragedy that killed almost 3,000 people instantly, but it was also an environmental catastrophe that has sickened countless people, had demonstrable effects on children born to mothers who lived near Ground Zero, and will probably kill or have long-term health effects on tens of thousands of people who were exposed to the toxic cloud that hovered over the site of the twin towers for months.

In an effort to demonstrate the causal connection between exposure to those toxins and the growing number of deaths, cancers, and other diseases, the Detectives’ Endowment Association (DEA) released the results of an autopsy done on Det. James Zadroga by the Ocean County, New Jersey, Medical Examiner.

That autopsy found that Det. Zadroga died as a direct result of respiratory failure brought on by the exposure to toxic substances and fine particles that he inhaled while working for some 470 hours at Ground Zero.

Det. Zadroga’s wife died of a stress-related heart attack only last year. His death earlier this year left his daughter an orphan.

The DEA wants Det. Zadroga’s death re-classified as having been in the “line of duty” so that his daughter will be able to receive a larger pension (100% instead of 75%) for at least seven additional years.

A number of other detectives appeared at the news conference. Each is suffering from serious respiratory problems or cancers that have left them totally disabled or terminally ill.

These NYPD officers are but a small number of the thousands of rescue workers and other responders who are claiming that the toxic cloud of airborne chemicals and solid particles that hung over the WTC site for weeks has killed and permanently injured many of them.

Shortly after Det, Zadroga’s death in January, the New York Daily News reported that 22 other relatively young men may also have died from respiratory-related illnesses caused or accelerated by their exposure to the same toxic environment while aiding in the post-9/11 cleanup.

Like Zadroga, most of the 22 men were only in their 30s and 40s. According to their families, they have died as a result of the deadly mixture of chemicals they were exposed to as they searched for survivors in the ruins of the World Trade Center or aided in the clean-up efforts in the days and weeks following the terrorist attack.

While the attack was immediately responsible for killing almost 3,000 innocent victims who were in and around the WTC, it now appears 9/11 has had, and will continue to have, far reaching effects on possibly thousands of other individuals who responded to the catastrophe that day and in the weeks that followed as part of the massive rescue, recovery, and cleanup efforts, without any regard to their own personal safety.

Many medical experts have already expressed serious concern that the first responders, rescue and recovery workers, volunteers of all kinds, and construction workers at the scene will inevitably suffer significant, if not fatal, health consequences as a result of their protracted exposure to all types of dust, debris, toxins, and other dangerous substances that polluted the WTC disaster site for several months following the collapse of the WTC buildings.

Among the additional 22 who have died are private employees, a sanitation worker, a correction officer, a utility worker, transit workers, firefighters, and police officers. Some, like Zadroga, suffered from black lung disease, while others died from cancers of the esophagus and pancreas.

David Knecht, a Lucent Technologies employee, worked for two months to re-establish communications at businesses near Ground Zero. At 35 he was diagnosed with lung cancer and died in March 2005, leaving behind two girls, now ages 3 and 4.

His wife Cathleen Knecht, 38, of Berkeley Heights, N.J. said “He was a nonsmoker and a swimmer.”

Knecht was one of many who have claimed to have been sickened with debilitating and potentially deadly ailments related to their presence at the WTC site. Thousands are sick and suffering from respiratory illnesses. Nearly 400 firefighters and paramedics have left the job because of career-ending illnesses that followed their work at Ground Zero.

David Worry, the attorney for approximately 7,300 Ground Zero workers says that rescue and clean-up workers were not properly protected for the dangerous job they had to perform. “This was a toxic waste site. People should have been walking around in moon suits.”

He anticipates there will be many more deaths and illnesses from worker’s exposure to deadly waste at Ground Zero. It is estimated that as many as 50,000 people worked at the site in the months after 9/11.

Worry’s firm has filed a class-action lawsuit, which is pending in United States District Court in Manhattan. The suit alleges that government officials and construction contractors negligently exposed workers to dangerous levels of toxins at the cleanup site.

The attorneys for the City deny any direct medical link between exposure to debris and the respiratory illnesses and cancers. Some doctors treating Ground Zero workers are also skeptical because cancers resulting from toxic exposure can take up to 15 to 20 years to develop.

They are disturbed, however, by the substantial number of young and otherwise healthy people who have died or become ill following similar exposure to the same environmental conditions.

“It’s still too early to say if WTC responders are at increased risk for cancer,” said Dr. Robin Herbert, director of the World Trade Center Health Effects Treatment Program at Mount Sinai School of Medicine. “But we remain very concerned.”

Another death involved Bob Shore, a city correction officer, who worked at the makeshift morgue at Ground Zero for at least two weeks, wearing only a paper mask. At the end of his first day handling body parts, Shore climbed into the shower fully dressed and cried for two hours.

Shore, a 53-year-old father of two died last August from pancreatic cancer. His doctor attributes his disease, which caused the once 300-pound bodybuilder to waste away to 110 pounds and to have his gallbladder, spleen, and pancreas removed, to his work at Ground Zero.

Shore’s widow, like many families of 9/11 recovery and rescue workers, says she now faces the impossibility of paying the medical bills, as much $200,000 for all her husband’s treatments.

Nevertheless, Michelle Shore remembers her husband’s selfless contribution to the recovery efforts: “He never regretted doing it,” she said “He was my hero, the city’s hero.”

Among the 7,300 plaintiffs in the class-action are several cancer cases including at least eleven for what is normally a rare, and often deadly, form of brain cancer. Three of the victims have already died and many of the others are seriously ill or dying. In all, 41 deaths are now alleged to have been caused by toxic exposure.

The police union and the attorney representing the plaintiffs in the class-action have pointed to police officers, firemen, a Red Cross worker, an EMS technician, an EPA employee, a construction worker, and other responders as examples of what appears to be an alarming (and growing) number of brain cancer victims.

In addition to these concerns was, and still is, the impact on babies of mothers who were pregnant when the attacks occurred and who lived within two miles of the World Trade Center.

As we reported only last month, the Columbia Center for Children’s Environmental Health (CCCEH) at the Columbia University Mailman School of Public Health has been conducting an ongoing study called the World Trade Center Pregnancy Study. Other institutions, organizations, and independent researchers have also studied the actual and potential future effects the massive amounts of toxins that were released as a result of the fine particles of pulverized building materials and the fires that incinerated the debris thereby releasing any number of cancer-causing chemicals into the air. (http://www.mailman.hs.columbia.edu/ccceh/research/wtc_pregnancy.html)

A number of articles were published between August 2003 and late 2004 that documented the fact that babies born to mothers who were pregnant when the attacks occurred and who were in or near the collapsing towers or who lived in close proximity to the site were smaller and had lower birth weights.

On August 5, 2003, the Associated Press reported that:

“Exposed pregnant women in the study faced double the risk of delivering babies who were up to about a half-pound smaller than babies born to non-exposed women.

The size differences among babies born to women exposed to dirt and soot from the attacks suggest a condition called intrauterine growth restriction, or IUGR, which has been linked with exposure to air pollution.

Previous research also has found that babies affected by IUGR may be at increased risk for heart disease, hypertension and other health problems in adulthood, said Dr. Philip Landrigan, chairman of Mount Sinai School of Medicine’s community and preventive medicine department, and one of the researchers.

While duration of the exposure was relatively short, ’the intensity of exposure to soot and dust was extraordinarily high,’ Landrigan said.

The study appears in Wednesday’s Journal of the American Medical Association.” http://www.cbsnews.com/stories/2003/08/05/health/main566807.shtml

The CCCEH study has published extensive amounts of information on the subject including the following:

“The destruction of the World Trade Center (WTC) on September 11, 2001 was an unprecedented environmental disaster, with enduring effects on the physical and psychological well-being of a nation. In lower Manhattan, the event released large amounts of dust and toxic pollutants into the air, including fine particulate matter derived from the burning of materials during the explosion and fires, construction debris, and asbestos. These exposures are known to be especially toxic to the vulnerable populations of pregnant women and their unborn infants, and have been linked to reduced fetal growth and subsequent neurodevelopmental problems. Widespread psychological distress could also affect birth outcomes and subsequent child functioning.

The Center’s study, launched in December 2001, is assessing the effects of prenatal exposure to contaminants released by the WTC destruction on gestational age, birth size, respiratory health, and neurocognitive development in 300 women who had term pregnancies. Thus far, study results show that babies born to women who were pregnant on 9/11 and lived near the WTC in the weeks after 9/11 were born lighter and shorter than were babies born to women living further away. Previous research shows that even small reductions in birth weight may lead to learning and behavioral problems.

The Center’s WTC Pregnancy Study is the only one of its kind to compare women with known exposure levels living and working close to the WTC site to a control group living and working further away from the site. The study is also unique in that pregnant women were enrolled prior to delivery, thereby eliminating participation bias that could arise from already knowing the outcome of their pregnancy.

Preliminary Findings

Results on birth size from the World Trade Center Study were published recently in Environmental Health Perspectives, a peer-reviewed journal (please click here to read the EHP paper):

Babies born to women who were living within 2 miles of the WTC in the month following 9/11/01 were on average 5 ounces lighter than babies born to women who lived further away.
Babies born to women who were living near the WTC in the month following 9/11 were on average 1/3 of an inch shorter at birth than babies born to women living further away.
All women were full term, however; women in their first 13 weeks of pregnancy on 9/11 (regardless of their distance from the WTC) had a shorter pregnancy by an average of 3.6 days compared to women who were in a later stage of pregnancy on 9/11. Babies born to mothers with shorter pregnancies had smaller head circumference than other babies.
Findings of decreased birth weight and length among full term infants of mothers who resided within 2 miles of the WTC site are potentially important for subsequent health and development. Lower birth weight, even within the normal range (>2500 g), is associated with increased fetal mortality, neonatal mortality, and infant mortality, subsequent poorer health, delayed physical and cognitive development, and increased susceptibility to stress in adulthood.”

In March, The New York Post ran an “EXCLUSIVE” by Susan Edelman that did an excellent job of bringing the public up to date on the progress and most recent findings of the CCCEH study.

In that article, interviews with investigators and the director of CCCEH, Dr. Frederica Perera, revealed that, as feared, genetic damage to the children being studied has been greater than in the case of other city children.

In fact, a considerable number of the children (about 50%) have DNA profiles with “significant levels of combustion-related toxins” (NY Post).

These findings are a sign of genetic damage and present the possibility of developmental damage and an increased risk of cancer although no such conclusions have been made at this point.

In light of this mountain of medical, scientific, and circumstantial evidence it is difficult to understand how the City can deny any causal connection between 9/11 and deaths like Det. Zadroga’s. Difficult to understand only until the money involved is considered, that is.

Regardless of whether some degree of liability is found on the part of the City of New York or any governmental agency, there seems to be little doubt that the number of victims of 9/11 will continue to climb for years or decades to come and that the full extent of the injuries and deaths caused to those who lived, worked, responded to, or were born near Ground Zero may never be known. The Zadroga autopsy may have supplied the first hard evidence of the connection despite what Commissioner Frieden says since his opinion appears to be driven more by economics than by medicine and science.


Bagolie Friedman Injury Lawyers

Friday, April 14, 2006

Treating Doctors vs. Defense Expert, Who Wins?

Very often in New Jersey workers' comp, the job will send an injured worker to one of their so called "independent" expert doctors. Usually, this is done when the insurance company disagrees with the treating doctor and wants to cut off treatment. When treatment and benefits are wrongfully terminated, it needs to be fought in Court and then it becomes a battle of the doctors.

There is hope for New Jersey's injured workers as their treating doctor will be given more weight than the insurance company's hired gun.

Pursuant to case law established in New Jersey, any conflict of opinion between
medical experts, generally greater weight is given to the opinion of the
treating physician. See Muews v. Union Bldg. & 'Contr. Cop., 45 N.J. Super.
89 (App. Div. 1957). Generally the physician treating the patient is in a
better position to express an opinion as to the cause and effect than one
making an examination in order to give expert testimony. Celeste v.
Progressive Silk Finishing Co., 72 N.J. Super. 233 (App. Div. 1962). Where
medical testimony is in conflict, greater weight ordinarily will given to
the testimony of the treating physician. Albelit v. General Motors Corp.,
46 N.J. Super. 475 (App. Div. 1957).

If you or a loved one has a work related injury, contact Bagolie Friedman Injury Lawyers now for a free and confidential consultation now.

Bausch & Lomb Urges Removal Of ReNu Contact Lens Solution

Apr 14, 2006 | Nishad Majmudar | www.democratandchronicle.com
Bausch & Lomb Inc. has asked all U.S. retailers to remove ReNu with MoistureLoc contact lens solution from their shelves.

"We find ourselves in a position where the safety of one of our products is in question," Chief Executive Ronald Zarrella wrote in a letter to consumers.

In the letter, which will appear today and Sunday in newspapers across the country, Zarrella said testing by the company and the Food and Drug Administration has so far not found a definitive link between the solution and reported case of a rare but threatening eye infection.

But he added, "Bausch & Lomb's first priority is the health and safety of consumers. If there is a problem with our product, we'll find it and we'll fix it. If there's not, when we come back, you'll be able to know with absolute certainty that we've taken every possible step to ensure your safety."

The company is recommending that consumers switch to another contact lens solution until an investigation into 109 U.S. cases of Fusarium keratitis is complete.

B&L said in a statement that it would offer product refunds.

The company had suspended U.S. sales of ReNu with MoistureLoc earlier this week because a disproportionately large number of the eye infections studied by public health authorities involved contact lens wearers who used a B&L lens cleaner made in the company's Greenville, S.C., plant.

B&L stock has fallen about 20 percent since Monday, but it rose slightly Thursday, finishing at $46.17, up 56 cents. But other ripple effects are now being felt.

Though no safety issues have arisen in Europe, two retail chains in Scandinavia, where B&L continues to ship ReNu with MoistureLoc, advised customers to change to a different brand until U.S. authorities have pinpointed the cause of the infections in the United States.

The chains were Synsam, which operates about 300 stores in Sweden, Finland and Norway, and Specsavers Blic Optik, which has about 40 stores in Sweden.

"Until this has been investigated in the U.S.A., the suspicion still remains," said Synsam's chief executive, Gunnar Harbom. "And for us, the suspicion is enough."

Several national retail chains, including Kmart, Sears, Walgreens, CVS, Rite Aid and Wal-Mart, had already pulled the product.

If you or a loved one experiences eye problems, contact Bagolie Friedman Injury Lawyers for a free and confidential consultation now.

Bausch & Lomb Urges Removal of ReNu Contact Lens Solution

Apr 14, 2006 | Nishad Majmudar | www.democratandchronicle.com
Bausch & Lomb Inc. has asked all U.S. retailers to remove ReNu with MoistureLoc contact lens solution from their shelves.

"We find ourselves in a position where the safety of one of our products is in question," Chief Executive Ronald Zarrella wrote in a letter to consumers.

In the letter, which will appear today and Sunday in newspapers across the country, Zarrella said testing by the company and the Food and Drug Administration has so far not found a definitive link between the solution and reported case of a rare but threatening eye infection.

But he added, "Bausch & Lomb's first priority is the health and safety of consumers. If there is a problem with our product, we'll find it and we'll fix it. If there's not, when we come back, you'll be able to know with absolute certainty that we've taken every possible step to ensure your safety."

The company is recommending that consumers switch to another contact lens solution until an investigation into 109 U.S. cases of Fusarium keratitis is complete.

B&L said in a statement that it would offer product refunds.

The company had suspended U.S. sales of ReNu with MoistureLoc earlier this week because a disproportionately large number of the eye infections studied by public health authorities involved contact lens wearers who used a B&L lens cleaner made in the company's Greenville, S.C., plant.

B&L stock has fallen about 20 percent since Monday, but it rose slightly Thursday, finishing at $46.17, up 56 cents. But other ripple effects are now being felt.

Though no safety issues have arisen in Europe, two retail chains in Scandinavia, where B&L continues to ship ReNu with MoistureLoc, advised customers to change to a different brand until U.S. authorities have pinpointed the cause of the infections in the United States.

The chains were Synsam, which operates about 300 stores in Sweden, Finland and Norway, and Specsavers Blic Optik, which has about 40 stores in Sweden.

"Until this has been investigated in the U.S.A., the suspicion still remains," said Synsam's chief executive, Gunnar Harbom. "And for us, the suspicion is enough."

Several national retail chains, including Kmart, Sears, Walgreens, CVS, Rite Aid and Wal-Mart, had already pulled the product.

If you or a loved one experiences eye problems, contact Bagolie Friedman Injury Lawyers for a free and confidential consultation now.

FOSAMAX ®, AREDIA ®, ZOMETA ® and ACTONEL ® Linked to Bone Death of the Jaw

FOSAMAX ®, AREDIA ®, ZOMETA ® and ACTONEL ® Bone Death of the Jaw
FOSAMAX ®, AREDIA ®, ZOMETA ® and ACTONEL ® are bisphosphonate medication used for bone loss. It's usage has been linked to the catastrophic condition known as "Dead Jaw" , also known as ONJ - Osteonecrosis of the Jaw or necrosis of the jaw or other bones.

If you or a loved one have taken any of these drugs for osteoporosis,cancer or multiple myeloma & you have experienced complications, contact Bagolie Friedman Injury Lawyers now for a free and confidential consultation.

In the U.S. Package Insert for both Aredia and Zometa, the following information on osteonecrosis had previously been added to the Adverse Reactions section under Post-Marketing Experience.

"Cases of osteonecrosis (primarily involving the jaws) have been reported in patients treated with bisphosphonates. The majority of the reported cases are in cancer patients attendant to a dental procedure. Osteonecrosis of the jaw has multiple well documented risk factors including a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids) and co-morbid conditions (e.g., anemia, coagulopathies, infection, pre-existing oral disease). Although causality cannot be determined, it is prudent to avoid dental surgery as recovery may be prolonged."

If you have been injured by Fosamax®, Actonel ®, Aredia®, or Zometa®, contact Bagolie Friedman Injury Lawyers now for a free and confidential consultation. Call toll free at 1-866-333-3529 or email at info@bagoliefriedman.com

Merck Sued Over Fosamax Health Risks

Merck Sued Over Fosamax Health Risks
From Bloomberg News
April 11, 2006


Merck & Co., which faces more than 9,000 lawsuits over its Vioxx painkiller, misrepresented the safety of its osteoporosis drug Fosamax by withholding warnings that it could kill jawbone tissue, according to a lawsuit filed Monday.

Linda Secrest, 59, sued Merck, accusing it of failing to warn doctors and patients that Fosamax could hamper blood flow to the jaw. Secrest, who began taking the drug in 2000, says she was diagnosed with jawbone tissue death in 2005. The condition is irreversible.

Merck should be ordered to change the Fosamax prescribing information given to doctors and pay the cost of medical monitoring for users, Secrest says.

The complaint, in federal court in Fort Myers, Fla., seeks to represent more than 10 million Fosamax users. It is the second of about 200 suits that Secrest's attorney said he planned to file.

Merck spokesman Chris Loder said claims of jawbone tissue death caused by Fosamax were "exceedingly rare." A warning notice was added to the drug's label in July 2005 at the Food and Drug Administration's request, he said.

Fosamax and Fosamax Plus D together are the most-prescribed medicine for osteoporosis in post-menopausal women.

If you or a loved one suffers from bone problems, contact Bagolie Friedman Injury Lawyers for a free and confidential consultation now

Merck Sued Over Fosamax Health Risks

Merck Sued Over Fosamax Health Risks
From Bloomberg News
April 11, 2006


Merck & Co., which faces more than 9,000 lawsuits over its Vioxx painkiller, misrepresented the safety of its osteoporosis drug Fosamax by withholding warnings that it could kill jawbone tissue, according to a lawsuit filed Monday.

Linda Secrest, 59, sued Merck, accusing it of failing to warn doctors and patients that Fosamax could hamper blood flow to the jaw. Secrest, who began taking the drug in 2000, says she was diagnosed with jawbone tissue death in 2005. The condition is irreversible.

Merck should be ordered to change the Fosamax prescribing information given to doctors and pay the cost of medical monitoring for users, Secrest says.

The complaint, in federal court in Fort Myers, Fla., seeks to represent more than 10 million Fosamax users. It is the second of about 200 suits that Secrest's attorney said he planned to file.

Merck spokesman Chris Loder said claims of jawbone tissue death caused by Fosamax were "exceedingly rare." A warning notice was added to the drug's label in July 2005 at the Food and Drug Administration's request, he said.

Fosamax and Fosamax Plus D together are the most-prescribed medicine for osteoporosis in post-menopausal women.

Tuesday, April 11, 2006

Bausch & Lomb Suspends Contect Lens Solution Shipment

Officials Probe Eye Infection Outbreak
Apr 10, 2006 ANDREW BRIDGES AP

Bausch & Lomb voluntarily suspended shipment of a contact lens solution after federal health officials linked it Monday to a fungal eye infection that can cause temporary blindness.The

Centers for Disease Control and Prevention is investigating 109 reports of Fusarium keratitis infection in patients in 17 states since June 2005.Federal and state health officials have interviewed just 30 of those patients. However, of the 28 who wore soft contact lens, however, 26 reported using Bausch & Lomb's ReNu brand contact lens solution or a generic type of solution also made by the Rochester, N.Y., company.Bausch & Lomb said it would temporarily suspend shipments of ReNu with MoistureLoc made at its Greenville, S.C., plant."The CDC data released today are both troubling and perplexing, as there is an apparent disproportionate representation of U.S.-manufactured ReNu with MoistureLoc in the underlying data.

The source of these infections has not been determined," company chairman and chief executive officer Ronald Zarrella said. Five of the 26 patients also reported using other types of solutions in addition to ReNu, Bausch & Lomb said. And nine said they wore their lenses overnight, which is known to increase the risk of infection, the CDC said.Dr. Daniel Schultz, director of the Food and Drug Administration's Center for Devices and Radiological Health, said it was too early to determine if Bausch & Lomb's solution was the cause of the infections. Both the FDA and CDC are investigating a growing number of reports of infection by the fungus. An estimated 30 million Americans wear soft contact lenses."We are relatively early in this investigation. It may be we will find this particular product does not have an association. We may find a strong association," Schultz told reporters.

The fungus is commonly found in plant material and soil in tropical and subtropical areas. Singapore health officials noticed an increase in reports of infection in January and discovered 39 cases involving contact lens users from 2005 to February of this year. Cases have also been reported in Malaysia and Hong Kong.In February, Bausch & Lomb halted sales of its ReNu contact lens solution in Singapore and Hong Kong.Without treatment, which can last two to three months, the infection can scar the cornea and blind its victims. Eight U.S. patients have required cornea transplants.Soft contact users with eye redness or pain, tearing, increased light sensitivity, blurred vision or discharge should stop wearing contacts and contact a doctor immediately, said Dr. Malvina Eydelman, director of the FDA's Division of Ophthalmic and Ear, Nose and Throat Devices. The FDA also advises users to wash their hands well with soap and water before handling lenses and to follow cleaning and storage guidelines.In addition, contact lens wearers who use ReNu with MoistureLoc should do so with caution, the FDA said.

Friday, March 24, 2006

Compulsive Gambling Linked To Parkinson's Drug

As reported in HighRollerLife.com

Ever since Las Vegas has been in the business separating people from their money, there have been customers who have tried to get their money back. Of course, it almost never works. However, a recent complaint filed in U.S. District Court in Austin, Texas, claims that a man who suffers from Parkinson's disease took a drug that caused him to lose $10 million at the tables here. And based on early clinical studies of the drug prescribed for his disease, he may have a chance to recoup his losses.

Austin resident Max Wells, who suffers from Parkinson's, lost those millions gambling between September 2005 and January 2006. Most, if not all, of it right here in Las Vegas. At the end of January, his wife found out. In fact, she discovered that prior to the $10 million he lost here, he had already lost a few million dollars more. On Feb. 27, Wells filed a civil action in Austin seeking $21.5 million from six Las Vegas casinos and a drug company he claims were responsible for his losses. "Obviously, you can always go to Nevada and sue a casino, but you get a completely different jury and atmosphere," gaming law expert I. Nelson Rose, professor at Whittier Law School, said. "People in Texas are going to say, 'This guy lost $12 million and was taken advantage of.' People in Nevada might say, 'Oh, come on. Just because you lose money doesn't mean you can sue and get it back.' "It's not a frivolous claim by any means, but he's got a few steps he's going to have to show to get the connection there," he added.

The complaint against the casinos hinges on four crucial points: * Is there sufficient correlation to draw a link between a prescription drug that Wells was taking and compulsive gambling? * Can Wells prove negligence because the drug company was obliged to properly alert him about the possible side effect? * Can he prove that the casinos knew about the compulsion? * Was there sufficient interaction between the casinos, the state of Texas and Wells in his home state so that Austin is the proper venue to hear the case?

THEFT LIABILITY ACT
The plaintiff names the parent companies of the Wynn Las Vegas, Venetian Resort Hotel-Casino, Mandalay Bay Resort-Casino, Treasure Island, Harrah's Las Vegas hotel-casino and the Hard Rock Hotel & Casino. Wells is suing the casinos under provisions of the Texas Theft Liability Act for "unlawfully appropriating his property." Wells' attorney, Tom Thomas of the, declined to comment on the case.

The lawsuit makes two separate claims: First, it targets Pennsylvania-based drug company GlaxoSmithKline over its prescription drug Requip. Wells asserts the company failed "to give adequate, proper and nondeceptive warnings" that the medication could "cause its users to develop an irresistible impulse to gamble." Requip, which is manufactured by GlaxoSmithKline, is a dopamine agonist that can help ease symptoms associated with Parkinson's. Similar to another Parkinson's drug, Mirapex, both drugs have been linked to compulsive behavior, including gambling, in two separate studies. According to the complaint, Wells was diagnosed with Parkinson's disease in 2000. Over time, he was first prescribed Mirapex, which is produced by Boehringer Ingelheim Pharmaceuticals. He then was switched to Requip in November 2004 after "Wells became aware that he was developing an irresistible compulsion to gamble" while taking Mirapex, according the complaint. The court papers describe the behavior as "contrary to (Wells') pre-Mirapex habits, practices and routines."

A 2003 report in the academic journal "Neurology" showed that out of 529 patients, eight who took Mirapex developed gambling addictions. The study was done by the Muhammad Ali Parkinson Research Center at the Barrow Neurological Institute in Arizona. The study was followed in July 2005 by researchers at the Mayo Clinic, stating that 11 patients developed gambling problems while taking "Mirapex or similar drugs" from 2002 to 2004 and an additional 14 also were later identified as having the same problem.

Calls seeking comment from GlaxoSmithKline had not been returned by press time. However, neither drug's Web site lists problem gambling as a possible side effect when taking their medications. WARNING SIGNALS? The complaint alleges that the drug company "could reasonably foresee" that Parkinson's patients on Requip "could develop an irresistible gambling compulsion" by mid-2005 and that the company was negligent because it "failed to warn the public or physicians." "The claim ... is that Wells was, by reason of intoxication, unable to make reasonable property dispositions," said University of Texas Law School professor George Dix via e-mail, after reading the complaint. "We do not let an accused rely on 'irresistible impulse' caused by mental illness to escape liability, but I am unaware of an absolute bar to relying on it as the plaintiff does here." After being confronted by his wife, Wells stopped taking Requip and he no longer gambles, according to the complaint.

The second part of the claim argues that the casinos were aware of Wells' condition, and that "in some instances" knew he was on either Mirapex and Requip. It also tries to lay claim to jurisdiction. The question arises to what the casinos knew, when they knew it and were they expected to know it and does it violate Texas penal code? That state defines theft as unlawfully appropriating property with the intent to deprive the owner of the property and that appropriation is unlawful if it is without "effective consent" of the owner. Texas Penal Code, Chapter 31.01(3) (C) says consent is not effective if "given by a person who by reason of youth, mental disease or defect, or intoxication is known by the actor to be unable to make reasonable property dispositions." "The weakest part of the case is not the connection that the drug caused compulsive gambling, which is still going to have to be proved," said Rose, who has also read the original complaint, "but that the casinos knew about it. They have to know that he is drugged and taking a medicine that has been shown to cause this."

CASINOS 'SPECIFICALLY AWARE'
The complaint against the casinos seems to rely on a belief that the casinos were "specifically aware" of the drugs' addictive side effects due to "heavy publicity surrounding the publication" of the 2005 Mayo Clinic study. Rose, who has written on compulsive gambling for 20 years and lost a family member to Parkinson's, says he only became familiar with the possible connections between Requip and Mirapex and problem gambling in the "last few months." Wells claims he was soon recognized by the properties as a heavy gambler and given a casino host whose job it was to induce gambling. The casinos also provided free first-class airfare to Las Vegas, free suites, meals, entertainment, expensive gifts, extension of a credit line and even a free Alaskan cruise. The properties also paid for Wells' wife to go shopping. The hosts also solicited him in Texas, even offering to discount his losses. The complaint attempts to set up jurisdiction by claiming the losses were paid out of accounts located in Texas and that $1.2 million worth of markers were sent to him in Texas, in addition to the gifts and phones calls sent to Texas by the casinos. "He may have trouble proving all this," said University of Texas Law School professor Douglas Laycock via e-mail after reading the complaint. "But if I were representing a casino, I would be inclined to settle before taking this one to a jury." The Mirage and Harrah's declined comment on pending litigation; the Venetian and Hard Rock Hotel did not return inquiries for comment by press time. A spokesperson for the MGM/Mirage, parent company for Treasure Island and Mandalay Bay, described the complaint as being "without merit."

Parkinson's Drug Linked to Gambling

Parkinson's drug link to gambling
Sunday Mar 19 22:19 AEDT
Medical researchers are investigating suspicions drugs prescribed to treat Parkinson's disease could turn patients into compulsive gamblers, the Washington Post reports.
Scientists at the US Food and Drug Administration have found a strong association between pathological gambling and the drugs, which boost the level of dopamine in the brain, according to the newspaper.
Dopamine, a chemical naturally produced in the human body, plays a key role in the way the brain controls movements. A shortage of dopamine causes Parkinson's disease. But the chemical is also associated with addictive behaviours such as drug use and pleasurable experiences such as sex and food.
Researchers, according to the Washington Post, are looking into the possibility that drugs for treating Parkinson's are turning "some patients into obsessive pleasure seekers".
But the article also said no firm links have been made between dopamine enhancers and compulsive gambling.
Some patients have filed lawsuits against drug manufacturers, citing lost jobs and gambling problems.
Pharmaceutical firms such as Germany's Boehringer Ingelheim have toughened warning labels on drugs as the company investigates reports, according to the newspaper.
But Eli Lilly and Co, noting the lack of scientific consensus, raised the possibility that gambling problems in Parkinson's patients could be related to more legalised gambling, the newspaper reported.

Friday, March 10, 2006

Ortho Evra Patch Case Lawsuits

Ortho Evra Patch Cases
Ortho Evra Patch CasesThe following Ortho Evra Patch Cases warrant investigation:

Our criteria is basically DVT, PE, CVA or MI suffered while on the patch, or shortly thereafter (I.e. during the week that the patch is not warn). In certain circumstances we are taking cases where there is a longer latency if there had been recorded complaints of related symptoms.

Please feel free to use this intake if you think it will help you.

If you have any questions don't hesitate to ask.

ORTHO EVRA QUESTIONNAIREDate: Name: Address: City: State: Zip: Age: Birth Date: Email: _____Home Phone: Work Phone: Cell Phone: Fax: Best time to contact you: Alternate Contact: Have you suffered: Date/State of Occurrence: Stroke (CVA): Yes No ____ Pulmonary Embolism (PE): Yes No Heart Attack (MI): Yes No Deep Vein Thrombosis (DVT): Yes No Primary Pulmonary Hypertension (PPH): Yes No Blood Clots (where?): Yes No Hospitalization (for above/how long?): Yes No Are you a smoker? Yes No Have you quit smoking? Yes No Describe smoking history (how much/how long): ORTHO EVRA HISTORYWhen did you begin to use Ortho Evra? When did you stop using Ortho Evra? What were the adverse symptoms? When did you first notice adverse symptoms? Current medications (Coumadin/Warfarin, Plavix, Aspirin, etc.): Other medications: Notes:

Ortho Evra Patch Case Lawsuits

Ortho Evra Patch Cases
Ortho Evra Patch CasesThe following Ortho Evra Patch Cases warrant investigation:

Our criteria is basically DVT, PE, CVA or MI suffered while on the patch, or shortly thereafter (I.e. during the week that the patch is not warn). In certain circumstances we are taking cases where there is a longer latency if there had been recorded complaints of related symptoms.

Please feel free to use this intake if you think it will help you.

If you have any questions don't hesitate to ask.

ORTHO EVRA QUESTIONNAIREDate: Name: Address: City: State: Zip: Age: Birth Date: Email: _____Home Phone: Work Phone: Cell Phone: Fax: Best time to contact you: Alternate Contact: Have you suffered: Date/State of Occurrence: Stroke (CVA): Yes No ____ Pulmonary Embolism (PE): Yes No Heart Attack (MI): Yes No Deep Vein Thrombosis (DVT): Yes No Primary Pulmonary Hypertension (PPH): Yes No Blood Clots (where?): Yes No Hospitalization (for above/how long?): Yes No Are you a smoker? Yes No Have you quit smoking? Yes No Describe smoking history (how much/how long): ORTHO EVRA HISTORYWhen did you begin to use Ortho Evra? When did you stop using Ortho Evra? What were the adverse symptoms? When did you first notice adverse symptoms? Current medications (Coumadin/Warfarin, Plavix, Aspirin, etc.): Other medications: Notes:

Saturday, March 04, 2006

Lawsuit Against EPA For Deeming WTC Site Safe Allowed To Go Forward

Lawsuit Against EPA For Deeming WTC Site Safe Allowed To Go Forward

A federal judge has cleared the way for a civil suit to proceed against the Environmental Protection Agency and its former head on the grounds that the agency misled the public when it deemed Ground Zero safe for workers and area residents to return.
The class action lawsuit was filed in 2004 by residents, students and workers in Lower Manhattan and Brooklyn who say they were exposed to hazardous dust and debris. They claim the EPA had no way of knowing whether it was safe or not to return, but told them to anyway.
The judge says former EPA head Christie Todd Whitman's assurance that the World Trade Center site was safe shortly after the 9/11 terror attacks was "conscience-shocking."
Just two days after 9/11, Whitman and the EPA declared the air seemed safe to breathe. An internal review later found the agency gave misleading assurances, at the White House's urging.
Critics say that the EPA was in a rush to declare that the air quality was good so that officials could reopen the New York Stock Exchange to help the economy. They also say the Bush administration didn't want to face the possibility of spending billions of dollars to clean people's homes.
Senator Hillary Clinton was highly critical of the EPA's decision.
"This is outrageous,” said Senator Clinton. “You know, New Yorkers should be able to depend on the federal government to provide them with accurate information about the air that we breathe and we should be able to count on the federal government to assess the level of ongoing risks."
The lawsuit seeks unspecified damages and reimbursement for cleanup costs. It also asks the court to order a medical monitoring fund be set up to track the health of those exposed to trade center dust.
Whitman defended the EPA, saying in a statement: "Every action taken...was designed to provide the most comprehensive protection and the most accurate information to the residents of Manhattan. To imply otherwise is completely inaccurate."
The EPA is expected to appeal, which means it could be months or even years before the case is settled.

Public Misled on Air Quality After 9/11 Attack, Judge Says

Public Misled on Air Quality After 9/11 Attack, Judge Says
By JULIA PRESTONNY Times

Christie Whitman, when she led the Environmental Protection Agency, made "misleading statements of safety" about the air quality near the World Trade Center in the days after the Sept. 11 attack and may have put the public in danger, a federal judge found yesterday.
The pointed criticism of Mrs. Whitman came in a ruling by the judge, Deborah A. Batts of Federal District Court in Manhattan, in a 2004 class action lawsuit on behalf of residents and schoolchildren from downtown Manhattan and Brooklyn who say they were exposed to air contamination inside buildings near the trade center.
The suit, against Mrs. Whitman, other former and current E.P.A. officials and the agency itself, charges that they failed to warn people of dangerous materials in the air and then failed to carry out an adequate cleanup. The plaintiffs are seeking monetary damages and want the judge to order a thorough cleaning.
In her ruling, Judge Batts decided not to dismiss the case against Mrs. Whitman, who is being sued both as former administrator of the E.P.A. and as an individual.
As a legal matter, the ruling established that the suit's charges were well-documented and troubling enough to meet a legal standard to go forward. But Judge Batts also criticized Mrs. Whitman's performance in the days after the collapse of the towers unleashed, by the E.P.A.'s estimates, one million tons of dust on lower Manhattan and beyond.
"The allegations in this case of Whitman's reassuring and misleading statements of safety after the Sept. 11, 2001 attacks are without question conscience-shocking," Judge Batts said.
Calls to the Whitman Strategy Group, Mrs. Whitman's current business, and to Glenn S. Greene, the Justice Department lawyer who is representing her and the E.P.A. in the case, were not immediately returned. Mrs. Whitman, a former New Jersey governor, was administrator of the E.P.A. from 2001 to 2003.
Mrs. Whitman knew that the towers' destruction had released huge amounts of hazardous emissions, Judge Batts found. But as early as Sept. 13, Mrs. Whitman and the agency put out press releases saying that the air near ground zero was relatively safe and that there were "no significant levels" of asbestos dust in the air. They gave a green light for residents to return to their homes near the trade center site.
"By these actions," Judge Batts wrote, Mrs. Whitman "increased, and may have in fact created, the danger" to people living and working near the trade center. Judge Batts said that Mrs. Whitman was not entitled to immunity because she was a public official. Judge Batts allowed the suit to proceed on some counts against the E.P.A. She dismissed claims against Marianne L. Horinko, an assistant administrator of the E.P.A. at the time.
Lawyers for the plaintiffs were "very gratified that the court has recognized that the E.P.A. failed in its obligation to protect the residents of downtown Manhattan and Brooklyn," said Justin Blitz, a lead lawyer on the case.
In a statement yesterday, Senator Hillary Rodham Clinton called the E.P.A.'s conduct "outrageous."
"New Yorkers were depending on the federal government to provide them with accurate information about the air they were breathing," she said. "I continue to believe that the White House owes New Yorkers an explanation."
About 2,000 tons of asbestos and 424,000 tons of concrete were used to build the towers, and when they came crashing down they released dust laden with toxins. After an expert panel failed last year to settle on a method for organizing an E.P.A. cleanup, the agency said it would proceed anyway with limited testing and cleaning of apartments in downtown Manhattan below Canal Street.

Ground Zero Team Sues Over Illness

Ground Zero Team Sues Over Illness


8/14/04
Hundreds of people who worked on the World Trade Centre clean-up have filed a class-action lawsuit alleging companies did little to protect workers from dust, asbestos and other toxins in the air.
The legal battle targets the leaseholder of the New York towers and those who supervised the job, including the subsidiary of an Australian company.
The lawsuit was filed in a US federal court on Friday and made public today.
It has been brought against Silverstein Properties and the four construction companies hired to oversee the removal of 1.5 million tonnes of debris after the September 11, 2001 terror attacks.
They include Bovis Lend Lease, a unit of Australian real estate firm Lend Lease.
David Worby, a lawyer for the plaintiffs, said he was seeking billions of dollars in compensation for victims.
The lawsuit also asks for the establishment of a system to track all those who were exposed for the next 20 years.
It alleges that many workers did not have access to protective gear, and those who did were not taught how to wear it properly.
Some of the plaintiffs suffer from afflictions ranging from tumours to heartburn.
Others have joined the action because they fear they risk developing cancer in the future.
Mr Worby said: "The tragic reality is that so many of the brave heroes who worked so tirelessly and unselfishly are becoming a second wave of casualties of this horrific attack, and we're only seeing the tip of the iceberg."
The companies involved said they had not seen the complaint and had no immediate comment.
The class-action case, with about 800 plaintiffs, was filed on the last day before a federal three-year statute of limitations expired for lawsuits related to the terrorist attack.
The US Government is already funding six health screening programs to monitor ground zero workers, but none are funded beyond 2009.
Last week, the federal Centres for Disease Control and Prevention released a study showing that many recovery workers suffered from respiratory problems long after the clean-up concluded, and that some were still battling ailments.
Problems identified included asthma, sinusitis, constant coughing and stuffy nose, facial pains, chest tightness, wheezing and shortness of breath.
Proper respiratory gear would have allowed the workers to block out smoke, dust, diesel exhaust, pulverised cement, glass fibres, asbestos and other chemicals and could have prevented throat and lung diseases, according to the CDC study.
It found that only about one in five of the workers wore respirators while they worked at the site.
The three companies in the clean-up with Bovis Lend Lease were Turner Construction, AMEC Construction and Tully Construction.
According to AMEC's website, the company stationed safety experts on site during the clean-up and provided respirators, hard hats and safety goggles to workers.

Ground Zero Team Sues Over Illness

Ground Zero Team Sues Over Illness


8/14/04
Hundreds of people who worked on the World Trade Centre clean-up have filed a class-action lawsuit alleging companies did little to protect workers from dust, asbestos and other toxins in the air.
The legal battle targets the leaseholder of the New York towers and those who supervised the job, including the subsidiary of an Australian company.
The lawsuit was filed in a US federal court on Friday and made public today.
It has been brought against Silverstein Properties and the four construction companies hired to oversee the removal of 1.5 million tonnes of debris after the September 11, 2001 terror attacks.
They include Bovis Lend Lease, a unit of Australian real estate firm Lend Lease.
David Worby, a lawyer for the plaintiffs, said he was seeking billions of dollars in compensation for victims.
The lawsuit also asks for the establishment of a system to track all those who were exposed for the next 20 years.
It alleges that many workers did not have access to protective gear, and those who did were not taught how to wear it properly.
Some of the plaintiffs suffer from afflictions ranging from tumours to heartburn.
Others have joined the action because they fear they risk developing cancer in the future.
Mr Worby said: "The tragic reality is that so many of the brave heroes who worked so tirelessly and unselfishly are becoming a second wave of casualties of this horrific attack, and we're only seeing the tip of the iceberg."
The companies involved said they had not seen the complaint and had no immediate comment.
The class-action case, with about 800 plaintiffs, was filed on the last day before a federal three-year statute of limitations expired for lawsuits related to the terrorist attack.
The US Government is already funding six health screening programs to monitor ground zero workers, but none are funded beyond 2009.
Last week, the federal Centres for Disease Control and Prevention released a study showing that many recovery workers suffered from respiratory problems long after the clean-up concluded, and that some were still battling ailments.
Problems identified included asthma, sinusitis, constant coughing and stuffy nose, facial pains, chest tightness, wheezing and shortness of breath.
Proper respiratory gear would have allowed the workers to block out smoke, dust, diesel exhaust, pulverised cement, glass fibres, asbestos and other chemicals and could have prevented throat and lung diseases, according to the CDC study.
It found that only about one in five of the workers wore respirators while they worked at the site.
The three companies in the clean-up with Bovis Lend Lease were Turner Construction, AMEC Construction and Tully Construction.
According to AMEC's website, the company stationed safety experts on site during the clean-up and provided respirators, hard hats and safety goggles to workers.

NYPD Officer Who Collapsed And Died Worked At WTC Site

January 29, 2006
The police officer who collapsed and died during a pursuit Friday night, reportedly spent a lot of time at the World Trade Center Site.
While the cause of death is still unclear, Kevin Lee's family members told the Daily News they fear he may have gotten sick because of the long hours he worked at the site after September 11th.
The Medical Examiner is working to determine the cause of death. Officer Lee collapsed while he and his partner were chasing three men on the Upper East Side wanted for stealing a laptop from a Lexington Avenue store.
Early reports suggested that Lee suffered a heart attack, but the hospital did not confirm that information.
Lorenzo Walter, 18, and 19-year-old Julio Marquez were arrested Friday night, Rico Banks, 19, surrendered to police Satruday. All three men face robbery charges.
Police say Lee struggled with one of the men right before he collapsed.
Lee, a 10-year veteran of the NYPD and a member of the department's Grand Larceny Unit, was rushed to Lenox Hill Hospital where he was pronounced dead. He lived in the Bronx and is survived by a wife and 6-year-old son.
Mayor Michael Bloomberg spoke with Lee's mother who told him that being an officer was something her son always wanted.
"All his life, all he wanted to do was be a cop. In high school there was some kind of a program where he could study what police offers do. It's all he ever talked about. He attended John Jay College and decided what her really wanted to do is be a cop."
Police officer Lee was the second officer to collapse during a pursuit this year. Earlier this month, police officer Francis Hennessey collapsed and died from a brain aneurysm while on duty.

FDA Finds Benzene in Soft Drinks

FDA finds benzene in soft drinks
Mar 3, 2006 DAVID GOLDSTEIN Knight Ridder Newspapers
When small amounts of benzene, a known cancer-causing chemical, were found in some soft drinks 16 years ago, the Food and Drug Administration never told the public.That's because the beverage industry told the government it would handle the problem and the FDA thought the problem was solved.A decade and a half later, benzene has turned up again. The FDA has found levels in some soft drinks higher than what it found in 1990, and two to four times higher than what's considered safe for drinking water.Both the FDA and the beverage industry said the amounts were small and that the problem didn't appear to be widespread."People shouldn't overreact," said Kevin Keane, a spokesman for the American Beverage Association. "It's a very small number of products and not major brands.""The issue here is not something that should cause anyone alarm or terrific concern," said George Pauli, a top food safety expert at the FDA, "but if there's something that can be reduced, we want to reduce it."Neither Keane nor Pauli would identify the drinks being tested because the investigation is still under way.Pauli said that people ingest more benzene by breathing than they would if they drank a can of soda containing the chemical. Small amounts of the chemical also are naturally present in some foods such as fruits, vegetables and dairy products.Still, Pauli added, "You want to avoid it in any degree you can."Of the 60 or so varieties of sodas, sports drinks, juice drinks and bottled waters that the FDA has tested so far, benzene levels have ranged from two and three parts per billion to more than 10-20 parts per billion.The Environmental Protection Agency's safety standard for benzene in drinking water is five parts per billion. If it exceeds that, authorities are required to notify the public.Keane said it was "tough to compare" the safety standard for water with soft drinks because the water rule is based on the fact that people drink more water each day.Benzene is an industrial chemical that's found in tobacco smoke, car exhaust and vapors from household products such as paint, detergents and furniture wax. Long-term exposure can cause leukemia and other cancers of the blood, according to the Centers for Disease Control and Prevention.Benzene can show up in soft drinks when two common ingredients react: ascorbic acid, otherwise known as vitamin C, and either sodium benzoate or potassium benzoate. Both are preservatives used to prevent the growth of bacteria.But the presence of these chemicals doesn't necessarily produce benzene."It's not as simple as looking at the label, and if you see those two, there will be problems," Keane said.Pauli said that a catalyst such as temperature or light is needed to trigger the formation of benzene. That's what scientists suspect occurred in 1990 when authorities found benzene in products made by Cadbury Schweppes and Koala Springs, an Australian beverage company.But a health safety watchdog organization said the FDA should inform the public, particularly since so many soft drinks are marketed to children."Most people would prefer there are no known human carcinogens in what they drink," said Jane Houlihan, vice president for research at the Environmental Working Group, a nonprofit, nonpartisan scientific research group that studies toxic chemicals. "This is a case where industry agreed to get it out of the products, and all the evidence says they didn't."Soft drink manufacturers PepsiCo and Coca-Cola declined to comment and referred calls to the American Beverage Association.When benzene first turned up 16 years ago, FDA officials met with representatives of the beverage industry who "expressed their concern about the presence of benzene traces in their products and the potential for adverse publicity associated with this problem," according to an internal FDA memo from December 1990.Keane said the industry told the FDA that it was reformulating its products to alleviate the problem. Adding sugar, for instance, or replacing the vitamin C, can inhibit the chemical reaction that produces benzene, Pauli said.An FDA official who asked not to be identified said that the agency didn't inform the public about the benzene problem 16 years ago because it didn't consider it a public health concern since the levels were low and the companies were reformulating.He said the FDA conducted follow-up testing in the early 1990s, but not since because "we thought the problem was gone and over. Then it resurfaced."The current investigation began when an activist concerned about soft drink machines in schools tried to get the FDA interested in the issue. He then sent lab results showing some soft drinks with higher-than-normal benzene levels."Our first reaction was, `Yes, we looked at this in 1990 and essentially there was nothing there,'" Pauli said. "Then he came up with some numbers and we said, `That's not what we came up with back then. We have to go back and look.'"Asked why the problem would resurface 16 years later, Keane said the industry took the necessary steps at the time, but it's possible some manufacturers just didn't know."It's a very fast-growing industry, both in terms of companies and new brands, so a lot has changed in the last 16 years," he said.Food safety authorities in Great Britain and Australia also are testing soft drinks for benzene.

Friday, February 24, 2006

Workers Comp Law Blog: Chromium Industry Hid Cancer Risks, Report Says

Workers Comp Law Blog: Chromium Industry Hid Cancer Risks, Report Says

Chromium Industry Hid Cancer Risks, Report Says

Chromium Industry Hid Cancer Risks, Report Says

Researchers charge that businesses skewed data to weaken a proposed federal standard

Feb 24, 2006 Marla Cone Los Angeles TimesAs federal regulators are poised to announce a new standard for protecting workers, a team of scientists reported Thursday that the chromium industry and its consulting scientists withheld and skewed data that suggested workers exposed to low levels of chromium were dying from lung cancer.David Michaels, a professor of environmental and occupational science at George Washington University, and two other researchers detailed what they called an orchestrated campaign by the chromium industry to manipulate scientific data to persuade the Occupational Safety and Health Administration to weaken a proposed workplace standard.

Chromium-producing corporations and metal-finishing companies have opposed stricter limits on workers' exposure to hexavalent chromium since 1976, when OSHA first proposed changes in the regulation. The agency faces a court order to announce its new standard by Tuesday.About 380,000 U.S. workers are exposed to hexavalent chromium, which is widely used in metal-plating, aerospace production, stainless steel processing and dye manufacture, among other businesses.

Chromium is considered one of the most dangerous toxic contaminants in California's air.Classified as a human carcinogen, hexavalent chromium has been tied to lung cancer for about 50 years. But the debate over the new standard centers on whether low levels now found at modern plants increase workers' cancer rates.Michaels' report faults the handling of a cancer study at four large chromium production plants in the U.S. and Germany."This was a 10-year campaign to shape the science to fit the industry's agenda rather than shape the regulation to fit the science," Michaels, director of the Project on Scientific Knowledge and Public Policy at George Washington University's school of public health, said in an interview Wednesday.

Michaels and the two other researchers, whose report was published in the online journal Environmental Health, obtained internal documents through an industry foundation's bankruptcy proceedings that showed the industry representatives were aware in 2002 of an elevated cancer risk reported among workers.A representative of Elementis Chromium, the world's largest chromium producer, said there was no conspiracy. He said that during the period the study was conducted, the industry was in turmoil with plants shutting down and changing owners which led to delays and problems with the data's release."I would categorically say there was not an orchestrated effort to hide anything," said Joel Barnhart, vice president of technical issues at Elementis Chromium's plant in Corpus Christi, Texas. "What I can say is that it certainly may have not been handled well."Kate McMahon, an attorney for the Chrome Coalition, an industry trade group, called the allegations "completely and utterly baseless and absolutely dead wrong."OSHA officials declined to comment Thursday on the report, saying only that they expected to meet Tuesday's deadline for the chromium standard.The agency has been reviewing whether to tighten its chromium standard, which was set 35 years ago. A federal appeals court, ruling in a case filed by a union and the Public Citizen Health Research Group, ordered OSHA to act by this year.The workplace standard is 52 micrograms of chromium per cubic meter of air. In 2004, OSHA proposed 1 microgram. Michaels and others say the agency will probably adopt a standard of 5 micrograms.Industry groups say the agency's 1-microgram proposal would bankrupt businesses and cost the metal-finishing industry $380 million annually.In the mid-1990s, a foundation working for the Chrome Coalition commissioned a study of workers at four production plants, "the results of which confirmed the elevated lung cancer risk," Michaels wrote.The consultants who conducted the study reported their findings to the industry foundation in 2002. But the industry did not tell OSHA, according to Michaels. "Even when the agency specifically asked for precisely these sorts of data during its 2004-2005 rulemaking proceedings, the chromium industry and the authors remained silent," Michaels' report says.Then, the industry consultants, employees of ENVIRON, an international environmental consulting firm, rewrote the findings to remove the elevated cancer data, Michaels said. They divided the study into two parts: one with data from the American plants and one with data from the German plants.Originally, the study of the four plants found increased cancer at low chromium levels. But after the data from the U.S. and German plants were separated, the study at the U.S. plants, which was published in April in a peer-reviewed occupational medicine journal, reported no cancer link, and the German results reported elevated cancer only at high chromium levels.

Michaels said that splitting the workers into two groups disguised the cancer rate, and that industry groups used that misleading data to support their claim to OSHA that a strict standard was unwarranted.

The ENVIRON consultants, in a letter published in a medical journal in October, commended the industry for sponsoring research of its employees and said there was a valid scientific reason for dividing American and German workers: Their exposure was measured differently, monitoring air in the United States and urine in Germany.But Michaels said data from all four plants needed to be combined to create a study large enough to be statistically sound something the consultants emphasized in their original proposal. "It's not sound to look at your results and split them because you don't like the results," Michaels said. "The scientifically honest approach is to report the results using the method you said you would use."The handling of the studies "raise troubling questions about the ability of government to effectively issue rules protecting public health when studies are conducted, controlled and selectively published by the regulated industry," Michaels and his co-authors said in their report.The two U.S. plants, in Texas and North Carolina, are now owned by Elementis, a British company.Barnhart, of Elementis Chromium, said the study data came at a time of "chaos." The foundation that funded the study, he said, went bankrupt, two German plants shut down and the North Carolina plant was purchased by the British corporation. He said the companies involved did not review the findings and did not tell the consultants to change or withhold the cancer data."There certainly wasn't any conspiracy," Barnhart said. "It was as much ineptitude by me and maybe others who were aware of [the study] but didn't push to get it released in a form that was useful."