People who are returning to the Gulf Coast after Hurricane Katrina are finding that they may be exposed to life-threatening hazards.  

Citizens have to deal with leaking natural gas lines, the potential of carbon monoxide poisoning, and a number of contaminated materials.

The Environmental Protection Agency (EPA) and its Federal Partners released a warning urging returning residents to take the following precautions:

·Be aware of possible combustible or explosive gases. Many natural gas and other fuel lines were broken during Hurricane Katrina.  Highly explosive gas vapors may still be present in many buildings.  In addition, methane and other explosive gases may accumulate from decaying materials.

·Open all windows when entering a building. Upon entering a home or building, don’t smoke, light matches, operate electrical switches, use either cell or conventional phones, or create any other source of ignition.  If the smell of gas or the sound of escaping gas is present, exit the building immediately, leaving windows and doors open.  Immediately upon leaving the building, contact emergency authorities and do not re-enter the building until authorities advise that it is safe to do so.

·Avoid carbon monoxide poisoning. Carbon monoxide is a colorless, odorless gas that is produced when any fuel is burned.  Ingesting high levels of carbon dioxide can cause death.  Never use fuel-burning devices such as gasoline-powered generators, camp stoves and lanterns, or charcoal grills inside homes, garages, or any other confined space.  Opening doors and windows or using fans will not prevent carbon dioxide buildup in the home.  Carbon dioxide poisoning symptoms include feeling sick, dizzy, or weak.  If these symptoms occur, people should get to fresh air immediately.

·Avoid problems from mold, bacteria, and insects. Standing water is a breeding ground for a wide range of micro-organisms and insects, such as mosquitoes.  Mosquitoes can spread diseases like West Nile Virus.  Micro-organisms, including bacteria and mold, can become airborne and be inhaled.  

It is important to remove standing water as quickly as possible.  Remove wet materials and discard those that cannot be thoroughly cleaned and dried within 48 hours.  Virtually all building contents made of paper, cloth, wood and other absorbent materials that have been wet for over 48 hours need to be discarded.

Micro-organisms and other contaminants can penetrate deep into soaked, porous materials and later be released into air or water.  A building that has been immersed in contaminated flood waters will need to be completely dried out.  This may require the removal of ceiling, wall, insulation, flooring and other materials.  If a house or building is not dried out properly, a musty odor, signifying growth of micro-organisms, can remain long after the flood.

It is very important to limit contact with flood water.  When removing materials or furnishings contaminated with mold, it is important to wear goggles, gloves, and a respirator or dust mask.

·Avoid problems from the use of cleaners, disinfectants, and pesticides. Disinfectants, sanitizers, and other pesticides can contain toxic and hazardous substances.  Mixing certain types of household cleaners can produce toxic fumes that can result in injury or even death.  Read and follow all instructions carefully.  When using cleaners and disinfectants, provide fresh air by opening windows and doors.

·Avoid problems from airborne asbestos and lead dust. Elevated concentrations of airborne asbestos can occur if asbestos-containing materials present in many older homes are disturbed.  Buildings constructed before 1970 are more likely to contain asbestos.  Airborne asbestos can cause lung cancer and mesothelioma, a cancer of the chest and abdominal linings.  

Lead is a highly toxic metal which produces a range of adverse health effects, particularly in young children.  Many homes built before 1978 may contain lead-based paint.  Disturbance or removal of materials containing lead-based paint may result in elevated concentrations of lead dust in the air.

If it is known that the house or building contains asbestos or lead-based paint, contact public health authorities before doing any cleanup.

·Avoid problems with contaminated drinking water. A large number of drinking water facilities in Louisiana are either operating on a boil water notice (water must be boiled before it is consumed), or are not operating at all.  Exposure to certain micro-organisms in water can make people sick, and may cause diarrhea.  Exposure can come from drinking contaminated water, cooking with it, making prepared drinks or brushing teeth.  

Residents can find out the status of their water system by checking their utility bill for the name of the water system that provides the water.  A list of parish water systems under a boil advisory can be found at the Louisiana government website.  Vigorous boiling for one minute will kill disease-causing micro-organisms present in water.

If residents get their water from a private well, it is necessary to have an expert check the quality of the water. 

On October 14, 2005, the U.S. Consumer Product Safety Commission, in cooperation with the Kelty Division of American Recreation Products of Boulder, CO, announced a voluntary recall of the Kelty Speedster Jogging Stroller.

The stroller’s handle-locking clips can unlock during use, causing the stroller to collapse.  Kelty has received two reports of handle clips unlocking during use.  No injuries have been reported.  

The recalled stroller has an aluminum frame and a cloth seat, with a sun canopy.  It has model number 20050016 and serial numbers S1000001D0504 through S1000800D0504 and S1000001D0506 through S1000200D0506.

Each stroller has a tag, located inside the child’s sear compartment, which lists the model name and number.  A sticker on the rear frame lists the serial number.  There are two yellow handle-locking clips, one on each side of the stroller frame that secures the handle from movement.

Two hundred and thirty strollers are involved in the recall.  They were sold at juvenile baby product stores, sporting good stores, and Web retailers from May 2005 through July 2005 for $250.

Consumers should stop use immediately and call Kelty at (800) 535-3589 between 8 AM and 5 PM Mountain Time Monday through Friday to arrange the return of the affected units to Kelty.  A full refund, plus a free daypack, is provided for all units returned by consumers.

A new study published in the October 2005 American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine has found that Californians who live close to naturally occurring asbestos sources are at an increased risk for developing malignant mesothelioma.

Malignant mesothelioma is a cancer of the membrane covering the lung.  The study’s authors, Marc B. Schenker, M.D., from the University of California, Davis, and four of his associates, investigated 2,908 malignant mesothelioma cases reported in California between 1988 to 1997.  Over half of the patients either had no or low occupational exposure to asbestos.  Exposure to asbestos fibers is the only known cause for malignant mesothelioma.

Dr. Schenker said that while studies have confirmed the link between mesothelioma and occupational exposure to asbestos, almost all population-based studies have found that many mesothelioma cases have no known occupational exposure to asbestos. 

The research showed that people who lived closer to an asbestos source had a greater risk of developing mesothelioma, and that the chance decreased as the distance from exposure increased.  According to the study, the odds of developing mesothelioma decreased 6.3 percent for every 10 kilometers farther from the asbestos source.

Per the authors, California has more naturally occurring asbestos source rocks than any other state in the U.S..

In an editorial in the same issue, Marcel Goldberg, M.D., Ph.D. and Daniele Luce, Ph.D., of the Institut National de la Sante et de la Recherche Medicale in Saint Maurice, France, wrote “while exposure in environmental settings is generally much lower than in occupational circumstances, the levels may not be negligible.” 

They add that in studies in which elevated risk of mesothelioma was demonstrated, people typically lived in close vicinity of naturally occurring asbestos sources.  “It is thus likely that lifelong cumulative exposure may have been as high (if not higher) as in some occupational settings.”

 

  

At the request of the U.S. Food and Drug Administration (FDA), on October 12, 2005, the U.S. District Court for the Northern District of Illinois issued a warrant for the seizure of three types of infusion pumps manufactured by Baxter Healthcare Corporation. 

The pumps were seized because FDA inspections revealed that the firm has continually failed to follow medical device manufacturing requirements.

Infusion pumps are electronic devices intended to control delivery of solutions and medications to patients.  Pump shutdown could result in serious injuries or death to critically ill patients who depend on continuous infusion medications and/or life-sustaining medications.  The seized products are:

·    SYNDEO PCA Syringe Pumps
·    Colleague Volumetric Infusion Pumps
·    Colleague CX Volumetric Infusion Pumps

Baxter has distributed these products worldwide. 

Four thousand SYNDEO and Colleague infusion pumps were seized by the U.S. Marshals Service from Baxter’s warehouse in Buffalo Grove, IL, and 135 SYNDEO pumps from a distributor’s warehouse in Waukegan, IL.  No products were seized from healthcare facilities or individual users, and there are no plans to do so.

Healthcare facilities can continue to use pumps in their possession, but should have a backup plan in place, especially in situations where the pump is part of a life-saving function. 

Baxter was previously issued Warning Letters from the FDA outlining the violations.  Per the FDA, Baxter was given an opportunity to correct the violations, but failed to take appropriate actions.  On February 25, March 15, July 6, and July 20, 2005, Baxter notified the public of the potential health hazard associated with these products. 

The FDA alleges that none of the seized infusion pumps were manufactured under the proper controls and that the Colleague pumps have a design defect that may cause the pumps to stop and shut down during infusion therapy.  Further, the FDA believes Baxter failed to inform the FDA of the Colleague infusion pump failures, in violation of the Medical Device Reporting regulation of the Federal Food, Drug and Cosmetic Act.

Baxter Corporation issued a news release last week addressing the charges made by the FDA.  The company stated that they have developed an aggressive corrective action plan and remain in discussions with the FDA concerning the infusion pump issues.

“The quality of our products is our highest priority,” said Robert L. Parkinson, Jr., chairman and chief executive officer.  “We are committed to working with the agency and our customers to resolve these issues as quickly as possible.”

Toyota Motor Corp. has announced the recall of some 2004 and early-2005 Prius hybrids to fix a software problem that could cause the gasoline engine to shut off.

The Prius has a gas engine and a battery-powered electric motor that can run separately or together to save fuel. The Prius was the world’s first commercially mass-produced hybrid.

The National Highway Traffic Safety Administration (NHTSA) has received 68 reports of Prius engines stalling. No injuries have been reported to this point. The NHTSA investigation was closed after Toyota said it would recall the vehicles voluntarily.

When the problem occurs, dashboard warning lights may come on and the gasoline engine shuts down. Toyota said the hybrid’s electric motor will continue operating in a limited capacity, enabling drivers to steer to the side of the road. The engine then can be restarted.

Owners will be notified about the recall this month. Toyota is attempting to repair the defect as quickly as possible since the Prius is enjoying a surge in popularity. For the first nine months of 2005, U.S. sales more than doubled the same period in 2004, to 81,042.

Investigators have found that dozens of doctors in the U.S. have bought an unapproved form of botulinum toxin being offered as an inexpensive substitute for the highly successful wrinkle treatment, Botox.

Botulinum toxin in its raw form, however, is one of the most powerful neurotoxins and can be extremely dangerous to anyone injected with it.

Unfortunately, investigators have found that some 1,000 people may have been injected with unapproved batches of the toxin.

In December 2004, news reports indicated that four people were paralyzed after being injected with a Botox knockoff sraight from a manufacturer.

Many experts regard the distribtion and use of unapproved botulinum as a very risky practice that can only result in serious injuries at some point even if no injuries have occurred to this point. Botulinum toxin that has not been approved for human use is a dangerous substance, more powerful than cyanide, and must be carefully regulated and monitored.

Next month, a trial is scheduled to start in federal court in Fort Lauderdale, Florida, in which Toxin Research International (TRI) and its owners stand accused of selling the unapproved toxin and marketing it as a Botox sustitute. No one is known to ave been injured by the TRI toxin, however.

TRI is claimed to have told doctors that its product was as safe as Botox and that it was about to be approved. According to case documents, at least 180 doctors including plastic surgeons, dermatologists, and naturopaths ordered Botulinum Toxin Type A from TRI. A five-dose vial would cost $1,250 as compared to about $2,000 for actual Botox.
 

For some time now, it has been well-publicized that Accutane, a drug used to treat severe acne, can pose a significant risk of birth defects if taken during pregnancy. 

Both Accutane and its generic versions, which include the active ingredient known as Isotretonin, are known to cause birth defects when taken by pregnant women.

The FDA and the drug’s manufacturer, Hoffman-LaRoche, now provide information about this adverse health risk in the labeling and packet information for Accutane.

New information, however, indicates, that despite all the warnings, some women continue to use Accutane while pregnant.

A recent report appearing online in Birth Defect Research found that 34 women called a hotline run by the Organization of Teratology Information Services between April 2002 and September 2004 claiming they didn’t remember hearing the guidelines relating to Acctuane usage and pregnancy. (A teratogen is a substance that causes birth defects.) 

Surprisingly, eight of the 34 women said that they didn’t recall being counseled about birth control prior to taking Accutane, and 25 said that they had not taken a second pregnancy test before taking the drug. 

In light of these continued problems connected to education about the drug, the FDA introduced a new program with an entirely new set of rules for Accutane.

Up until recently, women who wished to begin treatment with Accutane had to get birth control counseling and have two negative pregnancy tests prior to beginning treatment with the drug. 

The new program, called “iPLEDGE,” requires that all women of childbearing age take the following steps:

• Sign an informed consent form in their doctor’s office;
• Personally register with iPLEDGE;
• Take two negative pregnancy tests in a doctor’s office within seven days of beginning treatment;
• Agree to use two forms of birth control while taking the drug;
• And get another negative pregnancy test in a doctor’s office within one week of requesting a refill.

Men are also asked to sign an informed consent form to indicate that they too are aware of the risks but they do not have to personally register with iPLEDGE. 

Doctors, pharmacies, and wholesalers are required to register with iPLEDGE.  Doctors must make sure that patients are aware of the drug’s risks before they sign a consent form and begin the procedures to ensure safety in relation to Accutane usage. 

Pharmacies must make sure that they log onto iPLEDGE before filling a prescription for Accutane to make sure that the patient has taken the necessary safety steps.  Finally, wholesalers must agree to only supply Accutane to pharmacies that have registered with iPLEDGE.

For more information about iPLEDGE visit www.ipledgeprogram.com or call (866) 495-0654.

Since its approval in 1982, Accutane has been linked to serious potential side-effects including:

• birth defects when taken by pregnant women
• psychological problems including possible suicide
• neurological problems
• stomach, bone and muscle problems
• hearing and vision problems
• problems with fats and cholesterol in the blood
• ulcerative colitis
• Crohn’s disease
• inflammatory bowel disorder
• rectal bleeding
• abdominal pain
• central nervous system injuries
• bone and muscle loss
• cardiovascular injuries
• liver and kidney damage
• pancreatitis
• immune system disorder
• lupus
• thyroid disorders
• various allergic reactions
• Some minor side effects include dry
skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds.

In 1998, the Food and Drug Administration advised doctors who prescribe Accutane to watch their patients for signs of depression.

Afterward, Hoffman-LaRoche, the maker of Accutane, notified doctors that the drug “may cause depression, psychosis, and, rarely, suicidal ideation, suicide attempts and suicide.” This was one of the first indications that Accutane was headed for further problems. In January 2001, Roche began mailing doctors, psychiatrists, and pharmacists, information about the recent discovery of links between Accutane and various psychological problems.

By that time, the FDA had already received reports concerning 66 suicides and 1,373 cases of psychiatric problems. The drug’s information packet had already been updated in 1986 to include information about links between Accutane and depression.

Birth defects are perhaps the most severe side effects to be linked to Accutane. The list of possible birth defects include: hydrocephaly (enlargement of the fluid-filled spaces of the brain); microcephaly (small head); heart defects; facial deformities; and mental retardation.

The warnings originally released with Accutane in 1982 designated it as Category X, which means that it must be avoided under all circumstances by pregnant women and nursing mothers. Yet in 1983 reports of babies being born with certain defects began to surface.

As a result, in 1988, Roche launched the Pregnancy Prevention Program (PPP) with a kit that included a contraceptive booklet, checklists to help assess whether patients could comply with the drug’s requirements, and a consent form for patients to sign stating that they were fully aware of the risk of birth defects.

In 2001, Roche and the FDA also developed what is known as the System to Manage Accutane-Related Teratogenicity (SMART), a plan which requires those female Accutane users in their childbearing years, who have not had hysterectomies, to take and submit a pregnancy test every month before receiving a 30-day refill of the medication.

Since Accutane’s market approval, there have been 2,000 incidences of pregnancies among users, many of which ended in abortion. The FDA, however, has calculated that more than 160 babies were born with defects directly attributable to Accutane usage.

It is likely that there were actually more pregnancies that occurred in female Accutane users because there was no system for reporting Accutane-linked pregnancies at the time.

Apparently, however, these precautions and amendments relating to Accutane were not enough to prevent the continuation of some of the most severe side effects associated with the drug.
Reports of suicides and birth defects relating to Accutane continued to surface forcing the FDA and Roche to once again review Accutane’s warning label.

In May of 2005, a new study published in the American Journal of Psychiatry suggested that Accutane can actually change brain functioning. This is the first study to monitor brain functioning of Accutane patients and the first to show a direct biological link between the drug and depression.

The team of psychiatrists conducting the study found that the group of young adults taking Accutane showed decreased brain functioning of up to 21% in the front part of the brain an area known to mediate symptoms of depression.
The authors of the study have now urged the FDA and Hoffman-La Roche to conduct further research on the drug. Accutane has now been linked to 266 cases of suicide in the United States including some high-profile cases such as the death of U.S. Congressman Bart Stupak’s son.

The March of Dimes, a national voluntary health agency whose mission is to improve the health of babies by preventing birth defects, premature birth and infant mortality, applauds the recent efforts of the FDA. Still, the organization has its doubts about the new registry.

For one thing, the registry will not regulate internet sales, therefore people can still acquire Accutane over the internet without understanding the severity of the health risks associated with it.

There is also concern that people might get confused with the many generic forms of isotretinoin and may still end up taking Accutane and putting themselves at risk without even knowing it.

In their alert regarding Accutane released in May of 2005, the FDA advised all Accutane patients to discontinue usage of the drug and inform their health care professional immediately if they experienced any of the following symptoms:

• Feelings of sadness or crying spells
• Loss of interest in activities once enjoyed
• Sleeping too much or having trouble sleeping
• Having increased irritability, anger, or aggressivity (i.e. temper outbursts, thoughts of violence)
• Change in appetite or body weight
• Trouble concentrating
• Withdrawal from family or friends
• Loss of energy
• Feelings of worthlessness or inappropriate guilt
• Thoughts of self-harm or suicide
In some situations, discontinuing the drug may not alleviate the problem and psychiatric evaluation or further medical investigation may be necessary.

Currently, litigation involving the following injuries is either in progress or being considered in a number of states:

• Inflammatory Bowel Disease
• Premature Closure of Growth Plates
• Birth Defects
• Ulcerative Colitis
• Crohn’s Disease
• Inflammatory Bowel Syndrome
• Rectal Bleeding
• Abdominal Pain
• Central Nervous System Injuries
• Bone and Muscle Loss
• Cardiovascular Injuries
• Liver and Kidney Damage
• Pancreatitis
• Immune System Disorder
• Lupus
• Hearing and Vision Damage
• Thyroid Disorders

Many experts and consumer advocates believe the range of serious health risks (physical and psychological) associated with Accutane should have doomed the drug long ago. The fact that it is nothing more than a treatment for acne (regardless of how serious it may be) makes its survival all the more astounding to its critics.

Litigation Experts See Mass of Evidence against Merck as Virtually Insurmountable When the Company Defends Long-Use and Death Cases.

Another day, another negative study involving COX-2 inhibitors; the class of drugs that includes Vioxx, Celebrex, Bextra, and other NSAIDs. All along, critics of these drugs saw them as dangerous, unnecessary, overpriced, “super aspirins” that would ultimately wind up injuring and killing people.

Merck and Pfizer, however, saw the drugs as potential blockbusters and, in what has been called the ultimate triumph of marketing over science, turned Vioxx, Celebrex, and Bextra into multi-billion dollar cash cows.

The latest study from Bispebjerg University Hospital in Copenhagen, which was funded by the Danish Heart Foundation and the Danish Pharmaceutical Association, has found that COX-2 inhibitors increase the risk of death among patients who have already survived a previous heart attack, especially when taken in high doses. The data was released yesterday at the American Heart Association conference in Dallas, Texas.

The study of 58,000 Danish patients showed that heat disease patients taking 25 mg of Vioxx per day were five times as likely to die as patients not taking the drug. The figure for Celebrex was 4.2 times for patients taking a 200 mg daily dose.

While this latest study is “a cause for concern” according to lead researcher Dr. Gunnar Gislason, it really isn’t any different in theme than all of the negative evidence that sits right now in litigation files involving the most serious of the 7,000 or so remaining cases against Merck.

This is significant because Judge Carol Higbee, who controls the progress of some 3,500 Vioxx cases pending in New Jersey, has now ordered that the next 10 trials involve plaintiffs who took Vioxx for at least 18 months.

Merck has already acknowledged the existence of an increased risk of heart attacks in long-term Vioxx users and even pulled the drug from the market for that very reason. Thus, legal analysts see Judge Higbee’s ruling as one that will make it virtually impossible for Merck to duplicate its recent victory where there were many factors in Merck’s favor.

Thus, a number of litigation attorneys we spoke with late last evening were of the opinion that this latest study merely confirms, yet again, the fact that Vioxx was always a dangerous drug regardless of what Merck wanted the public to believe and despite its approval by the FDA. In fact, each attorney said basically the same thing “the second trial was a lucky break for Merck because it had a number of weaknesses in it as far as the plaintiff’s case was concerned.” The cases Judge Higbee now wants tried will have none of those weaknesses and that will only accentuate the overwhelming nature of the negative evidence.

In the recent New Jersey case that Merck won, there were a number of factors which favored Merck including: the plaintiff only took Vioxx for two months before his heart attack; he survived his injuries and actually appeared to be in surprisingly good health at trial despite the injuries he claimed to have suffered; plaintiff had a number of serious (non-Vioxx) risk factors that could have caused his heart attack; and Merck’s attorney made every effort to make it appear as if the trial judge was being unfair to the drugmaker with her rulings. The jury also was not enthralled by plaintiff’s trial attorney.

The negative evidence being referred to by those familiar with the Vioxx litigation is voluminous and quite damaging to say the least. It dates back to 1996 and never indicated a single reason why Vioxx or any of the COX-2 inhibitors should have been approved or allowed to be marketed in so cavalier a fashion as they were.

The Unbroken Chain of Damaging Evidence

Going back as far as 1996, the evidence is clear and consistent when it comes to the potential risks posed by Vioxx and the other COX-2 inhibitors like Bextra and Celebrex.
·Nov. 21, 1996 – Memo by a Merck official shows the company wrestling with the issue of Vioxx’s (Rofecoxib) involvement in increased cardiovascular events. At this early date, Merck avoided a trial to prove Vioxx gentler on the stomach than older painkillers because in such a trial, "there is a substantial chance that significantly higher rates" of cardiovascular problems would be seen in the Vioxx group.
·February 25, 1997 – Internal Merck e-mail warns that if a proposed Merck trial was carried out "you will get more thrombotic events" – more blood clots – "and kill [the] drug."

·In response, Alise Reicin, later a Merck vice president for clinical research, said in an e-mail that the company was in a "no-win situation." She went on to propose that people with high risk of cardiovascular problems be kept out of the study so the difference in the rate of cardiovascular problems between the Vioxx patients and the others "would not be evident."

·The FDA approved Vioxx on May 20, 1999 for the use for the management of acute pain in adults and for relief of the signs and symptoms of osteoarthritis. (The original safety database included approximately 5,000 patients on Vioxx and did not, according to Merck, show an increased risk of heart attack or stroke).

·November 18, 1999 – Meeting of the Data and Safety Monitoring Board (DSMB) discusses concerns over the "excess deaths and cardiovascular adverse experiences" that was observed in the group using Vioxx as compared to the patients taking Naproxen.

·March 9, 2000 – Merck’s research chief, Edward Scolnick, e-mailed colleagues that the cardiovascular events "are clearly there" and stated "it is a shame but it is a low incidence and it is mechanism based as we worried it was."
·Worried about the affect on Vioxx, Dr. Scolnick wrote that he wanted other data available before the results were presented publicly, so "it is clear to the world that this" was an effect of the entire Cox-2 class, not just Vioxx.

·That same month, however, the company’s public statements continued to reject the link between Vioxx and increased intrinsic risk. Merck made no mention that the study found a "mechanism based" connection between Vioxx and the statistically significant increase in cardiovascular events.

·March 17, 2000 – Merck updated the label by adding reported in the "adverse events" section of the label certain "cardiovascular" reports.

·June of 2000 – Information presented at the European United League against Rheumatism, (Merck is a member and a corporate sponsor of this organization) demonstrated a statistically significant increase in hypertension and myocardial infarction.

·The VIGOR study (VIGOR – Vioxx® Gastrointestinal Outcomes Research) sponsored by Merck was submitted to the FDA in June 2000. The study was primarily designed to look at the effects of Vioxx on side effects such as stomach ulcers and bleeding. While the study showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking another drug, Naproxen, it revealed a statistically significant increase in the number of cardiovascular events (over 100% increase), myocardial infarctions/heart attacks (approx. 400% increase) and strokes in patients who have taken Vioxx compared to those receiving Naproxen.

·The VIGOR study was published in the November 2000 issue of the New England Journal of Medicine but did not provide detailed information about other serious cardiovascular complications such as strokes or blood clots.

·February 1, 2001 – Memo by Dr. Shari L. Targum, Medical Officer, Division of Cardio-Renal Drug Products of the FDA documented the serious cardiac events and myocardial infarctions and related deaths for participants in the study who were using Vioxx.

·February 8, 2001 – FDA Arthritis Advisory Committee Meeting discusses the VIGOR study expressed concern over the unexpected findings of cardiovascular risks and myocardial infarctions associated with the use of Vioxx that was disclosed in the VIGOR study. Merck eventually was required (April, 2002) to add some of the data as to cardiovascular events to their label.

·February 2001 – Letter by Dr. James Fries, senior professor and medical doctor from Stamford University Medical School to Merck complaining about the intimidation by Merck’s investigators including the threatening of the loss of funding because of the school’s discussion of cardio-vascular events associated with Vioxx.

·2001 – The concerns arising out of the VIGOR study were crystallized by Debabrata Mukherjee, Steven Nissen, and Eric Topol in JAMA in their review paper specifically highlighting the cardiovascular side-effect profile of COX-2 inhibitors.
·May 22, 2001 – Despite the mounting evidence of the strong association of Vioxx to strokes and heart attacks, Merck issued a press release entitled "Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx", claiming Vioxx has a "favorable cardiovascular safety profile"

·June 16, 2001 – Merck issued another press release (released in Europe), entitled "Vioxx Similar to Placebo and Three (3) Widely Prescribed NSAID’s Regarding Cardiovascular Events".
·July 11, 2001, Merck modified the package insert for Vioxx.

·August 22, 2001 – Study published in Journal of the American Medical Association by Drs. Mukherjee, Nissen, and Topol, researchers from the Cleveland Clinic, indicated that Vioxx was linked to a 200% increase in blood clots, heart attacks and strokes based on their review of previous clinical trials.
·September 2001, the American Heart Association, the National Stroke Association and the Arthritis Foundation asked Merck to test whether Vioxx increased the risk of heart attack and stroke.

·After it reviewed all of its Vioxx studies, Merck claimed there was no evidence that, in comparison with other NSAIDs, the drug increased the risk of heart problems. Merck (erroneously as it turned out) attributed the difference to a heart-protective effect it said the other drug had.

·During this time period, Merck published training materials to be used by their sales rep’s, one was entitled "Dodge Ball Vioxx". Each of the 1st 12 pages lists a scenario that maybe posed by a physicians questions or concerns. Each of the last four pages contain a single word in capital letters "DODGE!" clearly indicating that Merck was training its sales reps to "dodge" the tough questions and concerns of the physicians regarding the cardiovascular risks that had started to make its way into publications.
·    
September 17, 2001 – FDA sends Merck a strongly worded "Warning Letter" regarding Merck’s minimizing the potentially serious cardiovascular risks of Vioxx disclosed by the VIGOR trial and promoting Vioxx for unapproved uses. The letter demanding that Merck discontinue promoting Vioxx to doctors for unofficial uses, found after a review of several of Merck’s promotional conference calls and sales pitches, that the promotions by Merck "are false, lacking in fair balance, or otherwise in misleading in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations." It also required Merck to send letters about the deception to the medical community.

·April 11, 2002 – FDA instructed Merck to include in the package insert certain precautions based on results of the VIGOR studies regarding a higher cumulative rate of serious cardiovascular thromboembolic adverse events (such as heart attacks, angina pectoris, and peripheral vascular events).

·August of 2002 – Dr. Topol and Dr. Falk, a Cleveland Clinic gastroenterologist, published an editorial in The Lancet, encouraging further warnings and labeling regarding the cardiovascular effects of Cox-2 drugs. Even following these warnings, and in the face of mounting evidence for the cardiovascular side-effects of Vioxx, aggressive direct-to-consumer marketing of Vioxx continued unabated.

·April 14, 2004 – Study sponsored and conducted by Merck and Harvard Medical School and published in the journal Circulation, found an elevated risk of acute myocardial infarction associated with Vioxx but not with Celebrex. The risk was statistically significant in persons taking greater than 25 mg of Vioxx, was elevated during the first 90 days of exposure but not thereafter. These results were observed consistently in relation to several reference groups studied. What was especially noteworthy was that the elevation of relative risk was similar when Vioxx was compared with patients not taking any NSAID (Non-steroidal anti-inflammatory drugs), naproxen (e.g. Naprosyn, Aleve) or ibuprofen (e.g. Advil, Nuprin, Motrin).

·Merck asked the researchers to delete or tone down the part of the statement about this no-painkiller group, but the researchers refused, according to Daniel Solomon, a Brigham and Women’s Hospital – Harvard professor who was the lead author. "We made a decision that we should let the science rule the day," he says (WSJ, 11/01/04, page A1).

·Just before the paper was published in Circulation (the journal of the American Heart Association), dated May 4, 2004, Merck removed the name of a key researcher, Carolyn C. Cunnuscio, from the study. She was employed by Merck and had worked on the study. Upon learning that Merck had removed their employee’s name from the Circulation article, the current JAMA editor, Catherine DeAngelis expressed her disappointment, and rounded-off her comments by saying "Aren’t they seeking truth?"

·May 14, 2002 – E-mail from Ann Trontell, FDA deputy drug safety director, warned colleagues that a Merck official had reminded her that "there had been an agreement that Merck would be informed prior to any FDA publication about one of their drug products".

·August 12 2004 – Trontell wrote in an e-mail to another official that the study’s recommendation was "unnecessary and particularly problematic" because FDA funded the study and Graham (David Graham, an Associate Director for Science in FDA Drug Center’s Office of Drug Safety and the FDA officer in charge of the report) also might be asked to present "alternative FDA opinion" on the drug, She added that Merck should be notified about the study results before they became public "so they can be prepared for extensive media attention that this will likely provoke".

·August 13, 2004 – John Jenkins, director of FDA’s office of new drugs, wrote that Graham’s conclusion uses "pretty strong language since, to my knowledge, FDA is not contemplating such a warning or labeling." Jenkins suggested that the conclusion be changed to read, "[T]his and other studies suggest an increased risk of AMI (acute myocardial infarction, or heart attack) with Vioxx use and should be considered by prescribers when making individual treatment decisions"

·Shortly thereafter, Graham responded in an e-mail response to supervisors, "I’ve gone about as far as I can without compromising my deeply held conclusions about this safety question. I’ve also shared with you the perspectives of my co-authors, and I think it’s safe to say they share these same conclusions"

·August 25, 2004 – At a medical/pharmaceutical conference in Bordeaux, France, at the annual meeting of The International Society for Pharmacoepidemiology, Graham presented new data from a trial sponsored by the Food and Drug Administration that indicated patients administered Vioxx 25 mg or more per day have a risk of experiencing an acute myocardial infarction (AMI) or sudden cardiac death that is more than three times that of remote non-steroidal anti-inflammatory drug users.

·Researchers analyzed data from a subset of Kaiser Permanente patients, aged 18 to 84 years, who were treated with a COX-2-selective or NSAID (Non-steroidal anti-inflammatory drugs) between Jan. 1, 1999, and Dec. 31, 2001. In the trial, approximately 1.4 million patients contributed 2.3 million person-years of observation time. Results showed that treatment with Vioxx 25 mg/day or more conferred a 3.15-fold greater risk of AMI or sudden cardiac death compared with "remote use of any NSAID." Such a risk was also observed with lower doses of Vioxx (less than 25 mg/d), but did not achieve statistical significance.

·September 8, 2004 – Vioxx received approval from the FDA for the relief of the signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) in children two years and older and who weigh at least 22 pounds.
·September 30th, 2004 – Sudden global withdrawal of Vioxx during the APPROVe study (Adenomatous Polyp Prevention Vioxx®) which was a multi-centre, randomized, placebo-controlled, double-blind study investigating the effects of Vioxx on the recurrence of neoplastic large bowel polyps in 2600 patients with a previous history of colorectal adenoma. The study participants were screened so that anyone with a history of heart disease was screened out.

·On September 14, 2004, the Data and Safety Monitoring Board received the data that eventually lead to the September 30th withdrawal. The polyp study was stopped prematurely on the suggestion of the Data and Safety Monitoring Board and a Merck statistician (James Neaton) after the investigators, who had access to all of the data, found that after 18 months treatment, patients taking Vioxx had twice the risk of a myocardial infarction compared with those receiving placebo.

·September 17, 2004 – Merck statistician and the four safety committee members had a conference call with John Baron who was the principal investigator of the polyp study and other Merck officials. After the Merck officials and Baron left the call, the four safety committee members agreed that the study had to be stopped. Neaton then called John Baron and explained to him the committee’s decision. After reviewing the data that the decision was based on, Baron concurred.
·Baron then took the next week to meet with the people at Merck including the steering committee, to explain to them the decision that both the committee and he arrived at, that is halting the polyp trial.
·September 23, 2004 –The full steering committee agreed to the halting of the polyp trial. Baron then advised Merck that same day that Vioxx presented an unacceptable risk of a cardiovascular event.
·Baron spent the next few days presenting the data and the conclusions to other experts in and outside of Merck. Merck also spent the next few days reviewing all of the data from the polyp study.
·September 27, 2004 – Ranking officers at Merck decided that Vioxx needed to be withdrawn. However, the decision was made to take this decision to the board of directors.
·Merck’s board of directors met on September 28. About this time, Merck notified the FDA that they needed to have an emergency meeting with them that afternoon informing them of Merck’s decision to withdraw the drug.
·September 29, 2004 – Merck informed its international affiliates of the decision and asked them to withhold informing the regulators in their jurisdiction until the information was made public.

·September 30, 2004 – Merck & Co., Inc. announced a voluntary withdrawal of the arthritis and pain relief drug from the worldwide drug market. Merck’s action was not ordered by the U.S. Food and Drug Administration (FDA), but was initiated by Merck based on its own findings from the clinical trial.

·Senate Finance Committee Chair Charles Grassley (R-Iowa) started an investigation into the FDA. On October 7, Grassley compared Graham’s experience to that of Andrew Mosholder, another FDA scientist whose research on the link between antidepressants and suicidality in children faced from superiors at the agency. "Dr. Graham described an environment where he was ‘ostracized,’ ’subjected to veiled threats’ and ‘intimidation,’" Grassley said in a statement after committee investigators interviewed the researcher. He added, "Merck knew it had trouble on its hands and took action. At the same time, instead of acting as a public watchdog, [FDA] was busy challenging its own expert and calling his work ’scientific rumor.’"

·The Senate Finance Committee is one of three congressional committees examining FDA’s actions. In addition, the Government Accountability Office has expanded its investigation of FDA’s conduct in regard to Mosholder and the risks of antidepressants to include its handling of Vioxx studies.

·November 2, 2004 – FDA posted an abridged version of study conducted by Dr. David J. Graham, associate director for science in the FDA’s office of drug safety. The report, dated September 30, 2004 (the same day Merck withdrew Vioxx from the market) builds upon research that he presented at a medical conference in France in late August (referred to above). "Rofecoxib [Vioxx] increases the risk of serious coronary heart disease as defined by acute myocardial infarction [heart attack] and sudden cardiac death,"

·Graham’s report said. Rofecoxib is the scientific name for Vioxx. Graham defined a high dose of Vioxx as more than 25 milligrams; a standard dose is equal to or less than 25 milligrams. The study, posted Tuesday, says the recently withdrawn Vioxx increased by 3.7-fold the risk of "serious coronary heart disease" when compared to Pfizer’s Celebrex. The study also says a standard dose of Vioxx increased the cardiovascular risk by 1.5 times over Celebrex. "The population impact of rofecoxib’s increased risk is great because of the widespread exposure to the drug," said Graham.

·November 5, 2004, a major study, published in The Lancet, pooled data from more than 25,000 patients who participated in 18 clinical trials and 11 observational studies all conducted before 2001. The study demonstrated that patients taking Vioxx had 2.3 times the risk of heart attack as those prescribed placebos or other NSAIDs.
·In addition, the researchers found an increased risk of myocardial infarction involving both short-term and long-term usage concluding that patients taking Vioxx for only a few months were also at risk.

·The researchers specifically refuted Merck’s position that there is no excess risk in the first 18 months of using Vioxx. In addition, the researchers also refuted Merck’s contention that cardio-vascular involvement was dose-dependent. As to Merck’s contention that in their VIGOR Study, Naproxen was cardio-protective and, therefore, influenced the outcome, these researchers found that if such evidence does exist, its effect is so small that it is not justified to claim Naproxen as a factor in the findings of the VIGOR Study.

·In concluding their findings, the researchers stated that "If Merck’s statement in their recent press release that ‘given the availability of alternative therapies, and the questions raised by the data, we conclude that a voluntary withdrawal is the responsible course to take.’ was appropriate in September, 2004, then the same statement could and should have been made several years earlier, when the data summarized here first became available. Instead, Merck continued to market the safety of Rofecoxib. This clearly demonstrated that Merck had, by the end of 2000, sufficient statistically significant information that required the immediate withdrawal of Vioxx from its world-wide market.”

·Accompanying the study published in The Lancet on November 5, 2004 was an editorial that was even more damning than the study. Referring to the findings of the study, the editorial states "This discovery points to astonishing failures in Merck’s internal systems of post marketing surveillance, as well as to lethal weaknesses in the Food and Drug Administration’s Regulatory Oversight. The evidence showing that Vioxx caused significant adverse events was apparent well before data from the APPROVe trial triggered Merck’s overdue intervention. This week’s report by Peter Juni and colleagues will add significant weight to on-going litigation by patients who believe they were harmed by this drug."

·The editorial went on to find "the FDA tried to shore up its tarnished reputation by posting on its website an early version of a recently completed observational study into the safety of Vioxx. The report comes with a warning that it has ‘not been fully evaluated by the FDA and may not reflect the official views of the agency’. The FDA investigation estimated that over 27,000 excess cases of acute myocardial infarction and sudden cardiac death occurred in the USA between 1999 and 2003. ‘These cases’ they write, ‘would have been avoided had celecoxib been used instead of Rofecoxib’. It is unclear why the FDA could not have waited for the fully evaluated report to have been scrutinized, revised, and published according to the norms of scientific peer review. Bypassing independent peer review smacks of panic in the FDA, which is under intense reputational pressure. And, yet, its decision to try to undermine the integrity of its work shows, that the agency’s senior management is more concerned with external appearance than rigorous science."

·Finally, the editorial concludes "with Vioxx, Merck and the FDA acted out of ruthless short-sighted and irresponsible self-interest." This is the most condemning editorial in a well-respected medical journal that most observers have ever seen.

·It also turns out that Vioxx, despite the slick TV and magazine ads, has not been shown to be significantly more effective than the much less expensive non-prescription anti-inflammatories such as Tylenol and Advil.
Merck Withdrew Vioxx from the Market for Purely Economic Reasons

Although Merck attempted to make the best out of a very bad situation by making it appear as if its voluntary withdrawal of Vioxx was motivated by concern for the public, the evidence does not support that position.  

Most business experts have little doubt that the removal of Vioxx from the market was anything but a purely financial consideration on the part of Merck which stood to lose $700 to $750 million in the fourth quarter of 2004 alone. The lawsuits were piling up and some of the cases were close to trial.

Corporate analysts who commented on Merck’s action saw it as a sound business move under the circumstances.  They did not attribute it to any sudden pangs of conscience on the part of Merck’s CEO or Board of Directors.  

In fact, the evidence showed that Merck was deeply interested in widening the market for COX-2 inhibitors. That evidence included the following:

·The study (APPROVe trial) which led to Merck’s decision to voluntarily withdraw Vioxx from the market was really aimed at gaining FDA approval for Vioxx as a treatment for preventing the recurrence of colon polyps. It had nothing to do with safety and everything to do with gaining approval from the FDA for even wider use of Vioxx).

·In Merck’s open letter to “VIOXX Patients,” which appeared in newspapers across the country, Merck claimed that the study was “a clinical trial to better understand the safety profile of VIOXX.” It was actually no such thing. In fact, had the 3-year study not been halted abruptly on September 24 by the Data Safety Monitoring Board for safety reasons, Vioxx would probably still be on the market.

·Merck had already developed a new COX-2 pain reliever called Arcoxia which was being marketed in 47 countries and for which Merck expected FDA approval in the near future. While Arcoxia was not yet the billion dollar drug Vioxx was, it is clear that Vioxx was well on the way to being replaced when it was pulled from the market.

·Finally, even though Vioxx was finally exposed for what it was; a dangerous drug, Merck stated in its press release that the drug was being withdrawn despite Merck’s belief that “it would have been possible to continue to market Vioxx with labeling that would incorporate these new data” Thus, Merck would still have kept Vioxx on the market had it not met with the FDA on September 28 and been forced to confront the disastrous results of its own study.

Most experts who are familiar with the history of Vioxx from either a medical or business perspective were not surprised by Merck’s sudden withdrawal of the drug from the market. The only surprise any of these experts seems to have is why it took so long for it to happen.

Dr. Sidney Wolfe of Public Citizen was quoted in the San Francisco Chronicle (10/1/04). He stated: “This family of drugs, the COX-2 inhibitors, once referred to as ‘super aspirins,’ are turning out to be more like super disasters.”

Dr. Eric Topol, Chief of Cardiovascular Medicine and Chief Academic Officer of the Cleveland Clinic, was a co-author of the VIGOR Study discussed above. His comment to the Washington Post (10/1/04) was that Merck’s action was “the right decision about three years too late. This is the sort of thing that Merck should have studied earlier, but they were too busy refuting the warning signs.”

The Wall Street Journal (10/1/04, page B1) noted that “Merck also may face more criticism for having strenuously denied for several years suggestions by outside researchers that use of Vioxx led to heart problems. The company even published its own studies suggesting the drug wasn’t causing harm.”

The Disturbing Senate Testimony of FDA Whistleblower David J. Graham, MD, MPH
Dr. David Graham, an Associate Director for Science and Medicine in the FDA’s Office of Drug Safety is a scientist with impeccable credentials as well as a man of unchallenged integrity. He has devoted his entire professional life to making a real difference in the cause of patient safety.

Although he fought long and hard against Vioxx based upon the overwhelming evidence of its serious cardiovascular risks, he was little more than “a voice crying in the wilderness” who received no support within the FDA. He was also the target of Merck’s scorn since he posed a threat to its corporate balance sheet.

Once Vioxx was pulled from the market, however, Dr. Graham could no longer be ignored nor could his medical opinions be marginalized by his detractors. Suddenly, those in authority wanted to hear from this public servant turned whistleblower.

On November 18, 2004, Dr. Graham appeared before the Senate Finance Committee Chaired by Sen. Charles Grassley (R-Iowa). Dr. Graham delivered compelling and often shocking testimony (http://finance.senate.gov/hearings/testimony/2004test/111804dgtest.pdf) concerning the very real dangers of Vioxx and the unconscionable delay in pulling the drug from the market which has exposed the public to a degree of risk never before seen with respect to any prescription drug including sulfanilamide and thalidomide.

Dr. Graham presented the evidence against Vioxx in painstaking detail. He also set forth the disturbing facts surrounding the FDA’s efforts to suppress his research, censor and alter his scientific and medical findings and conclusions, and discredit his work.

Probably the most striking portion of Dr. Graham’s testimony involved his carefully formulated opinion that (even using Merck’s own VIGOR and APPROVe trials) some 88,000 to 139,000 Americans alone have already suffered heart attacks as a result of taking Vioxx and of that number, “30-40% probably died.” (Note that Dr. Eric Topol estimated the heart attack figure to be up to 160,000).

Dr. Graham put these astounding figures in perspective by using various examples. Most compelling, however, was the following statement:

“Imagine that instead of a serious side effect of a widely prescribed prescription drug, we were talking about jetliners. If there were an average of 150 to 200 people on an aircraft, this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky. This translates to 2-4 aircraft every week, week in and week out, for the past 5 years. If you were confronted by this situation, what would be your reaction, what would you want to know and what would you do about it?”

“Even more revealing, a mere 6 weeks before Merck pulled Vioxx from the market, CDER, OND and ODS management did not believe there was an outstanding safety concern with Vioxx. At the same time, 2-4 jumbo jetliners were dropping from the sky every week and no one else at FDA was concerned.”

“At this meeting [Sept. 22, 2005], the reviewing office director asked why had I even thought to study Vioxx and heart attacks because FDA had made its labeling change and nothing more needed to be done. At this meeting a senior manager from ODS labeled our Vioxx study ‘a scientific rumor.’ Eight days later, Merck pulled Vioxx from the market, and jetliners stopped dropping from the sky.”  

Merck’s Victory in the Most Recent Trial is of
Little Significance

In terms of what Merck’s recent victory means litigation-wise, Merck’s defense team is experienced enough to know it means very little since it is somewhat like trying to stop a tidal wave with a sponge.

Merck would have to win virtually all of the remaining 7,000 (and growing) cases to stave off a financial catastrophe since each negative verdict has the potential of being in the millions of dollars. Even scattered losses for Merck can add up to a financial disaster.

Is such a possibility realistic? Not even Merck’s attorneys could believe that. Shortly after the verdict we spoke with several seasoned trial and appellate attorneys who were all of the same opinion; Merck’s victory means little, if anything, to the overall litigation situation the company faces. This is especially true since Merck has repeatedly stated that it intends to fight each case individually.                          

The reason for this is that each case Merck wins only serves as a victory on the particular facts of that case since every plaintiff’s claim is factually different and the law allows each injured party to have a chance to prove his or her case.

Each case that Merck loses, however, has a cumulatively negative effect since it has gotten another chance to prove its lack of culpability and has failed. As one attorney put it: “Each plaintiff has only one chance to prove he’s right in order to win, but Merck has to show it’s right another 7,000 times in order to walk away without being liable. The likelihood of that is zero.”    

It is highly unlikely that there will be a confluence of all of the factors that favored Merck in any of the remaining cases. Many of the remaining cases involve factors which will make Merck’s job much harder.

These cases involve deaths, long-term use of Vioxx, plaintiffs without additional risk factors for heart attack, and different plaintiffs’ trial attorneys (a factor which cannot be underestimated).

In addition to the immediate problems Merck faces in New Jersey, Texas (the site of the $253 million verdict against Merck) is still not finished with the company since the state itself has brought charging Merck defrauded it out of hundreds of millions of dollars in Medicaid payments by misrepresenting the safety of Vioxx for several years. While Texas was the first state to do this, it probably will not be the last.

In addition to $168 million in damages, the state is seeking additional civil penalties. Texas Attorney General Greg Abbot believes the state can prove total damages in excess of $250 million including treble (triple) reimbursement of $56 million (or $168 million) for five years of filled Vioxx prescriptions.

It is estimated that 700,000 Vioxx prescriptions were filled through Medicaid during those five years in Texas alone. Abbot sees these prescriptions as part of a willful misrepresentation on Merck’s part as to the safety of the drug. To him, the entire affair represents nothing more than “a prime example of a company’s drive for profit steamrolling its duty to be safe.”

Clearly, as Merck’s legal problems mount, no one victory will mean very much while each loss will be extremely damaging indeed. Each loss will make manageable personal injury settlements impossible and virtually guarantee the success of the types of actions brought by Local 68 and the state of Texas. This could spell financial ruin for Merck.

Finally, if Merck is found to have knowingly, or even carelessly, engaged in conduct which forces the company into Chapter 11 or otherwise destroys its once enormous profitability or stock value, disgruntled and very angry shareholders will no doubt explore the possibility of commencing a stockholders derivative suit to recoup their investment losses.

Judge Higbee has scheduled a hearing with respect to her decision to proceed with the most serious cases next. That hearing is scheduled for Thursday at which time Merck’s attorneys hope to convince the judge to change her mind.

Plaintiffs’ attorneys welcome the judge’s plan as a way to move the litigation along. While no definite figure is available, estimates put the number of 18-month (New Jersey) cases at somewhere between 1,400 and 2,100.

Merck’s lead outside attorney Ted Mayer has stated that: “We are confident in our defense of 18-month cases.” One has to wonder, however, if that is anything more than saber-rattling given the additional negative evidence that will directly impact Merck in those particular cases.

Since it is unlikely Judge Higbee will accede to Merck’s request that the court change its decision with respect to the order in which Vioxx cases will be tried, Merck must begin to accept the very real possibility that the next several months may significantly affect the financial future of the world’s fifth largest pharmaceutical company, and not in a positive way.    

After three years of legal bickering, the Archdiocese of Los Angeles has finally released some records that reveal, that for decades, church officials did little more than transfer priests accused of sexual molestation between counseling and different locations.

The complaints, though extremely serious were, for the most part, ignored.

The attorneys for the 500 alleged victims had consented to release the information but until last month the defense attorneys for the Archdiocese had prevented them from publishing it. An appellate court finally ordered the release of the documents.

The records show that in the majority of instances, the church provided years of therapy to accused clergy because bishops believed the offenders could be rehabilitated. The sex violators were reassigned to different parishes, where they frequently accrued new complaints for the very same offenses.

The records, however, are still far less extensive and complete than those turned over in connection with litigation against other dioceses such as Boston.

Here, the documents released are only summaries of personnel records rather than the actual personnel files which in the case of the Archdiocese of Boston, for example, contained doctor’s reports, internal church memoranda regarding meetings with parents, and evidence corroborating the charges of insensitivity to the victims.

In the case of the Boston disclosures, the damaging evidence eventually led to the resignation of Cardinal Bernard Law, the archbishop of Boston.

The records cover priests who were ordained as far back as the 1920s. Cardinal Roger Mahony, who has led the archdiocese since 1985, had overseen many of those priests.

The Los Angeles archdiocese, which is the nation’s largest, serves some 3.6 million people in 284 parishes. It has posted about 150 pages of summaries on its Web site.

A spokesman for Mahony has insisted the cardinal wanted to reveal the information to promote reconciliation with victims, but was barred by confidentiality laws.

The lead plaintiffs’ attorney in Los Angeles, regards these disclosures as only a first step. He believes the complete personnel files should be made public.
The lead plaintiffs’ attorney stated: “The significance of these files is that they provide a little more information for the public about the church’s knowledge and frankly their participation in the molestation of children, but until the (entire) files are made public, we’re not going to be satisfied.”

Although the documents offer some details in numerous cases, many of the summaries have shied away from using the term molestation. Instead they used euphemisms such as “boundary violations” to describe the highly inappropriate actions of the accused priests.

The attorney for the archdiocese, J. Michael Hennigan, claims that the summaries provided “are accurate descriptions of the content of the files, without disclosing confidential communication.”

Among the victims, however, the conduct of Cardinal Mahony has been harshly criticized. David Clohessy, national director of the Survivors Network of those Abused by Priests has accused Mahony of “shameless posturing as some sort of reformer,” while he used legal maneuvers to block a full accounting of his role in the crisis.
“Mahony is grasping at straws to convince his flock that he’s not as awful as many of his colleagues. And as he has for years, Mahony is trying anything he can dream up to avoid having to fully reveal how little he did to safeguard innocent kids from abusive clerics.” Los angeles divorce lawyer.

Among the summaries provided is one concerning a priest who served as a teacher and administrator at numerous Southern California schools. He was convicted of molesting two boys and given probation. That conviction was later expunged from his record. A subsequent report in 1994 referred to “boundary violations” in which he allegedly patted the buttocks of a teenager. After entering an alcohol treatment program he was eventually placed on leave.

Another of the summaries involves a priest who had been the subject of repeated complaints with respect to “inappropriate sexual conduct with children” beginning in 1959. The records, however, indicate that no significant action was taken against him until 1994 when he was relieved of his duties.

Although the legal dispute regarding the issue of disclosure may be far from over, one thing is already clear; the Archdiocese of Los Angeles engaged in a pattern of denial, avoidance, and insensitivity when it came to the manner in which it dealt with an undeniable problem of sexual molestation and abuse by many of its priests. In that way, it was no different than other dioceses around the country that also hid this dark secret from the world for decades.

Despite the continuing high levels of serious injuries sustained by passengers and especially children under 16 involving all-terrain vehicles (ATVs), the U.S. Consumer Product Safety Commission (CPSC) voted to defer a 2002 petition from the Consumer Federation of America (CFA), American Academy of Pediatrics (AAP), and seven other organizations, seeking a ban of the sale of adult-sized ATVs for use by children.

Instead, the CPSC voted to issue an "Advanced Notice of Proposed Rulemaking" (ANPR) regarding the risks of injury and death posed by ATVs.

“The profound increase in injuries and deaths caused by ATVs show how pervasive this national epidemic has become. This tragic problem is in need of an aggressive and immediate solution by CPSC and state governments,” said Rachel Weintraub, Director of Product Safety for Consumer Federation of America.

“Pediatric emergency department physicians have learned to expect devastating injuries when a child crashes an ATV,” said Gary Smith, MD, DrPH, FAAP, Chair of the AAP Committee on Injury, Violence and Poison Prevention.
“In 2004, ATVs killed at least 130 children and injured over 44,000. This is the equivalent of two school buses full of children dying and the entire population of Palm Springs, California being severely injured. For almost 20 years, physicians and consumer advocates have been pressing the CPSC to pass meaningful regulations to reduce the carnage. It’s time for real action," Smith said.

The CPSC 2004 Annual Report on ATV-related Deaths and Injuries announced the following results.

• Serious injuries requiring emergency room treatment increased almost 8% from 125,500 in 2003 to 136,100 in 2004.

• The estimated number of ATV-related fatalities increased from 617 in 2002 to 740 in 2003 another record.

• In 2004, ATVs killed at least 130 children younger than 16 accounting for 28% of fatalities.

• Children under 16 suffered 44,700 serious injuries in 2004, or 33% of all injuries. This is an almost 16% increase from 2003 when children suffered 38,600 serious injuries. This increase in 2004 is statistically significant.

• Between 1985 and 2004, children under 16 accounted for 31% of all injuries.

The risk estimate for 2004 is 187.9 compared with 188.4 in 2003. According to CPSC, this slight reduction is not statistically significant.

CPSC Chairman Hal Stratton has directed Commission staff to issue a broad review as an Advanced Notice of Proposed Rulemaking (ANPR). This could ultimately lead CPSC to take regulatory or non-regulatory action to protect consumers from ATV deaths and injuries, but is just the first step in a multi stage rulemaking process with no definitive timeline for the full process. The public has 60 days to respond to this ANPR.

While the ANPR outlines many issues to evaluate, of particular importance is the development of a “transitional ATV” for children 14 and older. The CPSC, the ATV industry, and many consumer advocates recommend that children 12 through 15 not ride ATVs with engines larger than 90 cc’s. The American Academy of Pediatrics recommends that no child under age 16 ride an ATV of any size.