For years, Accutane has been under siege from numerous medical experts, consumer watchdog groups, and even many officials within the FDA itself because of the many serious health risks linked to the drug.

One problem associated with the current FDA approval and review process that is quite troublesome, is the dramatic increase in the harm or risk that will be tolerated when weighing the potential benefits of a new prescription drug.

Traditionally, even drugs which promised significant benefits would be subjected to greater testing over longer periods of time when significant side-effects or adverse reactions were possible. If the drug was developed to treat a relatively minor condition, the possibility of dangerous side effects usually spelled the end of the drug in terms of FDA approval for marketing.

Today, however, drugs are routinely given FDA approval without sufficient long-term testing using large study groups and without adequate warnings despite evidence of significant side-effects and adverse reactions. Drugs are also permitted to remain on the market far longer than they should be once significant problems are suspected or even confirmed.

This has repeatedly resulted either in the need for upgraded warnings one or more times after a drug is already on the market or in dangerous drugs being pulled from the market only after causing numerous serious injuries or deaths.

Probably the most alarming situation today, however, is when a drug designed to treat a relatively minor condition is approved by the FDA and permitted to remain on the market despite clear evidence of significant side effects or adverse reactions.

In such cases, the risk versus benefit equation has all but vanished from the pharmaceutical companies’ consideration and the FDA’s standards. Accutane is an example of such a drug.

For all of the positive results it might have achieved, Accutane is still nothing more than an acne drug. This fact alone has caused a wide range of critics of the drug to wonder how it has been permitted to remain on the market at all.

Recent developments with respect to the drug and the manner in which Accutane is regulated and monitored requires a fresh look at the drug and its uncanny ability to survive when other drugs used to treat far more serious conditions with considerably less serious side-effects have been pulled from the market. 

Accutane is manufactured by Hoffman-LaRoche Pharmaceuticals. Its active ingredient is known as isotretinoin and it is primarily used to treat nodular acne, a condition that is resistant to other treatments, including antibiotics, and is characterized by the appearance of many nodules or cysts.

These nodules are inflammatory lesions filled with pus and get lodged deep within the skin. The lesions can cause pain, permanent scarring, and negative psychological effects.

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. 

Just this past month, the FDA announced that there would be a new National Registry for all Accutane users that will take effect in December 2005.  Both male and female patients will have to enroll in the registry as well as doctors and pharmacies. 

The purpose of this registry, called iPLEDGE is to eliminate the risk of birth defects by strictly monitoring female patients to make sure that they are not pregnant when beginning treatment and that they do not become pregnant during treatment. 

Until now, women of childbearing age have been required to use two forms of birth control, get two negative pregnancy tests before their first Accutane prescription, and show proof of another negative pregnancy test before each refill. 

The computerized registry system will now make sure that these precautionary measures take place as each woman will have to enter this information into the registry either by phone or by internet. 

While the registry doesn’t officially begin until December, it opened on August 22 in order to allow doctors, patients, and pharmacies time to understand how to use it before everyone signs on at the end of the year.

In addition to taking part in the registry, all patients will also have to read, review, and sign a document informing them of the risks associated with Accutane, specifically psychiatric side effects and pregnancy-related issues. 

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.

The Food and Drug Administration (FDA) has issued a reminder to consumers that drinking fruit and vegetable juices that have not been treated to kill harmful bacteria can pose serious health risks.

The FDA continues to receive reports of serious outbreaks of foodborne illness caused by untreated juices. Bacteria often contaminate fruits and vegetables as they are juiced and can be harmful if the juice is not treated to destroy them.

Healthy people’s immune systems can usually fight foodborne bacteria but for children, the elderly, and people with weakened immune systems there are significant risks including serious illnesses or even death.

Symptoms of foodborne illness usually include vomiting, diarrhea, and abdominal pain; or flu-like symptoms such as fever, headache, and body ache. Although symptoms can occur within 20 minutes or up to six weeks after ingesting the affected food source, sickness usually develops in one to three days.

As a protective measure, since 1999, the FDA has required juice manufacturers to place warning information about the health risks of drinking untreated juice or cider on product containers.

Almost all juices sold in supermarkets, including refrigerated juices and products sold in boxes and containers are treated for bacteria.
Untreated products are required to have the following warning label:

WARNING: This product has not been pasteurized and therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.

The FDA warning label requirements do not apply to fresh-squeezed juices and juices bought by the glass at farmers’ markets, roadside stands, or in juice bars.
 
Consumers should note that untreated juice is most likely to be sold in the refrigerated section of a grocery store. When in doubt, FDA advises consumers to ask if a juice product is treated, especially for juices purchased in health food stores, cider mills, or farmers’ markets.

For more information on handling food safely, contact: The U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Food Information Line at 1-888-SAFEFOOD (toll-free), 24 hours a day. Or visit the FDA’s Food Safety Web site at: cfsan.fda.gov

Jennifer R. Clason, Jeffrey A. Kilbride, and James R. Schaffer have been accused of sending numerous span emails advertising pornographic websites.

The three were indicted by a federal grand jury in Arizona (U.S.) and accused of violating the CAN-SPAM Act of 2003 and other crimes.

According to the Justice Department, the pornographic Web sites that were being promoted would pay the trio for directing internet traffic to their sites.

The unsolicited spam emails generated by the three were ranked in the top 200 largest sources of spam on the Internet according to the Internet anti-spam monitor The Spamhaus Project.

The Department of Justice stated that America Online received more than 600,000 complaints between late January and early June 2004 related to spam from this particular operation. It is estimated that tens of millions of users may have received the email.

The spam operation functioned by buying large amounts of Internet bandwidth from major service providers along with which came large blocks of IP addresses, a small number of which could be used for spamming.
They used these addresses until they were blocked by anti-spam systems or were terminated by their ISP. At that point they would find a new ISP and repeat the process.

Each of the three indicted individuals is charged with two counts of fraud and one count of criminal conspiracy. Kilbride and Schaffer face an additional two counts of interstate transportation of pornographic material via the internet, two counts of interstate transportation of obscene material for the purpose of sale or distribution, and one count of money laundering.

In addition, Schaffer has one count of operating three pornographic Web sites without including required statements regarding the performers.

The three face long prison sentences if convicted for the crimes contained in the indictments. Kilbride and Schaffer face a maximum of 25 years in prison for money laundering and obscenity charges.

The spamming and criminal conspiracy charges carry maximum sentences of five years each. Schaffer also faces up to two years on the charge of improper pornographic record keeping.

Andrew Ellifson, a fourth individual implicated in the group’s activities pleaded guilty to a violation of the CAN-SPAM act and one count of criminal conspiracy. His role was creating, managing, and operating the computer network used for spamming.

Ellifson’s sentencing will occur on September 26 and he could serve up to a total of 15 years in prison if convicted on all three counts of the indictment.  In a plea bargain he agreed to relinquish the profits he made through the spam emails.

Carrington Labs of Irving, Texas, has issued a voluntary recall of Medline labeled alcohol-free mouthwash. As a result of this recall, Medline Industries, Inc. Mundelein, Illinois, is initiating a voluntary recall of Personal Hygiene Admission kits containing the same alcohol-free mouthwash.

The FDA has been apprised of this action.

The recall includes Alcohol-Free Mouthwash, Medline Label, 2 oz. reorder number MDS095029 and Alcohol-Free Mouthwash, Medline Label, and 4 oz. reorder number MDS095030. The product was distributed to hospitals, medical centers, and long-term care facilities nationwide.

The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The Centers for Disease Control and Prevention (CDC) has confirmed hospital illnesses in two states associated with the use of the affected mouthwash.

B. cepacia poses little medical risk to healthy people. However, people with certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), may be more susceptible to infections with B. cepacia.

B cepacia is a known cause of infections in hospitalized patients. B. cepacia bacteria are often resistant to common antibiotics. The effects of B. cepacia on people vary widely, ranging from no symptoms at all, to serious respiratory infections, especially in patients with CF.

Product lot numbers beginning 0503 through 0508 are affected. Affected product can be identified by checking the lot code stamped on the bottom of the bottle.

Additionally, affected product can be identified by checking for the identification code RA05CRR on the lower portion of back display panel of the product label.

The mouthwash may also be found packed in certain Medline Personal Hygiene Hospital Admission Kits. If you received mouthwash labeled for Medline Industries, Inc. from your healthcare provider please check to see if the reorder number on the label matches the recalled reorder numbers listed above, then check to see if the lot number matches the recalled lot number(s).

Customers who have Medline labeled alcohol free mouthwash which is being recalled should stop using the product and contact Medline Industries, Inc. for instructions.

Medline Industries, Inc. is notifying their customers via overnight mail and is arranging for all products to be returned for credit. For a complete list of admission kits involved, go to www.medline.com or call Medline Industries at 1-800-MEDLINE for details.

Following an emergency hearing before the Massachusetts Board of Registration in Medicine, Dr. Michael R. Brown, a Cape Cod physician, has lost his medical license on the grounds that he wrote an incredible number of prescriptions for the powerful painkiller, OxyContin.

The doctor is also facing criminal drug possession charges for allegedly buying back painkillers he had prescribed to a patient.

Dr. Brown, who became known as “Dr. Feel Good,” wrote so many prescriptions for OxyContin in 2004 that it is estimated he single-handedly accounted for approximately 300,000 of the 923,000 tablets sold in the entire state for the year. Many of the prescriptions deemed to be excessive were to children. 

OxyContin is an FDA approved medication for the relief of chronic pain and is often used by cancer patients. The drug, however, also has a dark side and has become a widely abused and addictive “street” drug that offers a quick heroin-like high.

Nancy Achin Audesse, executive director of the Board, said that although Brown had been required in 2001 to take courses in pain management, he continued to over-prescribe OxyContin. This resulted in the emergency action by the Board which believed Dr. Brown posed "an immediate and serious threat to the public safety and welfare."

The doctor can appeal the suspension, which will remain in effect indefinitely.

On Tuesday, Brown, 52, pleaded innocent to 13 counts of illegal drug possession within intent to distribute. The doctor has also been accused of buying back painkillers he had prescribed to a patient. 

Following an emergency hearing before the Massachusetts Board of Registration in Medicine, Dr. Michael R. Brown, a Cape Cod physician, has lost his medical license on the grounds that he wrote an incredible number of prescriptions for the powerful painkiller, OxyContin.

The doctor is also facing criminal drug possession charges for allegedly buying back painkillers he had prescribed to a patient.

Dr. Brown, who became known as “Dr. Feel Good,” wrote so many prescriptions for OxyContin in 2004 that it is estimated he single-handedly accounted for approximately 300,000 of the 923,000 tablets sold in the entire state for the year. Many of the prescriptions deemed to be excessive were to children. 

OxyContin is an FDA approved medication for the relief of chronic pain and is often used by cancer patients. The drug, however, also has a dark side and has become a widely abused and addictive “street” drug that offers a quick heroin-like high.

Nancy Achin Audesse, executive director of the Board, said that although Brown had been required in 2001 to take courses in pain management, he continued to over-prescribe OxyContin. This resulted in the emergency action by the Board which believed Dr. Brown posed "an immediate and serious threat to the public safety and welfare."

The doctor can appeal the suspension, which will remain in effect indefinitely.

On Tuesday, Brown, 52, pleaded innocent to 13 counts of illegal drug possession within intent to distribute. The doctor has also been accused of buying back painkillers he had prescribed to a patient. 

According to California’s Attorney General, Bill Lockyer, the state’s Medicaid program was bilked out of hundreds of millions of dollars by drug makers that inflated their prices.

As the number of defendants in the federal lawsuit increased to 39, Lockyer has made it clear that he believes Medi-Cal, California’s health insurance program for the poor, elderly, and disabled was the victim of price gouging by these companies which provided false and misleading drug pricing information to the state.

By engaging in these practices and defrauding the state into paying inflated reimbursement rates, the drug companies created an artificial incentive for doctors and pharmacies to prescribe their products.

Under California’s False Claims Act, the companies could be liable for treble (triple) damages and penalties of up to $10,000 per false claim. This could expose each of the companies sued to liability awards of up to $40 million.

Several other states have already filed similar suits and they have been consolidated in the United States District Court in Boston. This litigation could also cause the federal government to step up its own ongoing investigations into the matter of price gouging.

All of this litigation stems from a 1998 whistleblower lawsuit filed by Ven-A-Care, a small pharmacy that alleged Medi-Cal had based its drug reimbursement rates on false and misleading (inflated) drug-pricing information provided by the pharmaceutical companies.

In 2003, the state intervened in the Ven-A-Care lawsuit and the case was removed from state court and consolidated with the federal litigation pending in Boston.

The companies being targeted by the lawsuit maintain that they did nothing wrong and were in full compliance with law and all applicable guidelines.

The CPSC has announced the voluntary recall of Maptangle™ World Edition Floor Mat Map Games made in Taiwan by Team WorldWide Corp., of Taipei City, Taiwan (floor mat only) and distributed by Hidden Hills Productions Inc., of Westlake Village, California. Customers should stop using the product immediately.

Although only some 140 units are involved, the recall is a serious one because of the danger posed to children from lead exposure. Here, the orange paint on the floor mat maps contains excess levels of lead. Lead poisoning is associated with behavioral problems, learning disabilities, hearing problems and growth retardation. To date no injuries have been reported.

The floor map game consists of a 6-foot by 5.5-foot vinyl Maptangle™ floor mat that has various multicolored geographic locations and landmarks painted on the floor mat and a set of 103 playing cards consisting of corresponding geographic locations and landmarks.

The object of the game is for a team of players to locate, and place their feet on all of the landmarks and geographic locations. The game is age-graded for children 7 years and up. This recall pertains only to the floor mat, and does not include any other components of the game. Floor mat map games with manufacture date codes are not subject to this recall.

The games were sold at educational, book, museum, and specialty toy stores nationwide from February 2005 through June 2005 for about $25.

Consumers are advised to immediately stop using the recalled game maps, and contact Hidden Hills Productions Inc. for information on returning the recalled maps and receiving a free replacement map or refund.

Contact Hidden Hills Productions Inc. at (800) 641-9996 between 9 a.m. and 5 p.m. PT Monday through Friday, or visit the company’s Web site at http://www.borderlinegames.com

As more testing is done on bullet proof police vests containing a fiber known as Zylon, it is becoming clear that they simply do not do what they are supposed to do, which is to stop bullets.

In the latest study conducted by the Justice Department 103 Zylon vests performed so poorly that there were immediate changes made to federal safety guidelines. At least one of six bullets fired at each vest penetrated 60 of the 103 tested (58%).

Even when the vests were not penetrated, 91% sustained damage that was extensive enough to have caused blunt-force trauma to the officers who would have been wearing them. Such damage was regarded as completely unacceptable by the director of the justice institute.

Previous tests showed that Zylon deteriorated quickly, especially when exposed to light, heat, and moisture. The test results released this weak only served to emphasize the questionable value of the product and the potential risks it exposes law enforcement officers to when they wear it.

The New York City Police Department uses vests made of Kevlar, a material which has shown no sign of failure and has protected numerous police officers from multiple gunshots which would have serious injured or killed them. No such glowing endorsements are associated with Zylon.

In an article that appeared in our July 5 edition we reported on the claims that Zylon’s manufacturer was aware of the product’s shortcomings and with respect to the related lawsuit brought by the Justice Department. At that time we wrote the following:

Few defective products could be more dangerous to their users than bulletproof vests that turn out not to be bulletproof. That would be bad enough. But, what if the manufacturer and the supplier of the bullet-resistant material actually knew about the problem before the vests were sold thereby consciously exposing thousands of law enforcement officers to serious injuries or death? That would be unconscionable.

Unfortunately, this is precisely what appears to have happened in the case of some 230,000 or more bulletproof vests manufactured by Second Chance Body Armor Inc. (Second Chance) of Central Lake, Michigan, with bullet-resistant fiber supplied by Toyobo Co. (Toyobo) of Japan.

Last November 15, the Wall Street Journal (WSJ) reported Second Chance was aware of test results that “cast doubt on the vests’ effectiveness” for at least two years before one California police officer was killed and a Pennsylvania officer was seriously wounded by bullets that pierced the “bulletproof” vests they were wearing.

The WSJ stated that the test results were withheld “because executives feared bad news might hurt plans for an initial public stock offering.” Aaron J Westrick, a whistle-blower who was once the research director at Second Chance, has claimed (and testified) the company was aware (in 2001) that the strength of the Zylon (the fiber made by Toyobo) deteriorated much more quickly than the five-year warranty.

Test results from Toyobo in 2001 showed the resilience of the Zylon fibers was weakened when exposed to high temperature and humidity. Research by Second Chance on used vests then showed more rapid loss of bullet-resistance than expected. A second report by Toyobo later that year showed an even sharper decrease in Zylon’s effectiveness over time. 

According to the WSJ, depositions and other documents filed as part of ongoing civil litigation reveal during 2001 and 2002 there was considerable internal conflict at Second Chance over what to do about the mounting evidence that the vests were seriously flawed in terms of long-term resilience. The company continued to conceal the problem and avoided any recall or warning.

At least one Second Chance official claims to have told the executive committee in 2002 that it had two choices. It could do nothing “until a customer is injured or killed” or until the problem is discovered and then “make excuses as to why we didn’t recognize and correct the problem,” or it could notify customers and stop selling the 100% Zylon vests. There are allegations that the company attempted to destroy all copies of the memo of that meeting.  

Mr. Westrick says “he was told to keep the results quiet because company executives stood to lose as much as $20 million if the company didn’t launch an IPO.”

In September 2003 Second Chance announced it would upgrade and replace 130,000 potentially defective vests. Thereafter, the company filed for bankruptcy under Chapter 11 (October 2004) citing the cost of replacing those vests and mounting legal fees.

Now, the Justice Department has joined the fray by filing its own civil suit against Second Chance and Toyobo on behalf of several federal agencies that bought thousands of Zylon vests. The complaint alleges that between 1998 and 2001, the two companies “kept silent as to the ever-mounting information in their possession that the Zylon fabric degraded substantially faster than expected.”    

Second Chance now appears to be blaming Toyobo for the entire problem while Toyobo claims the failure of Second Chance to share critical information about vest-failure tests with Toyobo, the public, and investigating authorities makes Second Chance the “bad actor.”

The Justice Department claims that from as early as 1998, test results showed Zylon fiber deteriorated “rapidly” when exposed to visible and fluorescent light. Moreover, a document prepared by Second Chance and given to Toyobo stated the two companies “must avoid even the perception of a possible problem.” Finally, the additional testing in 2001 showed the vests bullet-resistance broke down upon exposure to high temperatures and humidity.

The federal government purchased 40,000 vests made with Zylon in 1998. The WSJ reports that, last week, Second Chance recommended an additional 98,000 vests made with Zylon be replaced citing new research that showed they “may fail to perform and result in serious injury or death.”

Officials are still in the process of investigating the death of 5-year-old Abubakar Tariq Nadama to determine why he went into cardiac arrest and died following chelation therapy on August 24.

Chelation therapy is a treatment that involves an intravenous injection of a synthetic amino acid known as ethylene diamine tetra-acetic acid that attaches to heavy metals and then leaves the body through urine. The child had just received his third such treatment when he went into cardiac arrest at the Advanced Integrative Medicine Center in Portersville, Pennsylvania.

Although the Food and Drug Administration (FDA) has approved the treatment only for acute heavy-metal poisoning that has been confirmed by blood tests, some believe the therapy can help autistic children based upon the belief that autism is linked to mercury or lead exposure.

Some experts regard using the treatment for this purpose to be risky. In fact, the Advisory Board on Autism-Related Disorders claims it was just a matter of time before a death would be linked to the therapy.