The American Academy of Pediatrics (AAP) issued new guidelines today concerning Sudden Infant Death Syndrome (SIDS). SIDS is the sudden death of an infant under 1 year of age which remains unexplained after a thorough investigation.  

According to the Academy, Sudden Infant Death Syndrome continues to be responsible for more infant deaths in the United States than any other cause of death during infancy.  The occurrence of SIDS is rare during the first months of life, increases to a peak between 2 and 3 months of age, and then decreases.  The primary risk factors for SIDS are:

•    Prone sleep position
•    Sleeping on a soft surface
•    Maternal smoking during pregnancy
•    Overheating
•    Late or no prenatal care
•    Young maternal age
•    Preterm birth and/or low birth weight
•    Male gender

Consistently higher rates are found in black and American Indian/Alaska Native children – 2 to 3 times the national average.

In 1992, the American Academy of Pediatrics released a recommendation that infants be placed down for sleep in a non-prone position.  Both side sleeping and back sleeping were recommended. Campaigns to encourage parents to put babies to sleep on their sides or back resulted in a consistent decrease in the SIDS rate.

After further study, AAP no longer recognizes side sleeping as a reasonable alternative to back sleeping.  Studies have found that the side sleep position is unstable and increases the chances of the infant rolling onto his or her stomach.  The Academy now recommends that parents use the back sleep position during every sleep period.

Research into SIDS has shown an interesting relationship between pacifiers and SIDS, with several studies reporting a protective effect of pacifiers.  The Academy now recommends the use of pacifiers at nap time and bedtime throughout the first year of life.

The new guidelines issued by the American Academy of Pediatrics include the following:

•    Infants should be placed on their back for every sleep.
•    A firm crib mattress, covered by a sheet, is the recommended sleeping surface.
•    Keep soft objects and loose bedding out of the crib.
•    Do not smoke during pregnancy and avoid exposing infants to second hand smoke.
•    Bed sharing during sleep is not recommended.  A separate but close sleeping environment is recommended such as a separate crib in the parent’s bedroom.
•    Consider offering a pacifier at nap time and bedtime.  The pacifier should be used when placing the infant down for sleep and should not be reinserted once the infant falls asleep.
•    The infant should be lightly clothed for sleep, and the bedroom temperature should be kept comfortable.
•    Assure that everyone caring for the infant is aware of the recommendations.

In a physician’s advisory dated October 6, 2005, St. Jude Medical Inc. announced that it has discovered that background levels of atmospheric ionizing cosmic radiation, more commonly known as cosmic rays, can affect a limited number of its older generation implantable cardioverter defibrillator (ICD) products.

The ICD products are within the Photon and Photon Micro device families and in certain Atlas devices.

They identified a particular vendor-supplied memory chip that can be affected at a low frequency rate by background cosmic radiation.  Background cosmic radiation bombards the earth constantly.  While the earth’s atmosphere acts as a shield and absorbs much of the cosmic radiation, some amount of high energy particles do arrive at the earth’s surface. 

When the chip is exposed to background levels of cosmic radiation, it can trigger a high current drain condition, which will deplete the battery voltage rapidly.  This can result in loss of output for a period of up to approximately 48 hours.  During this period, a patient would be without pacing or defibrillation therapy.  

The following St. Jude Medical ICDs are involved:

•    Photon DR (Model V-230HV) (certain serial numbers)
•    Photon Micro VR/DR (Models V-194/V-232)
•    Atlas VR/DR (Models V-199/V-240)

Approximately 26,000 of these devices are in service. To date, the incidence rate is low and there have been no serious patient injuries or deaths reported to St. Jude Medical attributable to this anomaly.

St. Jude Medical began using a different vendor, who utilized a different memory chip design, in 2002.  According to St. Jude Medical, laboratory testing and clinical experience indicate that the newer generation memory chip does not share the cosmic radiation problem.

St. Jude Medical notified the U.S. Food and Drug Administration (FDA) of the physician’s advisory, and the FDA may choose to recall the impacted devices.

The CPSC and the Coleman Company, Inc. of Wichita, Kansas, have recalled about 124,000 Coleman® Gas Grills and about 6,200 Coleman® Patio Heaters because the regulators on these can leak propane when the propane cylinder is turned on and the product is not in use, posing a serious fire or explosion hazard to consumers.

The regulators on these products were manufactured in China by TPA Metals and Machinery of China and sold at Lowes, Expo Design Centers and various pool and patio retailers nationwide.

The grills were sold from January 2004 through July 2005 for between $270 and $1,260, while the patio heaters were sold from June 2004 through July 2005 for between $500 and $600.

Coleman voluntarily recalled the products after the company received 98 reports of the regulators leaking propane. There have been no reports of injuries or property damage to date.

Consumers should stop using the grills and heaters immediately and contact Coleman for a free replacement regulator assembly. Once the regulator is replaced, the grill or heater may be used.

The recall includes Coleman® Gas Grills with model numbers 5100, 5300, 5400, 5600, 6000 and 7700, and Coleman® Patio Heaters with model number 5040. The model name and number can be found directly on the front of the grills and on the inside cover of the heaters.

For more information on the recall, please contact the Coleman Company, Inc. toll-free at (866) 584-8587 anytime, or log on to the company’s Web site at www.coleman.com. The CPSC hotline is 800-638-2772.

The CPSC and Pottery Barn Kids of San Francisco have announced a recall of approximately 7,600 spinal cribs because the spindles on the crib’s front rail can loosen and detach from the rail, allowing the child to fall from the crib and posing a risk of entrapment.

The spinal cribs were manufactured in Taiwan and sold nationwide at Pottery Barn Kids retail stores, through the Pottery Barn Kids catalog and on PotteryBarnKids.com from January 2004 through July 2005 for between $300 and $500.

Pottery Barn Kids has received six reports of incidents involving spindles detaching from the crib. No injuries have been reported to date.

Consumers should stop using these cribs immediately and contact Pottery Barn Kids to receive a free replacement front rail or a full refund (including shipping).

This recall involves the Spindle Crib, model number 4825402. The product name and model number are printed on a label affixed to the base of the crib. Sold in white, pink and blue, the cribs are made of hardwood and measure 30.5 x 54.5 x 45” high.

For more information, consumers should contact Pottery Barn Kids at (800) 330-6905 between 7 a.m. and 12 a.m. ET daily or visit the firm’s Web site at www.potterybarnkids.com

Consumers may also contact the Potter Barn Kids Media Contact, Abigail Jacobs, at (415) 616-8432. The CPSC hotline is 800-638-2772.

In a short letter (http://199.79.180.162/prepos/files/Artemis/Public/Recalls/2005/V/RCDNN-05V388-9228.PDF) to the National Highway Traffic Safety Administration (NHTSA), the Director of Ford Motor Company’s Automotive Safety Office announced a major recall involving some 3.8 million vehicles.

As required by federal regulations (49 CFR Part 573) the letter was accompanied by a detailed report describing the history and scope of the problem.

Although the attached report includes the acknowledgement that there have been allegations that “three deaths” and other injuries have been linked to fires caused by the faulty switch, Ford strongly denies the connection. 

The recall actually expands upon one already in operation and being monitored by the NHTSA (http://www-odi.nhtsa.dot.gov/cars/problems/recalls/results.cfm); however, it marks the first time that the giant automaker itself has openly acknowledged the seriousness and massive scope of the problem.

Only last month, Ralph Nader demanded the NHTSA alert vehicle owners to the potential fire hazard in numerous models of Ford and Lincoln SUVs and trucks. Nader wrote to Jeffrey Runge, head of NHTSA, insisting he issue a public warning about "life-threatening hazards" from a faulty cruise control switch in those vehicles.

At that point, Ford was in the process of recalling about 750,000 Ford F-150s, Expeditions, and Lincoln Navigators manufactured in 2000.

That recall was to replace cruise control switches which may catch fire in the above mentioned vehicles. The NHTSA, however, was continuing its investigation to determine whether the same fire hazard exists in another 4 million Ford SUVs and light trucks.

The government investigation, which began in March, involves F-150 pickups manufactured from the 1995 to 1999 and 2001 to 2002 and Ford Expeditions and Lincoln Navigator models from 1997 to 1999 and 2001 to 2002.
The NHTSA has received more than 550 complaints of engine fires as a result of the cruise control switch in the Ford models.

The most dramatic case wherein one of these faulty switches has been blamed for a serious fire is the one involving the Mohlis family. 

As we previously reported, after 911 was called, 74-year-old Darletta Mohlis died in an attempt to escape from her burning house. Her three children and husband, Earl, are suing the Ford Motor Company in a wrongful death action claiming a faulty cruise-control deactivation switch on Mr. Mohlis’s 1996 Ford F-150 pickup truck caused the fatal fire. 

In its ongoing investigation of fires linked to faulty cruise control shut off switches in Ford vehicles, CNN has already reported that despite the fact that Ford is aware of 16 million 1992 to 2003 vehicles at risk, only slightly over one million have been recalled.

The switch (manufactured for Ford by Texas Instruments) costs $20.57 and has already being linked to 559 fires reported to the National Highway Traffic Safety Administration (NHTSA).

Many of these fires have completely destroyed the vehicle. In this case, however, Mrs. Mohlis died when her entire house burned down after the family pickup truck caught fire while parked in the garage.

The fires are spontaneous and often occur when the ignition switch is off and the key removed. This is because Ford designed the switch to remain on or “hot” at all times. When a crack develops in the film (supplied by Dupont) separating the brake fluid from the electrical circuit, the leak will cause a fire.

Since May 1999, Ford has recalled a total of 1,071,000 vehicles in two separate recalls. CNN reports, however, that a document it has obtained shows Ford is aware that it installed a total of 16 million of the switches between 1992 and 2003 in the following vehicles:

·    Mark VII/VIII from 1994-1998
·    Taurus/Sable and Taurus SHO 2.3 L 1993-1995
·    Econoline 1992-2003
·    F-Series 1993-2003
·    Windstar 1994-2003
·    Explorer without IVD 1995-2003
·    Explorer Sport/Sport Trac 2002-2003
·    Expedition 1997-2003
·    Ranger 1995-2003

In March 2005, the NHTSA opened an expanded investigation into more than 3.7 million of these vehicles. Ford, however, chose not to recall all of the vehicles arguing that the switch has performed well for years in most vehicle models.

As a result, Ford has limited their recalls to those models “with an increasing fire rate report.” A recent recall notice was clear as to the risk, however.  Ford stopped using the switch last year in favor of a new design.
In the case involving the Mohlis family, inspections of the truck and fire scene have been performed by two experts hired by the family’s attorney, officials from the NHTSA, and inspectors from Ford.

The family’s experts, an electrical engineer and a certified fire investigator, believe the switch caused the fire. Ford claims the fire started elsewhere and spread to the truck and the switch had nothing to do with the fire. The NHTSA has made no public statement as to its investigation or findings. Mr. Mohlis stated the truck had been parked in the garage and shut off for four days before the fire.

The mounting pressure from consumer advocates (like Nader), the steady stream of reports of fires linked to the very same switch, the ongoing NHTSA investigation, and consistently bad publicity related to this issue (like CNN’s investigative reports) probably played a role in Ford’s belated acknowledgment that there is, indeed, a serious problem and its not going to go away.

The recall is the fourth largest for Ford and, according to NHTSA spokesman Rae Tyson, the fifth largest auto recall in the nation’s history behind: (1)1996, Ford recalled 7.9 million vehicles for faulty ignitions; (2)1971, GM recalled 6.7 million vehicles for engine failure; (3)1981, GM recalled 5.8 million vehicles for a rear axle problem; and (4)1972, Ford recalled 4.1 million vehicles for a shoulder-belt problem.

The NHTSA announcement describes the remedy as follows:

“AS AN INTERIM REPAIR, OWNERS WILL BE INSTRUCTED TO RETURN THEIR VEHICLES TO THEIR DEALERS TO HAVE THE SPEED CONTROL DEACTIVATION SWITCH DISCONNECTED. AS SOON AS REPLACEMENT PARTS ARE AVAILABLE (EXPECTED MID-OCTOBER 2005), OWNERS WILL BE INSTRUCTED TO RETURN TO THE DEALERS FOR INSTALLATION OF A FUSED WIRING HARNESS. THE INTERIM OWNER NOTIFICATION IS EXPECTED TO BEGIN DURING THE WEEK OF SEPTEMBER 12, 2005. OWNERS SHOULD CONTACT FORD AT 1-800-392-3673.”

Ford’s recall number is 05S28. Customers can also contact the NHTSA directly through its Vehicle Safety Hotline at 1-888-3274236 (TTY 1-800-424-9153), or by going to http://www.safecaar.gov.

In a short letter (http://199.79.180.162/prepos/files/Artemis/Public/Recalls/2005/V/RCDNN-05V388-9228.PDF) to the National Highway Traffic Safety Administration (NHTSA), the Director of Ford Motor Company’s Automotive Safety Office announced a major recall involving some 3.8 million vehicles.

As required by federal regulations (49 CFR Part 573) the letter was accompanied by a detailed report describing the history and scope of the problem.

Although the attached report includes the acknowledgement that there have been allegations that “three deaths” and other injuries have been linked to fires caused by the faulty switch, Ford strongly denies the connection. 

The recall actually expands upon one already in operation and being monitored by the NHTSA (http://www-odi.nhtsa.dot.gov/cars/problems/recalls/results.cfm); however, it marks the first time that the giant automaker itself has openly acknowledged the seriousness and massive scope of the problem.

Only last month, Ralph Nader demanded the NHTSA alert vehicle owners to the potential fire hazard in numerous models of Ford and Lincoln SUVs and trucks. Nader wrote to Jeffrey Runge, head of NHTSA, insisting he issue a public warning about "life-threatening hazards" from a faulty cruise control switch in those vehicles.

At that point, Ford was in the process of recalling about 750,000 Ford F-150s, Expeditions, and Lincoln Navigators manufactured in 2000.

That recall was to replace cruise control switches which may catch fire in the above mentioned vehicles. The NHTSA, however, was continuing its investigation to determine whether the same fire hazard exists in another 4 million Ford SUVs and light trucks.

The government investigation, which began in March, involves F-150 pickups manufactured from the 1995 to 1999 and 2001 to 2002 and Ford Expeditions and Lincoln Navigator models from 1997 to 1999 and 2001 to 2002.
The NHTSA has received more than 550 complaints of engine fires as a result of the cruise control switch in the Ford models.

The most dramatic case wherein one of these faulty switches has been blamed for a serious fire is the one involving the Mohlis family. 

As we previously reported, after 911 was called, 74-year-old Darletta Mohlis died in an attempt to escape from her burning house. Her three children and husband, Earl, are suing the Ford Motor Company in a wrongful death action claiming a faulty cruise-control deactivation switch on Mr. Mohlis’s 1996 Ford F-150 pickup truck caused the fatal fire. 

In its ongoing investigation of fires linked to faulty cruise control shut off switches in Ford vehicles, CNN has already reported that despite the fact that Ford is aware of 16 million 1992 to 2003 vehicles at risk, only slightly over one million have been recalled.

The switch (manufactured for Ford by Texas Instruments) costs $20.57 and has already being linked to 559 fires reported to the National Highway Traffic Safety Administration (NHTSA).

Many of these fires have completely destroyed the vehicle. In this case, however, Mrs. Mohlis died when her entire house burned down after the family pickup truck caught fire while parked in the garage.

The fires are spontaneous and often occur when the ignition switch is off and the key removed. This is because Ford designed the switch to remain on or “hot” at all times. When a crack develops in the film (supplied by Dupont) separating the brake fluid from the electrical circuit, the leak will cause a fire.

Since May 1999, Ford has recalled a total of 1,071,000 vehicles in two separate recalls. CNN reports, however, that a document it has obtained shows Ford is aware that it installed a total of 16 million of the switches between 1992 and 2003 in the following vehicles:

·    Mark VII/VIII from 1994-1998
·    Taurus/Sable and Taurus SHO 2.3 L 1993-1995
·    Econoline 1992-2003
·    F-Series 1993-2003
·    Windstar 1994-2003
·    Explorer without IVD 1995-2003
·    Explorer Sport/Sport Trac 2002-2003
·    Expedition 1997-2003
·    Ranger 1995-2003

In March 2005, the NHTSA opened an expanded investigation into more than 3.7 million of these vehicles. Ford, however, chose not to recall all of the vehicles arguing that the switch has performed well for years in most vehicle models.

As a result, Ford has limited their recalls to those models “with an increasing fire rate report.” A recent recall notice was clear as to the risk, however.  Ford stopped using the switch last year in favor of a new design.
In the case involving the Mohlis family, inspections of the truck and fire scene have been performed by two experts hired by the family’s attorney, officials from the NHTSA, and inspectors from Ford.

The family’s experts, an electrical engineer and a certified fire investigator, believe the switch caused the fire. Ford claims the fire started elsewhere and spread to the truck and the switch had nothing to do with the fire. The NHTSA has made no public statement as to its investigation or findings. Mr. Mohlis stated the truck had been parked in the garage and shut off for four days before the fire.

The mounting pressure from consumer advocates (like Nader), the steady stream of reports of fires linked to the very same switch, the ongoing NHTSA investigation, and consistently bad publicity related to this issue (like CNN’s investigative reports) probably played a role in Ford’s belated acknowledgment that there is, indeed, a serious problem and its not going to go away.

The recall is the fourth largest for Ford and, according to NHTSA spokesman Rae Tyson, the fifth largest auto recall in the nation’s history behind: (1)1996, Ford recalled 7.9 million vehicles for faulty ignitions; (2)1971, GM recalled 6.7 million vehicles for engine failure; (3)1981, GM recalled 5.8 million vehicles for a rear axle problem; and (4)1972, Ford recalled 4.1 million vehicles for a shoulder-belt problem.

The NHTSA announcement describes the remedy as follows:

“AS AN INTERIM REPAIR, OWNERS WILL BE INSTRUCTED TO RETURN THEIR VEHICLES TO THEIR DEALERS TO HAVE THE SPEED CONTROL DEACTIVATION SWITCH DISCONNECTED. AS SOON AS REPLACEMENT PARTS ARE AVAILABLE (EXPECTED MID-OCTOBER 2005), OWNERS WILL BE INSTRUCTED TO RETURN TO THE DEALERS FOR INSTALLATION OF A FUSED WIRING HARNESS. THE INTERIM OWNER NOTIFICATION IS EXPECTED TO BEGIN DURING THE WEEK OF SEPTEMBER 12, 2005. OWNERS SHOULD CONTACT FORD AT 1-800-392-3673.”

Ford’s recall number is 05S28. Customers can also contact the NHTSA directly through its Vehicle Safety Hotline at 1-888-3274236 (TTY 1-800-424-9153), or by going to http://www.safecaar.gov.

A study in the September 7 issue of the Journal of the American Medical Association reports that medical students are being influenced by drug-promotion through the pharmaceutical industry’s practice of giving free gifts.

Dr. Frederick S. Sierles, a professor of medicine at Rosalind Franklin University of Medicine and Science, in North Chicago, Illinois, collected data in anonymous questionnaires sent to 1,143 third-year medical students at eight medical schools.

They found that 93.2% of the students were asked or required by a physician to attend at least one drug company-sponsored lunch. Thus, Sierles observed that the gift-giving practice was encouraged by professors and professionals in the field.

In addition, 68.8% of the students believed gifts would not influence their practices, and 57.7% thought gifts would not affect colleagues’ practices. There was also a tendency among those surveyed to believe the gifts would influence colleagues more than themselves.

Surprisingly, 80.3% of the students believed they were entitled to gifts.

Results showed that third-year medical students get, on average, one gift or attend one activity sponsored by a drug maker each week. Most students think this marketing is probably biased but believe they aren’t swayed to a company by it.

Sierles observed that the marketing by pharmaceutical companies began early on in students’ careers. "This contact with drug companies begins in the weeks and months after students graduate from college. By the third year of medical school, they are being saturated with this," he said.

While many students and professionals do not believe they are being influenced, there is evidence from other studies that gifts and marketing events do influence what is prescribed. The danger is that this will lead to the improper prescribing of medications.

In addition, many students were uniformed about the policies of their school or the national medical organizations in regard to the acceptance of gifts and promotional meals. Sierles argued that "medical schools should consider restricting exposure to drug reps."

Leana Wen, President of the American Medical Student Association and a medical student at Washington University in St. Louis, agreed that it was important to limit the influence of the pharmaceutical companies.

"We think that big pharma has gotten intricately involved in every aspect of medical education and clinical practice.

Medical schools really have a duty to educate students about the proper ways to interact with drug companies" she said
Another expert, Jan D. Carline, a professor of medical education and biomedical informatics at the University of Washington, was alarmed by the findings, especially students’ feelings of entitlement toward these gifts which he sees as an indicator of the values and behaviors of the professionals teaching them.

According to a new study the sleep deprivation of doctors in residency impairs their reaction and decision making abilities as much as alcohol.

While the 90-hour work weeks of doctors-in-training have become a sort of initiation ritual for entry into the medical field, researchers found that such stresses can lead to serious errors that put patients at risk.

Residents with a 90-hour work week performed worse on a driving simulation test than those on a 44 hour per week rotation who had consumed alcohol up to a 0.05% blood alcohol level (a 0.08% blood alcohol is considered driving while intoxicated).

A survey of residents also found that they were three times more likely to have been involved in a motor vehicle crash.

The study, published in the Journal of the American Medical Association, reiterates the findings of earlier research which showed that medical interns with demanding schedules made 50% more mistakes with patients and had 22% more serious errors on critical care units.

The author of the study Todd Arnedt of the University of Michigan, Ann Arbor, writes: "Residents must be aware of post-call performance impairment and the potential risk to personal and patient safety." 

He advises that residency programs should also be aware of these concerns and create alternative call schedules and provide napping quarters. New rules established in 2003 reduced the maximum weekly schedules for U.S. interns to 80 hours.

On Friday a former popcorn-plant worker was given $15 million for his claim that his exposure to butter-flavoring fumes led to severe respiratory problems.

The case was filed by Stephen McNeely a 35-year-old machine operator from Carthage, Missouri, who filled popcorn bags with salt and butter flavoring.

McNeely is one of many former workers for International Flavors & Fragrances Inc. of New York, a subsidiary of Bush Boake Allen Inc., to file lawsuits against the company. Last week’s verdict brings the total awarded in the last two years to nearly $53 million.

The plant where the plaintiffs worked, the Gilster-Mary Lee Corp. microwave popcorn factory in Jasper, Missouri, has paid the employees workers’ compensation and has not been involved in the lawsuits.

McNeely worked at the Jasper plant from 1989 to 2001 and developed bronchiolitis obliterans, a serious and unusual lung disease that may require him to get a lung transplant.

McNeely’s lawyer, who also represents 30 other Jasper plant popcorn workers who have sued International Flavors and Bush Boake, had no comment on the case, saying the judge had issued a gag order. Attorneys for International Flavors could not be reached for comment.

Four other plaintiffs reached confidential settlements with the defendants last year and at least 20 more cases are awaiting trial.

Previously, newsinferno.com reported that 36-year-old former popcorn plant worker, Kenneth Moenning, who believed his respiratory illness resulted from a chemical used to make butter flavoring, sued International Flavors and Fragrances Inc. was awarded $2.7 million by a jury in July.

The plaintiffs claimed the company knew that it was using chemicals that cause lung cancer to synthesize butter flavor and did not warn workers.

Moenning, who also has bronchiolitis obliterans, worked in the plant’s flavoring room from 1993-1996 and experts testified that his lung disease resulted directly from exposure to diacetyl and other chemicals used to make butter flavor.

Defense attorneys stated that management was unaware of the danger the chemicals posed to employees. "Someone is trying to blame the defendants for something no one knew or could have known," said Mike Patton, the attorney for International Flavors and Fragrances, in his closing arguments.

The jury deliberated for seven hours. When it returned its verdict in the Jasper County Circuit Court, nine jurors (the minimum necessary) supported a $2.69 million award to Moenning and $50, 000 for his wife. Moenning had asked for $20 million, plus $5 million for his wife for emotional suffering.

While health officials claim microwave popcorn is safe, they admit the chemicals released during popping require additional study. If pre-packaged, fake-flavored foods taste too good to be true, the recent verdicts suggest they probably are.

The Food and Drug Administration (FDA) and the United States Attorney for the Western District of Missouri, in Kansas City, have announced the indictment of 11 individuals, a drug re-packer, and two wholesale distributors in cases related to the sale of counterfeit Lipitor, the most widely prescribed cholesterol reducing drug.

The indictment alleges numerous charges including conspiracy to sell counterfeit, illegally imported and misbranded drugs as well as conspiracy to sell stolen drugs.

The conspiracy involved the manufacture of counterfeit Lipitor at a secret facility in Central America, the purchase of genuine Lipitor intended for distribution in South America, and the illegal importation of both products into the U.S.

"This case demonstrates that the FDA will take the necessary steps to protect the drug supply in America," said FDA Commissioner Dr. Lester Crawford. "I am pleased that the U.S. Attorney’s Office and FDA have been able to put together this case and stop these fraudulent schemes to sell pharmaceuticals of unknown safety and efficacy to the public."

In 2003, Albers Medical Distributors, Kansas City, MO, (a drug wholesaler) distributed over $20 million in illegally imported and counterfeit Lipitor that was sold to H.D. Smith Wholesale Drug Company (Wood Dale, IL).

H.D. Smith distributed these Lipitor tablets throughout the U.S. The counterfeit Lipitor was repackaged by Med-Pro, Lexington, NE., a drug re-packer. All three participants in this scheme were named in the indictment today. It is believed that these particular counterfeit Lipitor products are out of circulation.

In addition, it is alleged in the indictment that members of the conspiracy distributed pharmaceuticals stolen from GlaxoSmithKline and Roche Pharmaceuticals and counterfeited drugs.

The FDA’s Office of Criminal Investigation (OCI) was able to put together the case by tracing back the various steps in this scheme. OCI was able to document where the chemicals and products came from, where the counterfeit was being manufactured, and how it was distributed.

Working together with the U.S. Attorney’s Office in the Western District of Missouri, these findings led to today’s indictment of all parties involved.

The FDA and federal law enforcement authorities are also becoming increasingly concerned with the sale of counterfeit drugs over the Internet and at pharmacies in Mexican border towns.

Although the operators of several Internet (and mail-order) operations have been arrested recently and charged with illegal drug sales through online pharmacies, the authorities have been frustrated by the fact that new websites are up and running almost immediately.

The Mexican problem is also becoming quite serious since counterfeit versions of drugs like Lipitor, Viagra, and Evista, which can be quite dangerous, are readily available in border towns like Juarez, Los Algodones, Nogales, and Tijuana.

The FDA has been working with Mexican authorities to address this problem throughout Mexico and, as a result, 19 pharmacies have been suspended and over 105 tons of medicines have been confiscated. Counterfeiting is known to be taking place in China and Russia.

Recently, five heart patients in Hamilton, Ontario, Canada may have died after taking fake medication dispensed from the same pharmacy. The drug in question, Norvasc, is used to treat unstable angina and high blood pressure.

An investigation prompted by a local woman who was suspicious of an oddly colored pill in her supply of Norvasc. The pill turned out to be made of talcum powder.

The Medicines and Healthcare Products Regulatory Agency (MHRA), which is the UK equivalent of the FDA, in conjunction with Pfizer, recently announced a recall of 20mg Lipitor tablets as a result of finding counterfeit versions of that particular dosage of the drug.

The fake tablets can be identified because they do not come in the sealed packages used to market the real 20mg pills.

Since 2004, the UK too has been encountering a growing problem with counterfeit medications. Previously, fake batches of Cialis and Reductil were discovered there.