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The FDA's Math Problem

Fentanyl’s Body Count

by EVEYLYN J. PRINGLE

Describing fentanyl as a "very strong narcotic," on July 15, 2005, the FDA issued a Public Health Advisory regarding the safe use of transdermal fentanyl patches in response to reports of 120 deaths in patients using the patch for pain management, stating that some patients and doctors might not be fully aware of its dangers.

A cursory investigation of drug deaths listed in various databanks around the country indicates a severe math deficiency in officials within the nation’s safety agency because the number of deaths attributed to fentanyl is far larger than the mere 120 cited by the FDA.

For instance, in the year 2004, fentanyl patch abuse was found to be responsible for 115 deaths in Florida alone, according to research conducted by University of Florida toxicologist Dr Bruce Goldberger.

The patches are intended for the relief of chronic pain that requires treatment around the clock and cannot be controlled by other narcotics. The patches contain fentanyl in gel form and can provide up to three days’ relief from severe pain,

The products under scrutiny, include the brand name patch, Duragesic, the generic patch manufactured by Mylan Laboratories, and Sandoz, the generic patch manufactured by the Alza Corporation, the same company that manufactures Duragesic for Johnson & Johnson.

An overdose of fentanyl can put a patient into a coma and shut down breathing. Removing the patch will not reverse the effects because the drug builds up in the patient’s system and can continue to be absorbed from the skin for up to 17 hours or more.

The FDA advisory warns that people wearing the patches may suffer overdoses or other serious side effects if they drink alcohol, have an increase in body temperature or are exposed to heat from sources like hot tubs, saunas, heating pads, electric blankets, heat lamps, or heated water beds.

The FDA says doctors should prescribe the lowest effective dose of the medication, and that patches should not be used to treat short-term pain, or pain after an operation.

According to the Drug Enforcement Agency, fentanyl was first synthesized in Belgium in the late 1950s and has about 80 times the potency of morphine. "The biological effects of the fentanyls are indistinguishable from those of heroin, with the exception that the fentanyls may be hundreds of times more potent," the DEA’s web site reports.

In the latter part of the1970s, fentanyl began appearing in designer drugs. The term "designer drug" was first coined in California to describe the private synthesis of drug analogs slightly different from their parent compounds, that by design rendered them temporarily immune from control by the DEA.

The fentanyl analogs were first developed and marketed as a substitute for heroin. The most frequently used fentanyl analog was given the street name China White but others were called New Heroin, Tango and Cash, and Goodfella.

Whether it was because of the drug’s strength or its unknown pharmacological properties, users of China White suffered a high number of fatal overdoses, while many people who took New Heroin developed symptoms similar to Parkinson’s disease.

In the late seventies, deaths began to mount in heroin users on the West Coast who had purchased "China White." The illicit marketing of fentanyl products ultimately caused more than 100 overdose deaths on the West Coast by 1986, according to Designer drugs: past history and future prospects, J Forensic Sci 33:569-575, 1988.

In 1991, the analog Tango and Cash was implicated in at least 28 deaths, primarily in the northeast area of the country. Fentanyl gained widespread attention the same year, when 12 people in New York, Connecticut and New Jersey overdosed and died in a single weekend.

In 1992, China White was determined to be the cause of death in 21 overdoses during a 2-month period in Philadelphia.

Fentanyl gained international notoriety in 2002, when authorities in Moscow, ended a hostage crisis at a theater by pumping an aerosol version of drug into the building, intended to put the nearly 800 hostages and their captors to sleep. In the end, 129 hostages and 41 terrorists died from breathing the gas.

Over the years, not all cases of fentanyl abuse and overdose resulted in death; many more people ended up in hospital emergency rooms. In 1999 alone, there were 337 emergency-room visits related to fentanyl abuse throughout the US, according to estimates from the Drug Awareness Warning Network The network collects information from 500 hospitals across the country and extrapolates the data nationwide.

Overall, emergency room doctors in the US saw the number of overdoses on fentanyl grow from 28 in 1994, to 1,506 in 2002, according to the most recent numbers available from the Federal Substance Abuse and Mental Health Administration.

In many cases it is unknown whether death is due to abuse or misuse. The Florida Department of Law Enforcement records for the 115 deaths in 2004, were not clear about how people obtained the drug, whether by a prescription of their own or from one that had been stolen or otherwise not used according to doctor’s instructions, the UF study said.

In addition to the placement of multiple patches on the body, the study found users devised techniques for the removal of the contents of the drug reservoir for oral, IV or smoked administration.

Sudden deaths are also occurring regularly in other states. The Indiana Poison Center located at Methodist Hospital in Indianapolis, recorded an increase in fentanyl-related deaths from 2002 to 2005. The Center listed 15 fentanyl-abuse cases in 2002, 18 in 2003, 25 in 2004, and 23 in 2005.

The Center also recorded 17 medical misuses of the drug and 38 suicide attempts using the fentanyl patch between 2002 to 2005.

Seven people were found dead in 2005 in the two Indiana countries of Johnson and Shelby due to the abuse or misuse of fentanyl.

Charles Owen McCormick IV, 18, died on May 27, 2005, in his room at his parents’ home Greenwood, Indiana. He had 3 times the lethal dose of fentanyl in his system, the Johnson County Sheriff’s Department said.

Jacqueline Young, 44, died December 15, 2005, in bed at a Greenwood hotel where she was living. She was wearing two fentanyl pain patches and had 3 times the lethal dose in her body at the time of her death. Two heating pads were found in her bed, and heat is known to accelerate fentanyl to a fatal level.

In other Indiana deaths, Anna Layton, 48, and her son Christopher Layton, 28, were found dead on March 21, 2006. Police found Ms Layton dead when they arrived to tell her about her son’s death. Both had eaten and injected fentanyl from patches, the coroner said. Toxicology reports showed Ms Layton had nearly 15 times the lethal dose of fentanyl in her system; and her son had nearly 3 times the lethal dose.

In 2005, Utah statistics from the latest mortality data available from the State Health Department show fentanyl was related to 29 accidental deaths, up from nine in 2004.

In December 2005, surviving family members of two Utah women filed lawsuits against Janssen Pharmaceutica and Alza Corporation, the manufacturer and distributor of the Duragesic skin patch, which the families say leaked and caused the deaths of both women.

Autopsy reports said Gina Danise, 42, and Victoria Price, 56, both died from drug poisoning after using drug pain patches.

A third lawsuit, by the Utah family of Marilyn Titus, 72, who died two years ago, was also filed in December 2005.

The Los Angeles County Coroners Office reports a growing number of accidental over-doses by patients misusing the patch, listing 127 deaths over the last six years, according to a CBC News report on December 20, 2005.

Fentanyl abuse is on the rise among medical professionals who handle the drug. A Florida study showed that while only 5.6% of physicians in Florida were anesthesiologists, nearly 25% of physicians followed for substance abuse/dependence were anesthesiologists. When sorted by drug of choice, anesthesiologists had more fentanyl abuse and dependence than other physicians.

Data from the Florida impaired physicians database allowed researchers to categorize all fentanyl abusing and/ or dependent physicians, and showed 75% were anesthesiologists.

Fentanyl remains a popular street drug today. The DEA Philadelphia Division recently noted that a new prescription fentanyl drug, Actiq, is available on the streets. An Actiq unit consists of a medicated, raspberry-flavored lozenge on a handle and is known on the street as a "Percopop," likely due to their resemblance to lollipops.

According to the 2005 DEA Pennsylvania Fact Sheet, investigations indicate that diversion of products such as fentanyl patches and Actiq, continues to be a problem. "Primary methods of diversion being reported are illegal sale and distribution by health care professionals and workers, "doctor shopping" (going to a number of doctors to obtain prescriptions for a controlled pharmaceutical), forged prescriptions, and the Internet," it states.

On May 10, 2005, ABC News reported that a string of overdose deaths and robberies, all linked to fentanyl, raised concerns among police officials in parts of Pennsylvania, New York and Ohio.

All of the deaths occurred when people cut open fentanyl patches and sucked out the drug, "which the Drug Enforcement Administration describes as 50 times stronger than heroin and 80 times more powerful than morphine," ABC noted.

In most of the cases the fentanyl linked to the overdoses had been taken from a relative of one of the people involved, ABC reported.

On August 15, 2005, NBC News reported that police said fentanyl disguised as heroin had caused multiple overdoses on the West Side of Chicago and had been given away by members of a street gang in order to acquire new customers.

Six months later, on February 6, 2006, Chicago police warned that drug dealers on the South Side might be selling fentanyl as heroin on the city streets.

On February 7, 2006, the Chicago Sun-Times reported from unnamed sources that the drug may be linked to as many as a dozen recent fatal overdoses in a small area of Chicago’s South Side.

The Sun-Times reported on February 11, 2006, that laboratory "tests on some of the fatal overdose victims who Chicago Police suspected may have died last month from a bad batch of heroin indicate the presence of the powerful pain-killer fentanyl."

At least 10 fatal overdoses are under investigation the Times said.

On February 23, 2006, the Associated Press reported that four Aiken County South Carolina residents had recently died from overdoses of fentanyl. The deaths were caused by people either injecting or inhaling fentanyl after extracting the drug from a patch, according to the County Coroner, Tim Carlton.

Demi Garvin, forensic lab director for the Richland County Sheriff’s Department, told the AP reporter: "We probably get several a month that are related to the drug across South Carolina."

Its obvious that the FDA needs to conduct a much more thorough investigation when considering whether to allow fentanyl patches to remain on the market. However, its not likely to happen while the FDA officials in charge are joined at the hip to drug companies because the patches are real money-makers for Pharma.

Mylan introduced its generic version of the patch in January 2005 and it accounted for substantially all of the $55 million in revenue the company earned from new products in its fiscal first quarter which ended June 30, 2005.

Worldwide sales of Duragesic in 2005 were $1.59 billion, according to Teresa Gaines, spokeswoman for Johnson & Johnson. The cost of a 30-day supply of patches can range from $348 at Target to $408 at Wal-Mart.

Information for injured parties can be found at Lawyers and Settlements.com

Evelyn Pringle can be reached at: evelyn.pringle@sbcglobal.net