The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

April 2007 Big Pharma Litigation Update – Drugs – Part I

Evelyn Pringle April 5, 2007

For the last two decades, illegal drug marketing schemes have paid off well for Big Pharma. However, as the old saying goes, all good things must come to an end, and every major drug company is currently involved in massive litigation.

Some companies are facing thousands of lawsuits with a common complaint that the drug maker deliberately concealed the side effects of their products while illegally promoting the drugs for off-label use.

Off-label refers to prescribing drugs to treat conditions other than those approved by the FDA and listed on the label. It can include prescribing drugs to unapproved populations, such as children or the elderly, or in higher doses than specified on the label.

It is illegal for drug companies to promote a drug for off-label uses, but doctors are allowed to prescribe a drug for any use they choose. Almost without exception, the lawsuits currently pending accuse the pharmaceutical companies of influencing doctors to prescribe the product for unapproved uses.

On August 18, 2006, Bloomberg News reported that Wyeth has accumulated more than 175,000 lawsuits since the Fen-Phen diet combination was removed from the market after studies revealed that the drugs caused heart valve damage, and primary pulmonary hypertension, or PPH, a life-threatening lung disorder. All total, Wyeth has set aside more than $21 billion to cover legal costs and settlements since the drugs were withdrawn, according to Reuters on May 24, 2006.

There was a national class-action settlement involving claims for heart valve damage, but it did not include claims for PPH which are proving to be costly. In one 2004 case alone, a Texas jury awarded over $1 billion to the family of a woman who died of PPH after taking Fen-Phen for about two years, including $113.4 million in compensatory damages and $900 million in punitive damages, according to Wyeth’s 2005 Annual Report. The case was later settled for an undisclosed amount.

PPH is a life-threatening condition that can require a heart-lung transplant. According to the FDA, PPH “results in death in about 40% of affected individuals within 4 years.”

The Fen-Phen combination was never FDA approved for any use, which means every prescription was off-label. Patients were able to get Fen-Phen on the internet, and Jenny Craig and Nutri-System set up weight-loss programs where doctors would prescribe the drugs to customers.

And there appears to be no end in sight for Fen-Phen lawsuits. On December 5, 2006, five more women who took the drugs in 1996 and 1997, filed lawsuits against Wyeth after being diagnosed with PPH. When it comes to liability, a plaintiff’s attorney, Paul Rheingold, in “Fen-Phen and Redux: A Tale of Two Drugs,” says, “there is blame enough to go around.”

The doctors who set up store-front Fen-Phen clinics and prescribed the drugs are obvious culprits, he says, and so are drug companies that profited financially from the fad and may have neglected to pass on information about deadly side effects.

On August 18, 2006, Bloomberg reported that Wyeth was facing 5,000 lawsuits over the menopause drug, Prempro, alleging that Wyeth misled the plaintiffs through deceptive marketing about the cancer risks associated with estrogen and progestin. As many as 6 million women took Prempro before it was linked to cancer in a 2002 study.

Financial analysts are predicting that, Merck in the end, will pay out as much as $50 billion for Vioxx litigation. On March 12, 2007, Reuters reported that a New Jersey jury found the drug was responsible for a plaintiff’s heart attack and awarded $20 million in damages.

According to Reuters, the jury also found that Merck committed consumer fraud by making misrepresentations concerning the heart risks, and intentionally concealing safety information from doctors prior to the plaintiff’s heart attack.

A large number of lawsuits have also been filed against Merck, over the osteoporosis drug Fosamax, and against Johnson and Johnson, over the Ortho-Evra birth control patch. The plaintiff’s allege that Fosamax causes jaw-bone death (OJN) and that the patch causes blood clots, which in turn lead to strokes.

Legal experts predict causation in cases involving Fosamax and the Ortho patch will be easy to prove because the plaintiffs have what is referred to as a “signature disease,” meaning a condition easily tied to the drug because it is rare.

The jaw-bone death occurring in people taking Fosamax is extremely uncommon. Kenneth Hargreaves of the University of Texas, noted the increasing cases in the April 3, 2006 LA Times. “We’ve uncovered about 1,000 patients in the past six to nine months alone,” he said, “so the magnitude of the problem is just starting to be recognized.”

FDA approved in 1995, Fosamax is a relatively new drug, and unreported cases may be higher than expected because doctors may attribute the pain caused by ONJ to osteoporosis, according to Diane Wysowski of the FDA’s Office of Drug Safety.

Dr Salvatore Ruggiero, an oral surgeon and one of the first doctors to notice the rise in ONJ in 2001, told the Times, “Even though the chances of getting this are small, considering there are 23 million women taking this drug, we could be talking about a significant number of people.”

The same goes for the Ortho patch. Blood clots seldom develop in young women of childbearing age. And legal experts say, for that reason, many Ortho patch lawsuits have already ended in confidential settlements with hardly a peep in the mainstream press, and J&J has made it clear to other plaintiffs’ attorneys that the company is willing to cut a deal.

Experts predict that many more lawsuits will be filed because there are thousands of young patch victims who are still unaware that the patch caused the health problems. In 2005 alone, more than 9.4 million prescriptions were written for the Ortho patch, according to IMS Health, an industry-tracking firm.

The FDA says it has received about 9,000 reports of adverse events related to the patch, but the agency also acknowledges that only between 1% and 10% of adverse events are ever get reported.

There are over a hundred more lawsuits filed against J&J involving the Duragesic pain patch. The device is supposed to deliver controlled doses of fentanyl, a drug so powerful that high doses can turn off the respiratory center in the brain.

On July 8, 2006, the Associated Press reported that a Houston jury had awarded $772,500 to the daughter of a woman who died after a leak on the patch increased the dose of the painkiller, and the jury found J&J negligent in the way the patch was made.

Another fentanyl product that legal experts say will bring a wave of lawsuits in the next couple of years, is Cephalon’s painkilling lollipop, Actiq. The product was only approved to treat cancer patients in chronic pain who are already on an opioid drug, because life-threatening conditions can occur at any dose in patients without a built-up tolerance for opioids. But a recent study by Prime Therapeutics found Actiq is being prescribed off-label nearly 90% of the time.

Fentanyl is reportedly 80 times stronger than morphine, and is a Schedule II narcotic drug, in the same category as cocaine, opium, methamphetamine and methadone, a class known to have the highest potential for abuse and overdose.

In 2004, there were an estimated 8,000 emergency-room visits for fentanyl overdoses, according the US Substance Abuse and Mental Health Services Administration. Overdose can result in sudden death through respiratory arrest, cardiac arrest, severe respiratory depression, cardiovascular collapse or severe anaphylactic reaction, according to the agency. As of November 16, 2006, there were 653 deaths confirmed in the US since 2005.

In November 2006, the Wall Street Journal, said evidence obtained in litigation showed Cephalon had set high sales quotas for its sales representatives that could not be reached without promoting Actiq off-label.

Internal company documents show sales reps were regularly sent to doctors who treated no cancer patients, with free coupons for doctors to pass out to patients. According to the Journal, Dr Stephen Leighton, a general practitioner with only 3 cancer patients at any given time, said a Cephalon saleswoman stop by once a month and gave him about 60 to 70 coupons to pass out to patients for 6 Actiq lollipops.

He told the Journal that the coupons led him to try the drug for migraines and back pain and said he prescribes Actiq 15 to 20 times a month to patients who do not have cancer.

According to the November 3, 2006, report in the Journal, Actiq sales increased from $15 million in 2000, to more than $400 million today.

The consequences of the off-label prescribing of this product are far reaching. On January 22, 2006, the Free Press reported that the wife of a minister, a former schoolteacher and mother of three, was charged with involuntary manslaughter because she gave Actiq to a friend for a migraine, and the friend died of a drug overdose.

More lawsuits are sure to be filed against Eli Lilly since secret internal documents obtained in litigation by attorney, Jim Gottstein, from Dr David Egilman, an expert in previous Zyprexa litigation, prove that the company concealed Zyprexa’s link to severe weight gain, high blood sugar, and diabetes for a decade, while Lilly promoted the drug for so many off-label uses that more than 20 million people have taken Zyprexa.

To date, Eli Lilly has spent well over $1 billion to settle about 26,000 Zyprexa lawsuits, with still more litigants waiting in line. Zyprexa has been linked to serious side effects, including diabetes, hyperglycemia and pancreatitis.

On January 14, 2005, a class-action lawsuit was filed in Canada with claims that Lilly also withheld information on the safety of Prozac. The plaintiffs allege that the reason Lilly failed to disclose the documents was because they showed a drastic increase in suicide attempts and other violent acts in patients taking Prozac, when compared to patients taking 4 other drugs.

All through the 1990s, Lilly swore that Prozac did not increase the risk of suicide or violence, while the company was quietly settling lawsuits out of court which made it possible to keep the incriminating evidence hidden with court orders, just as it has been doing with Zyprexa until the secret documents showed up in the press in December 2006.

Similar lawsuits are being filed against AstraZeneca over its antipsychotic drug, Seroquel, which reportedly has been used by more than 16 million people since it came on the market in 1997. The plaintiffs in those cases also claim that Astra downplayed the diabetes risks and concealed safety information.

Filed under: 2007, AstraZeneca, Cephalon, Eli Lilly, fen-phen, fentanyl, Fosamax, Johnson and Johnson, Merck, ONJ, Ortho, patch, PPHN, Seroquel, settlement, Vioxx, Wyeth, Zyprexa

Off-Label Prescribing of Pain Lollipops Turns Deadly

Evelyn Pringle January 24, 2007

The painkilling lollipop, Actiq, is approved to treat chronic pain in cancer patients who are already on an opioid drug. But a recent study by Prime Therapeutics found the drug is being prescribed off-label for unapproved uses nearly 90% of the time.

For those suffering with the agonizing pain of late stage cancer, the painkiller on a stick brings fast relief because it is 80 times more potent than morphine, which makes it a prime drug to watch for law enforcement officials because of its potential for illicit use.

Actiq contains fentanyl, a drug classified as a Schedule II substance by the Drug Enforcement Administration, in the same category as cocaine, opium, methamphetamine and methadone. Schedule II drugs have the highest potential for abuse and overdose.

Fentanyl is also available in a skin patch, and overall, prescriptions for the drug have increased from about 0.5 million in 1994 to 6.95 million in 2005, according to IMS Health, a pharmaceutical industry tracking firm.

Actiq is only FDA approved for the management of pain in cancer patients who are already being treated with opioids because life-threatening conditions can occur at any dose in patients without a built-up tolerance for opioids.

According to a November 5, 1998, talk paper prepared for agency personnel at the time of the product’s approval, the FDA approved Actiq, as a “new product developed specifically for cancer patients with severe pain that breaks through their regular narcotic therapy.”

“Because Actiq may be fatal to children (as well as to adults not already taking opioid narcotics),” the paper said, “FDA approved Actiq under special regulations that restrict distribution as defined in a comprehensive risk management plan.”

The FDA noted that the agency was “extremely concerned that this product be packaged and marketed to minimize the opportunity for diversion, abuse, or access by children.”

However, the DEA, reports that fentanyl is being diverted by pharmacy theft, fraudulent prescriptions and illicit distribution by patients, physicians and pharmacists, and theft at nursing homes and other long-term care facilities. Actiq is typically sold on the street for $20-25 per lollipop and the drug’s street name is “perc-a-pop.”

In 2004, there were an estimated 8,000 emergency-room visits for fentanyl overdoses, according the US Substance Abuse and Mental Health Services Administration. Overdose can result in sudden death through respiratory arrest, cardiac arrest, severe respiratory depression, cardiovascular collapse or severe anaphylactic reaction, according to the agency. As of November 16, 2006, there were 653 deaths confirmed in the US since 2005.

On June 20, 2006, the US Department of Health and Human Service sent a letter to emergency department physicians and personnel to make them aware that the CDC was receiving increasing reports of fentanyl overdoses among illicit drug users in multiple states.

However, the fact that fentanyl cannot be detected with standard opiate screens has caused major problems. Currently, the ER protocol recommended is to assume the presence of fentanyl when a patient has symptoms of narcotic overdose but fails to test positive for heroin.

The Utah based drug maker Anesta Corp, a company acquired by Cephalon in 2000, developed Actiq. Since the Cephalon taker-over in 2000, Actiq has become one of the drugs most often prescribed off-label in the US.

Off-label refers to the use of drugs to treat conditions other than those approved by the FDA and can include prescribing drugs to unapproved populations such as children or the elderly or in higher doses than specified in the drug’s labeling. Drug companies are not allowed to promote a drug for off-label uses, but doctors are permitted to prescribe a drug for any use they believe would be helpful.

The study released this month by Prime Therapeutics, a pharmacy benefit manager, analyzed 95 patient claims from a Midwestern commercial health plan from April through June 2005, and found that only 21 patients had a diagnosis of cancer or AIDS.

In addition, Prime found that only 11 of those 21 patients were taking a long-acting opioid painkiller. Overall, 84 of the 95 Actiq prescriptions, or nearly 90%, were off-label.

The Prime study also found that more than 15% of the prescriptions were for more than the recommended dose of 120 lollipops per month.

Government investigators have been looking into Cephalon’s off-label promotion of Actiq in Connecticut and the Philadelphia area for two years, and the company is also being investigated by the FDA’s Office of Criminal Investigations.

In November 2006, Connecticut Attorney General, Richard Blumenthal, concluded an investigation, which according to the Wall Street Journal, uncovered evidence that suggests Cephalon set high sales quotas for its sales representatives that could not be reached without promoting Actiq off-label.

Of course, just like every other company busted for off-label marketing in recent years, Cephalon claims it does not market Actiq off-label. But internal company documents reveal that sales reps were regularly sent to primary care doctors and specialists, who treat no cancer patients, armed with free coupons for doctors to pass out to patients.

For instance, Dr Stephen Leighton, a general practitioner who says he only has 3 cancer patients at any given time, told the Journal that a Cephalon saleswoman comes by once a month and gives him about 60 to 70 coupons for patients to trade in for six Actiq sticks.

He says the coupons spurred him to try the drug on patients with migraines and back pain and that he prescribes Actiq 15 to 20 times a month to patients who do not have cancer.

As a further indication of off-label promotion by Cephalon’s Actiq sales force, the Journal cites a survey by the research firm ImpactRx, that found visits to non-cancer doctors increased 6-fold from 2002 to 2005.

According to company documents, Cephalon instructed sales reps to ask non-cancer doctors, “Do you have the potential to treat cancer pain?”

And even if the answer was no, they were instructed to give the doctors free coupons to pass out. One document quoted by the Journal, says the coupon program “is a remarkably effective promotional tool” that increased sales by 75 prescriptions a week at little cost.

Cephalon uses many tactics to influence doctor’s prescribing habits. Mr Blumenthal’s investigation found instances where Cephalon flew doctors to company funded seminars where paid speakers promoted the off-label use of Actiq. For instance, the Journal described a September 2003, New York seminar, where one of the topics was “Opioid use in headache.”

At another October 2003, meeting, the Journal reports, a topic was “Use of Actiq in opioid-naive patients,” even though the product label says it should be prescribed only to patients already taking opiate narcotics and can tolerate the drug.

In fact, the Actiq package insert states: “Do Not Take OTFC if you: are not already taking other opioid pain medicines for your constant (around-the-clock) cancer pain.”

It also states: “Never use OTFC for short-term pain from injuries or surgery or pain that will go away in a few days, such as pain from doctor or dentist visits, or any short-lasting pain.”

In 2002, Cephalon began zeroing in on neurologists and a document titled “Actiq in Migraine,” instructed sales reps to pitch Actiq as “an ER on a stick.”

The off-label use of Actiq by opioid naive patients has resulted in devastating consequences for some people. On January 22, 2006, the Free Press reported that the wife of a minister, former schoolteacher, and the mother of three sons, was arrested and charged with involuntary manslaughter because she gave Actiq, her cancer pain medication, to a friend who had a migraine and the friend died of a drug overdose.

On November 3, 2006, the Journal reported a case where a pregnant woman was prescribed Actiq for migraines by a neurologist. By the time of delivery, the woman, who the Journal noted had previously struggled with addictions to milder narcotics, was consuming five lollipops a day.

Upon birth, the infant was cranky and could not sleep and doctors told the woman that her son had become addicted to Actiq and was going through withdrawal.

When approving Actiq in 1998, the FDA set up a risk-management program with guidelines that said sales reps should “promote only to the target audiences,” defined as oncologists, pain specialists, their nurses and office staff.

An provision of the program requires Cephalon to report whether “groups of physicians (such as a particular specialty)” who represent “potential off-label usage greater than 15 percent” are prescribing Actiq. If such a group exists, the FDA says, Cephalon should warn the doctors against the off-label use of the drug.

According to the market research firm, Verispan, for the first half of 2006, two groups of doctors exceeded the 15% quota, anesthesiologists at 29.5%, and physical medicine and rehabilitation specialists at 16%. Oncologists or cancer doctors accounted for only 1% of the prescriptions at retail pharmacies in the US, the Journal reports quoting Verispan.

In 2003, a company auditor, David Brennan, determined that Cephalon was not complying with the 15% rule, but says he was fired when he reported his findings to his superiors, according to a June 2004, wrongful termination lawsuit filed in Camden, NJ.

For Cephalon to act naive about the level of off-label prescribing of Actiq while the cash register is ringing up the sales is laughable. According to the November 3, 2006, report in the Journal, sales of Actiq went from $15 million in 2000, to more than $400 million today.

Filed under: 2007, addict, Cephalon, fentanyl, patch, prices

Add Triaminic Vapor Patch to List of Dangerous Patches

Evelyn Pringle June 25, 2006

On June 19, 2006, Novartis Consumer Health issued a recall for the cough-suppressing Triaminic Vapor Patches in the US, about three weeks after Health Canada issued a warning after a Canadian child who chewed on a patch suffered a seizure.

There have been eight adverse events with the patch, all involving ingestion, Navartis spokesperson, Julie Masow, told the Philadelphia Inquirer on June 21, 2006.

The patches were sold over the counter at pharmacies and retail stores and Novartis said it has sold more than 50 million vapor patches since they came on the market in 2000.

The Swiss drug maker warned consumers to stop using the patch immediately and said they should either be discarded or returned to the place of purchase for a full refund.

The patches contain camphor, eucalyptus oil and menthol and are meant to be applied to the chest or throat of children as young as 2 years-old. Novartis said the placement of the patch can allow children to remove them and place them in their mouths. It is difficult to believe that the idea never occurred to the drug maker that a 2 year-old would attempt to pick the cherry-scented patch off and eat it.

Ingesting camphor or eucalyptus oils can cause a burning sensation in the mouth, nausea, headache, vomiting and seizure. Other complaints received by the company associated with the patch include reports of blistering, bruising, scarring, hyperactivity and depigmentation.

Whether the patch will remain off the market is not known. According to a June 21, 2006, Press Release by the LecTec Corporation, in January 2004, LecTec entered into a Supply and License Agreement with Novartis under which LecTec licensed certain of its patents to Novartis for the production of vapor patches.

In response to a question from LecTec, a representative of Novartis indicated that no decision had been made whether to reintroduce the product in certain markets, although the patches would definitely not be reintroduced for use by young children, the press release said.

The royalties received by LecTec under this agreement represented substantially all of the firm’s revenues in fiscal 2005, as well as the first quarter of fiscal 2006. The specific patch that caused the seizure was not manufactured by LecTec, according to Novaris quoted in the press release.

Over roughly the past 25 years, patch medications have become a booming business for Big Pharma. More than 30 different types of patches have been used by 12 million people worldwide for conditions ranging from birth control to heart disease to chronic pain to bladder control. The first antidepressant patch was approved by the FDA this month.

In 2004, patch sales totaled about $3.4 billion, according to the medical market research firm Greystone Associates.

All medication releasing patches work the same, according to Bozena Michniak, who studies transdermal patch delivery systems at the Center for Biomaterials at Rutgers University. The medication seeps through the skin into the bloodstream, and the increased blood flow causes the body to absorb the drug.

As more versions of the medication patches are introduced on the market, medical experts say that many of them are unsafe. Multiple studies have shown that heat has a dangerous effect on the patches, whether from a high fever, exercise or a hot tub. Heat increases the absorption rate of the medication and sometimes with fatal results.

As far back as 1986, a study found that just 20 minutes of bicycling with a nitroglycerin patch increased concentration of the drug two to threefold. Similar results were found after 30 minutes in a sauna, according to an article in Philly.com on March 5, 2006.

But yet there was no public warnings added to the Fentanyl pain patch until 36-year-old Kurt Hophan died in Pennsylvania on March 4, 1994.

Fentanyl, a schedule II narcotic analgesic, is roughly 50-80 times more potent than morphine and is used to manage both pain during surgery and for persons with chronic moderate to severe pain who already are physically tolerant to opiates, according to the US Center for Substance Abuse Treatment.

Mr Hophan applied the patch for pain relief associated with a back injury and went to his bedroom in his mother’s home and fell asleep with a heating pad and an electric blanket.

When the heat from the pad and the blanket came into contact with the patch, the amount of Fentanyl released into Mr Hophan’s bloodstream was estimated to be about 100 times greater than the amount prescribed, according to a judge’s opinion in a lawsuit filed by Mr Hophan’s mother, Elaine Hophan, against the drug’s maker.

In 2001, a jury awarded Ms Hophan $5 million in damages but after an appeal, the case was settled under a confidential settlement agreement.

Fentanyl patches are sold under a variety of brand and generic names. Johnson and Johnson’s Duragesic was the first on the market arriving in the early 1990s. It’s the most popular patch with four million prescriptions filled at US pharmacies last year.

Worldwide sales of Duragesic in 2005 were $1.59 billion, according to J& J’s earnings reports. The cost of a 30-day supply ranges from $348 at Target to $408 at Wal-Mart, according to FDA documents.

On April 5, 2004, J&J issued a recall for defective patches that applied to specific lots of patches, which had a faulty seal that permitted Fentanyl to seep from the patch, resulting in patients being given an overdose of Fentanyl.

On July 15, 2005, the FDA issued a public health advisory about the proper way to use the Fentanyl patches to avoid overdose, in response to reports of deaths in patients using the narcotic patch for pain management.

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

“They’re not getting the relief that they want. Therefore they’re slapping more patches on trying to get that instantaneous relief,” says toxicologist Daniel Anderson. “What they don’t realize is that most of these patches are to be applied over a three-day period.”

Utah statistics according to the latest mortality data from the state Health Department show Fentanyl was related to 29 accidental deaths in 2005, up from nine in 2004, and 13 in 2002, according to the March 14, 2006 Salt Lake Tribune.

Lawsuit are being filed as a result of the high accidental overdose rate. Robert Debry & Associates, in Salt Lake City has taken about a dozen cases involving deaths allegedly from Fentanyl. One lawsuit is filed on behalf of the family of Marilyn Titus who died December 14, 2003, at age 72 and alleges Ms Titus, was suffering from severe back pain, and was sold defective and leaking patches.

In December 2005, surviving family members of two more Utah women filed wrongful death lawsuits, alleging the patches leaked and caused the deaths of both women.

Autopsy reports said the women died from drug poisoning after using pain patches. Both lawsuits claim the women were prescribed the patch and were found dead in their homes within one or two days of using the patch.

Both lawsuits claim negligence for failing to research and design the patch and allege the companies misrepresented the safety of the patch for human use.

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

In March 2006, the FDA announced it would conduct a review of all medication patches beginning with Fentanyl and the Ortho Evra birth control patch, also made by J& J.

The following month, an April 10, 2006, Long Island Newsday report said that “hundreds” of women had filed lawsuits against Ortho-McNeil, the J&J division that manufactures the Ortho Evra patch.

And there will no doubt be many more filed against the company because in 2005, doctors wrote more than 9.4 million prescriptions for the birth control patch, according to IMS Health, an pharmaceutical industry monitoring firm.

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra Patch.

In the new warning, Ortho McNeil admits for the first time that women who use the patch are exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. It is widely understood that any increase in the exposure to estrogen also increases the risk of blood clots.

A lawsuit filed in Federal Court in New Jersey on September 2, 2005, by a Georgia woman, who suffered a pulmonary embolism, alleges the company promoted the patch despite knowledge of its health risks, for financial gain while failing to warn of the risks of blood clots and other injuries.

Around the time the company introduced the patch to the market, the lawsuit claims, Ortho’s patent for its contraceptive pill, Ortho Tri-Cyclen, was about to expire, creating pressure to make up for lost revenue.

In November 2005, CBS News aired a story about documents that surfaced in a lawsuit involving a young mother who was paralyzed by a stroke and remained a total invalid, that showed the company had received nearly 500 reports of adverse events between April 2002 and December 2004. During the same time frame, only 61 adverse event reports were filed in connection with all type of birth control pills.

The news segment also revealed that during the same time frame, 4 times as many strokes occurred in women using the patch when compared to women using the pill, even though 3 times more women were taking the pill. Overall, in medically confirmed cases, the risk of blood clots was found to be 14 times more likely to occur in women using with the patch.

Since the FDA only receives reports for between 1% and 10% of the serious adverse drug events, the actual death and injury rate for women on the patch is estimated to be much higher that the number of reports registered so far with the FDA

The Ortho Evra Patch was approved by the FDA in November 2001. Over 4 million women have reportedly used the patch since its approval and it remain on the market today.

Filed under: 2006, allergy drugs, birth control patch, fentanyl, Johnson and Johnson, Novartis, Ortho, patch, settlement, Triaminic Vapor Patch

Fentanyl Deaths – Severe Math Problems at FDA

Evelyn Pringle March 27, 2006

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.

Filed under: 2006, addict, fentanyl, Johnson and Johnson, Mylan, patch, prices, Sandoz

Avandia FDA Mole Hawks Lethal Medication Patches

Evelyn Pringle August 12, 2007

Douglas Arbesfeld, the pharmaceutical industry’s mole inside the FDA, recently revealed his existence quite by accident when he attempted to destroy the reputation of cardiologist Dr. Steve Nissen by sending a malicious email to reporters after Dr. Nissen published a study that found the diabetes drug Avandia possibly increases the risk of heart attack and death.

Apparently, a reporter made Dr Nissen aware of the email sent by Mr Arbesfeld from his official FDA email account which subsequently led to his unexpected outing as the industry’s mole.

The email also sought to discredit the Cleveland Clinic by inferring that the Clinic and Dr Nissen published a bogus study on Avandia to punish its maker GlaxoSmithKline because the company does not do research at the clinic.

As a means of emphasizing this point, Mr Arbesfeld included derogatory comments posted on the internet by a supposedly “anonymous” blogger listed as Brian A, who accused Dr Nissen of running the Clinic like the characters in a Mafia TV series stating: “The Cleveland Clinic was one of the most respected names in medicine, now they are positioning themselves as candidates to take over for a new series on HBO to replace the Soprano’s”.

The email also warned other drug companies that they would face a “firing squad” from Nissen and company if they did not hire the Clinic to do research.

For the record, Nissen and the Cleveland Clinic are respected worldwide for the research they conduct and Nissen’s name appears on Time Magazine’s list of the top 100 most influential people. When a drug or medical device is dangerous, he says so.

Most famously, Nissen warned the world about the serious health risks associated with Merck’s Vioxx, and lived to talk about it while the reputations of other esteemed scientists were destroyed by Merck.

Mr Arbesfeld’s attempt to smear Dr Nissen while on the clock at the FDA has led to a Congressional investigation by lawmakers on both sides of the isle. The investigation is focused on Mr Arbesfeld’s alleged ties to the pharmaceutical industry and more importantly, how it came to be that he was hired as a media consultant for the FDA to begin with straight from a company whose products are regulated by the FDA.

It also seems more than a bit odd that the FDA would chose now to hire a media consultant employed by J&J being the company is currently under investigation for the illegal marketing of many of its products while hiding dangerous side effects by several Congressional Committees, the US Department of Justice, the FBI, the US Department of Health and Social Services, and attorneys general in states all over the country.

But then on the other hand, what better time than now for the industry as a whole to have a mole inside the FDA to keep it apprised of the progress or lack of in the numerous investigations underway.

The lawmakers have linked Mr Arbesfeld to drug giant J&J but in fact, a few days of investigating revealed that his employment in the industry has involved just about every drug company at one time or another, including Avandia maker GlaxoSmithKline in 2002.

A few years back, Mr Arbesfeld was hawking medication patches that have since been found to be lethal on behalf of J&I’s Ortho-McNeil division which is currently facing a large number of lawsuits alleging the company and the FDA hid studies that showed the Ortho-Evra birth control patch caused blood clots and promoted the off-label use of its narcotic Duragesic pain patch.

On October 10, 2004, Susan Edelman of the New York Post reported that a “popular and profitable contraceptive patch promoted by sexy TV ads caused 11 times as many fatal or life-threatening blood clots as a leading birth-control pill, a new lawsuit charges.”

She said the patch had been found responsible for 17 deaths in women age 17 to 30 since its release in 2002.

Ms Edelman used the Freedom of Information Act to obtain records from the FDA which also revealed 21 other life-threatening conditions such as blood clots, strokes, and heart attacks.

In the Post article, Mr Arbesfeld maintained that the “adverse event reports for Ortho Evra are consistent with the health risks of other hormonal contraceptives.”

On October 25, 2004, he told the Associated Press that four million women in the US had used the patch since it came on the market in 2002 and about 800,000 women were currently using it.

But when the story got legs due to reports about the large number of adverse events recorded in the FDA database, Mr Arbesfeld said in the New York Post, “We believe that there may have been duplicates in the FDA reports.”

“The way adverse-event reporting works is that reports go in to the FDA as raw data, which has to be analyzed,” he stated. “Several people could report on the same incident, such as a doctor, a relative, a nurse.”

J&J has consistently denied knowledge of any problems with the patch. However, according to a story by CBS News, documents have surfaced in a lawsuit that show the company’s own records reveal that it received some 500 reports of serious problems associated with the patch between April 2002 and December 2004.

In fact, documents that surfaced in litigation showed the company had been analyzing the FDA’s death and injury reports on women using the patch, and had charts that showed a higher rate of blood clots and deaths in women on the patch when compared to women who take birth-control pills.

In July 2005, the Associated Press conducted an investigation that tracked adverse reactions in women using the patch since it was approved for sale in the US. In response to a FOIA request, the FDA provided the AP with a database that contained roughly 16,000 adverse reaction reports.

Since the FDA estimates that it only receives reports on between 1% and 10% of the adverse events that actually occur, the death and injury rate for products is known to be significantly higher that indicated in the database.

Within the group of 16,000 adverse reaction reports, the AP determined that there were 23 deaths. Doctors who reviewed the 23 deaths said about 17 appeared to be clot-related.

According to the AP, about a dozen women, mostly in their late teens and early 20s, died from clots in 2004, and dozens more experienced strokes and other clot-related problems.

In addition, according to the Associated Press on November 11, 2005, an internal company memo shows that in 2003, the company refused to fund a study comparing the Ortho patch to the company’s Ortho-Cyclen pill because there was “too high a chance that study may not produce a positive result for Evra” and a “risk that Ortho Evra may be the same or worse than Ortho-Cyclen.”

According to J&J’s Annual Report, as of December 31, 2006, there were approximately 1,500 claimants who have filed lawsuits or made claims regarding injuries to due to the Ortho Evra patch.

Because J&J knows that blood clots rarely develop in young women of childbearing age, legal experts say not to expect to see public jury trials in cases involving the birth control patch. In fact, many lawsuits have quietly ended in confidential out-of-court settlements but with little fanfare in the mainstream press.

J&J has also been hit with over a hundred lawsuits involving the Duragesic pain patch, a device that is supposed to deliver safe doses of fentanyl, a drug so powerful that high doses can shut down the respiratory center in the brain.

Fentanyl is a Schedule II narcotic, said to be 80 times stronger than morphine, listed in a class of drugs due to the high potential for abuse and overdose.

Here once again, fentanyl was approved for use by cancer patients with unremitting pain who were monitored closely, but before long it was being been prescribed off-label for many uses without any patient monitoring.

In 2004, pharmacists filled more than 4 million prescriptions for J&J’s fenanyl patch according to the November 25, 2005 LA Times. In the six years before the article, the Times reported, the Los Angeles County coroner’s office alone had investigated over 230 deaths involving fentanyl.

In Florida, the Times said, state authorities reported 115 deaths from fentanyl in 2004.

The history of the patch shows that the FDA knew about the risks but ignored the growing use of the narcotic. The US Substance Abuse and Mental Health Services Administration found that emergency-room cases involving fentanyl rose from 28 in 1994 to 1,506 in 2004, according to the federal Substance Abuse and Mental Health Services Administration.

FDA official Dr Robert Meyer, head of the office that oversees painkillers, told the Times that safety officers had just noticed a trend of adverse reactions involving the drug that year.

However, back in 2001, the Times reports, a drug safety group of the Institute for Safe Medication Practices, warned the FDA that patients on the patch were dying of overdoses and doctors were prescribing it for patients who did not tolerate opioid drugs well. And yet it took another four years for the FDA to issue a nationwide alert, on July 15, 2005.

Responding to the reports, Mr Arbesfeld told the Times that the drug met an important need for cancer patients and others with chronic pain and the company was working with the FDA, doctors and patients to make sure it was used safely.

“We take the health and safety of the patients who use this product very seriously,” Mr Arbesfeld said. “We work very closely with the FDA to look into all reports of serious adverse consequences, and we believe that the product is safe and effective when used as directed.”

Yet according to the Times, J&J has promoted the narcotic patch to doctors as superior medication for back pain and other problems. “Game, uninterrupted,” reads the caption on a Duragesic brochure that showed a middle-aged man shooting pool, the Times said.

Another photo showed a pair of hands kneading bread dough. “1,360 loaves … and counting,” with the caption. “Work, uninterrupted.”

Mr Arbesfeld told the Times that the company had stopped using that literature.

It would be impossible for him to not know the narcotic was being massively prescribed off-label for unapproved uses. According to the Times, from 2000 to 2004, sales of the patch more than tripled and the number of prescriptions more than doubled

In 2004, with $1.2 billion in sales the Duragesic patch even surpassed Vioxx, according to Drugtopics.com. However, J&J’s Annual Report says that as of December 31, 2006, there were approximately 100 lawsuits filed against the company related to the patch.

Filed under: 2007, Avandia, birth control patch, FDA, fentanyl, Johnson and Johnson, Ortho, patch

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