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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 All total, Wyeth has set aside more than $21 billion to cover legal costs and settlements since the drugs were withdrawn, according to Reuters on May 24, 2006.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

Reviewing ADHD Drugs – FDA Goes Through the Motions

Evelyn Pringle March 12, 2006

Some of the top-selling drugs of all time are those prescribed to treat attention deficit disorders. Drug companies have physicians in every field of medicine pushing these medications and dole out millions of dollars worth of free samples each year to make sure they are passed out like candy.

A new ADHD drug is set to come on the market that supposedly can keep people awake for days at a time with no problems. Just what we needed, especially for hyper little kids.

I wonder if this means they will remain calm as they sit wide-awake watching TV and playing video games for days while the rest of the family sleeps.

The drug Sparlon is manufactured by Cephalon and is a clone of Provigil, another drug already on the market. Sparlon contains modafinil, the same exact active ingredient contained in Provigil which is approved for the treatment of patients with narcolepsy, sleep apnea and shift work sleep disorder, according to the FDA.

The drug’s approval will be considered by the FDA’s Psychopharmacologic Drugs Advisory Committee at a public hearing scheduled for March 23, 2006.

The day before the Sparlon hearing, the FDA’s Pediatric Advisory Committee is scheduled to meet to discuss neuropsychiatric adverse events and cardiovascular adverse events reported on patients who were treated with ADHD stimulant drugs already on the market.

The drugs under review include Ritalin from Novartis, Adderall and Adderall XR from Shire Pharmaceuticals, Concerta from Johnson & Johnson, and generic versions of Ritalin.

On February 9 and 10, 2006, the FDA’s Drug Safety & Risk Management Advisory Committee held hearings on the same topic, and after reviewing the information provided at the hearing, the panel recommended that black box labels be added to the labels of all stimulants.

However, the FDA is not bound by the recommendations of its advisory panels, and critics of the drugs say the close 8-7 vote by the panel, means there will be spirited debate within the agency over whether black box labels will be added.

Several members of the panel said they voted for the warning in part, because they were alarmed over the sharp rise in prescriptions written for both children and adults. During the hearing, the committee was informed that between 1999 and 2003, roughly 78 million prescriptions were written for children under the age of 18, and 14 million more were written for adults.

In a stark contrast, only 190 million prescriptions were issued for children and adults during the 12 year period between 1992 and 2004.

According to the FDA numbers on adverse events, between 1999 and 2003, there were 25 deaths reported for persons using ADHD drugs, and 19 were children. The agency also acknowledged that more than 50 cases of cardiovascular-related events were reported in the same time period including stoke, heart attack, hypertension, palpitations and arrhythmia.

Critics say the numbers revealed at the hearings represent a gross understatement because only 1% to 10% of adverse reactions are ever reported to the FDA, and it would therefore be better to add a black box now and remove it later if studies prove there is no link between the stimulants and sudden death and heart disease.

Supporters of the drugs, say the warning is based on inconclusive evidence and would deter physicians from prescribing the medications and scare patients away from taking the drugs.

Because Cephalon claims Sparlon should not be classified as a stimulant, analysts predict the company could get a boost if the FDA agrees and requires the other drugs to carry a black box warning. One of the issues discussed at the March 23, hearing will likely be how to distinguish Sparlon’s labeling from other ADHD drugs.

If approved, Sparlon will be co-marketed under an agreement with Johnson & Johnson, which will focus on the pediatric market through its McNeil Consumer & Specialty Pharmaceuticals unit.

McNeil’s sales team will promote Sparlon to psychiatrists, pediatric neurologists and pediatricians, while Cephalon’s 400-person sales force will focus on non-pediatric specialists and primary care physicians.

When Cephalon requested FDA approval for Sparlon, it submitted the results from three clinical trials on children aged 6 to 17 that the company said indicated better results in children taking Sparlon compared to children who received a placebo. Each trial lasted 9 weeks and the most common side effects noted were loss of appetite, mild insomnia and headaches.

But Cephalon has not been sitting idle while waiting for approval of its Provigil clone. Last year it had to figure out a way to deal with the fact that Provigil’s patent was set to expire in 2006. Through some last minute legal footwork, the company was able to negotiate agreements with 4 generic firms that will allow Cephalon to continue to sell the drug unchallenged until at least 2011

Provigil’s approval for a silly diagnosis like “shift-work sleep disorder” is a good example of disease-mongering, described in the book, “Selling Sickness: How The World’s Biggest Pharmaceutical Companies Are Turning Us All Into Patients,” by Ray Moynihan and Alan Cassels, which explains how drug companies foster the creation of bogus disorders to create markets for their pills, through “medicalization” of normal states of health.

In the same vein, many experts say the sale of ADHD drugs in general is nothing but a racket. Dr Fred Baughman, a board certified child neurologist and Fellow of the American Academy of Neurology, calls ADHD the “greatest health care fraud of modern times.”

Clinical social worker Peter Dwyer, has seven years’ experience working with troubled children, and has served as director of a large therapeutic foster care program. He also attributes the ever-rising sales numbers for ADHD drugs to a grand marketing scheme.

“It is easy to see why stimulants dominate the treatment of ADHD,” he says, “drug companies spend over $20 billion a year on promotion – more than they spend on research.”

“The bottom line,” Mr Dwyer explains, “professionals and the public are bombarded with a stream of “research” and “information” financed and spun by the people who make and sell these drugs.”

“The conflict of interest is palpable,” he adds.

And anyone who believes Provigil is free of the side effects associated with other ADHD medications needs to speak to Susan Florence who experienced a terrifying adverse reaction to the drug.

“I took one pill and I thought I was coming out of my skin,” she recalls, “I felt as if someone had climbed inside me.”

“It was one of the worst experiences of my life,” she says.

Nonetheless, Cephalon has done an excellent job of promoting Provigil. The US Air Force has even adopted the drug as one of its official “go pills” for pilots whose missions stretch out more than 12 hours, according to Business Week on November 1, 2004.

Ever since Provigil hit the market, Cephalon stayed busy figuring out ways to promote its off-label use for a multitude of ailments including ADHD, and with obvious success. SG Cowen & Co analyst, Eric Schmidt, told Business Week he figures more than 50% of Provigil sales are for unapproved uses.

And 50% in off-label sales adds up to enormous profits. In 2004, US doctors wrote 1.9 million prescriptions for Provigil, generating $414 million in sales. In 2005, Cephalon saw Provigil sales reach $512 million, according to Forbes.com on March 13, 2006.

While waiting for Sparlon to be approved, the company has been using every trick in the book to boost sales of Provigil for the treatment of ADHD.

For instance, Dr Fletcher Taylor, from Tacoma, Washington, was paid to meet with small groups of doctors to talk about Provigil.

He conducted a study on the use of Provigil for ADHD, which he claims showed positive results. However, according to Business Week, Dr Taylor says “he does not bring up the use of Provigil for ADHD in his talks, but he answers questions – as he is permitted to do – if one of the doctors in the group brings it up.”

“Usually people do ask,” he told Business Week.

I’m quite sure they do ask, probably much like the people on TV who used to just happen to step out of the audience to be cured by faith-healer 50 years ago.

Cephalon also employs the well-known off-label marking technique of funding continuing medical education seminars (CMEs), under the guise of providing doctors with information related to how certain ailments can be treated by drugs that the company just happens to sell.

For example, Cephalon paid for a CME that focused on the treatment of daytime sleepiness experienced by Parkinson patients and explained how Provigil might be a useful therapy.

The sponsor of the program, a firm called Projects in Knowledge, told Business Week that Cephalon paid for the program but had no input on the material discussed.

And of course I believe that.

Another tried and true method of promoting off-label use involves publishing the results of favorable studies funded by drug companies in medical journals. “Journals have devolved into information laundering operations for the pharmaceutical industry,” according to Richard Horton, editor of the Lancet, in March 2004

In a prime example of this practice, the August 4, 2005 New England Journal of Medicine, published a report on a study funded by Cephalon in which the lead author, Dr Charles Czeisler, from Harvard Medical School and Brigham and Women’s Hospital, had a professorship endowed by $2 million from Cephalon.

In the report, Dr Czeisler claimed night-shift workers remained more alert with Provigil and wrote a glowing summary of the study. “I would characterize [Provigil] as the treatment of choice with patients with shift-work disorder,” he said.

However, Dr Robert Basner, director of Columbia University’s Cardiopulmonary Sleep and Ventilatory Disorders Center, published an editorial on the study in the same issue of the NEJM and said the researchers’ data showed only slight improvements in workers wakefulness and productivity with Provigil, and pointed out that the drug seemed to exacerbate insomnia for some patients.

“That’s not a very robust endorsement of the drug coming from the investigators themselves,” Dr Basner wrote. “This drug is little better than nothing in terms of making them less sleepy during shift work at night,” he added.

Experts pretty much agree that Sparlon will be approved for treating children with ADHD so before too long the “little better than nothing” clone will not doubt be ringing up the cash registers all over the US.

Filed under: 'ADHD', 2006, Adderall, Cephalon, Concerta, FDA, FDA hearing, Johnson and Johnson, Novartis, Provigil, Ritalin, Shire, Sparlon

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