The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Neurontin Deal a Slap On The Hand To Pfizer

Evelyn Pringle May 25, 2006

The off-label prescribing of drugs has become a serious problem over the past decade. Doctors are adjusting dosage levels and prescribing drugs for medical indications and treatment durations for which the drugs were never approved or intended.

When the FDA approves a drug, it also approves the labeling for the drug, which explains the manner in which the medication is to be used. While physicians may prescribe approved drugs as they see fit, its against the law for drug companies to promote drugs for uses outside of the approved labeling, but they do it all the time.

Neurontin remains the most notorious example of an illegal, but highly successful, off-label marketing campaign. The drug was approved for the limited use of treating epileptic seizures but nonetheless, became an overnight blockbuster with sales that soared from $97.5 million in 1995, to more than $2.5 billion in 2003.

While Neurontin might be the most notorious, it is certainly not the only problem. A study published in the May 8, 2006, Archives of Internal Medicine, determined that more than one out of every 7 prescriptions written for 160 commonly used drugs were for off-label uses that lacked scientific support.

The study was based on information from the IMS Health National Disease and Therapeutic Index that defines drug prescribing patterns and provides market data on drug companies.

In 2001, an estimated 150 million prescriptions, or 21% of prescriptions written, were for off-label use, according to the Archives study.

To reach its results, the study first determined whether a prescription was off-label and then assessed the level of available scientific evidence supporting the use, through the Drugdex system, a comprehensive summary of evidence supporting off-label uses of prescription drugs.

The study found that 73%, or 109 million off-label prescriptions, had little or no supporting evidence. The study does not explain why doctors prescribe so many drugs off-label but one explanation may be that “both physicians and patients have misunderstood the role of the FDA,” the study’s lead author Randall Stafford says.

“I think there’s sort of a presumption that if a drug has made it onto the market,” he notes, “the FDA has vouched for its safety and efficacy for all of its potential uses.”

One way drug companies have been able to increase the off-label sale of drugs is by influencing doctors in public institutions, and state policy makers, who are involved in the development of drug formularies that list which drugs will be used in state institutions and by persons covered by government health care programs like Medicaid and Medicare.

Allen Jones, a former Pennsylvania fraud investigator, explains that each state has a menu of approved drugs that doctors must prescribe to persons in state institutions. “Before a drug can be prescribed by a state physician for somebody in the state system,” he says, “it has to be on the list.”

According to Mr Jones, the drug companies “have bought the decision-making process from our government officials all the way down to the guy who decides what drugs get on the formulary.”

Doctors who sit on the expert panels and decide which drugs will be on the lists, he says, are paid by drug companies to give positive opinions in order to circumvent the FDA approval process.

“The FDA has no control over what an individual doctor does or says,” Mr Jones explains, “the pharmaceutical industry has funded a mechanism whereby they can gather favorable opinions.”

“They then amplify and magnify those opinions,” he says, “and put them in the form of a treatment protocol that can be implemented in any state with the approval of a few key decision-makers.”

Stacking the deck with industry friendly “experts” is apparently common. An investigation by the scientific journal Nature found “extensive” financial connections between drug companies and the advisory panels, with as many as 70% of the panels affected. In one instance, Nature found every member of a panel had received payments from the company making the drug that was recommended.

In the summer of 2002, Mr Jones discovered an off-the-books account where drug companies were depositing “educational grants” from which state officials and policy makers involved in developing Pennsylvania’s drug list were receiving payments.

“We had state officials accepting $2,000 honorariums,” he noted, “and physicians who were taking trips, perks and gratuities.”

One of the officials Mr Jones named in his investigation was the state pharmacist, Steven Fiorello. In April 2005, the State Ethics Commission fined Fiorello over $27,000 after finding that he repeatedly took money from drug makers, Pfizer and Janssen, while serving on the panel that decided which drugs could be given at 9 state mental hospitals. The commission’s report cited repeated failures to disclose his income from the drug companies.

On June 10, 2005, Senators Chuck Grassley and Max Baucus announced the beginning of an investigation by the Senate Finance Committee, which has oversight responsibility for government health care programs, into the practice where drug companies give money to state governments.

“The drug companies call the awards educational grants,” their press release said, “but the senators are concerned that the dollars are more focused on product promotion than education.”

The Senators said their inquiry was based on reports that companies have awarded grants as inducements to prescribe medications the companies produce.

In some cases, they said, “such grants to state agencies may have prompted those agencies to develop programs leading to over-medication of patients at the expense of patient health or to unnecessary expense for taxpayers.”

“We need to know how this behind-the-scenes funneling of money is influencing decision makers,” Senator Grassley said. “The decisions result in the government spending billions of dollars on drugs.”

In recent years, investigations into the prescribing patterns for people on Medicaid and Medicare has led to the discovery of a drastic increase in off-label prescribing to children and the elderly, of drugs never approved for use with children and the elderly.

One class of drugs found to be prescribed off-label most often without scientific support are psychiatric medications. In 96% of the psychiatric drugs prescribed off-label, the Archive study found support was lacking.

According to the report, Death by Medicine (2003), by Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio, MD; and Dorothy Smith, PhD, a study on prescription drug use by the elderly conducted by Medco Health Solutions found that 6.3 million senior citizens received more than 160 million prescriptions and a total of 7.9 million medical alerts were triggered by off-label prescribing, with 2.2 million alerts indicating excessive dosages unsuitable for seniors, and about 2.4 million indicating clinically inappropriate drugs for the elderly.

Drug companies have promoted the off-label use of psychiatric drugs with children even after their own studies have shown the drugs to be dangerous. In 2004, New York attorney general, Eliot Spitzer, filed a lawsuit against GlaxoSmithKline for withholding studies that raised doubts about the effectiveness and safety of Paxil in treating children, and revealed that more than 2 million prescriptions for Paxil were written off-label to treat children in 2002.

In late 2004 the FDA ordered black box warnings on all SSRI antidepressants after it was discovered that drug makers had suppressed studies that showed the drugs were linked to an increased risk of suicide in children.

Documents that have surfaced during litigation reveal that drug makers knew about this risk before the SSRI antidepressants arrived on the market but continued to find ways to get doctors to prescribe the drugs to kids. A report by Express Scripts, Inc, a pharmacy benefit manager, titled “Trends in the Use of Antidepressants in a National Sample of Commercially Insured Pediatric Patients,” shows that between 1998 and 2002, the overall use of antidepressants among children increased from 160 children per 10,000 in 1998, to 240 per 10,000 in 2003.

Tom Woodward’s daughter Julie hung herself after being prescribed the antidepressant, Zoloft, off-label. He is angry at the Bush administration and the FDA for failing to protect the public against drug companies who hide studies that show drugs are dangerous when given to children.

“It is clear that the FDA is a political entity and its leadership has protected the economic interests of the drug industry,” he says.

According to Mr Woodward, officials in leadership positions have strong ties to the industry. “FDA’s chief counsel Daniel Troy has spent his career defending the drug industry,” he noted, “if a study does not favor a drug, the public never hears about it.”

“Under the Bush administration,” Mr Woodward said, “the FDA has placed the interests of the drug industry over protecting the American public.”

He points out that 86% of the millions of dollars in campaign contributions by drug companies went to Bush and Republican candidates and he wants to know, “what did Pfizer, Eli Lilly, and GlaxoSmithKline Beecham buy?”

A recent study reveals that even when the FDA does add a black box warning to a label, the highest form of drug safety alert available, doctors will continue to prescribe the drug.

The February 14, 2006 Archives of Internal Medicine featured a report on a study where researchers reviewed the records of 324,548 patients seen at several Boston area medical facilities between January 1, 2002 and December 31, 2002 and found that 33,778 patients were prescribed a drug that had a black box label, and 2,354 of those prescriptions were written contrary to the guidance set forth in black box warning.

The study found that in about 1,000 cases, patients were taking one drug at the same time as another when the warning said that taking the 2 drugs together should be avoided, and in about 90% of the cases, a drug was prescribed to treat a condition for which the drug was not approved.

According to Death by Medicine, each year approximately 2.2 million US hospital patients experience adverse drug reactions to prescribed medications and experts say many are caused by prescribing drugs for uses not approved.

The dangerous off-label prescribing practices have come under scrutiny in recent years because so many of the drugs are covered by government health care programs, and lawmakers charged with oversight of programs like Medicaid and Medicare became suspicious about the skyrocketing prescription drug costs.

In some of the largest cases involving Medicaid and Medicare fraud, former industry employees came forward with information about marketing schemes and filed lawsuits under the False Claims Act.

The Washington DC based Taxpayors Against Fraud, is a non-profit organization dedicated to combating fraud against the federal government through the promotion and use of the qui tam provisions of the False Claims Act.

Qui tam is a mechanism that allows persons with evidence of fraud to bring suit on behalf of the government. TAF educates the public about the FCA and its qui tam provisions and provides assistance to whistleblowers and their attorneys and sometimes files amicus curiae briefs on important issues.

TAF also has a staff of lawyers and other professionals who are available to assist anyone interested in the FCA and publishes the False Claims Act and Qui Tam Quarterly Review.

Whistleblower lawsuits are proving to be highly effective in exposing fraud. Of the 10 top FCA Medicaid fraud recoveries to date, the top 5 are whistleblower cases against drug companies.

According to TAF, during FY 2004, between October 1, 2003 and September 30, 2004, the US Department of Justice settled 3 whistleblower cases against drug companies for a total of over $800 million, raising the total recoveries in such cases by nearly 50% to $2.46 billion.

Two of the settlements involved both criminal fines and civil penalties. The recoveries included $290 million in criminal fines, $275 million in civil penalties and damages to the federal government, and nearly $235 million to state governments. All three settlements involved allegations of fraud against Medicaid.

Two of the cases began as lawsuits filed under the FCA by whistleblowers and the third began as a case under the Texas Medicaid Fraud Prevention Act.

The defendant in one case was the nation’s largest drug maker, Pfizer, with annual sales of $30 billion. The conduct at issue concerned a Pfizer subsidiary, the Parke-Davis Division of Warner-Lambert, acquired by Pfizer in 2000.

Drug maker Schering-Plough was the defendant in the other 2 cases.

Government recoveries from Pfizer totaled $430 million, and the two Schering settlements were $345 million and $27 million.

This is the second FCA whistleblower settlement entered into by Pfizer, and the second largest drug maker settlement ever when measured by the combined civil recovery of $430 million and the criminal fine of $240 million.

The Pfizer case broke new legal ground by recovering losses to Medicaid resulting from the illegal off-label promotion of a drug for uses other than those approved as safe and effective.

At the time of the settlement in May 2004, Pfizer’s drug, Neurontin, ranked 9th among all drugs sold in the US, with annual sales of $2.7 billion, according to IMS Health, “Leading 20 Products by U.S. Sales, Moving Annual Total, June 2004,” [imshealth.com].

The whistleblower, David Franklin, a former medical liaison for Parke-Davis, who filed the FCA lawsuit, received a $24.6 million settlement, when Warner-Lambert agreed to plead guilty to two felonies to settle charges that it fraudulently promoted Neurontin for a wide variety of unapproved uses.

Among the tactics the DOJ found the company using to achieve its goal of increasing off-label use of Neurontin were the following:

1. Encouraging sales reps to provide one-on-one sales pitches, or “details,” to physicians about off-label uses of Neurontin;

2. Utilizing medical liaisons, who represented themselves, often falsely, as neutral scientific experts on Neurontin, to promote off-label uses, working in tandem with the sales reps to directly sell Neurontin to physicians for off-label uses;

3. Paying doctors to allow a sales reps to see patients with the doctor and to participate in discussing the treatment plan;

4. Paying physicians, through both direct payments, and trips, hotel rooms, dinners and other benefits, to attend meetings termed “consultant” or “advisory” meetings or “speaker bureau trainings” in which doctors listened to presentations about off-label uses;

5. Implementing frequent teleconferences in which doctors were paid to speak about Neurontin on off-label topics to other doctors; and

6. Sponsoring independent “medical education” events on off-label uses where there was actually extensive input from the company on topics, speakers, content, and participants.

“Neurontin was marketed for four broad categories of unapproved use: pain, psychiatric use, monotherapy and dosage,” the DOJ stated. In fact, the company promoted the drug for so many unapproved uses, the DOJ said, “some employees referred to the list of these uses as the “snake oil” list.”

In the settlement agreement, the company admitted that it aggressively marketed the drug by illicit means for unapproved uses including pain, bipolar disorder, migraines, and drug and alcohol withdrawal.

The prosecutors described the harm that resulted from the off-label scheme as:

1. health care reimbursement programs such as Medicaid paid more in reimbursement;

2. consumers paid for ineffective, experimental use and may have been improperly medicated;

3. improper medication could have resulted where Neurontin was not as effective as another approved drug; and

4. unnecessary exposure of patients to adverse side effects of Neurontin.

The prosecutors said Warner-Lambert turned Neurontin into a blockbuster drug with promotional tactics like paying doctors “honoraria” to listen to sales pitches on the off-label use of the drug and by treating physicians to luxury trips to Florida, Hawaii, and Atlanta for the 1996 Olympics.

According to court documents filed in the case, doctors were paid honoraria to listen to presentations that took place at: “Bus to Yankee Stadium,” “World Yacht Cruise” and “Braves Stadium.”

On one weekend in April 1996, the DOJ discovered that Warner-Lambert had arranged 2 weekend “consultant” meetings, one at the Jupiter Beach Resort in Palm Beach, Florida, and the other at the Ritz-Carlton in Aspen, Colorado. Both were 3 day affairs, for which each attendee received a $250 cash payment, plus airfare, and all other expenses paid at the resort, and the doctors who acted as faculty were also paid between $1,500 and $2,000.

According to the DOJ, the total cost for the Jupiter Beach weekend was approximately $361,000 for about 100 doctors, meaning the price per doctor was about $3,000, and the cost of the Aspen weekend ran about the same.

Documents showed that both meetings included presentations on off-label topics such as “Neurontin: Use as Monotherapy,” and “Reduction of Pain Symptoms During Treatment with Gabapentin,” that were designed to present information to the attendees, rather than to receive information from consultants.

One advisory board was treated to an extravaganza at the 1996 summer Olympics in Atlanta, Georgia. Along with free Olympics tickets valued at $650 each, the company staged an Epilepsy Advisory Meeting, at the Chateau Elan Winery and Resort, in Atlanta.

The brochure for the event describes the resort as: “Chateau Elan has made a name for itself as a fine winery. It is now earning a reputation as a one-of-a-kind resort… Here, you’ll enjoy all the comforts and amenities you’d expect of a fine resort, mellowed by the warm ambiance of a French country inn.”

“During your meeting breaks,” the brochure says, “you will have the opportunity to play a round at one of three accessible golf courses, swim, play tennis, explore the Georgia hill country by foot or by horseback, or escape to Chateau’s European style spa for a pampering body treatment….”

For this event, records show the company paid all expenses for 18 advisers and their spouses, and each adviser was given $750 in cash for spending. In planning the Olympics advisory board meeting, a company document obtained by the DOJ, referred to the cost of the event as a “$3 million investment.”

Another example of the lavish meetings doctors attended for free, was the Western Advisory Board Meeting, held at the Grand Wailea Resort, Hotel & Spa in Maui, Hawaii in April 2000.

Only one of the attendees resided in Hawaii and the company paid for all of the others to fly to Hawaii for a two night stay at the resort to attend only 3 hours of meetings, all on off-label uses of Neurontin, according to the DOJ.

In planning this meeting, the company targeted doctors whose uses for Neurontin were only off-label and “evidence shows this event was promotional, not an independent, scientific meeting,” according to the DOJ’s sentencing memorandum.

The DOJ said Parke-Davis held hundreds of meetings where doctors were paid to attend, and paid even more to speak, and that Parke-Davis was especially interested in two types of physicians: (1) those who prescribed large amounts of anti-convulsants; and (2) those who had a prominent reputation.

These doctors were often referred to as the “movers and shakers” or “thought leaders” because of their influence, and were recruited as spokespersons on behalf of Neurontin.

Parke-Davis paid key “thought leaders” who could be counted on to deliver a strongly favorable message on off-label use. At least 20 of these doctors, the DOJ said, were paid more than $50,000 over time for speaking on the company’s behalf. In fact, some received in excess of $250,000.

Corporate documents show, the DOJ says, that the company focused its attention on recruiting doctors from major teaching hospitals to serve as “Neurontin champions.”

For example, documents show that Dr Steven Schachter, a professor at Harvard Medical School and a physician at Beth Israel Deaconess Medical Center in Boston received $71,477 between May 1994 and September 1997, and a Dr B.J. Wilder, a former professor of neurology at the University of Florida, was paid more than $300,000 for speeches given between 1994 and 1997. Six other doctors, including some from top medical schools, the DOJ said, received more than $100, 000 each.

The most common forums for speakers were consultant and advisory board meetings, where doctors were gathered to listen to a presentation. Parke-Davis justified holding these meetings, because it entered into pro forma consultant agreements with the physician attendees and doctors were paid anywhere from $250-$2,500 to serve as consultants or advisers.

In one 6-month period alone, the DOJ said, Park-Davis held over 50 meetings and despite being called “consultant” meetings, the actual objective was to provide off-label information to the doctors rather than to receive information from the consultants.

During its investigation, the DOJ discovered that doctors were misled into believing that educational programs they attended were independent programs when they were actually led by the drug maker. For example, prosecutors found a Ward-Lambert relationship with a company known as Physicians World where Warner-Lambert employees transferred to Physicians World to run the company’s speakers bureau.

At the same time, a division of Physicians World, known as Professional Post-Graduate Services, purported to be an independent education provider for a program on anticonvulsants for pain, when in fact, Ward-Lambert staff planned and developed the program and thousands of US doctors took the classes.

This program was provided to thousands of doctors all around the country and in each instance, the materials stated that they were created in compliance with ACCME guidelines, which prohibited content control by Parke-Davis as a condition of accreditation, and required disclosure of all financial affiliations.

The materials did not disclose the relationship between Physicians World and Parke-Davis, and did not disclose the financial links between Parke-Davis and each of the faculty members, all of whom were paid consultants, the DOJ said.

For instance, one physician was a regular Neurontin speaker who had received payments of more than $10,000 and yet by the listing of each faculty member, there was an asterisk indicating “no significant financial or other affiliation reported.”

“This evidence,” the US attorney said, “demonstrates that Parke-Davis knew that these events were unlawful promotional activities.”

Another method of promoting face-to-face was the preceptorship, or “shadowing.” This involved paying a doctor to allow a sales rep to follow the doctor through the course of a day seeing patients. In one example, a sales rep did a preceptorship with a neurologist and after they saw a teenage patient, the doctor and the sales rep discussed treatment options.

The sales rep advised the doctor to increase the Neurontin dose and at the same time, taper the patient off other epilepsy medication to reduce side effects, thus resulting in Neurontin being used for monotherapy. According to the sales rep, as recorded in a voice mail sent in to the company obtained by the DOJ: “I really felt I made a difference. I saw the actual prescription generated in front of me… and I certainly felt that by me being there, I had some influence on that medical decision.”

Another patient seen was a 65 year old veteran who suffered neuralgia with pain in his limbs. The patient developed blurred vision while on Neurontin; and the sales rep told the doctor that such side effects are mild and transient and so the doctor kept the patient on the drug. In the sales rep’s own words: “I felt like I influenced that particular situation. So again, another prescription was generated for us. Overall, the day went, you know, very well. And we had the immediate impact of two prescriptions written.”

The DOJ said the drug maker decided not to seek an expanded use for Neurontin with the FDA because it would have required solid proof from clinical trials so instead, the company boosted sales through promotional strategies, even for conditions where studies had indicated that Neurontin was not effective.

In his sentencing Memorandum the US Attorney noted: “One of the psychiatric uses for which Neurontin was promoted… bipolar disorder, was particularly troubling because the Company had very weak evidence of Neurontin’s efficacy in treating this condition.”

“Indeed,” the prosecutor wrote, “in one study… the placebo was as effective or more effective than was Neurontin.”

Moreover, the DOJ found the company paid no attention even when the FDA did refuse to approve an additional use. For instance, Parke-Davis sought approval for use as a monotherapy on September 16, 1996, but because one of 2 clinical trials submitted with the application showed no demonstrable monotherapy efficacy, on August 26, 1997, the FDA rejected the application.

Nonetheless, the DOJ found that Parke-Davis had actively promoted the drug for monotherapy before it applied for approval, and after the FDA rejected its application right through at least 2000, when slides, lecture summaries and audiotapes obtained by the DOJ demonstrate that Parke-Davis continued to promote Neurontin for monotherapy without ever mentioning the fact that the FDA had rejected its application.

Documented examples listed by the DOJ, of statements made after the FDA’s non-approval include a marketing event in 1998, where Parke-Davis went so far as to state that Neurontin was “now approved as monotherapy for seizures.”

In his whistleblower lawsuit, Mr Franklin explained how Warner-Lambert had hired two marketing firms to write favorable articles about the unapproved uses of Neurontin and to find doctors willing to sign their names as the authors. The marketing firms, he said, were paid $12,000 for the articles and the doctors were paid $1,000 for signing off as authors.

The off-label scheme proved to be highly successful. By government estimates, citing company documents and independent market research, by 2002 94% of Neurontin’s sales were for off-label use, up from 40% in 1995.

At the time of the settlement in 2004, Vermont Attorney General, William Sorrell, noted that a 30-day supply of Neurontin at a common dose sold for $205.

Under the terms of the settlement agreement, Pfizer agreed to:

1. plead guilty to inadequately labeling of Neurontin and to introducing Neurontin into interstate commerce for unapproved purposes, which, by virtue of its prior violation of the Food, Drug & Cosmetic Act, constitute felony violations of the Act, and to pay a $240,000,000 criminal fine;

2. settle its False Claims Act and other civil liabilities and to pay the Government $83,600,000, plus interest, in civil damages for losses suffered by the federally funded portion of the Medicaid program as a result of off-label promotion of Neurontin;

3. settle its civil liabilities to the 50 states and the District of Columbia in an amount of $68,400,000, plus interest, in civil damages for losses suffered by the state-funded portion of the Medicaid program as a result of off-label promotion of Neurontin;

4. settle its civil liabilities to the Consumer Protection divisions of 50 states and the District of Columbia state attorney general’s offices in an amount of $38,000,000, plus interest, in civil damages for losses suffered by consumers and to fund a remediation program designed to offset the impact of the improper marketing of Neurontin; and

5. comply with the terms of an amendment to the corporate compliance program of its parent, Pfizer, which, among other things, prescribes off-label marketing and requires training of employees and audits of its marketing practices.

At the time of the settlement, Pfizer issued a statement that said the illegal practices took place before Pfizer acquired Warner-Lambert in 2000. However, even if true, sales figures reveal that Pfizer was still reaping the benefits of the scheme at the time of the settlement.

For instance, on August 19, 2004, USA Today noted that: “Pfizer’s confession that the success of one of its top drugs was built partly on fraud may have been humbling, but it isn’t hurting the bottom line. Neurontin sales last quarter rose 32% from a year ago, and 2004 sales should pass last year’s $2.7 billion.”

“With few exceptions,” USA said, “state Medicaid programs pay for Neurontin just as before and so do major insurers.”

Pfizer’s denials also rang hollow at the time due to the fact that the company’s regulatory filings showed the DOJ was also scrutinizing its off-label marketing of the Genotropin growth hormone and a federal grand jury in Maryland was taking testimony from former Pfizer employees about the diabetes drug, Rezulin, that was pulled off the market in 2000 after it was linked to over 60 liver-related deaths.

But as far as fearing the FDA, the drug companies had no fear and apparently for good reason. documents unearthed in litigation reveal that the FDA was well aware of the company’s off-label marketing scheme eight years before the settlement. In July, 1996, FDA official, Lesley Frank, wrote to Parke-Davis and said in part:

“Parke-Davis may be promoting Neurontin for ‘off-label’ uses… in printed promotional materials, in detail or sales presentations to physicians, and through the use of company-solicited physician participation in a series of teleconferences.

“These promotions of Neurontin for off-label uses included, but were not limited to, its use in chronic pain, bipolar disorders, and other psychiatric conditions. As you are aware, Neurontin’s only approved indication was for adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy.”

Documents show that after 11 months, Parke-Davis responded and denied all allegations and the FDA simply accepted the company’s denial and the issue was dropped.

As part of the settlement with the DOJ, Warner-Lambert pleaded guilty only to conduct that occurred before August 21, 1996, even though illegal conduct is documented as occurring much later than 1996.

This part of the agreement made it possible for Pfizer to continue to participate in government health care programs despite an August 21, 1996, health care fraud law that would have led to its exclusion.

In addition to financial fraud, the company pleaded guilty to criminal misbranding of the drug in promotional and advertising material claiming that “the drug is safe and effective for uses which have not been approved by the FDA.”

Pfizer’s settlement with the DOJ did not cover damages for any patients who may have been harmed by Neurontin and those patients are entitled to file personal injury lawsuits.

Pfizer is currently engaged in multi-district litigation (MDL). On October 26, 2004, the Judicial Panel on Multidistrict Litigation consolidated nearly all Neurontin off-label cases in the US District Court for the District of Massachusetts.

The JPML is a panel of seven federal judges chosen by the Chief Justice of the US Supreme Court that decides on the appropriateness of establishing an MDL, and where the MDL should reside. The MDL brings together lawsuits with common claims to determine pretrial matters.

The MDL primarily involves cases of consumers who purchased Neurontin for off-label uses that Pfizer knew showed no efficacy but more lawsuits have been filed on behalf of persons who suffered adverse effects when Neurontin was prescribed for off-label uses. The first Neurontin trial is expected to take place later this year or early 2007.

In 2004, the New York law firm of Finkelstein & Partners filed several lawsuits and announced plans to file many more. At the time, the firm’s senior partner, Andrew Finkelstein, said he had gathered the names of 160 people who committed suicide and 2000 more who attempted suicide while taking Neurontin.

In addition to handling lawsuits, for more than 2 years Mr Finkelstein’s law firm has been warning the FDA about patients committing suicide while taking Neurontin and asked the FDA numerous times to add a black box warning to Neurontin’s label about the risk of suicide in patients taking the drug. As of October 2005, Mr Finkelstein has been contacted by the relatives of 425 people who committed suicide while on Neurontin.

After a year of inaction by the FDA, on March 21, 2005, Mr Finkelstein wrote a letter to the FDA’s Dr Russell Katz and said in part: “Enclosed you will find two hundred fifty eight MedWatch forms… Each represents a suicide of an American who was on Neurontin when he or she took his or her own life.”

Mr Franelstein told Dr Katz the “complete inaction by the FDA to warn an unknowing population that was relying upon the FDA to require warnings for potential adverse events from off-label usage, is deplorable.”

“Since our conversation of March 31, 2004,” he wrote, “my firm has learned of seventy four additional suicides that occurred after that date.”

“Many of these suicides likely could have been prevented,” he said, “had both the treating physician and unsuspecting families been armed with full knowledge of the risks of suicide that was known to both the FDA and the manufacturer.”

Neurontin was recommended for approval by the Neuropharmacolgical Drug Products Division of the FDA in 1992, and according to Mr Finkelstein, at that time, Mr Katz oversaw the FDA’s analysis of the clinical data supplied by the sponsor seeking approval to sell Neurontin.

Mr Finkelstein obtained the FDA’s 1992 analysis of the New Drug Application for Neurontin, and in reviewing the data, he told Dr Katz he found “shocking information.”

“During your evaluation of serious adverse events that occurred during original clinical trials,” he advised Dr Katz in the letter, “the risk of Neurontin causing suicide was both known and a major concern.”

The FDA reviewer from your Division, Mr Finkelstein pointed out, “specifically stated in December, 1992:

“Serious adverse events may limit the drug’s widespread usefulness. Depression, while it may not be an infrequent occurrence in the epileptic population, may become worse and require intervention or lead to suicide, as it has resulted in some suicidal attempts during
clinical trials.

“In fact, during the clinical trials… Neurontin was attributable to four people actually attempting suicide, two more having depression with suicidal ideations and twenty-two participants reporting depression so severe it required pharmacologic intervention.

“Additionally,” he said, “nineteen of the seventy-eight participants who reported depression during the clinical trials had no prior history of depression.”

“Clearly,” Mr Finkelstein wrote, “the FDA did not approve this drug with any expectation of use beyond the approved indication.”

“Even though the FDA knew Neurontin caused depression that may lead to suicide and that Neurontin’s effects were never fully tested on people who suffered from chronic pain, bipolar disorder or other psychiatric conditions,” he told Dr Katz, “the FDA acted with no urgency.”

Mr Finkelstein reminded Dr Katz of the company’s 2004 conviction for fraud in the DOJ case and said: “The complicity by the FDA in Parke-Davis’s scheme to defraud physicians and consumers is more egregious than the underlying fraud itself.”

“The governmental body charged with the responsibility of protecting the health and safety of Americans has done absolutely nothing to prevent entirely preventable deaths,” he continued. “Such complicity borders on criminality,” he added.

On October 14, 2005, Mr Finkelstein wrote another letter to Dr Katz and summarized the efforts by his law firm to get the FDA to warn people about the risk of suicide over 2 years and began by saying: “Due to the continued public danger facing a substantial class of prescription drug users, I am compelled to write to you regarding the FDA’s ineffective oversight related to appropriate warnings for Neurontin.”

“On March 31, 2004,” he reminded Mr Katz, “you were advised of thousands of serious psychiatric adverse events that occurred while Americans were taking Neurontin.”

“At that time,” he said, “the FDA recognized a potential imminent health crisis existed, yet nothing was done to require enhanced warning labels.”

“Due to the FDA’s inaction,” Mr Finkelstein continued, “my firm filed a citizen’s petition on May 17, 2004 with the hope that the FDA would investigate the potential for Neurontin contributing to self-injurious behavior.”

In addition to the black box warning, the Petition asked that a Dear Doctor letter be sent to health care providers cautioning them to be on alert for increased depression in patients taking Neurontin.

“The FDA took six (6) months to respond,” Mr Finkelstein told Dr Katz, “and stated no decision had been reached and more time was needed to investigate.”

“All investigations, if any,” he wrote, “have been couched in secrecy and not open to public scrutiny while the same serious health crisis continues.”

“Regrettably,” the letter concluded, “this is an example of why the American people have lost faith in the FDA’s ability to protect them from unsafe drugs.”

“While your real motivations are not known at this time,” he advised, “it is clear your interest is not in discovering the truth or protecting the health and safety of the American people.”

Author, Dr Marcia Angell, also recognizes the massive influence that drug companies exert over the FDA, Congress, and doctors, and how this influence is harming Americans.

After she resigned as interim editor-in-chief of the New England Journal of Medicine in 2000, Dr Angell decided to write a book about the biases in clinical trials but in doing her research, says she discovered that “all roads led back to drug companies.”

Her book, “The Truth about Drug Companies: How They Deceive Us and What to Do About It,” provides an indepth account of the entanglements between Big Pharma and every area of the health care field including government agencies, doctors, medical journals, Congress, and universities, as well as how these relationships harm the public.

During an August 18, 2004 interview with Business Week Online, Dr Angell told reporter Amy Tsao, that she saves her harshest criticism for her fellow physicians and the medical profession as a whole. “After all,” she said, “the industry is in business to make money, but that isn’t what doctors and medical schools should be doing.”

“They don’t have to be in bed with the drug companies,” she said. “But they are.”

Dr Angell explained how drug companies finance most of the continuing education seminars for doctors, as well as meetings of professional societies, and how they lavish all kinds of gifts on doctors including dinners in fancy restaurants and trips to exotic resorts.

“And they provide speakers and meals for interns and residents in teaching hospitals,” she told Business Week.

All of which, she says, adds to the high cost of prescription drugs. “The profession should acknowledge that this is all a form of marketing,” she said, “which adds to the prices of prescription drugs.”

“Doctors should take responsibility for their own education and buy their own meals,” Dr Angell said.

The most perverse examples of off-label marketing involve drugging children. In 2001, Dr Stefan Kruszewski, a Harvard-trained psychiatrist working for the Pennsylvania Department of Public Welfare, began investigating the widespread off-label use of psychotropic drugs and found cases of what he calls “horrendous polypharmacy.”

The first disturbing pattern he noticed was that an overwhelming number of patients were being prescribed Neurontin to treat conditions like anxiety, depression, psychosis and impotence. “The FDA had not approved using that drug for mental illnesses,” he noted.

Dr Kruszewski found patients on as many as 5 medications at the same time, something he says is “hard to justify.”

One of the most disturbing cases he found was a mentally retarded 15-year-old girl who was supposedly being treated for defiance and sexual promiscuity.

Dr Kruszewski discovered that the girl was on 11 different drugs, including five anti-psychotics, even though she had no diagnosis of a psychiatric disorder. “She was so overmedicated,” he said, “that she had trouble getting out of bed or standing up by herself.”

“Although physicians can choose to prescribe virtually any medication for any condition,” he explains, “the promotion of Neurontin remains the subject of intense scrutiny since Pfizer’s off-label promotion was previously the subject of civil and criminal penalties by the US Department of Justice.”

“In my opinion as a clinical and academic psychiatrist,” Dr Kruszewski says, “Neurontin’s link to severe emotional and cognitive disturbances, including mania, depression, suicide and memory loss, continues to be the most egregious aspect of Neurontin’s promotion.”

“It causes suffering, morbidity and death,” he noted, “problems that Pfizer and the current generic makers of Neurontin have failed to make known to consumers and potential victims,” he said.

Attorney, Zena Crenshaw, Executive Director for National Judicial Conduct and Disability Law Project, agrees that off-label prescribing is a major problem and says any drug manufacturer even suspected of such “market expansion” should be called to the carpet.

“The idea of salesmen hyping drugs to doctors,” she says, “for conditions beyond those for which the products were approved, is unnerving.”

“Considering that even dire prescription drug warnings probably reflect a minimum level of adequate care,” she warns, “prescribing drugs off-label should seem universally hazardous.”

When Dr Kruszewski warned his superiors that off-label use of the drugs was not only harmful to patients but could also expose the state to liability from lawsuits by injured patients, he was told “it’s none of your business.”

When Dr Kruszewski continued to voice his concerns he was told to quit digging up dirt, and when he refused to let go, he was fired. He has since filed a whistleblower lawsuit against state officials and 6 drug companies including Pfizer, alleging, among other things, that the defendants: “through the use of political friendships, money and other emoluments, effectively achieved a level of influence with Pennsylvania’s state government that allowed them to abuse state finances and state citizens with impunity.”

The Government Accountability Project (GAP) is a nonprofit public interest group that promotes government and corporate accountability by advancing occupational free speech, defending whistleblowers, and empowering citizen activists.

The GAP is assisting Dr Kruszewski with his lawsuit against the drug giants. Mark Cohen, an attorney with the GAP, describes whistleblowers like Dr Kruszewski as “regular people who have been pushed beyond the limits their consciences can bear.”

“They feel a moral duty to set the situation right,” he says.

“They can no longer “go along to get along” in the face of wrongdoing,” he explains. “And they can’t simply opt out – take another job and keep their lips sealed – and ignore the wrongdoing,” he says.

“But if “right” and “wrong” mean anything,” Mr Cohen says, “they feel they don’t really have a choice but to blow the whistle.”

“Of course, they do so at great personal risk,” he says. “Speaking up puts their current job in jeopardy and it threatens to brand them as trouble-makers with other employers.”

In fact, people who do expose the highly profitable Medicaid fraud or off-label practices often find themselves fired, like Dr Kruszewski. However, the False Claims Act now provides a cause of action for whistleblowers with remedies that include reinstatement to their job, 3 times the wages lost, compensatory damages, and attorney’s fees.

Filed under: 2006, MEDICAID, MEDICARE, Neurontin, Pfizer, suicide, TMAP, whistleblower

Pfizer Celebrex Lawsuits – 1500 and Counting

Evelyn Pringle September 5, 2006

The first Celebrex trial, originally set for June 6, 2006, has been delayed indefinitely, reportedly to give attorneys more time to gather information. Although no new trial date has been set, legal analysts now predict that Celebrex trials will begin in early 2007.

The delay was requested by a federal judge in San Francisco, where Pfizer is facing around 1,500 lawsuits related to its painkillers Celebrex and Bextra, according to Bloomberg News. In light of the studies on Celebrex that have surfaced over the past year, any media update should say 1,500 lawsuits and counting.

The lawsuits filed actually list defendants involved in the development, manufacturing and distributing of Celebrex as Pfizer Inc, Pharmacia Corp, Monsanto Co, and GD Searle & Co.

On August 30, 2006, Health Day News doused Pfizer’s last hope of ever finding a reason to justify the over-prescribing of Celebrex when it reported that the “final word on whether the cox-2 painkiller Celebrex might be used to prevent colon cancer is a definite “no,” according to the long-awaited results of two major studies.”

“Both of the three-year trials found that the drug reduced the occurrence of precancerous polyps called adenomas in people at risk for colon cancer,” Health Day wrote, “but it more than doubled patients’ risk for heart attack and other serious cardiovascular events.”

“The message is that celecoxib has no role as a chemotherapeutic agent — in people with adenomas or in people among the general population,” said Dr Bruce Psaty, a professor of medicine, epidemiology and health services at the University of Washington in Seattle, who co-authored an editorial on the two studies, published in the August 31, 2006, New England Journal of Medicine.

According to Dr Psaty, the take home message is that the cardiovascular risks “far outweighed even the most optimistic projections about the drug’s cancer-prevention properties.”

More bad news was reported a week earlier on August 24, 2006, by MedPage Today, in the results of a Canadian study that found women who take NSAIDs (nonsteroidal anti-inflammatory drugs), such as Celebrex, during the first trimester of pregnancy have twice the risk of having babies with congenital anomalies, particularly cardiac septal defects, researchers reported.

Of 1,056 women who filled prescriptions for NSAIDS during the first trimester of pregnancy, 8.8% had infants with congenital abnormalities, compared with 7% of 35,331 women who did not use NSAIDs, said Anick Berard, PhD, of Sainte-Justine Hospital, and colleagues, in the September 2006, issue of Birth Defects Research Part B.

And a few months ago on March 1, 2006, the Scotsman reported: “In a study involving more than 4,000 patients, Celebrex, which is the most commonly used Cox-2 inhibitor, was found to increase the risk of heart attacks by 2.26 times.”

The leader of the study, Professor Richard Beasley, from the Medical Research Institute of New Zealand, warned that, “Given the popularity of this in the treatment of arthritis, drug regulators must undertake an up-to-date risk assessment based on the findings presented here.”

The study was published in the Journal of the Royal Society of Medicine and reported that in addition to the increased risk when compared to a placebo, the use of Celebrex also had a 1.88-fold increase in the risk of heart attacks when compared with other painkillers.

According to a November 16, 2005, study conducted in Denmark, presented to the American Heart Association, people who have survived a previous heart attack and take Celebrex are at an increased risk of death, especially if they take Celebrex at higher doses.

The lead researcher, Dr Gunnar Gislason, stated that people with heart disease or history of heart attack should not use Celebrex. The study showed that heart disease patients who take 200 mg of Celebrex a day are more than four times more likely to die.

The first Celebrex trial that was delayed involves the case of Rosie Ware, an Alabama woman who alleges that a stroke at age 53, in February 2005, was caused by Celebrex and that the stroke has resulted in medical, hospital, and after-care costs of “substantial sums of money.”

Ms Ware is represented by the law firm of Beasley, Allen, Crow, Methvin, Portis & Miles, in Montgomery, AL. On February 28, 2006, Attorney Jere Beasley told the Wall Street Journal that his client, a nonsmoker whose health was “very good” before her stroke, took Celebrex for back pain and was left disabled and unable to work after the stroke.

Mr Beasley also told the Journal that he is undeterred by the fact that Celebrex has been deemed safe by federal regulatory agencies. “I don’t think that makes much difference,” he said. “The FDA is just an extension of the drug industry.”

Ms Ware alleges in her lawsuit that had it not been for Pfizer’s overly aggressive marketing campaign with misleading claims about the safety and efficacy of Celebrex, she would never have taken it to begin with.

This allegation is pretty much verified by a study published on January 24, 2005, in the Archives of Internal Medicine, titled, “National Trends in Cyclooxygenage-2 Inhibitor Use Since Market Release,” which concludes that the “aggressive marketing techniques to patients and physicians” caused a growth not only in use of COX-2 inhibitors but also in overall market demand, resulting in the use of such drugs by patients who did not need them.

The study in Archives found that 63% of patients who received COX-2 inhibitors were at a low risk for developing the ulcers and gastrointestinal problems that the drugs were supposed to prevent, and that the marketing campaign played a significant role in the over-use of COX-2 inhibitors for this type of patient.

In both the non-risk and at-risk population, the study found, Celebrex was neither more effective or safer than NSAIDs, meaning that there was a small population for which it might be a superior product, but for the vast majority of users, its use was excessive.

According to Merrill Goozner in the new best-selling book, “The $800 Million Pill:”

“Sales exploded the instant the FDA gave the okay for the drugs’ makers to rev up their marketing machines. Commercials featuring frisky seniors flooded the airwaves. Detailers inundated doctors with free samples. Millions of people pestered their physicians to give them prescriptions for the new drugs, requests that fell on receptive ears.”

Mr Goozner states that, “Wall Street’s stock analysts considered the rollouts of Celebrex and Vioxx the most successful drug launches in pharmaceutical industry history.”

“Within a year of its launch,” he notes, “Celebrex was generating more than $2 billion a year in sales for Pharmacia and its comarketer Pfizer.

“Arthritis pain relief medicine that had once cost pennies a day,” he says, “was now costing millions of patients and their insurers nearly three dollars a pill.”

Celebrex in fact, has no proven superiority over other NSAIDs and yet it sells for anywhere between $2.50 to $6.50 per day depending on the dose, while NSAIDs sell for $0.21 to $0.31 per day which means Pfizer has made billions of dollars off Celebrex by charging an outrageous price for a drug that in reality is not even better than over-the-counter drugs that cost pennies per pill and have been on the shelves for years.

Had the truth been known about the drug’s lack of safety and efficacy, critics says, Celebrex would have sold for a price similar to other NSAIDs and would not have become a standard in the treatment of arthritis and other forms of pain relief.

In 2004, Pfizer spent $117 million promoting Celebrex and sales reached $3.4 billion worldwide, according to the April 28, 2006, New York Times. The following year, after advertising of Celebrex ceased, sales dropped 48% to $1.73 billion in 2005, the WSJ reports.

Although scrutiny over marketing practices intensified following the Vioxx recall, violations of advertising regulations have been getting worse, according to Tom Abrams, director of the FDA’s Division of Drug Marketing, Advertising, and Communications, speaking in an interview for Pharmaceutical Executive on December 1, 2005.

FDA regulations require drug companies to submit promotional materials to the FDA at the time of first use which means Mr Abrams and his staff of 35 receive an average of 53,000 promotional pieces a year, he estimates.

He says the biggest public misconception is that the FDA screens and approves all ads before they are released but that most ads are launched without the agency reviewing them first. “We get complaints from consumers and physicians who call us up and say, ‘Tom, how can you allow that TV ad to be on?'” Mr Abrams said during the interview.

“They’re flabbergasted,” he says, “when we say, ‘We didn’t approve it before it went on TV.’ Often, we’re seeing it at the same time as the American public. DDMAC has limited resources and we use our limited resources as effectively as we can to do our job.”

He told Pharmaceutical Executive that competing marketing campaigns within the pharmaceutical industry have become fierce. “Currently, industry spends $25 billion a year on promotion,” he said in the interview.

“I think it is going to continue to increase,” he added.

When the FDA determines that ad is violating regulations, it sends the drug company either a notice of violation letter or a warning letter. Notice of violation letters are untitled and are issued for the least serious offenses. “They pretty much tell companies, ‘Stop what you’re doing and don’t do it again,” says Mr Abrams.

Warning letters, he explains, request that the drug company stop the promotion and disseminate corrective messages, and are issued for more serious or repetitive violations.

Over the years, the misleading and deceptive ads for Celebrex have led to regular correspondence between Pfizer and the FDA.

Since its arrival on the market, Celebrex has been promoted as having the ability to improve the quality of life with ads in which patients go from not being able to work or do much of anything, to being able to work and do everything else pain-free.

In one infomercial, Celebrex patients talk about being able to “do anything,” “do as much as I want to do,” being “back to doing what I do,” and such. They talk about “enjoying life” again, how the drug improved their “quality of life,” and how the drug “gave them back their lives.”

One person states that “you can be free,” and another says that Celebrex “brought new vitality in life.”

Such claims portray Celebrex as a superior pain relief drug when in fact, the FDA has stated that, “none of the comparative studies with naproxen, ibuprofen, and diclofenac to-date has been designed to demonstrate superiority or a specified degree of similarity in a rigorous way.”

Typical of the phony “improve the quality of life” commercials is a TV ad that promotes the use of Celebrex for osteoarthritis or rheumatoid arthritis, with a woman playing a guitar. The visuals focus on her hands and fingers and playing ability with a voice-over saying, “With Celebrex, I will play the long version.”

Combined, the image and voice-over imply that there is a direct benefit to the woman’s wrist, hand, and finger joints so that she can now play the long version and that prior to taking Celebrex she could not.

This misleading ad earned the drug maker the most serious FDA “warning letter” stating: While the Guitar TV ad suggests a direct benefit to this patient’s wrist/hand/finger joints related to movement and flexibility, it fails to state the actual approved indication (e.g., relief of signs and symptoms of osteoarthritis).

It also fails to include any risk information about Celebrex, the FDA said, thus omitting the major side effects and contraindications (including warnings and precautions). Omission of this information, the warning letter said, implies that there are no risks to the patient who takes Celebrex which overstates the drug’s safety.

The Canada’s regulatory agency were also keeping a close watch on Celebrex and apparently so were consumers. On November 4, 2004 a class action lawsuit was filed in Canada alleging that Celebrex caused cardiovascular related side effects and on November 28, 2004, Canada’s Adverse Drug Reaction Monitoring Program confirmed 14 Celebrex related deaths.

About 2 weeks later in mid-December 2004, the announcement came that a clinical trial investigating a new use of Celebrex to prevent colon polyps, conducted by the National Cancer Institute and Pfizer, was discontinued because of an increased risk of cardiovascular events in patients taking Celebrex versus those in the group taking a placebo.

Patients in the trial who were taking 400 mg of Celebrex twice a day were found to have a 3.4 times greater risk of cardiovascular events compared to patients taking a placebo and patients taking the 200 mg dose had a risk that was 2.5 times greater.

The news of this study came a mere 10 weeks after Merck’s recall of Vioxx, when a study found that Vioxx doubled the risk of heart attack and stroke among patients taking the drug to prevent colon polyps.

In fact, on September 30, 2004, in response to Merck’s announcement, Pfizer issued a press release bragging that over 27 million patients in the US had been prescribed Celebrex since it was approved and said people should use it instead of Vioxx.

“Because of its outstanding long-term safety profile and broad indication base including osteoarthritis, rheumatoid arthritis and acute pain, Celebrex is an appropriate treatment alternative,” said Dr Joe Feczko, Pfizer’s president of worldwide development.

The press release claimed that a recent FDA sponsored study of 1.4 million patients, found that those patients who received Celebrex demonstrated no increased risk of cardiac events. “Pfizer is confident in the long-term cardiovascular safety of Celebrex,” Dr Joe Feczko stated.

Well, that glory was short-lived because in January 2005, following a sharp decline in new prescriptions for Celebrex after the December 2004 study was revealed, Pfizer investors filed a federal class action lawsuit against Pfizer in Connecticut alleging that the company misled investors about the safety of Celebrex.

A former Vice President of Pfizer turned whistleblower, Peter Rost, says shareholders were rightfully upset and estimates that the fiasco probably cost Pfizer $3-4 billion.

As for the potential damages to the company from all the lawsuits filed, Mr Rost states companies like Pfizer usually carry some insurance but says, “Most comes out of shareholders pockets.”

He predicts that more hidden studies and documents will pop up during litigation.

And that too seems likely being Pfizer has been forced to acknowledge that a study that was testing Celebrex as a treatment for Alzheimer’s disease between 1997 to 1999, showed patients taking Celebrex quadrupled their risk for a heart attack compared to those patients taking a placebo.

The study found patients on Celebrex had a 3.6 times greater occurrence of a serious heart event compared to those on a placebo, according to an analysis of the data by the patient advocacy group, Public Citizen.

On January 24, 2005, Public Citizen petitioned the FDA to immediately remove Celebrex from the market and a week later on January 31, 2005, Citizen accused Pfizer of burying the study. Sidney Wolfe, director of Public Citizen’s Health Research Group, said “there is no excuse for this study not being made more public.”

Critics say this study proves that the drug makers knew that Celebrex was a total fraud before the drug even hit the shelves.

According to Merrill Goozner, author of the $800 Million Dollar Pill, the only legitimate selling point for the Cox-2 inhibitors was the claim that they would eliminate the ulcers and deaths that on rare occasions resulted from the prolonged use of generic painkillers.

“Yet the FDA didn’t allow them to claim that in their advertising or literature,” he points out, “since the clinical trials failed to turn up evidence that the new drugs were safer than NSAIDs.”

“The package insert, which goes out with every prescription,” he notes, “contained the same warning label as all the other NSAIDs.”

Critics predict that Vioxx, Celebrex and Bextra will go down in history as a shining example of the danger posed by allowing the unbridled promotion of prescription drugs to both doctors and patients.

Experts blame the doctors for over-prescribing and being so gullible to trust the information in promotional materials furnished by drug companies. On June 22, 2000, Dr Marcia Angell, wrote in the New England Journal of Medicine:

“Unfortunately, many doctors do indeed rely on drug-company representatives and promotional materials to learn about new drugs, and much of the public learns from direct-to-consumer advertising. But to rely on the drug companies for unbiased evaluations of their products makes about as much sense as relying on beer companies to teach us about alcoholism. The conflict of interest is obvious.”

“The fact is,” she said, “marketing is meant to sell drugs, and the less important the drug, the more marketing it takes to sell it.”

“Important new drugs do not need much promotion,” she wrote.

Filed under: 2006, Celebrex, NSAIDs, Pfizer, Scoop, whistleblower

Spotlight Focused On Pfizer’s Lipitor Follies

Evelyn Pringle August 30, 2006

According to the book, “Health Myths Exposed,” by former pharmaceutical chemist turned whistleblower, Shane Ellison, “When used as prescribed, pharmaceutical drugs kill more people than terrorism, car crashes, AIDS, and street drugs combined.”

Although many health care professionals have come forward in recent years with warnings that prescription drugs are one of the largest killers in the field of medicine, the general public apparently remains unaware of the yearly death toll attributed to legal drug use – judging by the on-going over-prescribing of prescription drugs.

And nowhere is this fact more obvious than in the case of Lipitor. By use of the manufactured fear of high cholesterol, Pfizer has been able to transform tens of millions of people into life-long customers for Lipitor.

Without question, Lipitor is the all-time granddaddy of blockbuster drugs. It was the first drug to reach $10 billion in sales worldwide, and it has earned close to $50 billion in revenue for Pfizer since 2000.

According to Pfizer’s first quarter SEC filing for 2006, Lipitor “is the most widely used treatment for lowering cholesterol and the best-selling pharmaceutical product of any kind in the world, reaching over $3.1 billion in worldwide sales in the first quarter of 2006, an increase of 1% compared to the same period in 2005.”

“In the U.S.,” the filing reports, “sales of $2 billion represent growth of 3% over the previous year’s first quarter.”

In fact, according to an estimate in Bloomberg News on August 24, 2006, by Deutsch Bank analyst, Barbara Ryan, Lipitor generated about 40% of Pfizer’s 2005 profits.

Lipitor recently bagged a special honor for Pfizer when the Prescription Access Litigation Project (PAL), announced the winners of the 2006 Bitter Pill Awards on April 26, 2006 and the drug shared an award with Crestor, its archrival anti-cholesterol drug. The Awards honor drug makers “engaging in over-zealous and questionable marketing practices,” to highlight the problems caused by the heavy marketing of prescription drugs, and specifically Direct-to-Consumer Advertising (DTCA), to include television, radio, magazine and internet ads that target consumers directly, rather than doctors.

According to PAL, statin drugs vary in price from about $33 a month for generics to $162 for brand-names, but millions of people for whom a generic would be fine are taking Lipitor and Crestor, due to their aggressive marketing campaigns.

Overall, the pharmaceutical industry spent $4.65 billion in 2005 for DTC advertising of brand-name drugs, a 4.7% increase over 2004. But experts say its money well-spent because every dollar invested brings back between $1.50 to $4.20 in additional sales, according to PAL.

In 2005, Pfizer spent a total of $93,435,000 on DTC for Lipitor and as a result, the drug’s price increased by more than 50% of the rate of inflation.

Another contributing factor to the rise in Lipitor’s price might well be due to the salaries of Pfizer’s top executives. For instance, as CEO, recently retired Henry McKinnell’s annual compensation package in 2005 included: $2, 270,500 (salary) + 3,700,000 (bonus) + 14,499,795 (stock options) + 5,489,400 (LTIP Payouts) + 427,370 (other) = $26,387,065.

However, analysts say the top brass in the company executives are looking for ways to calm investors who are infuriated over the $83 million retirement package Mr McKinnell recently walked off with, after watching a 40% slide in Pfizer stock price during the CEO’s 5-year reign. The blue-chip stock, which reached its peak of $50 in 1999 is now trading in the range of $20.27, according to Trading Markets on August 20, 2006.

In announcing the Lipitor-Crestor Bitter Pill award, PAL stated, “The enormous potential market for these drugs, which patients take (and pay for) for years, has caused our award winners to significantly overpromote their drugs.”

“The marketing campaigns,” PAL said, “have created the impression that anyone and everyone with even slightly high cholesterol needs them.”

“This marketing gives short shrift to the much cheaper but effective generic statins,” the report notes, “as well as to lifestyle changes, such as better diet and more exercise, that should be the first line of treatment for millions of people who have high cholesterol but no other major risk factors.”

DTC is used as a promotional tool to expand the market for drugs far beyond their intended purpose. Lipitor is FDA approved for people who already have heart disease or are at great risk of developing heart disease. But as a result of Pfizer’s massive marketing campaign, millions of people with only elevated cholesterol levels are taking the drug every day.

But yet, experts say, despite the drastic increase in statin use, the death rate from heart disease has not changed over the last 75 years. If low cholesterol prevents heart disease, they say, by now studies should show a correlation between lower cholesterol and less heart disease, but they don’t.

In reality, experts say, the only thing Lipitor does is lower cholesterol. According to Dr John Abramson, MD, clinical instructor of ambulatory care at Harvard Medical School and author of Overdosed America, “The idea that lowering cholesterol always reduces the risk of heart disease has become the conventional wisdom, which drug companies like Pfizer have taken great pains to promote.”

“But for women under 65 and people over 65 with no history of heart disease or diabetes,” he told Consumer Affairs, “the evidence just isn’t there.”

“Millions of women and seniors,” he said, “are spending huge sums to take Lipitor every day despite a lack of proof that it’s doing anything beneficial for them, and may actually be harming the elderly.”

A recent study in the August 10, 2006, New England Journal of Medicine, funded by Pfizer, appears to back up these assertions, at least when it comes to stokes.

The study found Lipitor to be not much better, if any, than a placebo at preventing stokes. And in fact, the study showed the drug to be far less effective in preventing the worst kind of strokes than a placebo.

The study involved more than 4,700 people who had recently had a stroke or “mini-stroke.” The subjects had no known coronary heart disease, and their level of “bad” cholesterol was higher than optimal.

They were assigned to take either Lipitor or a placebo daily. After an average of nearly five years, 265 of those in the Lipitor group had had another stroke, compared with 311 in the placebo group, or a difference of 16%, but the study found that mortality rate was about the same in both groups.

However, the study showed that the most serious type of stroke, the hemorrhagic stroke, was by far more common in the Lipitor group with 55 cases, verses only 33 cases in the placebo group.

That said, a key factor not highlighted by the authors of the study, is that hemorrhagic stroke is associated with a higher death rate than ischemic stroke, according to the National Heart Foundation.

But then a caveat at the end of the article explains why the interpretation of the study is manipulated with words that favor Lipitor where it says the study was funded by Pfizer, the maker of Lipitor, which also has financial ties to the study’s authors.

Pfizer received another surprise of sorts in September last year when Health Care For All, a PAL coalition member, and others, filed a nationwide class action lawsuit in US District Court for the District of Massachusetts against the company on behalf of women who have taken Lipitor and who have no history of heart disease or diabetes; people aged 65 and over who have taken Lipitor and who have no history of heart disease or diabetes; and third-party payers such as insurance companies, union health and welfare funds, self-insured employers and others, who paid for Lipitor for patients in these groups.

The lawsuit alleges that the success of Lipitor is due in large part to a deceptive advertising and promotional campaign to convince doctors and patients alike that Lipitor reduces heart disease and heart attacks for nearly everyone with elevated cholesterol.

The lawsuit claims Pfizer misled consumers into using Lipitor despite the absence of evidence that the drug is of any benefit to large segments of the population and promoted Lipitor by claiming it prevents heart disease in women and the elderly, where no clinical test has established such a benefit. And in fact, according to the complaint, women in a study without heart disease actually suffered 10% more heart attacks while taking Lipitor, than women who received a placebo.

The plaintiffs allege that as a result of a deceptive marketing campaign, Pfizer created an artificial demand for Lipitor which would not have existed had there been full and fair disclosure regarding the lack of evidence proving a relationship between Lipitor and a reduced risk of heart disease.

The complaint alleges that Pfizer violated state consumer protection laws against deceptive advertising and seeks reimbursement for persons who bought Lipitor needlessly as a result of Pfizer’s marketing and promotional campaign.

“We believe Pfizer intentionally ignored the scientific evidence — and lack thereof — and launched a multi-million dollar ad campaign designed to push the drug to anyone they could convince to buy it,” said Steve Berman, the lead attorney in the case, to Consumer Affairs on September 29, 2005..

“We intend to prove in this case that Pfizer’s false advertising created an enormous artificial demand for Lipitor,” he said, “much of which would not exist if Pfizer had fully and fairly disclosed the truth about the drug.”

“We intend to prove that Pfizer pocketed billions in sales to those who do not benefit from Lipitor,” he told Consumer Affairs.

Critics point out that the over-prescribing of Lipitor comes at a high cost to taxpayers. “We all pay the price for the over-prescription of drugs, like Lipitor, because we have to foot much of the bill for state pharmacy programs for seniors,” said Melissa Shannon, Consumer Health Policy Coordinator of Health Care For All.

“We can’t allow drug companies,” she warns, “to trick seniors into taking expensive, unnecessary drugs that will drive up the already-high costs that Medicare will be paying for seniors’ drugs.”

For the purpose of the lawsuit, member of the class include:

(1) All women in the United States without previously medically diagnosed heart disease or diabetes who have taken and paid out of pocket for Lipitor in the last four years;

(2) All female or males in the United States without previously medically diagnosed heart disease or diabetes who have taken and paid out of pocket for Lipitor in the last four years and who did so while over the age of 65.

(3) Third-Party Payors (health plans, union benefit funds, self-insured employers and others) who paid for Lipitor used by the patients described above.

The suit seeks monetary recovery for the consumers and payors, as well as an order enjoining Pfizer from continuing its off-label promotion of Lipitor.

On thing is certain, Pfizer attorneys will not be seen in the unemployment lines anytime soon. According to Pfizer’s May 8, 2006 SEC Filing, since March 2006, a number of purported class actions have been filed against Pfizer in various federal courts alleging claims relating to the promotion of Lipitor.

“The plaintiffs allege that,” the filing states, “through patient and medical education programs and other actions, the Company promoted Lipitor for use by certain patients contrary to cholesterol guidelines, which are referenced in the product labeling, that recommend changes to diet and exercise.”

According to Pfizer, the plaintiffs seek to represent nationwide and certain statewide classes consisting of health and welfare funds and other third-party payors that purchased Lipitor for such patients or reimbursed such patients for the purchase of Lipitor since January 1, 2002.

“Each of the actions alleges, among other things,” Pfizer states in the report, “fraud, unjust enrichment and the violation of the federal Racketeer Influenced and Corrupt Organizations Act (“RICO”) and certain state consumer fraud statutes and seeks monetary and injunctive relief, including treble damages.”

The filing is no doubt referring to a class action lawsuit filed against Pfzer in late March 2006, by the Welfare Fund of Teamsters Local Union 863 in US District Court in Newark, NJ, that accuses the company of marketing Lipitor for off-label uses not included in the federal guidelines.

The aggrieved plaintiffs are insurance companies and drug benefit plans that paid for off-label prescriptions that, according to the lawsuit, might not have been written if Pfizer had not marketed Lipitor off-label illegally.

In a nutshell, the lawsuit says Pfizer has been promoting the use of Lipitor for cholesterol levels that are below those specified in the guidelines in the Third report of the Adult Treatment Panel, developed by the National Cholesterol Education Panel, which is a panel of the National Heart, Lung, and Blood Institute (ATP III).

To that end, the lawsuit says Pfizer influenced doctors to prescribe Lipitor to patients with cholesterol levels lower than the guidelines recommend. Or simply put, Pfizer sold Lipitor to patients who did not need it.

The suit relies on the federal Racketeer Influenced and Corrupt Organizations Act (RICO) to build a national class of defrauded third-party payers, but in case the RICO class fails, the plaintiffs’ lawyers say they are filing additional state lawsuits.

According to plaintiffs attorney, Geoffrey Jarvis, of Grant and Eisenhofer, in an interview with Pharmaceutical Executive on March 29, 2002, the law suit is about the low-risk people, those that have less than a 10% chance of contracting coronary heart disease in the next five years.

“For that group of people,” he says, “according to the drug label, unless their cholesterol is above 160, statin drug therapy is not recommended.”

The plaintiffs claim that Pfizer worked to get physicians to prescribe Lipitor to people with a low risk of heart disease and cholesterol levels below 160. “There are about 15 million people in that group,” Mr Jarvis said in the interview. “Basically, they are trying to expand the market of the drug to people who really ought to not be on it.”

The complaint also alleges that Pfizer misrepresented Lipitor’s potential market to investors by claiming “millions more potential patients than would be expected under the government guidelines.”

The complaint states that “Pfizer also employed purported ‘independent’ third parties … to promote Lipitor’s off-label use.”

In addition to paid consultants and marketing firms, it says, the company engaged organizations such as Emerging Science in Lipid Management and the National Lipid Education Council to offer physicians continuing medical education courses as well as to publish articles extolling Lipitor’s off-label usage.

The complaint claims, “both organizations are fully funded by Pfizer” and have become an active part of the marketing plan for Lipitor.

Critics are quick to point out that the off-label scheme described in the current complaint resembles the charges in the fraud case that Pfizer lost in 2004 where the company paid a $430 million penalty for promoting and marketing the epilepsy drug, Neurontin, for off-label uses not approved by the FDA.

“Once you connect the dots and see the elaborate sophistication and reach of Pfizer’s plan to go way beyond the federally mandated guidelines for prescribing Lipitor, there is no other way to describe it except as a fraudulent scheme, whose true purpose has been to extract illegal payments from third-party payors for Lipitor’s off-label use,” said Jay Eisenhofer of Grant & Eisenhofer in explaining the racketeering claims, on the Freight Teamster’s Web sit.

“Between the company’s own off-label marketing and the coordinated campaign by its various consultants and captive physician education groups, Pfizer has reaped billions of dollars in insurance payments to cover prescriptions for patients for whom Lipitor therapy is not recommended under FDA approved usage standards,” Mr Eisenhofer noted.

The drug plan plaintiffs allege that Lipitor’s dramatic rise in sales from $5 billion in 2000 to $12.1 billion in 2005, is a direct result of Pfizer’s off-label promotion of the drug during that period.

“This is a classic case of unjust enrichment,” Mr Eisenhofer said. “Pfizer has built colossal sales of Lipitor through the pipeline of third-party payors such as our clients and countless other drug plans – including Medicaid and Medicare – much of it based on prescriptions that the FDA’s guidelines say never should have been written in the first place.”

Analysts predict that more suits of this kind are on the horizon. “States are going to tighten up this sort of thing because it’s a way to control Medicare costs,” Les Funtleyder, an analyst for Miller Tabak told CNN Moneyline on March 28, 2006.

“If suits like this start proving to be successful,” he said, “then you’ll start to see a cascade effect.”

The list of initial plaintiffs participating in the class action include:

Welfare Fund of Teamsters Local Union 863 (New Jersey) Southern Illinois Laborers and Employers Health and Welfare Fund Midwestern Teamsters Heath & Welfare Fund (Illinois) NECA-IBEW Health and Welfare Fund (Illinois) Cleveland Bakers and Teamsters Health and Welfare Fund (Ohio) Electrical Workers Benefit Trust Fund (Indiana) Sidney Hillman Health Center of Rochester (New York State)

But then Pfizer and Lipitor are certainly no strangers to litigation, and ripping off government health care programs is nothing new for them either. Back in October, 2002, Pfizer paid $49 million to settle a federal qui tam lawsuit filed in Texas, with charges that the company overcharged for Lipitor and fraudulently avoided paying money owed to the state and federal government under the Medicaid Rebate program.

According to the Justice Department, the unreported discounts allowed the company to retain more than $20 million in rebates owed to Medicaid.

And for what it is worth, which apparently is nothing, in addition to the $20 million payment, the Justice Department said, Pfizer agreed to a 5-year corporate integrity agreement intended to prevent future problems.

The agreement is especially funny in light of the fact the company was busted for false advertising a month earlier in September 2002, when the FDA instructed Pfizer to immediately pull all magazine advertisements that claimed Lipitor caused fewer side effects than the other statin drugs.

According to the FDA, the ads appearing in magazines such as Reader’s Digest and Time indicated that Lipitor “lacks” the side effects of other cholesterol drugs and claimed that other drugs in Lipitor’s class of medications may cause a severe debilitating muscle condition.

The ads were knowingly false and misleading because at the time, Lipitor’s own label stated that all statins increased a patient’s chance of developing myositis and rhabdomyolysis, potentially fatal conditions that cause muscle pain and muscle deterioration, and may lead to kidney failure symptoms.

However, it appears that Pfizer’s conduct of concealing and minimizing side effects has come back to haunt the drug maker. In June 2006, two men filed personal injury lawsuits against Pfizer, alleging that the company concealed serious health risks associated with Lipitor.

The lawsuits accuse Pfizer of promoting Lipitor as a safe drug and failing “to inform consumers and the medical profession of serious side effects associated with the statin Lipitor,” according to a statement released by plaintiff attorney, Mark Krum.

Both plaintiffs, Charles Wilson, 60, a former insurance executive, and Michael Mazzariello, 47, an attorney from New York, filed their lawsuits in New York State Supreme Court.

Although they filed separate actions, each man is charging that Lipitor caused extensive memory loss, irreparable nerve damage, and bouts of fatigue.

Three years after terminating use of the drug, Mr Wilson says he continues to suffer from loss of balance, fatigue, and burning sensations in his hands and feet.

And, according to the lawsuit, Mr Mazzariello, who took the drug for only two months, has suffered debilitating nerve and muscle injury, has endured repeated hospitalizations, and now walks with a cane.

But Pfizer’s latest marketing trick beats anything described above. According to Bloomberg News on August 24. 2006, Pfizer said that it had increased second-quarter revenue from Lipitor by persuading doctors to prescribe higher doses of the drug.

Pfizer says it sent thousands of sales people to doctors’ offices to tout studies showing that higher doses cut the risks of heart attack, stroke and death, better than other cholesterol drugs.

As a result of selling more of the higher priced pills, Lipitor revenue increased by 2% to $3.1 billion in the second quarter, even though about the same number of patients took the drug, according to Pfizer.

The number of patients taking the highest doses in June rose by more than 10% compared with May. A 10 milligram Lipitor pill costs $2.44, while the 40 and 80 milligram doses are $3.33 each, or 36% more, according to the Drug Store.com web site .

Some heart experts say that the company’s promotion may spur doctors to prescribe higher doses for everyone, even though the majority of patients do not need them, according to Steven Findlay, an analyst for Consumers Union, a nonprofit company that publishes Consumer Reports magazine.

To give this story a happy ending that indicates drug makers can not keep getting away with murder forever, its worth noting that on March 28, 2006, the Wall Street Journal reported that federal prosecutors were reviewing Pfizer’s alleged off-label marketing “because of the billions of dollars spent on Lipitor every year by Medicaid and the states.”

On the same day that the Journal ran its article, Pfizer acknowledged to CNN Moneyline, that an investigation had been initiated against the company by the US Attorney’s office in Brooklyn, New York, reportedly because of marketing practices.

Filed under: 2006, Lipitor, MEDICAID, MEDICARE, Pfizer, statins, whistleblower

Implant For-Profit Industry Not Deserving of Preemption Protection – Part I

Evelyn Pringle July 9, 2007

In addition to the question of how many soldiers will be dead or injured by the time self-proclaimed “war President” George Bush leaves office, Americans need to ask themselves how many citizens will be dead or injured as a result of an FDA controlled by the industry most credited with funding his move to the White House.

Last year, the FDA announced that the agency’s approval of a pharmaceutical product preempts product liability lawsuits against the industry giants in state courts, even when a company actively conceals information that shows serious injury and death are known to be associated with a product.

With the solid backing of the FDA, preemption is now being used as an argument to dismiss lawsuits filed by injured citizens in state courts against medical device makers.

Critics point out that many risks associated with a new product will not be known at the time of FDA approval and that additional safety information often surfaces only after a device is widely used on the market.

Furthermore, FDA regulations allow device makers to add stronger warnings when a risk becomes known, without requiring FDA approval. However, all too often, company documents which surface as a result of litigation show that the device maker was aware of safety risks long before the product was approved and that they actively concealed the information from the FDA.

Legal experts say the legal remedies available under state laws are set up to give additional protection to consumers over and above the minimal protection provided by the FDA approval process, and especially at times like this, when the FDA is run by appointed industry insiders who refuse to police the medical device industry.

The Medical Device Amendments to the Federal Food, Drug and Cosmetic Act establish a federal statutory and regulatory scheme governing the sale of devices in the U.S., but the MDA provides no private cause of action against device makers and therefore, the preemption of state law claims would eliminate most, if not all, legal remedies for persons injured by defective products.

Whether or not the administration has succeeded in immunizing device makers will likely be known in 2008, because on June 25, 2007, the U.S. Supreme Court agreed to hear an appeal in Riegel v Medtronic, involving a case against Medtronic which could determine whether patients will have the right to file lawsuits against device makers under consumer protection laws enacted by the individual states.

The Public Citizen Litigation Group is representing Charles Reigel, who was injured in 1996 when a balloon catheter burst while he was undergoing an angioplasty, a procedure used to open clogged arteries.

After the Second Circuit Court found the lawsuit was preempted based on FDA approval, Public Citizen attorneys Allison Zieve, Wayne Smith and Brian Wolfman, filed a petition asking the Supreme Court to consider whether the Food, Drug, and Cosmetic Act expressly preempts state-law actions brought by patients who have been injured by devices that received pre-market approval, and to issue a ruling due to the inconsistent rulings on the preemption issue in cases filed in the lower courts.

The petition argues that the FDA has switched positions on whether pre-market approval preempts state law claims since the government’s views were solicited by the Court in 1997, when the FDA supported the right to pursue state law claims.

The Supreme Court asked the Solicitor General to offer the government’s views and, of course, the FDA used tax dollars collected in large part from the injured plaintiffs who might have cause to file claims in state courts, to send up a brief that backed Medtronic 1000% in it use of preemption to prevent Americans from suing the device giant.

In direct harmony with Medtronic, the FDA brief tells the Court not to bother with the conflict in preemption rulings in the lower courts because there are now more rulings on one side of issue than the other.

“Also like Medtronic,” Public Citizen responds in a reply brief, “the government asks the Court to overlook the undisputed conflict because it might simply go away.”

“What has changed since 1997,” Public Citizen notes, “is the government’s view on the merits of the question presented.”

“The government’s inconsistency on this question of statutory meaning only underscores the need for this Court to resolve the question presented,” the brief states.

Legal experts say the ruling in this case has the potential to affect thousands upon thousands of lawsuits currently filed in state courts against the makers of medical devices, including defective products implanted in patients with heart disease, such as defibrillators, pacemakers and drug-eluding stents, and devices used during spinal surgery.

A favorable ruling for Medtronic could literally save Boston Scientific from the poor house because, at last count, the company was facing over 75 class actions and 1,100 individual lawsuits involving defective defibrillators and pacemakers manufactured by the recently-acquired Guidant Corp, according to Boston’s SEC filing.

Also, the number of litigants against Boston is rising by the month. On June 15, 2007, the Brown & Crouppen law firm of St Louis filed a 39-count product liability lawsuit in St Clair County on behalf of 14 plaintiffs against Guidant, Boston and Cardiac Pacemakers, alleging the defibrillators/pacemakers were defective and required them to be hospitalized.

These latest lawsuits claim the devices were defective in design, did not conform to federal requirements and subjected users to risks of heart attacks, death and other illnesses that exceeded the benefits of the devices. Other safer products were available, and the makers actively concealed the product defects in order to prevent adverse publicity.

According to the June 29, 2007, Madison St Clair Record, this is at least the third complaint filed by Brown & Crouppen against these same companies.

Spinal surgery represents another division of the implant for-profit industry. A study in the November 2006 Spine journal, conducted at Dartmouth Medical School, analyzed data on lower back (lumbar) surgery among Medicare recipients aged 65 and older nationwide and found that surgery rates in 2002-2003 were almost 8 times higher than in 1992 in some areas of the U.S., and in 2003, Medicare spent over $1 billion on spine surgery.

On August 5, 2006, the LA Times reported that spinal surgery has become a very lucrative business, “with at least $3.2 billion spent last year in the U.S. on spinal fusion.”

In October 2004, Johnson & Johnson obtained FDA approval for the Charite artificial spinal disc as an alternative to spinal fusion surgery, but experts contend that the superiority of the two procedures is limited to the cost. Charite replacement can run as high as $50,000, while spinal fusion surgery costs less than half that, at roughly $23,000.

A favorable ruling on preemption would be great news for Johnson & Johnson, considering that SEC filings reveal that there were 100 lawsuits pending against the company at the end of 2006 related to the Charite artificial spinal disc, alleging that the company knew the disc was defective and boosted profits by implanting the device for uses not approved by the FDA and in patients who would not benefit from the device.

Between the time the disc was approved in October 2004 and July 2006, the FDA had already received over 130 reports of serious adverse events in patients implanted with the device and, in most cases, the disc was implanted in patients who did not meet the criteria for disc replacement as specified by the FDA.

Although a favorable Supreme Court ruling would be beneficial to the device makers in dealing with lawsuits filed by private plaintiffs in state courts, it will do nothing to stop the on-going investigations into the marketing of devices to determine whether device makers are funneling money to doctors and hospitals to increase the use of their products.

Anti-kickback statutes make it illegal for doctors or medical facilities to receive financial incentives to increase the use of devices, which in turn increase the number of implant procedures, in patients covered by public health care programs.

In the end, it was the greed, evidenced by drastic rise in the use of not only defibrillators and pacemakers, but all medical devices with Medicare patients over the past few years that drew the attention of lawmakers and law enforcement officials to the implant for profit industry.

On September 26, 2006, the New York Times reported that overall, Medicare payments to hospitals for implant procedures grew from $10 billion to $14 billion, an increase of about 40%, in just 2 years.

As of today, every major device maker is under investigation for working with doctors and hospitals to increase profits by billing public health care programs for implant procedures performed on patients who, in many cases, did not need the devices.

The FBI, the U.S. Department of Justice and the Department of Health and Human Services have set up a Medicare Fraud Strike Force, and the Strike Force is predicting that as much as $2.5 billion can be saved by cracking down on the device makers, doctors and hospitals involved in the implant industry.

The investigations of J&J and its DePuy Division are not limited to the Charite disc. In June 2006, the company was served a subpoena by the Antitrust Division of the DOJ, requesting documents related to the manufacture and sale of the company’s orthopedic devices, and search warrants were executed in connection with the investigation, according to documents filed by J&J with the SEC on August 8, 2006.

SEC filings also show that Medtronic is responding to a subpoena from the Office of the U.S. Attorney for the District of Massachusetts, issued under the Health Insurance Portability & Accountability Act of 1996, requesting documents relating to pacemakers and defibrillators; monitoring equipment and services; benefits to persons in a position to recommend purchases of such devices; and the company’s training and compliance materials relating to the fraud and abuse and federal Anti-Kickback statutes.

Investigations are also underway into over-use of the new drug-eluting stents (DES), marketed by Boston and Johnson & Johnson, with the average cost to Medicare ranging from $11,184 to $14,287, according to the Centers for Medicare and Medicaid Services.

The first DES was approved in 2003, and on December 4, 2006, Bloomberg reported that, in 2005, the new stents accounted for 43% of total sales for Boston and 52% for Johnson & Johnson. By the end of 2006, the new stent was a top-selling device for Boston, bringing in about $2 billion.

On March 1, 2007, the House Oversight and Government Reform Committee, which conducts oversight of Medicare spending, ordered Johnson & Johnson and Boston to turn over documents, related the marketing of drug-eluting stents.

In May 2007, the Strike Force reported that one Maryland cardiologist had implanted 25 unnecessary stents in 2006, with most patients covered by Medicare.

The salary for the cardiologists who benefit from stent procedures is roughly half-a-million dollars a year, according to an article in Slate Magazine on May 8, 2007.

Legal analysts are predicting that the lawsuits filed by patients injured as a result of the massive over-use of medical devices will involve all the co-conspirators in the medical profession who helped turn the implant business into a billion-dollar industry overnight.

Filed under: 2007, Boston Scientific, Charite, DePuy, Guidant, Johnson and Johnson, MEDICAID, medical devices, MEDICARE, Medtronic, Preemption, Riegel, stents, Supreme Court

Implant For-Profit Industry Not Deserving of Preemption Protection – Part II

Evelyn Pringle July 10, 2007

All the major medical device makers are using the preemption argument against patients who were implanted with defective devices, but Minneapolis-based Medtronic is a regular pen-pal with the Justices at the US Supreme Court.

The Court ruled against the company on preemption in Medtronic v Lohr, 518 US 470 (1996), a case where a pacemaker failed and resulted in the need for emergency surgery, and the plaintiff brought design, manufacturing and warning defect claims under state negligence and strict liability theories.

The Medical Device Amendments to the Federal Food, Drug and Cosmetic Act establish a federal statutory and regulatory scheme governing the sale of medical devices in the US.

After considering the case, the Supreme Court determined that the preemption clause did not preempt “all common law claims,” because all such claims do not create “requirements” that would conflict with federal law under the MDA and because the MDA provides no private cause of action against manufacturers, and that preempting all common law claims would bar most, if not all, relief for persons injured by defective medical devices.

Further, the Court determined that, if Congress had intended to preempt all state law remedies, it would have said so, and the Court noted the lack of legislative history going back to any such intent.

The Court stated that the state law damages remedy “merely provides another reason for manufacturers to comply with identical existing requirements,” and did not amount to “additional” or “different” requirements than the federal law.

So basically, legal experts say, in order to convince the court that �360k preempts a state law claim, device makers must establish that the MDA procedure under which their device was marketed created an adequately specific or otherwise preemptive federal “requirement” and convince the court that the state law based cause of action creates a preemptible “requirement” that is “different from,” or “in addition to,” requirements imposed by the MDA procedure.

As one of the largest heart rhythm device makers in the US, Medtronic is currently facing scores of lawsuits in state courts with allegations that it failed to adequately inform doctors and the FDA when it learned of a potential battery shorting problem in January 2003.

The firm waited until February 11, 2005, to warn physicians about the defect in 8 models of defibrillators. By that time, approximately 87,000 patients had been implanted with devices powered by batteries that could go dead without notice which were manufactured between April 2001 and December 2003.

Doctors were provided with a list of affected patients, and Medtronic recommended that doctors contact the patients and manage the issue in a way they felt appropriate.

When the defibrillators were recalled in 2005, the company offered to provide free replacement devices but would only agree to pay $2,500 to patients for out-of-pocket expenses for the replacement surgery.

The same year, on June 22, 2005, Bloomberg reported that Medtronic’s cardiac rhythm management business, which includes pacemakers and defibrillators, accounted for 46% of the company’s $2.78 billion in sales in its latest quarter. The cost of a defibrillator is about $20,000, according to Bloomberg.

On February 18, 2006, the New York Times reported that, because Medtronic did not offer to pay the hospital and doctor bills for the replacement procedures, “publicly funded plans like Medicare and private insurers are typically paying them.”

At the time of the article, the Times said, about 19,000 patients had undergone the replacement surgery since the recall.

Any patients who developed complications during the operations were left to fend for themselves. According to Bloomberg in February 2006, the cost of a defibrillator replacement and post-operative complications at a Des Moines hospital reached $100,000 for an unemployed 45-year-old father of six, who was uninsured and disabled when Medtronic sent a letter saying the defibrillator might need to be replaced.

Lawsuits have since been filed by private plaintiffs all over the country claiming personal injury and also by third-party payors seeking reimbursement of costs that resulted from with recall.

The lawsuits were consolidated in Multidistrict Litigation in the U.S. District Federal Court in Minneapolis before Judge James Rosenbaum, and in July 2006, Medtronic filed a motion for summary judgment arguing that the lawsuits should be dismissed, claiming FDA regulations for medical devices preempt the state laws on which the lawsuits are based and that the FDA had special authority over life-saving medical devices.

In the legal filings, Medtronic claimed the lawsuits are baseless, or preempted, because the defibrillator had passed the FDA approval process.

Documents revealed in litigation since the recall show that Medtronic knew of the problem that could cause the defibrillators to suddenly stop working long before the firm warned doctors who were implanting the devices. Company documents filed in a Federal court in San Jose, California, in the case of Randall v Medtronic, show the firm discovered the battery problem in January 2003.

In response to Medtronic’s motion, the plaintiffs argued that the FDA’s approval should have no bearing on the litigation because Medtronic provided the FDA with incomplete information when obtaining approval of the defibrillators, did not comply with the reporting obligations and failed to notify patients and the FDA of the defects in the devices.

On November 28, 2006, in what could be a major defeat for all device makers involved in similar litigation, the Minnesota Judge ruled against Medtronic and issued an order and opinion denying the motion and refused to accept the federal preemption argument.

In the opinion, the Judge stated that Medtronic “asks the Court to look past evidence, which if believed, tends to show it withheld critical information from the FDA while seeking the PMA Supplement approval for its newly designed battery.”

“Plaintiffs have produced credible evidence,” he wrote, “indicating that – after Medtronic discovered the design defect, and confirmed the discovery through patients’ device failures, and after obtaining FDA approval for the modified battery – Medtronic continued to ship and sell devices containing the defective battery.”

“In doing so,” the court continued, “it failed to notify the FDA, physicians, or patients that the battery was defective.”

The judge said Medtronic’s own actions and inactions may have placed it entirely beyond the scope of FDA approval protection. “Congress has chosen, and FDA regulations impose,” he wrote, “a scheme under which the manufacturer – not the government – determines a medical device to be safe and efficacious.”

He said it is the duty of the manufacturer to develop, produce and offer products it knows to be safe. “The FDA,” the judge wrote, “has only the most limited role in independently obtaining the information it needs; the duty to develop and fully disclose information concerning a medical device’s safety falls upon the manufacturer.”

In fact, the judge said, Medtronic’s own actions and inactions may have placed it entirely beyond the scope of FDA approval protection. “Congress has chosen, and FDA regulations impose,” he wrote, “a scheme under which the manufacturer – not the government – determines a medical device to be safe and efficacious.”

The judge pointed out that a device maker’s failure to disclose its own knowledge about the danger of an approved device has its own effect: “the company’s failure to exhibit absolute probity could be found to have knowingly deprived the FDA of information needed to confer its approval for the device to be implanted in humans,” he stated.

“If proven,” the court wrote, “such a failure to fully comply with Congress’s self-disclosure scheme may have deprived Medtronic of federal preemption protection altogether.”

He pointed out that the FDA recall did not occur until after Medtronic issued its February 2005 “Dear Doctor” letter, and said it defies logic and flies in the face of Congress’s decision to impose a regime strictly regulating medical device makers, “to think Congress intended the result Medtronic advocates.”

A favorable ruling on preemption in the Supreme Court might have allowed Medtronic to escape all liability, had the company not been so greedy in ripping off public health care programs and the Democrats had not taken control of Congress last fall.

Filed under: 2007, medical devices, Medtronic, Preemption, Supreme Court

FDA Avandia Mole Defends Off Label Marketing of Natrecor

Evelyn Pringle August 12, 2007

It looks like that Mafia guy, Dr Steven Nissen, leader of the Cleveland Clinic gang, who blew the whistle on the diabetes drug Avandia and before that Vioxx, was on to something when he voted against the FDA’s approval of the heart failure drug Natrecor in 2001.

Giving once- or twice-weekly outpatient injections of Natrecor does not reduce the risk of death or hospitalization for heart or kidney problems, according to research presented at the American College of Cardiology meeting in New Orleans in March 2007.

In fact, the study of 920 patients found that outpatient use of Natrecor provided absolutely no benefit. The finding should halt the practice of giving once- or twice-weekly Natrecor to outpatients, said researcher Dr Clyde Yancy, medical director of the Baylor Heart and Vascular Institute in Dallas, Health Day reported on March 26, 2007.

Of course, the revelation that Dr Nissen was running the Cleveland Clinic Mafia and that they were out to get GlaxoSmithKline by publishing a study that showed Avandia increased the risk of heart attacks and deaths came in an email to reporters from FDA spokesman Douglas Arbesfeld, which included the warning to other drug companies, “if you don’t hire the Cleveland Clinic for your big trials then you face the firing squad from Nissen and Company.”

Mr Arbesfeld left his position as a highly-paid spokesperson for Johnson & Johnson to become a dedicated public servant at the FDA, if his supporters are to be believed.

When his conduct of sending the email came under scrutiny, Peter Pitts, who co-authored a June 6, 2007, critical commentary in the Washington Times about the Avandia study and fondly referred to Dr Nissen as a “Patron Saint of Drug Safety” and “Saint Steven the Pure,” put out a statement on the internet saying that, by sending the email, Mr Arbesfeld was just defending the FDA and praised his selfless work, stating:

“I know Doug Arbesfeld,” he wrote, “and he is a guy devoted to advancing the public health,” he wrote.

“He is also a guy who took a pretty significant pay cut to put in some time in public service,” Mr Pitts pointed out.

In response to that assertion, it could certainly be argued that a mole at the FDA would be in a position to earn far more money by selling invaluable insider information to all the drug companies than as media person working for one company.

It should be noted that in his email to reporters, Mr Arbesfeld also referred to Dr Nissen as St Steven – surely just by coincidence.

For the record, the Cleveland Clinic is rated as the top cardiac center in the country by US News and World Report, and Dr Nissen holds the number 72 position on Time Magazine’s list of the 100 most influential people in our world.

An effort that included at least 50 different google searches on the internet over a period of several days found no similar praise listed for Mr Arbesfeld other than Mr Pitts’ recent two-liner that showed up on about every search.

At the end of his Times commentary, Mr Pitts listed himself as the president of the Center for Medicine in the Public Interest and a former FDA associate commissioner, but a little checking revealed that he is also a Senior Vice President at the public relations firm of Manning, Selvage & Lee.

A review of the Manning website shows that the firm’s clients have included Pfizer, Eli Lilly, AstraZeneca, Sanofi-Aventis, Johnson & Johnson, Genentech, Novartis, Amgen and Hoffmann La-Roche.

A review of Mr Pitts’ articles on the internet clearly shows that he is in lockstep with his industry clients against: (1) allowing Americans to import drugs from other countries to cut costs; (2) allowing the government to negotiate lower drug prices; (3) barring drug makers from promoting their drugs for uses not approved by the FDA; (4) cutting back on direct-to-consumer advertising, and (5) adding black box warnings to product labels.

As luck would have it, a bit more checking found a December 16, 1999, press release by the Healthcare Marketing & Communications Council which reported that Mr Arbesfeld had joined Manning, Selvage & Lee as Senior Vice President.

The list of pharmaceutical companies that Mr Arbesfeld has worked for over the years includes Ciba-Geigy in 1994, and Rhone Poulenc Rorer Pharmaceuticals in 1998, the same year the company announced that it would merge with Hoechst AG to become Aventis, which merged with Sanofi-Synthelabo in 2004 to become Sanofi-Aventis.

In 1999, Mr Arbesfeld would have been working for the Manning clients listed above, and on August 5, 2002, he identified himself to Reuters as promoting a prescription drug card program called “Together Rx” for 7 drug companies that included Bristol-Myers, Aventis, GlaxoSmithKline, Johnson & Johnson, AstraZeneca, Abbott Laboratories and Novartis.

Finally, Mr Arbesfeld is listed as the contact person for Johnson and Johnson subsidiaries Janssen Pharmaceutica, Ortho-McNeil Pharmaceutical and Ortho Biotech Products in the 2005 Reporters Handbook.

While his supporters say Mr Arbesfeld’s email to reporters was justified, lawmakers on Capitol Hill see it differently and have launched an investigation into what they refer to as a smear campaign against Dr Nissen. At a June 6, 2007, hearing before the US House Oversight Government Reform Committee, in response to questions about Mr Arbesfeld email stunt, FDA Commissioner Andrew von Eschenbach claimed that he did not approve of the email and told the lawmakers, “I completely concur with you that it was inappropriate and unacceptable.”

“It was an inappropriate and unfortunate act on the part of an individual,” he said, “which has been addressed through disciplinary procedures.”

In a letter to the FDA Commissioner, the lawmakers said they found it troubling that Mr Arbesfeld might be trying to settle old scores with Dr Nissen because he cast the lone vote against the approval of the heart drug Natrecor (nesiritide) and later spoke out against the off-label use of the drug in a New York Times article in which Mr Arbesfeld spoke on behalf of the drug’s maker J&J subsidiary Scios.

The fact is, a review of the regulatory history behind Natrecor proves that Dr Nissen was right then, just as he is now about Avandia.

The drug was approved for limited use by hospitalized patients with acute congestive heart failure, to be administered intravenously under close supervision. However, due to a massive off-label marketing campaign, the drug was soon being administered in outpatient settings at a much greater dose and for longer periods of time than recommended.

In May 2005, the New York Times reported that tens of thousands of patients were undergoing “tune-ups” at outpatient clinics by receiving weekly infusions of Natrecor over a period of months.

In the July 14, 2005, New England Journal of Medicine, apparently another Mafia guy from the Cleveland Clinic gang, Dr Eric Topol, was out to get J&J because he reported that the company was encouraging physicians to open their own infusion centers to bill Medicare for Natrecor treatment and that company documents instructed doctors to bill Medicare $408 for eight hours of observation during the infusion, above and beyond the actual cost of the drug, which was around $500 per vial, he said.

In addition, the company set up a toll-free telephone hotline for “Natrecor Reimbursement Support” and published a 46-page reimbursement and billing guide to provide doctors with specific Medicare billing codes.

“Natrecor was never shown to be superior for reducing death or reducing the need for repeat hospitalizations,” Dr Topol said, and asked: “How could this happen? All of a sudden we have 600,000 people using this drug.”

He also pointed out that other drugs, costing less than $10 a dose, were equally effective.

The Natrecor infusion-for-profit scheme was indeed on a roll. J&J had recruited doctors and nurses with experience in administering infusions to deliver presentations at medical seminars, and some clinics had programs set up to administer Natrecor to patients twice a week for up to 12 weeks. In 2004, Natrecor brought in about $400 million for J&J, and sales were projected to be $700 million for 2005.

However, the profiteers were hit with a ton of bricks on April 20, 2005, when a study appeared in the Journal of the American Medical Association that reported patients treated with Natrecor were 80% more likely to die in the 30 days following the treatment than patients given a placebo, by Dr Jonathan Sackner-Bernstein of the North Shore University Hospital in Manhasset, NY; Drs Marcin Kowalski and Marshal Fox, of St Luke’s-Roosevelt Hospital Center in NY; and Dr Keith Aaronson of the University of Michigan.

On April 26, 2005, in response to the findings of the study, Mr Arbesfeld told HeartWire, “We take any question about the safety of Natrecor seriously.”

“At the same time,” he said, “a review of Scios’s full clinical study data set does not show a statistically significant difference in mortality.”

Although the collective data from the studies reflects a 23% higher death rate for those taking Natrecor, Mr Arbesfeld said, the number of patients in the studies was too small to produce conclusive results of death risk, in a Reuters article on April 25, 2007.

In response to comments about Natrecor not being approved for outpatient use, Mr Arbesfeld told the Times that the FDA label did not specify where the drug could be administered, so giving it in an outpatient setting did not run counter to its approved use.

However, that Mafia guy from the Cleveland Clinic, Dr Nissen, told the Times that treating patients in ambulatory settings was “inappropriate and cannot be recommended.”

Before long, more doctors began speaking out. Cardiologist Dr Milton Packer, chairman of the advisory panel that voted to approve the drug, told the Times on May 17, 2005, that Natrecor was not intended for outpatient use. “We said this is a drug that should be approved for patients who are short of breath at rest, who are hospitalized,” he said.

He also faulted the FDA’s approval of a label that did not specify that Natrecor was for hospital use only.

Dr Sackner-Bernstein expressed outrage in the Health Day Report. “The people involved at Scios and others who knew about this data should be hanging their heads,” he said.

“What is wrong with everybody,” he continued, “that you’ve got a drug that increases renal dysfunction and death, and costs 50 times as much as a regular treatment, and yet it’s given to hundreds of thousands of people?”

After the April study came out, J&J hired a heart specialist, Dr Eugene Braunwald, to form a committee to review the studies, and the committee reached the same conclusion, that it was inappropriate to use Natrecor except with acutely ill hospitalized patients.

Specifically, the panel said, Natrecor should be used only when patients show up at a hospital with acute heart failure; that it should not replace diuretics as the front-line treatment; and that it should not be used where patients schedule appointments to receive the drug ahead of time.

Their report also stated: “Scios should immediately undertake a proactive educational program to inform physicians regarding the conditions and circumstances in which [Natrecor] should and should not be used.”

So what did J&J do in response? According to Dr Packer, who was a member of the panel, the committee members were shocked several weeks later when they received invitations from a mass mailing to enroll in a continuing medical education program, sponsored by Scios, that appeared to promote the outpatient use.

“We were flabbergasted,” Dr Packer told the Times on August 1, 2005. “Scios was sponsoring meetings to discuss nesiritide and its potential use in outpatients.”

As so often happens these days, this drugging-for-profit scheme caught the attention of lawmakers because about 80% of the patients receiving Natrecor were on Medicare.
D-Day came on December 5, 2005, when the Centers for Medicare and Medicaid Services announced that Medicare would no longer pay for outpatient infusions.

But the Natrecor story is far from over because, according to Johnson & Johnson’s 2006 Annual Report, the company received a subpoena from the US Attorney’s Office, District of Massachusetts, in July 2005, seeking documents related to the sales and marketing of Natrecor, and in August 2005, J&J was advised that the investigation would be handled by the US Attorney’s Office for the Northern District of California in San Francisco.

The latest news came on March 12, 2007, when J&J revealed that it had received 3 new subpoenas from the US Attorneys’ offices in Philadelphia, Boston and San Francisco wanting information for the investigation into the company’s sales and marketing of Natrecor.

More recently, in an apparent repeat of the exact same scam, investigators have found that J&J and Amgen have been paying doctors to administer the anemia drugs Aranesp, Epogen and Procrit off label for profit. On May 9, 2007, the New York Times reported that drug makers are paying “hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines.”

The Times cited documents obtained from a former employee of a group of 6 cancer doctors which showed that between them, the 6 doctors received $2.7 million from Amgen for prescribing $9 million worth of anemia drugs in 2006.

On May 10, 2007, the Wall Street Journal cited a document provided by a former J&J sales representative-turned-whistleblower which showed that a doctor who purchased nearly $1 million worth of Procrit over 15 months would receive $237,885.

In March 2007, the FDA ordered black box warnings on the drug’s labels about an increased risk of numerous adverse events and issued a public health advisory warning health care providers to administer the lowest possible dose necessary to treat anemia.

According to the FDA, as of March 2007, there are five clinical trials that demonstrated decreased survival time in cancer patients receiving the drugs compared with those receiving transfusion support.

The agency also reported a higher rate of blood clots, strokes, heart failure, heart attacks and death were found in patients with chronic kidney failure when the drugs were given to raise hemoglobin levels higher than recommended.

The FDA advisory also noted a higher risk of blood clots in patients who were scheduled for major surgery and received the anemia drugs and also warned of an increased rate of tumor growth in patients with advanced head and neck cancer receiving radiation therapy and metastatic breast cancer patients receiving chemotherapy, when the drugs were given to maintain levels higher than recommended.

J&J is already facing several class-action lawsuits filed by shareholders as a result of the revelation of this latest drugging-for-profit scheme, and the company has also received a subpoena from New York’s attorney general requesting information on the sales and promotional activities related to Procrit.

But then, why should J&J worry over a minor little investigation by the NY attorney general. The feds have been investigating the Natrecor fiasco for more than 2 years, and the J&J executives who reaped the benefits have probably not lost one wink of sleep.

Filed under: 2007, Amgen, anemia drugs, Aranesp, Avandia, Epogen, FDA, Johnson and Johnson, Manning, MEDICAID, MEDICARE, Natrecor, Pitts, Procrit

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