Part 3 of 3 parts; Off-label prescribing of prescription drugs: Pfizer embroiled in massive lawsuit over off-label use of Neurontin
By Evelyn Pringle
Online Journal Contributing Writer

Jun 1, 2006, 00:55

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 2,000 more who attempted suicide while taking Neurontin.

In addition to handling lawsuits, for more than two 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. He 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 in depth 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 five 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 on 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 six 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. He recognizes, "Speaking up puts their current job in jeopardy and it threatens to brand them as troublemakers 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, three times the wages lost, compensatory damages, and attorney�s fees.

For more information for injured parties go to Lawyers and

Evelyn Pringle is a columnist for OpEd News and an investigative journalist focusing on exposing corruption in government.

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