Pfizer Sued in California: Covering up Zoloft Side Effects
Categories23 July 2004 - Pfizer has been sued in the Los Angeles Superior Court by Roberta Madison, a nurse who decided to file her claim on behalf of all the persons that have been misled by Pfizer's claims of the safety and effectiveness of Zoloft, reports the Miami Herald.
Zoloft is a hot selling drug that rakes in billions for the pharma manufacturer. While no more effective than placebo - the drug is showing serious side effects, inducing violent and suicidal behaviour in many of those who take it.
Meanwhile another drug maker, Janssen Pharmaceutica, has admitted in a letter to doctors that a similar drug, Risperdal, has been promoted with misleading claims and that the company has minimized its potentially fatal risks.
Both drugs are implicated in a recent scandal over pharmaceutical corruption, resulting in guidelines for the prescription of psychiatric medication that favour the drugs of those pharma manufacturers who sponsored the development of the guidelines, first piloted in Texas and now being exported to more states.
The drugs recommended by the tainted guidelines already rake in billions for their makers, but business will certainly be even better if the psychiatric testing program recommended by Bush's 'Freedom Commission' for Mental Health takes off.
Psychiatric drugs are not child's play. Children suffer and die from them, says whistleblower Dr. Stefan Kruszewski a psychiatrist hired by the Bureau of Program Integrity in the Pennsylvania Department of Public Welfare to root out fraud, abuse and waste within the Department. When he did his job and insisted on making public what he found, he was promptly fired. Kruszewski discovered that four children and one adult who had been prescribed potentially lethal combinations of medications died while under state care. He believes they died from drug toxicity, but he was not permitted to review the autopsy reports.
Meanwhile, implementation of the testing-and-drugs initiative seems to be well under way. Illinois is the first state set to require universal testing of pregnant mothers and of children up to 18 years of age, according to an article in The Illinois Leader.
Lawsuit charges Pfizer misled public about anti-depressant Zoloft
ALEX VEIGA || Associated Press
Posted on Fri, Jul. 23, 2004
LOS ANGELES - A California woman is suing Pfizer Inc., claiming the drug maker mislead physicians and patients about the safety, effectiveness and side effects of the anti-depressant drug Zoloft.
The 19-page complaint, filed Friday in Los Angeles Superior Court, contends that Pfizer buried evidence showing the drug was no more effective than a placebo and its users tended to develop an array of side effects, including withdrawal symptoms, dependency, convulsions and psychosis.
The lawsuit also accused the New York-based drug maker of suppressing data indicating the drug increased the risk of suicidal and violent impulses in users.
"Pfizer has engaged in repeated and persistent false and misleading conduct by misrepresenting, concealing and otherwise failing to disclose to physicians and other prescribing health care providers information in its possession ... concerning the safety and effectiveness of Zoloft," the lawsuit claims.
The woman, Roberta Madison, was identified as a nurse and doctor of Public Health who lives in Los Angeles.Madison's claim does not stem from personal injury, the suit states. Instead she decided to sue on behalf of all Californians who "have been misled about Zoloft," the law firm representing her said in a statement.
The suit asked the court to order Pfizer to pay an undetermined amount of money in restitution, including proceeds from Zoloft sales, to users of the drug in California. It also seeks a court order forcing Pfizer to give access to Zoloft research studies.The lawsuit asserts that while Pfizer has been known to publicize positive information about Zoloft, the company has "intentionally withheld and concealed" negative information on the drug, ultimately hampering physicians' ability to determine whether to prescribe the drug.
The suit also claims early Pfizer studies of the drug's effectiveness were negative, failed or were neutral, and the majority of the studies showed there were no clinically or statistically significant differences between the drug and placebo, but the drug maker concealed the results.
"Many Pfizer studies not only failed to demonstrate that Zoloft is efficacious, they clearly demonstrated that Zoloft is associated with serious, severe and sometimes fatal side effects," the suit claimed.A message left after hours with a Pfizer spokesman was not immediately returned Friday.
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Original in: Miami Herald (need to be registered to get access)
CHILD WELFARE
Maker of drug admits hiding its risks
Posted on Sat, Jul. 24, 2004BY CAROL MARBIN MILLER
The maker of a billion-dollar antipsychotic medication has acknowledged misleading doctors and other healthcare providers about the safety of its product, minimizing potentially deadly side effects.The drug, Risperdal, has been commonly prescribed to Florida children in state care, including to a handful of boys who developed lactating breasts after taking it.
On Wednesday, drug maker Janssen Pharmaceutica wrote a two-page letter to doctors, warning them that the company, in promotional material, had ''minimized potentially fatal risks, and made misleading claims'' that the medication was more safe in treating mental illness than other drugs in the same category.
Most physicians received the letter Friday.
Risperdal is the leading drug used to combat schizophrenia and other types of psychotic disorders, earning Janssen about $2.1 billion in annual sales. The drug was first marketed about eight years ago, and is prescribed to more than 10 million people worldwide.
The ''important correction of drug information'' came shortly after federal regulators had accused Janssen of ''disseminating'' advertising and marketing material that was ``false or misleading.''
A letter from Janssen to doctors, dated Nov. 10, 2003, claimed Risperdal did not increase the risk of diabetes among consumers compared with other similar drugs, called neuroleptics or antipsychotics.
But an April 2004 letter from the U.S. Department of Health and Human Services to Janssen asserts quite the contrary. Research indicated ''an increased risk of hyperglycemia-related adverse effects and diabetes with Risperdal,'' the letter stated.
A TROUBLED HISTORY
In 2001, The Herald published a series of stories about the common use of Risperdal among children in state care. Child-welfare advocates said the drug routinely was being used by foster care providers as a ''chemical restraint'' on children whose unruly behavior was a frustration to caretakers.
''I had clients who were displaying severe side effects, and I tried to alert the Department of Children & Families both as to the local problem and the growing national concern about a range of psychotropic medications, Risperdal and other antipsychotics in particular,'' said Coral Springs attorney and children's advocate Andrea Moore.
''They listened, but they did not hear me,'' Moore added.
Broward Circuit Judge John A. Frusciante, who must approve requests from doctors before they can prescribe mind-altering drugs to children whose cases he oversees, said Risperdal continues to be used frequently by doctors who treat children in state care.
''It is not uncommon,'' Frusciante said.
''This whole psychotropic drug issue is a problem for us,'' Frusciante said. "It's a very scary area to be in, because we know medication can be a tremendous help for a number of children. But we also know that there are risks to the children who are taking these medications.''
Friday, DCF officials told The Herald they would review the new material and ask doctors who care for foster children to re-evaluate their medication options.
''We will make this information available to all our districts, program supervisors, community-based care agencies and partners,'' said DCF spokesman Bill Spann. "In addition, we will provide this information to all the physicians who care for the children in foster care, and ask them to review the cases of any children who are on the drug."
''We will ask them to take the appropriate action,'' Spann said.
ONE IN THREE TREATED
The state Agency for Health Care Administration, which pays the drug bill for most children in state care, as well as needy children who are insured by Medicaid, could not say Friday how many Florida Medicaid recipients are being administered the drug.
In 2001, after The Herald's series, DCF reviewed the records of most foster children. Records showed about about one in three foster children taking a powerful mood-altering drug. Many were taking untested combinations, or ''cocktails,'' of the drugs.
Infants and toddlers were being given psychiatric drugs, according to a 2003 study by the Florida Statewide Advocacy Council.
Antoinette R. Appel, a Plantation neuropsychologist, studied the records of about 50 South Florida foster children who had been prescribed Risperdal.
She said many of the children developed severe side-effects, including obesity, lethargy, lack of concentration, hormonal disorders and the inappropriate development of secondary sexual characteristics, such as lactating breasts in boys or young girls.
Carolyn Salisbury, associate director of the University of Miami's Children & Youth Law Clinic, has pleaded with child welfare authorities for about five years to curtail the widespread use of mood-altering drugs among foster kids, who often complain the drugs make them more ill.
VICTORY IN COURT
One of the clinic's most high-profile clients, identified in court papers as M.W., won a Florida Supreme Court ruling that child welfare authorities cannot lock up foster kids in psychiatric hospitals without a hearing. M.W. had developed lactating breasts after doctors forced him to take Risperdal, court records show.
One of Salisbury's clients, a 15-year-old girl, begged her to prevent the child welfare agency from forcing her to take Risperdal, Salisbury said. The girl had become obese and suffered from dramatic mood swings, alternating between feeling agitated or very depressed.
''I always object to my foster child clients being placed on Risperdal... ,'' Salisbury said. "However, DCF continues to place children in their care on the drug, even though DCF knows full well the horrible side effects foster children continue to suffer on this drug.''
There are a number of interesting comments on the page of the British Medical Journal, where the plans for widespread testing in the US were originally exposed. One of the latest comments is Allen Jones' reaction to the many concerned voices, making reference to the Bush testing plan already being put into effect in Illinois:
I am gratified to read the responses of so many persons who are concerned about the unbridled screening of our nation's children on the basis of a government initiative of dubious origin. To those who remain skeptical, or in disbelief, please read the following from the state of Illinois:
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