Patients vs. Bayer

BayerPatients vs. Bayer
Bayer Official Offers Defense in Texas Trial of Drug Suit

By MELODY PETERSEN
The New York Times

Melody Peterson of the New York Times reports that in the first case brought against Bayer involving its anticholesterol drug, Baycol, a senior official of Bayer AG testified in court in Corpus Cristi, Texas. He acknowledged that company officials in Germany proceeded with the marketing of Baycol despite the reluctance of US company officials to do so.

Patients vs. Bayer

3/1/2003

Bayer Official Offers Defense in Texas Trial of Drug Suit

http://www.nytimes.com/2003/03/01/business/01DRUG.html?ex=1047531517&ei=1&en =2c00117efe2c31f7

By MELODY PETERSEN
The New York Times

Melody Peterson of the New York Times reports that in the first case brought against Bayer involving its anticholesterol drug, Baycol, a senior official of Bayer AG testified in court in Corpus Cristi, Texas. He acknowledged that company officials in Germany proceeded with the marketing of Baycol despite the reluctance of US company officials to do so.

More than 30 people who took the drug died in the US of rhabdomyolysis (rhabdo) before it was withdrawn from the market in 2001.

Internal Bayer company documents reveal a corporate culture among its executives that puts sales above patient safety. The documents reveal that the company was „overwhelmed‰ by the avalanche of spontaneous adverse drug reports from doctors: “The steadily increasing numbers of spontaneous reports of rhabdomyolysis associated with Baycol, along with the additional telephone activity, has overwhelmed the available safety assurance resources.”

Bayer‚s vice president of scientific affairs wrote in an e-mail: „Many of the cases are ugly,” including reports of “dialysis, long hospitalization, disability and two potentially related deaths.”

However, the Times reports, even after numerous reports of rhabdo were mounting “there is not a real push to find out about statins and rhabdo.”

Of greater interest to Bayer officials were its sales. The Times reports that the minutes of a Bayer meeting indicate that Dr. Wolfgang Plischke, president of Bayer’s North American pharmaceutical division, “reiterated the need to drive future sales and his belief that we can achieve blockbuster status.”

Inexplicably The FDA obliged Bayer with its marketing strategy that increased fatalities by approving a higher dose formula of Baycol in July 2000: The Times reports that Bayer „executives said their goal with the higher dose was to capture 15 percent of the market. At that time, the minutes said, Baycol had 5 percent.‰

FDA did nothing to protect the public from a lethal drug until Bayer pulled Baycol off the market in 2001 after more than 30 deaths were linked to the drug.

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) http://www.ahrp.org Contact: Vera Hassner Sharav 212-595-8974 e-mail: veracare@ahrp.org

A senior executive at Bayer testified in court yesterday that company officials in the United States recommended against selling the anticholesterol drug Baycol several years before it was introduced in 1997 because they thought its sales potential was limited.

But Baycol was introduced because officials in Germany, where Bayer is based, decided to push ahead when market conditions improved and the potential for profit looked promising for many years.

Sales of Baycol increased rapidly until Bayer pulled Baycol off the market in 2001 after more than 30 deaths were linked to the drug. The company has been dealing with the aftermath since.

The Bayer executive, Dr. Lawrence Posner, senior vice president for pharmaceutical development, was testifying in county court in Corpus Christi, Tex., in a case brought by a patient who contracted a muscle disorder called rhabdomyolysis after taking Baycol.

It is the first case involving Baycol to go to trial. More than 10,000 patients or the families of those who died after taking Baycol have filed lawsuits against Bayer.

Dr. Posner defended the company for several hours yesterday as lawyers for the plaintiff, Hollis Haltom, 82, introduced dozens of internal company documents into evidence.

He said Bayer had monitored reports of rhabdomyolysis, known as rhabdo, in patients taking Baycol and had properly informed doctors about the risks of the medicine as it learned of them.

But several memos from Bayer’s safety officials in 1999, made public earlier in the trial, describe how its staff was struggling to respond to an increasing number of reports of patients who had become ill with rhabdo while taking Baycol.

In a memo written on Dec. 30, 1999, and addressed to Dr. Posner, safety officials said they had received reports of 60 cases of rhabdo in the United States in the previous two months. Doctors and others observing people becoming ill or dying while taking a medicine voluntarily file the reports in question, known as adverse event reports, with regulators and the drug’s manufacturer.

“The steadily increasing numbers of spontaneous reports of rhabdomyolysis associated with Baycol, along with the additional telephone activity, has overwhelmed the available safety assurance resources,” the officials, who were not individually identified, wrote.

Philip S. Beck, an outside lawyer for Bayer, said in an interview yesterday that he disagreed that safety officials were ever overwhelmed. “The company provided all the manpower that was needed,” he said.

One document that lawyers for the plaintiff have mentioned at least twice is an agenda for a meeting of Bayer’s scientific relations department staff in January 2000. It is covered with handwritten notes, some describing Bayer’s willingness to study reports of rhabdo before introducing a new higher dose of the drug, which is an anticholesterol medicine known as a statin.

The notes on the agenda say that because Bayer had described the risk of rhabdo in Baycol’s label, “there is not a real push to find out about statins and rhabdo.”

The note – by a person not yet identified in court – also says that a safety database has been developed. “Some are scared to uncover such data (bad data) because of the launch of 0.8 mg,” it says about the higher dose. “If F.D.A. asks for bad news, we have to give, but if we don’t have it, then we can’t give it to them.”

Bayer did undertake an internal analysis of the reports of rhabdo cases around that time. In March 2000, Steve Niemcryk, an epidemiologist at Bayer, and Paul Cislo, a database analyst, reviewed the reports of rhabdo that regulators received through June 1999. They said Baycol “substantially elevates” the risk of rhabdo, compared with similar drugs on the market.

But the analysts also said the magnitude of the problem could not be determined with the available data. The report said the company was talking to health insurers and other organizations with large numbers of patients taking Baycol about doing a better analysis.

Mr. Beck said the study was not scientific. The adverse event reports, he said, say only that a drug may be associated with the side effect, not that it actually caused it.

About that time, Dr. Richard Goodstein, vice president for scientific relations at Bayer, wrote an e-mail message to two dozen Bayer executives working on Baycol in the United States. He said that “alleged cases” of rhabdo caused by Baycol were coming into his office at a rate of about one a day.

„Many of the cases are ugly,” he wrote, including reports of “dialysis, long hospitalization, disability and two potentially related deaths.”

Dr. Goodstein continued, “To me, it has never been an issue of, should-if-will we need to respond, but rather to whom, how, what?”

“It will be too long a time until the potentially helpful results of new epidemiologic/scientific studies envisioned by Bayer World-Wide are completed,” he wrote.

In videotaped testimony played for the Corpus Christi jury, Dr. Goodstein said he recalled being worried about the rising reports and said he had discussed with his boss and other Bayer executives whether the analysis by Mr. Niemcryk and Mr. Cislo should be disclosed to doctors. “We decided that it was not substantive data,” Dr. Goodstein said. “We can’t have anybody making decisions based on unreliable data.”

The documents also indicate that Bayer executives decided to limit the spread of studies with unfavorable findings on Baycol’s effectiveness.

For example, at a July 1997 meeting of Bayer’s Baycol publications committee, executives discussed a study comparing cerivastatin, the chemical name for Baycol, to simvastatin, a competing drug. “The U.S. did not want to publish this data, since simvastatin did better than cerivastatin” and included doses that were lower than those in another study, the minutes said.

Bayer has been largely silent about how important the higher dose of Baycol was to the company. But company documents indicate that Bayer was counting on the stronger pill to increase sales.

According to minutes of a meeting of the U.S. Baycol Project team in July 2000, just before the Food and Drug Administration approved the higher dose of the drug, executives said their goal with the higher dose was to capture 15 percent of the market. At that time, the minutes said, Baycol had 5 percent.

The minutes also say that Dr. Wolfgang Plischke, president of Bayer’s North American pharmaceutical division, attended the meeting and “reiterated the need to drive future sales and his belief that we can achieve blockbuster status.”

Pharmaceutical companies often refer to a blockbuster drug as one that reaches sales of $1 billion a year.

When Bayer pulled the drug from the market in August 2001, the F.D.A. said some of the 31 deaths reported had been linked to the stronger pill. Mr. Beck has said that Bayer knew that side effects increased with the higher dose, but that the company began selling it to help people with severe heart problems who needed a stronger medicine.

Another document that lawyers for the plaintiffs have raised repeatedly was created after Baycol was pulled from the market in August 2001. The document is a slide that was presented to top Bayer executives at a global planning meeting in December 2001 that says, “DIG; THROW (The Corpse); COVER (With sand).”

Lawyers for the plaintiffs say the document is one of many supporting their allegation that Bayer covered up information about the serious risks of Baycol.

But Mr. Beck told the jury that the document – one slide in a set presented to top global Bayer executives – should be disregarded. It refers, he said, to a plan by people at the company who wanted Baycol put back on the market. The author of the slide wished to make the point that putting Baycol back on the market was a bad idea that should be buried, Mr. Beck told the jury.

Copyright 2002 The New York Times Company

495 total views, no views today

Jefferson Co., Wisconsin vs. David Throm (Criminal Trial)

Throm is found guilty in death of girlfriend

By Steve Sharp
Daily Times staff

A 42-year-old Palmyra man was found guilty this morning of first-degree homicide and a charge of hiding a corpse by a Jefferson County judge.
Jefferson Co., Wisconsin vs. David Throm (Criminal Trial)

2/28/2003

Throm is found guilty in death of girlfriend

http://www.wdtimes.com/articles/2003/02/28/news/news2.txt

By Steve Sharp
Daily Times staff

A 42-year-old Palmyra man was found guilty this morning of first-degree homicide and a charge of hiding a corpse by a Jefferson County judge.

David W. Throm was found guilty of killing his live-in girlfriend and hiding her body by Judge William Hue.

Hue convicted Throm of the two charges after listening to testimony throughout the week. Opening arguments got under way Monday morning and approximately 28 witnesses testified during the bench trial.

Following the conviction this morning, Throm’s bond was revoked and he was returned to the Jefferson County Jail to await sentencing.

No date for his sentencing has been set.

If a request is filed for a pre-sentence investigation, the sentencing date will be 45 to 60 days from now. If no request is filed, a sentencing date will be held within 30 days.

Throm faces life imprisonment for the death of Colleen Ann Wilke, 39, of Palmyra, whose body was found July 2, 2002, in a remote area about one mile west of County Trunk H on Marsh Road in the town of Palmyra.

Throm was later arrested in Minnesota when deputies responded to an emergency call at a wayside near Blue Earth, Minn. Throm apparently attempted to commit suicide as deputies found a suicide note in his car stating his girlfriend, Wilke, was dead. The note also indicated where Wilke’s body could be found.

Wilke and Throm were not living together at the time of the incident because they had recently broken off their relationship. Both were on the rebound from recent divorces.

Throm’s attorney, Maura McMahon of the state public defender’s office, pursued an involuntary intoxication defense relating to Throm’s prescription to Paxil, an antidepressant drug.

Prior to Paxil, walking away from a situation was Throm’s defense mechanism, McMahon told the judge. Dr. Andrew Schroetner, a psychiatrist form Watertown, testified by video that he had increased Throm’s dose of Paxil on June 7, 2002. Two weeks before Wilke’s body was found and Throm arrested, Schroetner decreased the dosage of Paxil and added a dose of Seroquel.

District Attorney David Wambach presented testimony in which Throm’s care provider described him as angry, wounded and ready to explode. During his opening argument, Wambach referred to a statement Throm had made to Wilke that she “should fear him.”

A Madison pathologist testified Wilke sustained a bruised heart, nine rib fractures, lacerated liver, fractured voice box cartilage and four separate areas of neck hemorrhage.

Several neighbors, friends and family members of Wilke’s testified, including her 14-year-old daughter.

Throm did not take the stand during the trial.

889 total views, no views today

Taylor vs. Solvay Pharmacueticals

Taylor vs. Solvay Pharmacueticals

Drug firm settles with Columbine victim

By Howard Pankratz hpankratz@denverpost.com
Denver Post Legal Affairs Writer

Columbine survivor Mark Taylor today dropped his lawsuit against the manufacturer of a drug he claimed made Eric Harris homicidal and suicidal in return for the company contributing $10,000 to the American Cancer Society.

Taylor vs. Solvay Pharmacueticals

2/6/2003

Drug firm settles with Columbine victim

http://www.denverpost.com/Stories/0,1413,36%257E53%257E1162902%257E,00.html

By Howard Pankratz hpankratz@denverpost.com
Denver Post Legal Affairs Writer

Columbine survivor Mark Taylor today dropped his lawsuit against the manufacturer of a drug he claimed made Eric Harris homicidal and suicidal in return for the company contributing $10,000 to the American Cancer Society.

Under the terms of the settlement, Belgium-based Solvay Pharmacueticals won’t pay Taylor or his lawyers any money.

Taylor and Solvay executives agreed that dismissal of the lawsuit doesn’t mean either has waived from their contentions about the merits of Luvox. Taylor alleges Luvox is dangerous while Solvay says it has helped millions cope with depression.

“Mr. Taylor believes his claims had merit, but Solvay has always denied, and continues to deny, each of Taylor’s claims about Luvox,” said the agreement read in Denver federal court by U.S. District Judge Clarence Brimmer.

In accepting the settlement, Brimmer said he thought the case was one that needed to be settled and noted that a couple of years ago a Wyoming jury had issued an The $10,000 being given to the American Cancer Society is described as a “charitable donation” in the settlement.

“Both parties are pleased with the amicable resolution and dismissal of this case without the need of subjecting the Denver community and the victims of Columbine to a public trial of this case,” said the settlement.

Taylor just barely survived the April 20, 1999, Columbine rampage in which Harris and fellow student Dylan Klebold embarked on the nation’s deadliest school shooting.

Taylor was critically injured when Harris threw two pipebombs at him and unleashed a volley of shots that wounded Taylor at least six times.

Taylor was a sophomore at the time and saw Harris out of the corner of his eyes a fraction of a second before he was gunned down. Harris and Klebold fatally shot 12 students and a teacher before killing themselves.

One of Taylor’s experts, Dr. Peter Breggin, wrote in a report filed in U.S. District Court that he believed Luvox triggered Harris’ participation in the rampage.

“On April 20, 1999, at the time he committed multiple homicides and suicide, Eric Harris was suffering from a substance induced (Luvox-induced) mood disorder with depressive and manic features that had reached a psychotic level of violence and suicide,” Breggin wrote. “Absent persistent exposure to Luvox, Eric Harris probably would not have committed violence and suicide.”

Breggin contends that Luvox is one of a family of depressants called selective serotonin reuptake inhibitors (SSRIs) that cause people to become violent. The SSRIs include Luvox, Prozac, Zoloft and Paxil.

But the drug manufacturers deny that the drugs cause such adverse affects and say they have been very helpful to those who use the medications.

Solvay believes that Harris was exhibiting violent tendencies long before he started taking Luvox.

The settlement came after a marathon, after-hours negotiating session Wednesday night presided over by U.S. Magistrate Patricia Coan. Present were Taylor, his mother Donna, Taylor’s lawyer Ron Miller and a legal team representing Solvay Pharmaceuticals, the Belgium-based company that makes Luvox.

The terms of the settlement were announced at what was to have been two days of pre-trial motions in front of U.S. District Judge Clarence Brimmer.

796 total views, 1 views today

Taylor vs. Solvay Pharmacueticals

Taylor vs. Solvay Pharmacueticals

Columbine survivor, Wash. teen team up
Suit over antidepressants unites an unlikely pair

By Howard Pankratz
Denver Post Legal Affairs Writer

The common bond that brought them together is their crusade against pharmaceutical companies.

Taylor vs. Solvay Pharmacueticals

1/17/2003

Columbine survivor, Wash. teen team up
Suit over antidepressants unites an unlikely pair

http://www.denverpost.com/Stories/0,1413,36%257E53%257E1116943,00.html

By Howard Pankratz
Denver Post Legal Affairs Writer

One was a victim of the April 20, 1999, Columbine massacre.

Cory Baadsgaard, left, sits with Columbine High School survivor Mark Taylor on Thursday during an interview for a television documentary. Baadsgaard was on antidepressants when he took an English class hostage at a high school in Washington state in April 2001. He blames the drugs for his actions, for which he spent 14 months in a correctional facility. Mark Taylor is suing the manufacturer of the antidepressant Luvox, which killer Eric Harris was taking at the time of the Columbine rampage. Gary Null & Associates of New York is filming the documentary, which could air in the summer, about the drugging of children and outcomes such as school shootings.

The other was a rifle-toting student who terrified his high school classmates in Washington state on April 15, 2001.

On Thursday, Columbine victim Mark Taylor and Cory Baadsgaard, the Mattawa, Wash., student who held a high school English class hostage, spent hours with each other.

Taylor was shot at least six times by Columbine killer Eric Harris.

Taylor wasn’t sure he wanted to meet the 18-year-old Baadsgaard, who was flown to Denver for the filming of a documentary by Gary Null & Associates of New York.

“I was a little bit afraid. I just didn’t know what kind of person he would be,” said Taylor, 19.

But when Taylor met Baadsgaard on Wednesday night, he shook Baadsgaard’s hand and said, “It’s nice to meet you.”

Then they talked for hours.

“He is a very sweet kid,” Taylor said.

Baadsgaard, a tall, athletic-looking young man who was the starting center on his basketball team, was completely surprised by Taylor’s reception.

“I thought, ‘Wow, this kid (Taylor) went through all this and he has forgiven everybody,”‘ Baadsgaard said. “I think it is kind of ironic to have a friend who has been highly affected. It’s cool to know he doesn’t have a problem with me.”

The common bond that brought them together is their crusade against pharmaceutical companies.

Taylor has a lawsuit against Solvay Pharmaceuticals, which manufactured the antidepressant Eric Harris was taking at the time of the rampage.

Baadsgaard, who was being treated for depression at the time he walked into Michelle Hansen’s honors English class with a loaded big-game hunting rifle, blames the antidepressants he had been on for 10 months.

He says he can’t remember a thing about the incident, something he directly attributes to the drugs, including one that was in the same family of antidepressants that Harris took. He stopped taking that drug, Paxil, three weeks before he invaded the classroom and was on a different drug at that time.

Baadsgaard, who spent 14 months in a correctional facility, hasn’t filed a lawsuit against the antidepressant manufacturers. But his father, Jay, said Thursday that they are looking into it.

The companies that make the antidepressants say the drugs help people and don’t cause people to become violent or suicidal, as claimed by Taylor.

In fact, Solvay Pharmaceuticals, which manufactured Luvox, the antidepressant Harris was taking, has accused Taylor of presenting “pseudo-scientific” theories to bolster his claims against the company.

Solvay has portrayed Taylor as lawsuit crazy and relying on unscientific gibberish to back his assertions that Luvox caused Harris to kill.

Gary Null, who says he is one of the country’s leading health and fitness advocates, has also been attacked as a conspiracy theorist who particularly targets the pharmaceutical industry.

Manette Loudon, who is producing the documentary in Denver, said the company hopes to complete its work in June on the two-hour film, called “The Drugging of Our Children.”

Baadsgaard, who has been banned for five years from Mattawa and can’t come within 25 miles of the tiny town of 1,800, said he never drank or did illegal drugs before he burst into the classroom.

He said he is convinced the prescription medication made him do it. “I’ve been there. I know what it’s like,” Baadsgaard said. “It’s horrible; it’s terrible. I blame everything on the drugs. Obviously, I didn’t know what I was doing.”

536 total views, 1 views today

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

LA judge denies class action for Glaxo Paxil suit

Reuters

A U.S. judge in Los Angeles on Monday denied a request to certify as a class action a lawsuit claiming that GlaxoSmithKline Plc’s (GSK) anti-depressant Paxil is habit-forming. U.S. District Judge Mariana Pfaelzer said in her ruling that attorneys for a group of Paxil users failed to present a manageable trial plan.

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

1/13/2003

LA judge denies class action for Glaxo Paxil suit

Reuters

To learn more, go to http://www.baumhedlundlaw.com.

A U.S. judge in Los Angeles on Monday denied a request to certify as a class action a lawsuit claiming that GlaxoSmithKline Plc’s (GSK) anti-depressant Paxil is habit-forming.

U.S. District Judge Mariana Pfaelzer said in her ruling that attorneys for a group of Paxil users failed to present a manageable trial plan.

Glaxo, Europe’s biggest drug maker, argued that it would be difficult for the court to determine if each member of a large class experienced the alleged withdrawal symptoms, including nausea and dizziness.

In October, Pfaelzer rejected a request from the same attorneys that advertisements stating that Paxil is “non-habit forming” be permanently barred.

The company was supported in court by the U.S. Food and Drug Administration, which said it had previously reviewed in-depth Paxil’s side effects and concluded that the drug is not habit forming and, as a result, the ads did not mislead.

The Paxil users are suing the British-based drug maker in federal court in Los Angeles, claiming that it deliberately played down the severity of withdrawal symptoms associated with abruptly stopping the drug.

Paxil, Glaxo’s top-selling product, reached sales of $2.7 billion last year.

©2002 Reuters Limited.

500 total views, no views today

Cassidy vs. Eli Lilly

Cassidy vs. Eli Lilly

Lilly settles Prozac lawsuit Terms of the deal not disclosed; new litigation in Georgia is targeting metabolization issue.

By Jeff Swiatek

The Cassidys’ lawsuit, filed in federal court in Pittsburgh, charged that Diane Cassidy’s doctor prescribed the antidepressant Prozac to her for weight loss and that the drug caused suicidal thoughts that led her to slash her wrists and overdose on a painkiller. She suffered intracranial bleeding from the painkiller, which left her paralyzed on one side and mentally impaired, according to the lawsuit, which sought $4.84 million in tangible damages.

Cassidy vs. Eli Lilly

11/30/2002

Lilly settles Prozac lawsuit Terms of the deal not disclosed; new litigation in Georgia is targeting metabolization issue.

http://www.indystar.com/print/articles/3/004678-4923-092.html

By Jeff Swiatek

A two-year-old Prozac negligence lawsuit, set for trial Tuesday, has been settled out of court by defendant Eli Lilly and Co. and the Pennsylvania plaintiffs.

The case was brought by Diane and Melvin Cassidy, of Monroeville, who in July 2000 picketed outside Lilly’s corporate headquarters in Indianapolis, handing out fliers proclaiming, “Lilly, how many people are maimed or dead on your drug today?”

The Cassidys’ lawsuit, filed in federal court in Pittsburgh, charged that Diane Cassidy’s doctor prescribed the antidepressant Prozac to her for weight loss and that the drug caused suicidal thoughts that led her to slash her wrists and overdose on a painkiller. She suffered intracranial bleeding from the painkiller, which left her paralyzed on one side and mentally impaired, according to the lawsuit, which sought $4.84 million in tangible damages.

The Cassidys were represented by Houston trial lawyer Andy Vickery, who has negotiated settlements of several Prozac cases against Lilly.

Terms of the settlement, reached this week, were not disclosed.

The Indianapolis drugmaker said in a statement that it “made a business decision to settle . . . for factors completely unrelated to the safety and efficacy of Prozac. Such factors included the extensive time demands that litigation would have placed upon our scientists, keeping them away from their primary objective of discovering lifesaving medicines. In no way was our decision to settle in any way motivated by concerns over the safety and efficacy of Prozac.”

The settlement comes the same week that a fresh Prozac lawsuit was filed against Lilly, in U.S. District Court in Georgia. It raises a new charge in the more than decade long litigation over Prozac: that Lilly has failed to publicize research showing some people are “poor metabolizers of Prozac” and a test can reveal if a patient might be affected.

The Georgia product-liability and wrongful-death suit, in which Vickery is assisting the plaintiff, was brought by William H. Shell, the widower of LaVerne M. Shell. She shot herself to death at age 63 in November 2000, 11days after starting on a prescription of Prozac to treat migraine headaches.

The lawsuit charges that a human enzyme dubbed CYP2D6 normally metabolizes or breaks down Prozac and similar drugs in the body, but fails to do so in a minority of people. In their bodies, the active ingredient in Prozac builds up to high levels, putting them at risk of violence and suicide, the lawsuit says.

“Lilly is negligent in failing to make this information public, to convey it to doctors, or otherwise to take reasonable measures to implement appropriate patient screening techniques,” the lawsuit says.

Lilly spokesman Blair Austin said that company officials hadn’t seen the lawsuit and couldn’t comment on the new charge.

The metabolization issue is gaining currency among some activists who publicize side effects from the Prozac class of antidepressants and other drugs.

Self-employed businessman Jim Harper of Glendale, Calif., who runs a Web site called Prozactruth.com, said he hopes to soon offer a DNA test through his site that can tell if a person is a poor metabolizer of Prozac and related drugs.

“I should not have to be the one” to publicize the test, Harper said Friday. “I’d rather be doing other things on my nights and weekends.” But drug companies and doctors aren’t doing enough to warn users of serious side effects from antidepressants, said Harper, who noted he receives hundreds of e-mails a week from people who read his Web site.

Harper said he hopes to arrange to sell the test for about $245 through Genelex Corp. of Redmond, Wash., a direct-to-consumer DNA testing firm

815 total views, no views today

Holcombe and Gollin vs. GlaxoSmithKline

Holcombe and Gollin vs. GlaxoSmithKline

2 Wisconsin women sue anti-depressant maker

By TOM HELD
theld@journalsentinel.co
Journal Sentinel

Suits here and elsewhere claim Paxil addictive, consumers not warned.
Holcombe and Gollin vs. GlaxoSmithKline

11/3/2002

2 Wisconsin women sue anti-depressant maker

http://www.jsonline.com/news/metro/nov02/93028.asp

By TOM HELD
theld@journalsentinel.co
Journal Sentinel

Two Wisconsin women have filed a class-action lawsuit against the makers of the anti-depressant Paxil, joining hundreds of others in alleging that the drug left them with severe withdrawal.

The suit filed in Milwaukee County accuses GlaxoSmithKline of failing to warn consumers that the popular drug can be addictive and that patients may suffer nausea, sweating, agitation and tremors when they discontinue its use. Similar lawsuits have been filed in 14 states, and a national class-action suit is pending in California.

The local plaintiffs, Christen Holcombe of Milwaukee and Linda Gollin of Pewaukee, are seeking to join hundreds and possibly thousands of other Wisconsin residents who sought help from Paxil, their attorney James Murphy said.

A decision on certification of the national lawsuit in California is expected Nov. 18. If it is certified, the suits in Wisconsin and other states probably will be set aside, Murphy said.

The suit by Holcombe and Gollin brings to Wisconsin the ongoing battle over Paxil and its alleged addictive downside. Hundreds of users across the country have complained that they had crying spells, dizziness and electric shock sensations when they stopped taking the drug.

GlaxoSmithKline maintains that Paxil is not addictive and its users may experience “discontinuation symptoms” that dissipate after one to two weeks.

“Any claims that Paxil is addictive are without foundation,” said Mary Anne Rhyne, a spokeswoman for the Pennsylvania-based drug maker. “There is no reliable scientific evidence to that effect.”

Reviews from the medical community have been split on the drug.

Last month, GlaxoSmithKline gained a legal victory in its defense of Paxil when the judge in the California case rescinded an order that had barred the company from claiming the drug was non-addictive in its advertising campaign. The ruling followed a U.S. Food and Drug Administration finding that the company’s ads for Paxil were not misleading.

The drug, introduced in 1992, is similar to Prozac and Zoloft, two other anti-depressants.

Paxil is GlaxoSmithKline’s bestselling drug, reaching nearly $3 billion in sales in 2001, according to the company.

Murphy said the drug’s value to GlaxoSmithKline sales explains why the company has resisted honest disclosure about its danger of addiction and withdrawal symptoms.

“They don’t want to discourage people from using it or from having doctors stop prescribing it,” he said.

Rhyne said Paxil had helped millions of people who suffer from depression.

613 total views, 1 views today

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

Mass. group sues Paxil drugmaker

By Ellen Barry
Globe Staff

A group of Massachusetts plaintiffs filed a class-action suit earlier this month against the maker of the blockbuster antidepressant Paxil, alleging that withdrawal from the drug brought on such ill effects as nausea, sweating, agitation, tremors, insomnia, dizziness, and the sensation of electric ”zaps” in the brain.

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

10/26/2002

Mass. group sues Paxil drugmaker

http://www.boston.com/dailyglobe2/299/nation/Mass_group_sues_Paxil_drugmaker+.shtml

By Ellen Barry
Globe Staff

To learn more, go to http://www.baumhedlundlaw.com.

A group of Massachusetts plaintiffs filed a class-action suit earlier this month against the maker of the blockbuster antidepressant Paxil, alleging that withdrawal from the drug brought on such ill effects as nausea, sweating, agitation, tremors, insomnia, dizziness, and the sensation of electric ”zaps” in the brain.

The lawsuit, filed Oct. 9 in Suffolk Superior Court, is part of a multipronged legal challenge to Paxil, taken by millions of people in the United States alone. It joins a nationwide class-action suit and nine other statewide lawsuits in asserting that GlaxoSmithKline, which manufactures Paxil, intentionally misled physicians and consumers about the drug’s ”addictive” qualities – an allegation that was denied yesterday by the company and the physicians who recommend it.

Paxil is one of a multibillion-dollar class of drugs – including Prozac and Zoloft – that relieve depression by building up levels of the neurotransmitter serotonin around nerve endings in the brain. Called selective serotonin reuptake inhibitors, or SSRIs, the drugs have succeeded in large part because they lack the serious side effects of earlier treatments for depression and anxiety, including habituation. And although previous lawsuits have alleged that SSRIs can spur violence, they have had little effect on the drugs’ enormous popularity.

Sales of Paxil, which received FDA approval in 1992, lagged for years behind competitors Prozac and Zoloft, but have benefited from the expiration of Prozac’s patent and by its increasing use for anxiety disorders. Last year it was GlaxoSmithKline’s top-selling drug, netting the company $2.7 billion, a spokesman said.

The company acknowledges that there are side effects to the ”discontinuation” of Paxil, including dizziness and occasionally abnormal dreaming and the sensation of electric shocks, but most last no longer than two weeks, said spokeswoman Mary Anne Rhyne. Rhyne added that ”any claims that Paxil is addictive are without foundation.”

But Janelle Leonard, a Bradford schoolteacher, said neither she nor her doctor were prepared for what happened when she decided to stop taking Paxil. Only when she accessed Internet chatrooms – where dozens of people compared their experiences upon going off Paxil – did she realize where her disabling symptoms were coming from.

”Nobody had told me it was habit-forming,” said Leonard, who is 30. ”I ended up really ill … I was bedridden, sick. I had insomnia. I was paranoid, and I was still sick to my stomach. I had diarrhea. I couldn’t leave the house.”
So far, 6,000 would-be plaintiffs have contacted the Los Angeles law firm that filed the nationwide lawsuit, and 1,000 have been confirmed as plaintiffs, said Karen Barth, lead counsel for Baum, Hedlund, Aristei, Guilford & Schiavo. The nationwide lawsuit will reach the certification phase on Nov. 18, and attorneys plan to file lawsuits in all 50 states in case the nationwide suit does not go forward, she said.

The suit had resulted in an injuction against GlaxoSmithKline not to advertise Paxil as ”nonhabit-forming.” The judge rescinded her order Oct. 11, after the Food and Drug Adminsitration determined that the ads were not misleading.
Barth’s law firm has brought previous class-action suits on behalf of the families of patients who committed suicide while taking Paxil, Prozac, or Zoloft – but the suicides have been so rare that they have had little ripple effect on the public, she said.

A lawsuit based on the effects of withdrawal may have more traction, because the experience is far more widespread, said Dr. Joseph Glenmullen, a Harvard University psychiatrist and author of ”Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil, and other Antidepressants with Safe, Effective Alternatives. ”

”You have countless individuals who have terrible experiences. Too many doctors have seen this, it’s too undeniable. Too many patients are very, very upset by it,” Glenmullen said.

But several psychopharmacologists interviewed said they rejected offhand the idea that SSRIs are addictive. Although the brain does adapt to SSRIs, the term ”addiction” suggests craving, intoxication, or an increased tolerance that requires ever-higher doses, none of which have been documented with Paxil, said Dr. Alexander Bodkin, a research psychiatrist at McLean Hospital.

”Insulin is habit-forming. Digitalis is habit-forming,” said Dr. William Appleton of Harvard University. ”Exercise is habit-forming, but no one ever brings a class-action suit against that.”

But perhaps, Appleton said, the lawsuit is just part of a predictable backlash against SSRIs, which were greeted as wonder drugs a decade ago.
”One of the interesting things about drugs is they’re a little bit like shopping centers,” said Appleton, author of ”Prozac and the New Antidepressants. ” ”They come in clean and brand-new and full of hope,” he said. ”They go out old and tired and dirty.”

This story ran on page A3 of the Boston Globe on 10/26/2002.
© Copyright 2002 Globe Newspaper Company.

665 total views, no views today

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

Judge: Paxil ads can’t say it isn’t habit-forming

LOS ANGELES (AP)

A federal judge ordered the maker of the popular anti-depressant Paxil to stop all television commercials nationwide that say the drug is not habit-forming.

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

8/20/2002

Judge: Paxil ads can’t say it isn’t habit-forming

http://www.usatoday.com/news/health/2002-08-20-paxil-ads_x.htm

LOS ANGELES (AP)

To learn more, go to http://www.baumhedlundlaw.com.

A federal judge ordered the maker of the popular anti-depressant Paxil to stop all television commercials nationwide that say the drug is not habit-forming.

The ruling against GlaxoSmithKline comes about a year after a class-action lawsuit was filed on behalf of 35 patients who said they suffered withdrawal symptoms such as nausea, fever, and “electric zaps” to their bodies.

U.S. District Judge Mariana Pfaelzer found that in other countries, labels on the drug warn of adverse reactions when use of the drug is discontinued.

The commercials were “misleading and created inaccurate expectations about the ease of withdrawal from the drug,” Pfaelzer ruled Monday.

Company attorneys are appealing.

“The U.S. Food and Drug Administration — and not the courts — has the expertise and responsibility for reviewing and regulating pharmaceutical ads,” David Stout, president of U.S. Pharmaceuticals at Paxil’s producers, GlaxoSmithKline, said in a statement.

“The Paxil television ad was submitted for FDA review prior to use, and the agency raised no objections to the language at issue,” Stout said.

The plaintiffs’ lead attorney, Karen Barth, said GlaxoSmithKline changed its labeling on Dec. 14 but continued to run commercials and distribute brochures saying Paxil “may cause mild, usually temporary side effects in some individuals.”
Plaintiffs’ attorneys said a hearing was set for Oct. 7 to decide whether the lawsuit should be converted to a nationwide class-action.

The ads also said “Paxil has been studied both in short-term and long-term use and is not associated with dependence and addiction.”

Surging U.S. sales of Paxil and the asthma drug Advair led a 15 % increase in second-quarter profit for London-based GlaxoSmithKline. Global sales of Paxil grew 29%.

567 total views, no views today

Donald Schell vs. SmithKline Beecham

Donald Schell vs. SmithKline Beecham

Glaxo Raises White Flag, Settles Paxil Trial Appeal, and Pays Up

Rick Giombetti

In a bombshell comparable to the recent belated revelation of the disaster that hormone replacement therapy has been, I have learned that Paxil manufacturer Glaxo-Smith-Kline (GSK) has secretly settled its appeal of the ruling in the Paxil trial last year.
Donald Schell vs. SmithKline Beecham

7/23/2002

Glaxo Raises White Flag, Settles Paxil Trial Appeal, and Pays Up

http://www.counterpunch.org/giombetti0723.html

Rick Giombetti

In a bombshell comparable to the recent belated revelation of the disaster that hormone replacement therapy has been, I have learned that Paxil manufacturer Glaxo-Smith-Kline (GSK) has secretly settled its appeal of the ruling in the Paxil trial last year.

GSK was sued in federal district court in Cheyenne by family members of Donald Schell, the Gillette, Wyoming man who killed his wife, daughter, granddaughter and then himself on February 13, 1998 after two days on the pharmaceutical giant’s anti-anxiety/depression drug Paxil. The plaintiff’s position was that Paxil was the primary cause of Donald Schell’s actions in the murder-suicide. The jury agreed and the judge in the trial rejected GSK’s challenge of the validity of the scientific data presented to the jury by the plaintiff’s. As a public service I will be publishing the crucial expert testimony and cross examination of British psychiatrist and psychiatric historian David Healy soon.

GSK appealed the verdict in the case in Denver, but recently gave up, I have been told by Healy. The deal in the appeal settlement GSK made with the plaintiff’s calls for the company getting all of its documents back, and a set of confidentiality statements from the plaintiffs side to not release anymore details of the case not already in the public domain. This is an important development in the history of psychiatric medicine. The jury verdict forced GSK to cave in to the demands of the Medicines Control Agency, the British government agency that regulates prescription drugs, that it place a suicide warning on Paxil. GSK has had to place a suicide warning on Paxil in Britain for about a year now. Now the question remains will this same warning ever make it over to this side of the Atlantic, with as much publicity as the hormone replacement story has gotten? Not likely, I believe, but I hope I am wrong.

Even though there isn’t a widely publicized suicide warning being given for Paxil, or any other drug in its class, known as “Selective Serotonin Reuptake Inhibitors,” or “SSRI’s,” it’s not like there is a complete information black out about these newer generation psychiatric drugs in consumer prescription drug guides.

For example, in the recently published 10th edition of The Pill Book, it warns patients taking SSRI’s (i.e. Celexa, Luvox, Paxil, Prozac and Zoloft) that “The possibility of suicide exists in severely depressed patients and may be present until the condition is significantly improved. Severely depressed people should be allowed to carry only small quantities of SSRI’s to limit the risk of overdose.” The term “overdose” can just as easily be read as “killing themselves.” Also, “As many as 1/3 of people taking an SSRI experience anxiety, sleeplessness and nervousness.” In other words all the symptoms that can push a depressed person over the edge and into a suicide attempt. Finally, the recently published 5th edition of The Physicians’ Desk Reference Pocket Guide to Prescription Drugs warns patients considering taking the SSRI known as Zoloft “May also cause mental or emotional symptoms such as: Abnormal dreams or thoughts, aggressiveness, exaggerated feeling well-being, depersonalization (“unreal” feeling), hallucinations, impaired concentration, memory loss, paranoia, rapid mood shifts, SUICIDAL THOUGHTS, tooth-grinding, WORSENED DEPRESSION (emphasis is the authors).”

Now why on Earth are pharmaceutical companies allowed to get away with marketing these drugs as “anti-depressants,” or “anti-anxiety” agents when they can produce in patients exactly what they are supposed to treat at such high rates? This is the deeper question about the mass marketing of these drugs the mass media is simply avoiding by a combination of cowardice, laziness and just outright ignorance in reporting on these issues.

Rick Giombetti is a freelance writer who. lives in Seattle. Visit his website at: http://rjgiombetti.blogspot.com/. He can be reached at: rickjgio@speakeasy.net

889 total views, no views today