Over the past several years, new studies have shown the new generation of psychiatric drugs to be not only extremely dangerous but also ineffective, and the majority of these medications in fact now carry black box warnings about a number of life-threatening side effects associated with their use. The drugs include selective serotonin reuptake inhibitors antidepressants (SSRIs), like Paxil, Prozac, Zoloft, and Effexor, and the atypical antipsychotics, that include Zyprexa, Risperdal, Geodon, Seroquel, Clozaril, and Abilify.
Hidden studies dating back to before many of the drugs were even FDA approved have also surfaced, many as a result of litigation, that demonstrate that Big Pharma knew all about the problems with the drugs, but concealed the adverse event reports, and only allowed the findings from positive clinical trials to become public. GlaxoSmithKline has now lost several lawsuits because it knowingly concealed years of negative information about the serious adverse reactions to Paxil.
In one lawsuit it was shown that GSK deliberately misled both physicians and patients to believe that Paxil was not addictive and had no withdrawal reactions with a question and answer pamphlet distributed to doctors' offices to be disseminated to patients, in which GSK asks the question: "Is Paxil addictive?"And, in response, the pamphlet states: "Paxil has been studied both in short-and-long-term use and is not associated with dependence or addiction."
By the time the lawsuit was filed on August 21, 2001, the plaintiffs' attorneys had been individually contacted by approximately 500 Paxil withdrawal victims. As a result of GSK's fraudulent marketing of Paxil as non-addictive, the Las Angeles based Baum Hedlund law firm won a major settlement in this class action filed on behalf of patients who got hooked on the drug, and in many instances, found they were unable to stop taking it.
The documents that surfaced during litigation showed that since before Paxil was approved, GSK had known about the withdrawal affects from it own clinical trials and from many others conducted by prominent scientists, in addition to receiving thousands of complaints by individuals who used Paxil. According to the lawsuit's complaint, "GSK's motive of deliberately failing to advise physicians and the public of the adverse effects that can lead to withdrawal problems (and that it knew a percentage of users of the drug inevitably would experience) was for financial gain and its fear that, if properly labeled the drug,
Paxil would lose its share of the SSRI market."The complaint alleges that GSK over-promoted Paxil in order to increase sales at the expense of revealing the truth about the addictive and dependency nature of Paxil and fraudulently conveyed to all health care providers in the US that Paxil's side effects were only "mild," when in fact GSK knew the drug's withdrawal effects were severe. It also claims that GSK fraudulently conveyed to health care providers in the US that a British study involving 13,741 patients found that all SSRI's exhibited a similar rate of withdrawal reactions, when in fact GSK knew that the study found Paxil to have the highest rate of withdrawal reactions of any SSRIs.
Over the last several years, evidence has surfaced that also proves that GSK concealed negative information and studies that demonstrated that Paxil drastically increases the risk of suicide and self-harm, especially with children.
A report by psychiatrist, Dr Peter Breggin, a court certified expert and author of numerous books on psychiatric drugs, written years earlier when he served as an expert witness in a Paxil lawsuit, reveals how GSK not only concealed negative studies, but also manipulated data about Paxil-induced suicidality so that actual suicide attempts in clinical trials were underreported, while attempts by subjects taking a placebo were inflated.
The report also notes how GSK hid the events related to akathisia (agitation with hyperactivity) and stimulation, which Dr Breggin says, are known risk factors for suicidality and violence.
Excerpts from the report were recently published by Dr Breggin, in the Spring 2006 issue of Ethical Human Psychology and Psychiatry, Vol 8.His original report was attached to a July 21, 2001, affidavit submitted in the California case of Lacuzong v GSK, filed by the widow of a man who drowned the couple's 2 children, before drowning himself in a bathtub, after taking Paxil for only three days.After the Lacuzong case was resolved, at GSK's insistence, the report was sealed under a protective order.
However, in the more recent case against the company, Moffett v Glaxo SmithKline, in Mississippi the protective order was lifted and the report was entered in the public record. Dr Breggin has also made it available on his web site at www.breggin.com."The publication of a previously sealed report is rare," he says, "the first in my experience."
According to Dr Breggin, drug companies settle almost all lawsuits out of court in order to seal incriminating scientific data. "This deprives the FDA, medical profession and public of critical information on drug safety and efficacy," he says. He wants the laws changed so that they require drug makers to publish all of the safety and efficacy information they generate regarding their products. In March, 2006, Baum Hedlund's leading SSRI attorney, Karen Barth Menzies, filed another class action lawsuit against GSK, in federal court in the company's hometown of Philadelphia, this time on behalf of patients under the age of 18, who attempted suicide while on Paxil, and on behalf of the family members of children who committed suicide while taking the drug. Its important to note that Paxil has never been approved by the FDA for any use with children, and so therefore, every prescription written for the children involved in this lawsuit was for off-label use.
One suicide in the case involves 11-year-old Trevor Blain who was prescribed Paxil for "separation anxiety disorder" by his pediatrician in October 2000, and immediately began having trouble sleeping and exhibited angry outbursts. His family knew nothing about the connection between Paxil and these adverse events and so Trevor continued to take the drug. In early November 2000, Trevor hanged himself with his dog's leash in the family laundry room and although he initially survived the suicide attempt, he remained in a coma for several weeks before he died on December 7, 2000.
Another plaintiff in the case, is 17-year-old Tonya Brooks whose family doctor diagnosed her with "social anxiety disorder" and prescribed Paxil in 2004. While taking the drug, Tonya became agitated, aggressive and had difficulty sleeping. She first attempted suicide by taking an overdose of Paxil and sleeping pills. After surviving the first attempt, 2 days later Tonya gouged a hole in her leg with a pair of scissors and was hospitalized for several days. Recounting the horror when she found her daughter sprawled on the bathroom floor after her second suicide attempt, with blood everywhere, Tonya's mother, Cheryl Brooks, says, "no parent should have to go through what we did."
According to Attorney Menzies, this is another case where GSK concealed information to protect profits. "Through our Paxil litigation," Ms Menzies states, "we've obtained documents that show a seriously troubling mentality of profit over safety and a callous disregard for the welfare of children.""That's about as reprehensible as you can get," she adds. "Governmental regulators around the world have now analyzed the actual data from the clinical trials, not GSK's version of it," she notes, "and have found an increased risk of suicidality.""We wanted to make sure the rights of all of these kids," she says, "are protected by filing this lawsuit."
Pfizer's SSRI, Zoloft is no better than Paxil. There were also clear indications of probable suicidality risk in clinical trials on this drug long before it was approved. For instance, in a "healthy volunteer" Zoloft study conducted by Ian Hindmarch in 1983 in which 12 volunteers were randomized to either a placebo or Zoloft, every volunteer but one, who took Zoloft dropped out within days, due to severe agitation, after making comments such as "I was running like a machine inside" and "I have never felt as bad as this in my life"
In 2003, the Journal of the American Medical Association published the results of 2 trials on children treated with Lustral (Zoloft) in which 17 children who were given the drug were pulled out of the trial because of side effects, compared with five children who received a placebo, and only 10% more children improved on Zoloft than on a placebo. And yet the authors of the study wrote: "the results of this pooled analysis demonstrate that sertraline (Lustral) is an effective and well-tolerated short-term treatment for children and adolescents with major depressive disorder."
This drug has also been linked to severe violent behavior in children. On January 26, 2006, a psychologist on Court TV announced that 14-year-old, Cody Posey, was on Zoloft when he killed his parents and sister. He started taking the drug on April 20, 2004, and committed the murders on July 5, 2004. Cody's father was the range manager for well-known TV reporter Sam Donaldson. As for the granddaddy of SSRIs, Eli Lilly's Prozac, the first to be approved back in 1987, within one decade of the drug's arrival on the market, there were 39,000 adverse event reports submitted to the FDA's Medwatch, according to award-winning investigative reporter, Robert Whitaker. And that number is said to represent only about 1% of the actual number of adverse events, he reminds people. "So, if we get 39,000 adverse event reports about Prozac,"
Mr Whitaker said in an interview for Street Spirit in August 2005, "the number of people who have actually suffered such problems is estimated to be 100 times as many, or roughly four million people.""There were more adverse event reports received about Prozac in its first two years on the market," he told Street Spirit, "than had been reported on the leading tricyclic antidepressant in 20 years.""This makes Prozac the most complained about drug in America, by far," he said.
Linda Hurcombe, an American citizen who resides in the UK, lost her 19-year-old daughter, Caitlin, to suicide as a result of Prozac. She describes how 8 years ago, her "undepressed daughter saw an ad for antidepressants on television while visiting the US.""Caitlin decided she wanted this pill," Ms Hurcombe explains, "because she was nervous about final exams and had heard at the university too that Prozac made you lose weight and feel great."Caitlin got a prescription from the doctor, she said, with no problem."After 63 days on this medication," Ms Hurcombe says, "during which time her behavior descended into chaos, Caitlin hanged herself from a beam in the guest bedroom of our home."
Ms Hurcombe has written a book titled, "Losing a Child," and says, most shockingly, during the research for the book, "I have found that Caitlin was just one of thousands whose lives have been snuffed out in a similar manner."
On February 2, 2004, investigative reporter, Kelly O'Meara, wrote an article that reported on the first clinical trial of its kind, by Dr David Healy, director of the North Wales Department of Psychological Medicine at the University of Wales, in which Prozac was given to a volunteer group of mentally healthy adults.The study determined, apparently just as in the case of Ms Hurcombe's "undepressed" daughter, that even mentally healthy adults were adversely affected by the drug.
According to Ms O'Meara, between one in 20, and one in 10, people in the study on Prozac experienced akathisia, "whereby they become mentally restless or manic and lose all inhibitions about their actions.""People don't care about the consequences as you'd normally expect," Dr Healy explains, "they're not bothered about contemplating something they would usually be scared of."He said the study showed that: "We can make healthy volunteers belligerent, fearful, suicidal, and even pose a risk to others."
Kelly O'Meara's coverage of the adverse effects of psychiatric drugs is virtually unmatched by any other journalist in the US. During her 6-year stint with the Washington Times' Insight magazine, she wrote more than two dozen investigative articles about the link between SSRIs and the bizarre, violent acts committed by patients taking the drugs, which include the majority of children involved in school shootings in the US. Her new book, "Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill," is about informed consent. "The people need and deserve the whole truth about their psychiatric diagnosis," Ms O'Meara advises, "and the mind-altering drugs that are prescribed as treatment." Experts say the book is a must read for patients considering whether to take psychiatric drugs. The "chemical imbalance in the brain" theory that drug maker's tell patients they have when marketing the drugs, is debunked in the book by some of the nation's leading experts, and according to Ms O'Meara, the drug companies themselves have been forced to admit that they do not understand how the drugs work in the human brain during the treatment of an alleged mental illness. "In fact," she says, "a test that measures a person's brain chemicals does not exist.""Never in the history of the world has science discovered what the correct brain chemical levels are for any living person," Ms O'Meara explains, "making it impossible to know if these naturally occurring chemicals are out of balance.""If confirmable proof of a chemical imbalance were required prior to filling a prescription for any antidepressants," she says, "not a single prescription would be written because to date the only known method of determining chemical levels in the brain is during autopsy."
Over the last decade the drug companies have conned doctors into writing millions of prescriptions to children for these SSRIs, under the guise of protecting them from suicide, and yet the suicide rates for kids during this time period have remained statistically unchanged, with boys varying by at most one suicide up or down, and the rate for girls not moving an inch, according to a review of statistics put out by the Department of Health and Human Services.
Even though the atypical antipsychotics are not FDA approved for any use with children, and their package inserts specifically state that their safety and effectiveness with children have not been established, Big Pharma has doctors prescribing them off-label to children of all ages for a long list of so-called mental disorders.
According to a study in the March-April 2006, Ambulatory Pediatrics journal, between 1995 and 2002, the rate of children receiving antipsychotics increased five-fold, to an estimated 2.5 million, or an increase from 8.6 prescriptions for every 1,000 children in the mid-1990s, to nearly 40 in every 1,000 in 2002.
A recent review by USA Today of the FDA's adverse reporting system from 2000 to 2004, found at least 45 deaths in children under 18 listing atypicals as the "primary suspect."
There were also an additional 1,328 reports of other side effects, including many that were life-threatening. Other life-long physical adverse effects of these drugs are beginning to emerge in children.
The Children's Hospital of Philadelphia recently found that 19% of newly diagnosed Type 2 diabetic children were being treated with atypical drugs, according to Robert F Kennedy Jr vs the Medical Elite, by Mark Sircus Ac, OMD, on June 22, 2005. "The most studied adverse effect of the newer generation of antipsychotics," he notes, "is their association with hyperglycemia, in some cases leading to ketoacidosis, coma, or death.""Many of these drugs carry black box warning to alert MD's about the dangers of diabetes," according to Mr Sircus. Psychiatrist, Dr Stefan Kruszewski, also says the atypicals substantially increase the risk of other serious physical illnesses such as heart attack, hypertension, and stroke.
For the past 30 years, Dr Breggin, has served as a medical expert in lawsuits involving psychiatric drugs and has testified in cases involving tardive dyskinesia. All antipsychotics also now carry a warning about the extremely serious condition of tardive dyskinesia. According to Dr Breggin, the condition is a drug-induced movement disorder that is usually irreversible and there are no adequate treatments for the disorder."Tardive dyskinesia often looks so "strange" or "bizarre," Dr Breggin says, "that it is mistaken for a mental illness rather than a neurological disorder." The abnormal movements, he says, can afflict any muscle group of the body and can impair the ability to walk, speak, breathe and swallow."It is highly variable in expression and severity," according to Dr Breggin. One variety involves painful spasms of muscles, he says, that can literally torture the victim, and another involves an agonizing inner agitation that drives people to move their arms or legs, or to pace. "Some cases," he advises, "are painful, disfiguring, exhausting and ultimately disabling."
Dr Breggin has served as an expert in a half dozen tardive dyskinesia cases that resulted in verdicts for the plaintiffs including several cases in which Risperdal caused tardive dyskinesia in children, where the drug was prescribed to control behaviors that were in fact, he says, caused by stimulant ADHD drugs that the child was already taking. According to Dr Breggin, tardive dyskinesia occurs at a cumulative rate of 4-7% per year in otherwise healthy patients treated with antipsychotics and after only a few years, 20% or more of patients will be afflicted. In older patients, he says, the rate is even higher.
Overall, according to estimates by a 20-year career FDA scientist and researcher, Dr David Graham, the use of atypicals antipsychotics increases the annual death rate in the US by more than 12,000 people a year.They are approved for a very limited number of psychiatric disorders but once again, drug makers have found way to get doctors to prescribe them off-label for a multitude of unapproved illnesses for age groups that they were never intended.
The off-label prescribing of these drugs is so out of control that according to a July 7, 2006 report by Decision Resources, Inc, a leading research and advisory firm on pharmaceutical and healthcare issues, antipsychotics represented the fourth-highest-ranking class of drugs in worldwide sales in 2005, and two of the top ten drugs in sales are atypicals.
But the icing on the cake as to the absurdity of their widespread use, come from a government study published in the September 22, 2005, New England Journal of Medicine, that determined that the new atypicals are only barely more effective than no drugs at all.
Another increasingly popular class of dangerous drugs being over-prescribed to children of all ages are the ADHD medications, commonly known as "speed" to addicts.
Information released by the FDA in February 2006, showed that between 1999 and 2003, seventy-eight million prescriptions were written for ADHD drugs for children ranging in age from one to 18.
On March 14, 2006, the FDA posted a review on its web site of reported adverse events between January 2000, and June 30, 2005, that found nearly 1,000 reports of psychosis or mania possibly linked to ADHD drugs. Psychosis is defined as a mental disorder characterized by the inability to distinguish real and imaginary events. "The most important finding of this review is that signs of psychosis or mania, particularly hallucinations, can occur in patients with no identifiable risk factors, at usual doses of any of the drugs used to treat ADHD," according to a March 3, 2006, memo from 2 members of the agency's ADHD psychiatric review team.
The FDA also disclosed reports of 25 deaths in children and adults between 1999 and 2003, and 54 cases of serious cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia.
Yet experts say that the FDA is stalling at best, and refusing at worst, to add appropriate warnings to the labels of ADHD drugs to alert all the parents of the ever growing number of children being placed on these drugs, about their numerous life-threatening adverse effects, that experts predict, would no doubt result in a decrease in use.
Psychiatrist, Dr Grace Jackson, author of, "Rethinking Psychiatric Drugs: A Guide for Informed Consent," says that "whether by ignorance or design, the regulators remain oblivious to the evidence-based limitations of the prescription pad: at least 40% of all children fail to tolerate or respond to stimulant therapy; about twice as many respond at least as well to non-pharmacological interventions.""The long term outcomes for medicated children," she notes, "demonstrate diminishing returns over time, persistent suppression of growth (about 1 cm per year), and artificial behavioral improvements which dissipate when treatment is withdrawn.""The connection between stimulants, cardiovascular disability, and death," Dr Jackson says, "has long been documented in the medical literature, but physicians and government regulators have refused to acknowledge the hazards associated with prescriptions."
Dr Breggin, warns that all stimulant drugs can cause "a continuum of stimulation, including agitation and irritability, anger, hostility, disinhibition, hypomania and mania."The stimulant or activation syndrome, he advises, was observed decades ago with stimulant drugs such as amphetamines, Adderall, and Dexedrine, and methylphenidates such as Ritalin and Concerta.
In addition, Dr Breggin brings up an all too common situation with children who are recruited by the mental health industry. "As the child's emotional control breaks down due to medication effects, mood stabilizers may be added," he explains. "Eventually, these children end up on four or five psychiatric drugs at once and a diagnosis of bipolar disorder by the age of eight or ten," he warns. According to pediatric neurologist, Dr Fred Baughman, another well-known expert and author of the new book, "ADHD Fraud, How Psychiatry Makes Patients Out of Normal Children," in addition to the deaths listed by the FDA between 1999-2003, in persons using ADHD drugs, the MedWatch database also contains 186 more deaths between 1990 and 2000.
According to Dr Baughman, drugging kids has become rampant. "Its happening all across country," he says, "not by thousands but tens of thousands, picking most on the disenfranchized, powerless." "These children become for-profit receptacles for psychiatric drugs," he warns, "which will undoubtedly alter their bodies and brains." Dr Baughman's alarming prediction is apparently becoming a reality.
According to a study by Medco Health Solutions, a managed-care firm, there was an 85% increase in the use of sleeping pills among children between 2002 and 2004 and about 15% of the children who took sleeping pills were also taking ADHD drugs. Since stimulant drugs cause insomnia, experts say, the sleeping pills are obviously being used to counteract their side effects. Due to the fact that only between 1% and 10% of all adverse drug reactions are ever reported to the FDA, experts point out that the actual combined number of deaths and serious injuries associated with psychiatric drugs each year is much, much higher than FDA statistics indicate.
More information for injured parties can be found at Lawyers and Settlements.com
http://www.lawyersandsettlements.com/articles/pharma_lawsuits.html
Evelyn Pringle
evelyn.pringle@sbcglobal.net
Zantac Lawsuit
Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Wednesday, July 12, 2006
Sunday, July 09, 2006
Litigation Inoculation
Litigation Inoculation
By Thomas Ginsberg
Inquirer Staff Writer
Joseph Colacicco's wife, Lois, slashed herself to death with razor blades in 2003 while taking the antidepressant Paxil, painting her final thoughts in blood in their bathroom: "Thanks."
"She felt it was over, finally," Colacicco said of his wife's mental torment. "She had no inkling it was because of Paxil. The pharmaceutical companies fooled the public, fooled me, fooled my wife."
Colacicco's accusation stands out not just because it is tragic. His lawsuit has become a front-line case in the Bush administration's efforts to rein in claims against pharmaceutical companies, with tens of millions of dollars at stake on both sides.
Colacicco's claim that GlaxoSmithKline P.L.C. and Apotex Inc., maker of generic Paxil, failed to warn patients in 2003 about Paxil's suicide risks was dismissed last month in U.S. District Court in Philadelphia, where GlaxoSmithKline has a U.S. headquarters.
The dismissal was based partly on the newly articulated argument that the U.S. Food and Drug Administration alone is accountable for what is, and is not, written on prescription-drug warning labels, preempting any judge or jury. Under that principle, an FDA-approved warning label is the last word on safety, and courts shouldn't second-guess it.
Lawyers on both sides say such FDA preemption on prescription-drug warnings, if upheld, could block many "failure to warn" claims against drug companies. Such claims constitute many, although not all, of the infractions alleged in tens of thousands of pharmaceutical liability lawsuits each year.
Since 2000, the FDA had asserted the principle only in legal briefs in isolated lawsuits, not as an agency policy.
Now the principle is codified in the preamble of the FDA's new drug-labeling code, which was published in January and took effect June 30. Brandishing the preamble in recent months, drug companies have papered courtrooms nationwide with motions to dismiss failure-to-warn claims.
Most of the motions have failed. On June 6, New Jersey Superior Court Judge Carol E. Higbee denied Merck & Co. Inc.'s motion seeking dismissal of a Vioxx case, calling the FDA preamble "a political statement." On May 31, U.S. District Judge Joseph Bataillon, in Nebraska, rejected Pfizer Inc.'s motion in a case involving its antidepressant Zoloft, saying that the FDA had contradicted its own past positions and that Congress had never given the agency preemption power over courts in prescription-drug cases.
But on May 25 in Philadelphia, U.S. District Judge Michael M. Baylson threw out Colacicco's claim. In a broad ruling, Baylson said courts should defer to the agency's scientific expertise and regulatory authority. It is this deference that other judges have rejected.
"It is not the function of this court, or for a jury empaneled to decide this case, to substitute its judgment for the FDA's about medical issues," Baylson wrote.
He added: "Ultimately, this court believes it is far more desirable that the important issues presented by this case, indeed tragic in its facts, are better addressed by elected officials, legislative and executive, than by appointed judges."
Colacicco, of Long Beach, N.Y., appealed to the U.S. Court of Appeals for the Third Circuit in Philadelphia, taking the lead in a jurisdictional dispute that attorneys predict will not end until it hits the U.S. Supreme Court.
GlaxoSmithKline, which denies that Paxil led Lois Colacicco to kill herself, "believes the agency is in the best position to know what should or should not be in a label," said Andrew Bayman, a GlaxoSmithKline defense attorney from the Atlanta firm King & Spalding.
But Colacicco's attorneys, Derek Braslow and Harris Pogust of Conshohocken, said the FDA lacked the resources, punitive powers, and political support to protect every patient or prosecute drug companies that obscured data. Pogust noted that the FDA changed the label last year and ordered suicide warnings on Paxil, Zoloft and similar antidepressants.
"We really don't blame the FDA" for safety problems, Pogust said. "But what they're doing now with preemption is outrageous. They have no business in civil litigation."
If Colacicco's case doesn't get to the Supreme Court, others are right behind, lawyers noted. Pfizer has filed preemption motions in at least a dozen pending cases involving Zoloft, it said.
In one federal case in Philadelphia, a North Wales couple, Tom and Kathy Woodward, say their 17-year-old daughter, Julie, hanged herself in the family's garage after seven days on Zoloft.
The Woodwards have accused Pfizer of suppressing suicide-risk information, and Tom Woodward scoffed at the idea that the FDA alone could protect the public, offering his own insights as a former marketing-promotions consultant for drug companies.
"I would hear them talk about doctors in a very negative way, about the FDA in a very negative light," said Woodward, owner of a small consulting firm, the Pathway Group. "The FDA is always going to be one, two, three steps behind the drug companies."
Pfizer rejected the claim that Zoloft caused Julie Woodward to take her life in 2003. It insisted the elevated risk of suicide among some patients had not been proved until later, when the FDA responded by changing the label.
"If Pfizer had included a warning of any such association at that time, the Zoloft label would have been false and misleading under federal law," said Malcolm E. Wheeler, Pfizer's Zoloft defense lawyer from the Denver firm Wheeler Trigg Kennedy L.L.P.
Wheeler and Bayman said the FDA preamble was significant because, for the first time, it comprehensively spelled out the FDA position on litigation over drug labels, including excessive warnings.
"Patients may be discouraged from using important, potentially lifesaving treatments if the lawsuit-generated warnings are more severe than the neutral medical and scientific experts at FDA consider warranted," Wheeler said.
Critics scoff at the drug companies' suggestion that, if not for the FDA, they voluntarily would put extra warnings on their products.
"It's a naked power grab for the industry, and I think the courts are seeing through it," said Leslie Brueckner, staff attorney at Trial Lawyers for Public Justice, a Washington-based group that helps plaintiffs suing drug companies.
The sides are divided on the potential impact of preemption, a policy initiated by former FDA chief counsel Daniel Troy, who stepped down in 2004 and returned to corporate defense work.
"This will end failure-to-warn claims," said Pogust, who represents Colacicco and the Woodwards.
One member of Congress, Rep. Maurice Hinchey (D., N.Y.), has introduced legislation to limit the FDA's ability to preempt state consumer-protection laws.
But Wheeler called the fears "a Chicken Little argument." He said preemption would be "helpful" but not significant in reducing lawsuits because it would not affect fraud, faulty-design or negligence claims.
Eric G. Lasker, a pharmaceutical defense lawyer at Spriggs & Hollingsworth in Washington, said preemption would "not do away" with litigation but might provide some relief.
"Prescription-drug litigation now is a huge financial issue, and it's driving a lot of what drug companies have to do," Lasker said.
Colacicco himself said he agreed there were too many "frivolous lawsuits." But the pro-Bush registered Republican and entrepreneur said preemption might go too far.
"I do believe we have to support our pharmaceutical companies. But they have to be true to us, as well," Colacicco said.
Legal Basis for Drug Firms' Motions
Pharmaceutical companies cite the Food and Drug Administration's statement on preemption in its new labeling rules as a basis for dismissing lawsuits that assert the firms failed to warn patients about drug risks.
Excerpts from FDA statement
"FDA believes that State laws conflict with and stand as an obstacle to achievement of the full objectives and purposes of Federal law when they purport to compel a firm to include in labeling or advertising a statement that FDA has considered and found scientifically unsubstantiated."
Court rulings "can erode and disrupt the careful and truthful representation of benefits and risks that prescribers need to make appropriate judgments about drug use."
Example of preemption
The FDA offers six examples of lawsuit claims that it says its rules should preempt. Here is one:
"Claims that a drug sponsor breached an obligation to warn by failing to include in labeling or in advertising a statement, the substance of which FDA has prohibited in labeling or advertising."
Other claims are allowed
"The Supreme Court has held that certain state law requirements that parallel FDA requirements may not be preempted."
SOURCE: U.S. Food and Drug Administration
By Thomas Ginsberg
Inquirer Staff Writer
Joseph Colacicco's wife, Lois, slashed herself to death with razor blades in 2003 while taking the antidepressant Paxil, painting her final thoughts in blood in their bathroom: "Thanks."
"She felt it was over, finally," Colacicco said of his wife's mental torment. "She had no inkling it was because of Paxil. The pharmaceutical companies fooled the public, fooled me, fooled my wife."
Colacicco's accusation stands out not just because it is tragic. His lawsuit has become a front-line case in the Bush administration's efforts to rein in claims against pharmaceutical companies, with tens of millions of dollars at stake on both sides.
Colacicco's claim that GlaxoSmithKline P.L.C. and Apotex Inc., maker of generic Paxil, failed to warn patients in 2003 about Paxil's suicide risks was dismissed last month in U.S. District Court in Philadelphia, where GlaxoSmithKline has a U.S. headquarters.
The dismissal was based partly on the newly articulated argument that the U.S. Food and Drug Administration alone is accountable for what is, and is not, written on prescription-drug warning labels, preempting any judge or jury. Under that principle, an FDA-approved warning label is the last word on safety, and courts shouldn't second-guess it.
Lawyers on both sides say such FDA preemption on prescription-drug warnings, if upheld, could block many "failure to warn" claims against drug companies. Such claims constitute many, although not all, of the infractions alleged in tens of thousands of pharmaceutical liability lawsuits each year.
Since 2000, the FDA had asserted the principle only in legal briefs in isolated lawsuits, not as an agency policy.
Now the principle is codified in the preamble of the FDA's new drug-labeling code, which was published in January and took effect June 30. Brandishing the preamble in recent months, drug companies have papered courtrooms nationwide with motions to dismiss failure-to-warn claims.
Most of the motions have failed. On June 6, New Jersey Superior Court Judge Carol E. Higbee denied Merck & Co. Inc.'s motion seeking dismissal of a Vioxx case, calling the FDA preamble "a political statement." On May 31, U.S. District Judge Joseph Bataillon, in Nebraska, rejected Pfizer Inc.'s motion in a case involving its antidepressant Zoloft, saying that the FDA had contradicted its own past positions and that Congress had never given the agency preemption power over courts in prescription-drug cases.
But on May 25 in Philadelphia, U.S. District Judge Michael M. Baylson threw out Colacicco's claim. In a broad ruling, Baylson said courts should defer to the agency's scientific expertise and regulatory authority. It is this deference that other judges have rejected.
"It is not the function of this court, or for a jury empaneled to decide this case, to substitute its judgment for the FDA's about medical issues," Baylson wrote.
He added: "Ultimately, this court believes it is far more desirable that the important issues presented by this case, indeed tragic in its facts, are better addressed by elected officials, legislative and executive, than by appointed judges."
Colacicco, of Long Beach, N.Y., appealed to the U.S. Court of Appeals for the Third Circuit in Philadelphia, taking the lead in a jurisdictional dispute that attorneys predict will not end until it hits the U.S. Supreme Court.
GlaxoSmithKline, which denies that Paxil led Lois Colacicco to kill herself, "believes the agency is in the best position to know what should or should not be in a label," said Andrew Bayman, a GlaxoSmithKline defense attorney from the Atlanta firm King & Spalding.
But Colacicco's attorneys, Derek Braslow and Harris Pogust of Conshohocken, said the FDA lacked the resources, punitive powers, and political support to protect every patient or prosecute drug companies that obscured data. Pogust noted that the FDA changed the label last year and ordered suicide warnings on Paxil, Zoloft and similar antidepressants.
"We really don't blame the FDA" for safety problems, Pogust said. "But what they're doing now with preemption is outrageous. They have no business in civil litigation."
If Colacicco's case doesn't get to the Supreme Court, others are right behind, lawyers noted. Pfizer has filed preemption motions in at least a dozen pending cases involving Zoloft, it said.
In one federal case in Philadelphia, a North Wales couple, Tom and Kathy Woodward, say their 17-year-old daughter, Julie, hanged herself in the family's garage after seven days on Zoloft.
The Woodwards have accused Pfizer of suppressing suicide-risk information, and Tom Woodward scoffed at the idea that the FDA alone could protect the public, offering his own insights as a former marketing-promotions consultant for drug companies.
"I would hear them talk about doctors in a very negative way, about the FDA in a very negative light," said Woodward, owner of a small consulting firm, the Pathway Group. "The FDA is always going to be one, two, three steps behind the drug companies."
Pfizer rejected the claim that Zoloft caused Julie Woodward to take her life in 2003. It insisted the elevated risk of suicide among some patients had not been proved until later, when the FDA responded by changing the label.
"If Pfizer had included a warning of any such association at that time, the Zoloft label would have been false and misleading under federal law," said Malcolm E. Wheeler, Pfizer's Zoloft defense lawyer from the Denver firm Wheeler Trigg Kennedy L.L.P.
Wheeler and Bayman said the FDA preamble was significant because, for the first time, it comprehensively spelled out the FDA position on litigation over drug labels, including excessive warnings.
"Patients may be discouraged from using important, potentially lifesaving treatments if the lawsuit-generated warnings are more severe than the neutral medical and scientific experts at FDA consider warranted," Wheeler said.
Critics scoff at the drug companies' suggestion that, if not for the FDA, they voluntarily would put extra warnings on their products.
"It's a naked power grab for the industry, and I think the courts are seeing through it," said Leslie Brueckner, staff attorney at Trial Lawyers for Public Justice, a Washington-based group that helps plaintiffs suing drug companies.
The sides are divided on the potential impact of preemption, a policy initiated by former FDA chief counsel Daniel Troy, who stepped down in 2004 and returned to corporate defense work.
"This will end failure-to-warn claims," said Pogust, who represents Colacicco and the Woodwards.
One member of Congress, Rep. Maurice Hinchey (D., N.Y.), has introduced legislation to limit the FDA's ability to preempt state consumer-protection laws.
But Wheeler called the fears "a Chicken Little argument." He said preemption would be "helpful" but not significant in reducing lawsuits because it would not affect fraud, faulty-design or negligence claims.
Eric G. Lasker, a pharmaceutical defense lawyer at Spriggs & Hollingsworth in Washington, said preemption would "not do away" with litigation but might provide some relief.
"Prescription-drug litigation now is a huge financial issue, and it's driving a lot of what drug companies have to do," Lasker said.
Colacicco himself said he agreed there were too many "frivolous lawsuits." But the pro-Bush registered Republican and entrepreneur said preemption might go too far.
"I do believe we have to support our pharmaceutical companies. But they have to be true to us, as well," Colacicco said.
Legal Basis for Drug Firms' Motions
Pharmaceutical companies cite the Food and Drug Administration's statement on preemption in its new labeling rules as a basis for dismissing lawsuits that assert the firms failed to warn patients about drug risks.
Excerpts from FDA statement
"FDA believes that State laws conflict with and stand as an obstacle to achievement of the full objectives and purposes of Federal law when they purport to compel a firm to include in labeling or advertising a statement that FDA has considered and found scientifically unsubstantiated."
Court rulings "can erode and disrupt the careful and truthful representation of benefits and risks that prescribers need to make appropriate judgments about drug use."
Example of preemption
The FDA offers six examples of lawsuit claims that it says its rules should preempt. Here is one:
"Claims that a drug sponsor breached an obligation to warn by failing to include in labeling or in advertising a statement, the substance of which FDA has prohibited in labeling or advertising."
Other claims are allowed
"The Supreme Court has held that certain state law requirements that parallel FDA requirements may not be preempted."
SOURCE: U.S. Food and Drug Administration
Wednesday, June 28, 2006
MHRA FAIL YET AGAIN
Please find below correspondence to which I was copied into by Dr Aubrey Blumsohn.
I was copied in on the email and in the spirit of openness I am reproducing it without permission and will be interested to receive a reply
Dr Blumsohn is apparently one of the brave few doctors who seems to care about honesty. There is some information about scientific fraud and ghostwriting about the drug Actonel (Procter and Gamble Pharmaceuticals) and the story of what happened to him seems unbelievable. It involved ghostwriting of science in Dr Blumsohn's name. The reported study findings subsequently seemed to be fraudulent. Having received no help from the MHRA, the Research Dean of his Medical School, Sheffield University and after a journal editor attempted to suppress the information (follow the money) he went to the press and was fired.
For more information on Dr Aubrey Blumsohn and what happened to him - click on the following links
http://www.slate.com/id/2133061/
http://www.thejabberwock.org/jbmrs.htm
http://www.whistleblower.org/content/press_detail.cfm?press_id=507
http://www.whistleblower.org/content/press_detail.cfm?press_id=387
Dr Blumsohn's letter follows
28th June 2006
Ms Susan KramerLiberal Democrat MP for Richmond Park
Steve Webb MPLiberal Democrat Shadow Health Secretary
Dear Ms Kramer/Mr Webb
I was sent correspondence from yourself and Steve Webb about the MHRA from constituents concerned about scientific fraud in studies of SSRI antidepressants. I am a medical doctor and have some personal experience of this duplicitous agency involving other drugs. I don't believe you understand the gravity or nature of the problem.
You state that "While this is being examined, I have signed EDM 100 (Prescription Medication), which calls for FULL AND IMPARTIAL INFORMATION for consumers on the potential risks and side-effects of prescription medication. "
With respect, the problem is not one of providing consumers with "full and impartial information", rather that there is no longer any "impartial information" to provide. Doctors, researchers, and authors fronting scientific papers about pharmaceuticals are also being denied information about the drugs they are prescribing, and manipulated "scientific" material is being written by companies as if it derived from University academics (such as myself). The regulators are seemingly accepting the information fed to them by companies with blind faith - with demonstrably catastrophic results.
Your Colleague Steve Webb stated
"I have looked at EDM 2172 and will not at this stage be recommending that my colleagues sign it. Clearly to accuse the MHRA of a cover-up needs to have pretty solid evidence that this is the case. As you have been taking up this issue through my colleague Susan Kramer, I would suggest that you ask her to write to the MHRA on the issue and give them the right of reply."
This is not a matter of fine politics or "rights of reply" - at least 50,000 patients are estimated to have died in the US alone as a result of cover-ups and scientific fraud involving VIOXX. Scientific fraud involving SSRI's has almost certainly resulted in deaths and much suffering.
The evidence suggesting cover-up and conflicts of interest is extensive. The MHRA have already been given adequate opportunity to reply, but have failed to do so in anything other than a laughable manner. I have no personal interest in the SSRI issue, but the failures of reply with regard to this are already carefully documented by social policy experts for example
at http://www.socialaudit.org.uk/6040000.htm#New
Instead of perpetuating this infinite loop of gobbledegook and delay it would be better if you simply assessed the evidence and failure of answering and attempted to get answers yourself.
Astonishingly, the department of health seems now to be asserting (correspondence as of last week) that the MHRA does not in fact have any legal remit to investigate scientific fraud or ghostwriting by companies in studies involving pharmaceuticals, or in the use of such science in promotional material.
The whole structure of science in pharmaceutical medicine has failed, and the MHRA is certainly implicated in and has colluded with this failure.
If you would like to meet with me to discuss my own rather interesting involvement with this agency I would be most pleased.
Kindly
Dr Aubrey Blumsohn MBBCh, PhD, MSc, BSc(hons), MRCPath
I was copied in on the email and in the spirit of openness I am reproducing it without permission and will be interested to receive a reply
Dr Blumsohn is apparently one of the brave few doctors who seems to care about honesty. There is some information about scientific fraud and ghostwriting about the drug Actonel (Procter and Gamble Pharmaceuticals) and the story of what happened to him seems unbelievable. It involved ghostwriting of science in Dr Blumsohn's name. The reported study findings subsequently seemed to be fraudulent. Having received no help from the MHRA, the Research Dean of his Medical School, Sheffield University and after a journal editor attempted to suppress the information (follow the money) he went to the press and was fired.
For more information on Dr Aubrey Blumsohn and what happened to him - click on the following links
http://www.slate.com/id/2133061/
http://www.thejabberwock.org/jbmrs.htm
http://www.whistleblower.org/content/press_detail.cfm?press_id=507
http://www.whistleblower.org/content/press_detail.cfm?press_id=387
Dr Blumsohn's letter follows
28th June 2006
Ms Susan KramerLiberal Democrat MP for Richmond Park
Steve Webb MPLiberal Democrat Shadow Health Secretary
Dear Ms Kramer/Mr Webb
I was sent correspondence from yourself and Steve Webb about the MHRA from constituents concerned about scientific fraud in studies of SSRI antidepressants. I am a medical doctor and have some personal experience of this duplicitous agency involving other drugs. I don't believe you understand the gravity or nature of the problem.
You state that "While this is being examined, I have signed EDM 100 (Prescription Medication), which calls for FULL AND IMPARTIAL INFORMATION for consumers on the potential risks and side-effects of prescription medication. "
With respect, the problem is not one of providing consumers with "full and impartial information", rather that there is no longer any "impartial information" to provide. Doctors, researchers, and authors fronting scientific papers about pharmaceuticals are also being denied information about the drugs they are prescribing, and manipulated "scientific" material is being written by companies as if it derived from University academics (such as myself). The regulators are seemingly accepting the information fed to them by companies with blind faith - with demonstrably catastrophic results.
Your Colleague Steve Webb stated
"I have looked at EDM 2172 and will not at this stage be recommending that my colleagues sign it. Clearly to accuse the MHRA of a cover-up needs to have pretty solid evidence that this is the case. As you have been taking up this issue through my colleague Susan Kramer, I would suggest that you ask her to write to the MHRA on the issue and give them the right of reply."
This is not a matter of fine politics or "rights of reply" - at least 50,000 patients are estimated to have died in the US alone as a result of cover-ups and scientific fraud involving VIOXX. Scientific fraud involving SSRI's has almost certainly resulted in deaths and much suffering.
The evidence suggesting cover-up and conflicts of interest is extensive. The MHRA have already been given adequate opportunity to reply, but have failed to do so in anything other than a laughable manner. I have no personal interest in the SSRI issue, but the failures of reply with regard to this are already carefully documented by social policy experts for example
at http://www.socialaudit.org.uk/6040000.htm#New
Instead of perpetuating this infinite loop of gobbledegook and delay it would be better if you simply assessed the evidence and failure of answering and attempted to get answers yourself.
Astonishingly, the department of health seems now to be asserting (correspondence as of last week) that the MHRA does not in fact have any legal remit to investigate scientific fraud or ghostwriting by companies in studies involving pharmaceuticals, or in the use of such science in promotional material.
The whole structure of science in pharmaceutical medicine has failed, and the MHRA is certainly implicated in and has colluded with this failure.
If you would like to meet with me to discuss my own rather interesting involvement with this agency I would be most pleased.
Kindly
Dr Aubrey Blumsohn MBBCh, PhD, MSc, BSc(hons), MRCPath
Tuesday, June 27, 2006
MHRA INVESTIGATE MHRA
-----Original Message-----
From: FOI_Website_Request@mhra.gsi.gov.uk [mailto:FOI_Website_Request@mhra.gsi.gov.uk]
Sent: 05 June 2006 18:00
To: FOI_request Subject: FOI Website Request
Mon Jun 05 18:00:11 BST 2006
Details of information Required:
From correspondence with your information centre, I have been made aware that Glaxo SmithKline are currently under investigation by the MHRA.
Under the Freedom of Information Act (FOI) I request the following questions to be answered:
1. Will Dr Pete Breggin's 38 page report be used as part of the investigation?
2. Will Sir Alistair Breckenridge and Dr Ian Hudson play any part of the investigation? If so, what role will they play? If not, Why?
3. Have the police been drafted in to help with enquiries? If not, Why?
4. Will the Prof. Kent Woods, CEO of the MHRA accept full responsibility for the failings of the review boards concerning the anti - depressant drug Seroxat? If not, Why?
5. Evidence suggests that at least two members of the MHRA, Sir Alistair Breckenridge and Dr Ian Hudson, were both employed by Glaxo SmithKline during the adult trials for Seroxat. Given that - It is conceiveable that both knew that their employers had suppressed evidence from both the public and the MHRA. Will both Sir Alistair Breckenridge and Dr Ian Hudson be prosecuted?
I trust you can give me answers to these questions in due course. If for some reason you cannot, I request a full, detailed response as to why you cannot give me answers.
Meantime, I look forward to your reply.
Mr. Robert Fiddaman
-----------------------
RESPONSE FROM MHRA
----- Original Message -----
From: Lee-Frost, Danny
To: fiddaman64@blueyonder.co.uk
Sent: Tuesday, June 27, 2006 2:05 PM
Subject: Freedom of Information request
Dear Mr Fiddaman.
REF: FOI 06/189 Thank you for your enquiry of 5th June. I am writing to let you know that we are unable to supply part the information you have requested. Under the Freedom of Information Act (FOIA) certain exemptions apply to the information we can make available.
The information you have requested concerning a criminal investigation is subject to the exemption contained in the FOIA, namely exemption 30. We have concluded that disclosing this information would not be appropriate because it would prejudice an ongoing criminal investigation. I am satisfied that both categories in exemption 30 are applicable;
a) where information has at any time been held for the purpose of specified criminal and other investigations or proceedings; and
b) where information relates to the obtaining of information from confidential sources and was obtained or recorded for a number of specified investigations or proceedings.
Therefore it would not be in the public interest to disclose the outcome of the criminal investigation in advance of any potential court proceedings.
However I can confirm that the investigation to which you refer is being conducted by the Criminal Investigation Unit of the Enforcement & Intelligence Group and the services of the police have not been required. For more information on the work of this group please visit the MHRA website at www.mhra.gov.uk
If you have a query about this letter, please contact me. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 10th Floor, Medicines and Healthcare products Regulatory Agency, at the above address quoting the above reference. After that, if you remain dissatisfied, you may ask the Information Commissioner at
The Information Commissioner's Office Wycliffe House Water Lane Wilmslow Cheshire SKI OAF to make a decision on whether or not we have interpreted the FOI correctly in withholding information from you.
Yours sincerely
Danny Lee-Frost Head of Enforcement Medicines & Healthcare products Regulatory Agency
Room 18-108
Tel: 020 7084 2618/2173
Mob: 07712 556 352
danny.lee-frost@mhra.gsi.gov.uk
From: FOI_Website_Request@mhra.gsi.gov.uk [mailto:FOI_Website_Request@mhra.gsi.gov.uk]
Sent: 05 June 2006 18:00
To: FOI_request Subject: FOI Website Request
Mon Jun 05 18:00:11 BST 2006
Details of information Required:
From correspondence with your information centre, I have been made aware that Glaxo SmithKline are currently under investigation by the MHRA.
Under the Freedom of Information Act (FOI) I request the following questions to be answered:
1. Will Dr Pete Breggin's 38 page report be used as part of the investigation?
2. Will Sir Alistair Breckenridge and Dr Ian Hudson play any part of the investigation? If so, what role will they play? If not, Why?
3. Have the police been drafted in to help with enquiries? If not, Why?
4. Will the Prof. Kent Woods, CEO of the MHRA accept full responsibility for the failings of the review boards concerning the anti - depressant drug Seroxat? If not, Why?
5. Evidence suggests that at least two members of the MHRA, Sir Alistair Breckenridge and Dr Ian Hudson, were both employed by Glaxo SmithKline during the adult trials for Seroxat. Given that - It is conceiveable that both knew that their employers had suppressed evidence from both the public and the MHRA. Will both Sir Alistair Breckenridge and Dr Ian Hudson be prosecuted?
I trust you can give me answers to these questions in due course. If for some reason you cannot, I request a full, detailed response as to why you cannot give me answers.
Meantime, I look forward to your reply.
Mr. Robert Fiddaman
-----------------------
RESPONSE FROM MHRA
----- Original Message -----
From: Lee-Frost, Danny
To: fiddaman64@blueyonder.co.uk
Sent: Tuesday, June 27, 2006 2:05 PM
Subject: Freedom of Information request
Dear Mr Fiddaman.
REF: FOI 06/189 Thank you for your enquiry of 5th June. I am writing to let you know that we are unable to supply part the information you have requested. Under the Freedom of Information Act (FOIA) certain exemptions apply to the information we can make available.
The information you have requested concerning a criminal investigation is subject to the exemption contained in the FOIA, namely exemption 30. We have concluded that disclosing this information would not be appropriate because it would prejudice an ongoing criminal investigation. I am satisfied that both categories in exemption 30 are applicable;
a) where information has at any time been held for the purpose of specified criminal and other investigations or proceedings; and
b) where information relates to the obtaining of information from confidential sources and was obtained or recorded for a number of specified investigations or proceedings.
Therefore it would not be in the public interest to disclose the outcome of the criminal investigation in advance of any potential court proceedings.
However I can confirm that the investigation to which you refer is being conducted by the Criminal Investigation Unit of the Enforcement & Intelligence Group and the services of the police have not been required. For more information on the work of this group please visit the MHRA website at www.mhra.gov.uk
If you have a query about this letter, please contact me. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 10th Floor, Medicines and Healthcare products Regulatory Agency, at the above address quoting the above reference. After that, if you remain dissatisfied, you may ask the Information Commissioner at
The Information Commissioner's Office Wycliffe House Water Lane Wilmslow Cheshire SKI OAF to make a decision on whether or not we have interpreted the FOI correctly in withholding information from you.
Yours sincerely
Danny Lee-Frost Head of Enforcement Medicines & Healthcare products Regulatory Agency
Room 18-108
Tel: 020 7084 2618/2173
Mob: 07712 556 352
danny.lee-frost@mhra.gsi.gov.uk
Wednesday, June 07, 2006
SEROXAT LINKS
Here are some links to pages where you can see for yourself how Glaxo SmithKline and/or The MHRA have been duping the public.
http://health.groups.yahoo.com/group/seroxat/
http://www.socialaudit.org.uk/
http://www.ahrp.org/
http://www.paulflynnmp.co.uk/newsdetail.jsp?id=423
http://www.thejabberwock.org/mhra.htm
http://anti-depression.net/articles/Paxil.html
http://news.yahoo.com/s/huffpost/20060521/cm_huffpost/021388
http://paxilprotest.com/
http://www.redorbit.com/modules/news/tools.php?tool=print&id=131376
http://www.real-medicine.org/bull.htm
http://www.benzo.org.uk/press.htm
http://www.newmediaexplorer.org/sepp/2004/10/07/pharma_tame_watchdogs_not_protecting_public_health.htm
http://www.guardian.co.uk/uk_news/story/0,3604,415720,00.html
http://66.249.93.104/search?q=cache:sB2Xo91yJmMJ:www.emea.eu.int/pdfs/general/contacts/ihudson_DI.pdf+dr+ian+hudson+financial+interests&hl=en&gl=uk&ct=clnk&cd=1
UK VISITORS VOICE YOUR CONCERNS TO THE HEALTH SELECT COMMITTEE HERE:
http://www.parliament.uk/parliamentary_committees/health_committee/health_committee_members.cfm
EMAIL YOUR MP HERE:
http://www.writetothem.com/
EMAIL THE MHRA HERE:
http://www.mhra.gov.uk/ or directly to info@mhra.gsi.gov.uk
EMAIL THE CHIEF EXECUTIVE OF THE MHRA HERE:
kent.woods@mhra.gsi.gov.uk
http://health.groups.yahoo.com/group/seroxat/
http://www.socialaudit.org.uk/
http://www.ahrp.org/
http://www.paulflynnmp.co.uk/newsdetail.jsp?id=423
http://www.thejabberwock.org/mhra.htm
http://anti-depression.net/articles/Paxil.html
http://news.yahoo.com/s/huffpost/20060521/cm_huffpost/021388
http://paxilprotest.com/
http://www.redorbit.com/modules/news/tools.php?tool=print&id=131376
http://www.real-medicine.org/bull.htm
http://www.benzo.org.uk/press.htm
http://www.newmediaexplorer.org/sepp/2004/10/07/pharma_tame_watchdogs_not_protecting_public_health.htm
http://www.guardian.co.uk/uk_news/story/0,3604,415720,00.html
http://66.249.93.104/search?q=cache:sB2Xo91yJmMJ:www.emea.eu.int/pdfs/general/contacts/ihudson_DI.pdf+dr+ian+hudson+financial+interests&hl=en&gl=uk&ct=clnk&cd=1
UK VISITORS VOICE YOUR CONCERNS TO THE HEALTH SELECT COMMITTEE HERE:
http://www.parliament.uk/parliamentary_committees/health_committee/health_committee_members.cfm
EMAIL YOUR MP HERE:
http://www.writetothem.com/
EMAIL THE MHRA HERE:
http://www.mhra.gov.uk/ or directly to info@mhra.gsi.gov.uk
EMAIL THE CHIEF EXECUTIVE OF THE MHRA HERE:
kent.woods@mhra.gsi.gov.uk
Tuesday, June 06, 2006
Sunday, June 04, 2006
A WORK OF FICTION... OR IS IT?
Hello, my name is Sir Andrew Brokenbridge. I was knighted back in 97 for my work in the field of Medicines. Currently I serve the British public by being part of a team that regulate medicines - after all, we don't want you taking medicines that are bad for you do we?
In 1992, I was World Safety Officer for a Pharmaceutical Company where my job was to oversee that all medicines met our stringent criteria. Obviously, there was some medicines that never quite came up to scratch with our criteria but with a little tweaking here and there such as hiding clinical trial evidence or just not being forthright with the regulator we were able to run a smooth ship. After all, it was only a few people that would suffer opposed to the millions it would help. The public would never find out and no lawyer in his or her right mind would ever dare to take on a Pharmaceutical Company with an endless pot of money. Even if it did leak out that we suppressed clinical trial evidence we could always put up a smokescreen. We have a clever legal department you see and our own language when it comes to Patient Information Leaflets (The information you read that comes with your medicine) We stick to no dictionary - we have our own versions of the English language. The word 'Addiction' does not exist in our dictionary.
Through regular Freemason meetings, I was asked to join the Medicines regulator, where my job would be to regulate the medicines my employer was manufacturing. To my delight, I found that the Medicines regulator also had their very own dictionary and were made up of ex-Pharmaceutical Company employees. Therefore, with a nice golden handshake I left my employer, Smith DontKare (SDK) to take up my new post.
Sometime down the line I had the shock of my life when one of the drugs I monitored whilst employed at SDK came up for review by the Medicines regulator. My whole world came tumbling down but I was soon put at ease when I heard the suppressed evidence would not be submitted. Phew! I thought I was for the high jump then I can tell you. The second time this particular drug was reviewed I felt more at ease as basically the same evidence was submitted. No one would ever find out how my former employers were able to suppress evidence. Life just could not get any better.
I'd heard rumblings of support groups popping up over the internet regarding this particular drug and heard on the grapevine that BBC TV were running a special programme on their pioneer show 'Panorama'. I must admit I did have a giggle to myself about this although my colleague, Dr Liam Disdain, had fears. He too now worked alongside me and was also a former employee of SDK. He too knew about the suppressed evidence. Anyway, I reassured him that we were in the clear, as SDK would never allow their trial data to be looked at - even if they were subpoenaed, they would do everything in their power to make it difficult for the researcher looking for the particular trial data. I told Dr Disdain that they would probably stick some Professor in a room full of records and the possibilities of him/her ever finding what he/she was searching for was a zillion to one! We both laughed at that image.
The BBC ran the programme but little came of it. It certainly never bothered us in the Medicines regulator department. It did however build up a strong membership base in those pesky online support groups - even more so when a second programme was aired by the BBC. Again though, we here at the Medicines regulator department did not take much notice. The drug helped millions of people and even though lawsuits were happening in the States my former employers, SDK, could further suppress the hidden evidence by making substantial out of court settlements. When settled out of court both parties would agree to keep all the evidence sealed. Anyway, that was America - no one from the UK would ever dare take on a Pharmaceutical Company - for one they would not get public funding. Both Dr Disdain and I were quietly comfortable. In fact, we had both been given the nicknames 'The Untouchables' back at the Freemasons lodge.
A third programme was to be aired by the BBC and I was asked to do an interview with the investigative reporter. I took legal advice and was told what to say by my legal team - which amounted to sidestepping any questions the interviewer put to me. I really put her in her place by answering almost every question with, 'That is a matter that is currently being investigated'. Had the camera's been panned on her you would have been able to see the frustration in her face. I felt like Al Capone - I was untouchable.
This third programme however created a lot of public reaction and soon after a firm of Solicitors in Wales decided they would take on the might of SDK. They do not stand a chance, I told Dr Disdain. For one they will not get public funding! Dr Disdain told me that certain members of one of the pesky support groups were asking many questions about him and I. Luckily for us, the Chief Executive of the Medicine Regulatory Board was 100% behind us. Although Prof. Clark Kent was our boss he was also a good friend. We called him 'Superman' back at the Freemasons lodge for obvious reasons!
Clark told us both that support group members were asking for both mine and Dr Disdain's resignation from our posts here at the Medicines regulatory department. Whom did they think they were dealing with? I have more letters after my surname than they do in their Christian and middle names! Anyway, we were briefed not to give interviews to the press concerning this drug and any emails or letters we received we could pass off as Spam. To this day, I have not answered any emails sent to me by a member of the public. God, I feel so powerful.
The odd article would appear in the press over the coming months but it was nothing to lose sleep over. Today's news is tomorrow's fish & chip paper. SDK did finally admit that the particular drug was dangerous to children but to be honest they had already made millions of pounds from it so a loss of a few million would be of no significance seeing as their was an increase in depression in the adult population in the UK - they could now target GP's with free holidays and payments and let them know just how good this drug was. Unfortunately, the age where this drug caused problems had moved from under 18's to under 24's but using their dictionary they were able to claim that 18 to 24 did not include the adult population. The data they suppressed back then was for the adult population.
Those pests at the support group were relentless and were unearthing documents over the internet. Damn the internet. They were also lobbying MP's but fortunately, not many were interested as they had local issues to deal with.
On Saturday 13th May 2006, my butler woke me with breakfast and the day's newspapers. I was shocked to read that SDK had yet again moved the goal posts again on the age issue. They had now sent directives to GP's warning them that the drug could cause suicide in patients up to the age of 30. To be honest, I do not know how they get away with it - they have known for years that it is dangerous - as have I.
Oh well, Monday morning now and I am at my desk. I see those pesky group moderators from the support group have been emailing me over the weekend.... One click of the mouse... there you go... into my Spam folder. You cannot get me... I am untouchable.
Sir Andrew Brokenbridge
In 1992, I was World Safety Officer for a Pharmaceutical Company where my job was to oversee that all medicines met our stringent criteria. Obviously, there was some medicines that never quite came up to scratch with our criteria but with a little tweaking here and there such as hiding clinical trial evidence or just not being forthright with the regulator we were able to run a smooth ship. After all, it was only a few people that would suffer opposed to the millions it would help. The public would never find out and no lawyer in his or her right mind would ever dare to take on a Pharmaceutical Company with an endless pot of money. Even if it did leak out that we suppressed clinical trial evidence we could always put up a smokescreen. We have a clever legal department you see and our own language when it comes to Patient Information Leaflets (The information you read that comes with your medicine) We stick to no dictionary - we have our own versions of the English language. The word 'Addiction' does not exist in our dictionary.
Through regular Freemason meetings, I was asked to join the Medicines regulator, where my job would be to regulate the medicines my employer was manufacturing. To my delight, I found that the Medicines regulator also had their very own dictionary and were made up of ex-Pharmaceutical Company employees. Therefore, with a nice golden handshake I left my employer, Smith DontKare (SDK) to take up my new post.
Sometime down the line I had the shock of my life when one of the drugs I monitored whilst employed at SDK came up for review by the Medicines regulator. My whole world came tumbling down but I was soon put at ease when I heard the suppressed evidence would not be submitted. Phew! I thought I was for the high jump then I can tell you. The second time this particular drug was reviewed I felt more at ease as basically the same evidence was submitted. No one would ever find out how my former employers were able to suppress evidence. Life just could not get any better.
I'd heard rumblings of support groups popping up over the internet regarding this particular drug and heard on the grapevine that BBC TV were running a special programme on their pioneer show 'Panorama'. I must admit I did have a giggle to myself about this although my colleague, Dr Liam Disdain, had fears. He too now worked alongside me and was also a former employee of SDK. He too knew about the suppressed evidence. Anyway, I reassured him that we were in the clear, as SDK would never allow their trial data to be looked at - even if they were subpoenaed, they would do everything in their power to make it difficult for the researcher looking for the particular trial data. I told Dr Disdain that they would probably stick some Professor in a room full of records and the possibilities of him/her ever finding what he/she was searching for was a zillion to one! We both laughed at that image.
The BBC ran the programme but little came of it. It certainly never bothered us in the Medicines regulator department. It did however build up a strong membership base in those pesky online support groups - even more so when a second programme was aired by the BBC. Again though, we here at the Medicines regulator department did not take much notice. The drug helped millions of people and even though lawsuits were happening in the States my former employers, SDK, could further suppress the hidden evidence by making substantial out of court settlements. When settled out of court both parties would agree to keep all the evidence sealed. Anyway, that was America - no one from the UK would ever dare take on a Pharmaceutical Company - for one they would not get public funding. Both Dr Disdain and I were quietly comfortable. In fact, we had both been given the nicknames 'The Untouchables' back at the Freemasons lodge.
A third programme was to be aired by the BBC and I was asked to do an interview with the investigative reporter. I took legal advice and was told what to say by my legal team - which amounted to sidestepping any questions the interviewer put to me. I really put her in her place by answering almost every question with, 'That is a matter that is currently being investigated'. Had the camera's been panned on her you would have been able to see the frustration in her face. I felt like Al Capone - I was untouchable.
This third programme however created a lot of public reaction and soon after a firm of Solicitors in Wales decided they would take on the might of SDK. They do not stand a chance, I told Dr Disdain. For one they will not get public funding! Dr Disdain told me that certain members of one of the pesky support groups were asking many questions about him and I. Luckily for us, the Chief Executive of the Medicine Regulatory Board was 100% behind us. Although Prof. Clark Kent was our boss he was also a good friend. We called him 'Superman' back at the Freemasons lodge for obvious reasons!
Clark told us both that support group members were asking for both mine and Dr Disdain's resignation from our posts here at the Medicines regulatory department. Whom did they think they were dealing with? I have more letters after my surname than they do in their Christian and middle names! Anyway, we were briefed not to give interviews to the press concerning this drug and any emails or letters we received we could pass off as Spam. To this day, I have not answered any emails sent to me by a member of the public. God, I feel so powerful.
The odd article would appear in the press over the coming months but it was nothing to lose sleep over. Today's news is tomorrow's fish & chip paper. SDK did finally admit that the particular drug was dangerous to children but to be honest they had already made millions of pounds from it so a loss of a few million would be of no significance seeing as their was an increase in depression in the adult population in the UK - they could now target GP's with free holidays and payments and let them know just how good this drug was. Unfortunately, the age where this drug caused problems had moved from under 18's to under 24's but using their dictionary they were able to claim that 18 to 24 did not include the adult population. The data they suppressed back then was for the adult population.
Those pests at the support group were relentless and were unearthing documents over the internet. Damn the internet. They were also lobbying MP's but fortunately, not many were interested as they had local issues to deal with.
On Saturday 13th May 2006, my butler woke me with breakfast and the day's newspapers. I was shocked to read that SDK had yet again moved the goal posts again on the age issue. They had now sent directives to GP's warning them that the drug could cause suicide in patients up to the age of 30. To be honest, I do not know how they get away with it - they have known for years that it is dangerous - as have I.
Oh well, Monday morning now and I am at my desk. I see those pesky group moderators from the support group have been emailing me over the weekend.... One click of the mouse... there you go... into my Spam folder. You cannot get me... I am untouchable.
Sir Andrew Brokenbridge
Friday, June 02, 2006
SEROXAT VIDEOS
Each link will open either Windows media player or Real player
http://www.justiceseekers.com/html/WMV441kHzFinalWeb.wmv
http://g6publish.videodome.com/excite/portal/index.asp?channel=Mental+Health&clipid=54812&bitrate=300&format=wmp
http://www.gsk.com/media/paroxetine/benbow_sideeffect.wmv
(Benbow lying?)
http://www.gsk.com/media/paroxetine/benbow_discontinuation.wmv
(Benbow lying again?)
http://news.bbc.co.uk/olmedia/cta/progs/03/forums/panorama/seroxat11may.ram
(Panorama Interactive)
http://newswww.bbc.net.uk/olmedia/cta/progs/02/forum/panorama/seroxat14oct.ram
(Panorama Interactive Part 2)
http://newsimg.bbc.co.uk/olmedia/cta/progs/03/forums/panorama/seroxat11jul.ram
(Another exclusive and more lies?)
Bob Fiddaman
http://www.justiceseekers.com/html/WMV441kHzFinalWeb.wmv
http://g6publish.videodome.com/excite/portal/index.asp?channel=Mental+Health&clipid=54812&bitrate=300&format=wmp
http://www.gsk.com/media/paroxetine/benbow_sideeffect.wmv
(Benbow lying?)
http://www.gsk.com/media/paroxetine/benbow_discontinuation.wmv
(Benbow lying again?)
http://news.bbc.co.uk/olmedia/cta/progs/03/forums/panorama/seroxat11may.ram
(Panorama Interactive)
http://newswww.bbc.net.uk/olmedia/cta/progs/02/forum/panorama/seroxat14oct.ram
(Panorama Interactive Part 2)
http://newsimg.bbc.co.uk/olmedia/cta/progs/03/forums/panorama/seroxat11jul.ram
(Another exclusive and more lies?)
Bob Fiddaman
Friday, May 26, 2006
THE TRUTH WILL OUT
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting Openness, FullDisclosure, and Accountability http://www.ahrp.org/cms/
In the wake of the extraordinary acknowledgement this month by Glaxo SmithKline that the clinical trial evidence shows that not only children and adolescents are at increased risk of suicidal behavior if they take its antidepressant, Paroxetine/Paxil (or any other "new generation"antidepressant). Adults too are at increased risk of suicide if they take Paxil and that risk is six-fold compared to those given a placebo.
Our colleague in the UK, Charles Medawar, of Social Audit, has been closely monitoring British public officials, drug company executives and leading academic psychiatrists, almost all of who have a financial/professional stake in protecting the reputation of SSRI antidepressants. His primary focus has centered on the British cast of characters in this tedious and insidious shadow play. GSK's acknowledgement confirms that the"authorities"- academic, government regulators and industry - have denied, deceived, and concealed evidence of drug harm. GSK's acknowledgement refutes the recent claims made in the official organ of the American Psychiatric Association, The American Journal of Psychiatry.
The claimed findings reported by Dr. Gregory Simon and colleagues about their epidemiological study, Suicide Risk During Antidepressant Treatment, in The American Journal of Psychiatry 163:41-47, January 2006, vol.163.1.41 are unsupported by the data. Dr. Simon reported that there was no increased suicide risk during the first week of treatment with an SSRI. This claimed finding from a methodologically flawed, uncontrolled study was widely disseminated in the major press. "Depression Drugs Safe, Beneficial, Studies Say" (Washington Post). Uncritical reporters transcribed the investigators' claims without understanding that these were scientifically invalid. However, Charles Medawar found egregious inconsistencies in that published report. He inquired, ever so politely, of Dr. Simon, the lead author to explain the inconsistencies. The one sided correspondence reveals that academic psychiatrists have misrepresented what the data actually shows. "In agreement with Jick and colleagues (15), we found a significantly higher risk of suicide attempts in the first week of antidepressant treatment than in subsequent weeks". In Dr. Simon's initial response, he conceded: "Risk in week 1 was not higher than in weeks 2, 3, and 4. But risk in week 1 was higher than in subsequentweeks (from week 5 onward)." Uncorrected, inconsistent statements of findings confuse many readers: they serve to deflect from the very troubling evidence that these widely prescribed drugs pose a serious threat to those who take them, especially throughout the first month. Such misleading reports served industry's interests. http://www.socialaudit.org.uk/6060521.htm#ANTIDEPRESSANTS
The release simultaneously of two "positive" SSRI studies, both financed by the National Institute of Mental Health, seems suspiciously calculated. Our suspicions are validated by the accompanying editorial in the Amer. J of Psychiatry which questioned the need for the black box label warnings! It is especially troubling that that most of the uncritical media had accepted the claimed "positive" results on faith. But the report, like most of the scientific literature about SSRI antidepressant safety and efficacy provides false and misleading information tailored to conceal that these drugs induce suicides. Since SSRIs have failed to demonstrate an antidepressant effect, given that in controlled clinical trials placebo has matched and even outperformed SSRIs, critics are beginning to wonder on what basis the FDA approved these drugs as "antidepressants"? This may be a case of misbranding. Simon G, et al http://ajp.psychiatryonline.org/cgi/content/abstract/163/1/41
See also: http://www.ahrp.org/cms/content/view/94/94/;http://www.ahrp.org/cms/content/view/23/28/ Contact: Vera Hassner Sharav212-595-8974
veracare@ahrp.org
In the wake of the extraordinary acknowledgement this month by Glaxo SmithKline that the clinical trial evidence shows that not only children and adolescents are at increased risk of suicidal behavior if they take its antidepressant, Paroxetine/Paxil (or any other "new generation"antidepressant). Adults too are at increased risk of suicide if they take Paxil and that risk is six-fold compared to those given a placebo.
Our colleague in the UK, Charles Medawar, of Social Audit, has been closely monitoring British public officials, drug company executives and leading academic psychiatrists, almost all of who have a financial/professional stake in protecting the reputation of SSRI antidepressants. His primary focus has centered on the British cast of characters in this tedious and insidious shadow play. GSK's acknowledgement confirms that the"authorities"- academic, government regulators and industry - have denied, deceived, and concealed evidence of drug harm. GSK's acknowledgement refutes the recent claims made in the official organ of the American Psychiatric Association, The American Journal of Psychiatry.
The claimed findings reported by Dr. Gregory Simon and colleagues about their epidemiological study, Suicide Risk During Antidepressant Treatment, in The American Journal of Psychiatry 163:41-47, January 2006, vol.163.1.41 are unsupported by the data. Dr. Simon reported that there was no increased suicide risk during the first week of treatment with an SSRI. This claimed finding from a methodologically flawed, uncontrolled study was widely disseminated in the major press. "Depression Drugs Safe, Beneficial, Studies Say" (Washington Post). Uncritical reporters transcribed the investigators' claims without understanding that these were scientifically invalid. However, Charles Medawar found egregious inconsistencies in that published report. He inquired, ever so politely, of Dr. Simon, the lead author to explain the inconsistencies. The one sided correspondence reveals that academic psychiatrists have misrepresented what the data actually shows. "In agreement with Jick and colleagues (15), we found a significantly higher risk of suicide attempts in the first week of antidepressant treatment than in subsequent weeks". In Dr. Simon's initial response, he conceded: "Risk in week 1 was not higher than in weeks 2, 3, and 4. But risk in week 1 was higher than in subsequentweeks (from week 5 onward)." Uncorrected, inconsistent statements of findings confuse many readers: they serve to deflect from the very troubling evidence that these widely prescribed drugs pose a serious threat to those who take them, especially throughout the first month. Such misleading reports served industry's interests. http://www.socialaudit.org.uk/6060521.htm#ANTIDEPRESSANTS
The release simultaneously of two "positive" SSRI studies, both financed by the National Institute of Mental Health, seems suspiciously calculated. Our suspicions are validated by the accompanying editorial in the Amer. J of Psychiatry which questioned the need for the black box label warnings! It is especially troubling that that most of the uncritical media had accepted the claimed "positive" results on faith. But the report, like most of the scientific literature about SSRI antidepressant safety and efficacy provides false and misleading information tailored to conceal that these drugs induce suicides. Since SSRIs have failed to demonstrate an antidepressant effect, given that in controlled clinical trials placebo has matched and even outperformed SSRIs, critics are beginning to wonder on what basis the FDA approved these drugs as "antidepressants"? This may be a case of misbranding. Simon G, et al http://ajp.psychiatryonline.org/cgi/content/abstract/163/1/41
See also: http://www.ahrp.org/cms/content/view/94/94/;http://www.ahrp.org/cms/content/view/23/28/ Contact: Vera Hassner Sharav212-595-8974
veracare@ahrp.org
Thursday, May 25, 2006
Bowled over by Gisela Stuart MP
Bowled over by Gisela Stuart MP
Is it not surprising that in spite of overwhelming evidence that the drug manufacturers, GlaxoSmithKline, suppressed evidence during the adult trials for their best selling anti-depressant drug, Seroxat, Gisela Stuart MP, has not signed an Early Day Motion for a debate in the House of Commons proposed by her fellow MP, Mr. Paul Flynn
Meantime, Seroxat is still being prescribed to her constituents some of whom will undoubtedly experience suicidal thoughts and may even attempt suicide because of the anti-depressant prescribed. It has been established that Seroxat can cause suicide in both adults and children and last week the regulatory authority issued a warning to GPs and prescribers about the link between Seroxat and suicide.
A 38 page legal document from Dr. P. Breggin clearly indicates that GlaxoSmithKline have known for 15 years that Seroxat can induce suicide and aggression. This document has been sent to Gisela Stuart MP on four separate occasions yet she still has not signed the Early Day Motion for debate. This is particularly vexing in the light of her signing an Early Day Motion regarding coverage of televised cricket!
Email Gisela Stuart to voice your concerns at:
STUARTG@parliament.uk
Bob Fiddaman
Is it not surprising that in spite of overwhelming evidence that the drug manufacturers, GlaxoSmithKline, suppressed evidence during the adult trials for their best selling anti-depressant drug, Seroxat, Gisela Stuart MP, has not signed an Early Day Motion for a debate in the House of Commons proposed by her fellow MP, Mr. Paul Flynn
Meantime, Seroxat is still being prescribed to her constituents some of whom will undoubtedly experience suicidal thoughts and may even attempt suicide because of the anti-depressant prescribed. It has been established that Seroxat can cause suicide in both adults and children and last week the regulatory authority issued a warning to GPs and prescribers about the link between Seroxat and suicide.
A 38 page legal document from Dr. P. Breggin clearly indicates that GlaxoSmithKline have known for 15 years that Seroxat can induce suicide and aggression. This document has been sent to Gisela Stuart MP on four separate occasions yet she still has not signed the Early Day Motion for debate. This is particularly vexing in the light of her signing an Early Day Motion regarding coverage of televised cricket!
Email Gisela Stuart to voice your concerns at:
STUARTG@parliament.uk
Bob Fiddaman
Friday, May 19, 2006
Sir Alasdair Breckenridge - Playing the Stock Market?
Social Audit Ltd
P.O. Box 111 London NW1 8XE
Telephone/Fax: 020 7586 7771
mailto:socialaudit@gn.apc.org http://www.socialaudit.org.uk
Professor Sir Alasdair Breckenridge CBE, Chairman
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ
26 April 2005
Dear Sir Alasdair,
Following my letter of 14 April, I am writing to make an FOIA request to try to clarify the position you outlined in your letter of 12 April:
1. Did you disclose in writing your recreational interest in the stockmarket, and the steps you took to avoid possible conflicts of interest, to colleagues on the Sub-Committee on Pharmacovigilance, Committee on Safety of Medicines, Medicines Commission, Department of Health, European Medicines Evaluation Agency and the MCA and MHRA, and was your interest made clear to those centrally involved in your appointment as Chairman of [a] the CSM; and [b] the MHRA? If so, please provide a copy of any declaration(s), indicating the dates on which they were made.
2. Whether or not your interest was declared in any written statement, please would you indicate whether and how you communicated your interest to any or all of the above-mentioned colleagues in any other way.
3. What steps, if any, had the MHRA taken, prior to my initial enquiry, to satisfy itself of the adequacy of the arrangements you made to avoid possible conflicts of interest and, in particular: [a] whether you gave instructions to your stockbroker in writing and, if so, what they were? [b] whether instructions to your stockbroker made clear what "associated industries" were prohibited as investments, and specifically which companies associated with the pharmaceutical sector were excluded? [c] whether the instructions you gave to your stockbroker were in any way modified following your appointment as [i] Chairman of the CSM; and [ii] Chairman of the MHRA? [d] whether and to what extent your investment portfolio reflected your own recommendations to your stockbroker about investments in specific companies that should be bought or sold? [e] whether and to what extent members of your family held, bought or sold stock in their own name(s)? and [f] whether any family investments were held through nominees?
I have already made clear that the issue here is not to do with personal probity; it is about Agency and Departmental policies and perceived fitness for position, the man for the job. These questions arise mainly because I��m trying to understand more about the culture and organisation of drug regulation, and the legitimacy of the Agency��s claim to deserve public confidence. I am particularly anxious to know if your colleagues knew of your interest and regarded it as unexceptional. I have also wondered what standards might apply to other people centrally involved in drug regulation:
4. Would the Agency consider it appropriate for other MHRA staff, with similar interests in stockmarket investment, to disclose this and explain the steps taken to avoid possible conflicts?
5. Would such disclosure be considered appropriate for anyone now applying for appointment to the new Commission on Human Medicines, given that "the new appointees will be required to sign a form declaring their interest" and that the guiding principle on appointments is that, "there are robust arrangements in place to manage any interests that are declared"?
These issues seem all the more relevant, given the Parliamentary Health Committee��s recent conclusions on the MHRA (para 376 refers), also the circumstances in which the abortive November 2003 ��Intensive Review�� of the safety of SSRI antidepressants was set up, at the time you were chairman of the CSM. Given the steps you took to avoid investment in pharmaceutical and associated companies, it seems that much harder to understand the appointment to that review of two CSM members who were shareholders in the main company under investigation.
I look forward to hearing from you.
Yours sincerely,
Charles Medawar
The reply:
Medicines and Healthcare products Regulatory Agency
Market Towers1 Nine Elms Lane, London SW8 5NQ
Mr Charles MedawarSocial Audit LtdP.O. Box 111London NW1 8XG
General enquiriesTelephone 020 7273 0000 Fax 020 7273 0353E-mail info@mhra.gsi.gov.ukwww.mhra.gov.uk
Direct line: 020 7084 2600Direct fax: 020 7084 2737
Email: Roy.Alder@mhra.gsi.gov.uk
20th May 2005
Dear Mr Medawar,
I am writing on behalf of the Agency in reply to your FOIA request of 25 April 2005, addressed to Sir Alasdair Breckenridge.
You ask whether Sir Alasdair made known his recreational interest in the stockmarket on his appointment to the Chairmanship of the CSM and then the MHRA. The former appointment was subject to the then Code of Practice for Ministerial Appointments to Public Bodies, and while serving as Chairman on the CSM Sir Alasdair was subject to the rules relating to declarations of interest set out in the Code of Practice for Members of the Medicines Commission and Section 4 Committees and Sub-Committees. In his appointment as the Chairman of the MHRA, Sir Alasdair is subject to the Civil Service Management Code.
To take your points in turn:
1 and 2: There was no disclosure in writing by Sir Alasdair of his recreational interest in the stockmarket in relation to his appointments to the Chair of the CSM and of the MHRA. Recreational interests are not required to be disclosed unless the person believed that it could be regarded as influencing his advice.
3 and 4: MHRA took no steps to extract details on any of the areas you cite. Under the relevant Codes, the onus is on the individual Committee Chair or member, or staff member to disclose interests which he or she considers relevant. Once interests are disclosed, the Agency will advise that individual of any Agency requirements concerning the retention, disposal or management of those interests. The Agency is not required, under the relevant Codes, to investigate proactively the possibility of any interests other than those that have been declared:
5. The Code of Practice for applicants for the new Commission on Human Medicines is currently being finalised. But it is likely to specify that the Chairs and members of the CHM, the Homoeopathics Board and the new Herbal Medicines Committee must hold no direct personal interests in the pharmaceutical industry. This will apply also to the Chairs of Expert Advisory Groups. All Chairs and members of the advisory committees must declare any financial interest or other matters that could affect their impartiality, or that could reasonably be perceived as affecting their impartiality.
Yours sincerely,
Roy AlderDirector, Executive Support
P.O. Box 111 London NW1 8XE
Telephone/Fax: 020 7586 7771
mailto:socialaudit@gn.apc.org http://www.socialaudit.org.uk
Professor Sir Alasdair Breckenridge CBE, Chairman
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ
26 April 2005
Dear Sir Alasdair,
Following my letter of 14 April, I am writing to make an FOIA request to try to clarify the position you outlined in your letter of 12 April:
1. Did you disclose in writing your recreational interest in the stockmarket, and the steps you took to avoid possible conflicts of interest, to colleagues on the Sub-Committee on Pharmacovigilance, Committee on Safety of Medicines, Medicines Commission, Department of Health, European Medicines Evaluation Agency and the MCA and MHRA, and was your interest made clear to those centrally involved in your appointment as Chairman of [a] the CSM; and [b] the MHRA? If so, please provide a copy of any declaration(s), indicating the dates on which they were made.
2. Whether or not your interest was declared in any written statement, please would you indicate whether and how you communicated your interest to any or all of the above-mentioned colleagues in any other way.
3. What steps, if any, had the MHRA taken, prior to my initial enquiry, to satisfy itself of the adequacy of the arrangements you made to avoid possible conflicts of interest and, in particular: [a] whether you gave instructions to your stockbroker in writing and, if so, what they were? [b] whether instructions to your stockbroker made clear what "associated industries" were prohibited as investments, and specifically which companies associated with the pharmaceutical sector were excluded? [c] whether the instructions you gave to your stockbroker were in any way modified following your appointment as [i] Chairman of the CSM; and [ii] Chairman of the MHRA? [d] whether and to what extent your investment portfolio reflected your own recommendations to your stockbroker about investments in specific companies that should be bought or sold? [e] whether and to what extent members of your family held, bought or sold stock in their own name(s)? and [f] whether any family investments were held through nominees?
I have already made clear that the issue here is not to do with personal probity; it is about Agency and Departmental policies and perceived fitness for position, the man for the job. These questions arise mainly because I��m trying to understand more about the culture and organisation of drug regulation, and the legitimacy of the Agency��s claim to deserve public confidence. I am particularly anxious to know if your colleagues knew of your interest and regarded it as unexceptional. I have also wondered what standards might apply to other people centrally involved in drug regulation:
4. Would the Agency consider it appropriate for other MHRA staff, with similar interests in stockmarket investment, to disclose this and explain the steps taken to avoid possible conflicts?
5. Would such disclosure be considered appropriate for anyone now applying for appointment to the new Commission on Human Medicines, given that "the new appointees will be required to sign a form declaring their interest" and that the guiding principle on appointments is that, "there are robust arrangements in place to manage any interests that are declared"?
These issues seem all the more relevant, given the Parliamentary Health Committee��s recent conclusions on the MHRA (para 376 refers), also the circumstances in which the abortive November 2003 ��Intensive Review�� of the safety of SSRI antidepressants was set up, at the time you were chairman of the CSM. Given the steps you took to avoid investment in pharmaceutical and associated companies, it seems that much harder to understand the appointment to that review of two CSM members who were shareholders in the main company under investigation.
I look forward to hearing from you.
Yours sincerely,
Charles Medawar
The reply:
Medicines and Healthcare products Regulatory Agency
Market Towers1 Nine Elms Lane, London SW8 5NQ
Mr Charles MedawarSocial Audit LtdP.O. Box 111London NW1 8XG
General enquiriesTelephone 020 7273 0000 Fax 020 7273 0353E-mail info@mhra.gsi.gov.ukwww.mhra.gov.uk
Direct line: 020 7084 2600Direct fax: 020 7084 2737
Email: Roy.Alder@mhra.gsi.gov.uk
20th May 2005
Dear Mr Medawar,
I am writing on behalf of the Agency in reply to your FOIA request of 25 April 2005, addressed to Sir Alasdair Breckenridge.
You ask whether Sir Alasdair made known his recreational interest in the stockmarket on his appointment to the Chairmanship of the CSM and then the MHRA. The former appointment was subject to the then Code of Practice for Ministerial Appointments to Public Bodies, and while serving as Chairman on the CSM Sir Alasdair was subject to the rules relating to declarations of interest set out in the Code of Practice for Members of the Medicines Commission and Section 4 Committees and Sub-Committees. In his appointment as the Chairman of the MHRA, Sir Alasdair is subject to the Civil Service Management Code.
To take your points in turn:
1 and 2: There was no disclosure in writing by Sir Alasdair of his recreational interest in the stockmarket in relation to his appointments to the Chair of the CSM and of the MHRA. Recreational interests are not required to be disclosed unless the person believed that it could be regarded as influencing his advice.
3 and 4: MHRA took no steps to extract details on any of the areas you cite. Under the relevant Codes, the onus is on the individual Committee Chair or member, or staff member to disclose interests which he or she considers relevant. Once interests are disclosed, the Agency will advise that individual of any Agency requirements concerning the retention, disposal or management of those interests. The Agency is not required, under the relevant Codes, to investigate proactively the possibility of any interests other than those that have been declared:
5. The Code of Practice for applicants for the new Commission on Human Medicines is currently being finalised. But it is likely to specify that the Chairs and members of the CHM, the Homoeopathics Board and the new Herbal Medicines Committee must hold no direct personal interests in the pharmaceutical industry. This will apply also to the Chairs of Expert Advisory Groups. All Chairs and members of the advisory committees must declare any financial interest or other matters that could affect their impartiality, or that could reasonably be perceived as affecting their impartiality.
Yours sincerely,
Roy AlderDirector, Executive Support
Tuesday, May 16, 2006
SO MANY QUESTIONS...NOT ENOUGH ANSWERS
Gentlemen - it seems, as you know, that GSK has looked at some of its Seroxat data again... and I'm sure it has nothing to do with Dr Breggin's report becoming public several weeks ago - nothing at all..........
I notice that the MHRA continues to support the use of the drug in the UK - when even GSK itself is backing off:
"GSK added warnings acknowledging that patients on the drug may experience persistently worse depression, or may experience emergent suicidality or symptoms that might be precursors to worsening depression or suicidality and these symptoms may be severe, abrupt in onset, or were not part of the patient's presenting symptoms."
The company advises doctors: "Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication."It seems that this data is anything between 10 and 15 years old (perhaps Dr Hudson, you could tell us EXACTLY how long GSK have been sitting on this data)
Anyway - who's to blame for this terrible situation....
GSK for not analysing the data properly in the first place?
GSK for analysing the data and then HIDING the results for so long?
GSK for lying to the MHRA and the public?
The MHRA for ignoring the huge amount of anecdotal evidence about the lack of safety of seroxat?
The MHRA for dragging its feet while 'investigating' GSK?
The MHRA for not wanting to stir up any trouble for its paymasters?
Ian Hudson for appearing to be complicit in what can only be described as a cover up?
Kent Woods for being as much use to the public as chocolate fireguard?
The Government for allowing the MHRA to continue to function in its present form?
So many questions - so few answers.
You see, the problem is, that I don't know the answers - but I'm sure that someone out there does....
Yours
Roger Cleghorn
I notice that the MHRA continues to support the use of the drug in the UK - when even GSK itself is backing off:
"GSK added warnings acknowledging that patients on the drug may experience persistently worse depression, or may experience emergent suicidality or symptoms that might be precursors to worsening depression or suicidality and these symptoms may be severe, abrupt in onset, or were not part of the patient's presenting symptoms."
The company advises doctors: "Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication."It seems that this data is anything between 10 and 15 years old (perhaps Dr Hudson, you could tell us EXACTLY how long GSK have been sitting on this data)
Anyway - who's to blame for this terrible situation....
GSK for not analysing the data properly in the first place?
GSK for analysing the data and then HIDING the results for so long?
GSK for lying to the MHRA and the public?
The MHRA for ignoring the huge amount of anecdotal evidence about the lack of safety of seroxat?
The MHRA for dragging its feet while 'investigating' GSK?
The MHRA for not wanting to stir up any trouble for its paymasters?
Ian Hudson for appearing to be complicit in what can only be described as a cover up?
Kent Woods for being as much use to the public as chocolate fireguard?
The Government for allowing the MHRA to continue to function in its present form?
So many questions - so few answers.
You see, the problem is, that I don't know the answers - but I'm sure that someone out there does....
Yours
Roger Cleghorn
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