The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Novartis Failed to Warn About Elidel Cancer Link

Evelyn Pringle December 28, 2006

Most lawsuits in which drug makers have tried to use preemption to dismiss failure-to-warn claims have been against companies accused of failing to warn about the risk of suicide associated with antidepressants known as selective serotonin inhibitors or SSRIs.

However, a case in Pennsylvania against Novartis, involves a toddler who developed cancer due to a failure-to-warn about the risks associated with the topical drug Elidel. In an important decision sure to have an impact on many other cases in the US, on October 16, 2006, a US District Court in Eastern Pennsylvania refused to grant the drug maker’s preemption motion in, Perry v Novartis Pharma Corp, — F Supp 2d —, 2006 WL 2979388.

Elidel was approved by the FDA on December 13, 2001, to treat atopic dermatitis, commonly known as eczema, in a cream applied directly to the skin, for persons over the age of two.

Elidel belongs to a class of immunosuppressant drugs known as calcineurin inhibitors. At the time of its approval, there were already concerns about an association between Elidel and cancer because other calcineurin inhibitors that were used to treat organ transplant patients were known to increase the risk of cancer and lymphoma, and carried a Black Box warning to that affect.

At the time of its approval, Elidel had also been found to increase the risk of cancer in animals when administered at high doses.

Because of its concerns about cancer, the FDA placed restrictions on Elidel and approved it only for short-term and intermittent use, and as a second-line of treatment to be used only when traditional therapies such as corticosteroids were found to be ineffective.

Following FDA approval, Novartis aggressively promoted Elidel, and as a result millions of prescriptions were written, many of which were off-label, meaning outside the approved indications and limitations specified on the label.

In the case of young Andreas Perry, the prescription was off-label in that no other treatment had been tried for his eczema prior to prescribing Elidel. Six months after he began using the cream, in October 2003, Andreas was diagnosed with lymphoblastic lymphoma, a form of cancer.

Although his eczema was annoying and uncomfortable, it was not life-threatening and his parents never considered for a moment that Andreas would develop cancer from a medicated cream prescribed for a toddler who was barely 2-years-old.

But on the other hand, Novartis can hardly claim ignorance about the link between cancer and Elidel because when the reports of cancer started coming in, the FDA began openly discussing the need to strengthen the warnings and the fact that the drug was being over-prescribed off-label to children for unapproved uses.

In October, 2003, the FDA’s Pediatric Advisory Subcommittee to the Anti-Infective Drugs Advisory Committee met to evaluate the cancer rates among pediatric patients treated with calcineurin inhibitors and discussed the possibility of changing the label to specifically warn against their use in patients under two.

At the hearing, a pharmacist and safety evaluator reported that more than 3.2 million prescriptions for Elidel had been dispensed by August 2003, with 17% of those prescriptions written “off-label” for children under the age of 2, and representing 22% of the adverse event reports for the drug.

On February 15, 2005, the Committee met again amidst even more reports of off-label use of calcineurin inhibitors with children which caused concern for many members of the Committee. The briefing memorandum for the meeting reported that more than 500,000 prescriptions had been written for children under 2 during a one year period between June 2003 and May 2004.

At this meeting, the panel voted to recommend that a “Black Box” warning be added to the label about the increased risk of cancer associated with the topical use of the two calcineurin inhibitors, Elidel and Protopic, and also about the lack of long-term safety data on the drugs.

The FDA issued a public health alert on March 10, 2005, stating in part, “Animal studies have shown that three different species of animals developed cancer following exposure to these drugs applied topically or given by mouth, including mice, rats and a recent study of monkeys.”

“Based on the advice of the FDA Pediatric Advisory Committee, which met on February 15, 2005,” the alert advised, “FDA will require labeling changes for Elidel and Protopic, including the placement of a boxed warning about the potential cancer risk.”

However, this case illustrates another situation like Vioxx and the SSRIs, where the FDA is as much to blame as Novartis for patients being injured after the danger was known, because the agency knew that a “Black Box” warning should be added immediately but allowed the drug company to dilly-dally around for nearly a year before adding the cancer warning on January 19, 2006.

In their lawsuit, the Perrys allege that despite Novartis’s knowledge of the association between Elidel and cancer, Novartis promoted it as safe for the treatment of eczema. It also alleges that the drug was advertised, marketed, and promoted as safer than traditional corticosteroid treatments, in conscious disregard of the limitations that the FDA placed on its approval, and that these actions contributed to the inadequacy of the warnings.

In response, Novartis filed a motion to dismiss the failure-to-warn claims based on the FDA’s new preemption policy. On January 18, 2006, the FDA issued new regulations regarding the labeling of prescription drugs, supposedly to provide doctors and patients with clearer information. However, in the preamble to the new rules, the FDA inserted the claim that State tort lawsuits alleging a failure-to-warn about risks associated with drugs approved by the FDA are preempted by federal law.

After failing at efforts to implement tort reform, this move is largely seen as the Bush administration’s last ditch attempt to immunize the pharmaceutical industry with policies written by politically appointed officials carefully planted at the top of the nation’s regulatory agencies.

Right from the start, it should be noted that State failure-to-warn lawsuits against drug companies have existed for over a century. Back in 1852, in the New York case of, Thomas v Winchester, 1852 WL 4748, the court stated, “A dealer in drugs and medicines, who carelessly labels a deadly poison as a harmless medicine, and sends it so labeled into market, is liable to all persons, who, without fault on their part, are injured by using it as such medicine in consequence of the false label.”

Second, if Congress wanted to preempt State tort claims it would have done so. Congress was fully aware of these lawsuits in 1934, when it enacted the Food, Drug and Cosmetic Act, and chose not to include a private right of action for damages in the Act after determining it was “unnecessary,” because a “common-law right of action exists.”

For as former Chief Counsel of the FDA, Margaret Porter, wrote in 1997, “FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection.” The Lohr Decision: FDA Perspective and Position, 52 Food & Drug. L.J. 7, 11 (1997).

While it may be true that the FDA approves a drug’s label when it approves the drug, the label is not fixed in stone. It is well known that drugs are approved based on very limited clinical trials and understood that there is a strong likelihood that new risks will be identified as a drug is widely prescribed in the general population.

For this reason, under federal regulations, a drug maker’s duty to provide warnings to health care professionals and consumers continues as long as a drug is on the market. In its own regulations, the FDA itself has noted that labeling does not always contain the most current information because “advances in medical knowledge and practice inevitably precede formal submission of proposed new labeling by the manufacturer and approval by the FDA.”

And that’s why federal regulations put the responsibility on the drug company stating, “labeling shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.”

In the brief filed in support of its motion, Novartis contends that companies rarely, if ever, change labels under this provision because they know that they ultimately need to obtain FDA approval for the change.

The truthful explanation for its refusal to comply with this provision, would be that Novartis knew that adding a warning would have resulted in a drastic reduction in the profits that the company was enjoying from the “off-label” sale of Elidel to children.

When attempting to use the preemption defense, as a starting point, Novartis, and every other drug company, should be required to explain why it would have been difficult to add a specific warning to the label.

In an amicus brief submitted by the FDA that sides with Novartis overall, the agency quotes regulations and describes the simple procedure used to add a warning, and it takes a whole 30 days. According to the FDA:

“If the manufacturer of a non-generic prescription drug wishes to add or strengthen a warning, the manufacturer may provide FDA with a supplemental submission regarding the proposed labeling change, providing a full explanation of the basis for the proposed change.

“If FDA has not rejected the supplement within 30 days after its submission, the manufacturer may distribute the drug with the new proposed labeling.”

The FDA’s brief also states: “If a drug manufacturer has “reasonable evidence of a causal association” between the use of a drug and a “clinically significant hazard,” the manufacturer has an obligation to seek FDA approval for a labeling change, in order to add a warning of the new potential hazard.”

As far as “reasonable evidence” goes, it would not take a rocket scientist to figure out that if 3 species of animals were developing cancer from Elidel, infants and toddlers weighing between 6 and 30 pounds would probably do so as well.

In its brief, Novartis relies on the FDA’s argument in the preamble that it interprets the FDCA “to establish both a ‘floor’ and a ‘ceiling,’” and thereby preempts state laws imposing greater safety requirements.

However, in the FDA’s own words, liability will only attach, “if the additional statement is unsubstantiated or otherwise false or misleading,” which is certainly not the case with Elidel.

In their brief, the Perrys argue that the FDA does not impose a “ceiling” on truthful, substantiated risk information, which is precisely the type of warning they sought.

In this case, the FDA has never rejected stronger warnings for Elidel and the court held that preemption would only apply if a specific warning about pediatric cancer had been considered and rejected.

In addressing the claims in the FDA’s brief, the opinion states: “To be sure, because of its expertise in the area, the FDA’s construction of its own regulations is likely to carry great weight.”

“But where an interpretation has changed frequently in significant respects,” it points out, “the persuasive force of the argument diminishes.”

The court went on to explain that even if the preamble did represent a change of policy with the force of law, it would not apply to this case. “The FDA,” it said, “cannot retroactively absolve Novartis of a duty it may have owed the Perrys in 2003.”

The opinion also states that “a finding of preemption here will foreclose a remedy that was traditionally available and for which federal law provides no substitute.”

In conclusion, citing a September 23, 2006, New York Times report by Gardiner Harris, the court said, “given the recent concerns about the effectiveness of the FDA’s safety monitoring of recently approved drugs, . . . the availability of state law tort suits provides an important backstop to the federal regulatory scheme.”

Filed under: 2006, cancer, Elidel, Novartis, Preemption

DSM Billing Bible – Big Pharma Best Seller

Evelyn Pringle December 27, 2006

One-hundred percent of the experts involved in writing diagnostic criteria for mood disorders and schizophrenia for the, “Diagnostic and Statistical Manual for Mental Disorders (DSM),” have undisclosed financial ties to the pharmaceutical companies whose drugs are used to treat those conditions.

The April 2006 study in the journal, Psychotherapy and Psychosomatics, also determined that more than 80% of the members on the panels involved in decisions related to “anxiety disorders,” “eating disorders,” “medication-induced movement disorders” and “premenstrual dysphonic disorder” have financial ties to the pharmaceutical industry.

Experts say the importance of the manual, also referred to as the “Psychiatric Billing Bible,” cannot be understated, especially for the Big Pharma. The FDA will not approve a drug to treat a disorder that is not included in the DSM and public and private health insurance programs will not pay to treat a disorder that is not listed in the manual.

Medications for the treatment of schizophrenia and mood disorders are the top sellers of all psychiatric drugs in the US. In 2004, antidepressants and antipsychotics became the third and fourth-biggest selling classes of drugs, following cholesterol and heartburn medications, with combined sales of $20.7 billion.

The April study, led by Dr Lisa Cosgrove, a clinical psychologist from the University of Massachusetts, is the first of its kind, and was conducted in part, by sifting through legal files, conflict of interest databases, patent records, journal articles, and other records.

Dr Cosgrove told the Washington Post that she began the research after learning that 5 of six panel members deciding whether certain premenstrual problems should be considered a psychiatric disorder had ties to Eli Lilly, a company that was at the time seeking approval to market Prozac to treat those problems.

“I don’t think the public is aware of how egregious the financial ties are in the field of psychiatry,” she told the Post.

“The very vocabulary of psychiatry is now defined at all levels by the pharmaceutical industry,” according to Dr Irwin Savodnik, assistant clinical professor of psychiatry at the University of California, in a statement to the Chicago Tribune.

A co-author of the study, Sheldon Krimsky, a science policy specialist at Tufts University and author of, “Science in the Private Interest,” told the Washington Post, “When someone is establishing a clinical guideline for the bible of psychiatric diagnosis, I would argue they should have no affiliation with the drug companies in those areas where the companies could benefit from those decisions.”

Critics say the pill-promoting list of bogus “mental disorders” in the DSM apparently has no end and kids appear to be the most sought after customers. For instance, in the DMS, a child’s behavior become an “oppositional defiant disorder,” if a child exhibits at least four of eight behavior patterns, four of which are “often argues with adults,” “often loses temper,” “often touchy or easily annoyed by others” and “often spiteful or vindictive.”

And to treat these alleged “disorders” the drug companies have doctors prescribing the strongest, most expensive psych drugs on the market. On November 11, 2006, the New York Times reported that 13-year-old Paul Williams “has had almost as many psychiatric diagnoses as birthdays.”

“The first psychiatrist he saw, at age 7,” the Times said, “decided after a 20-minute visit that the boy was suffering from depression.”

A string of office visits with psychologists, social workers and psychiatrists led to labels with disorders such as “compulsive tendencies,” “oppositional defiant disorder,” and “pervasive developmental disorder,” or some combination of the others.

Each diagnosis was accompanied by a different regimen of drugs. By the time Paul was 11, his mother said, it was bipolar “with it a whole new set of drug prescriptions.”

In June 2006, a study in the Archives of General Psychiatry, said the use of antipsychotics to treat children for problems with aggression and mood swings had increased more than 5-fold between 1993 to 2002, even though none of the drugs are approved for children.

The study found that about a third of the kids who received antipsychotics were diagnosed with behavior disorders, such as attention deficit; another third listed psychotic symptoms or developmental problems; and the others were for mood disorders.

In addition to antipsychotics, the study found that more than 40% of the children were also taking one or more other psychiatric drugs.

Experts say the rise in prescribing antipsychotics to children corresponds with the introduction and heavy promotion of the new generation of antipsychotics known as “atypical” antipsychotics which include Risperdal, Zyprexa and Seroquel, promoted as superior to older and much cheaper antipsychotics like Haldol.

Atypicals are FDA approved for very limited uses in the treatment of adults with schizophrenia, psychosis, and bipolar disorder.

Over the past several years, these new antipsychotics have been shown to cause extremely serious side effects. According to Dr Stefan Kruszewski, MD, a Harvard trained psychiatrist from Harrisburg, Pennsylvania, they increase the risk of obesity, diabetes type II, hypertension, cardiovascular complications, heart attacks and stroke.

He says the atypicals were marketed as being safer and easier to tolerate than the older, cheaper antipsychotics because the drug companies said that they would cause fewer neurological injuries like tardive dyskinesia and akathesia.

Those claims have turned out to be totally false Dr Kruszewski says, and “at the same time they continue to cause neurological side-effects like the older antipsychotics.”

In addition, the new drugs have been shown to be less effective with children than the old. An August 2006 study by the New York Psychiatric Institute, found that the average response rate in children enrolled in 8 studies taking the new antipsychotics was only 55.7%, compared to 72.3% with children in 13 studies who were taking the older drugs.

The over-prescribing of the atypical drugs to children is found to be most rampant when the cost of the drugs is covered by government health care programs. For instance, a study in the August 3, 2004, Archives of Pediatric Adolescent Medicine, found the number of children in Tennessee covered by the state’s Medicaid program, who were prescribed antipsychotics nearly doubled in six years.

The age group with largest increase was children aged 13 to 18 at 116%, followed by a 93% increase in children aged 6 to 12, and perhaps the most alarming was a 61% increase in the use of antipsychotics with preschool children.

In the wake of budget busting costs, the state of Texas hired ACS-Heritage, a medical consulting firm, to investigate the prevalence of psychotropic drugs prescribed to children and billed to the state, and learned that during the months of July and August, 2004, more than 19,400 teens were prescribed antipsychotics, with nearly 98% prescribed for conditions not approved.

In fact, ACS said that almost half of the children did not appear to have a valid diagnosis warranting the use of the drug, and that one-third of the children were on 2 or more drugs.

The drug companies promote the life-long use of antipsychotics. For instance, a Relapse Prevention Booklet (2004), by the Manic-Depression Fellowship, sponsored by Eli Lilly, for Zyprexa states that “bipolar disorder is often a lifelong illness needing lifelong treatment; symptoms come and go, but the illness stays; people feel better because the medication is working; almost everyone who stops taking the medication will get ill again and the more episodes you have, the more difficult they are to treat.”

Some states have filed lawsuits against the drug makers to recoup the costs incurred by the over-prescribing of the atypicals for conditions not approved by the FDA, as well as the cost of medical care for citizens injured by the drugs.

A West Virginia lawsuit alleges that Eli Lilly promoted Zyprexa for “off label” conditions including anxiety, sleep disruption, mood swings, attention deficit hyperactivity and dementia. As a result of these actions, the complaint states, Lilly sold more Zyprexa than it would have sold if it had disclosed the risk of diabetes and other diseases.

The lawsuit also alleges that Lilly concealed the dangers of Zyprexa, such as an increased risk of diabetes, resulting in further cost to the state to treat Medicaid recipients who became ill from using the drug.

In June 2005, Lilly paid $690 million to settle claims by an estimated 8,000 people who claimed that before September 2003, the information on Zyprexa labels regarding the risk of hyperglycemia and diabetes was not adequate.

But on an up-note, according to the company’s SEC filings, Zyprexa’s sales are booming, with $4.2 billion in 2005, or 29% of Lilly’s corporate revenue.

All this money for a new drug that has been proven to be no better than the old antipsychotics which cost pennies a day. Referring to a study published in the New England Journal of Medicine, on September 21, 2005, The Age.com, reported that a “US Government-financed study of drugs used to treat schizophrenia has confirmed what many psychiatrists long suspected: newer drugs that are highly promoted and widely prescribed offer few — if any — benefits over older medicines that sell for a fraction of the cost.”

As for pushing pills for the mood disorders, with the help of President George Bush’s New Freedom Commission on Mental Health, put in place by an executive order as a gift to the drug companies in return for the millions of dollars in contributions, Big Pharma is zeroing in on children, even infants, as customers for Paxil, Zoloft, Prozac, Lexapro, Effexor, and Celexa, by setting up mental health screening programs in schools and daycare centers.

In a 2003 speech, the director of the Substance Abuse and Mental Health Services Administration, Kathryn Power, reported that mental health assessments are increasingly being conducted in “non-mental health settings,” and she praised one community for “placing mental health consultants in child care settings.”

She also bragged about the federal “Prevention and Early Intervention Grant Program,” and noted that the program’s goal is to reach children, and babies, before they have a diagnosable problem. At that time, Ms Power said that more than half of the administration’s programs were focused on infants and preschoolers.

Mental health screening programs for kids as young as age 0, are being implemented in states all across the country. For instance, in Minnesota an early childhood program is being integrated to ensure all children ages 0 to 5 are screened “early and continuously” and to link children and their families to mental health services.

In Florida, the Florida Strategic Plan for Infant Mental Health Plan is to develop a system to prevent children from 0 to age five from developing emotional and behavioral disorders.

In Illinois, “all children” are to receive social and emotional screens and the schools are to incorporate social and emotional standards as part of the state’s learning standards.

Its not as if infant recruitment schemes are necessary considering the record breaking sales of these drugs. According to SEC filings, Pfizer’s Zoloft, pulled in $2.5 billion in the first three quarters of 2005, and worldwide, Wyeth’s Effexor totaled $3.5 billion in 2005.

But then, Big Pharma would be out of the psych drug business in no time if not for the cooperation of the doctors writing the prescriptions. On August 17, 2005, the Wall Street Journal said, “If the icon of American psychiatry was for years a couch, it is now arguably a pill.”

“And that change in focus,” the Journal reports, “has brought to prominence a new type of psychiatrist: the psychopharmacologist.”

According to the Journal, “these doctors frequently prescribe complex cocktails of drugs for patients with multiple diagnoses of mental illnesses and sometimes prescribe other drugs to counterbalance side effects from the primary drugs.”

A 2003 study by the American Psychiatric Association, on “financial disincentives” for psychotherapy found doctors could earn about $263 an hour for holding three 15-minute medication management sessions per hour, compared to about $156 for a single therapy session, which boils down to an hourly pay cut of 41% for doctors doing therapy.

According to Dr Juan Riestra, associate director of medicine in the department of psychiatry at Mountainside Hospital in Montclair, NJ, a psychopharmacologist is often someone “using a trendy word as a marketing device.”

When a psychopharmacologist sees 30 or 40 patients a day, as some do, Dr Riestra told the Journal, “it becomes like a factory.”

Filed under: 2006, drugging children, DSM, KOL, settlement

Court Allows Eli Lilly to Bury Zyprexa Documents

Evelyn Pringle November 21, 2006

Alaskan attorney, Jim Gottstein, says that after being served with a mandatory injunction, he has returned the internal Eli Lilly documents that he obtained in litigation and provided to the New York Times to the court.

Information from the documents related to Lilly’s antipsychotic drug, Zyprexa, was highlighted two days in a row in front-page articles in the Times

The documents reveal the illegal marketing schemes used by Lilly to make Zyprexa its best-seller, which the company has managed to keep hidden for years by entering into out of court settlements in civil lawsuits which included confidentiality clauses and by getting judges to place the documents under protective orders to shield them from public view.

For instance, the documents under seal here are from a case where Lilly entered into an out-of-court settlement in June 2005, and agreed to pay $690 million to cover claims by about 8,000 Zyprexa victims. But in order to get paid, the plaintiffs were required to sign a confidentiality clause and basically keep their mouths shut about Zyprexa from then on.

It’s really comical the way Lilly keeps acting all indignant over the disclosure of these documents as if they contain brand new charges, when the company has been under federal and state investigations related to its off-label marketing of Zyprexa for several years already. The company is also facing Medicaid fraud charges in lawsuits all over the county.

In 1996, Zyprexa was approved for the treatment of adults with schizophrenia, and a few years later, it was approved for short-term treatment of adults with manic episodes associated with bipolar disorder.

Yet despite these extremely limited approved uses, Zyprexa went on to become the top selling antipsychotic worldwide with an estimated 20 million people having used the drug and Lilly’s best-selling product, with $4.2 billion in sales in 2005, which translates into 30% of its total revenues.

The documents provided to Times, span a decade and clearly show that the company promoted off-label the sale of Zyprexa for uses not approved by the FDA as being safe and effective. They also reveal that Lilly knew about Zyprexa’s link to drastic weight gain and diabetes for years but failed to inform prescribing doctors and consumers.

In fact according to the Times, Lilly knowingly distributed false information to doctors about the risks as late as 2001. On December 21, 2006, the Times reported that the information provided to doctors about the blood-sugar risks of Zyprexa did not match data circulated inside the company after a review of Lilly’s clinical trials.

The Times quotes a Lilly report from November, 1999, that shows that after examining 70 clinical trials, Lilly found that 16% of patients taking Zyprexa for a year had gained over 66 pounds. But instead of making these findings public, the company used data from a smaller group of trials that showed roughly 30% of Zypexa patients gained 22 pounds.

Mr Gottstein is not involved in the case in which the judge issued a protective order In re: Zyprexa Products Liability litigation, MDL No. 1596, United States District Court, Eastern District of New York (MDL 1596), “in any manner whatsoever,” he says.

He is the leader of, “The Law Project for Psychiatric Rights” (PsychRights), a public interest law firm devoted to the defense of people facing forced psychiatric drugging against their will.

Currently, Mr Gottstein represents an Alaskan patient and says the injunction will prevent him from using the Lilly documents to show that the side effects of Zyprexa are well-established by the company’s own clinical trials and therefore, his client should not be forced to take such drugs against his will.

In Myers v Alaska Psychiatric Institute, 138 P.3d 238 (Alaska 2006), a case argued by Mr Gottstein last summer, the Alaska Supreme Court ruled that Alaska’s forced drugging procedures were unconstitutional because they did not require the court to find such drugging to be in the person’s best interests, and that there were no less restrictive
alternatives.

In order to present the evidence in the case he is handling now, Mr Gottstein is looking to the Alaskan courts to issue a ruling that says his client’s right to avoid forced drugging outweighs Lilly’s right to keep the information about risks hidden.

He says the documents are highly relevant to a court inquiry, now required in Alaska, before a court can make an informed decision about whether to order forced drugging for his client.

In a December 17, 2006, letter to the court in the New York case, Mr Gottstein stated: “In large part, this state of affairs has been created by the lies told by the manufacturers of psychiatric drugs.”

“My impression is,” he wrote, “that Eli Lilly’s lies about Zyprexa form the basis of the plaintiffs’ claims in MDL 1596, but that is not PsychRights’ focus.”

“PsychRights’ focus,” he explained, “is helping people avoid being forcibly drugged pursuant to court orders, where the courts have been, in my view, duped by Eli Lilly and other pharmaceutical company prevarications.”

“In my view,” Mr Gottstein concluded, “the proper disposition of the question would be in favor of my client’s right to inform the court of the extreme harm caused by Zyprexa, which Eli Lilly has successfully hidden for so long, while making its billions off the pill.”

A court hearing was held in Brooklyn, New York, on a December 18, 2006, on a motion by Lilly, asking the court to order Mr Gottstein to return the documents to the court, and to bar him from disseminating them any further.

According to the transcript, Lilly also asked the court to require Mr Gottstein to “preserve all emails and all correspondence of any kind, whether it’s voice mail, written letters, emails, so that we can pursue a contempt proceeding against both he and Dr Egilman.”

Even though the Lilly documents prove that the company knew that Zyprexa was causing diabetes, and kept pushing the drug anyways, potentially harming millions more patients, the judges gave Mr Gottstein hell and threatened to find him in contempt for doing nothing more than warning the public about the side effects of Zyprexa after Lilly concealed the information for a decade.

There is not one single word in the transcripts about Lilly knowingly injuring and killing people with Zyprexa or illegally pushing the drug to unwitting victims for off-label use.

Instead, Judge Brian Cogan, granted Lilly’s motion, and told Mr Gottstein’s attorney that his client, “deliberately aided and abetted Dr Egilman in getting these documents released from the restriction that they were under, under the protective order. He knew what he was doing, and he did it deliberately.”

Judge Cogan went on to tell the attorney, “your client should be on notice that of this moment, he is under a mandatory injunction to return those documents … to take them down from any websites that he may have posted them on, and to take any reasonable effort to recover them from any sites or persons to which he has delivered them.”

On December 18, 2006, at an earlier telephone conference in Brooklyn, Judge Roane Mann also did not utter one word about Lilly’s illegal conduct, but instead admonished Mr Gottstein for not playing fair with poor Eli Lilly in making the information about Zyprexa public, stating:

“I personally am not in a position to order you to return the documents. I can’t make you return them but I can make you wish you had because I think this is highly improper not only to have obtained the documents on short notice without Lilly being advised of the amendment but then to disseminate them publicly before it could be litigated. It certainly smacks as bad faith.”

These judges apparently believe that an expert, such as Dr David Egilman, who is hired to review documents in a case and subsequently learns that people are being seriously injured and killed, should be forced to keep that knowledge a secret if a judge issues a protective order.

There is something very wrong with this picture. It begs the question of how can an ethical doctor not speak if he knows that patients are being harmed.

The reason always cited for the need to keep documents under seal is the claim that the information contains trade secrets. However, just as Lilly has done here, drug companies have for too long been abusing the process by using protective orders to hide illegal conduct by concealing documents that show the company is illegally promoting the off-label use of a drug or that a drug can cause serious injuries or that a drug does not work.

In a case like this, if a court truly does not have a choice and is required to seal documents even when they show blatant illegal conduct on the part of a drug company, then Congress had better get busy and pass a law to stop the use the US court system to protect what could very easily be described as corporate murder.

In response to an earlier article on this issue, reader Larry Bone wrote and asked this author, “Is the corruption on this so widespread that no one would dare prosecute?”

“It is criminal behavior,” he points out, “on a huge scale that is being virtually totally ignored by the authorities responsible for the public safety.”

“I just feel,” Mr Bone wrote, “that there has to be an attorney or someone in a judicial or ethical capacity who would have the guts, and persistence to prosecute Lilly.”

“It seems incredibly ridiculous,” he states, “let alone obscene, that such blatant wrongdoing seemingly continues to be ignored by the legal authorities with jurisdiction over these sorts of cases.”

“If these companies believe they have done nothing wrong,” he says, “then let them prove their innocence in court.”

Ellen Liversridge also wants a criminal investigation of Lilly. She lost her 30-year-old son, Rob, to the adverse effects of the drug. “He gained almost 100 pounds while taking Zyprexa,” Ellen says.

“Rob lapsed into a coma,” she recalls, “and died of profound hyperglycemia four days later on October 5, 2002.”

“I believe that the people who did this should have a criminal trial,” Ellen says. “Enron executives went to prison for wiping out people’s life savings,” she points out.

“Lilly executives should go to prison,” she says, “for knowingly being responsible for people’s deaths, shattered families; ruined and grieving families.”

Ellen has nothing but praise for the New York Times and its source. “I am grateful to Jim Gottstein for making available this awful truth and hope it results in justice being done.”

“If there can ever be justice for a crime as heinous as this,” she adds.

Daniel Haszard, of Bangor Maine, feels the same way. In 1996, he was prescribed Zyprexa off-label to supposedly treat Post Traumatic Stress Disorder, and he remained on the drug for 4 years.

Although he paid $250 a month for the drug, Mr Haszard says the drug did not relieve his symptoms of PTSD at all and in early 2000, he was diagnosed with diabetes.

He was shocked to hear the diagnosis, he said, because there was no history of diabetes in his family. Just as thousands of other Zyprexa victims, Mr Haszard did not make the connection between his diabetes and the drug until he saw a commercial for a law firm in December 2005.

Zyprexa causes diabetes, he says, and public health programs are left to pick up the tab for the medial expenses. According to Mr Haszard, “there are now 7 states going after Lilly for fraud and restitution,” related to the promotion of Zyprexa for off-label use and the concealment of its risks.

Dr Stefan Kruszewski, MD, a Harvard trained, certified psychiatrist in adult, adolescent, and geriatric psychiatry, from Harrisburg, Pennsylvania, also finds Lilly’s conduct appalling.

“Neither health professionals nor consumers,” he states, “can accurately provide information about the risk and benefits of a drug like Zyprexa – or any drug for any condition – without a comprehensive awareness of the risks and benefits.”

“If the clinical research data regarding effectiveness, efficacy or safety is sequestered or misrepresented from observation studies, randomized drug trials or meta-analyses,” he says, “then it is not possible for any provider to give any patient what he or she needs to make an informed consent.”

“At that point,” Dr Kruszewski says, “individuals receive drugs that may or may not help them, but always at their own peril.”

“Zyprexa causes both a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular problems,” Dr Kruszewski advises, “at the same time that it continues to cause neurological side-effects like the older antipsychotics.”

“Zyprexa and its antipsychotics cousins,” he explains, “were marketed to be safer and easier to tolerate because the pharmaceutical companies said that the newer drugs caused fewer neurological injuries, like restlessness or ‘akathesia,’ and tardive dyskinesia.”

Those assertions are false he says, and “what we have now is a drug whose massive revenues and promotion are based upon faulty disclosures by Eli Lilly.”

Filed under: 2006, antipsychotics, Eli Lilly, settlement, Zyprexa

Doctor’s Perks and Free Drug Samples Cost Patients Plenty

Evelyn Pringle December 20, 2006

In the debate over whether Big Pharma’s perks lead doctors to prescribe high priced brand-name drugs over equally effective generics, the question to ask is whether an industry would direct 90% of a $20 billion marketing budget at doctors if it did not work.

As lawmakers enact measures to limit the drug company’s influence over the medical profession, the profiteers within the industry are beginning to fight to reverse the policies in court. The New Hampshire, “Prescription Confidential Act,” was passed to stop the disclosure of information on doctors prescribing habits to drug companies. The law is now being challenged in court by two data mining firms that profit from selling the information.

IMS Health and Verispan LLC, say the Act violates the First Amendment right to free speech. A trial is scheduled in January 2007, to determine whether the law will stand. Judge Paul Barbadoro, of the US District Court for New Hampshire, refused a request to issue an injunction to temporarily overturn the law until the trial.

The outcome of the case may have an impact in other areas of the country. Congress and several other states are considering similar laws, and the ruling in the New Hampshire is expected to influence their decisions of whether to go forward on the matter.

The Act bars the sale of prescription information on both patients and doctors for commercial purposes. New Hampshire State Representative, Cindy Rosenwald, a sponsor the bill, said the Act is designed to reduce health care costs and protect the privacy of doctors.

She told the Concord Monitor on November 20, 2006, that selling the prescribing information drives up the cost of health care by making it easier for drug companies to push expensive drugs on prescribing doctors.

Medicaid for example, she said, together with the higher cost of drugs for prisoners and state employees adds up to a lot of taxpayer money.

Data on the prescribing habits of doctors has long been used by drug company sales representatives to target their customers. Former sales rep, Kathleen Slattery-Moschkau, told the San Francisco Chronicle, on August 6, 2006, that she received reports on every physician within her sales territory broken down by drug class, as well as “numerous other reports, such as the ‘Heavy Hitter List,’” she said, which would include the top doctors her company was trying to “convert.”

Ms Slattery-Moschkau says the reports helped her determine which doctors “were worthy of spending my monthly budgets on for lunches, dinners, days at the spa, etc.”

Overall, she said, the reports “were a great tool for determining which marketing tactics worked best.”

Drug companies pay enormous amounts of money each year to obtain these records that enable them to provide the reports to their sales reps. According to the Chronicle, IMS Health, one of the main data mining companies, generated revenues in 2005, of $847 million from its “Sales Force Effectiveness Offerings.”

Experts say the use of these profiles increases other health care costs. Dr Sharon Levine, an executive director with the HMO, Kaiser Permanente, told the Chronicle that the high cost of obtaining the records is not only reflected in higher drug prices, but the data itself is used to persuade doctors to prescribe expensive brand-name drugs when cheaper generics would work, causing a rise in patient co-payments and insurance premiums.

According to health care analysts, providing doctors with free drug samples also drives up the prices on prescription drugs in the long run. Studies have shown that supplying doctors with free samples of costly brand-name drugs greatly increases the rate of prescribing of those same drugs and the cost of the samples has to be factored in with increased drug prices. In 2005 alone, doctors were given free drug samples valued at about $16 billion, according to IMS Health.

And then there is the matter of the free meals provided to influence the doctor’s prescribing habits for specific drugs, and not only for doctors – in some instances for their entire staff.

After examining the interaction between doctor’s offices and sales reps, Dr John Scott, an assistant professor at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, told the New York Times, “We found that some offices get breakfast and lunch every day.”

According to the July 28, 2006 Times article, “The cost of the lunches is ultimately factored in to drug company marketing expenses working its way into the price of prescription drugs.”

Ms Slattery-Moschkau says free lunches were “incredibly effective” in boosting sales for Bristol-Meyers Squibb and Johnson & Johnson, the companies where she formerly worked.

She said sales reps could gauge the success of a free lunch immediately because they had the numbers from the prescribing records to show what drugs the doctor was prescribing. “If I brought in lunch one week,” she stated, “I could see the following week if that lunch had an impact.”

Analysts say the various methods of courting doctors adds up to mega-bucks over a year’s time. In 2003 alone, the industry spent about $5.3 billion on “detailing,” a term used for the face-to-face promotion activities by sales reps directed at doctors, according to IMS Health.

Early this year, a panel of medical experts called for the adoption of new conflict-of-interest regulations, saying the financial influence of Big Pharma was distorting treatment decisions and scientific findings.

In a paper published in the January 25, 2006, Journal of the American Medical Association, the group said that voluntary efforts to limit industry influence had failed, resulting in the overprescribing of some medications and the withholding of negative findings on others.

Cases like Vioxx, SSRIs for children and spinal implants by Medtronic, which all occurred with voluntary guidelines in place, they said, highlight the need for stricter measures.

The panel, made up of officials from medical schools and the Institute on Medicine as a Profession, called on the 400 teaching hospitals in the US to impose strict new rules, including a ban on all gifts and meals along with tighter restrictions on outside income.

The group also said medical schools and affiliated hospitals should refuse free drug samples and create a voucher system or distribution bank for indigent patients instead. “The availability of free samples is a powerful inducement for physicians and patients to rely on medications that are expensive but not more effective,” the JAMA article noted.

On January 25, 2006, Jordan Cohen, president of the Association of American Medical Colleges, and a co-author of the proposal, told the Washington Post, “We’ve become overly dependent on these kinds of blandishments to support our core activities, and that is jeopardizing public trust and scientific integrity.”

The relationships, he said, can prompt doctors to order unnecessary tests, prescribe more expensive drugs or advocate adding certain medications to a hospital’s list of preferred drugs.

“The problem has gotten worse and worse and worse,” Dr Cohen told the Post.

“Drug companies spend $13,000 per physician annually,” said another co-author, Dr David Rothman, a professor of social medicine at Columbia University Medical Center.

“Those marketing tactics,” he told the Post, “are very, very effective at getting physicians to do what each drug company wants — to prescribe their product.”

Other supporters of the proposal include Dr Jerome Kassirer, former editor-in-chief of the New England Journal of Medicine, and Dr David Blumenthal, director of the Institute for Health Policy at Massachusetts General Hospital.

The call for reform is apparently taking hold. On September 12, 2006, the New York Times reported that as of October 1, 2006, “Stanford University Medical Center will prohibit its physicians from accepting even small gifts like pens and mugs from pharmaceutical sales representatives under a new policy intended to limit industry influence on patient care and doctor education.”

The new policy is part of a small but growing movement among academic medical centers, the Times said, noting that the University of Pennsylvania and Yale have also announced similar rules.

In light of the FDA’s recent failure to protect consumers against the dangers of new drugs like Vioxx and the SSRIs, many medical experts now recommend that patients avoid taking a new drug if there is an alternative, saying preapproval studies do not allow for enough time, or include enough patients, to show all the potential side effects.

In her book, “The Truth about Drug Companies: How They Deceive Us and What to Do About It,” Dr Marcia Angell, former editor of the New England Journal of Medicine, tells patients to ask the following questions before accepting a prescription for a new brand-name drug:

(1) What is the evidence that this drug is better than an alternative drug or treatment approach?

(2) Has it been published in a peer-reviewed medical journal, or are you relying on information from drug company representatives?

(3) Is this drug better only because it’s given at a higher dose?

(4) Would a cheaper drug be as effective if it were given at an equivalent dose?

(5) Are the benefits worth the side effects, the expense and the risk of interactions with other drugs I take?

If its a free sample, Dr Angell says to ask the doctor whether there is a generic drug or other less-expensive equivalent to take when the free sample runs out.

Other segments of the health care field are also finding ways to drive down high prescription drugs costs. On November 21, 2006, BlueCross BlueShield of North Carolina announced plans to set up ATM-like machines in doctors’ offices to make it easy for physicians to pass out free samples.

However, the plan has Big Pharma crying foul because these free samples will no longer be the high-priced name-brand drugs, they will be generics.

Filed under: 2006, advertising, DTC

Flu Vaccines – Open Season

Evelyn Pringle December 15, 2006

For all the frantic, unvaccinated citizens fearing the “upcoming” peak of flu season—rest assured, coming down with a flu infection is the least of your worries.

Despite the governments statements urging individuals to vaccinate their children, the threat of an infantile influenza fatality is just about as serious as the dreaded hangnail.

Nonetheless, the Centers for Disease Control and Prevention (CDC) recently declared November 27 to December 3 as National Influenza Vaccination Week. The order stems from the governments “concern” that infection rates will soon come to a season high and, as having the flu is such a dire condition within the general population, the well-being of society rests on mass inoculation.

In fact, government agents are so adamant about protecting the nation that new recommendations have been made concerning vaccine administration, which, by the way, only protects against three specific strains of the countless, ever-evolving strains of the virus.

According to a November CDC publication, children less than two years of age are at high risk for infections and therefore, advocate ALL children aged 6 months to 18 years, in addition to pregnant women, be inoculated at least once a year.

Furthermore, if children under 9 years of age are getting injections for the first time, they are advised to receive two shots a month apart. CDC members say vaccinations should be administered in October or November, but since infections can occur as late as April “getting the vaccine in December or later still offers protection in most [I repeat, most] years.”

That being said, one has to question why the Health Industry Distributors Association’s (HIDA) April publishing states that demands for flu vaccines are highest in September and October “despite the public campaign to stretch flu shot ‘season’ into January.”

Weird…there must be a mistake somewhere; surely these decisions result from valid scientific studies, as well as endless hours of analyses and discussion regarding the best interests of the public.

Comforting maybe, but accurate—not so much.

Despite lack of publicity, programs have been in place for almost 20 years now that acknowledge vaccine injuries; the National Vaccine Injury Compensation Program (VICP) was launched in 1988 as a means of “reimbursing” patients’ adversely affected by inoculations, as if any amount of money can make up for a lifetime of suffering or more so, the death of a child. In addition, two years subsequent, the CDC and FDA created the Vaccine Adverse Event Reporting System (VAERS) so affected individuals or their representatives can report negative reactions occurring post-vaccination, which currently contains hundreds of thousands of documented tragedies.

Currently circulating flu vaccines contain the mercury-based preservative thimerosal. As if further explanation is needed, mercury is a horrible neurotoxin with a toxicity level 1000x higher than that of lead. Previously banned from over-the-counter products, animal vaccines, and ironically, in some states every other vaccine given to children, thimerosal remains in full concentration in flu vaccines.

Knowing that mercury levels in drinking water cannot exceed 2 parts per billion (ppb) without being toxic, or more appropriately, since any liquid containing more than 200 ppb of mercury is considered hazardous waste—it’s sickening that circulating vials of flu vaccine has 50,000 ppb of mercury, the only exceptions being Sanofi-Pasteur’s preservative free vaccines.

With four out of five manufacturers producing thimerosal-containing flu vaccines, over 90% of the 115 million doses distributed in America will contain 25 micrograms (mg) of mercury. This means that once the remaining 10% of mercury-free doses are used up, pregnant women and children will only have access to vials containing toxins measuring 250x the EPA’s safety limit.

For a person to safely receive the amount of mercury in one vaccine, he or she would have to weigh over 550 lbs, making the recommendation for pregnant women and children nothing less than an act of brutality.

As told in the Journal of American Physicians and Surgeons (Summer 2006), pregnant women who get inoculated with thimerosal-containing vaccines will be exposed to 3.5x the organic mercury limit set by EPA officials, but since mercury accumulates in fetal tissue, especially those of the central nervous system, concentrations found in the developing fetus can exceed maternal levels by a factor of 4.3.

The results of such an attack are devastating. “…brain damage, mental retardation, incoordination, blindness, seizures, and inability to speak” are just a few of the fetal reactions found by the Agency for Toxic Substances and Disease Registry (ATSDR).

In addition, the team clearly identified mercury, of any form, as posing a threat to the nervous system. Children exposed to mercury experience brain functioning difficulties such as “…irritability, shyness, tremors, changes in vision or hearing, and memory problems”, which further explains why American children are riddled with neurodevelopmental disorders ranging from autism and ADHD, to Guillain-Barre syndrome and speech disorders.

Americans will soon see for themselves what the selfish, money-driven vaccine industry has done for society. Not even officials will be able to deny the ever escalating autism epidemic when it stares them square in the eye; human flesh and blood, just as themselves, rather than numbers on a page in their office.

When the country’s social security trust depletes due to the cost of special education and assisted living facilities for these disabled children, and there are neither enough patients nor finances remaining to support the vicious “damage-treat” circle created by manufacturers and their loyal elected lapdogs—who will be blamed then? Where will the fingers point when greed isn’t paralyzing their conscience?

Time will soon provide the answer; unfortunately.

For those who still cannot seem to grasp the severity of thimerosal-containing vaccines, perhaps this will put things into perspective: if someone spilled a bottle of thimerosal indoors, the entire building would have to be evacuated immediately and remain so until a time when hazard crews thoroughly cleaned and secured the area.

It makes no sense to jeopardize a human life for a theoretical risk, especially not for a condition where, according to the November 30th publishing American’s Concern for Skin Infection, Flu, Spreads Across the County, “Proper handwashing is the simplest and most effective way to prevent these infections.”

As far as numbers go, the rate of influenza infections leaves something to be desired of the government’s national quest for total inoculation. According to the CDC’s Weekly Report: Influenza Summary Update (week ending November 18, 2006), World Health Organization (WHO) and National Respiratory and Enteric Virus Surveillance System (NREVSS) laboratories have tested 15,707 samples of suspected influenza viruses, with only 477 testing positive. Of the positive results, 308 were reported from Florida alone.

Now, call it audacity, but that sounds more reassuring than anything. Not only does it show incidence rates to be low throughout the country, it further establishes grounds for the useless vaccine debate. Highly counterproductive on their part, the preceding data shows just how easily misdiagnoses occurs and therefore, shows how ambiguous the reported 36,000 annual flu infections are.

Though that’s not all officials have up their sleeves, on top of being uncalled for and dangerous—the vaccines haven’t even been proven effective in providing immunity!

Dating back to 1935, a study conducted on thimerosal’s antibacterial and antifungal efficiency concluded the dangerous preservative, so to speak, was “35.3 times more toxic for embryonic chick heart tissue than for Staphylococcus aureus”, making it, as said by the FDA, “no better than water” in killing bacteria.

Confirming suspicions was the 1948, Journal of the American Medical Association’s publishing where authors concluded thimerosal was ineffective as a “disinfectant, germicide, and antiseptic,” in addition to stating thimerosal “may not completely kill cultures of …streptococci… in mice receiving an intraperitoneal injection of the culture-germicide mixture, after ten minutes’ [sic] exposure of the organisms to the drugs… usually die [all but one of the 17 mice injected], and hemolytic streptococci can be isolated from the heart’s blood after death of the mice.”

Subsequently, an American Academy of Pediatrics (1985) study revealed thimerosal to be “…only weakly bactericidal… not an ideal preservative”, which explains the FDA’s 1980 proposal to ban thimerosal from topical ointments, skin creams, and other over-the-counter products, along with the 1999 decision to exclude the chemical from future vaccine production due to “safety and efficiency” concerns.

Though, perhaps 2004 brought the most irrefutable of evidence when the British-based Chiron factory was found to have serious contamination problems. The company’s flu vaccine, Fluvirin, was pulled from distribution due to an unspecified number of lots containing an extremely dangerous microorganism, serratia, which is precisely the kind of threat thimerosal is supposed to eliminate.

Officials see the American public naively accepting whatever is put in front of them (i.e. Hepatitis B vaccines for 12 hour old babies, recent HPV vaccinations, unnecessary flu shots), and with the demolished state of check-and-balance within government bodies, officials are free to do whatever they choose without the fear of consequence.

As long as each scratches the others back, “scientific evidence” favoring the use of flu vaccines, and anything else they can think of, will continue regardless of necessity or safety. Manufacturers’ charge between $9.00 to $12.50 for every 10-pack of flu vaccines, so with over 100 million ready for distribution this year its not surprising that every government agency is practically celebrating vaccination.

Though perhaps the true motivation for mass vaccination lies in the Medicare reimbursement rate for flu vaccine administration, which, from 2002 to 2005, increased more that four times from an average of $3.98 to $18.57; or maybe in the five-year, $274 million contract awarded to GlaxoSmithKline in May 2006 to develop cell-based production models for future flu vaccines, but then again, it could be related to the “measly” $429 million reported in Chiron’s 2004 fourth quarter Fluvirin revenue, as opposed to the preceding years $555 million.

Whatever the situation, rather than simply accepting what is being pushed on us, its time to use some common sense and question why history is showing us one side of the story, while the government portrays a very different other.

Influenza infections, for the majority of citizens, are not life threatening, and even if they were—the occurrence rates do not justify injecting what both science and history has proven to be POISON into the desperately fragile bodies of infants and children.

Filed under: 2006, flu, prices, thimerosal, vaccines

Weighing Benefits of SSRIs Against Suicide Risk

Evelyn Pringle December 8, 2006

Before the FDA’s Psychopharmacologic Drugs Advisory Committee begins the discussion at the December 13, 2006, public hearing on the suicide risks associated with selective serotonin inhibitor antidepressants, it should get honest with the audience and openly admit that the SSRIs do not even work.

Medical professionals maintain that in order to justify the use of a drug, its benefits are supposed to outweigh its risks and therefore, there should be a discussion of exactly what benefits result from the use of SSRIs, in any population, that would outweigh the suicide risks associated with this class of medications.

The most popular SSRIs sold in the US include Paxil, Prozac, Zoloft, Lexapro and Celexa.

As far as the benefits of the various SSRIs, an April 2002 study in the Journal of American Medical Association compared the effectiveness of Zoloft, St John’s Wort, and a placebo and found that the placebo treated patients had the highest rate of remission of symptoms at 31.9%, and Zoloft’s 24.8% was barely better than the rate of remission with St John’s Wort of 23.9%.

The FDA’s own records on Celexa (citalopram) show the agency knew the drug to be ineffective when it was approved, and the agency based its approval on 2 marginally positive studies out of a total of 17 conducted.

A March 26, 1998, memorandum by Thomas Laughren, of the FDA’s Psychiatric Drug Products, notes a total of 17 clinical trials on Celexa, including 2 uncontrolled trials, 6 active controlled trials showing no difference between treatments, and 2 placebo controlled trials that were too small to be considered studies.

Dr Laughren’s memo discusses 5 short-term trials (85A, 91206, 86141, 89303, and 89306) and 2 long-term studies (89304 and 89305). “In summary,” he wrote, “I consider studies 85A and 91206 positive support for the claim of short-term antidepressant efficacy for citalopram.”

“While 3 other placebo-controlled short-term trials (86141, 89303, and 89306) were negative, and not easily interpretable since there were no active control arms,” he stated, “I feel there were sufficient reasons to speculate about the negative outcomes and, therefore, not count these studies against citalopram.”

Dr Laughman also counted 2 relapse prevention trials as effective to support the drug’s approval. “Overall,” he wrote, “I consider these results sufficient to support claims of both short-term and long-term antidepressant effectiveness of citalopram.”

However, other FDA officials were not so eager to stretch the truth about the weak studies with medical professionals and consumers. For instance, a May 4, 1998 memo by Paul Leber, Director of the Division of Neuropharmacological Drug Projects, on the subject of “Approvable Action on Forrest Laboratories NDA 20-822 Celexa,” said the pubic had a right to know the truth about all the trials submitted to the FDA for the approval of Celexa.

He advised that the drug labeling should not only describe the trials that showed Celexa’s adequate effects; but should also describe the “well controlled clinical studies that failed to do so.”

Dr Leber specifically pointed out that Study 86141, Study 89303, and Study 89306, all failed to provide results confirming the positive findings of Studies 85 and 91206, the two clinical trials that Dr Laughman listed to support the approval of Celexa.

“I am aware that clinical studies often fail to document the efficacy of effective drugs,” Dr Leber wrote, “but I doubt the public, or even the majority of medical community, are aware of this fact,” he said.

“I believe that labeling,” he stated, “that selectively describes positive studies and excludes mention of negative ones can be viewed as being potentially “false and misleading.””

“I believe it is useful for the prescriber, patient, and 3rd party payer to know,” Dr Leber wrote, “without having to gain access to official FDA review documents, that citalopram’s antidepressants effects were not detected in every controlled clinical trial intended to demonstrate those effects.”

“I am persuaded,” he stated, “they not only have a right to know, but should know.”

When Forest Labs got Lexapro approved in 2002, it was nothing more than a chemically altered version of Celexa, and Forest Labs spent a fortune on persuading doctors to switch patients to Lexapro before its top selling drug Celexa lost its patent protection in 2004.

At the time, Forest could point to only one lone study, that the company itself paid to have published that claimed Lexapro was any better than Celexa. The paper, by Dr Jack Gorman, of the Mount Sinai School of Medicine, pooled the results of three studies and concluded that Lexapro “may have a faster onset” than Celexa, according to a report by Melody Peterson in the November 22, 2002 New York Times.

Dr Gorman’s paper was published in CNS Spectrums, a medical journal he edits, and Forest paid Medworks Media, a small medical marketing company that publishes the journal, to print the article in a special supplement.

Other researchers disagreed with the study results. “The Medical Letter, a nonprofit newsletter respected for its independence from the pharmaceutical industry,” Ms Petersen reports, “reviewed the same clinical trials as Dr. Gorman and concluded … that Lexapro had not been shown to be better than any other antidepressant, including Celexa.”

As for Paxil, in June 2004, New York State Attorney General, Eliot Spitzer, charged GlaxoSmithKline, with fraud for hiding studies that “not only failed to show any benefit for the drug in children but demonstrated that children taking Paxil were more likely to become suicidal than those taking a placebo.”

According to Mr Spitzer, Glaxo published only one of 5 studies it conducted, and even that one showed mixed results.

Prozac (fluoxetine) was also known to be ineffective before it was approved for use in the US. While serving as an expert witness in a lawsuit, psychiatrist and SSRI expert, Dr Peter Breggin, author of, “Talking Back to Prozac,” reviewed a July 1985 in-house analysis by its maker, Eli Lilly, that showed Prozac had failed to demonstrate efficacy in clinical trials with patients taking Prozac verses a placebo or a tricyclic antidepressant.

“When this potential economic disaster for Eli Lilly was discovered,” Dr Beggin reports, “the FDA allowed the company to include in its efficacy data those patients who had been illegally treated with concomitant benzodiazepine tranquilizers in order to calm their over stimulation.”

“Basically, Prozac was approved in combination with addictive benzodiazepines such as Ativan, Xanax, and Valium,” he says, “but neither the FDA nor the drug company revealed this information.”

“With these patients included,” he states, “statistical manipulations enabled the FDA to find the drug marginally approvable.”

An internal Lilly document dated March 29, 1985, says, “The benefits vs. risks considerations for fluoxetine currently does not fall clearly in favor of the benefits.”

Medwatch is the reporting system by which adverse events involving prescription drugs are reported to the FDA. Within one decade of Prozac’s arrival on the market, there were 39,000 adverse event reports submitted to Medwatch and that number is said to represent only about 1% of the actual number of adverse events, according to an April 22, 2006 report by the Citizens Commission on Human Rights.

Serious questions about the possible link between suicide and SSRIs began in 1990, when Martin Teicher, of McLean Hospital in Massachusetts, reported on 6 patients who he said experienced “intense, violent suicidal thoughts” after taking Prozac.

He offered three possible theories for the increased suicidality: (1) SSRIs gave patients more energy before lifting their depression, allowing them to act on a suicidal impulse; (2) the drugs worsened depression in a small subset of patients; or (3) SSRIs caused a state of agitation and restlessness.

In a February 10, 1990, report titled, “Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment,” Dr Teicher said, “The purpose of this report is to suggest the surprising possibility that fluoxetine may induce suicidal ideation in some patients.”

“In our experience,” he wrote, “this side effect has occurred in 3.5% of patients receiving fluoxetine.”

Throughout the 1990s, Eli Lilly publicly denied that Prozac was associated with suicide or violence, but by the year 2000, the company had quietly paid an estimated $50 million to settle over 30 lawsuits, according to an Indianapolis Star investigation.

When reviewing Lilly’s studies on Prozac, Dr Breggin found that there were 12 suicide attempts in the Prozac group verses only one in the placebo group and one in the tricyclic antidepressant group, but that many of the suicide attempts were hidden under false categories.

“Even after the company winnowed out six of the suicide attempts,” Dr Breggin says, “the remaining 6:1 ratio was alarming.”

He also reviewed a November 8, 1998, study titled, “Activation and Sedation in Fluoxetine Clinical Trials,” that showed a 38% rate of stimulation in the patients taking Prozac, even though, he says, many patients were sedated and many parameters of stimulation were not counted.

Another group of documents that he examined, contained a study conducted by the FDA on increased spontaneous post marketing reports of “hostility” and “intentional injury” by patients on Prozac. “These documents,” Dr Breggin says, “were generated shortly before the 1991 FDA PDAC meeting that evaluated antidepressant-induced suicidality.”

For this study, the FDA used the antidepressant, trazodone, as a control and found a 24-fold relative increase of reports of hostility and intentional injury per prescription of Prozac when compared to patients on trazodone.

“The spike in Prozac reports,” Dr Breggins says, “occurred even before any public controversy surrounding Prozac and violence.”

The documents he reviewed also contained graphs showing a 40-fold relative increase in reports of suicide attempts, overdose, and psychotic depression, in patients on Prozac compared to patients on trazodone.

“In one memo,” Dr Breggin reports, “a Lilly employee expresses shame and regret about hiding this data.”

In the case where Dr Breggin testified, Lilly was able to have the records sealed by the court where they remained hidden for roughly 10 years.

On April 10, 2004, the British Medical Journal, citing Jurendi et al, criticized the authors of studies on SSRIs for exaggerating benefits and downplaying their harm and noted a clinical trial of 93 children on Paxil that produced 11 serious adverse events, including 7 hospitalizations, compared to only two in children in the placebo group.

But the Paxil suicide risk does not only apply to children. An August 22, 2005, study by Norwegian researchers found that Paxil also increases suicide risk in adults. In the study of over 1,500 adults, 7 Paxil patients attempted suicide compared to only one attempt in the group of patients on a placebo. The researchers recommended that the warning not to prescribe Paxil to children should be extended to adults.

In Insight News, on October 4, 2002, investigative reporter, Kelly Patricia O’Meara, author of, “Psyched Out, How Psychiatry Sells Mental Illness and Pushes Pills That Kill (2006),” revealed a study conducted by Dr Arif Khan, medical director of the Northwest Clinical Research Center in Bellevue, Washington, that disclosed the number of suicides committed or attempted by patients in the clinical trials on SSRIs, that were kept hidden from doctors and consumers.

For the study, Dr Khan examined the official clinical drug-trial data for all SSRIs approved by the FDA between 1985 and 2000.

According to Ms O’Meara, the rate of suicides in the general public is 11 in 100,000, but the incidence rate for people participating in the SSRI trials was 718 for every 100,000. Dr Kahn’s research also revealed that nearly 4% of study participants attempted suicide within the following year.

As for weighing the benefits against the above risks, the British Medical Journal published a study on July 16, 2005, by Joanna Moncrieff, senior lecturer in psychiatry at University College London, that found SSRIs no more effective than a placebo in reducing depression.

The study also found that trials on SSRIs with negative results were less likely to be published than those with positive results, and that even in the published trials, negative outcomes were often not presented.

Dr Moncrieff said she found “no good evidence that these drugs work.”

Filed under: 2006, Celexa, Effexor, Forest, Lexapro, Paxil, Prozac, Spitzer, SSRIs, Study 329, suicide, Teicher, Zoloft

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  • Dan Jenski - ADDicted
    Reblogged from The Bitter Pill: Kickstarter is a website for artists to use to raise money and complete awesome projects. The best thing to come to the informed consent movement since Thomas Szasz could just be the new, upcoming film by Dan Jenski, "ADDicted" which basically gives Ritalin, Adderall, Concerta and the like a great […]
  • Zoloft Fails to Outperform Placebo: Class Action
    Reblogged from The Bitter Pill: In the studies submitted to the FDA for approving Zoloft (a drug that has killed numerous families, babies, mothers, children), the drug maker covered up the fact that Zoloft failed to outperform placebo, according to a new consumer fraud lawsuit filed by the firms Baum, Hedlund Aristei & Goldman and […]
  • Antidepressants Again Linked to Preterm Birth & Seizures
    In what was more than likely originally an attempt to prove that depression causes birth complications, researchers from Yale, Tufts, et al found in two new studies that antidepressants increase the risk of preterm birth and seizures. Read more at this link on the newly redesigned UNITE website.
  • Who Could Do This On Purpose
    Read this blog to find out
  • Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed
    Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed (Cross-Posted on The Bitter Pill blog) Amery and Christiane Schultz have been asked to provide input on proposed recommendations regarding psychotropic drugs in pregnancy in Canada. Amery & Christiane are hard-working activists affiliated with UNITE and MADNAP. Please send […]

UNITE ARCHIVES – Victims & Survivors Against The MOTHERS Act: YouTube Playlist

Videos: Psych Drugs, Birth Defects, Infant Death, Violence & Suicide

UNITE ARCHIVES – Add Your Group To The Coalition Against The MOTHERS Act

CADIMA: 54 Groups and Counting!

UNITE ARCHIVES – The MOTHERS Act Citizen Voting Area on Open Congress

Status: 76% AGAINST S. 324 The MOTHERS Act. Vote & Comment.

UNITE ARCHIVES – Join the Coalition Against The MOTHERS Act on Facebook!

3,271 Facebook Members and Counting!

UNITE ARCHIVES – Stop The Dangerous and Invasive MOTHERS Act!

13,500 Signatures and Counting!

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