The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Dan Jenski – ADDicted

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 big gigantic middle finger. Dan is a friend of mine and I see huge potential in his work. I’m thinking Oscar. The short film version of ADDicted has made it into film festivals all across the country and now Dan and his co-producer Aaron Bickes need to raise enough money to be able to create the feature length film.

With fewer and fewer days left in this important campaign, you can make a difference today for future generations of children, high school, college, and graduate students BEFORE their moms, teachers, dads and doctors get a chance to diagnose them with some kind of problem leading to the use of risky and damaging, potentially fatal stimulants. This project needs donations. Please help us spread the word.

Check it out at http://www.kickstarter.com/projects/libproductions/addicted-feature-film?ref=live

Also read what award-winning writer Kelly O’Meara has to say about it here:

http://www.cchrint.org/2013/02/26/kick-starting-a-worthy-film-addicted/

Filed under: 'ADHD', Adderall, addict, addiction, adverse drug reactions, drugging children, Strattera

April 2007 Big Pharma Litigation Update – Drugs – Part II

Evelyn Pringle April 12, 2007

The anti-epileptic drug, Depakote (valproate), marketed by Abbott Laboratories, is one of the most heavily prescribed medications for off-label use. Experts say the evidence of harm caused by Depakote is just beginning to emerge.

According to Harrisburg, Pennsylvania psychiatrist, Dr Stefan Kruszewski, a recognized expert on psychotropic drugs, “we can anticipate a continuing series of tragic outcomes from the massive overuse of Depakote, secondary not only to birth defects and death, but also due to anemias, hepatic disease, obesity, diabetes type II, pancreatitis and other serious systemic and neurological dysfunctions.”

Bayer is under fire for hiding the adverse effects of the anti-clotting drug, Trasylol, used in heart surgery, and will no doubt be hit with plenty of lawsuits in the not to distant future, considering that Dr Dennis Mangano, the lead author of new study in the February 7, 2007, Journal of the American Medical Association, says that the Trasylol may be responsible for 10,000 deaths over five years.

On December 15, 2006, the FDA announced new labeling for Trasylol, and said a study suggests that, in addition to serious kidney damage, Trasylol may increase the chance for death, congestive heart failure (a weakening of the heart), and strokes.

Because Trasylol is administered during surgery, many victims may not even realize they have been injured by the drug. But plenty have, according to Dr Mangano, who says that in 2006, Trasylol, was administered to 246,000 patients.

Another drug on the legal chopping block is the Parkinson’s drug, Permax. As far back as December 2002, doctors at the Mayo Clinic reported heart valve disease in 3 patients who had been taking Permax, similar to damage caused by the Fen-Phen combination.

In 2004, HealthDay News reported that a study had confirmed previous findings that the drug could damage heart valves and surgery would be needed to correct it. Two new studies in the January 4, 2007, New England Journal of Medicine, report that the number of Permax patients who have developed valve damage is higher than expected.

One study, which included 155 patients taking various Parkinson’s drugs, and 90 healthy patients in a comparison group, and found moderate to severe valve problems in more than 23% of the patients on Permax, compared to less than 6% in the comparison group.

The second study found Permax users were 5 to 7 times more likely to have leaky heart valves than patients taking other types of Parkinson’s drugs, and patients taking the highest doses of Permax had a 37 times greater risk.

“This is not a rare side effect,” says Dr Bryan Roth, a professor at the University of North Carolina, who wrote an editorial accompanying the reports in the NEJM.

“That’s an extraordinarily high incidence,” he warns. “That makes this a serious problem.”

Heart valve damage is a life-threatening condition and costly to treat. Replacement requires open heart surgery, where the breastbone is divided, the heart is stopped, and blood is sent through a heart-lung machine, according to the Texas Heart Institute. No drug can reverse valve damage, making replacement surgery the only option. Medical experts are advising all Permax patients to undergo testing for valve damage.

The drug was introduced to the US market by Eli Lilly, but Valeant Pharmaceuticals now sells Permax. On March 29, 2007, Permax was pulled off the market after the FDA reviewed new information that associates it with heart problems.

During the last 2 decades, the antidepressants, known as selective serotonin reuptake inhibitors, or SSRIs, have been prescribed for more unapproved uses than any other class of drugs in history. A June 2005, study in the Journal of Clinical Psychiatry, found that 75% of SSRI prescriptions written were for unapproved uses.

SSRIs have now been linked to suicidality, extreme violence and homicide, several life-threatening birth defects, abnormal uterine or gastrointestinal bleeding, a decrease in bone mineral density, fertility problems, sexual dysfunction, and a severe withdrawal syndrome.

On April 10, 2004, the British Medical Journal, criticized the authors of studies on SSRI’s for exaggerating the benefits and downplaying the harm, including suicidality, and discussed a study of 93 children on Paxil that produced 11 serious adverse events, including 7 hospitalizations, compared to only 2 in children in the placebo group.

The Paxil suicide risk is not limited to children. An August 22, 2005, study by Norwegian researchers of over 1,500 adults, found 7 Paxil patients attempted suicide compared to only 1 attempt in the group on a placebo, and recommended that warnings not to prescribe Paxil to children should also apply to adults.

According to Forest Lab’s Annual Report filed on June 14, 2006, the company is a named defendant in approximately 25 lawsuits, with the majority involving the company’s top selling SSRI drugs, Celexa or Lexapro, for inducing suicidality.

A wrongful death lawsuit was filed in September 2005, by the Pogust & Braslow law firm in Conshohocken, Pennsylvania, on behalf of the family of 32-year-old man who unexpectedly committed suicide soon after being prescribed Lexapro.

A steady stream of lawsuits have been filed against GlaxoSmithKline over Paxil, stemming from the company’s concealment of the drug’s link to suicide, birth defects, violence and withdrawal syndrome.

On March 23, 2006, the California-based Baum Hedlund law firm filed a national class-action lawsuit against Glaxo on behalf of the mother of an 11-year old Kansas boy who committed suicide, and a teenager in Texas who attempted suicide while taking Paxil.

She says, Baum Hedlund has documents obtained in litigation that show there was an awareness of the suicide risk as far back as the late 1970’s, a decade before the first SSRI was approved for sale in the US.

A new round of Paxil lawsuits began on October 16, 2006, when Baum Hedlund filed a case alleging that Paxil use during pregnancy resulted in an infant being born with a life-threatening lung disorder, PPHN. Between 10% and 20% of infants born with PPHN end up dying, even when they receive treatment.

On July 28, 2006, Baum Hedlund also filed a lawsuit on behalf of the parents of an infant who was born with congenital heart birth defects as a result of his mother taking Paxil during pregnancy. Since birth, the child has undergone 3 open-heart surgeries and will likely have to undergo more and possibly a heart transplant at some point in the future.

Based on the company’s legendary history of concealing adverse effects, the lead attorney on the case, Karen Barth Menzies, says believes Glaxo has known about these risks and should have warned prescribing doctors and consumers about these birth defects long ago.

The Houston law firm of Robert Kwok & Associates is handling a Celexa birth heart defects case in Kentucky. The mother was prescribed Celexa during pregnancy, and her baby was born with Shone’s Complex, a form of congenital heart disease that consists of defects that lead to the obstruction of blood flow from the heart to the body.

Legal analysts are predicting that SSRI makers will offer early settlements in cases involving birth defects to avoid having these families appear before a jury.

Pfizer is still being sued left and right over adverse effects related to the epilepsy drug Neurontin. In 2004, the company pleaded guilty to charges involving a massive off-label marketing scheme and agreed to pay the second-largest settlement ever in a health care fraud prosecution of $403 million. By 2002, a full 94% of Neurontin sales were for off-label use, according to the August 16, 2004 USA Today.

Many private lawsuits involve Neurontin-induced suicidality. The Pogust & Braslow law firm is handling a case for Natalie Biedenbender, whose husband committed suicide at age 39, after being prescribed the drug off-label for back pain.

“Although Neurontin is prescribed for scores of off-label indications,” Attorney Derek Braslow reports, “since 1999, the off-label use continues to be most common in the areas where the company focused its illegal marketing efforts, such as bipolar disorder, peripheral neuropathy, and migraine.”

Two lawsuits were recently filed against Novartis and Astellas Pharma, the makers of the topical skin creams, Elidel and Protopic, used to treat eczema. Alan and Dayna Thomson filed a lawsuit in December 2006 after their daughter Haley died after using Elidel, and Ashley McDonald filed a lawsuit in January 2007 after being diagnosed with lymphoma following her use of Elidel.

In another case, Traci Reilly, of Naperville, Illinois, developed breast cancer after applying Protopic and Elidel for a condition that caused patches of discolored skin on her breast.

Protopic and Elidel belong to a class of drugs known as calcineurin inhibitors, so called because they reduce immune activity by inhibiting the activity of the enzyme calcineurin in organ transplant patients. Use of these drugs has long been known to increase the risk of cancer, and the drugs were labeled accordingly for use in transplant patients.

Protopic and Elidel have only been on the market for about 5 years and together have already been prescribed to more than 7 million people. In 2006, the FDA added a black box warning to the skin creams about the cancer risk.

On February 21, 2007, Tom Moore, the author of several books on the pharmaceutical industry, told CBS News that he had studied about 1,200 cases of suspected injuries pertaining to Protopic and Elidel reported to the FDA through 2005 and found more than 100 potential cancer cases in children and adults, with most involving lymphoma or skin cancer.

Filed under: 2007, addict, Birth Defects, cancer, Depakote, Elidel, Neurontin, Permax, SSRIs, suicide, Trasylol

Off-Label Prescribing of Pain Lollipops Turns Deadly

Evelyn Pringle January 24, 2007

The painkilling lollipop, Actiq, is approved to treat chronic pain in cancer patients who are already on an opioid drug. But a recent study by Prime Therapeutics found the drug is being prescribed off-label for unapproved uses nearly 90% of the time.

For those suffering with the agonizing pain of late stage cancer, the painkiller on a stick brings fast relief because it is 80 times more potent than morphine, which makes it a prime drug to watch for law enforcement officials because of its potential for illicit use.

Actiq contains fentanyl, a drug classified as a Schedule II substance by the Drug Enforcement Administration, in the same category as cocaine, opium, methamphetamine and methadone. Schedule II drugs have the highest potential for abuse and overdose.

Fentanyl is also available in a skin patch, and overall, prescriptions for the drug have increased from about 0.5 million in 1994 to 6.95 million in 2005, according to IMS Health, a pharmaceutical industry tracking firm.

Actiq is only FDA approved for the management of pain in cancer patients who are already being treated with opioids because life-threatening conditions can occur at any dose in patients without a built-up tolerance for opioids.

According to a November 5, 1998, talk paper prepared for agency personnel at the time of the product’s approval, the FDA approved Actiq, as a “new product developed specifically for cancer patients with severe pain that breaks through their regular narcotic therapy.”

“Because Actiq may be fatal to children (as well as to adults not already taking opioid narcotics),” the paper said, “FDA approved Actiq under special regulations that restrict distribution as defined in a comprehensive risk management plan.”

The FDA noted that the agency was “extremely concerned that this product be packaged and marketed to minimize the opportunity for diversion, abuse, or access by children.”

However, the DEA, reports that fentanyl is being diverted by pharmacy theft, fraudulent prescriptions and illicit distribution by patients, physicians and pharmacists, and theft at nursing homes and other long-term care facilities. Actiq is typically sold on the street for $20-25 per lollipop and the drug’s street name is “perc-a-pop.”

In 2004, there were an estimated 8,000 emergency-room visits for fentanyl overdoses, according the US Substance Abuse and Mental Health Services Administration. Overdose can result in sudden death through respiratory arrest, cardiac arrest, severe respiratory depression, cardiovascular collapse or severe anaphylactic reaction, according to the agency. As of November 16, 2006, there were 653 deaths confirmed in the US since 2005.

On June 20, 2006, the US Department of Health and Human Service sent a letter to emergency department physicians and personnel to make them aware that the CDC was receiving increasing reports of fentanyl overdoses among illicit drug users in multiple states.

However, the fact that fentanyl cannot be detected with standard opiate screens has caused major problems. Currently, the ER protocol recommended is to assume the presence of fentanyl when a patient has symptoms of narcotic overdose but fails to test positive for heroin.

The Utah based drug maker Anesta Corp, a company acquired by Cephalon in 2000, developed Actiq. Since the Cephalon taker-over in 2000, Actiq has become one of the drugs most often prescribed off-label in the US.

Off-label refers to the use of drugs to treat conditions other than those approved by the FDA and can include prescribing drugs to unapproved populations such as children or the elderly or in higher doses than specified in the drug’s labeling. Drug companies are not allowed to promote a drug for off-label uses, but doctors are permitted to prescribe a drug for any use they believe would be helpful.

The study released this month by Prime Therapeutics, a pharmacy benefit manager, analyzed 95 patient claims from a Midwestern commercial health plan from April through June 2005, and found that only 21 patients had a diagnosis of cancer or AIDS.

In addition, Prime found that only 11 of those 21 patients were taking a long-acting opioid painkiller. Overall, 84 of the 95 Actiq prescriptions, or nearly 90%, were off-label.

The Prime study also found that more than 15% of the prescriptions were for more than the recommended dose of 120 lollipops per month.

Government investigators have been looking into Cephalon’s off-label promotion of Actiq in Connecticut and the Philadelphia area for two years, and the company is also being investigated by the FDA’s Office of Criminal Investigations.

In November 2006, Connecticut Attorney General, Richard Blumenthal, concluded an investigation, which according to the Wall Street Journal, uncovered evidence that suggests Cephalon set high sales quotas for its sales representatives that could not be reached without promoting Actiq off-label.

Of course, just like every other company busted for off-label marketing in recent years, Cephalon claims it does not market Actiq off-label. But internal company documents reveal that sales reps were regularly sent to primary care doctors and specialists, who treat no cancer patients, armed with free coupons for doctors to pass out to patients.

For instance, Dr Stephen Leighton, a general practitioner who says he only has 3 cancer patients at any given time, told the Journal that a Cephalon saleswoman comes by once a month and gives him about 60 to 70 coupons for patients to trade in for six Actiq sticks.

He says the coupons spurred him to try the drug on patients with migraines and back pain and that he prescribes Actiq 15 to 20 times a month to patients who do not have cancer.

As a further indication of off-label promotion by Cephalon’s Actiq sales force, the Journal cites a survey by the research firm ImpactRx, that found visits to non-cancer doctors increased 6-fold from 2002 to 2005.

According to company documents, Cephalon instructed sales reps to ask non-cancer doctors, “Do you have the potential to treat cancer pain?”

And even if the answer was no, they were instructed to give the doctors free coupons to pass out. One document quoted by the Journal, says the coupon program “is a remarkably effective promotional tool” that increased sales by 75 prescriptions a week at little cost.

Cephalon uses many tactics to influence doctor’s prescribing habits. Mr Blumenthal’s investigation found instances where Cephalon flew doctors to company funded seminars where paid speakers promoted the off-label use of Actiq. For instance, the Journal described a September 2003, New York seminar, where one of the topics was “Opioid use in headache.”

At another October 2003, meeting, the Journal reports, a topic was “Use of Actiq in opioid-naive patients,” even though the product label says it should be prescribed only to patients already taking opiate narcotics and can tolerate the drug.

In fact, the Actiq package insert states: “Do Not Take OTFC if you: are not already taking other opioid pain medicines for your constant (around-the-clock) cancer pain.”

It also states: “Never use OTFC for short-term pain from injuries or surgery or pain that will go away in a few days, such as pain from doctor or dentist visits, or any short-lasting pain.”

In 2002, Cephalon began zeroing in on neurologists and a document titled “Actiq in Migraine,” instructed sales reps to pitch Actiq as “an ER on a stick.”

The off-label use of Actiq by opioid naive patients has resulted in devastating consequences for some people. On January 22, 2006, the Free Press reported that the wife of a minister, former schoolteacher, and the mother of three sons, was arrested and charged with involuntary manslaughter because she gave Actiq, her cancer pain medication, to a friend who had a migraine and the friend died of a drug overdose.

On November 3, 2006, the Journal reported a case where a pregnant woman was prescribed Actiq for migraines by a neurologist. By the time of delivery, the woman, who the Journal noted had previously struggled with addictions to milder narcotics, was consuming five lollipops a day.

Upon birth, the infant was cranky and could not sleep and doctors told the woman that her son had become addicted to Actiq and was going through withdrawal.

When approving Actiq in 1998, the FDA set up a risk-management program with guidelines that said sales reps should “promote only to the target audiences,” defined as oncologists, pain specialists, their nurses and office staff.

An provision of the program requires Cephalon to report whether “groups of physicians (such as a particular specialty)” who represent “potential off-label usage greater than 15 percent” are prescribing Actiq. If such a group exists, the FDA says, Cephalon should warn the doctors against the off-label use of the drug.

According to the market research firm, Verispan, for the first half of 2006, two groups of doctors exceeded the 15% quota, anesthesiologists at 29.5%, and physical medicine and rehabilitation specialists at 16%. Oncologists or cancer doctors accounted for only 1% of the prescriptions at retail pharmacies in the US, the Journal reports quoting Verispan.

In 2003, a company auditor, David Brennan, determined that Cephalon was not complying with the 15% rule, but says he was fired when he reported his findings to his superiors, according to a June 2004, wrongful termination lawsuit filed in Camden, NJ.

For Cephalon to act naive about the level of off-label prescribing of Actiq while the cash register is ringing up the sales is laughable. According to the November 3, 2006, report in the Journal, sales of Actiq went from $15 million in 2000, to more than $400 million today.

Filed under: 2007, addict, Cephalon, fentanyl, patch, prices

Business Booming for SSRI Makers

Evelyn Pringle January 8, 2007

The market for antidepressants is the largest segment of the Central Nervous System drug sector with global sales of $16.2 billion in 2005. Depression costs the US economy an estimated $44 billion a year and the World Health Organization predicts depression will be the leading cause of disability by 2020, according to a report by Research and Markets.

Currently, depression seems to have reached epidemic proportions in the US only. In 2005, the US market for antidepressants accounted for 66% of the global market, compared to 23% in Europe, and 11% for the rest of world, largely Japan, according to R&M’s December 18, 2006, press release.

Since the new class of selective serotonin reuptake inhibitor antidepressants, or SSRIs, arrived in the late-1980s, the market has exploded. In 1985, sales of antidepressants in the US totaled roughly $240 million, but from September 1, 2003 to August 30, 2004, sales rose to $11.2 billion, according to IMS, a health care tracking firm.

The most commonly prescribed SSRIs in the US include Prozac, by Eli Lilly, Paxil by GlaxoSmithKline, Zoloft by Pfizer, and Celexa and Lexapro by Forest Laboratories.

Award winning journalist and author, Robert Whitaker, reports that no coincidently, during the same time-frame, the “number of Americans disabled by mental illness has nearly doubled since 1987, when Prozac-the first in a second generation of wonder drugs for mental illness-was introduced.”

There are now nearly 6 million Americans disabled by mental illness, and this number increases by more than 400 people each day, according to Mr Whitaker’s report in the Spring 2005, issue of Ethical Human Psychology and Psychiatry, Volume 7, Number I.

In 1955, the number of people disabled by mental illness in the US was 3.38 per 1,000, but during the past 50 years, when psychiatric drugs have become the cornerstone of care, Mr Whitaker reports, “the disability rate has climbed steadily, and has now reached around 20 people per 1,000.”

“A review of the scientific literature,” he notes, “reveals that it is our drug-based paradigm of care that is fueling this epidemic.”

“The drugs,” he states, “induce new and more severe psychiatric symptoms in a significant percentage of patients.”

“In Prozac’s first 2 years on the market,” Mr Whitaker says, “the FDA’s Medwatch program received more adverse-event reports about this new “wonder drug” than it had received for the leading tricyclic in the previous 20 years.”

In terms of adding to the number of people disabled by mentally ill, Mr Whitaker says, “the propensity of Prozac and other SSRIs to trigger mania or psychosis is undoubtedly the biggest problem with these drugs.”

According to Harvard trained psychiatrist, Dr Stefan Kruszewski, “due to predictable neurochemical changes in the human central nervous system, SSRIs can also increase the risk of violence and aggressive acting out.”

And experts say, when that happens, instead of recognizing the side effects of SSRIs, doctors change the diagnosis to schizophrenia or bipolor disorder and prescribe more drugs which pretty much guarantees that disability due to mental illness is right around the corner.

It is at this junction that the tax payers become completely responsible for the injuries caused by the drug makers, and must pay not only for the patient’s medical care and drugs, but for the person’s very existence.

Dr Kruszewski says that because SSRI makers have concealed the research that identified the adverse effects, doctors who prescribe SSRIs have not been adequately warned about the risks. “Neither patients nor physicians,” he explains, “can accurately assess the risks and benefits of any medicine unless the manufacturers and the FDA work together to ensure that all information is transparent and readily available.”

Regulatory agencies have focused most of their attention on the link between suicidality and SSRIs. In October 2004, the FDA directed SSRI makers to change their labeling to include a black box warning about an increased risk of suicide and suicidal thoughts in children and adolescents. The FDA strengthened the warnings after assessments showed that at least 13 of the 15 studies on SSRI use with children failed to show efficacy and there appeared to be an activation syndrome associated with the drugs.

In July 2005, the FDA issued a public health advisory saying the possibility of a risk of suicidality should also be applied to adults taking SSRIs. And last month, the FDA’s Psychopharmacologic Drugs Advisory Committee held a public hearing to review the suicidality data on adults and SSRIs, and recommended a widening of the black box warning to include adults.

The data presented to the Committee by the FDA showed that SSRIs double the risk of suicidal behavior in young adults, from around three cases per thousand to 7, and for the first time, the FDA publicly acknowledged that SSRIs are linked to suicidality among persons over the age of 18.

Many of the world’s leading experts on SSRIs traveled to Washington to testify at the hearing, as did many family members who lost love ones to suicide. In many cases family members testified that the deceased patients were not depressed to begin with and that the SSRIs were prescribed for conditions other than depression.

The day before the hearing, the Alliance for Human Research Protection, together with WoodyMatters.com, arranged two press conferences, one at the National Press Club and the other at the Silver Springs Hilton in Maryland, to provide a forum for the experts to brief the public and media on the issues.

At the press conferences, presentations were made by Kim Witczak and Eric Swann, Vera Hassner Sharav, Dr Joseph Glenmullen, Dr David Healy, Dr John Abramson, Dr David Cohen, and Attorney, Karen Barth Menzies.

Kim Witczac and Eric Swann described their personal experience of living through the tragic suicide of Kim’s husband, Woody, a happy, healthy 37-year-old man who committed suicide after being prescribed Zoloft off-label for insomnia.

Vera Sharav, president of the Alliance for Human Research Protection, discussed how SSRIs have been marketed as “magic bullets,” but compared them to “snake oil.” She went over a long list of conditions for which the drugs are approved, followed by an even longer list of conditions for which doctors are prescribing SSRIs off-label.

Ms Sharav also pointed out the disparity between reports by the FDA and UK regulators when analyzing the same data. She noted that the UK found 16 suicides and 177 attempts in 40,000 patients, compared to the FDA’s report of 8 suicides and 133 attempts in 100,000 patients.

UK psychiatrist, Dr David Healy, a professor at North Wales Department of Psychological Medicine, at Cardiff University, and author of, The Antidepressant Era, and The Creation of Psychopharmacology, also discussed how data obtained from British regulators contradicts the data released by the FDA. He questioned the overall validity of the information used by the FDA to draw conclusions about SSRI induced suicidality.

Dr Healy explained how the effectiveness of SSRIs has been misconstrued, when in fact, the data reveals that only one in 10 patients on the drugs can be shown to respond specifically to the SSRI rather than a nonspecific factor or a placebo.

He discussed the manipulation of trial data and showed how suicide related events in previous trials were arbitrarily switched from drug treated groups to placebo treated groups and gave several examples of ghostwritten reports professing to validate safety and efficacy of SSRIs in clinical trials.

In his presentation, Dr David Cohen, co-author with Dr Peter Breggin of, “Your Drug May Be Your Problem,” explained why clinical trials used by the FDA to determine whether there is a link between SSRIs and suicidality are completely unsuited for that purpose.

He pointed out that these trials were conducted by drug companies as a means of testing a drug’s superiority over a placebo or its equivalency to an existing drug, and not to determine how a drug might be psychologically influencing patients who take the drug for a long period of time.

Dr John Abramson, a clinical faculty member at Harvard Medical School, and author of, Overdosed America, gave an overview of the overwhelming industry influence inside what experts say should be the most scientific and evidence-based forums of general and primary care physicians.

He presented slides illustrating the presence of the industry in every location at an annual convention for a professional organization, including drug ads at each registration desk, ads on the cards given to doctors to record attendance of specific courses for continuing education credits, and how ads were even placed in the bathrooms.

Dr Joe Glenmullen, an instructor at Harvard Medical School, and the author of, Prozac Backlash, and The Antidepressant Solution, gave a brief review of the literature related to antidepressant induced suicidality.

He explained that the difference between SSRI suicidality and ordinary suicidality can be easily distinguished due to an activation syndrome that usually accompanies SSRI suicidality which includes akathisia and mania.

According to Dr Glenmullen, the FDA has systematically swept the suicide issue under the carpet even though the agency has possessed ample research linking SSRIs to suicidality for many years.

Attorney, Karen Barth Menzies, a partner at the Baum Hedlund law firm, who has battled the SSRI makers in the legal arena for a decade, summarized the numerous instances where data on suicidality was suppressed by the drug companies for years and finally made public only after it surfaced in litigation.

Its not as if more studies are necessary to link SSRIs to suicide, but a recent study in the December 2006, issue of Archives of General Psychiatry, analyzed the data on 15,390 people, from age 10 to 100-years-old, who had been hospitalized after attempting suicide, and determined that 602 of these people went on to commit suicide, and 7,136 attempted suicide again, over the following 3 years.

In making their comparisons, the researchers found that although people who took antidepressants were slightly, or 9%, less likely to successfully commit suicide than people who took no drugs, antidepressant users were 36% more likely to attempt suicide than people who were not taking the drugs, and the risk was slightly higher for persons between 10 and 19-years-old.

Filed under: 2007, addict, FDA, FDA hearing, SSRIs, suicide

Drip Drip Drip – Paxil Info Leaks Out

Evelyn Pringle April 2006

Secrecy agreements in litigation hide information about defective products or a company’s negligence, and sometimes go so far as to prohibit the parties from discussing that there ever was a lawsuit. Such is the case with Paxil and as a result, unwitting patients continued to take the drug long after its dangers were known to GlaxoSmithKline.

Many lawsuits filed against Glaxo have been settled out of court, with confidential agreements that prevent the public from knowing about the harmful effects of the Paxil.

Previously sealed documents and internal company memos suppressed with protective orders, prove that Glaxo knew about the problems with Paxil before it received FDA approval, but continued to sell the drug for over a decade without warning consumers.

Long overdue legislation is currently pending in both the US House of Representatives and the Senate known as Sunshine in Litigation Act of 2005, which basically says that a court shall not enter an order restricting the disclosure of information obtained through discovery, an order approving a settlement agreement that would restrict the disclosure of such information, or an order restricting access to court records in a civil case.

Glaxo currently faces thousands of lawsuits over Paxil side effects related to addiction, dependence, and a severe withdrawal syndrome.

SSRIs (selective serotonin reuptake inhibitors) like Paxil, are not addictive in the sense that “an individual would mortgage their livelihoods and all they hold dear for further supplies of the drug,” according to Dr David Healy MD, FRCPsych, North Wales Department of Psychological Medicine.

SSRIs can hook patients in the sense of making you “physically dependent,” he explains.

Dr Healy is considered an expert on Paxil and has had access to confidential studies from the Glaxo archives. The common symptoms of withdrawal, he says, break down into two groups.

The first group may be unlike anything you have had before, he warns, including: Dizziness, Headache, Muscle Spasms, Tremor, Electric Shock-like Sensations, Other Strange Tingling or Painful Sensations, Nausea, Diarrhoea, Flatulence, Dreams, including Vivid Dreams, and Agitation.

The second group overlaps with general nervousness, Dr Healy says, and may lead to you or your physician to think that all you have are features of your original problem. These symptoms include: Depression, Lability of Mood, Irritability, Agitation, Confusion Fatigue/Malaise, Flu-like Feelings, Insomnia or Drowsiness, Mood Swings, Sweating, Feelings of Unreality, and Feelings of being Hot or Cold.

These symptoms appear in anywhere between 20% to 50% of patients taking SSRIs, Dr Healy says, sometimes within hours of the last dose.

In the class action case against Glaxo settled in 2005, In re: Paxil Products Liability Litigation, MDL No 1574, CD Calif, the plaintiffs were forever silenced by a strict confidentiality clause incorporated into the settlement agreement.

This author obtained a copy of the lawsuit’s complaint, dated August 23, 2001, as well as a copy of the settlement agreement with a secrecy clause that states in relevant part:

Plaintiffs and their attorneys, “will not make any statements, either directly or indirectly, by implication or innuendo, to anyone, including but not limited to consultants, experts, the press or media, concerning the amount or other terms of such settlement or settlements, or the nature and substance of settlement negotiations, or describing or characterizing the settlement in any way.”

Plaintiffs and their attorneys “will not, either directly or indirectly, publicize the fact of the settlement and that any inquiry into the settlement, its amount, meaning, interpretation or comparative value, or the negotiations leading to the settlement by anyone, including but not limited to the press or media, will be met only by a statement that the case has been resolved, and will decline any requests for interviews by the press or media regarding the settlement, its history or its terms.”

The clause even extends to the internet specifically in that plaintiffs and attorneys “will not maintain and instead will discontinue any website references to Paxil discontinuation or withdrawal.”

And, it says, they “agree to refrain from any future internet postings regarding Paxil discontinuation or withdrawal.”

Paragraph 5 of the lawsuit’s complaint says that over a 2 year period, “plaintiffs’ attorneys have been individually contacted by approximately 500 Paxil withdrawal victims.”

And, the pain and suffering experienced by each individual is the direct result of Glaxo’s “failure to warn users of Paxil’s addictive nature, the drug’s inducement of physical or psychologic dependency, and its infliction of dependency/ withdrawal syndrome when the patient’s Paxil dosage is reduced or terminated,” the complaint states.

Paragraph 16, lists withdrawal reactions that “can summed up as one or more of the following complaints: jolting electric “zaps,” dizziness, light headedness, vertigo, incoordination, gait disturbances, sweating, extreme nausea, vomiting, high fever, abdominal discomfort, flu symptoms, anorexia, diarrhea, agitation, tremulousness, irritability, aggression, sleep disturbance, nightmares, tremor, confusion, memory and concentration difficulties, lethargy, malaise, weakness, fatigue, paraesthesias, ataxia, and/or myalgia.”

Paragraph 7, says: “These reactions are “unexpected” to the victims and even their physicians because the manufacturer has deliberately failed to properly warn of this.”

“Both physician and patient unwittingly use Paxil without knowing the drug’s addictive traits,” the complaint says.

Paragraph 8, charges that because Glaxo has suppressed the information, patients and physicians are fooled into thinking that the reactions are caused by another condition, such as relapse into depression, thus prompting incorrect and unnecessary medical treatment, including increased dosages of Paxil.

While researchers have acknowledged the potential for withdrawal reactions with all SSRIs, Paxil is by far the worst. Citing data from the World Health Organization, the lawsuit’s complaint states: “Paxil has the highest incidence rate of withdrawal adverse experiences of any antidepressant drug in the world.”

Starting in December 2001, Glaxo finally added a minimizing precaution to Paxil’s label of some possible “discontinuation” side effects affecting “2 percent or greater” of patients based on studies.

However, documents reveal that Glaxo has always known about the withdrawal syndrome. For instance, in 1993, in a report that occurred 5 months after Paxil arrived on the market, Stoker and Eric noted Paxil withdrawal at the American Psychiatric Association’s annual meeting in San Francisco, May 22-27, 1993.

The authors of the study conducted 2 week tapering off periods for 186 patients in 6 to 12 week doubled blinded comparative studies. Low dose and high dose groups were studied. Paxil’s low dose group actually did worse than the high dose group, suffering 42% withdrawal rate, compared to 38% in the high dose group. And, both occurred even though the tapering off regime was initiated during dosage reduction.

The lawsuit’s complaint specifically describes close to 10 studies that reveal a high rate of withdrawal symptoms since Paxil came on the market that Glaxo was fully aware of. A fact well-evidenced in internal company documents.

A previously suppressed, May 1, 1997, Glaxo memo to, “Paxil Selling Team,” on the “discontinuation syndrome,” defines the withdrawal syndrome as, “a class effect that can occur when an SSRI is stopped abruptly. Symptoms may include asthenia, flu-like symptoms, fatigue, dizziness, nausea, and sleep disturbances (insomnia, vivid dreams or nightmares).”

However, the memo instructs Glaxo sales representatives to avoid using the term and says: “instead of ‘withdrawal syndrome,’ which implies addictive properties, try to refer to this phenomenon as ‘discontinuation symptoms.'”

Eight months later, in a December 1, 1997, “Business Plan Guide,” sales representatives were instructed to “minimize concerns surrounding discontinuation symptoms,” and told to explain to doctors that the “discontinuation incident rate is two in 1,000 patients.”

However, according to a 1997 review, one study found that 25% of patients experienced at least one discontinuation symptoms, verses 5.9% taking a placebo. In another study of patients with major depression, 42% experienced at least 1 discontinuation symptom.

Another internal memo kept hidden with a protective order, states: “Discontinuation: why this is an issue,” followed by, “’97 Seroxat/Paxil sales to end Sept already exceed $1 Billion”.

This particular memo carries a cartoon-like picture of a big black money-bag.

In Paxil literature, Glaxo flat-out lied to patients and specifically said that the drug was not addictive. For example, a pamphlet made available at doctors’ offices and disseminated to patients, asked the question: “Is Paxil addictive?”

The pamphlet then states: “Paxil has been studied both in short-and long-term use and is not associated with dependence or addiction.”

The withdrawal syndrome is real and in fact, it is now known that infants of women who take SSRIs in the last 3 months of pregnancy, may experience symptoms of withdrawal, including convulsions, according to a study published in the February 4, 2005 issue of the journal Lancet.

In addition, experts warn against the use of Paxil and other SSRIs with children. According to Fred Baughman Jr, MD, an adult and child neurologist in private practice for 35 years, “most antidepressants have not proved effective in treating depression in children and some studies suggest they may cause some children to become acutely suicidal.”

Yet in 2002, Dr Baughman says, “nearly 11 million prescriptions for the drugs were given to children, 2.7 million of them to children under 12.”

A report by an expert witness, previously sealed with a protective order, reveals how Glaxo concealed and manipulated data concerning Paxil-induced suicidality and how suicide attempts in studies by patients on Paxil were underreported and attempts by people taking a placebo were inflated.

Excerpts from the report were published by psychiatrist, Peter Breggin, MD, in Ethical Human Psychology and Psychiatry, (Volume 8, Spring 2006, pp. 77-84). Dr Breggin is a founder of the International Center for the Study of Psychiatry and Psychology (ICSPP) and the author of the Antidepressant Fact Book (2001).

His report also documents how Glaxo hid the incidence of akathisia (agitation with hyperactivity) and stimulation, which he says, are known risk factors for suicidality and violence.

Dr Breggin’s original report was based on a 3-day review of Glaxo’s sealed files, and was written for the California case of Lacuzong v GSK, and attached to a July 21, 2001, affidavit submitted in a case filed by the widow of a man who drowned their two children and himself in a tub after taking Paxil for three days.

At Glaxo’s insistence, the report remained sealed. However, in the more recent case of Moffett v Glaxo, in the US District Court for the South District of Mississippi, the report was filed in the public record.

“The drug companies,” says Dr Breggin, “settle almost all legal cases brought against them in order to seal incriminating scientific data.”

“The publication of a previously sealed medical expert report is a rare event,” he explains, “the first in my experience.”

In the book, The Antidepressant Solution, author Dr Joseph Glenmullen, a clinical instructor in psychiatry at Harvard Medical School, recommends tapering off antidepressants by following a 5-Step Antidepressant Tapering Program, to reduce both the incidence and severity of withdrawal reactions.

“Research has shown that when patients stop antidepressants cold turkey they can have high rates of withdrawal reactions,” Dr Glenmullen advises, “which vary depending on the particular drug.”

“In studies involving hundreds of patients, 66 percent of patients stopping Paxil,” he says, “have withdrawal reactions.”

Filed under: 2006, addict, Glaxo, Paxil, settlement, SSRIs

Fentanyl Deaths – Severe Math Problems at FDA

Evelyn Pringle March 27, 2006

Describing fentanyl as a “very strong narcotic,” on July 15, 2005, the FDA issued a Public Health Advisory regarding the safe use of transdermal fentanyl patches in response to reports of 120 deaths in patients using the patch for pain management, stating that some patients and doctors might not be fully aware of its dangers.

A cursory investigation of drug deaths listed in various databanks around the country indicates a severe math deficiency in officials within the nation’s safety agency because the number of deaths attributed to fentanyl is far larger than the mere 120 cited by the FDA.

For instance, in the year 2004, fentanyl patch abuse was found to be responsible for 115 deaths in Florida alone, according to research conducted by University of Florida toxicologist Dr Bruce Goldberger.

The patches are intended for the relief of chronic pain that requires treatment around the clock and cannot be controlled by other narcotics. The patches contain fentanyl in gel form and can provide up to three days’ relief from severe pain.

The products under scrutiny, include the brand name patch, Duragesic, the generic patch manufactured by Mylan Laboratories, and Sandoz, the generic patch manufactured by the Alza Corporation, the same company that manufactures Duragesic for Johnson & Johnson.

An overdose of fentanyl can put a patient into a coma and shut down breathing. Removing the patch will not reverse the effects because the drug builds up in the patient’s system and can continue to be absorbed from the skin for up to 17 hours or more.

The FDA advisory warns that people wearing the patches may suffer overdoses or other serious side effects if they drink alcohol, have an increase in body temperature or are exposed to heat from sources like hot tubs, saunas, heating pads, electric blankets, heat lamps, or heated water beds.

The FDA says doctors should prescribe the lowest effective dose of the medication, and that patches should not be used to treat short-term pain, or pain after an operation.

According to the Drug Enforcement Agency, fentanyl was first synthesized in Belgium in the late 1950s and has about 80 times the potency of morphine. “The biological effects of the fentanyls are indistinguishable from those of heroin, with the exception that the fentanyls may be hundreds of times more potent,” the DEA’s web site reports.

In the latter part of the1970s, fentanyl began appearing in designer drugs. The term “designer drug” was first coined in California to describe the private synthesis of drug analogs slightly different from their parent compounds, that by design rendered them temporarily immune from control by the DEA.

The fentanyl analogs were first developed and marketed as a substitute for heroin. The most frequently used fentanyl analog was given the street name China White but others were called New Heroin, Tango and Cash, and Goodfella.

Whether it was because of the drug’s strength or its unknown pharmacological properties, users of China White suffered a high number of fatal overdoses, while many people who took New Heroin developed symptoms similar to Parkinson’s disease.

In the late seventies, deaths began to mount in heroin users on the West Coast who had purchased “China White.” The illicit marketing of fentanyl products ultimately caused more than 100 overdose deaths on the West Coast by 1986, according to Designer drugs: past history and future prospects, J Forensic Sci 33:569-575, 1988.

In 1991, the analog Tango and Cash was implicated in at least 28 deaths, primarily in the northeast area of the country. Fentanyl gained widespread attention the same year, when 12 people in New York, Connecticut and New Jersey overdosed and died in a single weekend.

In 1992, China White was determined to be the cause of death in 21 overdoses during a 2-month period in Philadelphia.

Fentanyl gained international notoriety in 2002, when authorities in Moscow, ended a hostage crisis at a theater by pumping an aerosol version of drug into the building, intended to put the nearly 800 hostages and their captors to sleep. In the end, 129 hostages and 41 terrorists died from breathing the gas.

Over the years, not all cases of fentanyl abuse and overdose resulted in death; many more people ended up in hospital emergency rooms. In 1999 alone, there were 337 emergency-room visits related to fentanyl abuse throughout the US, according to estimates from the Drug Awareness Warning Network The network collects information from 500 hospitals across the country and extrapolates the data nationwide.

Overall, emergency room doctors in the US saw the number of overdoses on fentanyl grow from 28 in 1994, to 1,506 in 2002, according to the most recent numbers available from the Federal Substance Abuse and Mental Health Administration.

In many cases it is unknown whether death is due to abuse or misuse. The Florida Department of Law Enforcement records for the 115 deaths in 2004, were not clear about how people obtained the drug, whether by a prescription of their own or from one that had been stolen or otherwise not used according to doctor’s instructions, the UF study said.

In addition to the placement of multiple patches on the body, the study found users devised techniques for the removal of the contents of the drug reservoir for oral, IV or smoked administration.

Sudden deaths are also occurring regularly in other states. The Indiana Poison Center located at Methodist Hospital in Indianapolis, recorded an increase in fentanyl-related deaths from 2002 to 2005. The Center listed 15 fentanyl-abuse cases in 2002, 18 in 2003, 25 in 2004, and 23 in 2005.

The Center also recorded 17 medical misuses of the drug and 38 suicide attempts using the fentanyl patch between 2002 to 2005.

Seven people were found dead in 2005 in the two Indiana countries of Johnson and Shelby due to the abuse or misuse of fentanyl.

Charles Owen McCormick IV, 18, died on May 27, 2005, in his room at his parents’ home Greenwood, Indiana. He had 3 times the lethal dose of fentanyl in his system, the Johnson County Sheriff’s Department said.

Jacqueline Young, 44, died December 15, 2005, in bed at a Greenwood hotel where she was living. She was wearing two fentanyl pain patches and had 3 times the lethal dose in her body at the time of her death. Two heating pads were found in her bed, and heat is known to accelerate fentanyl to a fatal level.

In other Indiana deaths, Anna Layton, 48, and her son Christopher Layton, 28, were found dead on March 21, 2006. Police found Ms Layton dead when they arrived to tell her about her son’s death. Both had eaten and injected fentanyl from patches, the coroner said. Toxicology reports showed Ms Layton had nearly 15 times the lethal dose of fentanyl in her system; and her son had nearly 3 times the lethal dose.

In 2005, Utah statistics from the latest mortality data available from the State Health Department show fentanyl was related to 29 accidental deaths, up from nine in 2004.

In December 2005, surviving family members of two Utah women filed lawsuits against Janssen Pharmaceutica and Alza Corporation, the manufacturer and distributor of the Duragesic skin patch, which the families say leaked and caused the deaths of both women.

Autopsy reports said Gina Danise, 42, and Victoria Price, 56, both died from drug poisoning after using drug pain patches.

A third lawsuit, by the Utah family of Marilyn Titus, 72, who died two years ago, was also filed in December 2005.

The Los Angeles County Coroners Office reports a growing number of accidental over-doses by patients misusing the patch, listing 127 deaths over the last six years, according to a CBC News report on December 20, 2005.

Fentanyl abuse is on the rise among medical professionals who handle the drug. A Florida study showed that while only 5.6% of physicians in Florida were anesthesiologists, nearly 25% of physicians followed for substance abuse/dependence were anesthesiologists. When sorted by drug of choice, anesthesiologists had more fentanyl abuse and dependence than other physicians.

Data from the Florida impaired physicians database allowed researchers to categorize all fentanyl abusing and/ or dependent physicians, and showed 75% were anesthesiologists.

Fentanyl remains a popular street drug today. The DEA Philadelphia Division recently noted that a new prescription fentanyl drug, Actiq, is available on the streets. An Actiq unit consists of a medicated, raspberry-flavored lozenge on a handle and is known on the street as a “Percopop,” likely due to their resemblance to lollipops.

According to the 2005 DEA Pennsylvania Fact Sheet, investigations indicate that diversion of products such as fentanyl patches and Actiq, continues to be a problem. “Primary methods of diversion being reported are illegal sale and distribution by health care professionals and workers, “doctor shopping” (going to a number of doctors to obtain prescriptions for a controlled pharmaceutical), forged prescriptions, and the Internet,” it states.

On May 10, 2005, ABC News reported that a string of overdose deaths and robberies, all linked to fentanyl, raised concerns among police officials in parts of Pennsylvania, New York and Ohio.

All of the deaths occurred when people cut open fentanyl patches and sucked out the drug, “which the Drug Enforcement Administration describes as 50 times stronger than heroin and 80 times more powerful than morphine,” ABC noted.

In most of the cases the fentanyl linked to the overdoses had been taken from a relative of one of the people involved, ABC reported.

On August 15, 2005, NBC News reported that police said fentanyl disguised as heroin had caused multiple overdoses on the West Side of Chicago and had been given away by members of a street gang in order to acquire new customers.

Six months later, on February 6, 2006, Chicago police warned that drug dealers on the South Side might be selling fentanyl as heroin on the city streets.

On February 7, 2006, the Chicago Sun-Times reported from unnamed sources that the drug may be linked to as many as a dozen recent fatal overdoses in a small area of Chicago’s South Side.

The Sun-Times reported on February 11, 2006, that laboratory “tests on some of the fatal overdose victims who Chicago Police suspected may have died last month from a bad batch of heroin indicate the presence of the powerful pain-killer fentanyl.”

At least 10 fatal overdoses are under investigation the Times said.

On February 23, 2006, the Associated Press reported that four Aiken County South Carolina residents had recently died from overdoses of fentanyl. The deaths were caused by people either injecting or inhaling fentanyl after extracting the drug from a patch, according to the County Coroner, Tim Carlton.

Demi Garvin, forensic lab director for the Richland County Sheriff’s Department, told the AP reporter: “We probably get several a month that are related to the drug across South Carolina.”

Its obvious that the FDA needs to conduct a much more thorough investigation when considering whether to allow fentanyl patches to remain on the market. However, its not likely to happen while the FDA officials in charge are joined at the hip to drug companies because the patches are real money-makers for Pharma.

Mylan introduced its generic version of the patch in January 2005 and it accounted for substantially all of the $55 million in revenue the company earned from new products in its fiscal first quarter which ended June 30, 2005.

Worldwide sales of Duragesic in 2005 were $1.59 billion, according to Teresa Gaines, spokeswoman for Johnson & Johnson. The cost of a 30-day supply of patches can range from $348 at Target to $408 at Wal-Mart.

Filed under: 2006, addict, fentanyl, Johnson and Johnson, Mylan, patch, prices, Sandoz

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