Archive for November, 2010

Antipsychotic Drug Seroquel— Diabetes Lawsuits Hurt AstraZeneca Profits

Monday, November 8th, 2010

LawyersandSettlements.com, November 7, 2010

by Heidi Turner

Among Seroquel side effects is a reported increased risk of Seroquel diabetes.   Lawsuits alleging patients suffered serious Seroquel side effects reportedly hurt AstraZeneca’s third-quarter results.

Seroquel Diabetes Lawsuits Hurt AstraZeneca ProfitsAccording to the UK Press Association, AstraZeneca set aside $203 million to resolve approximately 18,000 claims in the US that Seroquel, a schizophrenia treatment, caused diabetes and other serious Seroquel side effects. A further $270 million was reportedly put aside for other claims and to cover AstraZeneca’s legal costs.

In August 2010, AstraZeneca said it settled approximately 17,500 lawsuits alleging Seroquel caused diabetes and other injuries for approximately $200 million. The lawsuits alleged the drug maker failed to adequately warn patients about the drugs’ risks.

Further eroding AstraZeneca’s profits are the effects of generic competition.

According to the San Francisco Chronicle (10/28/10), AstraZeneca reported net income of $1.55 billion in the third quarter, compared with $2.12 billion in the same quarter in 2009. The Wall Street Journal (08/10/10) reports worldwide sales of Seroquel reached almost $5 billion in 2009.

Meanwhile, an advocacy group called Taxpayers Against Fraud Education Fund alleges that the pharmaceutical industry is the number one source of Department of Justice (DOJ) fraud-related settlements. Number one on the list of pharmaceutical companies to settle with the DOJ was Allergan Inc., which paid $600 million to settle allegations of illegal marketing of Botox.

Second on the list was AstraZeneca, which paid approximately $520 million for the alleged illegal marketing of Seroquel.

Marketing of drugs is not illegal. What is illegal is marketing drugs for uses that have not been approved by the US Food and Drug Administration (FDA). Although Seroquel is approved to treat schizophrenia and bipolar disorder, it is not approved for use as a sleep aid, or to treat post-traumatic stress disorder or obsessive-compulsive disorder. It is also not approved for use in children younger than age 10, according to the US FDA-approved medication guide.

A study published online in BMJ (09/22/10) suggests that Seroquel is linked to an increased risk of blood clots. According to the study, of the patients included who were diagnosed with venous thromboembolism (VTE), 8.3 percent had received an antipsychotic medication in the two years prior to diagnosis, compared with 5.3 percent of those not diagnosed with VTE. The highest risk of VTE was found in patients who took quetiapine (known by the brand name Seroquel).

http://www.lawyersandsettlements.com/articles/15347/seroquel-side-effects-diabetes-16.html

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Anti-Anxiety Drugs linked to brain damage 30 years ago

Sunday, November 7th, 2010

MPs and campaigners predict class action after failures to mount full-scale research into warnings left millions of patients at risk

The Independent, November 7, 2010
by Nina Lakhani

There are a growing number of claims against individual doctors for negligent prescribing benzodiazepines

There are a growing number of claims against individual doctors for negligent prescribing benzodiazepines

(note  from CCHR, benzodiazepines are also called anti-anxiety drugs and include Xanax, Klonopin, Ativan, Valium as some of the more well known brand names.)

Secret documents reveal that government-funded experts were warned nearly 30 years ago that tranquillisers that were later prescribed to millions of people could cause brain damage.

The Medical Research Council (MRC) agreed in 1982 that there should be large-scale studies to examine the long-term impact of benzodiazepines after research by a leading psychiatrist showed brain shrinkage in some patients similar to the effects of long-term alcohol abuse.

However, no such work was ever carried out into the effects of drugs such as Valium, Mogadon and Librium – and doctors went on prescribing them to patients for anxiety, stress, insomnia and muscle spasms.

MPs and lawyers described the documents as a scandal, and predicted they could lead the way to a class action costing millions. There are an estimated 1.5 million “involuntary addicts” in the UK, and scores display symptoms consistent with brain damage.

The MRC hosted a meeting of eminent experts and government representatives in 1981 after research by Malcolm Lader, now emeritus professor of the Institute of Psychiatry, showed brain shrinkage occurred in some benzodiazepine patients.

Recommendations to carry out studies to examine long-term problems associated with these drugs, which GPs prescribed more than 20 million times last year, were accepted by the MRC Neurosciences Board in January 1982.

But then the trail goes dead. The documents, which have been seen by The Independent on Sunday and were marked “closed until 2014″, do not make it clear why no work to test Professor Lader’s findings properly was ever funded. The Department of Health has no record of the meeting.

Jim Dobbin, the chairman of the All-Party Parliamentary Group for Involuntary Tranquilliser Addiction, said: “Many victims have lasting physical, cognitive and psychological problems even after they have withdrawn. We are seeking legal advice because we believe these documents are the bombshell they have been waiting for. The MRC must justify why there was no proper follow-up to Professor Lader’s research, no safety committee, no study, nothing to further explore the results. We are talking about a huge scandal here.”

Catherine Hopkins, the legal director of Action against Medical Accidents, added: “The failure to carry out research into the effect of benzodiazepines has exposed huge numbers of people to the risk of brain damage. This research urgently needs to be carried out, and if the results confirm the suspicions of the 1981 expert group, it could lead to one of the biggest group actions for damages against the Government and the MRC ever seen in the courts.”

Initially advertised as completely harmless, benzodiazepines (“benzos”) were touted as the world’s first wonder drug in the 1960s. Within a decade they became the UK’s most commonly used medication.

Current guidelines for doctors say they should be prescribed for a maximum of four weeks. But some people become “involuntarily addicted” within days, unable to stop without withdrawal symptoms such as burning sensations, distorted vision, headaches and even fatal seizures.

Some patients who have taken the pills for months or years have enduring neurological pain, headaches, cognitive impairment and memory loss. But 30 years after the MRC first considered the idea, there is no medical research to confirm whether this is down to drug-induced brain damage or not.

Professor Lader said yesterday: “The results didn’t surprise us because we already knew long-term alcohol use could cause permanent brain changes. There should have been a really good, large-scale study but I was never given the facilities or resources to do it.

“I asked to set up a unit to research benzos but they turned me down… they could have set-up a special safety committee, but they didn’t even do that. I am not going to speculate why; I was grateful for the support they did give me. There were always competing interests for the same resources, so maybe it wasn’t regarded as important enough.”

He repeated the small study and found similar, inconclusive results, but then gave up. “I was getting on with other research and didn’t want to be labelled as the person who just pushed benzos… I should have been more proactive… I assumed the prescribing would peter out, but GPs are still swinging them around like Smarties.”

The MRC has funded around 20 benzodiazepine studies since 1982, mainly in laboratory animals, but the critical questions posed by Professor Lader in 1981 remain unanswered.

Heather Ashton, emeritus professor of clinical psychopharmacology at the University of Newcastle upon Tyne, set up the first NHS withdrawal clinic in 1984. In 1995 she submitted a research proposal to the MRC to investigate the link between long-term benzodiazepine use and permanent brain damage, using sophisticated EEG and MRI scans, and cognitive testing in a randomised control trial. Her proposal was rejected.

There are a growing number of claims against individual doctors for negligent prescribing benzodiazepines. Ray Nimmo, prescribed Valium as a muscle relaxant for stomach pain in 1984, received £40,000 in an out-of-court settlement in 2002 after 12 years of addiction.

In the 1980s 17,000 claimants began a class action against the pharmaceutical manufacturers Roche Products and John Wyeth. Procedural delays, technical motions and escalating costs prevented the cases coming to trial.

A small group attempted to continue unrepresented as litigants in person but failed. The manufacturer’s total costs, £35m, were awarded, but not enforced against one of those final litigants, Michael Behan, who now works for Jim Dobbin MP.

Emma Jones, a solicitor at Leigh Day & Co, said: “We’re aware of earlier litigation against the drug companies which did not succeed. It is interesting that these documents may well have been pertinent at that time. It seems rather strange that such information was kept ‘hidden’ for so long.”

Case study

Valerie Bell, 67 from Surrey, was prescribed lorazepam in 1984 after a panic attack. She weaned herself off in 2007 but still suffers from neurological pains in her head, neck and feet. No brain scan has even been done.

“I was running two florist shops in Essex with my husband; we had a great social life, and life was generally fantastic. On yet another diet, I had a panic attack at a party one night. My doctor said there was a wonderful new drug from the US, so I took it without asking questions. I didn’t feel right straight away. The doctor said it was my illness, increased the dose and added an anti-depressant. This went on for years, new pill after new pill. Some days I couldn’t even get out of bed.

I’ve seen 32 doctors but no one has said it could be the pills; for years I believed these men in white coats and Armani suits. When I decided enough was enough, it took me 15 years to come off: five tapered withdrawals made me loopy, hearing voices, unable even to make tea. No human being should suffer like this. We lost our home and our businesses. The drugs destroyed our lives.”

http://www.independent.co.uk/life-style/health-and-families/health-news/drugs-linked-to-brain-damage-30-years-ago-2127504.html

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EDITORIAL: Why are doctors writing so many prescriptions?

Friday, November 5th, 2010

TuscaloosaNews

November 5, 2010

ALABAMA: No doubt, Robert Bentley’s ‘to do’ list is growing daily as he prepares to become Alabama’s next governor, but we hope he will add this: getting the state’s Medicaid agency to release information on prescriptions written for expensive drugs.

U.S. Sen. Charles Grassley, R-Iowa, has been gathering information from across the nation to see why some doctors are writing stunning numbers of prescriptions that are paid for by taxpayers. Most states have provided this data; Alabama has not.

It is important because, as it turns out, some doctors are writing far more prescriptions for psychiatric drugs than are their colleagues. Not only does this add to the strain on Medicaid and Medicare, but it may indicate that some patients are being over-medicated.

Grassley, a member of the Senate Finance Committee, wrote to state Medicaid agencies earlier this year, asking them to list their top 10 prescribers of eight drugs commonly used in psychiatry. It may be that these doctors have good reasons for writing the most prescriptions for these drugs, such as OxyContin and Xanax, but it might also point out instances of overuse or even fraud.

In Florida, for example, one physician wrote 96,685 prescriptions for mental health drugs over a 21-month period. That works out to more than 150 prescriptions a day, seven days a week, for nearly two years.

Alabama refused to provide the senator with the information he requested. The response was that this information might be misinterpreted and these doctors may have

legitimate reasons for writing so many scrips.

Indeed, but the best way to provide an explanation is with more information, not less. If these doctors are asking the public to pay for these drugs, there should be some public accountability.

(Note from CCHR Int: Yep…)

Read the rest of the article here:  http://www.tuscaloosanews.com/article/20101105/NEWS/101109818/1012?p=2&tc=pg

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Antidepressant Drugs Are Not Safe During Pregnancy—No Matter What the Pharma Shills Say

Thursday, November 4th, 2010

by CCHR International

November 4, 2010

Medical News Today published an article entitled “Increased Depression Screening Needed During Pregnancy, Study Says,” that is so highly misleading,  we wonder if they ever bother checking the validity of what they’re forwarding under the guise of “medical news.”

We’re going to make this really simple—the study and its findings are bogus not to mention highly misleading and we’re only going to take up the two most egregious “facts” of the article to make our point.

The article states, “The authors of the study say their findings suggest that screening for depression should be a routine part of prenatal and postnatal care.  They conducted a 10-week pilot project at WIC clinics in Santa Fe and Las Vegas, N.M., finding that 109 of 467 women who were screened had a high enough score on the Edinburgh Postnatal Depression Scale to require a referral.”

FACT: The Edinburgh Postnatal Depression Scalealso called EPDS, is a screening method documented to triple the number of women diagnosed with Post partum depression, according to a study published in Obstecrics & Gynecology. The Scandinavian Journal of Public Health stated that EPDS screening was so unethical it should not be used.

So the authors are knowingly promoting a study which is known to triple the amount of women diagnosed postpartum depression,  has been called so unethical it should not be used.

Next, the article states, “There are antidepressants that are safe to take during pregnancy”

False.

FACT: Four countries have done nine studies on the effects of antidepressants during pregnancy or breast feeding.  They found that newer and older antidepressants can cause premature births, and increase the risk of cardiovascular interventions such as heart surgery in early childhood.  In addition, newer antidepressants could also cause withdrawal symptoms, respiratory problems, and neurological problems.

Six counties have issued a total of 15 drug regulatory warnings on antidepressants causing severe problems for newborns.

They warn of:

  • Newer antidepressants causing seizures,
  • Wellbutrin, Cipralex, Luvox, Remeron, Effexor and Zyban increasing the risk of a life-threatening lung condition in newborns,
  • Zoloft and Celexa causing withdrawal symptoms and increasing the risk of a life-threatening lung condition in newborns,
  • Paxil and Prozac causing withdrawal symptoms and increasing the risk of cardiovascular birth defects and a life-threatening lung condition in newborns

Like we said, the article and the “findings” are highly misleading to say the least.

We’d also like to suggest something to any press forwarding these psycho/pharma puff pieces— Its called Google Search.   Its pretty easy these days to check the facts before promoting bogus studies and or “findings”  that are not only false, but can harm pregnant women and can give false information under the guise of “medical news.”   We also recommend that anyone reporting on psychiatric drugs at least check  our psychiatric drug database to see what international drug regulatory agencies and international studies have warned about these drugs instead of just regurgitating the latest pro drug study http://www.cchrint.org/psychdrugdangers/

Here is  a very short video of what can happen to pregnant women when they are not given the facts about these drugs:

In Memory of Matthew Schultz / Effexor Baby Pregnancy Infant Death

http://www.youtube.com/watch?v=qnxuw2ufSug&p=7F22F2C419977E5A&playnext=1&index=70

And finally, the “Medical News” article:

Increased Depression Screening Needed During Pregnancy, Study Says

Medical News Today

Twenty-three percent of pregnant women screened at two Women, Infant and Children clinics in New Mexico met criteria for depression, according to a study by a work group of the New Mexico Health Department and state Human Services Department, the Albuquerque Journal reports.

Nationwide, 10% to 16% of pregnant women meet the criteria for depression, and 70% show some depressive symptoms, according to the American College of Obstetrics and Gynecologists.  In June, ACOG said that screening of pregnant women for depression should be “strongly considered” but that there is not enough evidence to recommend it.

The authors of the new study say their findings suggest that screening for depression should be a routine part of prenatal and postnatal care. They conducted a 10-week pilot project at WIC clinics in Santa Fe and Las Vegas, N.M., finding that 109 of 467 women who were screened had a high enough score on the Edinburgh Postnatal Depression Scale to require a referral. The work group recommended increased training on depression screening tools for providers and more support groups for women, in both English and Spanish.

Signs of depression in pregnant women include feeling dread about the pregnancy, anxiety, isolation from loved ones, suicidal thoughts, self-harm, constant sadness, changes in appetite and lack of ability to experience pleasure, according to therapist Stefanie Luna. Doctors say leaving severe depression untreated could increase the risk for low birthweight or premature birth. When women are depressed they also are less likely to care for themselves and more likely to drink or smoke. There are antidepressants that are safe to take during pregnancy (Schoenberg, Albuquerque Journal, 11/1).

http://www.medicalnewstoday.com/articles/206701.php

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Psychiatric Torture in China: One Child Policy Victim “Treated” with Electroshock, Injections

Wednesday, November 3rd, 2010

NewsBlaze, November 3, 2010

by Reggie Littlejohn

Gu Xianghong languishes in an “Ankang,” a special Chinese psychiatric hospital run by police, Radio Free Asia reports. In a video quoted by RFA, Gu says, “They put electrodes on my temples and they were burned black. They handcuffed me and chained my feet . . . My [entire family] and home have been ruined by the village government.” They also subjected her to injections against her will. According to the report, Gu has been jailed nine times in the Ankang since 1992.

Leaders of a Hubei-based human rights group, Civil Rights and Livelihood Watch, videotaped Gu from inside the Ankang and smuggled the video to Radio Free Asia. The Rights group is mounting a campaign called “Mental Hospitals SOS,” to call attention to official psychiatric abuse in China.

Why has Gu repeatedly been jailed and tortured in an Ankang? She sued the local government over “family planning issues.”

This is another example of the fact that the coercive enforcement of China’s One Child Policy causes more violence against women and girls than any other official policy on earth. This violence takes the form of forced abortion, forced sterilization, infanticide, gendercide, sexual slavery and female suicide. Now add to this grim list: psychiatric torture for those who dare to challenge family planning abuses.

Gu is not the first person the Chinese Communist Party has jailed to silence them on family planning abuses. Blind activist and Nobel Peace Prize nominee Chen Guangcheng exposed the fact that there were 130,000 forced abortions and sterilizations in Linyi County, Shandong Province, in 2005. For this, he served a four year, three month jail sentence, during which time he was severely beaten and denied medical treatment. He now remains under house arrest. To read a dozen expert reports documenting atrocities committed in the name of the One Child Policy, submitted in connection with the Congressional hearing on the One Child Policy of November 10, 2009, click here: http://www.womensrightswithoutfrontiers.org/index.php?nav=congressional

According to reports by Human Rights Watch and others, in China, psychiatric abuse is shockingly common against dissidents, who are jailed and silenced under the guise of psychiatric treatment. In one well-known case, Wang Wanxing was held in an Ankang for 13 years, for staging a brief, one-man pro-democracy protest on Tiananmen Square on the third anniversary of the massacre there. He was released unexpectedly in 2005 and sent to Germany, where he was evaluated by a team of psychiatric experts, who found no mental disorder. Wang told Human Rights Watch about the conditions he had endured. He stated, for example, that he had been forced to watch staff members administer “electric acupuncture treatments” in which the current used was excruciating. One inmate died of a heart attack during such a “treatment.”

According to a recent Epoch Times article, the Falun Gong Human Rights Working Group submitted a report to the United Nations, setting forth 1088 cases of psychiatric torture used against Falun Gong practitioners.

Meanwhile, like countless others deemed to be destabilizing influences by the Chinese Communist Party, Gu remains imprisoned in a psychiatric torture chamber. The brave Chinese human rights defenders who brought her case to the world are themselves victimized by local officials, who chased them as they escaped the Ankang with Gu’s videotape.

Gu should be released, immediately, along with all others trapped in Ankangs all over China, not because they have mental health issues, but simply to silence or break them. Psychiatric abuse of One Child Policy victims, and of all others that the Chinese Communist Party views as a political threat, must stop.

Read the rest of the article here:

Read CCHR’s Mental Health Declaration of Human Rights, here http://www.cchrint.org/about-us/declaration-of-human-rights/

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Forrest Labs “quietly” settling antidepressant liability lawsuits? Not so fast…..

Tuesday, November 2nd, 2010

Note from CCHR: Yesterday we posted an article from the St. Louis Post Dispatch regarding Forrest Laboratories quietly settling a slew of lawsuits with parents who claim the antidepressant drugs Celexa and Lexapro caused their children to become suicidal/violent.   Our question is this:  Why is this story remaining quiet?  Are the press not aware that 10 of the recent school shooters were under the influence of psychiatric drugs?  That Columbine ringleader Eric Harris was on the antidepressant Luvox? Or that Red Lake Minnesota school shooter was on Prozac, as was Springfield Oregon shooter Kip Kinkel?  And those are only the cases where toxicology reports were made public.  The FDA admits these drugs  can cause mania, psychosis, violence, and in the case of the antidepressant Effexor, “homicidal ideation.”  So we think the press should pay a bit more attention to this “quiet” story of a drug company settling lawsuits as they relate to acts of violence. To quote the Post Dispatch,   “In vivid detail, the complaints allege that children under the influence of Celexa and Lexapro committed acts of suicide and violence.  And the victims’ families accuse the pharmaceutical company of fraud and negligence in failing to warn physicians and the public about the drugs’ known dangers.” So again, we ask…why is this story remaining quiet?

See Fox News report from Douglas Kennedy, Deadly Drugs http://www.youtube.com/watch?v=9S-7aNPf33A Read the international drug regulatory warnings/studies here: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

FiercePharma,  November 2, 2010

by Tracy Staton

Forest Laboratories ($FRX) is quietly settling liability lawsuits over its antidepressant drugs Celexa and Lexapro, which parents claim caused their children to either attempt or commit suicide. According to the St. Louis Post-Dispatch, four lawsuits were settled Friday, with two more settled in recent weeks. The company faced a total of 54 suits with similar claims, all consolidated in St. Louis federal court.

More settlements are expected in the coming months, the newspaper reports, as Forest attempts to wrap up its legal troubles with Celexa and Lexapro. The settlement amounts aren’t public, but analysts don’t expect the litigation to have much effect on the company’s finances.

Just last month, the company agreed to pay $300 million to settle off-label marketing charges with the U.S. Attorney’s office in Boston. A company subsidiary pleaded guilty to criminal charges related to marketing the antidepressants for pediatric use, which wasn’t approved by the FDA.

- read the Post-Dispatch story

http://www.fiercepharma.com/story/forest-settles-antidepressant-liability-suits/2010-11-02

Also see CCHR’s mini-documentary Prescription for Violence,  here http://www.cchr.org/videos/psychiatrys-prescription-for-violence.html

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Psychiatric Hospital staff ‘puzzled’ by teenager’s fatal overdose—maybe they should brush up on their drug warnings

Tuesday, November 2nd, 2010

Note from CCHR:  This is pure negligence.  A teenager who was under psychiatric “care” was  found dead with two antipsychotic drugs in his system.  The consulting psychiatrist says he is “puzzled” about his death and that they have “no explanation at all.”  Really.   Perhaps the good doctor should brush up on the international drug regulatory warnings for the drugs they are prescribing.    CCHR’s psychiatric drug database contains 24 international drug regulatory warnings on Antipsychotic drugs, and 49 international studies citing side effects including diabetes, obesity, blood clots, heart problems,  cardiac events,  cancer, tumors, death/sudden death. Moreover, if as the psychiatrist claims,  this teenager was found to have two antipsychotics in his system, only one of which was prescribed (so they say) then obviously the psychiatric hospital staff is beyond negligent if in fact a teen already under the influence of mind-altering drugs, was able to get his hands on and ingest another psychiatric drug unbeknown to any of the staff.

A teenager with schizophrenia was found dead in a psychiatric hospital with a cocktail of drugs in his bloodstream, an inquest heard.

Patrick Bennett was discovered in his bed by a shocked nurse at Fulbourn Hospital, and a post-mortem revealed he had taken two anti-psychotic drugs – only one of which he had been prescribed – and paracetamol.

But doctors told an inquest in Huntindon they had no idea how the 19-year-old obtained them, and that he was too mentally ill to have planned and carried out a suicide.

Sue Lancaster, a staff nurse at the hospital, spoke of the moment she found the body of Mr Bennett, of Pound Lane, Kimbolton, on the morning of August 12, 2009.

She said: “It was then I saw his face and knew he was dead. His face still haunts me.”

Fellow nurse Margaret Molina said she was “certain” she had given Mr Bennett the correct dosage of 4.5ml of clozapine, an anti-psychotic drug, on the night before his death.

When asked about his behaviour, she added: “He didn’t seem clearly anxious or upset in any way, he just seemed bewildered.”

Dr Emilio Fernandez, a consultant psychiatrist who had assessed Mr Bennett, said he had “severe impairment in many daily activities”.

He told the inquest doctors suspected Mr Bennett had been hiding tablets in his mouth, so he was switched to a liquid form of clozapine.

He said this switch made his behaviour “more warm”, and he was transferred to a different ward days before his death.

Dr Fernandez described Mr Bennett as “one of the most severe cases I have ever seen in my life” who would not have had the “ability to plan or carry out any suicide attempt”.

He added: “We are all very puzzled about this, we have no explanation at all.”

Search international warnings and studies on antipsychotic and other psychiatric drugs here: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

Search for deaths reported to the US FDA from antipsychotic drugs here http://www.cchrint.org/psychdrugdangers/medwatch_psych_drug_adverse_reactions.php

Read the rest of the article here:  http://www.cambridge-news.co.uk/Home/Hospital-staff-puzzled-by-teenagers-fatal-overdose.htm

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Antidepressant Found ‘Ineffective and Potentially Harmful’

Monday, November 1st, 2010

The Epoch Times, November 1, 2010

by Dr. John Briffa

CLOSET SKELETONS: Of all the drug trials that have been done, how many more skeletons in the closet are there? (Photos.com)

If we wanted to find out if a drug or another treatment were any good, we would have to conduct some randomized controlled trials. This means individuals are randomly assigned to the drug being tested, a placebo, or another drug.

Neither the researchers nor the study participants know what’s being taken. Symptoms or other markers of health are monitored as well as side effects. After a period of time, the code is cracked, and we can learn who was taking what.

Now we can know if the drug being tested was more effective at helping people than the placebo and how safe it is. A few studies showing favorable results will usually get a drug passed as “fit for purpose.” This is how drugs end up getting licenses so that doctors can prescribe them to their patients.

Not so fast. While some (often the manufacturers) claim that there is a lot of research supporting a drug, it can sometimes be the case that the published research does not tell the full story.

Sometimes there exists other research that is not so supportive of the drug being tested—research that may not have seen the light of day. Drug companies want to publish supportive studies and shelve more-negative findings. There is an expression for this practice—publication bias.

Publication bias has gone on for decades but only relatively recently have some members of the scientific community taken steps to stamp it out. One huge step forward has been a decision in the United States for trials to be registered on a central database before or during a trial. That way the study has been logged, and if the results mysteriously fail to appear, then questions can be asked.

Not so long ago, trial results had to be forced out of the drug companies making the cholesterol-reducing agents simvastatin and ezetimibe. It took two years for the manufacturers to cough up their data after the conclusion of the study. Once the data came out, we learned why: This drug combo didn’t work to reduce signs of cardiovascular disease.

Subsequent studies have also proved negative. Not that long ago, such data would have been easily hidden, even from prying eyes. These days, drug companies don’t have things so easy.

Things are better now than they were. Now a natural question to ask is how many drugs earned their stripes based on publication bias? Some principled researchers are keen to answer this question by reassessing drugs using not only published data but also unpublished data.

An example of such a piece of work appeared online on Oct. 12 in the British Medical Journal. German researchers decided to assess unpublished and published data on the anti-depressant reboxetine, a relatively new type of antidepressant.

Reboxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI). This means it helps maintain brain levels of the chemical norepinephrine, which is believed to enhance mood. It is similar to the more commonly prescribed anti-depressants known as the selective serotonin reuptake inhibitors or SSRIs.

Previously published evidence showed that reboxetine was more effective in treating depression than placebo and was about as effective as the commonly prescribed SSRIs. It’s been licensed for use for depression in many European countries, including the U.K. and Germany, since 1997.

The researchers found that almost three-quarters of data on reboxetine was unpublished. This is disquieting in itself. And when they put this data into the mix, an altogether different picture emerged. When the totality of the evidence was assessed, it turns out that reboxetine was no better than placebo. Most researchers would summarize this by concluding that it doesn’t work.

Perhaps not surprisingly, reboxetine turns out to cause more harm than placebo and more adverse effects than the most-commonly prescribed SSRI (fluoxetine). The authors conclude that reboxetine is “an ineffective and potentially harmful antidepressant.” Yet here in Europe, it’s been licensed for more than a decade.

The authors of this re-analysis mention that here in the U.K., the National Institute of Health and Clinical Excellence (NICE) describes reboxetine as “superior to placebo and as effective as other antidepressants in the treatment of depression.” As the authors point out, “This conclusion can no longer be upheld.”

It is interesting to note that in the United States, reboxetine was originally licensed, but then its license was revoked. While it appears the U.S. authorities made the right decision, the discrepancy with some European countries suggest that the U.S. authorities had more data to go on or perhaps set different licensing criteria.

Such discrepancies and this flagrant example of publication bias do not instill confidence.

The good news is that at least some researchers are not content to do what paymasters in industry tell them to and genuinely appear to be seekers of the truth. I’d say we could expect many more skeletons to emerge from the closet over the coming years.

http://www.theepochtimes.com/n2/content/view/45212/

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Forest Labs settling wrongful death & personal injury lawsuits from parents of kids who took Celexa & Lexapro

Monday, November 1st, 2010

Stltoday.com

by Jim Doyle

A month after its Earth City subsidiary pleaded guilty of illegally marketing antidepressants to children and adolescents, Forest Laboratories is now settling a string of wrongful death and personal injury lawsuits from the parents of children who took the drugs Celexa and Lexapro.

Fifty-four lawsuits, mostly involving suicides and attempted suicides by teenagers in various parts of the country, accuse the New York-based pharmaceutical company of concealing a negative pediatric study on Celexa, duping physicians about the drug’s clinical trials, and targeting children in aggressive promotions of Celexa and a sister drug, Lexapro.

Four of the cases were settled Friday, and two additional cases were settled in recent weeks.

A surge of related settlements, which could total millions of dollars, is expected in the months ahead as the pharmaceutical company attempts to move beyond the controversy surrounding its marketing of antidepressants to children.

Last month, the company’s subsidiary — Forest Pharmaceuticals, based in Earth City — agreed to plead guilty to criminal charges involving its marketing and manufacturing practices and also to pay more than $300 million in criminal and civil penalties. The U.S. attorney’s office in Boston is continuing to investigate the potential criminal liability of Forest officers and employees.

According to federal regulators, Forest waged an aggressive campaign from 1999 through at least 2005 to promote the use of Celexa and Lexapro in children and teenagers, although neither drug was approved for pediatric use.

Details of Forest Laboratories’ monetary settlements with aggrieved families have not been made public, but the lawsuits themselves present a glimpse of the alleged harm caused by the company, including hefty payments to pediatricians and other physicians to tout the benefits of the drugs.

In vivid detail, the complaints allege that children under the influence of Celexa and Lexapro committed acts of suicide and violence. And the victims’ families accuse the pharmaceutical company of fraud and negligence in failing to warn physicians and the public about the drugs’ known dangers.

But the settlements are cloaked in secrecy, with each side vowing not to disclose the dollar amounts paid or other aspects of their agreements.

Frank Murdolo, the chief spokesman for Forest Laboratories, was unavailable for comment.

Harris Pogust, a Pennsylvania attorney who is the plaintiffs’ lead counsel in the multidistrict litigation, said, “I can’t really discuss anything that’s going on between the parties.”

The Celexa and Lexapro cases have been consolidated in federal court in St. Louis.

Several years ago, some of Pogust’s clients testified before Congress and the Food and Drug Administration about the dangers of marketing the drugs to children.

One of the cases settled Friday involves Andrew Tradd of Massachusetts, who was 13 when he tried to hang himself in April 2004. Seven days later, he died as a result of a brain injury suffered in that attempted suicide. He had been prescribed Celexa in 2002.

According to his family’s lawsuit, Forest was aware through numerous studies that some patients taking Celexa and similar drugs were much more at risk of suicidal behavior but chose not to warn physicians or strengthen the warning on the drug’s packaging.

Celexa’s sales skyrocketed from $92 million in 1999 to $1.6 billion in 2002. But the firm was under pressure to sell as much of Celexa as possible because the U.S. patent on the drug would expire in 2004.

H. Lundbeck, a Danish firm that developed Celexa, had placed a suicide warning on the drug in Europe for many years but not in the United States — until a “black box” warning was mandated for Celexa and similar drugs in 2004 by the FDA.

The Tradd lawsuit and another suit quote Howard Solomon, the chairman and chief executive of Forest Laboratories, as saying in a letter to shareholders, “We believe that the studies and experience with our products, Lexapro and Celexa, do not indicate any increased suicidality.”

But the Tradd family alleged that “contrary to these claims, for years Forest Laboratories Inc., was aware of clinical trials that showed that some persons who took Celexa suffered damaging side affects including agitation, aggressive and suicidal tendencies.”

Another settled case involves Rachel Weiss of Belchertown, Mass., who was 16 in November 2002 when she suffered a panic attack while at school. En route to the school nurse’s office, her suit alleges, Rachel threw herself down concrete and metal stairs, causing permanent injuries to her back and spine.

A high school sophomore, she had been taking Celexa for about nine days for depression and anxiety. After she began taking Celexa, the suit alleges, “her symptoms worsened dramatically.”

In 2002, a four-year clinical trial by the Danish Lundbeck firm revealed that Celexa did not help depressed adolescents more than a placebo. But the results were not made public until 2004, when they appeared on a single line of a chart contained in a Danish textbook, the suit alleges.

The U.S. attorney’s office in Boston has asserted that the results of the Lundbeck trial had been provided to Forest two years earlier, but the company chose to keep the negative results hidden from the public.

Another settled case involved Danielle Henrikson, who was 15 when she hanged herself in the garage of her parents’ Idaho home in July 2004. Within a few weeks after taking Celexa, their lawsuit alleges, her condition began to deteriorate.

“The company suppressed the negative results of some studies, which showed that Celexa could cause an increased risk of suicidal thinking and acts in those adolescents who were prescribed to it,” the suit alleges.

Forest Laboratories denied the allegation in court documents.

A case settled Friday was on behalf of Alex Kim of Gwinnett County, Ga., who hanged himself in June 2004 when he was 13 after his Lexapro dosage had been doubled. He had been taking the drug for about three months.

In their lawsuit, Alex’s parents asked for $10 million in general damages, plus $10 million in punitive damages from Forest for “failing to provide information regarding serious health risks, failing to publicize the risks, failing to timely alert the public, and failing to recall the product.”

Read the rest of the article here: http://www.stltoday.com/business/article_c569f2c4-58a7-5432-a939-ff22e90583e5.html

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US Soldiers’ Suicides Caused by Prescription Drugs?

Monday, November 1st, 2010

The Epoch Times, November 1, 2010

by Martha Rosenberg

The suicide rate among U.S. troops is astonishing.

In 2009 there were 239 suicides within the Army, including the Reserves, 160 active duty suicides, 146 active duty deaths from drug overdoses and high-risk behavior, and 1,713 suicide attempts, says the Army’s suicide report released in July.

More troops are dying from their own hands than in combat, says the Army report, titled “Health Promotion, Risk Reduction, and Suicide Prevention.” Thirty-six percent of the suicides were among troops who were never deployed.

Also astonishing is the psychoactive prescription drug rate among active duty-aged troops, aged 18 to 34, which is up 85 percent since 2003, according to the military health plan, Tricare. Including family prescriptions, since 2001, 73,103 prescriptions for Zoloft have been dispensed, 38,199 for Prozac, 17,830 for Paxil, and 12,047 for Cymbalta. All of the drugs carry a suicide-warning label.

In addition to the spike in SSRI antidepressant prescriptions, prescriptions for the anticonvulsants Topamax and Neurontin rose 56 percent in the same group since 2005, says Navy Times. The FDA warned last year that taking these drugs doubles suicidal thinking.

In fact, 4,994 troops at Fort Bragg, N.C., are on antidepressants right now, says the Fayetteville Observer. Six hundred and sixty-four are on an antipsychotic and “many soldiers take more than one type of medication.”

Troops may also be taking Chantix, an antismoking drug so linked to violence and self-harm that Secretary of Veterans Affairs James Peake was forced to defend its use before the House Committee on Veterans Affairs in 2008 even in drug trials. Related Articles

“If you know the drug induces suicidal thoughts,” an unappeased committee chair Bob Filner, D-Calif., asked Rep. Filner, “Why don’t you just stop [prescribing it]?”

The FDA says that even widely prescribed asthma drugs like Singulair and Advair are linked to suicide and have been cited in young people’s deaths.

Who knows what happens when the drugs are mixed with mood stabilizers, insomnia meds, pain pills, anti-anxiety drugs, and antipsychotic pills? These drug combinations have never been tested for safety.

Links between suicide and even murder-suicide and selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI) antidepressants have been long recognized.

Traci Johnson, a healthy 19-year-old with no mental problems, hung herself during Lilly trials of Cymbalta in the drugmaker’s own clinic in 2004. Columbine shooter Eric Harris had reportedly just switched from Zoloft to Luvox.

Red Lake shooter Jeff Weise who killed 10 on a Minnesota Native American reservation in 2005 had just upped his Prozac dose. And the Virginia Tech shooter, Cho Seung-Hui, was also on psychoactive medications, say news reports.

Even though Americans have doubled their antidepressants since 1999 so that 10 percent of the population or 27 million now take them, suicides have climbed by 5 percent since 1999 and 16 percent in middle-aged adults, says an article in the American Journal of Preventive Medicine in 2008.

In fact, the high percentage of civilian suicides on psychoactive drugs is probably the clearest indication that military life is not the only cause of the shocking troop suicides.

In September alone, there were 18 civilian suicides, 11 murders, 2 murder-suicides, and other violence linked to people who were using or had used antidepressants, according to published reports. (Ssristories.com/index.php?sort=what&p=recent)

A 54-year-old patient with a breathing tube and an oxygen tank and no previous criminal record held up a bank in Mobile, Ala. She had gone off her antidepressants.

An enraged man in Australia, also off his antidepressants, chased his mailman and threatened to cut his throat for bringing him junk mail.

A 58-year-old Amarillo, Texas, man with no criminal history tried to abduct three people, killing an Oklahoma grandmother in the process. He had “an antidepressant in his blood,” said police.

Also in the 30-day period, a 60-year-old grandmother in Seattle killed three family members and herself; a disc jockey in Bristol, U.K., set himself on fire; and a man in Exeter, U.K., was found to have stabbed himself in the heart. All were on antidepressants.

Finally, in the month of September, legal proceedings began against two mothers and a father charged with killing their own children.

Over 4,000 published reports of violent and bizarre behavior of people affected by antidepressants on the Web archive ssristories.com reveal the same out-of-character violence and self-harm in civilians that is currently seen in the military.

Twenty people set themselves on fire. Ten bit their victims (including a biter who was sleepwalking and a woman, on Prozac, who bit her 87-year-old mother into a critical condition.) Three men in the 70s and 80s attacked their wives with hammers.

Many stabbed their victims obsessively—one even stabbed furniture after killing his wife—and 14 parents drowned their children, a crime seldom heard of before the 2001 Andrea Yates case. Yates, who drowned her five children, was on the antidepressant Effexor, which manufacturer Wyeth (now Pfizer) “issued no public warning” about [the possibility of violent behavior], says the Associated Press.

Then there was the North Carolina pilot on Zoloft who sang “I’m going down for the last time” into the cockpit voice recorder before he crashed his plane in June. And the mayor of Coppell, Texas, Jayne Peters, who killed herself and her daughter in July over the grief of losing her husband. Police found antidepressants at the home.

Such murder-suicides committed by women used to be rare, says Betty Henderson the ssristories.com moderator and researcher. “Before the SSRI antidepressants, women committed 5 percent of the murder-suicides, and now they account for almost 15 percent of this type of violence,” she said in an interview.

Antidepressants are also causing women to become sexual predators, says Henderson. “There have been more than a dozen recent cases of women school teachers molesting their young students under the influence or withdrawal of antidepressants. Who heard of this type of sexual aberration before the antidepressant craze?”

Why don’t doctors and media outlets publicize the names of these volatile drugs?

“It’s a good question,” said Dr. Gary Kohls, a Minnesota family practitioner, in an op-ed written after Iraq veteran Matthew Magdzas killed his pregnant wife, their 13-month-old daughter, their dogs, and himself in Wisconsin in August.

“Nobody in the media has, to my knowledge, had the courage to report what the drugs were, nor have they interviewed the physician or his clinic to find out the rationale for prescribing drugs that have common violence-inducing effects (with black box warnings stating that in the prescribing information),” he writes. “Therefore nothing has been learned from this important teachable moment, probably because revealing the common reality of prescription drug-induced violence would be economically harmful for the sacred cows of Big Pharma and Big Medicine.”

Sen. Jim Webb, D-Va., called the fact that one of every six troops are now on psychoactive drugs “pretty astounding and also very troubling,” in Senate hearings this year.

Retired Col. Bart Billings, a former Army psychologist who has also testified before Congress, says, “I feel flat-out that psychiatrists are directly responsible for deaths in our military, for some of these suicides,” in a March Marine Times article. “I think it’s criminal, what they are doing.”

Even Katie Bagosy, the wife of Marine Sgt. Tom Bagosy, who took his own life in May, indicts the Neurontin medication he was prescribed for his downfall.

“He told me, ‘It all started to get worse when I got on this medication.’ Looking back, that was the beginning of the end,” she says in an article called “A Prescription for Tragedy” in the current National Journal.

http://www.theepochtimes.com/n2/content/view/45181/

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