Posts Tagged ‘Drug companies’

The Over-Prescribing of Psychoactive Drugs to Children: A Scourge of Our Times

Wednesday, September 1st, 2010

The Huffington Post

September 1, 2010

by Dr. Ronald Ricker and Dr. Venus Nicolino

Today, the administration of psychoactive drugs to children (6-17) is all too common and growing at an alarming rate. These drugs often cause the opposite of the intended effect, often condemning children to a life of misery and ill health. The prescription of these drugs is said to treat “chemical imbalances” which were said to cause ADHD, Depression and Bi-polar disorder. It turns out, however, that what we were calling “disease-causing chemical imbalances,” is simply incorrect . The sad irony is, the inappropriate use of these medications is in fact creating different chemical imbalances, which do cause mental disorders, many of which are both life-long and debilitating.

Furthermore, it is now clear that often we are diagnosing ordinary childhood and adolescent behavior as mental disorders (Wait, children are supposed to be bursting with energy? It’s normal for a teenager to be moody and aloof?). This diagnosing is not only based on this idea of “chemical imbalances,” but also a general and pervasive notion that every non-acceptable behavior is due to a mental illness. And last, but certainly not least, the prescribing of these medications by doctors is based on the disinformation provided them by the FDA, drug manufactures and often fraudulent studies, all in the name of making money, on the backs of our children.

In a recent lecture, respected journalist, writer and Nobel Prize Nominee, Robert Whitaker (PBS, Boston, June 15, 2010) highlighted not only the appallingly unscientific methodology used in the development, prescription and use of psychotropic drugs in school-aged children, but also how hopelessly corrupt and failed the systems that should be regulating the safety of medicines are in this country.

Unfortunately, many drug companies exist for one reason: to make money. As such, the people who run these companies have developed a worldview bereft of any more notion of ethics or morality than British Petroleum. Some drug companies’ success is not based on a drug’s usefulness or the safety of its products, but whether it makes money. The path to more money is simple: find new uses for their old drugs, invent new drugs and find new markets for both new and old drugs. Unfortunately, children are today’s newest market.

The FDA requires a “Successful Drug Trial” to approve new medications. “Trial” is often a misnomer, as the word implies some notion of impartiality and unknown outcome. These “trials” often are more like kangaroo courts. In one “trial,” in this case to prove the usefulness of Prozac, corruption and dishonesty were the rule. Children who responded to placebos were removed from the data, as were negative responders to the actual drug. This meant that the only children who were left in the study group were so-called “positive responders.” And, even then, the researchers and doctors, whose “research” funding was provided by the makers of Prozac, were the very ones to decide which subjects, if any, actually did respond “positively” to the drug. This, of course, is a massive conflict of interest. The doctors, researchers and drug companies all want the same thing — FDA approval and to make more money.

In a 2004 article published in perhaps the most prestigious British medical journal, Lancet, said the trial studies used to provide proof of the usefulness of anti-depressant drugs in children, were “nothing but fraudulent.” Following that assessment, all anti-depressants but Prozac were banned in the UK for use on children. (The fact that Prozac was not banned was based on very dubious, some say dishonest, research as documented above).

The true damage caused by the use of anti-depressant drugs like Paxil, Zoloft, Prozac, etc. (AKA of SSRI’s: Selective serotonin reuptake inhibitors) by school-aged children is only found by legitimate, longer studies, like those that continued from 17 months to six years. In one study, 25 percent of children who had been on SSRI’s for three years were re-diagnosed with the much more serious disorder of Bi-polar disease. This number increased to 50 percent after six years of SSRI use. Long-term use of new anti-psychotics may lead to even greater problems than the initial disease. Diabetes, morbid obesity and early death have all been linked to the use of these drugs. And, as written by us in a previous blog both short and long term use of stimulant drugs such as Adderall), have numerous serious side effects.

Read the rest of this article here: http://www.huffingtonpost.com/dr-ronald-ricker-and-dr-venus-nicolino/the-prescribing-of-psycho_b_665838.html

Note: To view all international drug regulatory warnings and studies on psychiatric drugs including those issued specifically for children,visit CCHR’s psychiatric drug search engine here: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

Also see this video – Drugging Our Children: Side Effects – http://www.cchrint.org/videos/

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New Review of FDA antidepressant drug trials suggests antidepressants only “marginally better” than placebo – Ineffectiveness of antidepressants called “jaw-dropping”

Tuesday, August 24th, 2010

Medscape
By Deborah Brauser
August 24, 2010

A new review of 4 meta-analyses of efficacy trials submitted to the US Food and Drug Administration (FDA) suggests that antidepressants are only “marginally efficacious” compared with placebo and “document profound publication bias that inflates their apparent efficacy.”

In addition, when the researchers also analyzed the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial, “the largest antidepressant effectiveness trial ever conducted,” they found that “the effectiveness of antidepressant therapies was probably even lower than the modest one reported…with an apparent progressively increasing dropout rate across each study phase.

“We found that out of the 4041 patients initially started on the SSRI [selective serotonin reuptake inhibitor] citalopram in the STAR*D study, and after 4 trials, only 108 patients had a remission and did not either have a relapse and/or dropped out by the end of 12 months of continuing care,” lead study author Ed Pigott, PhD, a psychologist with NeuroAdvantage LLC in Clarksville, Maryland, told Medscape Medical News.

Sustained Benefit “Jaw Dropping”

“In other words, if you’re trying to look at sustained benefit, you’re only looking at 2.7%, which is a pretty jaw-dropping number,” added Dr. Pigott.

Overall, “the reviewed findings argue for a reappraisal of the current recommended standard of care of depression,” write the study authors.

“I believe there are likely some people where [antidepressants] are truly beneficial beyond placebo. The problem right now is that we simply have no way of knowing who those people are,” noted Dr. Pigott. “My hope is that this kind of analysis creates ‘more oxygen’ for looking at other kinds of approaches to treatment.”

The study was published in the August issue of Psychotherapy and Psychosomatics.

When registering new drug application trials with the FDA, drug companies must prespecify the primary and secondary outcome measures, the investigators report. “Prespecification is essential to ensure the integrity of a trial and enables the discovery of when investigators selectively publish the measures that show the outcome the sponsors prefer following data collection and analysis, a form of researcher bias known as HARKing or ‘hypothesizing after the results are known’,” they write.

For this article, Dr. Pigott and his team reviewed the following meta-analyses:

  • 1. Rising and colleagues (reviewed all efficacy trials for new drugs between 2001 and 2002)
  • 2. Turner and colleagues (reviewed 74 past trials of 12 antidepressants)
  • 3. Kirsch and colleagues, 2002 (reviewed 47 trials of 6 FDA-approved antidepressants)
  • 4. Kirsch and colleagues, 2008 (reviewed depression severity and efficacy in 35 trials)

The researchers also sought to reevaluate the methods and findings of STAR*D, a randomized, controlled trial of patients with depression. Its prespecified primary outcome measure was the Hamilton Rating Scale for Depression (HRSD), whereas the Inventory of Depressive Symptomatology–Clinician-Rated (IDS-C30) was secondary for identifying remitted and responder patients.

“STAR*D was designed to identify the best next-step treatment for the many patients who fail to get adequate relief from their initial SSRI trial,” the study authors write.

“When I first read about STAR*D’s step 1 phase, it just seemed biased to me,” explained Dr. Pigott. “I thought of it as the ‘tag, you’re healed’ research design. Patients who were scored as having a remission during the first 4 to 6 weeks of up to 14 weeks of acute care treatment were counted as remitted, taken out of the subject pool, and put into the follow-up care phase. In other words, they didn’t have the ability to have a relapse. But as most people know, depression ebbs and flows.

“So what made me want to continue to follow this study was that it became clear that the only way that people were really going to be able to evaluate the antidepressants’ effectiveness was to wait for the publication of the follow-up findings,” he added. “After their major final summary study was published, I felt as though the results weren’t really being portrayed in a manner that was consistent with the study’s prespecified criteria.”

High Dropout, Low Remission Rates

In addition to reporting on low efficacy of antidepressants compared with placebo, the 4 meta-analyses “also document a second form of bias in which researchers fail to report the negative results for the prespecified primary outcome measure submitted to the FDA, while highlighting in published studies positive results from a secondary or even a new measure, as though it was their primary measure of interest,” the investigators write.

For example, they note, the meta-analysis from Rising and colleagues found that studies with favorable outcomes were almost 5 times more likely to be published and that over 26% of primary outcome measures were left out of journal articles. Turner and colleagues found that antidepressant studies were 16 times more likely to be published if favorable compared with those with unfavorable outcomes.

In reanalyzing the STAR*D methods, the researchers found that the high dropout rate resulted in frequently missed exit HRSD and IDS-C30 interviews. So the revised statistical analytical plan dropped the IDS-30 for the Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), which was given at each visit.

“Even with the extraordinary care of STAR*D, only about one fourth of patients achieved remission in step 1 [and] the dropout rate was slightly larger than the success rate,” the study authors write. Steps 2 through 4 also each showed increasingly fewer success rates and larger dropout rates.

Of the 4041 patients at the study’s initiation, 370 (9.2%) dropped out within 2 weeks, and only 1854 patients (45.9%) obtained remission “using the lenient QIDS-SR criteria.” Of these, 670 dropped out within a month of their remission, and only 108 “survived continuing care” and underwent the final assessment.

Dr. Pigott described reanalyzing STAR*D as being “a bit like an onion. Each time we thought we understood the results, we found another layer. It wasn’t until about a year and a half ago that we discovered that the secondary outcome measure, the QIDS-SR, was not originally supposed to be used as a research measure. What was particularly disconcerting to me was that in their summary article, they basically used the QIDS-SR to report all of the results, which clearly had an inflationary effect on the outcome.”

He also noted that STAR*D did not have a placebo design. “Because the patients knew they were receiving the active medication, I would have expected a higher remission rate than what you’d find normally in a placebo-controlled study.

“The inescapable conclusion from the STAR*D results is that we need to explore more seriously other forms of treatment (and combination thereof) that may be more effective. This effort will require developing new service delivery models to ensure that as treatments are identified, they are widely implemented,” the investigators conclude.

Read entire article here:  http://www.medscape.com/viewarticle/727323
(Free registration required)

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Study finds 85% of new drugs offer few if any benefits & are significant cause of US deaths due to toxic side effects

Monday, August 23rd, 2010

Pharmalot
By Ed Silverman
August 23, 2010

The lemon, of course, is a metaphor and is not a pretty one. But Donald Light, a sociologist and professor of comparative health policy at the University of Medicine and Dentistry of New Jersey, contends that the spate of instances in which drugmakers hid or downplayed info about serious side effects – or overstated benefits – has transformed the market for medicines into one for lemons.

“The basic idea is simple but arresting: just as there are hidden dangers and flaws in used cars, so there are in drugs. And just as used car salesmen have an incentive to profit from not disclosing risks the consumer cannot see under the shiny exterior, so drug companies and their reps have an incentive to profit from not disclosing risks the physician and patient cannot see inside a shiny new pill. In a number of ways, however, drug markets differ from used car markets. One way is that bad drugs do not drive good drugs out of the market, as Akerlof famously predicted in the article that helped him win the Nobel Prize. Rather, they stay in, mixed with higher risk drugs,” Light tells us, after presenting a paper on the subject at the American Sociological Association annual meeting last week.

According to his study, which is not yet published, independent reviewers found that about 85 percent of new drugs offer few if any new benefits. At the same time, though, prescription drugs are now a significant cause of death in the US due to toxic side effects or misuse. He notes that drugmakers spend “two to three times more on marketing than on research,” which are dollars used to persuade docs to prescribe new drugs. But the docs, he maintains, may get misleading info and then pass along the same info to patients. In his view, this is a “two-tier market” for lemons.

And in his study, Light says drugmakers have taken advantage of this two-tier system information market and monopoly rights to create what can he calls “the risk proliferation syndrome,” which consists of corporate, government, and medical practices that maximize the number of drugs put on the market with risks of adverse reactions and then maximize the number of people induced to take them.

Read entire article here:  http://www.pharmalot.com/2010/08/drugmakers-actually-make-lemons-not-medicines/

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Doctors, Drug Companies, Politicians & Corruptions

Friday, August 20th, 2010

The Asian Tribune, August 21, 2010

By Shenali Waduge

They say there’s no money in healthy people. But, why is the pharmaceutical industry the most profitable industry in the world? It is because they have mastered the art of concocting the disorder, creating the drug for the disorder and then bombarding the public with advertisements to convince them they’re afflicted, leaving little choice but to get “prescribed”.

The growth in the pharmaceutical industry began to expand towards the 1970s. Pharmaceutical companies began to form mutual partnerships and began dominating the production of medicines. Advertising boomed making it possible for consumers to be enticed into believing there were miracle cures or drugs that would make people look young forever, increase sexual libido, maintain youthful looking skin with zero after effects or side effects.

Companies spend billions on “inventing” new drugs…they also spend billions on marketing them, USD53billion to be precise. But, how “innovative” are these companies? Most research and clinical trials are carried out at universities and funded by Governments. What happens thereafter is that drug companies “buy these innovations” and quickly patent them and quickly set up manufacturing plants. The only “innovation” done by these companies is to modify the existing drug something as minor as changing the color of the coating! A patented drug generally lasts for 20 years. It is only after rigorous study and testing which takes a good 10 to 15 years that Governmental authorities grant permission to market and sell drugs.

Loopholes in patent systems ensure companies are able to keep generic competitors at bay for years. These patented branded drugs naturally provides high profit margins but before the patent expires and competitors enter with a generic drug sold at far lesser prices, owners of branded drugs put out a generic version before the branded version expires…giving his company a head start in the sale of generic drugs. In 2006, the world had spent US$643billion on prescription drugs with US accounting for almost half of global pharmaceutical market. The US pharmaceutical industry is the most profitable of all businesses in the US.

It would not surprise anyone that companies spent up to $11billion annually on free samples, $6billion on sales representatives, $3billion on vague advertisements, we can only guess how many more billions is spent on bribing doctors, bribing researchers, bribing universities, bribing health officers, pharmacists, providing kickbacks and even running bogus “medical education” programs.

Essentially, what drug companies’ end up doing is using tax payer’s money to pay for medical research which they buy off, they then spend on massive advertising campaigns aimed at misleading the public about the effects of these drugs and “encourage” doctors to prescribe them!

Year in and year out drug companies end up the most successful industry with stunning profits part of which are used to buy off politicians and further promote themselves as champions of social responsibility and good corporate ethics!

There are no business ethics in the pharmaceutical industry – the industry is synonymous with money, profits, power and control. Pharmaceutical companies have mastered how to market social phobia/anxiety disorders in order to sell mind altering drugs. Does it not surprise and make you wonder why scores of people are being treated for mental disorders?

There are teenagers on anti-depressants and anti-psychotics because pharmaceutical companies want to ensure they have customers for life! Some prescription drugs are sold at more than 500,000% markup over the actual cost of their raw ingredients, naturally drug companies will do anything to sell more pills and it is why they end up inventing fictitious diseases and force parents to make addicts out of their children. There are scores of drugs available that are “habit-forming” tranquilizers?

Despite the number of drugs available why are people sicker than ever? Drugs have not helped people instead drug companies have made people addicted to drugs and suffering further from the side-affects of taking so many different combinations of drugs. In the US, over 100,000 Americans die annually from prescription drugs while a further 2million are injured by them.

The dominating companies in global pharmaceutical industry today are MERCK, Roche (fined in the US and Europe for participating in illegal price fixing cartel), Pfizer (ranked no.1, the makers of viagra the wonder drug of the 90s…. and probably soon to put out a drug that may do the opposite of viagra!), Bayer the inventor of Asprin….however hundreds and thousands of people die every year from prescription drugs? 27,000 people died of vioxx which is a nosteroidal anti-inflammatory drug which has been withdrawn over safety concerns associated with heart attacks, strokes. (though first approved in 1999 but withdrawn in 2004) It is believed that over 80m worldwide prescribed it in 2003 and its producer Merck and Co made sales revenues of US$2.5billion.

What is ironic is that there is not a single chronic disease which has been cured as a result of taking prescription drugs. What these drugs have done is to only treat the symptoms. Has chemotherapy proved scientifically accurate? It does shrink tumors but it adds nothing to a patient’s lifespan. The world is becoming sicker, fatter and more depressed than ever. The advice that people should listen to is not being given…eat healthy, avoid processed foods, avoid refined carbohydrates, avoid soft drinks etc…are rarely highlighted.

What’s more our doctors are duping us too…! In the US some mid-sized drug companies have close upon 1000 representatives lobby with companies spending over $5billion annually on sending these representatives to physician offices. The US spends $19billion annually on promotions, influencing doctors and other health professionals. As a result the physicians are lured into prescribing drugs associated with particular drug companies who ensure these physicians are well looked after and patients end up paying far more than they are required to as well as end up having to take another set of prescribed drugs to cut off the side-affects associated with the earlier drug!

Doctors are even paid to conduct fraudulent clinical trials on patients who are encouraged to take drugs for a 12month period to see its affects while the drug company profits through that particular year and the doctors enjoy the kickbacks as well. Some doctors who prescribe a particular drug company’s products and avoided competing drugs are even paid “consulting fees”. It is all a scam, and a vast majority of physicians become party to these unethical medical acts, pocketing the benefits & dosing up their patients with whatever drugs they’ve been told to prescribe. Doctors today are recipients of airfares & hotel expenses, luxury vehicles, even repairs and tyre replacements!

What is poignant and significant is that while physicians who may attend academic sessions with the thought of updating their know-how they are at the risk of being manipulated by pharmaceutical companies who pay high-profile scientists/physicians to speak on topics relevant to their products. Similarly, medical journals also help to promote specific products whose manuscripts are written by the pharmaceutical companies.

Essentially the public is at risk as a result of the direct and indirect relationships between pharmaceutical industry and the physicians. It certainly does breach professional ethics and may even bring dangers to patients.

Read the rest of this article here:  http://www.asiantribune.com/news/2010/08/21/doctors-drug-companies-politicians-corruptions

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NY Times—U.S. Broadens Bribery Inquiry Into Drug Makers—Federal Prosecutors Investigating Payments Made to Doctors

Tuesday, August 17th, 2010

The New York Times
By Gardiner Harris and Natasha Singer
August 13, 2010

At least a dozen major drug and device makers are under investigation by federal prosecutors and securities regulators in a broadening bribery inquiry into whether the companies made illegal payments to doctors and health officials in foreign countries.

In previous investigations, federal officials have charged that some companies made these kinds of payments to encourage doctors abroad to order or prescribe their products. In the United States, companies routinely hire doctors as consultants to market drugs and devices to their colleagues and other health professionals at medical conventions and small gatherings. Such consulting arrangements are legal in the United States as long as the companies do not pay doctors directly to write prescriptions for their products.

But in much of the rest of the world, doctors are government employees. And even consulting arrangements that would be considered routine in the United States might violate the Foreign Corrupt Practices Act, particularly if the payments are outsize or the arrangements are not disclosed to the governments.

Of even greater concern to prosecutors in the United States are unusually large payments made to foreign doctors who oversee the growing number of clinical trials that drug and device makers conduct abroad, according to Kirk Ogrosky, a former top federal prosecutor who now represents drug and device makers at a Washington law firm.

More than 80 percent of the drugs approved for sale in 2008 involved trials in foreign countries, and 78 percent of all people who participated in clinical trials were enrolled at foreign sites, according to a recent investigation by Daniel R. Levinson, the inspector general of the Department of Health and Human Services. Medical ethicists have long worried that many of these trials are conducted in countries that federal auditors rarely visit and where research controls may be scant.

Now, prosecutors are investigating whether the payments made to doctors who conducted these studies abroad were appropriate. If evidence shows that such payments have influenced the results of some clinical trials, prosecutors will be inspecting the trials closely, Mr. Ogrosky said. An article about the inquiry appeared Friday in The Financial Times.

Last month, a federal drug official reported that he found repeated instances in a landmark clinical trial of Avandia, a controversial diabetes medicine, in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s crucial tally of adverse events. Many of the study’s trial sites were in foreign countries, and the study is a main reason that Avandia remains on the market in the United States. Government officials have not accused GlaxoSmithKline, the trial’s sponsor, of fraud.

“At the Justice Department, investigations that involve allegations of patient harm rise straight to the top and will attract the immediate attention of the F.B.I.,” Mr. Ogrosky said.

Read entire article here:  http://www.nytimes.com/2010/08/14/health/policy/14drug.html?_r=2&hp

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People & Power—Drug Money

Tuesday, August 17th, 2010

A 23 minute TV expose on Big Pharma by ALJAZEERA (see video at bottom of this page)

This piece pulls no punches exposing the rampant fraud, fatal drug side effects, off label marketing, criminal practices  and “absolutely jaw dropping” payouts Pharma makes to psychiatrists/doctors.

  • “There is so much money to be made in stealing from the United States Healthcare system,” says Patrick Byrnes, Taxpayers Against Fraud.
  • Lewis Morris, US Department of Health states, “One of the things we are now looking at is going after the executives in these companies and holding them personally accountable.”
  • Sharon Ormsky, FBI Financial Crimes Unit states, “Pharmaceutical fraud is one of our top three threats — everybody is touched by these frauds in the extent that when you look at the billions of dollars that go into healthcare for the United States, a good percent,  3-10% of that is believed to be siphoned off into fraud—that’s  money that  could be going to very needy patients.”

Now the U.S. government is fighting back.  In the last two years alone, the  government has fined six of America’s  top ten pharmaceutical companies for fraud.  Investigations are ongoing against another three.  In this period the industry has had to pay out over 5 billion dollars in fines, and topping the list is drug giant Pfizer, having recently settled civil & criminal charges resulting in $2.3 billion dollars —the biggest fraud case, the biggest criminal case, the biggest false claims act in U.S. history.   ALJAZEERA also exposes Pfizer’s “interesting way of doing business.  Witnesses in the case revealed just how the company persuaded doctors to prescribe its drugs. It entertained them in strip clubs, it told them that the blues teenagers feel when they don’t make the football team was signs of treatable depression and it paid them to endorse Pfizer drugs. One doctor received $150,000 in a year.

Also highlighted is the current scandal regarding antipsychotic drugs, including state law suits, dangerous documented side effects and how federal investigators are now looking into claims drug company Johnson & Johnson illegally marketed their antipsychotic drug Risperdal to children, paying “some of the most influential doctors in the field” in order to accomplish this.  And leading that pack sits none other than the  [now] infamous psychiatrist Joseph Biederman, who has been “credited” with the huge increase of children prescribed psychiatry’s most powerful/dangerous drugs, antipsychotics, while receiving millions in Pharma kickbacks that he failed to disclose.   Biederman is shown on tape being questioned under oath, and when asked “What rank are you?” Biederman responds, “Full Professor.” When asked “What comes after that?” Biederman responds, “GOD.”

This is a 23 minute expose well worth watching.

This is one of the best exposé’s on Big Pharma we’ve seen:

People & Power —Drug Money, produced by ALJAZEERA.  This piece pulls no punches exposing the rampant fraud, fatal drug side effects, off label marketing, criminal practices  and “absolutely jaw dropping” payouts Pharma makes to psychiatrists/doctors.

* “There is so much money to be made in stealing from the United States Healthcare system,” says Patrick Byrnes, Taxpayers Against Fraud.

* Louis Morris, US Department of Health states, “One of the things we are now looking at is going after the executives in these companies and holding them personally accountable.”

*Sharon Ormsky, FBI Financial Crimes Unit states,  ”Pharmaceutical fraud is one of our top three threats — everybody is touched by these frauds in the extent that when you look at the billions of dollars that go into healthcare for the United States, a good percent,  3-10% is believed to be siphoned off into fraud that’s  money that  could be going to very needy patients.”

Now the U.S. government is fighting back.  In the last two years alone, the  government has fined six of America’s 10 pharmaceutical companies for fraud.  Investigations are ongoing into another three.  In this period the industry has had to pay out over 5 billion dollars in fines, and topping the list is drug giant Pfizer, having recently settled civil & criminal charges resulting in $2.3 billion dollars —the biggest fraud case, the biggest criminal case, the biggest false claims act in U.S. history.   ALJAZEERA also exposes Pfizer’s “interesting way of doing business.  Witnesses in the case revealed just how the company persuaded doctors to prescribe its drugs. It entertained them in strip clubs, it told them that the blues teenagers feel when they don’t make the football team was signs of treatable depression and it paid them to endorse Pfizer drugs. One doctor received $150,000 in a year.

Also highlighted is the current scandal regarding antipsychotic drugs, including state law suits, dangerous documented side effects and how federal investigators are now looking into claims drug company Johnson & Johnson illegally marketed their antipsychotic drug Risperdal to children, paying “some of the most influential doctors in the field” in order to accomplish this.  And leading that pack sits none other than the  [now] infamous psychiatrist Joseph Biederman, who has been “credited” with the huge increase of children prescribed psychiatry’s most powerful/dangerous drugs, antipsychotics, while receiving millions in Pharma kickbacks that he failed to disclose.   Biederman is shown on tape being questioned under oath, and when asked “What rank are you?” Biederman responds, “Full Professor.” When asked “What comes after that?” Biederman responds, “GOD.”

This is a 23 minute expose well worth watching.

http://www.youtube.com/watch?v=1TwdsYVHjGA&feature=player_embedded#!

This is one of the best exposé’s on Big Pharma we’ve seen:

People & Power —Drug Money, produced by ALJAZEERA.  This piece pulls no punches exposing the rampant fraud, fatal drug side effects, off label marketing, criminal practices  and “absolutely jaw dropping” payouts Pharma makes to psychiatrists/doctors.

* “There is so much money to be made in stealing from the United States Healthcare system,” says Patrick Byrnes, Taxpayers Against Fraud.

* Louis Morris, US Department of Health states, “One of the things we are now looking at is going after the executives in these companies and holding them personally accountable.”

*Sharon Ormsky, FBI Financial Crimes Unit states,  ”Pharmaceutical fraud is one of our top three threats — everybody is touched by these frauds in the extent that when you look at the billions of dollars that go into healthcare for the United States, a good percent,  3-10% is believed to be siphoned off into fraud that’s  money that  could be going to very needy patients.”

Now the U.S. government is fighting back.  In the last two years alone, the  government has fined six of America’s 10 pharmaceutical companies for fraud.  Investigations are ongoing into another three.  In this period the industry has had to pay out over 5 billion dollars in fines, and topping the list is drug giant Pfizer, having recently settled civil & criminal charges resulting in $2.3 billion dollars —the biggest fraud case, the biggest criminal case, the biggest false claims act in U.S. history.   ALJAZEERA also exposes Pfizer’s “interesting way of doing business.  Witnesses in the case revealed just how the company persuaded doctors to prescribe its drugs. It entertained them in strip clubs, it told them that the blues teenagers feel when they don’t make the football team was signs of treatable depression and it paid them to endorse Pfizer drugs. One doctor received $150,000 in a year.

Also highlighted is the current scandal regarding antipsychotic drugs, including state law suits, dangerous documented side effects and how federal investigators are now looking into claims drug company Johnson & Johnson illegally marketed their antipsychotic drug Risperdal to children, paying “some of the most influential doctors in the field” in order to accomplish this.  And leading that pack sits none other than the  [now] infamous psychiatrist Joseph Biederman, who has been “credited” with the huge increase of children prescribed psychiatry’s most powerful/dangerous drugs, antipsychotics, while receiving millions in Pharma kickbacks that he failed to disclose.   Biederman is shown on tape being questioned under oath, and when asked “What rank are you?” Biederman responds, “Full Professor.” When asked “What comes after that?” Biederman responds, “GOD.”

This is a 23 minute expose well worth watching.

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GSK & AstraZeneca face corruption investigation—hospitality lavished on those who prescribe drugs could constitute bribery

Monday, August 16th, 2010

Market Watch
By London Bureau
August 14, 2010

U.K. pharmaceutical firms GlaxoSmithKline PLC (GSK 38.15, +0.01, +0.03%) and AstraZeneca PLC (AZN 51.88, +0.49, +0.95%) are facing a corruption investigation in the U.S. over claims that the hospitality lavished on those who prescribe their treatments could constitute bribery, The Independent newspaper in London reported Saturday, without citing sources.

The newspaper said the two firms are among those facing the investigation being carried out by the Department of Justice and Securities and Exchange Commission.

The investigation is thought to center around allegations that drug companies might have contravened the Foreign Corrupt Practices Act, which limits their ability to spend on such things as hospitality, charitable donations and other non-business activities, the newspaper said.

Read entire article here:  http://www.marketwatch.com/story/gsk-astrazeneca-facing-us-probe-report-2010-08-14

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US Department of Justice Probes Corruption in Big Pharma; Glaxo, Pfizer, Bristol-Myers Squibb, Eli Lilly & Merck

Friday, August 13th, 2010

Financial Times
By Stephanie Kirchgaessner
August 12, 2010

The US Department of Justice is scrutinising payments by leading pharmaceuticals companies for hospitality, consultants, licensing agreements and charitable donations in markets around the world as part of a wide-ranging corruption probe.

GlaxoSmithKline, Pfizer, Bristol-Myers Squibb and Eli Lilly, among others, have disclosed being contacted by the DoJ and Securities and Exchange Commission in connection with the investigation. Merck, the US drugs group, announced last week that it had also been contacted and was co-operating with investigators.

An industry attorney familiar with the probe said that the DoJ was looking at whether pharma companies had ignored a “systematic risk” inherent in the global drugs business and ignored obligations under local and US anti-bribery law.

The highly regulated nature of the business, combined with the fact that healthcare officials in many non-US markets were government funded, made the industry a natural target for such a probe, the person added.

The investigation is at a relatively early stage but is considered a priority for the DoJ.

While hospitality – including meals and all expenses-paid travel for conferences – has long been considered a potential risk for pharma groups, the DoJ’s probe is looking at all aspects of companies’ dealings in non-US markets, people familiar with the matter say. That includes the recruitment of physicians for clinical trials. In some markets, the same physicians may serve on regulatory boards that approve or deny drugs.

The DoJ declined to comment. But last November, Lanny Breuer, head of the DoJ’s criminal division, announced that investigators would be focusing on international corruption in the pharmaceuticals industry for “years”.

Mr Breuer warned a conference of pharmaceutical industry lawyers that prosecutors were gearing up for an investigation of international corruption in the sector. The drugs companies took notice.

That threat has now become a reality. Merck, AstraZeneca, Eli Lilly, Baxter, SciClone, and Bristol-Myers Squibb have in recent months received inquiries from the DoJ and the Securities and Exchange Commission in connection with an industry-wide bribery ­investigation.

GlaxoSmithKline, the UK drugmaker, told the Financial Times on Thursday that it too had received “inquiries” from US authorities, but that it disclosed the issue “reactively” only to selected reporters in April.

Pfizer, the world’s largest pharmaceutical group, said in February that it had voluntarily provided the DoJ and SEC with information concerning potentially improper payments outside the US and was exploring resolution of the matter.

There is perhaps no industry that is as vulnerable to violations of US anti-bribery laws as the pharmaceutical industry. In markets round the world, the companies deal, sometimes thousands of times in a single day, with doctors, clinicians, hospital operators and regulators who are considered under US law to be government officials, because they are employed by state-owned facilities.

Under the Foreign Corrupt Practices Act, the US anti-bribery law, companies may not offer items of value to foreign government officials for profit. One industry lawyer involved in the matter said global pharmaceutical companies operating in countries with state-run medical institutions deal with government officials at every turn of their business: whether it is seeking the go-ahead for a manufacturing site; obtaining drug licences; conducting clinical trials; importing drugs; selling and marketing drugs to physicians; or getting a product on to a hospital’s approved list.

“What most companies will find is that all of these areas are risky and, if they don’t train and educate their people, they are going to find themselves with issues. For example, if you have hired customs brokers, how do you know they aren’t bribing officials?” the attorney said.

According to the law firm Arnold & Porter, the DoJ is particularly interested in corrupt payments that may have influenced the reliability or integrity of data in clinical trials performed outside the US. A recent report by the Department of Health and Human Services found 80 per cent of marketing applications for drugs approved by the Food and Drug Administration in the US had relied on at least one foreign trial.

“Companies may find themselves facing critical legal issues if approval of products rested on the results of studies the DoJ deems corrupt,” Arnold & Porter said in an advisory letter to clients last month.

A person familiar with the investigation confirmed that clinical trials were one of several areas the DoJ was examining.

Alexandra Wrage, the president of Trace, a non-profit organisation that helps companies establish anti-corruption practices, said that alleged wrong­doing at pharmaceutical companies could often centre on inappropriately lavish hospitality, such as wining and dining doctors from state-run hospitals at conferences in Bali or Monaco.

Read entire article here:  http://www.ft.com/cms/s/0/9a8e8f90-a63e-11df-8767-00144feabdc0.html
(free registration required)

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OpEdNews.com—The Mothers Act: How Pharmaceutical’s Control Puts New Mothers & Infants in Grave Danger

Thursday, August 5th, 2010

Note: To see side effects of psychiatric drugs on pregnant women that have been reported to the US FDA,  click on this link http://www.cchrint.org/psychdrugdangers/medwatch_psych_drug_adverse_reactions.php scroll all the way down in the Drug Class/Drug Name drop down link and select ANTIDEPRESSANTS, then in the AGE RANGE category, select  age range of 0-1 years.

OpEdNews
By K. L. Carlson
August 5, 2010

Mom’s Opportunity to Access Health, Education, Research, and Support for Postpartum Depression Act sounds very supportive of new mothers. The truth is just the opposite. The cleverly worded title can be shortened to the Mothers Act and it was written by and for the pharmaceutical industry. It was introduced by Senator Robert Menendez of New Jersey; the state with the most pharmaceutical companies’ headquarters. According to the public interest group, Common Cause, Senator Menendez received over $2 million from the healthcare industry, including drug companies.

The Mothers Act was included in the immense health plan that was recently signed into law. New mothers need to be made aware that this Act was not written to benefit them, but to benefit the drug companies. This Act will have grave results literally.

Postpartum depression, as defined in the Act, is a “mood disorder” that has three categories. The most severe category is “postpartum psychosis.” Notice the use of psychiatric terms. The public is supposed to believe that motherhood can cause mental illness. Fear of a new mother suffering “postpartum psychosis” is then increased by the Act stating that one in every one thousand new mothers will suffer the mental illness.

The Act states that postpartum depression goes undiagnosed and untreated due to “social stigma surrounding depression and mental illness.” So giving birth and becoming a new mother with vastly fluctuating hormones and physiological changes, as well as the demands of a new baby, is now a mental illness. What is the probability the Mothers Act would have been written if psychiatric drugs did not reap more than $330 billion dollars a year?

The Act establishes federally funded grants to screen all new mothers before they leave their birthing centers and to continue screening during the first year. Although it is unknown why some women suffer depression after giving birth, and most likely there are many reasons including concerns of financially supporting a new baby, the pharmaceutical industry has ensured that it is considered a mental illness that will lead to non-curing, addictive, dangerous psychiatric drugs. As stated in the Act, “the new mother shall be referred to an appropriate mental healthcare provider.”

“There is no evidence that any mental disorder is caused by chemical imbalance,” a Surgeon General’s report states. The much-touted idea of brain chemical imbalance is a total myth with no scientific research ever supporting it. All psychiatric “disorders” are voted into existence by the American Psychiatric Association and have no objective diagnostic tests, such as blood tests or hormone tests. The Mothers Act is the latest version of the old story of the Emperor’s New Clothes – get people to believe something exists when in fact it does not. Mothers who have trouble emotionally after giving birth do not have any mental illness. They may have temporary hormonal imbalance. They may need a stronger emotional support system to feel confident they can get help with the new baby. They may need financial assistance. But they are not mentally ill.

The Act also funds clinical research “for the development and evaluation of new treatments for postpartum conditions, including new biological agents.” That means synthetic drugs. The pharmaceutical industry has ensured more tax dollars will continue to flow into its coffers.

“The suicide rate is 718 for every 100,000 people taking SSRI/SNRI drugs in clinical trials,” Dr. Arif Khan told NIH in August 2002. SSRI/SNRI drugs are antidepressant drugs, which is an oxymoron because the drugs cause depression. They should be called pro-depression drugs. The suicide rate in the general population not taking psychiatric drugs is about 11 for every 100,000 people. In fact, all 33 brands of SSRI/SNRI drugs carry the FDA’s most severe warning, a Black Box Warning, for suicide. Besides suicide the drugs have more than 100 other severe side effects, including anxiety, panic attacks, irritability, hallucinations, hostility, aggressiveness, and mania. Antidepressants are mind-altering drugs that have never been shown in any clinical study to help depressed people much more than the herb St. John’s Wort or the placebo (sugar pill). In one study the placebo group had significantly better results than the group receiving the antidepressant drug, confirming that the body has natural ways to deal with the ups and downs of life.

Once people are labeled with a mental disorder, such as postpartum psychosis, their behavior is then blamed on the disorder when in fact the drugs are causing the behavior. For a real life example, check out Amy Philo’s story on You Tube. She was anxious because her newborn son had a severe allergic reaction to a formula given to her by a physician. Amy’s fear and anxiety for her child was absolutely normal and would have subsided once she had her baby safely at home. Instead, she was diagnosed as suffering from postpartum depression and given an antidepressant. She asked if the drug would be safe for her baby since she was breast-feeding. A physician told her yes, the drug would make her baby happy too. Research results do not support what the doctor told Amy. “In conclusion, our results suggest that maternal exposure to fluoxetine (Prozac, Luvox, Sarafem, and Symbyax) during pregnancy and lactation results in enduring behavioral alterations “throughout life.” All psychiatric drugs, including antidepressants, are neurotoxins. That means they kill nerve cells everywhere in the body.

“After only being on the antidepressant for a couple of days I had thoughts of killing my baby.” Amy was horrified, but instead of blaming the drug’s known side effects, the physician blamed the label of postpartum depression. Obviously, Amy’s “mental illness” had worsened and she now needed to be put in a psychiatric ward. She didn’t agree to the incarceration but her resistance was again labeled as due to her mental illness. The white coats know best! Fortunately Amy’s story has a happy ending. She suspected the antidepressant was causing her strange thought patterns. She managed to be released from the psychiatric ward after only a brief stay and she stopped taking the drugs they had given her. All of Amy’s symptoms that had been labeled by the medical community as postpartum depression symptoms ceased when she stopped taking the drugs. Her baby and she were home together. A happy ending. That will not be the case when they initiate the Mothers Act. Since every mother is potential income to psychiatry and the pharmaceutical industry, we can predict that the majority of new mothers will be labeled and drugged for postpartum depression. It is about money, not health.

The pharmaceutical industry and psychiatry are conjoined twins joined at the wallet. “Adoption of the Mothers Act is a positive development for women and their families,” says Alan F. Schatzberg, MD, President of the American Psychiatric Association (APA). Scharzberg was one of several influential psychiatrists who Senator Grassley’s investigations found had failed to disclose financial ties to pharmaceutical companies.

“In order to survive we psychiatrists must go where the money is,” Dr. Steven Sharfstein, APA Vice President told Congress. The money is in prescription psychiatric drugs as demonstrated by the astounding fact that in 2007 the five leading psychiatric drugs grossed more money than the gross national product of half the countries in the world.

The French philosopher Voltaire wrote, “Those who can make you believe absurdities, can make you commit atrocities.” The conjoined twins of the pharmaceutical industry and psychiatry are doing their best to have the public believe the absurdity that the stress and emotional roller coaster of becoming a new mother is a mental illness. Then they get these vulnerable women to commit the atrocity of taking mind-altering, addictive antidepressant drugs that go directly into the baby through the mother’s milk. These drugs can make a new mother’s life a living hell. Ask Amy Philo.

Even if the mother does not suffer visible side effects from an antidepressant, she is still consuming an addictive drug that is a neurotoxin. And if she breast feeds, her baby is consuming a drug that has been shown to cause severe, irreparable damage.

Pregnant women taking antidepressants have babies who are 6 times more likely to have primary pulmonary hypertension (PPH) or a developing lung disorder. PPH is extremely serious. The drug causes developmental distortion of the lungs leading to lack of oxygen to crucial organs such as the brain, kidneys and liver. PPH is often fatal. Babies who initially survive PPH have long-term health problems including breathing difficulties, seizures and developmental disorders.

K.L. Carlson is a former drug rep turned whistleblower, author of the compelling expose, Diary of a Legal Drug Dealer – One Drug Rep. Dares to Tell You the Truth. She is also a CCHR International Commissioner (advisor)

Read the rest of this  article here:  http://www.opednews.com/articles/PHARMACEUTICAL-S-CONTROL-P-by-K-L-Carlson-100803-846.html

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Pharmaceutical companies deceive public—case in point; Antidepressants

Thursday, July 29th, 2010

The Star Phoenix
By Mark Lemstra
July 29, 2010

We could save $2 billion a year on health-care costs in Saskatchewan while improving health outcomes if we adopt evidence-based protocols.

To do so, we need to find about $40 million of efficiency in each of about 50 areas.

This is the third article in a five-part series on depression. My first column discussed the limitations in diagnosing depression. The second presented literature reviews that concluded antidepressants are no more effective than placebos in treating depression.

This column explains how the drug companies deceive us. Let’s start with some general information and proceed to specific examples for antidepressants.

In 2008, the editor of the New England Journal of Medicine wrote an editorial for the Journal of the American Medical Association, titled: Industry sponsored research: A broken system?

Based on her tenure as the editor of the world’s most prestigious medical journal, Dr. Marcia Angell made some accusations. She wrote that drug companies often design studies, conduct the data analysis, decide which data will be included or suppressed, write the papers, pay for prestigious clinicians to put their name on papers already written by the drug company, and then decide how and when the paper will be published.

Dr. Angell concluded: “Drug companies now finance most clinical research on prescription drugs, and there is mounting evidence that they often skew the research they sponsor to make their drugs look better and safer. Physicians can no longer rely on the medical literature for valid and reliable information.”

She also published a best selling and award-winning novel, The Truth about Drug Companies: How They Deceive Us and What to Do About It.

Let’s look at some examples from anti-depressants.

A research team from the United States, which was skeptical about the benefits of antidepressants, used the Freedom of Information Act to obtain results from the U.S. Food and Drug Administration for all placebo-controlled trials. The team was startled to learn that 40 per cent of the studies had been suppressed because of negative results.

When all the studies were included, incorporating the negative studies, the authors concluded that “antidepressants are little more than active placebos, drugs with very little specific benefit, but with serious side-effects.”

The resulting publication in Prevention and Treatment made headlines around the world. And although regulatory agencies in Europe have begun to respond, there has been no response in North America.

At this point, let’s discuss the potential side-effects of antidepressants in a review from Harvard Medical School, titled: What are the real risks of antidepressants?

The most serious of these includes the increased risk of attempted suicide, especially among children. Other side-effects include insomnia, skin rashes, headaches, joint and muscle pain, stomach upset, nausea, diarrhea, reduced blood clotting capacity, stomach bleeding, uterine bleeding, tics, muscle spasms, trembling limbs, restlessness, severe anxiety, reduced sexual interest, reduced sexual performance, reduced sexual satisfaction, disturbed heart rhythms and reduced liver function.

There are also complications when antidepressants are taken with other drugs, and there is a long list of side-effects when antidepressant use is discontinued, including dizziness, loss of co-ordination, fatigue, burning sensations, blurred vision, insomnia, vivid dreams, nausea, diarrhea, flu-like symptoms, irritability, anxiety and crying spells.

Recently, the antidepressant Serzone was removed from the market after it was associated with hepatitis and liver failure.

The most worrisome side-effect is the increased risk of suicide attempt so let’s take a closer look.

Another review from the Food and Drug Administration found that not only do antidepressants provide no benefit to children, but the drugs are associated with a 50 per cent increase in suicidal behaviour.

Regrettably, these negative results, too, were buried by the drug companies.

Read the rest of this article here:  http://www.thestarphoenix.com/news/Pharmaceutical+companies+deceive+public/3336124/story.html

Previous articles in this series: Effect of antidepressants, placebos similar by Mark Lemstra
http://www.thestarphoenix.com/health/Effect+antidepressants+placebos+similar/3307896/story.html

Expanding mental disorders list adds to cost by Mark Lemstra
http://www.thestarphoenix.com/health/Expanding+mental+disorders+list+adds+cost/3280676/story.html

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