Posts Tagged ‘clinical trials’

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Beware the ghost(writer)s of medical research

Friday, June 17th, 2011

The One Click Group – June 16, 2011

By Dr. Marc-André Gagnon
 and Dr. Sergio Sismondo
 Expert Advisors – EvidenceNetwork.ca

The medical research world has been concerned about the problem of ghostwriting for more than a decade.

The issue has been repeatedly raised in the mainstream media over the past few years, with most of the commentary focused on the ethics of academics serving as authors on papers they did not write and on some of the most egregious actions by pharmaceutical companies.

But these efforts miss the ways in which Big Pharma has developed new forms of medical research to serve its own interests.

How ghostwriting feeds Big Pharma profits

Big Pharma firms spend twice as much on promotion as on research and development (R&D). But it is worse than that: more and more medical R&D is organized as promotional campaigns to make physicians aware of products. The bulk of the industry’s external funding for research now goes to contract research organizations to produce studies that feed into large numbers of articles submitted to medical journals.

Internal documents from Pfizer, made public in litigation, showed that 85 scientific articles on its antidepressant Zoloft were produced and coordinated by a public relations company. Pfizer itself thus produced a critical mass of the favourable articles placed among the 211 scientific papers on Zoloft in the same period. Internal documents tell similar stories for Merck’s Vioxx, GlaxoSmithKline’s Paxil, Astra-Zeneca’s Seroquel, and Wyeth’s hormone-replacement drugs.

To promote the now-notorious Vioxx, Merck organized a ghostwriting campaign that involved some 96 scientific articles. Key ones did not mention the death of some patients during clinical trials. Through a class action lawsuit against Vioxx in Australia, it was discovered that Elsevier had created a fake medical journal for Merck – the AustralasSian Journal of Joint and Bone Medicine – and perhaps 10 other fake journals for Merck and other Big Pharma companies.

In another example, GlaxoSmithKline organized a ghostwriting program to promote its antidepressant Paxil. According to internal documents made public in 2009, the program was called “Case Study Publication for Peer-Review”, or CASPPER, a playful reference to the “friendly ghost”. Such strategies are not exceptions; they are now the norm in the industry. Most new drugs with blockbuster potential are introduced accompanied by 50, 60, or even 100 medical journal articles. Any firm that refused to play this game in the name of ethics would likely lose market share. Profits in the pharmaceutical industry depend on companies’ capacity to influence medical knowledge and create market share and market niches for their products.

A call for Evidence-Based medicine

In 2008, research showed that pharmaceutical companies systematically failed to publish negative studies on their SSRIs, the Prozac generation of antidepressants. Of 74 clinical trials, 38 produced positive results and 36 did not: 94 per cent of the positive studies were published, but only 23 per cent of the negative ones were, and two-thirds of those were spun to make them look more positive.

Physicians reading the scientific literature got a biased view of the benefits of SSRIs. This helps to explain the huge number of antidepressant prescriptions, in spite of the fact that, according to a meta-analysis in JAMA in January 2010, for 70 per cent of people taking SSRIs, the drug did not bring more benefits than a placebo. Compared to placebo, however, SSRI antidepressants can result in serious adverse drug reactions.

There we see one of the problems with the ghost management of medical research and publication. Pharmaceutical companies want upbeat reports on their drugs. They design, write, and publish studies that are likely to show their drugs in positive lights – and there are myriad ways to do so. Ghosts sometimes bend the truth, and sometimes even commit fraud, with grave results.

Why do academics serve as authors on scientific articles they did not write, using research they did not perform? Because they are rewarded, both by their universities and by their colleagues for how much they publish and for its prominence. Pharmaceutical companies and their agents are very good at placing articles in prestigious journals, and then make them even more prominent by having their armies of sales reps circulate them and talk them up.

Researchers who serve as authors on studies and analyses (perhaps scientifically correct) that are favourable to the industry can expect to see these articles increase their prestige and influence, and possibly even funding.

What happens, however, when a researcher produces studies and analyses (also scientifically correct) showing that some products are dangerous or inefficient, as some did about Vioxx before the scandal broke? Reading Merck’s internal e-mails, revealed during the class lawsuit, it was exposed that the company drew up a hit list of “rogue” researchers who needed to be “discredited” or “neutralized” – “seek them out and destroy them where they live,” reads one e-mail. Eight Stanford researchers say they received threats from Merck after publishing unfavourable results.

Corporate science

In the ghost management of research and publication by drug companies we have a new model of science. This is corporate science, done by many unseen workers, performed for marketing purposes, and drawing its authority from traditional academic science. The high commercial stakes mean that all of the parties connected with this new corporate science can find reasons or be induced to participate, support, and steadily normalize it. It also biases the available science by pushing favourable results and downplaying negative ones – and sometimes through outright fraud.

As long as pharmaceutical companies hold the purse strings of medical research, medical knowledge will serve to market drugs, not to promote health. And as long as universities grovel for more partnerships with these companies, the door will remain wide open to proceed with the corruption of scientific research.

http://www.theoneclickgroup.co.uk/news.php?id=6349#newspost

Dr. Marc-André Gagnon is assistant professor with the School of Public Policy and Administration at Carleton University. He is also an expert advisor with EvidenceNetwork.ca, a comprehensive and non-partisan online resource designed to help journalists covering health policy issues in Canada. Dr. Sergio Sismondo is professor of Philosophy and Sociology at Queen’s University. His current research is on the pharmaceutical industry’s relationships with academic medicine and practicing physicians.

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Doctors’ Conflicting Interests Can Cost Money and Lives, and Hinder Medical Discoveries

Monday, March 28th, 2011

ABC News – March 28, 2011

by Dr. Stefan P. Kruszewski, Psychiatrist

Psychiatrists who pimp for drug companies

The fact that doctors take money from pharmaceutical companies happens to be old news. But this time around, the docs in question come from Stanford University. Previous news stories reported that doctors receiving pharmaceutical funding hailed from Harvard, the University of Miami, the Medical College of Georgia and the University of Cincinnati College of Medicine.

More than a few of these doctors are psychiatrists who have received tax-supported, public National Institutes of Health and National Institute of Mental Health funding for clinical research, have participated in U.S. Food and Drug Administration advisory panels or have appeared on, or on behalf of, various not-for-profit psychiatric advocacy boards — some of which are heavily supported by the manufacturers of psychiatric medications.

In 2006, my colleagues and I wrote a brief letter to the editor to the Journal of the American Medical Association, one of America’s premier peer-reviewed medical journals. Our letter expressed concern about the lack of honest disclosure of conflicts by certain psychiatric authors in a previously published article.

Multiple authors had recommended specific antidepressant therapy but failed to reveal that they were being paid by multiple antidepressant manufacturers to speak, advocate and do research for the companies that sold the drugs.

During the review process, an associate editor at the journal asked the question (and inadvertently copied me on an email that had been sent to another associate editor), “What’s the big deal? What’s all this [expletive deleted] about conflicts of interest?”

Academic journals, heavily supported by advertising money, are biased and complicit in the conflict of interest fiasco.

Sometimes I wonder why I — or anyone else for that matter — should care about psychiatrists who pimp for drug companies. After all, physician spokespeople and drug manufacturers are capitalists, and capitalism is our economic cornerstone. Every day, any financial news consumer hears the refrain invoking the social advantages of free market capitalism. It is the mantra of a major financial television network. And even though I’m a psychiatrist, I’m also a capitalist, so why should I worry?

But I do worry, because drug promotion and clinical decision-making that are brokered on the backs of dollar bills have a greater chance of causing serious adverse outcomes, including illnesses and death. If a physician embellishes the effectiveness of a drug or minimizes its risk, that directly hurts you and me.

Physicians who are heavily supported by pharmaceutical companies and medical device makers are not forming independent, unbiased decisions. Instead, their brains have been lined with gifts, perks and money, which influences their rose-colored opinions.

My psychiatric colleagues are especially vulnerable here. The result is that your mother, your husband or my child can’t make a reliable decision about the risks and benefits of particular drugs. How could they? The prescribing doctors often don’t know the risks and benefits, so how could we be expected to learn what they don’t know?

Conflicts of interest promoted by pharmaceutical manufacturers negatively affect decisions about current and future medical care. That is tragic, because those half-baked recommendations come with a price that no amount of capitalism can justify. It’s simple and ugly: If you or your mom suddenly succumbs to an arrhythmia whose side effects were not appreciated by your doctor because your doctor was misinformed by another doctor serving as the manufacturer’s spokesperson, that is tragic.

I see it virtually every day in my clinical practice: in young men who have breast lesions and abnormal breast development from atypical antipsychotics; in sudden unexpected deaths, or “suds,” from psychiatric drugs in individuals who had no risk factors for sudden death; in tic and dyskinetic movement disorders in kids arbitrarily prescribed stimulants, and the huge weight gain and symptoms of type 2 diabetes in children and young adults who receive a sedative, such as quetiapine, for sleep.

The bad news doesn’t stop with current care. Conflicted clinical research — often done especially by and for a particular psychiatric pharmaceutical manufacturer — whose design and analysis are biased and whose summary and conclusions are misleadingly positive, fracture the backbone of scientific research.

The legacy of fraudulent research lingers for years before it is recognized and repudiated. That effort impedes real progress, wastes time, money and human resources that could be focused on finding real cures to help all of us. And that’s not good for anybody.

Dr. Stefan Kruszewski is an addiction psychiatrist and CEO of Kruszewski & Associates, a Harrisburg, Pa., company that focuses on health care and financial fraud.

Read the article and watch the ABC News video here:  http://abcnews.go.com/Health/medical-conflicts-interest-disaster-patients/story?id=13060973

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False peace of mind – Antidepressant Placebos

Thursday, March 10th, 2011

Antidepressant placebos remain a steady presence in clinical experiments, but not in public knowledge

The McGill Daily
Debbie Wang
March 10, 2011

Victor Tangermann | The McGill Daily

It’s the classic situation: with an imminent exam and a carefully planned cramming schedule, you awake one morning with the all too familiar symptoms of a common cold. Feeling sorry for yourself between sniffles and coughs, you self-medicate with the usual blend of OJ, vitamins and copious amounts of water, fervently hoping for a rapid recovery.

Most of us who catch a cold end up taking desperate measures to fix the situation, regardless of whether such measures are founded on scientific truth. Increased vitamin C intake? Not only is there zero proof that it prevents colds, there’s also none that it expedites recovery, according to a paper in Evidence-Based Child Health. Herbal remedies like echinacea? Hot liquids? Beyond the latter’s ability to provide temporary relief, neither will provide much help.

Indeed, the most powerful panacea of them all is our own gullible mind. Once convinced of the effectiveness of a cold cure through a lifetime of anecdotal accounts and lore, many of us will start feeling better after a day of downing orange juice even though it serves as much of a medical purpose as twiddling your thumbs. And while juice manufacturers don’t proclaim cold-fighting abilities on every carton, another highly lucrative industry relying heavily on the placebo effect does assert a claim: that antidepressants cure depression.

Beginning in 1998, a series of studies have repeatedly questioned the difference in efficacies between antidepressant drugs and placebos. Pioneering analysis work done by University of Connecticut researchers Irving Kirsch and Guy Sapirstein confirmed the effectiveness of antidepressants – but also their inert counterparts. In 38 studies conducted with over 3,000 depressed patients, placebos improved symptoms 75 per cent as much as legitimate medications.

“We wondered, what’s going on?” said Kirsch in a 2010 interview with Newsweek. The medical community, skeptical of his analysis, asked him to instigate a more comprehensive study with the results of all clinical trials conducted by antidepressant manufacturers, including those unpublished – 47 studies in total.

Over half of the studies showed no significant difference in the depression-alleviating effects of a medicated versus non-medicated pill. With this more thorough analysis, which now included strategically unpublished studies from pharmaceutical companies, placebos were shown to improve symptoms 82 per cent as much as the real pill.

Now also consider that any apparent advantage of the genuine medication might be more the mind’s handiwork than chemical effect. Patients in double blind clinical trials, where neither experimenter nor patient know if a placebo or real drug has been taken, may easily determine which is the placebo. The obvious side effects of the genuine pill, such as headaches or nausea, may alert the patient to which study group they’ve been placed in, and the knowledge that their pill is medicated may be enough to alleviate their depression.

Are antidepressant drugs really “a triumph of marketing over science,” as researchers have claimed? Kirsch and other experts are convinced that antidepressants do not chemically cure depression. A British agency charged with determining which treatments are effective enough for government funding has stopped endorsing antidepressants as the default treatment for anything but the most severe forms of depression. And drug manufacturers themselves don’t deny Kirch’s data. A spokesperson for Pfizer, producer of  Zoloft, has alluded to the existence of a “wealth of scientific evidence documenting [antidepressants’] effects,” yet the fact that treatment “commonly fail[s] to separate from placebo” is “well known by the FDA, academia, and industry.”

However, if experts and antidepressant manufacturers are aware of this, the general public certainly isn’t. Which is precisely why antidepressants work. Without the knowledge that even manufacturers of medications aren’t completely convinced of their product’s superiority, antidepressants will continue to be effective. This not a recommendation for current users to halt taking the pills; abrupt withdrawal is extremely dangerous, and there is still a range of perspectives on the topic of antidepressants versus sugar pills.

But you have it. Millions of people every year feel better, simply because they believe they’ll feel better. We’ve recovered from colds, headaches, pain, and depression, courtesy of the placebo effect. After all, there’s something to be said for feeling better.

http://www.mcgilldaily.com/2011/03/false-peace-of-mind/

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Psychiatrist on Payroll of Glaxo Pleads Guilty to Research Fraud

Monday, November 29th, 2010

NaturalNews, November 29,2010

by David Gutierrez

GlaxoSmithKline, manufacturer of Paxil, paid Palazzo $5,000 for every child she enrolled in the study.

A psychiatrist on the payroll of GlaxoSmithKline has been sentenced to 13 months in prison after pleading guilty to committing research fraud in trials of the company’s antidepressant Paxil on children.

Maria Carmen Palazzo is already serving a sentence of 87 months for defrauding Medicare and Medicaid.

Palazzo was accused by the FDA of enrolling children in a clinical trial even though she knew they did not actually suffer from major depressive or obsessive compulsive disorder, the conditions being studied. Palazzo then falsified records and psychiatric diagnoses.

GlaxoSmithKline, manufacturer of Paxil, paid Palazzo $5,000 for every child she enrolled in the study.

The case’s significance goes beyond simple research fraud, as Glaxo is now defending itself against charges that for 15 years it deliberately concealed evidence that Paxil increases the risk of suicide in children.

Glaxo is also defending itself against accusations that it manipulated data to conceal the risks of its diabetes blockbuster Avandia, and that it failed to warn parents that Paxil may cause birth defects if taken by pregnant women. The company has already agreed to pay more than $1 billion to settle roughly 700 birth defect lawsuits; another 100 or so suits are pending.

Although the FDA eventually required Paxil to carry a warning about the risk of birth defects and an even more prominent “black box” warning about suicide risk, many critics allege that the agency acted too slowly.

“There [had] been hints for many years that antidepressants, such as Paxil, when given to children, can cause serious side effects, including suicide, but the FDA delayed taking any action to prevent these drugs from being prescribed for children,” writes Brent Hoadley in Too Profitable to Cure.

Palazzo will not actually serve any additional prison time for potentially placing children’s safety at risk; her new term will be served concurrently with her first.

http://www.naturalnews.com/030557_psychiatry_fraud.html

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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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Pfizer ends trial after widespread overdosing of children with psych drug

Monday, October 18th, 2010

NaturalNews.com,  October 18, 2010

by David Gutierrez

Drug giant Pfizer has canceled a scheduled clinical trial of its antipsychotic drug Geodon after the FDA accused it of subjecting child participants in a prior study to “widespread overdosing.”

“After careful consideration, the company decided not to proceed with the study,” Pfizer spokesperson Gwendolyn Fisher said.

Fisher said that although the company had taken “preparatory steps” toward the trial, it had decided to abandon the study in order “to meet regulatory timelines.” No patients were enrolled.

Pfizer is seeking FDA approval to market Geodon for the treatment of bipolar disorder in children between the ages of 10 and 17. An FDA panel already rejected this use once in 2009 by a vote of 10-7, expressing concern that large numbers of participants had failed to complete clinical trials of the drug. The FDA asked Pfizer for further information on the drug’s safety in children, and the company responded by launching pediatric trials of the drug.

In April, the FDA warned the company that researchers in charge of the trials were engaging in “significant violations,” including “widespread overdosing” caused by inadequate company oversight.

Five months earlier, Pfizer had agreed to pay $2.3 billion to settle a collection of federal and state criminal and civil charges that it had improperly marketed Geodon and three other drugs.

Geodon, which made Pfizer $1 billion in 2009, is already approved for the treatment of bipolar disorder and schizophrenia in adults. Its competitors AstraZeneca and Eli Lilly have already secured FDA approval to use their respective antipsychotics Seroquel and Zyprexa to treat bipolar disorder in children.

Treatment of children with antipsychotics remains a controversial practice amid growing concern over major side effects such as severe metabolic changes and weight gain.

Although Geodon’s most recent safety trial has been canceled, the company made it clear that it still plans to secure FDA approval for pediatric use of the drug.

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Drug Firms Face Bribery Probe from US Department of Justice

Tuesday, October 5th, 2010

Justice Department, SEC Seek Information From Companies on Payments to Overseas Officials

Wall Street Journal, October 5, 2010

by Michael Rothfeld

Federal investigators are looking at ways that drug makers could be paying bribes overseas to boost sales and speed approvals, according to letters sent to the companies and people close to the matter.

Big companies—including Merck & Co., AstraZeneca PLC, Bristol-Myers Squibb Co. and GlaxoSmithKline PLC—in recent months have disclosed they are being investigated for possible violations of a 1977 law that makes it illegal for companies whose stock is traded in the U.S. to bribe government officials in other countries to get business.

[PHARMA]

The companies said they are cooperating with the government, with several adding that the investigation is industry-wide and broader than their companies specifically. Many said they have policies meant to ensure compliance with the Foreign Corrupt Practices Act.

So far, none of the companies has been accused of wrongdoing, and the investigation ultimately may not result in charges.

The Justice Department and the Securities and Exchange Commission requested that companies voluntarily report any violations of the FCPA. Some companies, including SciClone Pharmaceuticals Inc. and Eli Lilly & Co., disclosed receiving subpoenas from the SEC. Baxter International Inc. also has said it is being investigated.

The investigation is targeting transactions in Brazil, China, Germany, Italy, Poland, Russia and Saudi Arabia, people familiar with the matter said.

The Justice Department and the SEC declined to comment.

Such requests from the government typically kick off internal investigations at companies, which generally comply with the requests in order to win leniency from the government if a violation is found.

A lawyer for one drug company said the industry has been vexed because the recent requests were so broad and because the investigations, across operations in several countries, can cost millions of dollars.

“If you don’t have any specifics, a lot of this is just guesswork,” the lawyer said. “Everyone was running around to get in the door to meet with the government so they can better understand what the issues are.”

Letters from the government to one of the companies, which were reviewed by The Wall Street Journal, identified four types of possible violations: bribing government-employed doctors to purchase drugs; paying company sales agents commissions that are passed along to government doctors; paying hospital committees to approve drug purchases; and paying regulators to win drug approvals.

People familiar with the situation said the other companies received similar letters.

The requests are similar to the government’s actions in an older bribery probe involving medical devices. In that investigation, settlement talks are ongoing with several companies, according to a person familiar with the matter.

Representatives for Merck, AstraZeneca, Bristol-Myers, Glaxo and Baxter declined to comment on the probe beyond saying they were cooperating fully with the government.

A SciClone spokeswoman declined to comment beyond the company’s SEC filings, in which it said it was subpoenaed for documents relating to its practices in China. A Lilly spokesman referred to an SEC filing in which the company said the U.S. government expanded to other countries an investigation of its Polish subsidiaries that began in 2003.

U.S. officials and European regulators have become increasingly aggressive in investigating foreign bribery cases in recent years. U.S. officials recently have threatened to file charges against executives and not just their companies.

The pharmaceutical industry is particularly vulnerable because government plays a bigger role in administering medicine in many foreign countries than it does in the U.S. and drugs are highly regulated, which creates contact with public officials. Doctors and hospital administrators often are government employees overseas.

Some of the alleged bribes could involve payments to doctors to influence drug trials, people familiar with the situation said. Justice Department officials have said publicly that drug companies also could face charges if they bribe government officials in the guise of payment for travel, meals, entertainment or speaking fees.

Read the rest of this article here: http://online.wsj.com/article/SB10001424052748704847104575532091781199092.html

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Big Pharma’s Next Big Thing: Antipsychotic Medicines for Preschoolers

Thursday, September 9th, 2010

BNET

By Jim Edwards

Dr. Joan Luby, the preschool depression researcher at the center of a New York Times article that failed to mention her past research was funded by Johnson & Johnson (JNJ), Shire (SHPGY) and AstraZeneca (AZN), is currently testing the antipsychotic Risperdal on autistic children aged 30 months to 5 years old, according to the ClinicalTrials.gov database. Although the study is not funded by Janssen, the unit of J&J that makes Risperdal, it nonetheless typifies a new field of drug research: The use of mood-altering pharmaceuticals on the very, very young.

The NYT piece investigated the development of preschool depression as a diagnosis. Slate, like me, found it surprising that the author did not believe Big Pharma’s interest in the field was relevant. Minyanville thought the same thing. Such research is controversial. In November 2008, the FDA said antipsychotic drugs were over-used in children and that more should be done to discourage doctors from treating unruly kids with powerful drugs.

Luby — who also believes that certain antidepressants may be effective in children, according to this press release — is just one researcher looking at extending the use of antipsychotics to very young kids. Here’s a study on Lithium vs. Risperdal in kids aged 7 and up. And here’s a similar trial on kids aged 6 and up. GlaxoSmithKline (GSK) is currently testing Paxil on 7-year-olds despite that medicine’s well-document propensity to trigger suicides in young patients.

The reason the FDA has warned against use of these drugs in kids is twofold: First, many of these products are not approved for use in children. Risperdal — the product in the Luby study of 30-month olds — is only approved for use in autistic children older than 5; and for schizophrenics older than 13. Eli Lilly (LLY)’s competing antipsychotic Zyprexa is not indicated for anyone below the age of 13.

Read the rest of this article here http://www.bnet.com/blog/drug-business/big-pharma-8217s-next-big-thing-antipsychotic-medicines-for-preschoolers/5624?tag=content;drawer-container

To see what side effects doctors, pharmacists,  health care providers and consumers have reported to the US FDA regarding antipsychotics and antidepressants on children (including 0-1 year olds) search CCHR’s decrypted FDA Medwatch reports here http://www.cchrint.org/psychdrugdangers/medwatch_psych_drug_adverse_reactions.php

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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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Glaxo Still Haunted by Faked Paxil Studies in Kids; Crooked psychiatrist expected to plead guilty to criminal charges today

Thursday, August 19th, 2010

“The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.”

BNET
By Jim Edwards
August 19, 2010

A crooked doctor who faked data in a GlaxoSmithKline (GSK) study of the antidepressant Paxil in children pled guilty to criminal charges today, causing groans among GSK’s senior management as the company hopes to fend off a different criminal investigation into whether it manipulated clinical data on its diabetes drug, Avandia. She was sentenced to 13 months in prison.

The two cases are technically completely separate, but they’re both about data manipulation. GSK has been accused of sitting on data showing risks on both drugs; and the FDA previously shut down one of GSK’s factories where both drugs were made.

Thus, the expected guilty plea of Dr. Maria Carmen Palazzo today is a reminder to managers everywhere that cutting ethical corners can cause unwanted chickens to return to their roosts, even years later.

Palazzo was indicted in 2007 on 40 counts of defrauding Medicare and Medicaid at her New Orleans clinic, and 15 counts of conducting fraudulent clinical trials. The charges followed an FDA accusation that she had enrolled 26 children in studies of Paxil for obsessive-compulsive disorder and major depressive disorder. She included children in the trial — which was given the cutesey nickname “Kiddie-Sads-Present and Lifetime” — who did not have the diagnoses being studied. GSK gave her more than $5,000 for each child she enrolled.

At trial, Palazzo was convicted on 39 counts of healthcare fraud and was sentenced to 87 months in prison and forfeiture of $655,000. The clinical trial fraud charges were thrown out, but prosecutors appealed and won a ruling this year reinstating those charges. That appears to be the reason Palazzo is reappearing in court to make a plea.

The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.

Read entire article here:  http://www.bnet.com/blog/drug-business/10-years-later-glaxo-still-haunted-by-faked-studies-of-paxil-in-kids/5545

Read more about Palazzo here:
http://medicaresmostwanted.blogspot.com/2007/06/dr-maria-carmen-palazzo-has-been.html

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