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XTEND-15sec-NEWSt
3th March 2004

Please click on the summary link of interest:


Drug Company tells staff to withhold crucial information...n1

An internal document advised staff at the international drug giant GlaxoSmithKline (GSK) to withhold clinical trial findings in 1998 that indicated the antidepressant paroxetine (Paxil in North America and Seroxat in the UK) had no beneficial effect in treating adolescents.

The gist of this memo was to keep quiet the clinical findings of two trials which found:

  1. That a study in the US between 1993 and 1996 found that Paxil was no more effective than a placebo.
  2. That a later study established that the placebo was actually MORE effective than the drug itself.

Last year several countries banned this drug for children as it had been established as being responsible for suicides. For more information read an article published in the Canadian Medical Association Journal within the last few weeks. Click here.

Warren Matthews comments: Unfortunately this is just the 'tip of the iceberg' when it comes to manipulation of information in the pharmaceutical, and to some extent in the supplement industry. At least the manipulation in the supplement industry is usually accompanied with a fair degree of hype and most intelligent readers can see through it. But, people tend to believe the statements made by the big pharma companies as they are indirectly supported by government and mainstream medicine.

I have to say I find it hard to understand the heartlessness of the heads of some of these companies who obviously consider shareholder returns are more important than the wellbeing of their customers.

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Conflicts of interest... you be the judge!n2

US Rep. Billy Tauzin, resigned Tuesday as chairman of the House Energy and Commerce Committee, one of the most powerful positions in Congress. He announced he will not seek re-election in the fall.

He was instrumental in engineering passage of the new Medicare prescription drug law passed by Congress in December.

His resignation has raised eyebrows as it is believed that he is taking up a position as a potential head of a pharmaceutical lobbying group known as the Pharmaceutical Research and Manufacturers of America, or PhRMA, which represents big drug manufacturers such as Eli Lilly and Co. and Merck & Co. He has acknowledged interest in the job.

Common Cause, a private watchdog group, has expressed concern about Tauzin's having job discussions while still chairman of the committee that deals with legislation affecting those same industries.

Warren Matthews comments: I don't mean to be specifically 'picking' on pharmaceutical companies this week, but one can't help wondering how impartial legislators are when helping draft new legislation which will benefit specific industry groups whilst at the same time negotiating a possible personal employment contract with the very same group?

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Gouging the poor?n3

Last month there was an interesting article written by Barbara Ehrenreich of the "Progressive" relating to the treatment of non insured people by some US hospitals. In case you have the misfortune to end up in hospital you may wish to read this article which you can do by clicking here.

Warren Matthews comments: As you have heard me say many times... stay out of hospital as they are dangerous places! Nonetheless most of us end up in one at some time during our lives whether it is from an accident or some other cause. If you live in the US a stay in hospital can indeed be an expensive experience. If the facts are correct in the article above it could also be a potential ticket to jail time if you are uninsured and cannot pay.

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Important notice: All material provided within XTEND-15sec-NEWS is for informational and educational purposes only, and is not to be construed as medical advice or instruction. No action should be taken solely on the contents of this publication. Consult your physician or a qualified health professional on any matters regarding your health and wellbeing or on any opinions expressed within this newsletter. The information provided in this newsletter is believed to be accurate based on the best judgment of the editor but the reader is responsible for consulting with their own health professional on any matters raised within.





Pharmaceutical Industry (Full Article)f1

Drug company experts advised staff to withhold data about SSRI use in children

Wayne Kondro
Ottawa

An internal document advised staff at the international drug giant GlaxoSmithKline (GSK) to withhold clinical trial findings in 1998 that indicated the antidepressant paroxetine (Paxil in North America and Seroxat in the UK) had no beneficial effect in treating adolescents.

Paroxetine is 1 of 6 drugs in the class of selective serotonin reuptake inhibitors (SSRIs) that Britain and the US have since banned for pediatric use because of increased risk of suicide. On Feb. 2, Health Canada issued a public warning that the pediatric use of 7 antidepressants - paroxetine, bupropion (Wellbutrin), citalopram (Celexa), fluvoxamine (Luvox), mirtazapine (Remeron), sertraline (Zoloft) and venlafaxine (Effexor) - should proceed only after consultation with the treating physician "to confirm that the benefits of the drug still outweigh its potential risks."

The GSK internal document obtained by CMAJ offers a glimpse into the inner workings of a drug giant. Entitled "Seroxat/Paxil Adolescent Depression: Position piece on the phase III clinical studies," the confidential document was prepared by the Central Medical Affairs team (CMAt), a division of SmithKline Beecham (which subsequently merged with Glaxo Wellcome to form GSK).

The document provides guidance on how to manage the results of 2 clinical trials conducted into the efficacy of paroxetine (Seroxat). Given that the clinical trials results were, according to the document, "insufficiently robust" to support an application to regulatory authorities for a label change approving Seroxat for use in pediatric depression, CMAt recommended the firm "effectively manage the dissemination of these data in order to minimize any potential negative commercial impact."

Sales for Seroxat amounted to almost $4.97 billion worldwide in 2003.

Study 329, conducted in the US from 1993-1996, was the largest trial to date on using an SSRI in a pediatric population. According to the document, the results indicated paroxetine was no more effective than placebo. In the other trial, Study 377, carried out in Europe, South America and elsewhere, placebo was actually more effective than the antidepressant.

The CMAt document advised that "Positive data from Study 329 will be published in abstract form at the [European College of Neuropsychopharmacology] meeting" in November 1998 and that "a full manuscript ... will be progressed." It also stated that "It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine."

GSK spokeswoman Jill McKinlay-Morris said that "the memo draws an inappropriate conclusion and is not consistent with the facts." She didn't elaborate on that point, but went on to say "GSK abided by all regulatory requirements for submitting safety data. We also communicated safety and efficacy data to physicians through posters, abstracts, and other publications."

Study 329 was eventually published (J Am Acad Child Adolesc Psychiatry 2001;40[7]:762-72) in 2001. The authors concluded that paroxetine is "generally well tolerated and effective for major depression in adolescents." Among the 93 adolescents taking Seroxat, there were 5 serious cases of "emotional lability" (e.g., suicidal ideation/ gestures). Among the 95 patients taking the comparison treatment, imipramine (Tofranil), there was 1 such case, and among the 89 subjects receiving placebo there was also 1. According to the article, only 1 serious adverse event - headache in 1 patient - was considered by the treating investigator to be related to paroxetine treatment.

Britain's Medicines and Healthcare products Regulatory Authority (MHRA) advised doctors in June 2003 that paroxetine should not be prescribed to patients under the age of 18 because evidence from various clinical trials showed that episodes of suicidal behaviour were between 1.5 and 3.2 times higher in children taking the drug than in those receiving placebo. Several nations, including the US, France and Ireland, quickly followed suit.

The MHRA subsequently reviewed and banned the pediatric use of 6 other SSRIs (exempting fluoxetine [Prozac]) and is now reviewing their use among adults. The US Food and Drug Administration is now reviewing pediatric trials of 8 antidepressants. It's been estimated that as many as 11 million American, and 3 million Canadian children are taking antidepressants. - Wayne Kondro, Ottawa, and Barbara Sibbald, CMAJ.

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Gouging the Poor (Full Article)f2
By Barbara Ehrenreich
The Progressive

February 2004 Issue

There's been a lot of whining about health care recently: the shocking cost of insurance, the mounting reluctance of employers to share that cost, the challenge--should you be so lucky as to have insurance--of finding a doctor your insurance company will deign to reimburse, and so forth. But let's look at the glass half full for a change. Despite the growing misfit between health care costs and personal incomes, it is not yet illegal to be sick.

Not quite yet, anyway, though the trend is clear: Hospitals are increasingly resorting to brass knuckle tactics to collect overdue bills from indigent patients. Take the case of Martin Bushman, an intermittently insured mechanic with diabetes who, as reported in The Wall Street Journal, had run up a $579 debt to Carle Hospital in Champaign-Urbana. When he failed to appear for a court hearing on his debt rather than miss a day of work, he was arrested and hit with $2,500 bail. Arrests for missed court dates, which the hospitals whimsically refer to as "body attachments," are on the rise throughout the country. Again, on the half full side, we should be thankful that the bodies attached by hospitals cannot yet be used as sources of organs for transplants.

Mindful of their status as nonprofit charitable institutions, hospitals used to be relatively congenial creditors. My uninsured companion of several years would simply work out a payment arrangement--on the scale of about $25 a month for life--and go on consuming medical care without the least concern for his freedom. No longer, and it's not just the dodgier, second-rate hospitals that are relying on the police as collection agents. Yale-New Haven Hospital, for example, has obtained sixty-five arrest warrants for delinquent debtors in the last three years.

Of course, if you work for Yale-New Haven, it's not your body that gets "attached." On a recent visit to Yale hospital workers, I met Tawana Marks, a registrar at the hospital, who had the misfortune to also be admitted as a patient. Unsurprisingly, her hospital-supplied health insurance failed to cover her hospital-incurred bill, so Marks now has her paycheck garnished by her own employer--a condition of debt servitude reminiscent of early twentieth century company towns.

To compound the sufferings of the sick and sub-affluent, hospitals now routinely charge uninsured people several times more than the insured. The Fort Lauderdale Sun-Sentinel reports that one local hospital charged an uninsured patient $29,000 for an appendectomy that would have cost an insured patient $6,783. According to the Los Angeles Times, in one, albeit for-profit, California hospital chain, the uninsured account for only 2 percent of its patients, but 35 percent of its profits. The explanation for such shameless gouging of the poor? Big insurance companies and HMOs are able to negotiate "discounts" for their members, leaving the uninsured to pay whatever fanciful amounts the hospital cares to charge, such as, in one reported case, $50 for the use of a hospital gown.

Back in 1961, psychiatrist Thomas Szasz noted the "medicalization" of behavior formerly classified as crime or sin, such as drug addiction or what was defined as sexual deviance. Rather than seeing this as a benign and potentially merciful trend, the crotchety Szasz complained about the growing concentration of power in the hands of a "therapeutic state." How quaint his concern sounds today, when instead of the medicalization of crime, we are faced with the criminalization of illness.

Because almost everyone, no matter how initially healthy and prosperous, is now in danger of falling into the clutches of the medical/penitentiary system. It could start with a condition--say, high blood pressure or diabetes--serious enough to be entered into your medical record. Next you lose your job, and with it your health insurance--or, as in the case of 1,000 or so freelance writers (including myself) once insured through the National Writers Union, the insurance company simply decides it no longer wants your business. You go to get new insurance, but no one wants you because you now have a "pre-existing condition." So when that condition flairs up or is joined by a new one, you enter the hospital as a "self-pay" patient, incur bills four times higher than an insured patient would, fall behind in paying them, and, given the hospitals' predatory collection tactics, wind up in jail.

Sociologists have long seen a connection between sickness and criminality, classifying both as forms of deviance. Certainly, the relevant vocabularies have been converging: Note the similarity between the phrases "pre-existing condition" and "prior conviction," as well as the use of the terms "record" and "case." A doctor once told me that, although he had detected a new and potentially life-threatening condition, he would refrain from prescribing anything to correct it, lest my record be marred by yet another pre-existing condition.

The day will come when we look back on such small acts of kindness with nostalgia. Even as I write this, some bright young MBA at Aetna or Prudential is no doubt coming to the conclusion that a great deal of money and valuable medical resources could be saved through the simple expedient of arresting people at the first sign of illness. Skip the intermediate stages of diagnostic testing, hospitalization, and attempted debt collection, and proceed directly to incarceration. The end result will be the same, unless you succeed in concealing that cough or unsightly swelling from the cop on his or her beat.

I'm prepared for this eventuality, having been raised by a mother who was in turn raised by her Christian Scientist grandparents, and had thus been trained to greet her children's symptoms with contempt and derision. I was conditioned, in other words, to conflate physical illness with moral failure. Should a rash or sore throat arrive, I stand ready, at some deep psychic level, to serve my time.

But for those of you who still imagine that illness and pain should elicit kindly responses from one's fellow humans, I have one last half full observation: Our prisons do offer health care--grossly inadequate care to be sure--but at least it's free, even for child molesters, ax murderers, and those miscreants who have the gall to be both sick and uninsured.

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