Dr Mercola has published an article today about the testing of dangerous drugs and vaccines on children. He has a passionate concern to protect children from the serious harm that these drug trials can cause. "The first principle of the Nuremberg Code—that doctors must obtain voluntary informed consent from the person about to be experimented on—appears to be frequently ignored, especially when it comes to clinical trials of experimental vaccines. In recent news, the Argentinean Federation of Health Professionals accused GlaxoSmithKline of misleading participants and pressuring impoverished, disadvantaged families into enrolling their children in clinical trials of the experimental Synflorix pediatric pneumonia vaccine. Fourteen of the children participating in the experimental vaccine trial died." I urge you to read his article.
Illiterate patients say they never agreed to take part in trials run by industry worth £189m
Western pharmaceutical companies have seized on India over the past five years as a testing ground for drugs – making the most of a huge population and loose regulations which help dramatically cut research costs for lucrative products to be sold in the West. The relationship is so exploitative that some believe it represents a new colonialism.
Read article in The Independent (UK)
Read about it here. Why would Pfizer have chosen Africa for its drug trials, do you think? - I think we can make an educated guess. The legalities are easier. Possible victims would find it harder to seek compensation, even if they have managed to stay alive...
You could read John le Carré's novel The Constant Gardener or watch the excellent film of it, to learn rather more of the dark facts of African drug-trials. You may also find this blogpost of mine interesting. Sobering facts like these need to be borne in mind when new drugs are eagerly sought or welcomed. They come at a heavy cost, and it is not our cost.
See BBC News report. "Doctors and patients are being misled about the effectiveness of some drugs because negative trial results are not published, experts have warned.
Writing in the British Medical Journal, they say that pharmaceutical companies should be forced to publish all data, not just positive findings."
Pharmaceutical companies cannot be trusted. There is systematic manipulation and abuse of scholarly publishing by the pharmaceutical industry and its commercial partners in their attempt to influence the health care decisions of physicians and the general public.
Quite apart from the criticisms being published about these particular drug trials, it should be recognised that antidepressant drugs work no better than dummy pills anyway and should not be being prescribed. Most antidepressants make you fatter and damage your health in many other ways too, so it's best to avoid these harmful, useless drugs.
MIND, the mental health charity, recommends a walk in the country as being helpful in lifting depression.
Are you on a diet? - Dieting is an often overlooked, but significant cause of depression. Good nutrition is an excellent way to improve your health. Obviously when you are not eating enough for the needs of your body and your brain, you will experience both physical and mental harm. - It is not necessary (or desirable, or effective or even safe) to diet to lose weight. The safe, natural way to lose excess weight is to cut down on salt and salty food. Avoid ready meals and takeaways because these are usually highly salted and offer poor nutrition. They are likely to worsen your feelings of depression.
European ombudsman Nikiforos Diamandouros has called on the European Medicines Agency (EMA) to grant access to clinical study reports and trial protocols for anti-obesity drugs. His demand follows a complaint from Danish healthcare researchers who wanted to conduct an independent analysis of the drugs. In 2007, the researchers, from a health and information centre, asked to see clinical study reports and corresponding trial protocols for two anti-obesity drugs. They explained that they wanted to conduct an independent analysis given that, in their view, biased reporting on drug trials was common.
Read article at theparliament.com
See Jamie Horder's sensible article in today's Observer: here.
See Roger Highfield's article in the Telegraph.
I'm against drug testing on animals. Nor do I believe the results can ever be trusted. There are too many reports of falsification by or instigated by the drug companies.
A Zambian traditional leader has fumed over reports that a number of his female subjects who underwent a microbicide gel clinical trials have contracted HIV, the virus that cause AIDS. Close to a quarter of volunteers that took part in a microbicide gel clinical trials in Southern Zambia contracted HIV, 12 months after the commencement of the trial. Zambian authorities have remained mute over the development while officials from the Microbicide Development Programme in Zambia and United Kingdom have pains to explain what went wrong during the clinical trials. Chief Mwanachingwala who presides over the affected site in Mazabuka of southern Zambia has expressed regret at the leaked results of the trials. The traditional leader has claimed that the Microbicide Development Programme enrolled illiterate and uneducated women who did not understand the nature of the clinical trials and its consequences.
Read article at africanews.com
"Doctors and patients may not get the full story on some prescription drugs because companies sidestep rules and hide test results, according to researchers in Canada, France and Britain. Anyone doing a clinical trial of a drug is supposed to announce publicly that the trial is under way and describe its goals. But David Moher of the Ottawa Hospital Research Institute said many tests are conducted without this disclosure. This allows scientists, or the drug companies who pay for the work, to release good results but quietly cancel anything that looks bad for their product. "Selective outcome [result] reporting is prevalent," Dr. Moher's study concluded."
Read article in the Ottawa Citizen (Canada)
If you have often suspected that drug studies are rigged by the pharmaceutical manufacturer, you are right. "Drug studies skewed toward study sponsors," reported The Washington Post. "Industry-funded research often favors patent-holders, study finds." Specifically, the American Journal of Psychiatry study authors said, "In 90% of the studies, the reported overall outcome was in favor of the sponsor's drug... On the basis of these contrasting findings in head-to-head trials, it appears that whichever company sponsors the trial produces the better antipsychotic drug."
Read news release from the Orthomolecular Medicine News Service at orthomolecular.org
The following is from http://www4.dr-rath-foundation.org/Newsletter/archive/newsletter_2008_09_sep_23.html
Concern Raised about 'Cancer Publication Bias'
Less than 20 percent of registered clinical trials of cancer treatment are eventually published in medical journals, according to a study published online by the journal "The Oncologist."
Read article at marketwatch.com
Comment: The publication rate was particularly low for "industry-sponsored" studies, such as those funded by pharmaceutical companies -- just 5.9 percent, compared to 59 percent for studies sponsored by collaborative research networks. The researchers suspect that the rate of negative results is much higher in the studies that have gone unpublished.
Man dies in government cancer drug trial
Article in the Sunday Telegraph
Extracts:
"Gary Foster, 27, was repeatedly given twice the amount of chemotherapy drugs he should have been prescribed.
He was due to be married this month.
Reports have said his death was caused by an error in the setting up of the trial on the computer system at University College London Hospital (UCLH).
A second patient was affected by the same mistake, but survived.
When the MRC suspected patients had been given overdoses, instead of calling the hospital immediately it wrote a letter - which a nurse at UCLH failed to open until two days after Mr Foster had died."
"UCLH has been forced to suspend the trial, called TE23, which tests whether a combination of five drugs is better at treating testicular cancer than the standard treatment of three drugs.
It has, however, being continued at other UK hospitals.
Mr Foster, a graphic designer, had just been diagnosed with testicular cancer.
He was told he had a 60 per cent chance of survival."
"Mr Foster received the drugs during visits to UCLH between June and September 2007. On seven occasions, he received 30,000 units of bleomycin - of one of the five drugs - instead of 15,000.
A third patient died at a different hospital after receiving an overdose of the same drug due to an error by a nurse or doctor. However the Medical Research Council (MRC), the government body which ran the trial, said the drug was not the direct cause of his death.
An inquest heard Mr Foster began to show signs of deterioration after taking the drugs.
Eventually he developed a dry cough, a symptom of damage to his lungs that had been caused by the overdose of bleomycin. The lung damage was eventually fatal.
The inquest heard the cough should have been recognised by doctors and nurses as a warning sign. However, he was given a final dose."
Obviously there's a degree of medical negligence here that caused avoidable suffering and the sad death of Gary Foster. It was not just bad luck or mistakes. - But I'd be very surprised if any sanctions are taken against the negligent personnel responsible. - And therein lies the most common cause of medical negligence...
Cancer drug trials 'being stopped too soon'
Extract from the Telegraph:
"The usefulness of some cancer drugs is being exaggerated because manufacturers are stopping trials the moment they find a benefit, experts will warn today.
Researchers have discovered a sharp increase in the number of studies that are terminated early and they argue that drugs companies are halting the trials whenever benefits are discovered. They use the premature results as the basis for licence applications.
As a result, the researchers claim, drugs that are hailed as breakthroughs could be of less benefit or even cause more harm.
A team from the Mario Negri Institute for Pharmacological Research, in Milan, found that of 14 drugs trials stopped early between 2005 and 2007, 11 were used to support a licence application.
Writing in the online journal Annals of Oncology, Dr Giovanni Apolone, of the research team, said: "This suggests a commercial component in stopping trials prematurely.
"We are aware that trials stopped early because they are showing benefit may result in the identification of promising new treatments for patients.
"However, findings obtained in this way require subsequent confirmation. Without such evidence, unsafe and ineffective drugs could be marketed and patients' health could well be jeopardised."
Trials on well-known drugs regarded as breakthroughs, are among those which stopped early. They include Herceptin and Tyverb for breast cancer and Avastin for bowel and renal cancer."
From the latest newsletter of The Dr. Rath Health Foundation:
Big Pharma really makes me feel sick
FOR CLARITY'S sake, remind yourself that nobody at GlaxoSmithKline , Britain 's biggest pharmaceutical company (2006 revenues: $42.8 billion; income $10.135bn), is to face prosecution. The company insists that it did nothing wrong with regard to the anti-depressant drug Seroxat. The Medical and Healthcare Regulatory Agency believes, on the other hand, that the company withheld the full results of trials, particularly those suggesting that the medication could increase the chances of suicide among teenagers. The government is content, however, to "tighten" rules on information disclosure as they affect an industry that ranks, after oil, as Britain 's second biggest export earner.
Read article by Ian Bell in the Sunday Herald (UK)
Comment: Cynics might argue that the British government’s decision not to prosecute GlaxoSmithKline for withholding the full results of drug trials is a direct result of the fact that Jean-Pierre Garnier, GlaxoSmithKline ’s CEO, is a member of Prime Minister Gordon Brown’s Business Council…
So much for the wonder drug - Sunday Telegraph
Extracts:
"More than three per cent of the population are now taking statins, at a cost to the NHS of £730 million last year. They have gained the reputation of being something of a wonder drug and are now prescribed not just for patients already suffering from heart disease but also for those identified as being at risk of developing cardiac problems in the future. The Government claims that its policy of encouraging the prescription of statins saves up to 7,000 lives a year.
Now, though, doubts are being raised over whether statins really live up to the hype. Dr James LeFanu, medical columnist of The Sunday Telegraph, highlighted the issue a month ago - and has since received more than 400 letters from readers who have had a less than happy experience with the drugs."
"So far, the Government and the medical establishment disagree with Dr LeFanu and those patients who have stopped taking their statins. The biggest British study into the effectiveness of the drug, published in The Lancet five years ago, followed 20,536 patients who took simvastatin or a placebo over five years. It concluded that for high-risk patients, the drug could cut the risk of heart attacks, strokes or the need for surgery to unblock arteries by about one third. Critically, it said prescribing should be widened to cover increasing numbers of patients, because it had been shown the drug was "so well tolerated and safe".
But the study, funded by the Medical Research Council and the British Heart Foundation, was unusual in one significant respect. Of 63,603 patients screened to take part in the trial, about half - 32,145 - were selected as eligible. Of these, more than one third were subsequently excluded, following a "run-in period" where they tried the drug for up to six weeks. Reasons for their exclusion varied. Overall, 26 per cent either dropped out or were deemed by researchers to be unlikely to keep taking the drugs for the full five years. A further 10 per cent were excluded because their GPs warned of increased risks due to existing health conditions. Others were excluded because of apparent side-effects, such as rising levels of liver enzymes and creatine, and, in some cases, developing muscle weakness.
So, of the 63,603 initially selected, only 20,536 continued - a mere 32 per cent. The chairman of the British Heart Foundation, Professor Peter Weissberg, admits: "It tried everyone on the drug and only the ones who didn't have side-effects were continued. That is unusual, but dozens of other trials have looked at this in a more standard way and have concluded that the side-effects are not major. One of the problems with clinical trials will always be the drop-out rate. The key thing to establish with this trial was: if you take this drug, does it save your life or not? It concluded that it does.""
It's also worth looking at relative risk and number needed to treat
Lose weight AND lower your high cholesterol level AND lower your risk of heart attack by eating less salt! Go on! - Try it! - You will feel so much better!
See my website www.wildeaboutsteroids.co.uk
(The site does not sell anything and has no banners or sponsors or adverts - just helpful information.)
Victims of drug trial get ready to sue U.S firm for millions - Evening Standard article
Extracts:
"A legal letter, obtained by the Evening Standard newspaper, shows that if a deal is not on offer by Monday - the eve of the first anniversary of the test - writs will be issued, prompting a legal battle worth millions of pounds.
Six men suffered organ failure caused by a drug that had never previously been tested on humans. One of the volunteers was described as looking like the Elephant Man following the trial at a private clinic at Northwick Park Hospital in northwest London.
The men spent several weeks in hospital including the worst affected Ryan Wilson, 21, a trainee plumber from Islington, who has since had several toes and fingers amputated. "
"The letter sent to lawyers acting for Parexel, the US firm that carried out the tests on behalf of a German pharmaceutical company, states: "Our clients are champing at the bit for proceedings to commence.
With the anniversary of the trial coming up in a few days time they very fairly take the view that as Parexel has failed to come up with any sort of proposal over the last 12 months, it is highly unlikely your client will do so now.
However, we have persuaded them to give your client one final opportunity to come forward with a proposal that they are likely to find acceptable.
We write to put you on notice that if we do not receive this proposal by close of business-on the 365th day after the trial ie 12 March 2007 we are instructed to issue proceedings." "
Prosecutors target Russian clinic testing British firm's MMR vaccine
Extract:
"Russian prosecutors have opened a criminal investigation into a clinic after unsubstantiated allegations that a vaccine made by the British drugs company GlaxoSmithKline has had disturbing side effects in a clinical trial. Prosecutors in Volgograd are investigating a clinic that tested the chickenpox, measles, mumps and rubella vaccine on 100 babies between the ages of one and two.
Prosecutors say at least one of the children developed alarming symptoms after receiving the vaccine. A regional court last week halted the trial, by the city's Independent clinical hospital, amid complaints from parents that they had not been fully informed they were taking part in an experiment."
Doctors to face regular competency tests
Extract:
"Doctors are to face checks every five years to check that they are competent to continue working, under new plans announced today.
The Government is also to strip the doctors' regulatory body of a key powers, in a move likely to anger medical professionals.
The General Medical Council will lose the right to adjudicate in fitness to practise cases when complaints are made against doctors.
The GMC will still investigate concerns about doctors but the final decision on what happens to a doctor is likely to pass to an independent tribunal.
The Government's White Paper is part of a response to the Shipman inquiry, which was heavily critical of the GMC. "
Well it's certainly high time for the GMC to be stripped of its adjudication of complaints about doctors since it has always so scandalously favoured doctors over complainants. But I question the procedures that will comprise the competency tests. - Consider the following:
The high prices of new drugs is claimed to be necessary to pay the huge costs involved in the research and testing that by law has to precede the launch of a new drug. - But this 'justification' rings very hollow to me, a steroid victim.
The British National Formulary is a reference book doctors are assumed to use to look up important information about the drugs they prescribe. - For well over 20 years certainly, and maybe even longer, sodium retention has been among the side-effects listed for the drug that made me a steroid victim. - Because of this side-effect of sodium retention, all patients who are prescribed this medication, or any other of the many medications that result in sodium retention, should be warned not to eat salt or food containing added salt/sodium while taking the medication. - I was not given this VITAL warning and I do not know of even ONE person who was given this warning! - In consequence there are scores of thousands of steroid victims in this country - made needlessly and gravely ill and disabled because they were not given a simple piece of information, which surely, is the very reason that for all the expensive testing... - What use, then, all the testing? all the vast expense? all the laboratory animals that suffered to provide information for the researchers? - ARE ANY OF THE MANY, MANY DOCTORS WHO PRESCRIBE STEROIDS (INCLUDING PREDNISOLONE AND HRT) ET AL IN THIS NEGLIGENT WAY COMPETENT TO PRACTISE? - NOT IN MY OPINION. - THEY ARE CERTAINLY NOT COMPETENT TO PRESCRIBE OR TO MONITOR THESE DRUGS. - The drug companies themselves must have long known of the need to avoid salt while taking these medications and must also have soon become aware, as the numbers of steroid victims grew, that doctors were not giving the warnings, but there was no warning on the packs of drugs with which I was issued...
When is this scandalous situation going to be remedied? - My MP, Nick Clegg, wrote to the Secretary of State for Health about it last year but received only complacency in the response from Andy Burnham, and no promise of any action. See Individuals and agencies who are responsible for the 'Obesity Epidemic' - I hope you will read the whole page.
Anti-obesity drugs 'need safety data'
Extract from the report:
"In light of the lack of successful weight-loss treatments and the public
health implications of the obesity pandemic, the development of safe and
effective drugs should be a priority," Dr Raj Padwal and Dr Sumit Majumdar
from the University of Alberta Hospital, Canada, said.
"We think that anti-obesity drug trials powered to show clinically important
reductions in major obesity-related morbidity and mortality should be
required either before these drugs are approved for widespread use or as a
condition of ongoing approval".
Well I'm pleased that someone is concerned about the safety of these drugs. But in my informed opinion, "trials powered to show clinically important reductions in major obesity-related morbidity and mortality should be required" to test the efficacy of the universal advice from health professionals and their retinues, that to lose weight, obese people must eat fewer calories and/or take more exercise, because such trials HAVE NEVER BEEN DONE and there is therefore no scientific evidence to support the advice that is being given, either for its effectiveness or for its safety...)o:
Obesity is caused not by excess calories, but by fluid retention.
All that is normally necessary to lose weight is to eat less salt/sodium, and, preferably, eat plenty of fresh fruit and vegetables, because the potassium these contain helps to displace excess sodium from the body. See my website http://www.wildeaboutsteroids.co.uk/ and in particular read about the politics - on page http://www.wildeaboutsteroids.co.uk/story.html - of the 'medical misinformation' which is the cause of the increasing incidence and severity of obesity.
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