Wednesday, February 27, 2008
After antidepressant treatments are discredited, fears grow that other products may be ineffective
By Jeremy Laurance, Health Editor
Wednesday, 27 February 2008
The pharmaceutical industry came under assault from senior figures in medical research yesterday over its practice of withholding information to protect profits, exposing patients to drugs which could be useless or harmful.
Experts criticised the stranglehold exerted by multinational companies over clinical trials, which has led to biased results, under-reporting of negative findings and selective publication driven by the market, which was worth £10.1bn in the UK in 2006, amounting to 11 per cent of total NHS costs.
The latest attack was triggered yesterday by an analysis of published and unpublished trials of modern antidepressants, including Prozac and Seroxat, showing they offer no clinically significant improvement over placebos (dummy pills) in most patients. But doctors said patients on the drugs should not stop taking them without consulting their GPs.
It was the first time researchers – from the UK, Canada and the US – had successfully used freedom of information legislation to obtain all the data presented to regulators when the companies applied to license their drugs. In some cases it had not been made public for 20 years. Over the past two decades the drugs, known as selective serotonin re-uptake inhibitors (SSRIs), have been among the biggest selling of all time, earning billions of pounds for their makers. Yesterday's finding suggests that the money may have been misspent. Drug companies are required by law to provide all data on a drug, published and unpublished, to the regulatory authorities when applying for a licence. But this requirement does not apply to the National Institute for Health and Clinical Excellence (Nice), which assesses cost effectiveness and recommends which drugs should be used by the NHS.
Peter Littlejohns, the clinical and public health director of Nice, said: "The regulatory authorities have access to everything. Obviously we have access to the published data and we do ask the industry for unpublished data, but it is up to the companies whether to deliver it or not. We have no power to demand it. The issue is that it relies on the good will of the industry."
Professor Mike Clarke, the director of the UK Cochrane Centre, an international collaboration between researchers in 100 countries which has published more than 3,000 systematic reviews of published trials to establish best medical practice, said lack of co-operation from the drug industry was damaging medical care.
"When we ask for details of a trial the company might tell us nothing. We have even less power than Nice. Researchers trying to make sense of trials for decision-makers need to have access to this data. If we have only got access to half of the data, when we see evidence that a drug works we don't know whether to believe it or not.
"It makes us doubtful – that's the big worry. The companies are in the business of making profits – but they are also in the business of providing safe, effective health care."
Legislation to compel the drug industry to publish its results was included in Labour's manifesto at the 2005 election and last month the Commons Health Select Committee demanded that Nice be given unfettered access to all clinical trial results.
Yesterday, the Government said it had been told that compelling the industry to publish trial data would not be allowed and it was instead pursuing a voluntary approach, developing a "searchable register" of all trials that have taken place in the UK and pressing the EU to make its own confidential register public.
A spokesman for the Department of Health said: "The Government has consistently supported open access to information about research when the findings could affect decisions about treatment or health outcomes. We planned to support the principle of mandatory registration of clinical trials in the UK, but legal advice stated this would be illegal under EU law." A World Health Organisation working group is examining how to improve reporting of clinical trials and is expected to announce a consultation shortly.
The pharmaceutical industry was unrepentant about its strategy yesterday. Richard Tiner, the head of medicines at the Association of the British Pharmaceutical Industries, said: "The regulatory authorities have access to all the data – absolutely everything. Nice is not a regulatory authority – it is making decisions on whether medicines should be available on the NHS... There is no reason why the companies would restrict access – it depends what they are asked for. The industry is very much more transparent than it was 10 years ago."
GlaxoSmithKline, maker of Seroxat, said yesterday it "fully endorsed public disclosure of all clinical trial results" and had published all data relating to Seroxat on its website "regardless of study outcome".
The antidepressant debate
Paul Bough, 41: 'You name it, I've tried it: none of them worked'
"The findings go against several decades of experience. I have suffered three major traumas in my life – my father leaving home when I was 11, my husband having an affair, and now an unpleasant divorce – and I'm convinced these drugs helped me survive them. I've been close to suicide myself, but now, in my 60th year, I'm feeling positive and able to survive all the terrifying experiences each day throws at me. I take 20mg of Fluoxetine each day, and it makes me feel I can cope. I simply don't buy the idea that it's just a placebo – but then I suppose the point is even if it were I wouldn't care. These drugs are my crutch and my comfort; without them I would lose hope altogether. I'm staying on."
Sylvia Genge, 59: 'Without these drugs I would lose hope altogether'
"The findings of this latest report don't surprise me in the slightest. In fact, they confirm what I already knew.
"I've been a depressive for most of my life, and all of my adult life. After the umpteenth failed suicide attempt seven years ago my doctor said I should try taking antidepressant drugs. You name it, I've tried it. Diazepam, Citalopram, Prozac, Seroxat, Atenolol [a beta-blocker], Efexor: none worked. They turned me into a zombie, totally incapable of motivation or movement and forced to vegetate on a sofa.
"I'd say to anyone on these drugs, you're better off going cold turkey. Talk to people, have therapy, be sociable: but don't rely on these little happy pills. Having tried the lot, I'm coming off – and staying off."
Thursday, January 17, 2008
In October of 2001, my sister started getting very sick. She had stomach spasms and she was having a hard time getting around. Walking was a major chore. It took everything she had just to get out of bed; she was in so much pain.
By March 2002, she had undergone several tissue and muscle biopsies and was on 24 various prescription medications. The doctors could not determine what was wrong with her. She was in so much pain, and so sick.she just knew she was dying. She put her house, bank accounts, lifeinsurance, etc., in her oldest daughter's name, and made sure that her younger children were to be taken care of.
She also wanted her last hooray, so she planned a trip to Florida (basically in a wheelchair) for March 22nd.
On March 19 I called her to ask how her most recent tests went, and she said they didn't find anything on the test, but they believe she had MS. I recalled an article a friend of mine e- mail ed to me and I asked my sister if she drank diet soda? She told me that she did. As a matter of fact, she was getting ready to crack one open that moment.
I told her not to open it, and to stop drinking the diet soda! I e- mailed her the article my friend, a lawyer, had sent.
My sister called me within 32 hours after our phone conversation and told me she had stopped drinking the diet soda AND she could walk! The muscle spasms went away. She said she didn't feel 100% but she sure felt a lot better. She told me she was going to her doctor with this article and would call me when she got home.
Well, she called me, and said her doctor was amazed! He is going to call all of his MS patients to find out if they consumed artificial sweeteners of any kind. In a nutshell, she was being poisoned by the Aspartame in the diet soda...and literally dying a slow and miserable death.
When she got to Florida March 22, all she had to take was one pill, and that was a pill for the Aspartame poisoning! She is well on her way to a complete recovery. And she is walking! No wheelchair! This article saved her life.
If it says 'SUGAR FREE' on the label; DO NOT EVEN THINK ABOUT IT!
I have spent several days lecturing at the WORLD ENVIRONMENTAL CONFERENCE on "ASPARTAME," marketed as 'NutraSweet,' 'Equal,' and 'Spoonful.'
In the keynote address by the EPA, it was announced that in the United States in 2001 there is an epidemic of multiple sclerosis and systemic lupus. It was difficult to determine exactly what toxin was causing this to be rampant.
I stood up and said that I was there to lecture on exactly that subject.
I will explain why Aspartame is so dangerous: When the temperature of this sweetener exceeds 86 degrees F, the wood alcohol in ASPARTAME converts to formaldehyde and then to formic acid, which in turn causes metabolic acidosis. Formic acid is the poison found in the sting of fire ants.
The methanol toxicity mimics, among other conditions, multiple sclerosis and systemic lupus. Many people were being diagnosed in error. Although multiple sclerosis is not a death sentence, Methanol toxicity is!
Systemic lupus has become almost as rampant as multiple sclerosis, especially with Diet Coke and Diet Pepsi drinkers. The victim usually does not know that the Aspartame is the culprit. He or she continues its use; irritating the lupus to such a degree that it may become a life-threatening condition.
We have seen patients with systemic lupus become asymptotic, once taken off diet sodas.
In cases of those diagnosed with Multiple Sclerosis, most of the symptoms disappear. We've seen many cases where vision loss returned and hearing loss improved markedly.
This also applies to cases of tinnitus and fibromyalgia. During a lecture, I said, "If you are using ASPARTAME (NutraSweet, Equal, Spoonful, etc) and you suffer from fibromyalgia symptoms, spasms, shooting, pains, numbness in your legs, cramps, vertigo, dizziness, headaches, tinnitus, joint pain, unexplainable depression, anxiety attacks, slurred speech, blurred vision, or memory loss you probably have ASPARTAME poisoning!"
People were jumping up during the lecture saying, "I have some of these symptoms. Is it reversible?"
Yes! Yes! Yes! STOP drinking diet sodas and be alert for Aspartame on food labels! Many products are fortified with it! This is a serious problem.
Dr. Espart (one of my speakers) remarked that so many people seem to be symptomatic for MS and during his recent visit to a hospice, a nurse stated that six of her friends, who were heavy Diet Coke addicts, had all been diagnosed with MS. This is beyond coincidence!
Diet soda is NOT a diet product! It is a chemically altered, multiple SODIUM (salt) and ASPARTAME containing product that actually makes you crave carbohydrates. It is far more likely to make you GAIN weight!
These products also contain formaldehyde, which stores in the fat cells, particularly in the hips and thighs.
Formaldehyde is an absolute toxin andis used primarily to preserve "tissue specimens." Many products we use every day contain this chemical but we SHOULD NOT store it IN our body!
Dr. H. J. Roberts stated in his lectures that once free of the "diet products" and with no significant increase in exercise; his patients lost an average of 19 pounds over a trial period.
Aspartame is especially dangerous for diabetics. We found that some physicians, who believed that they had a patient with retinopathy, in fact, had symptoms caused by Aspartame.
The Aspartame drives the bloodsugar out of control. Thus diabetics may suffer acute memory loss due to the fact that aspartic acid and phenylalanine are NEUROTOXIC when taken without the other amino acids necessary for a good balance.
Treating diabetes is all about BALANCE. Especially with diabetics, the Aspartame passes the blood/brain barrierand it then deteriorates the neurons of the brain; causing various levels of brain damage, seizures, depression, manic depression, panic attacks, uncontrollable anger and rage.
Consumption of Aspartame causes these same symptoms in non-diabetics as well.
Documentation and observation also reveal that thousands of children diagnosed with ADD and ADHD have had complete turnarounds in their behavior when these chemicals have been removed from their diet. So called "behavior modification prescription drugs" (Ritalin and others) are no longer needed. Truth be told, they were never NEEDED in the first place! Most of these children were being "poisoned" on a daily basis with the very foods that were "better for them than sugar."
It is also suspected that the Aspartame in thousands of pallets of diet Coke and diet Pepsi consumed by men and women fighting in the Gulf War, may be partially to blame for the well-known Gulf War Syndrome.
Dr. Roberts warns that it can cause birth defects, i.e. mental retardation, if taken at the time of conception and during early pregnancy. Children are especially at risk for neurological disorders and should NEVER be given artificial sweeteners. There are many different case histories to relate of children suffering grand mal seizures and other neurological disturbances talking about a plague of neurological diseases directly caused by the use of this deadly poison."
Herein lies the problem:
There were Congressional Hearings when Aspartame was included 100 different products and strong objection was made concerning its use. Since this initial hearing, there have been two subsequent hearings, and still nothing has been done. The drug and chemical lobbies have very deep pockets.
Sadly, MONSANTO'S patent on Aspartame has EXPIRED! There are now over 5,000 products on the market that contain this deadly chemical and there will be thousands more introduced. Everybody wants a "piece of the Aspartame pie." I assure you that MONSANTO, the creator of Aspartame, knows how deadly it is.
And isn't it ironic that MONSANTO funds, among others, the American Diabetes Association, the American Dietetic Association and the Conference of the American College of Physicians?
This has been recently exposed in the New York Times. These [organizations] cannot criticize any additives or convey their link to MONSANTO because they take money from the food industry and are required to endorse their products.
Senator Howard Metzenbaum wrote and presented a bill that would require label warnings on products containing Aspartame, especially regarding pregnant women, children and infants. The bill would also institute independent studies on the known dangers and the problems existing in the general population regarding seizures, changes in brain chemistry, neurological changes and behavioral symptoms. The bill was killed.
It is known that the powerful drug and chemical lobbies are responsible for this, letting loose the hounds of disease and death on an unsuspecting and uninformed public. Well, you're Informed now! YOU HAVE A RIGHT TO KNOW!
Please print this out and/or e- mail to your family and friends.
They have a right to know too!!!!!!