Public 'misled' by drug claims

By Michelle Roberts Health reporter, BBC News
 

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.

The German team give the example of the antidepressant reboxetine, saying publications have failed to show the drug in a true light.

Pfizer maintains its drug is effective. Reboxetine (Edronax), made by Pfizer, is used in many European countries, including the UK.  But its rejection by US drug regulators raised doubts about its effectiveness, and led some to hunt for missing data.

This is not the first time a large drug company has come under fire about its published drug trial data.

Trial information Pharmaceutical giant GlaxoSmithKline (GSK) was criticised for failing to raise the alarm on the risk of suicidal behaviour associated with its antidepressant Seroxat.
GSK rejected claims that it improperly withheld drug trial information.

The research authors

But GSK has also been forced to defend itself over allegations about hiding negative data regarding another of its drugs, Avandia, which is used to treat diabetes.

Now researchers from The German Institute for Quality and Efficiency in Health Care say there is unpublished trial data for Pfizer's antidepressant reboxetine that should be made public because it could change views about the drug.

Dr Beate Wieseler and colleagues carried out their own assessment of reboxetine, looking at the results of 13 trials, including eight previously unpublished trials from the manufacturer Pfizer.

They found the drug was no better than a placebo in terms of remission and response rates. And its benefit was inferior when compared with other similar antidepressants.

Furthermore, a higher rate of patients had side effects with reboxetine than with placebo. And more stopped taking the drug because of side effects compared with those taking a placebo or a different antidepressant.

Biased picture The researchers said there has been a publication bias and this had overestimated the benefit of reboxetine and underestimated potential harm. And, they said, it was a widespread problem that applied to many of the drugs in use today.

"Our findings underline the urgent need for mandatory publication of trial data," they say in the BMJ.
They warn that the lack of all information means policy makers are unable to make informed decisions.
In the US, it is already a requirement that all data - both positive and negative - is published. The UK is also striving to achieve this.

The UK's regulator, the MHRA, said: "There is a European initiative to provide public access to the results of clinical trials. The currently planned timeline is that this information could become available in late 2011/early 2012."

A spokeswoman for Pfizer said: "In the UK, Pfizer's reboxetine is licensed for the acute treatment of depressive illness/major depression and for maintaining the clinical improvement in patients initially responding to treatment.
"This medicine presents an effective treatment option to clinicians for the use in patients suffering from these conditions.
"Pfizer discloses the results of its clinical trials to regulatory authorities all around the world. These regulatory authorities carefully balance the risks and benefits of each medication, and reflect all important safety and efficacy information in the approved product labelling.
"Pfizer will review the meta-analysis relating to reboxetine published in the British Medical Journal on 13th October 2010 in detail and will provide further comment after completing the review."
Others lay at least some of the blame with the medical journals that publish drug trial data.
In response, the BMJ has promised to devote an entire issue to the topic next year.
BMJ Editors Dr Fiona Godlee and Dr Elizabeth Loder said: "It is time to demonstrate a shared commitment to set the record straight."

Beauty Parlor Stroke

A grieving widower in the UK is warning women to beware of hair salon stroke, caused by their heads being bent back while being washed. Malcolm Crabb is convinced his wife died of stroke because her head was bent back at the beauty salon while they were washing her hair. His wife Pamela was 51.

He said "I think there should be warnings in hairdressers about it."

Mrs. Crabb had a stroke in September 2000. The stroke hit soon after her appointment. Her speech became slurred and her hands claw-like. She was taken to hospital where tests revealed she had had a stroke. Mrs. Crabb died last week after having a second stroke.

According to the Stroke Association (UK), no real research has been carried out to show a link between beauty salons (hair washing) and strokes. However, the association says there are many cases reported in medical journals. They would like to see research done into this.

According to experts, when you push a person's head back into a sink his/her neck over-extends. According to neurologists Dr. David Bateman, Cumberland, UK, the neck can be stretched so that it kinks for a long time - as in hair-washing at a salon - the arteries get stretched and can tear if you are unlucky. As the bleeding between layers of tissue continues you can get clots building up, this eventually leads to a stroke.

Mr. Crabb said, when talking about his wife's first stoke "When she got up she wasn't speaking like she normally would. She felt awful and I didn't know what the matter was. Her speech then became slurred and her hands became like claws."

When he took her to hospital he said they asked whether she had had her hair done.

Mr. Crabb said "After that it all fell into place and we connected the stroke with the way she had her hair washed."

After her first stroke she became increasingly intolerant to cold weather. The couple eventually moved permanently to southern Spain.

An article 8 years ago in the Lancet writes about a woman who had her hair washed for five minutes at a salon and developed a stroke as a result of it. The doctors said that salons should place a cushion so as not to over-extend the neck.

Recent Barbaric Experiments in Medicine

The following scientific experiments are considered sick, unethical or just plain sadistic by today's standards:

• 1939 ‘Monster Study,’ which involved berating and ridiculing children.
• World War II Porton Down Experiments, during which military servicemen were exposed to toxic nerve agents.
• Program F, which involved saturating public drinking water supplies in Newburgh, New York with high levels of fluoride for 12 years.
• 1971 Stanford Prison Experiment, a “mock” study of volunteer prisoners and inmates carried out in the basement of Stanford University that caused lasting psychological trauma to many study participants.
• Milgram Experiment, which studied the effects of authority on human behavior.
• 1950s to 1970s Holmesburg Dermatological Experiments, which involved injecting Holmesburg prison inmates with cancer-causing chemicals like dioxin.
• 1950s – 1960s Project MKULTRA, which involved the CIA giving LSD and other mind-altering drugs to uninformed test subjects.
• 1960s Willowbrook Hepatitis Experiment, during which researcher Saul Krugman infected mentally disabled children with hepatitis B so he could develop vaccine for it.
• 1970s – 1980s Aversion Project, which involved inhuman experiments like electroshock therapy, castration and forced sex-change operations among those suspected of being homosexual in South Africa’s military.
• 1932 Tuskegee Experiment, which involved 400 black men from Alabama with syphilis. Researchers did not inform them they had the disease (which allowed them to spread it to others), despite symptoms, and did not offer them treatment (even though it could have been treated with the development of penicillin in 1947).

An additional study, called the U.S. Public Health Service Sexually Transmitted Disease Inoculation Study of 1946-1948, involved intentionally infecting Guatemalans with syphilis, gonorrhea or chancres. The U.S. government just apologized for the study in October 2010.
The majority of these experiments happened years ago.

BENEFITS OF SATURATED FATS – traditional societies

Japanese in Okinawa
The people of Okinawa, an island in Southern Japan, are well known for their longevity and excellent health – to the extent that books have been written about the Okinawa diet. The main cooking oil used by the people of Okinawa is pork lard.
The Japanese, in general, are also known for their good health and long lives. This is often attributed to a low fat diet, but it is not true. Although the Japanese eat few dairy fats, the notion that their diet is low in fat is a myth; rather, it contains moderate amounts of eggs, pork, chicken, beef, organ meat, fish (fatty fish like tuna and salmon) and seafood. These are all foods relatively high in saturated fats and cholesterol.
The French
Well known for their love of good food, the French also have low rates of heart disease and other degenerative diseases compared with, say, the Americans. The French diet contains lots of saturated fats in the form of butter, cheese, cream. eggs, meats and liver, including pates.
Apart from using butter generously in their cooking, some French cuisine also feature goose fat!
in France the death rate from heart disease is 145 per 100,000, compared with 315 of every 100,000 middle-aged men who die of heart attacks in the US each year. In the Gascony region, where goose and duck liver form a staple of the diet, this death rate from heart disease is only 80 per 100,000.
The relatively good health of the French, called The French Paradox, is often attributed to them drinking wine. This could well be a reason.
But when one accepts the view that there are many health benefits of saturated sats, then the good health enjoyed by the French begin to make more sense.

Other Mediterranean groups
In general, people of the Mediterranean countries consume quite large amounts of saturated fats – and enjoy good health.
One explanation often cited is olive oil but, in fact, many of these people take far more saturated fats than olive oil. On the Greek island of Crete, for example, fat makes up about 70 percent of the total diet!
Again, while Olive oil is beneficial, these people are also enjoying the health benefits of saturated fats.

The Jews
The Jews, when they lived in Yemen, ate plenty of saturated fats from eggs, meat and butter. Yet they had low rates of heart disease and diabetes.
Modern Jews in Israel consume margarine and vegetable cooking oils – plus plenty of sugar. And they suffer high rates of heart disease and cancer.

Indians in North and South India
Originally, Indians in the North consumed plenty of meat and they cooked with ghee or clarified butter, which is high in saturated fats. Indians in the South were more vegetarian and fish eaters, and they cooked with coconut oil, which is also high in saturated fats.
Both groups originally had low rates of heart disease. Then the South Indians began to use less coconut oil and more margarine / vegetable cooking oils. And they developed a much higher rate of heart disease compared with North Indians who took a lot more saturated fats.
Now, the North Indians are also beginning to switch from ghee to margarine – and the heart disease rate is starting to increase.
Other societies
Other societies that enjoy the health benefits of saturated fats include:

• Swiss, Austrians and Greeks, who live as long as the Japanese but take much more fatty diets.
  
  
• The people of Soviet Georgia – where a study found that those who eat the most fatty meat lived the longest.
  
  
• The Eskimos who, because of their harsh environment, eat mainly meat and lard. They, too, have low rates of heart disease and “clean” arteries that are not clogged up with saturated fats.
  
  
• The Masai, an African tribe whose diet consists primary of meat, blood and milk.

The benefits of saturated fats

 

 

 

 

 

 

 

The much-maligned saturated fats—which Americans are trying to avoid—are not the cause of our modern diseases. In fact, they play many important roles in the body chemistry:

1. Saturated fatty acids constitute at least 50% of the cell membranes. They are what gives our cells necessary stiffness and integrity.
   
    
2. They play a vital role in the health of our bones. For calcium to be effectively incorporated into the skeletal structure, at least 50% of the dietary fats should be saturated.
   
    
3. They lower Lp(a), a substance in the blood that indicates proneness to heart disease. They protect the liver from alcohol and other toxins, such as Tylenol.
   
    
4. They enhance the immune system.
   
    
5. They are needed for the proper utilization of essential fatty acids.
   Elongated omega-3 fatty acids are better retained in the tissues when the diet is rich in saturated fats.
    
6. Saturated 18-carbon stearic acid and 16-carbon palmitic acid are the preferred foods for the heart, which is why the fat around the heart muscle is highly saturated. The heart draws on this reserve of fat in times of stress.
   
    
7. Short- and medium-chain saturated fatty acids have important antimicrobial properties. They protect us against harmful microorganisms in the digestive tract.

The scientific evidence, honestly evaluated, does not support the assertion that "artery-clogging" saturated fats cause heart disease. Actually, evaluation of the fat in artery clogs reveals that only about 26% is saturated. The rest is unsaturated, of which more than half is polyunsaturated.

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