AddThis Feed Button "Frequently Copied, Never Duplicated"

Showing posts with label drug trials. Show all posts
Showing posts with label drug trials. Show all posts

Sunday, October 17, 2010

Big PhRMA Misleads You and Your Doctor

UPDATE: 19 October

In the same vein as problematic drug trials, let it be known that the same may be true with vitamins, as PhRMA makes it move to grab control of any supplements that may help you protect yourself from dementia and Alzheimer's. (Read more in the 60+ related articles on Natural Health News)

More on Natural Substances to Combat Alzheimer’s—and Big Pharma’s Dirty Little Secret
By ANH-USA 
  Coconut oil [1] is showing great promise in the treatment of Alzheimer’s disease. New studies show that other natural substances are also offering big breakthroughs, and the drug industry is trying to jump on the bandwagon with them too.
Fish oil reduces inflammation, including the inflammation associated with dementia. The DHA form of fish oil also converts into neuroprotectins, which, as the name suggests, protect our nerve tissue. A recent study [2] suggests that the risk of Alzheimer’s may be reduced by a third if we consume this regularly. Another broad study [3] suggested that the risk of all forms of dementia could be reduced by almost half with fish oil.
Nattokinase is an enzyme extracted from a fermented, cheese-like soy food called natto, which has been eaten in Japan for many years. Nattokinase has a well-documented ability to dissolve clots, so it plays a role in cardiovascular health. Now it is being studied for another set of abilities. Alzheimer’s disease is characterized by brain deposits of a certain type of amyloid—a group of abnormal proteins that cause disorders in various organs. Getting rid of amyloids is one of the targets of Alzheimer’s disease research. A recent study [4] shows that nattokinase removes amyloid plaque.
Other encouraging Alzheimer’s news comes from the University of California at Irvine, where a study recently showed that mice with cognitive impairment had dramatic improvement with niacinamide [5]. Niacinamide is one of the water-soluble B-complex vitamins known as B-3. Niacin, or nicotinic acid, is another form. When an amide molecule attaches itself to niacin, it becomes niacinamide (also called nicotinamide). The body can convert niacinamide back into niacin but is unable to make niacinamide out of niacin. One major difference is that in doses exceeding 50 mg, niacin typically produces flushing of the skin, but niacinamide does not. Niacin and niacinamide also have different applications. In the niacinamide form, it reduces inflammation. Since many studies indicate that inflammation may trigger Alzheimer’s, researchers wondered if niacinamide would help Alzheimer’s.
Researchers gave mice the equivalent of a human dose of 2000 to 3000 milligrams of niacinamide, and the results were shocking. “Cognitively, they were cured,” said Dr. Kim Green, the head of the study. “The vitamin completely prevented cognitive decline associated with the disease, bringing them back to the level they’d be at if they didn’t have the pathology.” Niacinamide also improved memory in mice without Alzheimer’s.
Pioneering integrative physician and researcher Jonathan V. Wright, MD, notes that niacinamide has been widely used for a variety of purposes for more than 60 years, and its safety is well known [6]. He reports that as far back as 1943, William Kaufman, PhD, MD, a psychiatrist and exceptionally thorough clinical researcher, showed that niacinamide deficiency causes impaired memory, easy distractibility, an inability to concentrate, mental fog, slowed thoughts, difficulty comprehending, unwarranted anxiety, a lack of initiative, being uncooperative or quarrelsome, etc. And he discovered that all of these symptoms—and many more—“disappeared or…improved considerably” with the use of niacinamide.
Niacinamide isn’t the only B vitamin that may help significantly with Alzheimer’s. A study from Oxford University [7] found that fairly high dosages of three B vitamins (folic acid, B6 and B12) could reduce the rate of brain atrophy in patients with mild cognitive impairment—because these vitamins reduce homocysteine. (Other studies have found that TMG, or trimethylglycine, also controls homocysteine and is useful if the B vitamins are not enough.) Around 50% of people with mild cognitive impairment go on to develop Alzheimer’s.
But this study, widely trumpeted in the world press, wasn’t quite what it seemed. It was a study of B vitamins, yes, but it was at the same time a study of a patented drug. How could that be? Why was a drug company happy to see the curative role of B vitamins established? Here’s why: TrioBe Plus—the formulation of the B vitamin used in the study, is a patented drug, even though it is really just a blend of three ordinary vitamins and shouldn’t have received a patent. It is made by a Swedish drug company, Meda AB, based on a patent held by the chief researcher. As our colleagues at ANH-Int’l point out [7], the lead author of the research had to declare a conflict of interest because the patent for the use of these vitamins in this particular form is in his name. He will therefore personally gain massively if your local doctor starts to prescribe this to everyone who’s complaining about losing their car keys on a regular basis.
So the pharmaceutical industry is once again patenting and promoting a drug that’s not a drug, but is merely three forms of vitamin B you can get from any health food store. Supplements are not drugs—but drug companies are so unsuccessful in producing new drugs that they are looking greedily at supplements.

Article printed from Alliance for Natural Health – USA: http://www.anh-usa.org
URL to article: http://www.anh-usa.org/more-on-natural-substances-to-combat-alzheimers/
URLs in this post:
[1] Image: http://www.anh-usa.org../../../../../coconut-oil-and-alzheimer%E2%80%99s-disease/
[2] A recent study: http://www.ncbi.nlm.nih.gov/pubmed/20467837
[3] Another broad study: http://archneur.ama-assn.org/cgi/content/abstract/63/11/1545
[4] A recent study: http://pubs.acs.org/doi/abs/10.1021/jf803072r
[5] mice with cognitive impairment had dramatic improvement with niacinamide: http://www.jneurosci.org/cgi/content/abstract/28/45/11500
[6] niacinamide has been widely used for a variety of purposes for more than 60 years, and its safety is well known: http://ahha.org/Alzheimers.htm
[7] A study from Oxford University: http://anh-europe.org/blog/vitamins-for-alzheimers-study-reveals-pharma-gameplan



-----------------------------------------------------------------------------------------------------------------------

This certainly is not a new subject, but certainly welcome in terms of the number of adverse problems with drugs that are marketed to be more than they really are.
Benefits are constantly over estimated and proves the urgent need for publication of trial data. Other problems is that adverse effects are not usually found until the drug has been marketed and profits are high.  Post marketing trials are not being done as required and this certainly can be tracked tot eh drug approval Fast Track process.
Fast Track was introduced many years ago to allow for pharmaceutical firms to pay a fee to get their drug approved quickly.  This has been a major criticism of FDA practices and certainly one that has yet to be changed.
Just yesterday I provided a client with some information to take to their doctor. Basic information  about her drugs had not been given to her, and it is likely that her doctor and pharmacist never gave her the information as is required by law.
I am sure that if you are taking prescription drugs you may experience similar situations.
And I'd suggest you ignore  the drug ads like the plague, just like the stupid political ads running on channels near you.

'Public misled' by drug trial claims


Drugs need to undergo extensive testing in trials before approval
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 informationPharmaceutical 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.
"Our findings underline the urgent need for mandatory publication of trial data”
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. Continue reading this story

Monday, November 24, 2008

Drug Trials Only Adverts?

An exquisite essay on just how it is!
Clinical Drug Trials: See them for what they often are — advertisements
by Warren Bell, MD

Just about every week, an announcement is made about research concerning some sort of new treatment. In just about every case, the treatment is a drug.

This does not mean, however, that drugs are the most important or valuable type of therapy, but rather that modernday, multi-national “big pharma” drug corporations have enormous, financial clout. Due to their patent-based monopolistic profits, drug companies earn 10 times more than all other types of treatment combined. Cnsequently, they can afford to hire the best advertising and public relations experts to relentlessly promote their products in the industry and public media.

So-called announcements from big pharma can more accurately be described as advertisements. They are, in point of fact, carefully crafted propaganda for the latest product generated by clever drug development teams, whose most important members are often public-relations experts and lawyers.

Reading between the profit lines

Let’s look at a hypothetical but typical drug announcement, one piece at a time:

“The results of a double-blind, multicenter trial of the new drug Zaronda, announced today by a research team at the University of Great Hill, reveal that this new breakthrough treatment significantly lowered levels of LDL cholesterol compared to placebo. Dr. Ronald McDonald, chief researcher and Head of the Department of Internal Medicine at UGH’s University Hospital, noted that this new drug represented “An exciting development in the battle against the growing epidemic of heart disease.”

Zaronda was developed in the research laboratories of Muck, Rake and Klink. Share values for the company rose 18 percent after the results of this study were announced.”

Double blind, multi-center trial:

This kind of phrase is used to make the ad sound scientifically impressive. “Double-blind” is thought of as the golden star of study models because neither the subject nor the researcher knows who is receiving the actual treatment in comparison to the placebo (dummy pill). The model and term are used in this case to create the impression of impartiality and rigour.

Multi-center trial: Using such a phrase suggests that large numbers of experimental subjects were involved, implying that it was a serious trial that cost a lot of money.

In actual fact, of course, size counts for nothing in many cases. In 1747, an experiment using only 12 subjects proved that limejuice prevents scurvy and ensured British naval dominance for 150 years.

The new drug: Drug companies want you to believe that what you’re reading about is “hot off the press,” creating the impression of excitement and hope.

Zaronda: Believe it or not, advertising geniuses in the drug industry have
figured out that certain letters are more “sexy.” The letters Z, X, and Y, for example, sell more drugs than most others. That’s why you see strange names for drugs, such as Xanax, Zostrix and Zyloprim.

Research team at the University of Great Hill: Drug companies know that there is still a veneer of respectability attached to educational institutions. They strive to mention either a university or hospital in association with any new drug research. Even if the research is carried out in the company’s own laboratories, the university or hospital connection will likely always come first.

Breakthrough: A key of almost all drug advertisements is the “breakthrough.”
Once again, the word creates the sense of excitement and drama that drug companies know will help to sell their product to desperate people. However, in a typical year, with say 800 new drug submissions, no more than half a dozen can actually be termed useful, let alone a breakthrough.

Significantly lowered levels of LDL cholesterol: Contrary to what many people think, high or low cholesterol is not a significant measure of your health, which makes this phrase a surrogate marker. Getting sick or dying is significant, but changing the amount of a substance in your bloodstream is not. (Some skeptical experts believe that there is no direct connection between cholesterol and heart disease.)

By taking advantage of the fact that many people—including many doctors—mistakenly
equate the lowering of cholesterol with improving a person’s health, drug companies cleverly create the impression that their drug can help. One of the most famous drug trials in medical history involved a drug that lowered cholesterol dramatically but markedly increased the number of deaths from gallbladder disease.

Compared to placebo: Here is one of the best tricks of the drug industry. Instead of comparing a new treatment to older, established treatments, the industry almost always compares a new product to a placebo. That way, they don’t have to worry that the public will compare the new drug to something already on the market—something that might be as good as the new product or even better.

Dr. Ronald McDonald... Chief...Head: The impression created here is of a researcher with an armload of qualifications and exceptional scientific expertise. What is never mentioned is that the good doctor is undoubtedly receiving substantial sums of money from the company making the drug being tested. Numerous studies in medical literature have shown that when this happens, research studies almost always show that the drug works well. He who pays the piper, plays the tune.

An exciting development in the battle against the growing epidemic of heart disease: Once again, this phrasing is attempting to drum up the impression of action, movement and excitement.

Heart disease is mostly caused by over consumption of food, lack of exercise and other lifestyle factors. Taking an expensive pill to deal with this behaviour can hardly be considered an effective weapon. Nevertheless, drug companies use military jargon and scare tactics to drum up business.

Share values for the company rose 18 percent: This kind of information is increasingly tagged onto the end of these ads. The fact that it’s there at all
reveals the true underlying purpose of these so-called treatment creations. They are designed to make money for shareholders of giant multinational corporations.

Patents for profit

By now you may think I’m against all drug companies, but I’m not. Evidence shows that approximately one percent of new drugs are significantly useful. I feel that the real problem with clinical trials is that the vast majority are done on patented drugs.

No one is eager to do trials on vitamins, herbal preparations, homeopathic remedies, physical therapies, or any of the other numerous non-pharmaceutical interventions that many people use every day. Why? Because the profit margin on these approaches
is trivial compared to the windfall profits earned by patented drugs.

If even one-tenth of the money currently wasted on patented drug trials were diverted into independent studies of natural health products, manual treatments and community health-related programs, therapy would be revolutionized overnight.

Treatments and interventions would become safer, less expensive, more accessible
and more sustainable.

Until that happens (and it will require public funding to be done properly)we’re going to have to go on swimming in a sea of flagrant advertisements for drugs of questionable value and unknown risk, disguised as legitimate.

My hope is that this article throws you a modest life raft to help you avoid
drowning.

Warren Bell, MD, is a HANS member practicing in the heart of the Okanagan Valley. He’s also President of the Association of Complementary and Integrative Physicians of BC.
Courtesy HANS.org magazine.