Pharmacogenomics, the next frontier in medicine?

Friday, February 11, 2011 by: Dr. Carolyn Dean
Tags: pharmacogenomics, medicine, health news

(NaturalNews) A senior executive with GlaxoSmithKline (GSK) in the U.K. stunned the medical world on December 8, 2003 when he publicly stated that most prescription medicines do not work on most people who take them. Those of us who have studied drug side effects for decades know that they can often be ineffective as well as dangerous. But for Dr. Allen Roses, worldwide vice‐president of genetics at GlaxoSmithKline (GSK), to admit that less than half of the patients taking blockbuster drugs actually benefit from them sounded, at first, like mutiny.

The U.K. has the same problem with its health care system as North America. Only days before Dr. Roses spoke at a scientific meeting in London, the National Health Service reported that the total cost of drugs had soared by 50 percent in the previous three years, from $2.3 billion a year to an annual cost to the taxpayer of $7.2 billion.

An announcement by GSK the previous week promoted a line up of 20 or more new drugs under development that boasted potential earnings of up to $1 Billion (?600m) a year.

Dr. Roses is an academic geneticist originally from Duke University in North Carolina. In his talk he cited figures on how well different classes of drugs work in real patients. And he probably knew just what he was doing - heralding the "brave new world" of genetic engineering and genomics. When you want to promote a new therapy, you have to prove that the previous one is not doing the job or that the new modality at least improves on existing technology. Roses was doing just that when he talked about drugs for Alzheimer's disease working in less than one third of patients, and cancer chemotherapy being effective in less than one in four. Drugs for migraines, osteoporosis, and arthritis do somewhat better and work in about half the patients. His final analysis was that more than 90 percent of drugs work in only 30 to 50 percent of people. That's way less than the placebo effect!

The reason that drugs work effectively, on average, in less than one half of patients according to Dr. Roses, is because their genetic makeup interferes with the medicine in some unknown way. Some people thought it was a gaffe but others admitted that: "Roses is a smart guy and what he is saying will surprise the public but not his colleagues. He is a pioneer of a new culture within the drugs business based on using genes to test for who can benefit from a particular drug."

Roses is on a mission to promote his field of "pharmacogenomics", which applies human genetics to drug development by "identifying "responders", or people who benefit from the drug, with a simple and cheap genetic test that can be used to eliminate those non‐responders who might benefit from another drug. It may be the trend in medicine but it does fly in the face of an industry that markets drugs to the masses, not a select few.

Are we ready to leap into pharmacogenomics when we haven't even mastered nutrition? The late Dr. David Horrobin, a psychopharmacologist and a pioneer in the field of essential fatty acids, asked the quintessential question in his article, "Why do we not make more medical use of nutritional knowledge? How an inadvertent alliance between reductionist scientists, holistic dietitians and drug-oriented regulators and governments has blocked progress." He was probably frustrated with being misquoted so often over the years, thus he made his point perfectly clear in the unwieldy title of his paper.

Dr. Horrobin, a brilliant researcher, questioned whether there was "Something Rotten at the Core of Science?" in a 2001 issue of Trends in Pharmacological Sciences. Commenting on an analysis of the medical journal peer review system and a U.S. Supreme Court decision which questioned the authority of peer review, Dr. Horrobin concluded that, "Far from filtering out junk science, peer review may be blocking the flow of innovation and corrupting public support of science."

Horrobin and a handful of scientists have complained about the peer review process for decades, to no avail. A crack in the armor began in earnest when two researchers, Rothwell and Martyn, laboriously evaluated reviews of papers submitted to two neuroscience journals. They performed a statistical analysis on the correlations among reviewers' recommendations. They concluded that none of the reviewers seemed to agree on anything! Horrobin lamented that, "The core system by which the scientific community allots prestige (in terms of oral presentations at major meetings and publication in major journals) and funding is a non‐validated charade whose processes generate results little better than does chance. Given the fact that most reviewers are likely to be mainstream and broadly supportive of the existing organization of the scientific enterprise, it would not be surprising if the likelihood of support for truly innovative research was considerably less than that provided by chance."

Horrobin noted that scientists often become angry because the public rejects the results of the scientific process. However, the Rothwell and Martyn report indicates that the public may be on the right track and is waiting for science to do more than just state its superiority but actually put itself to objective evaluation. Dr. Horrobin found that in the midst of the rejection of science by the public there is also the fact that pharmaceutical research is failing. The annual number of new chemical entities submitted for approval is steadily declining. Horrobin concluded that drug companies are merging because of failure; it is not a measure of success.

In his field of psychopharmacology, Dr. Horrobin said he was able to find no improvement in the treatment of depression and schizophrenia in the past forty years. "Is it really a success that 27 of every 100 patients taking the selective 5‐HT reuptake inhibitors stop treatment within six weeks compared with the 30 of every 100 who take a 1950's tricyclic antidepressant compound?"

Of course, I say my Future Health Now! online lifestyle and wellness program is the future of medicine, not genetic engineering. William Leiss is past President of the Royal Society of Canada and a widely sought after advisor on the social and ethical implications of "risk controversies and public policy." In an interview available online, Leiss attempts to warn government and the public about galloping technology. Dr. Leiss says there is an unresolved tension between two competing aspects of the scientific revolution in the modern world.

There is a battle between inventive science, the creation of products, and transformative science, which results in cultural change. Inventive science goes from triumph to triumph virtually uncontested and is bolstered by unlimited funding. Even though Francis Bacon in the 1600s championed inventions as a way of improving the human race, it was not until the end of the 1800s that Bacon's dream was realized. The first inventions were in the field of chemistry.

Transformative science was championed in the 1700s as a way of not just understanding and overcoming nature but as an important new way of organizing the basis of social institutions, promoting universal education and rendering social policies and institutes more humane and just.

Dr. Leiss reminds us of the many risks we have overcome through advancement in invention and transformative science. Where would we be if it were not for the many products that have advanced the world through childbirth morality, infant and childhood mortality, infectious diseases, malnutrition, personal security, accidents, birth control, and the treatment of mental disorders reflected in an increase in average lifespan? Bacon would be happy that we have achieved results far beyond what he had expected, however, Leiss is afraid we don't know when to put the brakes on technology. He also asks why have we accepted without challenge most new inventions that have darkened our door?

When it comes to genetic engineering, affecting our very DNA, proponents envision programming perfection in humans, doubling the human lifespan, and developing entirely new life forms once scientists have mastered the necessary genome that will sustain human life.

Leiss thinks that by the late 19th century, the products of science began to be more important than improvement of society through transformative science. He reminds us that World War II brought us extremely close to nuclear war and changed the world immeasurably. But Leiss feels the final frontier is biotechnology that is capable of "modifying" genes at the embryo stage. For neurodegenerative diseases like Huntington's Chorea, this treatment could be a miracle. But what is to stop scientists from enhancing normal performance and creating super geniuses, super athletes, super entertainers, or super politicians. Many questions are yet to be asked. How will these changes affect the gene pool? What about the notion of extending human life? Leiss, with tongue firmly in‐cheek, speculates about a 200‐year life span and spending the last 100 years of life on cruise ships!

Dr. Epstein, a professor of environmental and occupational medicine at The School of Public Health, University of Chicago, spoke at The Lighthouse in New York on November 11, 2001. He said that this century has seen the emergence of new technologies: petrochemicals developed around 1940 with new methods of fractional distillation creating 1 billion pounds in 1940, 50 billion by 1950 and now an annual production of 900 billion pounds; a second concern is nuclear technology and fuel; a third is genetic engineering, an emerging technology with the potential for irreversible health effects.

Epstein says these technologies outstrip any social mechanism that would try to control them. Therefore, we have a complex set of factors, which add up to seeing the actual abolition and desecration of democratic structure by corporate influences on national and government levels. Most journalists in a knee‐jerk reaction cheer on the technologies, says Dr. Epstein, and furthermore, they never see a carcinogen they don't like.

Less than six months after Dr. Roses made his startling announcement that 90 percent of drugs only work on 30‐50 percent of the population, GlaxoSmithKline sponsored a special edition of the well‐known scientific journal, Nature. It was called "Nature: Insight on Human Genomics and Medicine" and GSK defined the parameters of the journal as follows:

1. Pharmacogenetics ‐ exploring the genetic basis for drug response to find the right medicine for the right patient.

2. Disease Genetics - studying patient populations with common disease: asthma, depression, COPD, osteoarthritis, early onset heart disease, and migraine in order to identify disease susceptibility genes.

3. Genomics/Proteomics ‐ understanding the functions of genes, proteins, and their complex interactions to discover and validate new drug targets and biomarkers.

4. Bioinformatics ‐ combining biology, genetics, statistics, and computer.

Exerpted and edited from Death by Modern Medicine: Seeking Safe Solutions, eBook. Dr. Carolyn Dean.

About the author:
About the Author:
Carolyn Dean MD ND is The Doctor of the Future�. She is a medical doctor and naturopathic doctor in the forefront of the natural medicine revolution since 1979.
She is working on several patents on novel products including the iCell in RnA Drops. Dr. Dean is a leading expert in magnesium and she has created a picometer, stabilized-ionic form of magnesium, called ReMag that's 100% absorbed at the cellular level and non-laxative making it one of the only magnesiums that can be taken in therapeutic amounts with no side effects. ReLyte is her multiple mineral product that is also completely absorbed at the cellular level and contains the 9 minerals necessary for supporting proper thyroid function. RnA Drops help make perfect cells via RNA through Chromosome 14 affecting DNA. ReNew, which is highly concentrated RnA Drops is a powerful skin serum and ReAline is a safe detox formula with methylated B's, l-taurine and dl-methionine (the precursor to glutathione), all available at www.RnAReSet.com
Dr. Dean is the author/coauthor of 33 health books (print and eBooks) and 106 Kindle books including The Magnesium Miracle, Death by Modern Medicine, IBS for Dummies, IBS Cookbook for Dummies, The Yeast Connection and Women's Health, Future Health Now Encyclopedia, Death by Modern Medicine, Everything Alzheimers, and Hormone Balance.
She is on the Medical Advisory Board of the non-profit educational site - Nutritional Magnesium Association (www.nutritionalmagnesium.org).
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