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Western populations‘) and the "worried well". The most disturbing such as reduced potassium and increased glucose and cholesterol aspect is that a strategy of dependency usually ends up as being levels, these did not lead to any difference in clinical outcomes and multi-product-based—often with pills being prescribed to counter _ the thiazides appeared to provide modestly improved outcomes for cts of the original treatment. most. As with most generic drugs, the cost of the thiazides was in a corporate-oriented world, some may say, where the _ cheaper at only US$0.05 to $0.30 daily, while the cost of the other share value is king, but a "sickness" industry singularly profits medications ranged from $1.15 to $1.50 daily." from increased drug-dependency and by targeting large markets Although future negotiations between healthcare payers and the with blockbuster drugs that generate 40-45 per cent of its revenue. — pharmcos will likely be based on clinical outcomes, the pharmcos Traditionally, pharmcos ignore any innovative research into drugs are looking to the emerging market of "predictive and preventive" that prevent, treat or cure, and instead plough funds into a small medicine—the industry's definition of the "wellness industry"— range of blockbuster drugs which can generate revenues of over where they will be able to predict predisposition through genetic US$20 billion during the life-spans of their patents.’ screening and then prevent the disease with drugs before we As the bubble bursts, the pharmcos are finally acknowledging become sick (this will also include mandatory vaccination that beneficial outcomes are limited to only 33 per cent of patients programs). Steve Burrill, of biotechnology company Burrill & and that up to 50 per cent may not respond. They focus the blame Company, predicts that everyone's genome and medical records for this failure on the variations in genetic make-up of individuals, will eventually be plugged into the system and that "[iJn the where, for example, some people may metabolise a drug before it future, babies could be given a smart card when they are born and has time to act. However, the real cause of we'll add to that as they go through life".'* failure is that the clinical trials, funded by the With new technology that can decode the drug companies themselves, use only carefully human genome and identify the key signalling selected individuals who do not reflect the molecules (targets) linked with disease, and opulation for whom these drugs are aimed— . . . with the capacity to make, test and screen people such as those suffering from one or walt will be possible thousands of new chemical compounds day in, more chrome degenerative diseases, or the to match a drug with ay out by puns a uray of mons of elderly. In addition, the studies may . chemicals, it will be possible to match a drug inaccurately reflect the true results of findings each new target as it with each new target as it is identified. By due to the vested interests of the authors or a Is identified. linking genetic variance to drug response, failure to report negative findings." one . scientists will be able to determine which Because scientific proof of effectiveness By linking genetic drugs will work best with each genetically and safety in the broad community is not variance to drug distinct group. Peter Goodfellow, of the required for drug approval, the testing only truly begins when the drugs enter the pharmco GlaxoSmithKline, says: "We'd like to create a drug for every target in the response, scientists will marketplace and are foisted one a be able to determine wunan genome. so you could start with rusting public. With a meaningless . . rugs, not the target. real-time reporting regime for adverse which drugs will work However, supporting a strategy in the absence of research into the full implications of altering gene expression, which leads us down the route of greater drug-dependency, is hardly intelligent, particularly as the World Health Organization has stated that 80 per cent of heart attacks, strokes and diabetes and 40 per cent of cancers are preventable and that it is cheaper to prevent disease whose patents have expired, against among healthy populations than to treat newer drugs. Approval for a new drug sick populations. Currently, only three is dependent upon achieving superior results compared with the per cent of healthcare spending is used in prevention."° reactions, which provides absolutely no contribution to any evidence-based research that can be accessed by other clinicians, the consequence is that adverse reactions have time to reap many casualties, as was seen in the cases of Thalidomide and Vioxx. Also under the spotlight is the effectiveness of older generic drugs, best with each genetically distinct group. drug it is replacing or improved clinical outcomes when added to Global pharmcos are also looking to capture the lucrative an accepted protocol. Pressure to replenish revenue streams with —_ alternative health industry to annihilate competition and control new patents as the old patents expire has led to inflated claims, product supply and consumer choice. Dirty tactics have so far and with no requirement to test the added value of a drug ina involved government regulatory bodies and the Codex real-life setting it is difficult to prove these claims. Alimentarius Commission, an international organisation that sets However, in 2002 when ALLHAT (Antihypertensive and Lipid international standards and codes for foods, establishes upper Lowering treatment to prevent Heart Attack Trial) published its limits for over-the-counter vitamin and mineral supplement findings from a five-year trial involving 30,000 patients, no dosages, and reclassifies all products that have therapeutic action difference was found in the clinical outcomes between using as medicines to be regulated under various drugs acts. cheaper diuretics (thiazides) over the more expensive angiotensin- The next stage involves the patenting of new products based on converting enzyme inhibitors (ACEIs) and calcium-channel natural products. Natural products cannot be patented, but what blockers (CCBs). There was no change in mortality, but a greater can be patented are the bio-active compounds of natural products, incidence in adverse events was seen with the ACEIs and isolated, synthesised and replicated in the laboratory, as well as increased occurrence of heart failure with the CCBs, while the the technology itself. Hence we see the emergence of thiazides reduced the incidence of stroke and had better effects on pharmaceutical versions of herbs (PharmaPrinting), nutritional lowering blood pressure. In spite of the negatives for the thiazides, products (Nutraceuticals) and functional foods based on a person's .»it will be possible to match a drug with each new target as it is identified. By linking genetic variance to drug response, scientists will be able to determine which drugs will work best with each group. NEXUS 23 genetically distinct DECEMBER 2007 — JANUARY 2008 www.nexusmagazine.com