The Cost of Unpersonalized Medicine

Quick Fact: It has been reported that more than 6% of all hospital admissions are due to adverse drug reactions(ADRs)and nearly 2% of these admissions result in death.(2)

Some of these deaths could be prevented by testing individuals for genetic variations indicating their susceptibility to toxic reactions. In addition to the numerous devastating deaths, such failures in drug development and the withdrawal of drugs from the market due to safety concerns also have significant financial implications for pharmaceutical companies and their investors. For example, unexpected cardiovascular side effects of the drug Vioxx led to the withdrawal of this non-steroidal anti-inflammatory in 2004, cutting the manufacturer Merck's share price by more than 25% and destroying $25 billion from its market value. Bayer, too, suffered extreme financial consequences after they withdrew their cholesterol-lowering drug, Baycol, from the market. This drug led to 30 deaths and nearly 10,000 lawsuits, costing Bayer over $1 billion and counting.(4)

In addition to direct financial costs, such safety scares also impact the pharmaceutical industry in more subtle ways. Publicity over ADRs has ensured that drug safety remains an issue in the public spotlight. Such events such as the withdrawal of Vioxx and Baycol contribute to a loss of reputation and confidence in the pharmaceutical industry within the general population. Consequently, there are major drivers from the public, health care providers, regulatory authorities, pharmaceutical companies, and shareholders to ensure that safer drugs are brought to the market.

Clinical Trials and Cancer Treatment

During a clinical trial, a drug is tested on a small number of eligible patients in a controlled manner and over a specific period of time. Although these trials are highly regulated to meet the safety requirements, adverse reactions still to occur both during the trial and after the drug is released to the public. Once a drug is licensed, a large number of various patients are exposed to the drug for durations much longer than that of the clinical trial. Also, this drug may be used combination with other medications that are they are not compatible with. A well-known example of this ongoing challenge is the drug Cisapride, which was licensed in the US in 1993 for nighttime heartburn. Within two years five million prescriptions were being filled yearly. However, after a report of 50 cases of cardiac arrhythmia and four deaths attributed to the use of the drug, Cisapride was completely removed from the market by 1999.(5)

In the systemic treatment of cancer, therapeutic decisions are made by weighing the benefits against the risks of a drug therapy for a particular individual. The traditional approach to treatment is limited because it does not account for the variability in drug response. Some patients may be biologically more susceptible to drug toxicity and some may be less likely to respond to a standard drug dosage. For example, many patients with stage II colon cancer do not require consequent chemotherapy, but small subgroup receive major benefits from it. However, administering chemotherapy to all colon cancer patients leads to adverse drug reactions in 1 out of 6 patients and the prevention of cancer related death in only 1 out of 30.(5)

Click HERE to learn about the recent health care reform bill and its implications on advancement of personalized medicine!


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