Vioxx recall may result in fundamental changes in drug approval

The recent case of Vioxx withdrawal and suspicion over other blockbuster drugs have intensified pressures on pharmaceutical companies to disclose all negative as well as positive results of industry-sponsored clinical trials. However, for most pharmaceutical companies, processes for monitoring drug safety are scattered throughout the organization. To give a complete picture of a clinical trial, pharmaceutical firms must integrate data from trial protocols, patient records, clinical records, adverse event reports and genomic data. Currently, no solution capable of meeting these needs exists. Life Science Insights predicts that the first vendor to market with a comprehensive solution will own the space.

Merck is not the first company that has done a poor job of acting on information from studies after the launch of a drug. Many experts have complained that the approval for Vioxx was given in a hurry without adequate testing. If that was the case, the FDA should have been more vigilant in monitoring drug performance after the approval. Since FDA did not do that, Merck took advantage of the situation and tried to suppress data that was definitely not going to help its top and bottom lines. (Related article: Why Merck did not recall Vioxx?)

Life Science Insights predicts that technology spending will increase in later stages of the pharmaceutical value chain, in areas such as clinical trial management systems, electronic data capture, and electronic lab notebooks. Spending on technology for classic discovery and development will remain flat. To make the R&D for drug faster and more accurate, pharmaceutical companies are increasingly looking for a low-cost edge. R&D is a good place to look, especially as countries such as China and India ramp up their R&D capabilities. Academic institutions will play a more significant role in commercial drug discovery.

Pharma lawsuits by states' attorney generals will drive a new market for compliance software, and make Sarbanes-Oxley look like a picnic. After all, the health of Americans is a responsibility of everyone and the pharmaceutical companies should not be the one to take advantage of a weakened FDA.

Life Science Insights is further stating that the pendulum is slowly swinging back to tools and platforms and the rush to revenue is decreasing. Technologies that enable the drug discovery and development process will see increased funding in the near term. Drug companies are under tremendous pressure to reduce the product development cycle for drugs and that means relying on less pre-launch data. The Vioxx debacle has shown that while new drugs should be available to Americans as soon as possible, it does not mean that they be can used as guinea-pigs by the drug industry.

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Source: Life Science Insights