OCTOBER 01, 2005
Harvey E. Maldow, RPh, MS

Recent reports about the alleged dangers of certain prescription drugs are testaments to the fact that we are at a critical point in the history of drug development.

As an official of the pharmaceutical industry, the increasing numbers of unsubstantiated and misleading news stories and inflammatory headlines about prescription drugs discourage me. The industry must continue to combat this misinformation by stating the facts plainly to set the record straight where misperception exists. Most importantly, we must continue to do what we have done all along: maintain our unwavering commitment to patient safety and the development of products that have a positive risk-benefit profile.

One critical area of misperception is the safety of prescription drugs. In this "post-Vioxx era," there is a dangerously distorted public view that today's pharmaceuticals should not carry any risks and that the pharmaceutical industry, as a whole, has been less than forthcoming in discussing the safety profile of its products.

Collecting evidence of the safety of a drug is perhaps the most challenging aspect of drug development, involving years of study and thousands of hours of patient experience prior to launch. At AstraZeneca, patient safety is our top priority. As part of one of the most regulated industries in America, we are committed to and employ the highest safety standards.

To determine a medicine's safety profile, tremendous resources must be invested in clinical research. Good Clinical Practice (GCP) guides the industry during the clinical development process. Compliance with GCP and consultation with Independent Review Boards make up the cornerstone of good clinical trial management.

Our researchers incorporate safety testing throughout the clinical development process, by scrutinizing the available patient data in search of safety signals to enhance each new medicine's safety profile. With the achievement of each additional drug-development milestone, safety assessment becomes even more rigorous, and safety-related investment increases. After a drug is launched, a pharmaceutical company continues to monitor and investigate serious adverse events reported for its medicines. This process continues for the life of every product that we market. For example, at AstraZeneca we develop risk management strategies, with the goal that the company's medicines are used as safely as possible.

One of the challenges for the pharmaceutical industry these days is not only how we practice drug safety, but also how it is communicated. To ensure that patients, physicians, and pharmacists get the true picture of the safety profile of a product, you must take a look at the totality of its clinical data, as opposed to looking at a single source of data, to draw any definitive conclusions. Otherwise, inaccurate conclusions can be made.

Crestor (rosuvastatin calcium) provides a timely example. Of all statin therapies available, Crestor was the most widely studied prior to launch, with more than 12,500 patients evaluated in clinical trials. Since launch, Crestor has been part of a robust phase 4 clinical trial program and has a rigorous postmarketing safety program. In addition, the FDA conducts regular assessments of postmarketing safety surveillance data for Crestor. In March 2005, after a thorough review of all of the available Crestor data, the FDA stated that the safety profile of Crestor is similar to that of other marketed statins. (To view the full FDA response, please visit

Yet, there are those who continue to interject flawed data analysis and mischaracterizations about pharmaceutical products in the media. Doing so raises undue concern among patients—something that ultimately causes more potentially threatening health risks for patients, as medications are often stopped without consulting a health care provider. At AstraZeneca, our goal is to ensure that patients and health care providers get an accurate picture of today's generation of products.

It is the shared responsibility of physicians, pharmacists, and all health care providers to take strong steps to provide patients with important, accurate information on the medicines available to them. Even more important, health care providers must play an active role in ensuring that patients adhere to their prescribed treatment plans.

We are at a critical point in the history of drug development, where the pharmaceutical industry must act to correct the incorrect perceptions. It is important that we not only continue to practice what we preach, but that we also truly preach about what we practice, so that patients and health care providers know how serious the pharmaceutical industry is about its commitment to patient safety.

Mr. Maldow is the director of professional relations for AstraZeneca Pharmaceuticals LP and a member of the Pharmacy Times Board of Advisors.

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