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Update Presented On Pharmaceutical Health Services Research

November 6, 2012

Special issue honors Frances O. Kelsey, pioneer in drug safety and regulation

Pharmaceutical health services research goes beyond studying the effects of individual drugs, to looking at the complex and interrelated effects of medications on the health of patients and the population. The special November issue of Medical Care highlights important new papers in key areas of pharmaceutical health services research. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

The 14 papers in the special issue cover a wide range of topics related to the health effects of marketed medications, with special attention to monitoring drug safety throughout the product lifecycle. It honors the pioneering efforts of Frances O. Kelsey, MD, PhD.

Dr Kelsey is most famous as the FDA staff member who resisted approval of thalidomide, citing lack of evidence of safety of a drug later shown to be a cause of major congenital malformations. “Dr Kelsey is an icon in the history of drug development and regulation–a woman of remarkable strength and insight,” writes Julie M. Zito, PhD, Professor of Pharmacoepidemiology and Psychopharmacology, University of Maryland Schools of Pharmacy and Medicine, Guest Editor of the special issue.

Drug Ethics–An Emphasis on Public Health Ethics?

The lead article is an invited commentary by Howard Brody, MD, PhD, Director of the Institute for the Medical Humanities at University of Texas Medical Branch, Galveston. Traditionally, ethical issues at the intersection of medicine and the pharmaceutical industry have focused on “medical professionalism”–particularly disclosing potential conflicts of interest between physician/researchers and drug companies.

But Dr Brody believes that other ethical perspectives need to be considered as well. He makes the case for a renewed emphasis on public health ethics, and specifically a more expansive approach based on social justice. He writes, “[P]ublic health practitioners have a positive duty to promote social justice related to health, especially by attending to the needs of the most vulnerable populations in society.”

For example, from a public health perspective, it would be wrong for pharmaceutical companies to focus on developing drugs that will be highly profitable in wealthy countries, while neglecting diseases that affect a much larger percentage of people in poor countries that can’t afford costly medications. Other issues that would come to the fore under a “public health ethical framework,” include drug promotion and marketing that promotes overuse of prescription drugs; a patent system that causes “me-too” drugs rushed to market without adequate safety testing; and the lack of key safety information until after drugs are approved for marketing.

New Papers on ‘Money Matters,’ ‘Safety Matters,’ and More

Many of these issues arise in the original research papers in the special issue, which Dr Zito groups into four areas:

Money Matters.–For example, how do low-income subsidies affect access to Medicare drug coverage? Does access to HIV drugs differ by race? How do drug company financial promotions on “off-label” use of medications.

Safety Matters.–An update on the FDA’s new “Sentinel System”– using electronic health data to monitor the long-term safety of drugs after approval. Also, new studies look at the safety of antipsychotic medications in vulnerable groups of older adults.

Regulatory Matters.–Recent improvements in the FDA’s drug safety oversight of marketed medications, including the activities of a new Drug Safety and Risk Management panel; and the effects of “black box” safety warnings for an ADHD drug.

Quality Matters. – New medication safety initiatives, such as programs to reduce prescription of “potentially inappropriate medications” in older adults and to improve drug safety in patients with chronic diseases such as diabetes.

This year marks the 50th anniversary of Dr Kelsey’s receipt of the Distinguished Civilian Service Medal for preventing thalidomide’s entry into the U.S. market. Throughout her long career at the FDA, Dr Kelsey planed a critical role in advancing clinical trials of medications to a higher scientific standard. Dr Zito concludes, “The broad range of clinical pharmaceutical health services/pharmacoepidemiologic research presented in this special edition underscores an important core value of Frances Kelsey–that science must lead decisions in therapeutics, no matter how convinced any one stakeholder group may be of a drug’s effectiveness and safety.”

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