PHARMACY

FDA ponders use of biomarkers in drug trials

BY Drew Buono

WASHINGTON The Food and Drug Administration may soon support using biomarkers during tests in an effort to identify risk of experimental drugs in patients sooner, which could lead to the drugs being marketed quicker, according to published reports.

A biomarker is an indicator that can be used to test a biological function. Some biomarkers turn up when organs are injured and cells within the damaged tissue release substances into the blood, urine or saliva. These substances can then be used to detect dangerous side effects.

Currently, experimental drugs are tested in animals before being taken to human clinical trails. But animals’ reactions aren’t always the best predictor of whether substances will be safe for humans. Drugs harmless to animals can hurt humans, and vice versa. If a drug toxic to the kidneys passes animal tests today, the damage might not show up until it is too late.

“Using current tests, you have lost about 70 percent of the kidney function before you pick it up,” says William Mattes, director of toxicology at the Critical Path Institute.

The new biomarker process has the potential to save a patient’s kidneys.The ultimate goal of the pharmaceutical industry is to have a range of such marker tests that would signal such dangerous side effects as heart failure, liver damage or cancer. Samples of blood, urine or saliva, for example, would be taken from participants in a clinical trial. If certain biomarkers indicated the patient was at risk, the trial could be stopped before any major damage occurs.

Seventeen companies have joined the research into biomarkers at the Critical Path Institute. These include giants like Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck and Pfizer.

Initially, seven biomarker testing processes will be qualified by the FDA for use in preclinical animal studies, and only as a complement to current tests.

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Analysis shows pain reduction for fibromyalgia patients using Lyrica

BY Diana Alickaj

CHICAGO A pooled analysis presented at the annual Academy of Neurology meeting reports that Pfizer’s Lyrica reduced pain in patients with fibromyalgia, whether or not they experienced symptoms of anxiety or depression.

The results were determined by analysis of data from three clinical trials that used a placebo as a control ranging from eight weeks, to 13 weeks and finally 14 weeks in more than 2,000 patients that had fibromyalgia. According to published reports, they also studied different dosages given to patients and where asked to measure their pain from a scale of zero to 10. The analysis confirmed that pain reduction was the greatest change in patients who used the drug regardless of whether they still had feelings of depression or anxiety.

According to published reports, Fibromyalgia is the most common, chronic pain condition in the United States, and patients who have it usually experience symptoms of poor sleep, stiffness and fatigue.

According to Dr. Lesly Arnold, one the authors of the study and associate professor in the department of psychiatry at the University of Cincinnati Medical Center, “The data showed that Lyrica reduced fibromyalgia pain, and alleviating that pain was associated with patients’ overall feeling of well-being. Understandably, many patients with a chronic pain condition, such as fibromyalgia, also experience depression and anxiety, and importantly we found that Lyrica helped reduce pain in patients regardless of the presence of symptoms of these co-morbid conditions.”

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NACDS urges Congress to refrain from adopting e-pedigree mandate

BY Jim Frederick

ALEXANDRIA, Va. New federal legislation to require that pharmacies and drug wholesalers establish electronic pedigrees for every drug they sell or distribute would throw both industries into turmoil and add “extraordinary” costs to their operations, the head of the National Association of Chain Drug Stores warned Thursday.

The Safeguarding America’s Pharmaceuticals Act of 2008 was introduced Thursday by Reps. Steve Buyer, (R-Ind., and Jim Matheson, D-Utah. If passed and signed into law, the bill would mandate electronic pedigree requirements to assist in the tracking and tracing of prescription drugs in the domestic supply chain.

NACDS president and chief executive officer Steve Anderson responded quickly to the proposal. “While instances of drug counterfeiting may occur,” he said, a federal e-pedigree mandate is the wrong approach.

“Despite the perception that e-pedigree and track and trace mandates are quick solutions, their adoption and implementation would be extremely complex and costly for retail pharmacies and others in the supply chain, and without the desired benefit,” Anderson asserted. “These systems are many years away from full development, have not been fully tested and lack uniform standards and patient privacy safeguards.”

There are alternatives to assure a safer drug supply as the industry gears up for e-pedigrees, Anderson added. Among them: adopting tougher uniform federal licensing standards for drug distribution and using the Food and Drug Administration to certify that manufacturers, distributors and pharmacies follow secure supply-chain guidelines.

“These steps would go a long way in improving safety and further protecting the supply chain by building on effective systems currently in place,” Anderson said.

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