Dear Health-Conscious Friend,
Im sure youd agree its devastating when illness strikes. Being sick changes your entire life.
Thats why I stay alert to research and news of treatments than can help you detectand even reverse health problems BEFORE they cause long-term damage to your health!
In this weeks Monday Edition of Health News Weekly, you ll find out the details behind the FDAs decision to reject a cholesterol-lowering drugfor a second time! Youll also discover new research aimed at improving treatment for people who suffer with chronic fatigue syndrome.
If youre interested in these and other tips to help protect you from a host of health problems, lets get started!
FDA Shoots Down Second Proposal for
New Cholesterol Drug!
The Food and Drug Administration (FDA) issued a second rejection for a Merck & Co. experimental cholesterol drug.
According to an Associated Press report, the FDA issued a not approvable letter on April 28. The agency said it needed more information on Cordaptive, a cholesterol-lowering drug which has been under fire this year.
Merck said its new cholesterol drugalso known as MK-0524Acan both lower bad LDL cholesterol, and raise good HDL cholesterol.
We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the drugs risks and benefits, said Peter S. Kim, president of Merck Research Laboratories, in a statement.
This is not the first time Merck has faced trouble with its cholesterol-lowering drugs. The superstar drug Zocor® lost some of its shineand billions in annual salesafter facing generic competition in 2006. The company partners with Schering-Plough Corp. of Kenilworth, N.J., to sell the cholesterol drug Zetia® and the combination drug Vytorin®which contains Zetia® and Zocor®.
A previous Health Resources revealed the drug makers efforts to delay the release of study results that showed Vytorin® and Zetia® worked no better than much-cheaper Zocor® at eliminating fatty plaque from arteries. Some industry analysts speculate the delay was part of an effort to protect profits from drug sales.
But after two congressional probes and heavy media attention, Merck decided to cut its 2008 revenue forecast for the drugs by $700 million.
The new drug Cordaptive combines an extended-release form of the B vitamin niacin with a chemical that helps reduce the niacin side effect called flushing. This can cause redness, burning and tingling of the face.
Dr. John Paolini, head of the Cordaptive development team at Merck, said the flushing problem has prevented many patients from reaching the most effective dose. It has also caused many others to stop taking niacin.
Some analysts have said that compared with extended-release niacin, Cordaptive produced slightly higher levels of substances in the blood that can indicate potential liver damage, muscle damage and blood-sugar problems.
In a 24-week study of about 1,600 patients, reported at a European cardiology conference last fall, researchers found that compared with a placebo, Cordaptive produced an 18 percent drop in LDL cholesterol. The drug also caused a 26 percent drop in the blood fat called triglycerides, and a 20 percent increase in HDL levels
The FDA letter said the agency also rejected the proposed trade name of Cordaptive for the new drug. Merck said it expects to pursue the alternative name Tredaptive for use in the United States.
Fast Fact
Echinacea, if taken in high doses at the onset of viral infection, can reduce the severity of the illness. This is because of the herbs immunological stimulant effect on upper respiratory and urinary tract infections.
CDC Launches Study to Unravel
Mysteries of Chronic Fatigue
Researchers from the Centers for Disease Control and Prevention (CDC) and Emory University School of Medicine in Atlanta recently initiated a comprehensive population-based clinical study of patients with chronic fatigue syndrome (CFS). The study includes about 90 Atlanta patients who will participate in a three-day, inpatient clinical trial.
An agency statement said investigators hope the study results will provide a better understanding of how the syndrome affects peoplewhich could lead to more successful treatment.
Launching this research study with Emory will help us draw a clearer picture of how CFS affects people that ultimately could lead to more effective treatment of patients with CFS, said William C. Reeves, M.D., Chief of the Chronic Fatigue Syndrome Research Program at the CDC.
Each participant will spend three days at Emory University Hospital General Clinical Research Center (GCRC). The patients will undergo repeated blood and saliva sampling, as well as computerized testing and functional magnetic resonance imaging (fMRI) of the brain. Researchers plan to complete the study within a year.
CFS is a condition characterized by fatigue, memory problems and pain. Some experts estimate between one and four million people in the United States may suffer from CFS.
Unfortunately, an estimated 80 percent of all CFS patients have not yet been diagnosed by a medical provider.
The CDC-Emory study will focus on changes in hormone regulation and in the immune system, as well as alterations in the brain circuits involved in cognitive function and mental fatigue. Researchers also plan to explore the role that genes may play on these alterations.
We believe this research will lead us to a better understanding of the causes of CFS, both from a psychological and biological standpoint, said Andrew Miller, M.D., Timmie Professor of Psychiatry and Behavioral Sciences at Emory.
Health E-Hints
This Kitchen Condiment May Help a Skin Condition!
Black pepper could be a surprising treatment for the disfiguring skin condition vitiligo!
The disease, which affects about 1 percent of the worlds population, destroys the melanin that gives your skin its color. Melanin protects the skin from ultraviolet rayswhich means victims run a much higher risk of skin cancer.
In an animal study conducted at Kings College London, researchers showed that piperinethe compound that gives black pepper its spicy flavorhelped stimulate even-colored pigmentation in the skin of people with vitiligo.
According to study results to be published in the British Journal of Dermatology, piperine was especially effective when combined with ultraviolet radiation phototherapy.