US LEADS THE WORLD IN BUYING DRUGS
New York, Feb 2005. Who buys drugs and why? Well, IMS Health, a global healthcare information company that specializes in tracking sales of drugs by the pharmaceutical companies, announced that the world spent $351 billion dollars for prescription drugs in the 12 months ending February, 05. Half of this ($177 billion) was spent by Americans. In the world, this represents a 6% increase over the proceeding 12 months but in the US sales were up 8%.

The US spends most of its money for drugs affecting the central nervous system (for example, medications for anxiety, depression, sleep, seizures, Parkinson’s Disease, and Alzheimer’s Disease). Expenditures for cardiovascular medications are a close second (for example, medications for high blood
holesterol, high blood pressure, and blood thinners for stroke prevention). In addition to CNS and cardiovascular, Americans spend their money for drugs affecting gastrointestinal track problems, infections, lung/breathing problems, and musculo-skeletal (arthritis) pain.

The single most commonly purchased drug worldwide is Lipitor (atorvastatin) which topped $10 billion in sales, which increased 14% for the period. Other top sellers, in decreasing order, included Zocor (simvastatin), Nexium (esomeprazole, the purple pill), Plavix (clopidogrel, used with aspirin to prevent strokes and clots after a heart attack), and Norvasc (amlodipine, used to treat high blood pressure). Plavix was the hot drug for the period, growing by 24%.

The top pharmaceutical companies, in terms of total sales were, in decreasing order, Pfizer, GlaxoSmithKline, Merck, Sanofi-Aventis, and AstraZeneca.

National Clinical Research is studying new drugs in each of these major categories which seek to improve effectiveness and reduce side effects. If you are interested in learning more about studies in any of these areas, call 755-2300 to learn more.

IS HEART DISEASE DUE TO AN INFECTION?
Some years ago, scientists discovered bacteria living in the plaque lining the walls of coronary blood vessels. This led to the theory that the plaque (atherosclerosis) was caused by an infection and that prescribing an antibiotic may prevent it from causing heart problems.

The Wizard trial, in which National Clinical Research participated, was carried out to test this theory. Now the answer is in: Giving an antibiotic to patients who had experienced a heart attack made no difference. Just as many people who received the antibiotic had another heart attack as those who did not receive the antibiotic. Taking cholesterol-lowering medications remains one of the best ways to prevent future heart attacks.

FDA AFFIRMS SUPPORT FOR ROSUVASTATIN
Washington, DC, March 2005. In March 2004, Public Citizen, a public interest organization head-quartered in Washington, DC, petitioned the FDA to remove rosuvastatin, one of the most potent statins for cholesterol lowering, from the market due to reports of muscle and kidney side effects. This request received wide media attention and caused a flood of calls to doctor’s offices from concerned patients about the safety of this product. The manufacturer of rosuvastatin, AstraZeneca, released public statements refuting these charges and reiterating that the drug’s safety and benefit from lowering high levels of heart-disease causing cholesterol levels. These releases received only modest attention by the media.

In March 2005, the FDA, after a year of comprehensive study of data from all sources available to it, denied the Public Citizen petition. The 36 page report focused primarily on the accusation that rosuvastatin may cause adverse effects on muscle and the kidney. After an extensive review of the scientific data, the FDA made the following statements:

• “Regarding rosuvastatin and muscle toxicity, after careful examination of the available information, we see no compelling evidence to date of clinical risks of rosuvastatin that distinguish it from other approved statins”
• There is no convincing evidence that rosuvastatin poses a risk of serious renal (kidney) injury.

Furthermore, the FDA said what all health professionals know who work with statin drugs to reduce the risk of heart disease, “The benefits of statins outweigh the small risk of adverse events.” This is perhaps the most important message to patients. Statins, including rosuvastatin, are very effective at lowering LDL-cholesterol, the bad cholesterol, and by doing so effectively lowers the risk of heart attacks and strokes, the nation’s number one killer. In fact, scientists agree that the more this bad cholesterol is lowered, the better. This means that drugs such as rosuvastatin, which is capable of lowering LDL-cholesterol the most, is a very useful drug to physicians and patients.