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October 2, 1998     Cape Gazette
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34 - CAPE GAZETTE, Friday, October 2 - October 8, 1998 HEALTH & FITNESS New AIDS drugs show promise: regimens easier By Kerry Kester New drugs available for HIV- positive and AIDS patients are showing promise for better keep- ing the disease controlled, im- proving drug regimen schedules arid reducing side effects. Despite positive, preliminary data, howev- er, physicians advise caution: be- cause the Federal Drug Adminis- tration now allows AIDS drugs to be fast-tracked to the market, long-term data is not available. Since the advent of protease in- hibitors, monotherapy - using on- ly one drug : is no longer the stan- dard of care. Most patients are now treated with a drug "cocktail," or a combination of drugs from the three classes of drugs used to treat AIDS pa- tients: nucleo- sides, nonnucle- OLEWILER osides - both nicknamed "nukes" - and protease inhibitors. Generally, cocktails involve three drugs: two nukes and a pro- tease inhibitor. Although the cocktails are proving effective for most patients, the drug regimens can be difficult to control. Prior to research that led to changing quantities and frequency of dosages, it was comion for pa- tients to take 40 or more pills per day, at exact times. Patients often had difficulty maintaining schedules, and if pills were missed or taken at the wrong times, the drugs' efficacy was hampered. Lifestyles revolved around pill taking; sleeping sched- ules were timed, traveling - even for a'day - required careful plan- ning, and normal activities had to be calculated to fit With the pill- Speedy FDA By Kerry Kester The Federal Drug Administration has longbeen known for its exceptionally high standards for new drug releases. The orga- nization has also long been criticized for its very conservative stance against releasing new products before extensive testing and data collection can prove the drug is truly effective and safe. The history of the Federal Drug Admin- istration (FDA) is that before it Would al- low a new product to be released for mar- keting i n the United States, the drug would undergo rigorous testing, clinical trials and five to 10 years of data collection to ensure the drugs were safe. The results of the FDA's conservatism often proved wise. For example, years ago a drug was mar- keted in Europe that was not yet approved by the FDA for use in the United States. In its testing phases, a limited number of peo- ple were involved in the clinical trials, but indications were that the drug was safe and effective. The drug thalidomide was released for widespread use as a sleeping pill, in Euro- approval may not offer HIV/MDS pean countries. However, after it became marketed to a greater mass of people - many of whom were pregnant women - much more data was collected and scien- tists learned the drug caused birth defects. "That's why we have the FDA," said Dr. Scott Olewiler, Beebe Medical Center in- fectious disease specialist. 'q'here has to be a balance between getting new things out and protecting people." However, he said, by the late 1980s, AIDS reached epidemic proportions, and people clamored to have experimental drugs released. People were dying by the thousands, so the FDA changed its position on the protocol for new drugs that were used as AIDS treatment. "They didn't have time to wait," said Olewiler, "so the FDA made an exception for HIV. It made the process much faster but more dangerous." In clinical trials, there may be only a few hundred people who test a new drug; but it is data collected from greater numbers that gives a clearer picture of how safe and effective a new drug is. taking schedule. Now, however, three new nukes are changing the face of therapy. According to Dr. Scott Olewiler, infectious disease specialist at Beebe Medical Center, efavirenz, a nucleoside similar to AZT, at- tacks the AIDS enzyme; it is well tolerated by most and requires on- ly one dose per day. It is used in combination with two other drugs. Adefovir, a nucleoside analog, is also taken only once per day, in combination with two other drugs. The third new drug, abacavir, is i n the nucleoside family and is pre- scribed at a dosage of one pill patients twice a day. The three drugs are available on expanded access, said Olewiler. In other words, the drugs are still at an experimental stage - the clin- ical trial phase. Patients enrolled in the trial must have physicians who are registered as investigators and who carefully monitor and re- port what patients using the drugs experience. "Drugs available in the study should be given only to patients in whom all standard, better studied treatments have failed," said Olewiler. "We never get an ade- Continued on page 38 the best drug treatments Protease inhibitors, for ,example, were quickly released to the market, and for many people the drug seemed like a mira- cle. Protease inhibitors were of a new class of drugs that attacked AIDS in a different manner; patients saw their viral loads drop considerably. The drugs have now been mass marketed for approximately two years to millions of people. The miracle no longer seems quite so miraculous. Data collected since pro- tease inhibitors went into use on a wide giving bodies distorted appearances. Other side effects include the onset of di- abetes, with a resistance to insulin, and triglycerides or cholesterol boosts. "Now we know these drugs come with bad and good, like anything else," he said. There are two other sides of the issue, he noted: despite the adverse effects of pro- tease inhibitors, mortality rates are better. There is also no data from long-term use, so other side effects couldbe pending. "What will patients have in 10 years? Is it heart at- scale shows side effects from the drugs are tacks, strokes?" he rhetorically asked. severe for many patients, said Olewiler. "Nobody is dying from protease in- hibitors," said Olewiler. However, patients who have been on the drugs for some time may develop lipodystrophy, or abnormal fat distribution. They may have very thin arms or legs, with normal fat redistributed to the back of the neck or stomach areas, "Everybody thinks the FDA-is the bad guy but it's the good guy," he said. It is un- fortunate that after pressuring the federal government to change its method of releas- ing new products, that people are now com- plaining about side effects from those prod- ucts. "You can't have it both ways," said Olewiler. Chiropractic medicine may help diabetics Diabetes is one of the most common disorders, and it is esti- mated that 16 million people in the United States have the disease, although nearly 7 million are not even aware they suffer from it. Despite the fact that millions of dollars are spent each year for dia- betes treatment and research, no known cure has been discovered. To better treat an illness, we must first fully understand the condi- tion. Diabetes is a disease that affects the w.ay the body uses food. Dur- ing the normal process of diges- tion, the pancreas, which is locat- ed in the center of the upper ab- domen, produces critical enzymes to assist the breakdown of food. The chemical produced is called insulin, which helps regulate the blood sugar, or glucose. Insulin is what turns food into energy. When insulin is working the way it should, the glucose is either used by the body or stored in the liver for future use. HEALTH TOPICS Dr. Christopher Bald1 Dr. Christopher Baldt is practicing chiropractic medi- cine at Long Neck Chiroprac- tic, 945-4575. In a person with diabetes, food is changed into glucose, but either there is not enough insulin to complete the process or the body is simply unable to use the insulin properly. When this happens, the cells do not receive their supply of glucose, or energy, which means serious complications for the body systems. Glucose levels be- come high in the blood and left untreated, can cause death. There are two types of diabetes. Diabetes insipidus, and diabetes mellitus. Diabetes insipidus is a rare metabolic disorder caused by a deficiency of the pituitary hor- mone. This form of diabetes is characterized by the production of enormous amounts of urine re- gardless of the amount of liquid consumed. Diabetes mellitus is a result of an underproduction of in- sulin by the pancreas. This type is divided into two categories, Type I, insulin dependent or juvenile di- abetes, and Type II, which occurs later in life. The symptoms of Type I include irritability, frequent urination, ex- cessive thirst or hunger, nausea, weakness, sudden weight loss and blurred or abnormal vision. The second type of diabetes, of- ten called maturity onset diabetes, is likely to occur in individuals with.a family history of the dis- ease. The warning signs of Type II usually develop gradually. They may include any of the symptoms of Type I and additionally, tin: gling or numbness in the legs, feet, or fingers, slow healing of wounds, especially around the feet, obesity, drowsiness and rash- es or itchy skin infections. A good balance of diet can of- ten control Type II diabetes so that insulin is not required. Obesi- ty is a major factor in Type II dia- betes. A weight reduction pro- gram will greatly improve the condition of Type II diabetes; however, it is very important to -follow the dietary guidelines giv- en by a qualified physician or cer- tified diabetes educator. Diabetes requires continued medical care. Careful and con- stant monitoring greatly reduces the chances for serious complica- tions. People diagnosed with dia- betes are recommended to see their health-care professional every three months. Because of the problems associated with dia- betes, it is often necessary to as- semble a team of health-care providers. A primary care physician will most likely be the director of any health-care team. He or she moni- tors overall care and can make re- ferrals for specialized concerns. An endocrinologist is a physi- cian who specializes in treating disorders of the endocrine system, which regulates the chemicals, like insulin, produced in the body. Diabetes is one of the most com- mon disorders seen by this type of physician. Another critical mem- ber of the diabetes health-care team is an ophthalmologist. Vi- sion trouble is common in dia- betes patients and must be closely watched. A complete eye exam should be done once a year. Continued on page 41