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By Source: HealthWatch • www.ProHealth.com • December 1, 1992


It must be noted that these findings were not reported under scientifically controlled conditions. Rather, they are simple observations of patient responses from small samples. In order for clinicians to adhere to strict scientific standards double-blind placebo studies would be required. Therefore, these treatments are presented for information purposes only.

AMPLIGEN REPORT

HEM Research, the makers of Ampligen, submitted their request for an expanded CFIDS study to the FDA in September. At an American Society for Microbiology conference, HEM reported that Ampligen produced global changes in the lives of more than half the PWCs who received it. Symptoms were reduced, the need for other medications decreased, and both cognitive and physical abilities improved.

Most PWCs studied had abnormally high levels of lymphokines and cytokines (natural immune fighting compounds). Those with an acute infection responded particularly well. High levels of HHV-6 and, in some people, anatomical holes in the brain were also reported.

Despite these findings, the FDA put a clinical hold on Ampligen, making it temporarily unavailable for general use. They expressed concern about the drug's safety and requested additional data. HEM maintains that the action is unwarranted. Doctors involved in the trial agree that Ampligen's benefits far outweigh its risks and should be further studied. It is impossible to tell when the FDA will lift its hold.

Meanwhile, participants in the now closed Ampligen 502 trial have obtained injunctions requiring HEM to provide them with the drug until their suit against the company comes to trial. The court apparently upheld the participants' long-standing claim that HEM promised them continued access to Ampligen.

MAGNESIUM SHOTS

Recently, several CFIDS clinicians, following a report describing considerable improvement among PWCs from daily shots of magnesium, have started offering this treatment to their patients. Early attempts to determine efficacy have produced varied results. One leading clinician administered the treatment to 40 patients for six weeks with a third of those patients reporting possible improvement. Other clinicians, like Dr. Cheney, Dr. Peterson, and Dr. Rest report minimal results at best.

However, some clinicians report substantial improvement among their patients in regard to certain symptoms. In a study of 400 patients, over 300 reported improvement in headaches, sleep disorders, muscle pain and weakness, and fibromyalgia aches. Also 30% reported increases in energy levels. This study administered 2cc a week for six weeks and then switched to oral doses unless symptoms returned. Dr. Levine also observed a reduction in muscle pain and sleep disorders, but not in overall energy levels.

While magnesium shots may be administered by someone other than your doctor to keep costs down, most clinicians warn that the injections are quite painful.

KUTAPRESSIN

In November 1990 at the CFIDS conference in Charlotte, Dr. William Hermann, Jr., and Dr. Thomas Steinback announced positive response rates from 600 PWCs after using IM Kutapressin.

Further results, however, have been mixed. Three clinicians have reported improvement in only 1% of patients, and that improvement was slight. But others, like Drs. Levine and Cheney, have reported positive results. Over half of Dr. Levine's 375 PWCs reported improvement in the aches and flu
symptoms, while Dr. Cheney reported that 60% of his 200 patients improved in most symptoms, except for cognition.

Dr. Levine administered 1cc of Kutapressin per day for three months, then scaled back to every second day. Dr. Cheney prescribed 2cc/day for one month, then as needed.

It has been rumored that Schwartz Pharmaceuticals, manufacturers of Kutapressin, is working on a highly concentrated and purified Kutapressin derivative that may become a useful treatment for CFIDS. The manufacturer would neither confirm nor deny this information.




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