Nonsteroidal anti-inflammatory agents are a major factor in the pathogenesis of gastric and duodenal ulcers, upper gastrointestinal bleeding, and death. According to estimations, the COX-2 inhibitor celecoxib (Celebrex^®/ Searle & Pfizer) is associated with a substantially lower rate of untoward events such as the frequency of ulcer, hemorrhage, and other complications. In addition, the rates of dyspepsia in patients were found to be diminished after taking the specific COX-2 inhibitors.

This month’s feature in our ongoing review of herbal remedies has been a compound used since early Greek medicine. The name "Feverfew," from the Latin word for "fever reducer," was given to the plant Tanacetum parthenium by the Greek physician Dioscorides, who prescribed the herb for "all hot inflammations." In the modern day, feverfew is developing a reputation as an alternative remedy in the treatment of migraine headaches. Medical interest in feverfew was renewed in Great Britain after a story was published in Prevention magazine in 1978. This story related the anecdotal success that a certain woman had in using feverfew for her migraines. Since then, medical studies have been conducted and research is underway on various components of feverfew.

According to laboratory studies, parthenolide, a lactone considered the active compound in feverfew, causes vasodilation of blood vessels, and reduces inflammation at the sub-cellular level by inhibiting the over aggregating of platelets in the bloodstream. Other constituents of the herb are reported to inhibit phagocytosis, platelet aggregation, and secretion of inflammatory mediators such as arachidonic acid and serotonin.⁽¹⁾ Feverfew is thought to down regulate the brain’s response to biogenic amines which appears to be consistent with feverfew’s ability to prevent headaches but not cure them, and is consistent with the months of use needed for clinical efficacy.

Proper concentration of parthenolide in feverfew extracts is critical for effective prevention of migraines. A critical consideration in commercial Feverfew products has been the consistency in parthenolide content. "Standardized extracts", developed in the last few years are suggested to insure a minimum parthenolide content of at least 0.2 percent. Patients purchasing feverfew products should purchase only those extracts with a guaranteed parthenolide content of at least 0.2%.

Since some promising results exist, feverfew is considered inexpensive, safe, and helpful in some major studies. Further high-quality research is required, but funding may be difficult, since herbs are not patentable in the United States. Herbal manufacturers are not required to sink large investments into researching the herbs they sell.

Heptinstall S, White A, Willimson L, Mitchell J. Extracts of Feverfew inhibit granule secretion in blood platelets and polymorphonuclear leukocytes. Lancet. 1985;1:1071-1074.

In June of 1999 the FDA issued a public health advisory to physicians concerning the risks of liver toxicity associated with the use of the oral antibiotic trovafloxacin and alatrofloxacin (Trovan^®/Pfizer)). Trovafloxacin, a fluoroquinoline antibiotic has been used to treat many different types of infections. It was approved for marketing in December of 1997, and became available on the market in February of 1998. Based on new safety data related to serious liver injury, the FDA is advising physicians that trovafloxacin should be reserved for use only in patients who meet ALL of the following specific criteria:

Have at least one of the following infections that is judged by the treating physician to be serious and life- or limb-threatening:

1. nosocomial pneumonia
2. community acquired pneumonia
3. complicated intra-abdominal infections (including post-surgical infections)
4. gynecologic and pelvic infections
5. complicated skin and skin structure infections, including diabetic foot infections
6. receive their initial therapy in an in-patient health care facility (i.e., hospital or long- term nursing care facility)
7. the treating physician believes that, even given the new safety information, the benefit of the product for the patient outweighs the potential risk.

From FDA Health Advisory: Lumpkin, Murray M. Deputy Center Director (Review Management)
Center for Drug Evaluation and Research, June 9, 1999

Much to the chagrin of the American Medical Association, a 253-page package of "patients’ rights" legislation was passed in mid-July by the U.S. Senate. According to the AMA, the bill had not even been seen or reviewed by some of those who voted on it, which, they said, contained last-minute special protections for the insurance industry.

The AMA president, Thomas Reardon, held a press conference and expressed disappointment in the Senate, accusing them of bowing to the insurance industry as well as denying the American public the fundamental right to health care when they need it. "This is really an HMO Bill of Rights that rewards the insurance industry and betrays patients," said D. Ted Lewers, MD, chair of the AMA. "They were in such a hurry to take care of the HMOs, they completely forgot about our patients."

The President vowed to veto this bill if it passes through the House of Representatives. Even so, the state of American health care has taken the center stage in American politics. This bill will undoubtedly be a key issue in the upcoming presidential campaign. In the meantime, the AMA will continue to urge Congress to develop a bill that will protect patients and physicians. Hopefully, allowing them to make decisions based on the best interests of the patient rather than basing treatment decisions solely on cost.

Thanks to AMA News Release: In the Light of Day: "HMO Protection Act" Looks Even Worse: AMA http://www.ama-assn.org/ad-com/releases/1999/990716.htm July 19, 1999

Pitt D. et al: N Engl J Med 1999; 341: 2