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Publication in The Lancet

Six months after its presentation before the International Society for Rheumatic Therapies, the Harvard scleroderma study was published in one of the worlds leading peer-reviewed medical journals. The following news release was issued three days later by M. Evans & Company, the New York publishers of Henry Scammells book, Scleroderma.

"THE LANCET" REPORTS REMISSIONS, REVERSALS

IN HARVARD SCLERODERMA STUDY

Therapy Described in Book Passes Peer Review in Prestigious Journal

New York, December 1, 1998: The successful clinical trial of a new therapy for an often-fatal systemic disease, reported in the book, SCLERODERMA, by medical writer Henry Scammell, has now been published in the leading British medical journal, The Lancet. Performed at Harvard Medical School under the joint sponsorship of The Road Back Foundation and the National Institutes of Health, the study examined the effects of minocycline therapy on eleven patients suffering from this rare but increasingly common disease. The article by Drs. Christine Le, Alejandro Morales and David Trentham reports nine of the patients improved substantially, and two-thirds of those completing the study were in full remission, free of all disease activity. No other therapy has ever come close to the kind of result reported in the Harvard study. ?

Four out of five systemic scleroderma patients are women. Until now, the disease has been regarded by most physicians as untreatable, with one peer-reviewed study showing that two-thirds of its victims die within ten years of onset. "I must admit we were pleasantly surprised," says Dr. David Trentham of Bostons Beth Israel Hospital, the largest teaching hospital of Harvard Medical School. "Patients may live three to five to ten years, but they increasingly become more and more disabled. [But] five patients were in total remission: no existing, ongoing evidence of disease activity in their bodies, [which is] as close to a cure as you can get. Its safe and highly, highly effective in a condition that previously had no real, definitive way of control."

The Lancet article verifies details of the Harvard study as described by author Scammell in SCLERODERMA: The Proven Therapy That Can Save Your Life (M. Evans, New York 1998). The book offers a unique, insiders view of research at the leading Harvard teaching hospital, beginning with a history of both the disease and the therapy, and including intimate life portraits of the first patients to recover. "Until now, patients and their doctors have had to rely on anecdotal evidence that this safe, simple therapy can remit and reverse the disease," Scammell said. "But all the anecdotes in the world cant equal the authority of a peer-reviewed journal."

However, there are several reasons Scammell feels the therapy described in the Harvard study is likely to remain controversial even after publication in The Lancet. "This particular treatment isnt expensive and it isnt in patent, so the pharmaceutical industry has little incentive to spend the tens of millions for approval of this application from the FDA. Plus, we can expect the usual resistance from researchers and their backers who have spent a lot of time and money unsuccessfully searching for this kind of result in other places."

A painful, disfiguring disease whose name means hard skin, scleroderma afflicts some 400,000 Americans. In its systemic form, the disease often attacks the lungs, heart, kidneys and liver. It also thickens the skin, causing pain and crippling disfigurement. The clinical trial of this safe, simple, inexpensive new therapy promises to dramatically change a previously devastating prognosis.

With this peer-reviewed publication of the Harvard study results, scleroderma joins a growing family of connective tissue diseases which recently have proven to respond favorably to antibiotic therapy. The drug used in the latest trials, minocycline, has been pronounced "safe and effective" in the treatment of rheumatoid arthritis, with the majority of patients reporting substantial improvement, and remission rates as high as one in three. Minocycline is also widely used in the treatment of teenage acne; often described as safer than aspirin, it is in a class of antibiotic least likely to encourage resistant strains of the organisms it attacks.

SCLERODERMA brings major new insights  and new hope  to a previously obscure and bewildering medical mystery.