Dangerous ‘therapies’ from abroad – unapproved drugs

Dangerous ‘therapies’ from abroad – unapproved drugs – Updates

Dangerous “Therapies’ from Abroad

Patients who go abroad for unorthodox medical treatments have been warned by FDA not to bring back unapproved drugs and other substances used in their therapy. These products not only lack evidence of effectiveness and are illegal, but some may be contaminated with hazardous substances, including the viruses that cause AIDS and hepatitis B.

Targets of the warnings are the so-called Immuno-Augmentative Therapy agents used by Lawrence Burton in his Immunology Researching Center in the Bahamas and various minerals, vitamins, and animal and plant extracts used by Hans A. Nieper, a West German physician, for treating cancer, heart disease, and multiple sclerosis.

Burton, a zoologist, claims he can boost the body’s immune system through injections of an undisclosed “blood serum,’ although there is no evidence this therapy is effective in the treatment of any disease.

Some samples of blood serum from the Burton clinic have been found contaminated with a variety of disease-producing organisms, as well as HTLV-III antibody (strongly suggesting the presence of the virtus that causes AIDS–acquired immunodeficiency syndrome) and hepatitis B surface antigen (strongly suggesting the presence of that virus).

To protect U.S. citizens, FDA has alerted U.S. Customs and Postal Service authorities to detain any of this serum being brought into the United States.

Many patients who have gone to Germany for Nieper’s unorthodox treatments have been led to believe that international law or World Health Organization regulations permit importing drugs that have been prescribed abroad. In fact, no international laws, regulations or treaties provide for such importation.

Since September 1985, FDA has advised Nieper’s patients that his products are unapproved, illegal, and may be detained. Drugs are almost always labeled only in German and seldom have directions for use.

More than 75 misbranded and unapproved drugs prescribed by Nieper have been found in patients’ mail and personal baggage coming into the United States. The patients may have been referred to the Nieper clinic by groups in Wisconsin and California. FDA has advised these groups that they should correct any promotional materials that suggest drugs prescribed at the Nieper clinic can be legally shipped to the United States.

FDA has advised Nieper and shippers of his products from West Germany that such shipments are illegal because the products have not been proven safe and effective. Nieper has taken no steps to bring the products into compliance. As a result, FDA is working with the U.S. Customs Service to halt the illegal flow of his drugs.

The American Cancer Society reports that the Nieper cancer therapies include the discredited amygdalin (Laetrile) and such other unproved substances as Iscador, fresh cell therapy, and wobe-mugos enzyme. The American Heart Association says the drugs reportedly used for his cardiovascular treatments include bromelain, carnitine, selenium, magnesium orotate, and potassium orotate–for which “there are no significant data indicating that any of these drugs are efficacious.’ The American College of Cardiology strongly warns against any use of unapproved drugs for treatment of cardiovascular disease, adding that “the FDA review process has done much to protect the American people from exposure to unsafe and ineffective drugs.’

And the National Multiple Sclerosis Society advises that the calcium products, frequently prescribed as part of an expensive program of massive drug intake and special diets, “have not been demonstrated to be effective in controlled experiments.’ The German Multiple Sclerosis Society, according to its counterpart here, strongly advises against Nieper’s treatment methods.

FDA permits tourists and other travelers to carry in their baggage small supplies of drugs needed during their travel. However, this does not apply to quantities of dangerous drugs or to entries whose nature and number indicate a commercial venture or where the agency has stated its enforcement policy on the products involved, as with the Nieper products.

COPYRIGHT 1986 U.S. Government Printing Office

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