Alert Issued on Nieper Therapies
FDA Talk Paper 86-64
August 15, 1986
Hans A. Nieper, a West German physician, has claimed for some years to have treatments for cancer, heart disease and multiple sclerosis. He utilizes a mix of numerous minerals, vitamins and animal and plant extracts for which therapeutic representations are made, and other drugs, for which he has not sought U.S. approval. Dr. Nieper travels in the United States on speaking engagements which encourage patients to go to Germany for his unorthodox "treatments."
Patients have been led to believe that international law or World Health Organization regulations permit the importation of drugs that have been prescribed abroad. This is not true. There are no international laws, regulations or treaties that provide for such importations.
Because patients have been misled in this manner:
- Since September 1985, FDA has issued notices and advised patients bringing these products into the United States in their baggage or receiving them by mail that, contrary to what they may have been led to believe, these unapproved products are illegal and may be detained in the future. Almost always, the drugs are labeled in German with no English-language labeling, and seldom do they contain directions for use. [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 indicates a commercial venture or where the agency has stated its enforcement policy on the products involved (import alert) as with the Nieper products.]
- FDA has advised Dr. Nieper and shippers of these products from West Germany regarding the illegality of these shipments and has told them of the need to provide scientific data and otherwise follow U.S. procedures designed to protect U.S. citizens from unproven, unsafe and ineffective products.
Despite this advice, shipments of these unproved products have continued. Dr. Nieper has taken no steps to bring the products into compliance. As a result, FDA is now working with the U.S. Customs Service to halt this illegal flow. FDA regrets the impact that may be felt by patients who were misled into believing the drugs could be legally imported.
However, FDA warns prospective patients that FDA can find no evidence that the Nieper therapies are soundly or scientifically founded, and no studies that show his therapies are either safe or effective. FDA notes that individual testimonials on his behalf are meaningless, since temporary impressions of improvement are frequent among patients on any newly tried product. Unfortunately, when reality catches up with false hope, the collapse in patient morale can be severe—and, in the meantime, the patient may have failed to get worthwhile treatment. The following background may be useful:
More than 75 misbranded and unapproved drugs prescribed by Nieper have been detected in mail and personal baggage importations. These are directed to patients who may have been referred to the Nieper clinic by promotional groups in Wisconsin and California, including the recently established Hans A. Nieper Foundation. FDA has advised these groups that they should correct any materials they send out that suggest drugs prescribed at the Nieper clinic can be legally shipped to the United States.
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 lithe 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, including calcium aminoethyl phosphate or CaEAP, frequently prescribed as part of an expensive program of massive drug intake and special diets "has not been demonstrated to be effective in controlled experiments. II The German Multiple Sclerosis Society, according to its counterpart here, strongly advises against the treatment methods of Dr. Nieper.
In a 1981 advisory, the National Multiple Sclerosis Society emphasized that "when a physician makes a claim of producing a clinical improvement in MS, that physician has a moral and professional responsibility to prove scientifically the specificity of the treatment." Nieper had by then been making claims about multiple sclerosis for more than a decade and had not yet—and still has not—been willing or able to demonstrate the effectiveness of his therapies to other scientists.
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. Talk Papers are not intended for general distribution outside FDA, but all information in them is public, and full texts are releasable upon request. Nieper died in October 1998 at the age of 70, but many of his products are still marketed. In 1993, the FDA learned that a company based in the United states was illegally manufacturing orotates and other Hans Nieper products. The company's president was prosecuted and the products were seized and destroyed.
This article was posted on June 24, 2006.