DHEA Returned & Ozone Clinic Raided
Illegally Seized DHEA Returned Due To Pressure From LEF And Dr. Whitaker
By John Hammell, Political Coordinator Life Extension Foundation
We are pleased to INFOrm you that the DHEA, which had been illegally seized from Life Extension Foundation (LEF) member Paul Gallo, has finally been returned to him, and that the Bergen County New Jersey Prosecutor's office has admitted wrongdoing in the matter.
In the February, 1966 issue of LIFE EXTENSION Magazine, we reported on the great job LEF attorney Ralph Fucetola did in assisting 75-year-old LEF member Paul Gallo in getting charges dropped against him for possession of DHEA, which the Bergen County NJ Narcotics Task Force had claimed was an "illegal anabolic steroid" (a controlled dangerous substance and schedule 3 drug). Although charges had been dropped against Gallo, his illegally seized property had yet to be returned to him.
In that article, we discussed how Gallo had been arrested at the Oradel, NJ post office after being summoned there by the postal inspector in order to receive his package of DHEA. We recounted how Gallo had been interrogated, thrown in a jail cell, fingerprinted, and had mug shots taken in what was clearly a case of false arrest.
We jumped to his defense, and quickly proved that DHEA, a metabolite of cholesterol, is no more an "anabolic" substance than cholesterol is. We had expert witnesses prepared to state this fact in court. We also quickly demonstrated that DHEA had never been listed in the Federal Register as a scheduled drug, as is required by law. When this was pointed out to the Bergen County Prosecutor's Office, they dropped all charges against Mr. Gallo, but refused to return his illegally seized DHEA!
Dr. Whitaker Joins The Fight
Dr. Julian Whitaker then picked up the story from our magazine and published an article about the illegal Gallo raid in his newsletter, within which he included the phone number of the Bergen County Prosecutor's office, requesting that his readers call to demand that Gallo's illegally seized property be returned to him promptly.
Upon reading Dr. Whitaker's article, I posted the phone number of the Prosecutor's office in several Internet newsgroups. The Prosecutor's office was then flooded with so many calls that they decided that their easiest course of action would be to return Gallo's DHEA!
Other Charges Dropped As Well
Six days before the Gallo raid, Ellen Linda Minquet, another LEF member had also been raided for possession of DHEA as a "controlled dangerous substance", but we didn't report that raid for legal reasons. Prosecutors also dropped all charges in her case and returned the seized DHEA.
In an article entitled "Purchasers of Hormone Caught in Drug War", the New Jersey Daily Record reported on Dec. 28, 1995 on the return of Gallo's and Minquet's DHEA, stating that:
"The arrests have raised concerns in health and medical journals about the overzealous enforcement of drug laws and the rights of individuals to obtain experimental drugs or dietary supplements for personal use."
Confusion At The FDA
They went on to report that:
"Joan Baran, a Customs spokeswoman at Kennedy airport in NYC, stated that the DHEA had been seized as a result of a customs alert issued by the FDA, however the FDA denied ever having issued such an alert for DHEA."
The New Jersey paper quoted Dr. Michael Klein at the FDA's Center for Drug Evaluation and Research as saying that:
"The FDA does not consider the hormone to be a controlled substance."
Paul Schwenwede, an assistant prosecutor in the County's drug task force was quoted by The Record as saying that his office had:
"...relied on the NJ State Police Crime Labs determination that DHEA was an illegal anabolic steroid to set up the sting that led to Gallo's arrest.
The record quoted Schwenwede as saying that:
"Whether or not something is a steroid or a particular substance, that s a controversy involving the chemists. When we as a law enforcement agency receive INFOrmation from the lab that something is a controlled dangerous substance, we act accordingly."
LEF's and Dr. Whittaker's teamwork were what forced the NJ State Police Crime Lab to reevaluate their erroneous pronouncement about DHEA. "In the medical community, the definition of these drugs is debatable," said John Haggerty, a police spokesman. Initially, Haggerty said the seized products could not be returned but our pressure convinced him otherwise.
Capricious Regulation By The FDA
Attorney Fucetola says it was capricious regulation by the FDA that resulted in the arrests of his clients. He called these arrests examples of a drug war gone crazy.
Like Gallo, Minquet's DHEA was seized at Kennedy airport. The Monmouth County Prosecutor's office dropped the charges against her after the state police crime lab determined that DHEA is not an anabolic steroid, Prosecutor John A. Kaye made the following comment after the DHEA was returned.
"Its hers," Kaye said. "Its legal."
Ozone Clinic Raided,
Kessler Thumbs Nose At FDA
By John Hammell, Political Coordinator Life Extension Foundation
On Jan. 4, 1966, at 8:30am, 10 FDA agents and 2 state troopers with drawn guns, burst into the Lazare Clinic and home of owners Richard Harley and Jackie Kubie in Shawnee on the Delaware, Pennsylvania.
Co-owner Jackie Kubie recounted the terrifying ordeal in which the armed agents burst into her home, yanked her son out of the shower, and herded everyone into the dining room, while they rifled through everything in the house, indiscriminately grabbing personal files, dietary supplements, and numerous other items not listed on their Search Warrant.
Their warrant, which was signed by Magistrate Raymond J. Durkin of the U.S. District Court for the Middle District of Pennsylvania, authorized the raiders to seize:
...Ozone/oxygen therapy devices and all accessories, topozone oil and any materials used to manufacture it, records, files, documents, receipts related to the sale and promotion of ozone/oxygen therapy devices and or topozone oil, and any other unapproved drug or device.
Ms.Kube complained that they took all her olive oil which she needs for cooking. They took the computer, peripherals, client records, all sales brochures...everything that wasn't nailed down!
No Charges Filed...No Probable Cause Revealed
Typically, no charges were filed and the clinic was not closed down. It reopened a few days later with equipment borrowed from friends. Though not owned by a medical professional, the staff includes a medical doctor and nurses.
Before opening in September 1995, Lazare had gotten approval from the Commonwealth of Pennsylvania and had a letter of assurance that he was operating legally dated Nov. 22, 1995, from the Department of Health and Human Services Center For Alternative Medicine Research In HIV/AIDS, under the review of Leanna Standish, ND, Director of Research at Bastyr University.
The clinic's staff physician was not raided. Calls by Lazare and attorney Nancy Lord, M.D. to the Assistant U.S. Attorney General had not yet been returned as of the writing of this article. INFOrmation as to what testimony or affidavits had been used to establish probable cause have not been made available to Lazare or Lord.
Staff Is Bewildered And Angered
Jackie Kubie, Richard Harley, and their staff are bewildered because they had gone to great lengths to comply with all regulations. Their patients fear being cut off from all future treatment. Bastyr University of Seattle, Washington, which is respected internationally in the emerging field of alternative medicine, had been serving as the institutional review board for Lazare's research. Clinic staff are deeply angered at this gross intrusion into their business, which would have resulted in the deaths of several severely ill patients had they not been able to borrow equipment from friends in order to reopen the clinic within days of the raid.
Attorney Lord fails to see any way in which the Pennsylvania based clinic was engaged in interstate commerce, as is implied by the FDA's actions, and questions their jurisdiction in the matter.
A Slap In Barton s Face
As the first FDA raid since Congressman Joe Barton (R-TX) included his last FDA oversight hearing on December 5, 1995, this raid had Kessler's fingerprints all over it because the agents didn't just come from the local Pennsylvania offices, but instead from FDA headquarters in Rockville, MD. In sending their "calling card", the Rockville agents clearly sought to mock Congressman Barton's oversight efforts by claiming that the clinic s World Wide Web site home page on the Internet constitutes "mail fraud."
Thus, this raid is not just an attack on the U.S. Constitution, and on an ozone clinic, it also poses a clear threat to the inhabitants of cyberspace who are seeking the same constitutional protections as exist for other media. If you are online, please check in with me at jhammell@ix.netcom.com so that we can work together to protest this gross abuse of authority.
The Lazare Home Page On The Web
Upon visiting the Lazare home page at: http://www.lazare.com, all I found was a description of ozone therapy, a description of the clinic and its research on ozone therapy as a treatment for HIV and AIDS, and a public service solicitation for volunteer research patients. Finally, there was an ad for Topozone oil, which the FDA clearly feels is an "unapproved drug".
The FDA wanted to shut Lazare down, but failed to do so. They weren't interested in the legality of their action because their goal is to protect Burroughs-Wellcome (makers of AZT), and the other pharmaceutical giants. It simply isn't in the best interests of big business to allow research to be conducted on the use of ozone, an inexpensive, easily produced gas. Lazare's oxygen/ozone therapy is patented and they used it to treat viral, bacterial, and fungal infections.
Will Congress ever be able to reign in this terroristic agency? How will Congressman Barton respond to this slap in the face by Kessler? With health care costs breaking the back of the country, a climate must exist in which research can be conducted in peace, without the constant threat of FDA terrorism. This type of suppression of health care alternatives cannot be tolerated in a free society.
Support The Access To Medical Treatments Act
It is very important that you call your Congressional representative and Senators to voice your support for the Access to Medical Treatments Act, which is intended to block the FDA from raiding alternative clinics, so long as they are doing no harm and patients are provided with proper INFOrmed consent, so that they fully understand the nature of the experimental treatment being used.
Any member of Congress can be called through the Congressional switchboard at 1-800-962-3524. Discuss the Lazare raid with your Congressional offices. Fax or mail this article to them along with a signed copy of the form letters for both the Access to Medical Treatments Act and the Food and Dietary Consumer INFOrmation Act, which follow this article. Persuade others to do the same. Writing your own personal letters to Congress also helps a lot.
To facilitate your work, order a copy of the U.S. Congress Handbook by calling 1-800-229-3572. It has all the phone and fax numbers you'll need, along with committee assignments, etc. After you contact your own representatives, focus your efforts on the Senate Labor Committee and the House Commerce Committee where all health legislation originates. Download this article from the LEF home page at http://www.lef.org/index.html , and forward it to appropriate Usenet newsgroups, online mailing lists, media sources, family, friends, business associates, and, of course to members of Congress.
Reporters who d like additional INFOrmation about the Lazare raid should contact Kay Ness, Media Relations for Dr. Lord at: 1-770-416-3845.
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