July 1995
The FDA Threatens Criminal Charges Against Offshore Pharmacies
The FDA is constantly threatening to file criminal charges against The Life Extension Foundation for recommending offshore pharmacies that supply Americans with low-cost medications that are years away from FDA approval.
We have never capitulated to these threats and continue to assist our members in obtaining lifesaving medications from other countries. The FDA is now trying to intimidate offshore pharmacies with letters threatening criminal prosecution if they do not stop mailing personal use quantities of these unapproved medications to Americans.
A European drug called Metformin that we have been recommending since 1990 has just been approved by the FDA to treat adult-onset diabetes. What follows is an article from The Orlando Sentinel about this "breakthrough" drug:
The Orlando Sentinel, Fla. Knight-Ridder/Tribune Business News June 7 1995
NEW MEDICATION TO TREAT DIABETES EARNS F.D.A. APPROVAL
For the first time in 20 years doctors have a new medication to help treat type 2 diabetes. It's a drug with a past dating to the 1950s but arriving near century's end when some doctors have begun to re-think this type of diabetes, often striking in mid-life. Endocrinologists throughout Florida are hailing the medication's arrival as a new treatment option for one of the state's biggest medical problems.
Called metformin and sold as Glucophage, the oral drug was approved late last month by the U.S. Food and Drug Administration. Doctors are just beginning to prescribe the medication for people who have failed to respond to standard therapy, usually exercise, diet and other medications to keep blood sugar in check.
An estimated 1 million Floridians have diabetes - 900,000 of them have type 2. This form of diabetes usually begins about age 40, and with Florida's rapidly aging population, diabetes has become an inescapable health-care issue. "This adds to our armament," said Dr. Samuel Crockett, an endocrinologist and medical director of the Diabetes Center at Florida Hospital Orlando.
Type 2 diabetics usually produce some insulin, a vital hormone, but cannot get glucose out of the blood and into tissues where it is used as fuel for walking, running, typing a letter - or powering the brain for thinking, wishing and dreaming. The American Diabetes Association in Orlando estimates half of Floridians with type 2 diabetes are undiagnosed. Type 2 diabetes - like type 1 - can lead to blindness, heart and blood vessel disease, kidney failure and stroke. Type 1, often considered the more severe form of diabetes, usually begins in childhood and is typified by a complete inability to produce insulin. Nationally, nearly 14 million people have diabetes, 95 percent of them with type 2. Diabetes is the country's fourth-leading cause of death.
"We have only had the medication for a short time, so it's difficult to say how people are doing," Crockett said. But he's hopeful. He started patients on the medication within days of its approval. Some patients have been on it for only a week. But so far, so good, Crockett said.
"This medication has been around since the late 1950s, but it was withdrawn (in this country)," he said, because was it was linked to kidney damage. The FDA, which oversees drug development and approval, considered the problem too serious to allow the drug to be marketed. But European researchers continued working on the medication, producing variations with fewer side effects. The drug has been available in several European countries since the 1960s. There is still potential for complications, but primarily among people who already have kidney failure.
Doctors are uncertain how many patients will be helped by metformin in this country. It is estimated that half of patients in Europe with type 2 diabetes are successfully treated with the medication. While doctors are pleased with the drug's arrival, some say it may be time to re-think the definition of type 2 diabetes. For years it was thought that obesity triggers the condition because many who have it are overweight by 20 percent or more. Researchers, however, have since found a gene linked to type 2.
Dr. Marvin Mengel, medical director of the diabetes program at Orlando Regional Medical Center, thinks type 2 diabetes actually could be as many as five distinct conditions, with each characterized by the body's inability to properly utilize insulin. Obesity may exacerbate type 2 diabetes, Mengel theorizes, because the larger a person, the more insulin needed to get glucose into even more cells.
Dr. Noel Maclaren of the University of Florida in Gainesville contends some type 2 diabetics actually may be type 1. Maclaren thinks diabetes that develops between age 20 and the late 40s could be late-onset type 1, once known as juvenile diabetes. His hypothesis has led to a study in which people who show signs of low-blood levels of insulin are being given preventive injections of the hormone to stave off the disease. But for now, Crockett said it's wait-and-see to determine how well the new glucose-controlling drug works. "This isn't initial therapy at this time, but it's a good option for a very large group...," he said.
Despite the FDA's "approval" of Metformin, 30 years after it was first used successfully in Europe, and the expectation by physicians that Metformin may help save the lives of more than 6 million Americans with Type 2 Diabetes, the FDA is now threatening to bring criminal charges against European pharmacies who have been selling Metformin to Americans for many years, and continues to threaten The Foundation with criminal charges for recommending this lifesaving drug to Americans!
Is there no end to the FDA's criminal actions? After contributing to the premature death of millions of American diabetics over a 30-year period, the FDA is now threatening to imprison those who had the courage to help save a few of those lives! This is terrorism pure and simple that MUST BE STOPPED NOW! This issue of The FDA Raid Report provides you with a few specific examples of FDA terrorism against Americans and what The Life Extension Foundation is going to do about it.
Why We Are Suing The FDA
By John Hammell, Political Coordinator Life Extension Foundation
One of the unique services The Foundation provides to its members is access to safe-and-effective therapies not available in the U.S. We also INFOrm our members that drugs which are available in the U.S. can be purchased in other countries at much lower prices. The fact that there are so many drugs unapproved in this country that are saving the lives of Europeans, Asians and others is an outrage that can no longer be tolerated.
The FDA's response to our efforts to help our members obtain the health and economic benefits that citizens of other countries take for granted has been a 15-year campaign to destroy The Foundation, fueled by millions of taxpayer dollars. The FDA has also been meddling in the affairs of other countries by attempting to put the companies that sell these drugs out of business, and the agency has been confiscating the property of Americans who purchase these drugs. The FDA's actions are illegal, unconstitutional, and in direct violation of their own policy of allowing Americans to import unapproved drugs for their own personal use.
Although most unapproved drugs mailed to Americans from offshore pharmacies manage to get through the relatively porous net the FDA has set up to seize them, a number of these drugs are, in fact, being detained and confiscated by the FDA.
Helping Americans Fight For Their Rights
When The Foundation learns that the FDA has illegally seized the private property of Americans, we do everything in our power to help the victims of these crimes reclaim their stolen property. If you have been victimized in this manner by the FDA, please give us a call at 1-800-333-2553.
The problem with individual citizens fighting the FDA is that it is expensive and time-consuming for them to do so. To give you an idea of what the victims of these crimes have to go through in fighting for their rights, here are a few stories that tell what can happen if you attempt to pressure the agency into returning your property.
The Stories of Jim Gebhard, Melinda Vadas, Ph.D. and Jack R. Haney
On Oct. 17, 1994, Robert A. Sittig, Compliance Officer of the FDA's Chicago District Office sent a two sentence letter to Jim Gebhard, of Sitka, Alaska INFOrming him that a shipment "appears to be in violation of the FD & C Act and other related Acts, and the Public Health Service Act."
Gebhard was INFOrmed that he "had the opportunity to appear at the district office of the Food and Drug Administration (in Chicago) to introduce testimony relative to the admissibility of the article or to file a statement in writing within 10 days following the date of detention." (If the items could not be "brought into compliance" enough to suit Sittig, they would be "refused admission".
Gebhard fought back. His detained piracetam, vinpocetine, vasopressin, and dilantin had cost him $175, but he ran up a phone bill of over $300.00, wrote 7 long notarized, certified letters to the FDA and to Alaska Senators Murcowski and Stephens, and retained legal counsel because the FDA had arbitrarily seized his property, which he had paid for and legally imported for his own personal use!
The following excerpts from Gebhard's letter of November 19th to Sittig at the FDA illustrate the kind of frustration people have reported to me when attempting to communicate with the Chicago district office of the FDA about a product detention...
"Dear Mr. Sittig,
Your letter of 11/15/94 arrived yesterday, giving me until 11/25/94 to answer your letter. Your letter yet again ignored my questions. You continue to ignore my phone calls as well. This is my fifth letter now to your office regarding the medication which you have detained. Between 11/14 and today I have continued trying to call you and have left 2 messages on your machine; more than a dozen calls to you have been made before this. Your lack of courtesy and respect in responding to a taxpaying citizen in need is outrageous."
"I ask again, for the fourth time formally in writing, on what legal basis you are requiring my physician to write you a letter revealing my condition to you, and requiring him to justify the need for a medication, as a condition for release of my medication. Your requirement that this be provided violates my constitutional right to privacy and it is not part of any statute, regulation or policy that you have provided to me. My condition is between me and my physician; it is private and confidential. Your requirements appear to be personal, arbitrary, and capricious and well beyond legal limits. Your conduct appears malicious, with deliberate, conscious criminal intent to do me physical harm, and may be the basis for legal action against you personally."
On Dec. 7, 1994, the FDA finally released Gebhard's products with this statement: "Consideration under the above designated Act(s) of your shipment has been completed and based on the examination of samples or other evidence, it is concluded that the merchandise need not be further detained, insofar as said section of designated Act is concerned. This notice does not constitute assurance that the merchandise involved complies with all provisions of the FD&C and other related Acts and in no way precludes further action should it be determined that the merchandise is violative."
The Ordeal Of Dr. Vadas
Melinda Vadas, Ph.D. of Oak Ridge, NC also ran afoul of FDA bureaucracy. She suffers from Chronic Fatigue Syndrome and Osteomalacia-a bone disease. Her letter to Linda Hunt, District Director of Customs, FDA in Baltimore reflects the extreme suffering imposed by the FDA on patients who require foreign drugs. Melinda's letter of January 11, 1995 reads as follows:
"Dear Ms. Hunt:
I have been disabled by Chronic Fatigue Syndrome for a number of years. I receive $442 per month in Social Security Disability Insurance. I have also recently been diagnosed with Osteomalacia, a bone disease. I take probably a dozen prescription medications. Because I can no longer afford the increasing cost of my prescription drugs purchased here in the US, I have chosen to purchase some of them overseas, as, according to FDA policy, is my right. These drugs are entirely for my own use, and they are not controlled substances. (I think the number of menopausal disabled women selling Premarin on street corners to schoolchildren is probably pretty small.)
"Now I have been told that you have seized two of my prescription medications, Calcitriol and Premarin. (No mention was made of the five tubes of acne medication that were in the same package. I assume you have seized them as well.) I cannot afford to purchase these medications locally nor, since I have already paid for the drugs you have (their total cost is $205) can I afford to re-purchase them from overseas. I ask that you return my medications to me in a timely manner. (I will run out of Premarin in two weeks.) Though I accept that you personally may be and probably are acting with good intentions, I regard the FDA's unstated policy of seizing low-cost medications ordered from overseas as a cynical assault on disabled, retired, and other fixed income consumers, done in the name of 'consumer protection', when what the FDA is in fact protecting is the right of large American drug companies such as Roche to sell me Calcitriol at nearly three times the price at which I can purchase the same drug, made by the same company, overseas. For this sort of 'protection' I don't need the FDA; I believe the Mafia offers the same sort of services.
Yours most sincerely, Melinda Vadas, Ph.D.
With the help of Congressman Howard Coble's office, Melinda Vadas was able to get her detained medications back from the FDA 6 weeks later. She was forced to make a lot of expensive phone calls and write many letters. During that time, her health suffered because she ran out of medication and could not afford to buy more. Upon returning her medications, the FDA's Diane Thompson sent her a rather alarming letter stating that she would not be able to continue purchasing low cost medications from overseas, pointing out that such purchases are a "hazard to her health". In a letter to Congressman Coble thanking him for his assistance, Vadas questions how the Calcitriol that she buys overseas could possibly be dangerous given that it is made in Switzerland by Roche-the exact same product that is sold at much higher prices in the U.S. Vadas states that the FDA is engaging in illegal restraint of trade, and is also acting capriciously since the AIDS Buyers Clubs are purchasing large quantities of unapproved drugs from overseas with no interference by the FDA!
The FDA's Assault On Americans
With Multiple Sclerosis
Jack R. Haney of Englewood, Colorado has Multiple Sclerosis (MS). Haney is the founder of a support group of MS, heart, and cancer patients called Americans for Medical Freedom (AMF). Members of this group have all benefited from the nutritional expertise of Hans Nieper, MD whose mineral products are on the FDA's Import Alert list. The FDA has banned these products in the United States in spite of their safety and effectiveness. The most effective of them for MS sufferers appears to be Calcium EAP.
Haney, and the members of AMF, feel that the main reason the FDA is blocking shipments of Dr. Nieper's Calcium EAP is because - at $2 - $3 per day average cost per patient - it costs only a fraction of the cost of Betaseron, the only drug approved by the FDA for Multiple Sclerosis, and doesn't have the toxic side effects of Betaseron. Haney and his group feel that the FDA is engaging in illegal restraint of trade, to put it mildly.
Americans for Medical Freedom has testimonials from Nieper's patients throughout the United States. The letters are written to the press, members of Congress, and medical researchers. Some are angry letters to the FDA and Congress regarding detained products.
Many letters were written by people who recovered from the symptoms of MS, only to have them return. It must be extremely upsetting to find a therapy that enables you to regain motor control over your body, including control over bowel and urinary functions, only to lose control over these functions again because some bureaucrat at the FDA has stolen your medication!
Jack Haney's letter of June 11, 1993 to Steve Edelstein of the Health Care Task Force discusses the suppression of Calcium EAP, the needless suffering resulting from this suppression, and the effect the FDA is having in the escalation of U.S. medical costs.
"Dear Mr. Edelstein,
"At the suggestion of Mr. Mike Stratton of Denver, I contacted you recently to request your assistance in placing the enclosed letter and packet of materials in Mrs. Clinton's hands.
"I am an MS patient of a German doctor, Dr. Hans Nieper. These treatments, used with a 80% success rate since the early 1960s, have stabilized and even, in most cases, reversed the effects of this disease for thousands of Americans. Through the use of these treatments, I have been able to remain a productive member of society.
"Diagnosed in 1987, I was quickly degenerating having lost control of my bowel and bladder, experiencing extreme fatigue in the afternoons, muscle spasms, and most disturbing the interruption of mind/hand coordination and periods of difficulty in cognitive functions, most noticeably concentrated thinking involved with engineering design (I am a consulting structural engineer). My wife and I became concerned that I would not be able to continue employment.
"Before going to Germany, I was given no hope by my neurologist. I was offered steroids, with their known side effects and no indication of their effectiveness. Given no real hope in our country, I sought out Dr. Hans Nieper, and was tested and treated by him in May of 1989. Those treatments primarily utilize the minerals calcium, potassium and magnesium bonded to the mineral transporter AEP which allows these minerals to penetrate the cell wall.
"As stated earlier these treatments have, without side effects, reversed most of the MS effects on my body functions, allowing me to remain a productive member of our society. I work many 12 hour days.
"Now the reason for my request. The FDA has a policy of confiscating these Nieper treatments at entry into our country. Our past faxes to President Bush were intercepted by staff and referred to the FDA to answer their own policies. Their response, to us and a number of U.S. Senators and Representatives, was a Xerox file containing many unchallenged false statements and innuendos.
"It is important to thousands of Americans on these treatments, and in a broader sense the whole American public, that the overly restrictive policies of the FDA be changed. The American public should be allowed their right to chose from the proven international medical treatments available. In so doing, our national health care costs will be reduced dramatically.
"Could it be that the FDA is a major player in our skyrocketing health care costs? Their policies do not protect those of us with degenerative or terminal diseases, who are offered no real hope in our country, but rather protect our pharmaceutical companies. If our pharmaceutical companies would have to compete on a worldwide basis with the many natural treatments available, the costs of our medical treatments would be reduced dramatically. (My cost for the treatments from Germany are about $4. per week, including shipping.) I appreciate the time you have taken to read this and your assistance in getting this package to Mrs. Hillary Clinton."
The FDA's Import Alert against Dr. Nieper's products remains in effect today and these products are still being seized by U.S. Customs officers at our borders.
The Foundation's Legal Assault On The FDA
We are sick and tired of hearing these kinds of tragic stories from Americans who are being victimized by their own government. In an effort to solve the problem once-and-for-all, The Life Extension Foundation is about to file a lawsuit on behalf of all Americans who have had to suffer from the FDA's illegal seizure of their products, as well as the millions of others who are unaware of the availability of lifesaving therapies abroad, or who have been afraid to order such products. We'll be telling you more about this lawsuit in the next issue of FDA Raid Report.
We have also been urging the foreign companies that are offering unapproved products to Americans, who have also been victims of the FDA's illegal seizures of these products, to file their own lawsuit against the FDA. Stay tuned for more news about this lawsuit.
An LEF SPECIAL REPORT
An Exclusive Report
From Saul Kent -
President, Life Extension Foundation
The FDA Is Running Scared
Washington DC - Last month, John Hammell and I met with Congressional and think tank staff members in our nation's capitol in an attempt to assess current legislative efforts against the FDA. It had been four years since my last visit to Washington and the contrast was remarkable.
In 1991, The Foundation was lobbying Congress desperately in an effort to stop a bill, which would have markedly increased the FDA's law enforcement powers - a consequence that would have had disastrous effects on the healthcare of the American people.
Back then, the Democrats were in control of Congress and FDA supporters such as Henry Waxman and John Dingell in the House and Ted Kennedy in the Senate had a stranglehold over the Congressional subcommittees that have authority over the FDA.
At the time, newly appointed Commissioner David Kessler was considered the "golden boy" who would bring respectability back to the FDA and who would be staking out new areas of power for a re-invigorated agency. Kessler was then actively lobbying for an infusion of new funds from Congress to carry out his ambitious plans for the FDA.
New Bills To Curb The FDA's Powers
Today, with Republicans such as Thomas J. Bliley of Virginia and Joe Barton of Texas in charge of the subcommittees overseeing the FDA, we met with staffers of several members of Congress who are rushing to introduce new bills to curb the FDA powers. It is not yet clear whether a single omnibus bill covering several areas of FDA reform will emerge, or whether individual bills will be introduced.
FDA Oversight Hearings
The House Subcommittee on Oversight and Investigation has started to hold hearings to investigate the FDA in order to provide Congress with evidence of the need for FDA reform. The only hearings to date have dealt with the lengthy delays in the approval of new drugs caused by the regulatory hoops the FDA forces companies to jump through. At our meetings in Washington, John and I made it clear that, although The Foundation supports efforts to untangle the bureaucratic gridlock that keeps vital new medications off the market, we aren't focusing our attention on this issue because it is being very well supported by the pharmaceutical companies.
We prefer to focus our attention on consumer issues, such as the rights of Americans to learn about and obtain alternative medical treatments, safe-and-effective unapproved drugs from other countries, and truthful INFOrmation about the health benefits of foods, drugs, and nutrient supplements.
We told everyone we spoke to that investigative hearings and new legislation is needed to provide Americans with more freedom in healthcare and to open up the medical marketplace to a vast number of innovative therapies now being suppressed by illegal FDA policies and actions.
Removing The Fuel From The FDA Machine
One of the most encouraging signs of the new anti-regulatory stance of Congress is the realization that the best and fastest way to reduce FDA power is to withhold the money the agency needs to fuel its control over our healthcare system. We spoke with Diana Burns, the aide of Congressman Jack Kingston of Georgia (who recently brought up the outrage of the FDA's raid on Dr. Jonathan Wright at an Appropriations hearing) about his efforts to slash the FDA's budget through the House Appropriations Committee.
We also met with Patti Mitchell, the aide of Democratic Senator Thomas A. Daschle of South Dakota, who is working with Democrat Peter A. DeFazio of Oregon to introduce a bill to help Americans get better access to alternative medical treatments. Senator Daschle introduced a similar bill last year, which failed to get adequate support, but is more hopeful about this year's bill.
Killing The FDA's "Taj Mahal"
The FDA's plan to build a billion dollar "campus" in Maryland, from which to launch its illegal attacks on innovative medicine and the healthcare of the American people, was recently killed after being approved on two occasions by congressional subcommittees. The campaign to stop the FDA from building a vast, luxurious palace at taxpayer expense involved a coordinated effort, which included consumer groups such as Citizens For A Sound Economy and representatives such as John J. Duncan, Jr. of Tennessee, who serves on the House Transportation and Infrastructure Committee. Duncan is the one who dubbed the FDA's exercise in extravagance the "Taj Mahal".
Fear At FDA Headquarters
Insiders in Washington believe that one of the major reasons the FDA wanted its new Taj Mahal "campus" is so the leaders of the agency could further remove themselves from direct contact with the public. If the FDA's dream headquarters had been erected, the agency would have had hundreds of acres of land to protect it from the increasing numbers of Americans who are protesting the FDA's illegal actions.
Now that their "Taj Mahal" is dead, FDA officials must remain in the agency's building on Fisher's Lane in Rockville, which is fully exposed on all flanks to the will of the people.
Since the Oklahoma City bombing, we were told, the FDA has locked every door at its Rockville building, except for the front entrance, which is being guarded heavily. As far as we know, there have been no threats of violence against the FDA, Commissioner Kessler, or any of his underlings. It may be that the fear at FDA headquarters these days is nothing more than paranoia...or, perhaps, feelings of guilt.
As FDA reform continues in congress, we will ONLY get hearings on the four issues listed here, if enough people call the key legislators and your own Congresspersons and Senators. Congressman Joe Barton has requested your grassroots input as to what FDA oversight hearings we'd like to have - so tell them you want the following:
1. The FDA's obstruction of the importation of unapproved drugs for personal use (legal under FDA rules, but they don't enforce them evenly or fairly). A good example is the banning of Calcium EAP.
2. The FDA's obstruction of truthful claims for dietary supplements. Recent New England Journal of Medicine studies show that vitamin E reduces the risk of heart disease by almost half, but we can't tell people about this on the label!
3. The FDA's illegal raids on dietary supplement companies, alternative physicians, and private citizens in which due process rights have been trampled on and antitrust laws have been broken.
4. The FDA's mindless approval of dangerous drugs which kill thousands of Americans every year, while safer, more effective alternatives are being suppressed.
YOU MUST CALL NOW!
Congressman Thomas Bliley
Chairman of the House Commerce Committee
202-225-2815
Ask for Brent Del Monte
House Commerce Committee
202-225-2927
Leave message for Alan Slobodin, counsel for the Committee person who coordinates the oversight hearings
Congressman Joe Barton
Chairman of the Oversight Committee
202-225-2002
Ask for Beth Hall
Senator Nancy Kassebaum
Chairwoman - Senator Labor Committee
202-224-4774
Ask for Jane Williams
Foundation Political Coordinator John Hammell will be in Washington from July 8 - Aug. 31. Please show him your support by calling the numbers above!
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