As We See It
Are Offshore Drugs Dangerous?September 2001
By William Faloon
If you suffer from type II diabetes, you’re likely to be prescribed a drug called Glucophage. This drug lowers glucose and other blood risk factors that cause lethal diabetic complications.
Glucophage works by enhancing cell sensitivity to the effects of insulin. Since type II diabetes is characterized by cellular insulin resistence, the fact that Glucophage helps restore insulin sensitivity makes it a potent weapon against a disease that currently afflicts 16 million Americans.
Glucophage also reduces the amount of glucose produced by the liver and decreases intestinal absorption of sugar.1 The result is that glycemic control is restored and patients often lose some weight. Clinical studies dating back to the 1950s demonstrate Glucophage’s efficacy and safety when properly used.
For several decades, Americans could not legally obtain Glucophage. That’s because the FDA said it was toxic and banned its sale in the U.S. The Europeans did not agree that Glucophage posed a health risk and approved its use decades ago. (Glucophage is sold under the name “metformin” in other countries.)
The FDA was proven wrong about Glucophage and the drug was finally approved in December 1994. It is difficult to calculate exactly how many Americans died while Glucophage was kept out of the United States. It is very easy, however, to document that American consumers are being price gouged because of the FDA’s error. A one-month supply of Glucophage costs $4.12 in other countries, while Americans pay $32.83 for the same quantity.
The reason for this unconscionable price disparity is that Glucophage is old news in Europe, where it has been used since the 1960s. The FDA’s delay in approval has enabled Glucophage to enjoy a virtual monopoly in the United States, causing U.S. citizens to pay more than seven times the price this same drug sells for in other countries.
The number of people who die each year from diabetic complications is staggering. American diabetics perished while Glucophage was being safely used throughout the world. Because of FDA ineptitude, U.S. citizens pay grossly inflated prices to obtain a drug (Glucophage) that is more than 30 years old.
The FDA’s latest charade
The FDA now has the audacity to ask Congress to ban just about ALL imports of medications from other countries under the guise of “protecting” Americans against dangerous drugs.
On June 7, 2001, the FDA told Congress that they want to halt almost all small shipments of foreign drugs mailed to consumers in the U.S. The FDA wants U.S. Custom Service agents to send back all small foreign drug shipments they find. The only exemption would be for “compassionate use,” so that seriously ill patients who have exhausted all approved treatments could order drugs from overseas that are unavailable in the U.S.
The FDA says it needs to turn away all foreign drug shipments because of the sheer volume of drugs being imported. More American consumers are learning they can obtain prescription drugs at a fraction of the price charged in the U.S. The FDA now admits that the number of shipments far exceeds the agency’s ability to review them on a case-by-case basis. The FDA told Congress, “We need to be able to make a blanket assessment that these things are not safe for American consumers and should be turned back.”
The fraud being perpetrated by the FDA is the assertion that medications imported from other countries are automatically illegal, counterfeit or contaminated. This is what the FDA would have said about Glucophage before they approved it in 1994. The facts are that drugs from other countries cost far less and are sometimes more advanced than what is available on the American marketplace.
The FDA told Congress that an estimated 2 million packages containing drugs enter the United States through international mail each year. “The inescapable conclusion is these drugs are virtually all unapproved in the United States.… They may be counterfeit or worse,” the FDA said to Congress.
The truth is that most of the drugs the FDA complains about are already FDA-approved and are manufactured by the same companies that sell them to American pharmacies. The FDA is using scare tactics to protect the profits of the pharmaceutical industry…not the health of the public.
Currently, the law says that Customs must contact recipients if it detains drugs at the border. The FDA’s new proposal would waive that requirement. In other words, the FDA wants all drugs to be turned away without even providing the U.S. citizen (who paid for the drug) with a notice and opportunity to explain why they need them.2
The emperor has no clothes
Drugs the FDA says are safe kill over 100,000 Americans every year, while the agency cannot demonstrate drugs imported from other countries are hurting anyone.
That’s not to say that some day an American won’t suffer an adverse reaction from an imported drug. After all, many of the drugs being imported are the same FDA-approved medications that are killing over 100,000 Americans every year.3-5 Could it be that Americans who are smart enough to buy their medications from lower cost foreign suppliers also read the package inserts in order to reduce their risk of suffering an adverse reaction?
The FDA denied Glucophage to Americans for decades, but rapidly approved Rezulin to treat Type II diabetics. Rezulin killed about 391 Americans before it was withdrawn, according to a tabulation done by the Los Angeles Times.6 Those afflicted with Type II diabetes suffered and died waiting for the FDA’s belated approval of the relatively safe drug Glucophage.
So while the FDA brazenly testified before Congress that all drugs imported from other countries are “dangerous,” the facts show the agency’s assertion is blatantly false and misleading. Today’s drug emperor (the FDA), has no clothes (veracity) in arguing against Americans purchasing their medications from other countries.
The FDA preys on fear and uncertainty, while American consumers are extorted into paying the highest prices in the world for their prescription drugs.
Undoing this travesty
We believe the FDA lacks the moral and scientific legitimacy to deny Americans access to medications that are approved by health ministries in other countries. The FDA’s delay in approving Glucophage is a prime example of why this agency should not be allowed to embargo drugs from other countries.
Bureaucratic barriers at the FDA stifle the development of novel medicines, while drug company influence enables lethal drugs (like Rezulin) to be “approved” by the agency as safe and effective.
There exists a unique opportunity to change this pattern of incompetence, deceit and arrogance. President Bush will soon decide who to nominate as the next FDA Commissioner.
One candidate for the Commissioner’s job has a plan to radically reform the FDA. The name of this candidate is Mary J. Ruwart, Ph.D. In the July 2001 issue of Life Extension, we published information to show that Dr. Ruwart is uniquely qualified to reform an agency that has lost touch with scientific objectivity.
It is imperative that health freedom activists notify President Bush that Dr. Ruwart is the best person to remedy the problems that exist at the FDA. Please mail the letter that appears below on this page to the President at the address we have provided.
Following this letter to President Bush is a letter you can mail to your Senators to urge them to support a bill that will allow Americans to purchase their prescription medications from other countries without FDA interference.
Inefficient government thrives on citizen apathy, so please take the time to mail out the letters to President Bush and your two Senators.
For longer life,
- Physician’s Desk Reference 2001, p. 1005.
- Statement of William K. Hubbard, Senior Associate Commissioner for Policy, Planning and Legislation, Food and Drug Administration, before the Subcommittee on Oversight and Investigations Committee on Energy and Commerce, U.S. House of Representatives, June 7, 2001. http://www.fda.gov/ola/2001/drugimport0607.html
- Lazarou J, et al. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998 Apr 15;279(15):1200-5.
- Bates DW. Drugs and adverse drug reactions: how worried should we be? JAMA 1998 Apr 15;279(15):1216-7.
- imons M. “FDA Moves to Reduce Accidental Drug Deaths.” LA Times May 10,1999. Home Edition Section: PART A Page: A-1.
- Willman David “Rise and Fall of the Killer Drug Rezulin” Life Extension magazine, Sept. 2000, p. 31-39.