|LEF Magazine September 1998 |
Life Extension Vs. The FDA
Why The Agency's Approval
Of Ribavirin Is Inadequate
Consumer Health Free Speech Act Petition
The U.S. Food and Drug Administration has just approved ribavirin for the treatment of hepatitis C. Ribavirin is a drug that could save about 5,000 lives a year. However, 60,000 hepatitis C victims already have died while waiting for this drug to be approved, and many more Americans will perish because the FDA has only approved it for limited use. This is not the typical story about the FDA being too slow to approve lifesaving drugs. The circumstances surrounding this drug include several criminal investigations, felony indictments, stock market manipulation, squandered tax dollars, FDA agents traveling to Europe, contamination of the nation's blood supply and lots of dead Americans.
By William Faloon
The events began in the early 1980s, at a Southern California research laboratory, where scientists made the unique discovery that ribavirin, then sold in Mexico, could cure feline leukemia. Since ribavirin was able to eradicate the feline leukemia virus, the scientists began taking ribavirin themselves when they contracted the flu and, in most cases, their flu symptoms disappeared within 24 to 48 hours.
This was no ordinary research laboratory. It was partially funded by the Life Extension Foundation, which meant that when the discovery was made, Foundation members learned about it quickly. In 1986, the Foundation recommended that members with serious viral diseases travel to Mexico to buy ribavirin, or order it from offshore mail order companies. The FDA did not like this (and similar recommendations we made) and, in 1991, the Foundation's officers were indicted on 28 criminal counts of conspiring to import unapproved drugs into the United States.
About the same time, the FDA also launched a criminal investigation against the New York Stock Exchange company, ICN Pharmaceuticals, that owned ribavirin, for the "crime" of promoting the use of ribavirin in adults. The FDA viewed this action as criminal because at that time it had approved ribavirin only to treat a viral infection that affects infants. Thus, ICN was charged with promoting an "unapproved" (for adults, that is) drug.
The FDA asked the Justice Department to impanel a federal grand jury to see if ICN officials should be charged with criminal misconduct. Shortly thereafter, the Securities and Exchange Commission also launched an investigation to determine if ICN had committed securities fraud by promoting ribavirin's anti-viral effects.
To avoid a felony indictment and avert financial disaster, ICN entered into a consent agreement to stop promoting ribavirin. The FDA scored a temporary victory by keeping ribavirin out of the hands of adults.
The FDA, however, was facing some serious problems of its own. Tens of thousands of Americans were contracting viral diseases from blood transfusions, and investigative reporters exposed the fact that the FDA had failed to protect the nation's blood supply. Of course, the media failed to appreciate that the FDA had kept itself busy by conducting record-breaking numbers of raids against vitamin companies, seizing personal-use shipments of drugs like ribavirin in the mails, and trying to throw people in jail for selling ribavirin to adults.
Not only was the FDA failing to inspect blood banks, but it also was dramatically reducing the number of food safety inspections. Meanwhile, tens of thousands of Americans continued to die from viral diseases that ribavirin was curing in other countries.
During this entire period, studies were appearing in major medical journals showing that ribavirin is effective against a wide range of viral diseases. Health ministries throughout the world were approving ribavirin as a broad-spectrum anti-viral drug. What made the FDA's stonewalling so serious was that there was no effective anti-viral drug approved in the U.S. Elderly people affected with influenza either got better on their own or died.
Influenza kills as many as 60,000 (mostly elderly) Americans in a bad year, and ribavirin stops many influenza viruses from replicating. While Third World countries were using ribavirin to treat their citizens infected with influenza, hepatitis and other viral diseases, American citizens were dying from these same diseases.
The irony is that many hepatitis C patients contracted their disease from contaminated blood that the FDA was supposed to have inspected. Rather than properly regulating blood banks, FDA bureaucrats choose instead to squander the agency's resources in an attempt to deny access to a drug (ribavirin) that could have saved the lives of hepatitis C patients.
Many of the hepatitis C patients who could have been saved by ribavirin are not dead yet, but their livers have suffered severe damage. While the FDA stonewalled the approval of ribavirin, these patients faced a significant risk of developing cirrhosis or liver cancer.
The Life Extension Foundation never stopped informing its members about the anti-viral benefits of ribavirin. The criminal indictments against the Foundation's officers were dismissed in 1995 at the request of the Justice Department, but the FDA continued to harass Americans who imported ribavirin for their own personal use.
In 1997, FDA agents managed to convince European health ministries to raid companies that were shipping ribavirin to Americans for personal use...even though ribavirin was approved for sale to European citizens. The Foundation responded by launching a massive communications campaign to inform the public that the FDA had taken draconian steps to deny hepatitis C patients access to a drug that was shown to be a highly effective treatment against the disease when combined with interferon.
The most significant study shows that ribavirin combined with interferon is 10 times more effective in treating hepatitis C than interferon alone. The FDA's response was to instigate more raids against companies in Europe shipping ribavirin to Americans, thus condemning many hepatitis C patients to the permanent liver damage that often results in disability and death.
(Do not use ribavirin to treat HIV infection. While some studies show it to be effective, there are better anti-viral drug combinations that are specific to HIV.)
The economic cost to the Foundation for fighting for the approval of this one drug was enormous. Full page ads were taken out in newspapers, thousands of press releases were sent to the media, and hundreds of thousands of first-class letters were mailed urging Foundation supporters to protest the FDA's actions. I appeared on national TV and radio programs accusing the FDA of denying, for political reasons, ribavirin to Americans.
The Foundation went so far as to produce and repeatedly air a half-hour TV infomercial attacking the FDA for failing to approve ribavirin and other lifesaving drugs that were already approved in other countries.
After 12 long years of battling the FDA, and after the needless, premature death of at least 430,000 Americans, ribavirin was finally approved this past June. There still remains a significant problem, however: The FDA has restricted the use of ribavirin (sold in the U.S. under the name Rebetol) only to chronic hepatitis C patients who first fail to benefit from interferon alone.
Approximately four million Americans are chronically infected with the hepatitis C virus, according to the Centers for Disease Control. The CDC has estimated that 20 to 50 percent of chronically infected hepatitis C patients will develop liver cirrhosis, and 20 to 30 percent of those will go on to develop liver cancer or liver failure requiring a liver transplant. Hepatitis C infection contributes to the deaths of 8,000 to 10,000 Americans every year. This toll is expected to triple by 2010 and exceed the number of annual deaths due to AIDS.
Nevertheless, the FDA has mandated that hepatitis C patients must first fail a grueling six month therapy period with recombinant interferon-alpha before they can try the ribavirin-plus-interferon combination therapy that is proven to work 10 times better than interferon by itself. The maker of ribavirin is petitioning the FDA to allow more hepatitis patients to have access to ribavirin.
The Life Extension Foundation regards the FDA's recent approval of ribavirin as a hollow victory. After battling FDA bureaucrats for 12 years, most Americans are still being denied access to this lifesaving drug. Some people are actually applauding the FDA for approving ribavirin so fast.
In December 1997, massive political pressure forced the FDA to put ribavirin on the "fast-track," and seven months later, the FDA said that some hepatitis C patients can now use the drug legally. Somehow the 430,000 Americans who died waiting for FDA approval of the drug were forgotten.
A study published in the April 15, 1998, issue of the Journal of the American Medical Association (JAMA) showed that toxic side-effects from FDA-approved drugs are the fourth to sixth leading cause of death in the United States. This shocking fact exposes the FDA's failure to provide the public with safe medicines. The FDA-induced delay in approving ribavirin is irrefutable proof that the "drug lag" is causing Americans to die. Why is this irrefutable? Because, while the FDA itself now says that ribavirin is effective, history shows the FDA intentionally denied this lifesaving medicine to the public, to the point of spending millions of tax dollars trying to incarcerate those involved in promoting it.
FDA actions (and inactions) contribute to more premature deaths in the United States than any other cause. The agency routinely approves deadly, dangerous drugs that kill Americans, while failing to approve safe and effective lifesaving drugs for patients suffering from life-threatening diseases.
Here is another example: Research is demonstrating that the combination of two drugs-angiostatin and endostatin-may cure most cancers, but FDA regulations will keep these drugs from any terminal cancer patients for another 18 months or longer. These drugs could have been tried in terminal cancer patients in 1995 had it not been for FDA restrictions. It is, therefore, likely that every single terminal cancer patient whose life might have been saved by these drugs will die before the FDA permits any of them to try them.
We ask all members and other Life Extension magazine readers and subscribers to protest to their members of Congress the latest attempts by the FDA to censor truthful, non-misleading scientific information. Letters of petition appear in this issue for your use.
Vitamin consumers won a major victory in 1994 when Congress passed the Dietary Supplement Health and Education Act (DSHEA) a bill that took away the FDA's power to regulate dietary supplements as drugs. However, as detailed in last month's issue,
At Odds -- Again -- with Your
The FDA has now proposed new rules, designed to enforce DSHEA, that would prohibit Americans from learning about certain types of medical information.
The FDA's proposed rules say that consumers can be told about how a vitamin affects the "structure or function" of the body, but that any reference to how the vitamin affects specific diseases will be classified as illegal speech. If the FDA's proposed rules become law, most consumers will not be able to find out about the nutrients they need to prevent, mitigate or treat any disease.
Examples of what the FDA has proclaimed to be illegal speech include such descriptions of benefits as "reduces nausea associated with chemotherapy," "protects against cancer," and "treats hot flashes." In other words, specific treatments for specific illnesses. But that is often exactly why consumers turn to natural, alternative therapies.
For example, since the FDA contends it's illegal to suggest anything but drugs to reduce nausea associated with chemotherapy, it would also be illegal to recommend coenzyme Q10 and vitamin E to reduce chemotherapy-induced heart muscle damage, melatonin to reduce chemotherapy-induced immune system damage, and N-acetylcysteine to reduce chemotherapy-induced liver damage.
The FDA is proposing that cancer patients be denied information about how to protect their hearts, livers, guts and immune systems against the lethal effects of FDA-approved chemotherapy drugs. These new proposed rules mandate suffering for cancer patients. They are not only immoral, they are blatantly unconstitutional.
The Life Extension Foundation is calling on all Americans to protest the FDA's most recent attempts to gain dictatorial power over our cherished right to free speech. Success rests solely on the willingness of our members and other Life Extension magazine readers to protest the FDA's actions.
Please complete the petitions that appear on the following pages. Make photocopies for others who believe that a free press is the ultimate protection against governmental malfeasance.
Americans have only until August 27 to respond to the FDA's proposed new rules. These petitions should be completed by every Life Extension Foundation supporter. To locate the names and phone numbers of your Congressional representative and two senators call 1-202-224-3121.
Consumer Health Free Speech Act Petition
"Is Ribavirin Toxic?"
"How to Use Ribavirin"