Life Extension Magazine®
On July 8, 2003, an editorial by the Reverend Jerry Falwell was published in The Washington Times newspaper. The purpose of this editorial was to discourage lawmakers from passing a bill that would enable Americans to purchase lower-cost medications from countries that have safety standards comparable to those of the United States. Since there is no logical basis for denying Americans identical FDA-approved drugs sold in other countries, the pharmaceutical industry (and Jerry Falwell) have launched a defamatory campaign against consumer advocates who support this drug importation bill. In his editorial, Jerry Falwell makes allegations against The Life Extension Foundation that are blatantly false and misleading. Reverend Falwell’s comments reveal just how desperate the drug cartel is to protect its monopoly on sales of over-priced pharmaceuticals to Americans.
Jerry Falwell is the TV evangelist who set up an organization called “The Moral Majority.” One purpose of this organization was to induce Congress to enact laws that would impose the “moral” standards of Jerry Falwell on the entire U.S. population. This group exerted a lot of pressure on Congress before it was disbanded in 1989. One of Jerry Falwell’s most famous attacks was on a children’s TV show called “Teletubbies.” In an article published in his own National Liberty Journal, Falwell announced that one of the Teletubby puppets was exhibiting homosexual behavior and that this was promoting a “gay role model.” At the time, I had young children who watched Teletubbies, and my wife had to go to great length to show me which of the puppets was exhibiting this alleged homosexual behavior. Upon being enlightened to the purported gay puppet, I became convinced that Jerry Falwell should move to Iran where his imaginative abilities might actually be appreciated. Not that the Iranian people could tolerate him, but perhaps the hard-line theocratic government of Iran might have used his edicts to create even more draconian laws against individual liberty. Falwell has built a reputation of making ridiculously offensive statements. For instance, two days after the terror attacks on the World Trade Center, Falwell stated: “The abortionists have got to bear some burden for this because God will not be mocked. And when we destroy 40 million little innocent babies, we make God mad. I really believe that the pagans, and the abortionists, and the feminists, and the gays and the lesbians who are actively trying to make that an alternative lifestyle, the ACLU, People for the American Way, all of them who have tried to secularize America, I point the finger in their face and say: you helped this happen.” After withstanding a couple of days of public denunciations, Falwell issued a retraction as follows: “I would never blame any human being except the terrorists, and if I left that impression with gays or lesbians or anyone else, I apologize.”
What Jerry Falwell Said About Life Extension We were unable to re-print Jerry Falwell’s entire defamatory editorial because his media relations office denied us permission. In lieu of re-printing Falwell’s entire editorial, we have excerpted statements he made against Life Extension and followed them with our rebuttals. Falwell first sought to discredit the drug importation bill by attacking groups that support it. Falwell states: “What’s more, ratcheting open the walls that protect our market for medicines means that those who want to import bizarre and unethical medications will have that much more opportunity to do so. Consider those supporting drug importation off Capitol Hill, and that perverse motivation becomes clear.” The facts are that the drug importation bill only permits Americans to obtain identical FDA-approved prescription drugs. Jerry Falwell is using bogus scare tactics to imply that the American marketplace will be flooded with “bizarre and unethical medications”. When the enormous profits of the drug industry are threatened, truth goes out the door. Reverend Falwell then attacks Life Extension: “For instance, drug importation advocates regularly cite research from the Alcor Life Extension Foundation in their arguments. But the so-called Life Extension Foundation (LEF), ironically, is a rabidly anti-life organization. It has cited RU-486 as an ‘anti-aging’ medication that once just missed its top 10 list of life-extending drugs.” The Reverend Falwell has problems getting his facts straight. He has confused The Life Extension Foundation (LEF) of Florida with another organization called the Alcor Life Extension Foundation of Arizona. LEF and Alcor are separate organizations involved in different activities, but when it comes to a political smear campaign, simple facts are apparently irrelevant to the Reverend.
RU-486 has demonstrated anti-aging and anti-cancer properties that could save lives.1-6 Since it is also used to induce abortions, however, it has become highly politicized and cancer patients cannot easily get it. A few gynecologists prescribe and dispense RU-486, but most American doctors prescribe a morning-after pill called Preven® that is sold at American pharmacies. RU-486 is not freely sold anywhere that we could find. In most European countries, patients must consume RU-486 in front of their doctors, as it is not stocked in pharmacies. The bill that would enable Americans to import lower-cost FDA-approved prescription drugs would not provide greater access to RU-486 than already exists, but again, facts are of no concern to the self-righteous Falwell.
Reverend Falwell then states: “LEF has demonstrated its disregard for human life not only by advocating cloning but embryonic stem cell research to reverse the signs of aging. Those who support taking the lives of unborn children to support the selfish desire to live a longer and fuller life are not the allies we hope to see advocating public policy changes for America.” Life Extension has long been a proponent of embryonic stem cell research. Stem cell therapies used today, however, do not involve “taking the lives of unborn children.” Scientists are harvesting patients’ own stem cells, growing them in the laboratory, and then injecting the stem cells into the specific organ affected by a disease process (see sidebar on next page). The proposed use of embryonic stem cells to treat aging involves pre-embryonic cells taken long before a child has been formed. None of this, of course, has anything to do with the right of Americans to access lower-cost medications. Falwell has attacked stem cell research in order to divert Congress’ attention from the real issue of passing a bill that would greatly reduce the price of prescription medications. To sidetrack members of Congress from the fact that Americans are grossly overcharged for their prescription drugs, Falwell is mischaracterizing the abortion issue, which has absolutely nothing to do with the drug importation issue. | ||||||||
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| The Reverend Falwell then attacks Alcor, which he again confuses with LEF: “That is only the beginning, however. LEF also conducts bizarre cryogenics experiments. They are reported to have the body of baseball slugger Ted Williams frozen for eventual reanimation. The president of the organization, Saul Kent, likewise froze his mother’s severed head, prompting a three-year investigation into the possibility that she was euthanized.” Saul Kent is not the President of Alcor. The Life Extension Foundation did not freeze Ted Williams’ body. Saul Kent also did not kill his mother. None of this, of course, has anything to do with the artificially inflated prices Americans pay for their drugs. Nor does it have any relationship to the fact that identical drugs can be purchased for far less money from other countries. But again, facts and relevance mean nothing to Falwell, who argues that Americans should not be allowed to purchase lower-cost medications from Canada, Europe, and other countries, even though they have regulatory standards comparable to those of the United States.
Falwell’s final mudslinging against LEF is as follows: “And they traffic in untold numbers of questionable ‘life-extending’ medications that are the subject of numerous federal investigations — raising a significant question about their motivations for advocating drug importation.” The drug bill that Falwell is attacking would legalize the importation of FDA-approved prescription drugs only, not “questionable life extension medications,” as Falwell erroneously asserts. Falwell’s statement that we are “the subject of numerous federal investigations” was news to us. That was until an FDA inspector showed up at our door eight days after Falwell’s editorial was published. The FDA inspector commenced an intensive five-day dissection of our operations. As you will read in an article by Saul Kent that appears later in this issue, we believe the drug industry may be behind the FDA’s sudden interest in Life Extension. Our attorneys have filed a Freedom of Information Act request to determine if a drug lobbyist urged the FDA to initiate this inspection. The drug cartel views The Life Extension Foundation as a threat to their profits. Drug companies routinely hire lobbyists to persuade the FDA to go after those who are a challenge to their multi-billion dollar annual earnings. Long-time members know that Life Extension fought an 11-year battle with the FDA, which we won in 1996. Life Extension is currently supporting numerous First Amendment actions against the FDA that seek to force the agency to recognize health claims such as “omega-3 fatty acids may reducethe risk of coronary artery disease.” Who Is Behind These Attacks? Life Extension members may wonder how Jerry Falwell could have written such an erroneous editorial and why The Washington Times would publish it. We think the answer lies in the massive lobbying campaign the pharmaceutical industry launched to stop the Pharmaceutical Market Access Act of 2003 from passing Congress. According to Public Citizen’s Congress Watch (a non-profit group founded by Ralph Nader), the drug industry hired 675 lobbyists from 138 firms last year. Since 1997, the drug industry has spent a whopping $650 million lobbying Congress, which includes hiring academics and funding non-profit organizations that support their causes. According to the June 23, 2003 Wall Street Journal, one of the drug industry’s biggest issues is barring imports of lower-cost medications from other countries.
An example of drug company influence can be seen in the lobbying efforts of a religious group (other than Falwell’s) that is attacking members of Congress who support the drug importation bill. This coalition represents some 43,000 churches and has distributed letters urging lawmakers to oppose the Pharmaceutical Market Access Act of 2003. It turns out the letters, written on this religious coalition’s letterhead, were drafted by an attorney representing the drug industry. The Washington Post (not The Washington Times) has been investigating drug company influence using non-profit organizations to front for their cause. Documents provided to The Post reveal the key role that drug lobbyists played in sending letters out to the constituents of members of Congress who support this bill. Representative Dan Burton and several other conservatives are blaming the drug companies for the dirty mail campaign to discredit the bill. The Washington Post quoted Representative Burton as follows: “I do not understand . . . how a religious organization can be manipulated by the pharmaceutical industry to do this sort of thing. They are supposed to be moral people. And yet I am confident, in fact I am dead sure, that the Traditional Values Coalition did not have the money to mail this kind of trash out to congressional districts all across the country.”
Why Drug Companies Want to Discredit Life Extension Life Extension’s drug price comparison charts have been enlarged and presented before Congress as evidence that Americans are overpaying for medications they need to stay alive. Since drug companies cannot argue against the irrefutable fact that identical drugs cost more in the United States than in other countries, they have made a concerted effort to paint the bearer of this information (The Life Extension Foundation) in a negative light. As you will read later in this issue, the good news is that despite this intensive drug company lobbying campaign, the Pharmaceutical Market Access Act of 2003 passed in the House of Representatives. It now has to be voted on in the Senate. If the bill becomes law, the savings to Americans will be so substantial that today’s health care cost crisis will be substantially mitigated. The Life Extension Foundation is the only organization that has investigated, calculated, and published exactly what the active ingredients in prescription drugs actually cost (see chart on next page). This information reveals that if Americans could freely import their medications from other countries, the cost of some $300 prescription drugs could drop to under $10.
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| The FDA Deceives Congress There is no inherent reason why prescription drugs should cost so much in the U.S. The identical medications can be purchased in Europe and Canada at far lower prices. The trouble is that the FDA has fabricated sworn testimony to mislead Congress into believing that drugs from other countries are counterfeit, contaminated, or dangerous. Life Extension has shown that the FDA’s assertions are baseless, false, and misleading (see “The FDA Versus The American Consumer,” Life Extension magazine-October 2002). On June 7, 2001, the FDA told Congress that it wants to halt almost all small shipments of foreign drugs mailed to consumers in the U.S. The only exemption would be for compassionate use, so that seriously ill patients who have exhausted all approved treatments could order drugs from overseas. 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.” In response to the FDA’s assertions, Life Extension sent Freedom of Information Act requests in June 2001 asking the FDA to substantiate its sworn testimony before Congress that drugs imported from other countries are dangerous.
Even though the FDA is legally mandated to respond to Freedom of Information Act requests, it has ignored our repeated written requests and phone calls to substantiate its sworn testimony about the supposed dangers of imported medications. More than two years have now passed since the FDA told Congress that medications imported from other countries are counterfeit, contaminated, and dangerous. As more Americans learn they can obtain identical drugs from Canada and other countries at lower prices, the flow of imported drugs has grown enormously. Yet the FDA has yet to produce a single report of an adverse reaction from an imported prescription drug, despite being highly motivated to find just one “victim” to parade before Congress. That does not mean there have not been any victims of prescription drugs ordered from other countries. The facts are that FDA-approved prescription drugs kill over 100,000 Americans every year. Since these same FDA-approved drugs are being imported from other countries in record amounts, undoubtedly some Americans have suffered adverse effects, just as they would have had they bought the same drug at their local pharmacy. The undeniable fact, however, is that prescription drugs used by Canadians and Europeans are identical to those sold in American pharmacies. In fact, when regulators alleged that a generic European Hydergine product was “adulterated,” Life Extension had the product assayed and proved that this European Hydergine was identical to the name brand (Sandoz) sold in the United States. The FDA’s assertion that prescription drugs imported from other countries are dangerous is a hoax that never had a credible basis. It is a scare tactic to protect the pharmaceutical industry’s stranglehold over the American consumer. Counterfeit Drugs Sold in American Pharmacies Counterfeiters tend to copy expensive items. You don’t find many fake $5 bills, but $100 bills have long been a favorite of those involved in criminal currency counterfeiting. Prescription drugs sold in other countries don’t cost a lot, so the incentive to counterfeit them is not great. These same drugs sold in the United States, however, are so expensive that counterfeit drugs are increasingly showing up in American pharmacies.
Procrit® is a drug used to treat anemia. Cancer patients often use Procrit® to guard against chemotherapy-induced hypoxia (a low oxygen environment that enables cancer cells to thrive). The CBS News program 60 Minutes reported on an epidemic of Procrit® counterfeiting that is occurring as illicit wholesalers sell bogus Procrit® to American pharmacies. The counterfeit Procrit® has little or no active ingredient and some batches are contaminated with bacteria that have made patients very ill. The startling part of this story was when CBS News asked the FDA about Procrit® counterfeiting, the FDA responded that this was a problem for state pharmacy boards to address and was not in the FDA’s jurisdiction. The FDA’s statement that Procrit® counterfeiting is not its problem is grossly inconsistent and hypocritical, considering its vigorous opposition to American consumers importing lower-cost medications from other countries. Cancer patients who buy Procrit® from Canada often do so because they cannot afford to pay inflated American prices for this life-saving drug. The FDA seeks to deny these desperate people access to lower- cost Procrit® under the assumption that it might be dangerous, while virtually ignoring egregious counterfeiting going on in the American marketplace. Growing reports of Procrit® counterfeiting have since motivated the FDA to take limited action. The FDA later stated that fake Procrit® poses a serious danger to patients and posted a warning on its website (www.fda.gov). To help identify the dangerous counterfeit, the maker of Procrit® has posted pictures of the real and fake version on its website, www.procrit.com. When American pharmacies recently became flooded with 130,000 bottles of counterfeit Lipitor®, the FDA did take more aggressive action. Lipitor® is the most popular cholesterol lowering “statin” drug. Since the active ingredient for 90 tablets (10 mg) of Lipitor® costs only $2.18, which American consumers then pay over $170 for, it is easy to see the economic motivation for counterfeiting this drug. The Pharmaceutical Market Access Act of 2003 requires all prescription drugs produced at home and abroad to use counterfeit-resistant packaging, similar to the technology used by the U.S. Department of the Treasury. The Pharmaceutical Market Access Act contains language written by the legal team at the FDA that requires wholesalers to test each pharmaceutical shipment, unless the packaging uses counterfeit-resistant technology. The FDA’s strict language was written to provide for the safety of imported pharmaceuticals from anywhere in the world. What this means is that if this drug import bill is passed, lower- cost medications imported from other countries would be subjected to better scrutiny than those produced in the United States. Drug company (and Jerry Falwell) propaganda that imported drugs are dangerous has no basis in fact. The unfortunate reality is that expensive prescription drugs sold in the United States are being counterfeited because the profit opportunity is much greater than in other countries. If the Pharmaceutical Market Access Act of 2003 is not passed, however, we fear that there may be more counterfeiting as increasing numbers of Americans are economically forced to turn to offshore pharmacies in order to afford medications they need to stay alive. There are so many elderly Americans importing drugs from other countries, that the FDA has admitted it cannot possibly intercept them all. So if this bill is not passed, personal use drug importation will continue with no regulatory protections in place. Some members of Congress are alleging that some counterfeiting of Canadian drugs is already occurring, but as we just discussed, this problem exists for drugs sold in American pharmacies as well. Failure to pass this bill will result in more counterfeiting, as Americans increasingly turn to lower-cost sources (both foreign and domestic) for their medications.
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| Taking on the Challenge Since 1984, The Life Extension Foundation has battled against the high cost of prescription drugs. We long ago predicted that a health care cost crisis would erupt if Congress failed to rein in the artificially inflated prices that Americans pay for their medications. To expose the incestuous relationship that exists between the FDA and the pharmaceutical giants, we made hundreds of appearances on TV and radio shows, mailed out millions of pieces of mail, ran full-page newspaper ads, and set up anti-FDA websites (www.stopfda.org). We did this for the purpose of encouraging consumers to act against the blatant corruption that is bankrupting the nation’s health care system. As a result of our relentless attacks against high-cost prescription drugs, The Life Extension Foundation has become the target of a vicious propaganda campaign. Profit margins on prescription drugs have become so gargantuan that pharmaceutical companies will do almost anything to prevent foreign competition from developing. Large drug companies intensely lobby Congress to pass laws that give them extended exclusivity; file lawsuits to delay generic competition; petition the FDA to stop the importation of lower-cost medications; and go as far as to pay off generic companies not to compete. By inducing a well-known member of the clergy (Reverend Jerry Falwell) to make blatantly false statements about medicines sold in other countries, the drug cartel may have sunk to its lowest level yet. Consumers are paying for these morally bankrupt schemes every time they buy an over-priced prescription drug.
Life Extension Will Not Capitulate Several of our Directors thought it might be best to ignore Jerry Falwell’s baseless attacks because of concerns that any rebuttal might offend some Life Extension members. I argued that to ignore these obvious lies would be an effrontery to all of those who support free choice as it relates to where Americans may purchase their medications. If Life Extension has proven anything over our 23-year history, it is that we don’t back down on irrefutable scientific, rational, or moral issues. We hear every day from our members about the outlandish prices they are paying for drugs that are much less expensive in other countries. Some of our less fortunate members cannot afford all the drugs their doctors prescribe. Life Extension is not going to backpedal from its multi-decade campaign to legalize the importation of lower-cost medications, despite Jerry Falwell’s unfounded vilification. The drug cartel has spent millions of dollars on pubic relations to distort the facts so that Congress would be dissuaded from passing the Pharmaceutical Market Access Act of 2003. One objective of this smear campaign has been to disparage members of Congress who support this legislation. Life Extension anticipates increased attacks as these public relations agencies seek to create the false impression that anyone who favors legalized prescription drug importation is involved in all kinds of unsavory activities. Discrediting the Good Work of Others Jerry Falwell’s groundless attacks against the right of Americans to access lower-cost medications offends the integrity of the many honest clergymen seeking to make a positive difference in their communities. Falwell’s shabby attempt to bring up totally unrelated issues (such as abortion) as reasons not to pass this drug importation bill adversely affects the credibility of those who make legitimate arguments to justify their positions. The Reverend Falwell has inappropriately ventured into a political/scientific arena that has nothing do to with the benevolent purposes of his various organizations. This improper and deliberate abuse weakens the compassionate pillars on which his organizations were founded. Let Your Voice Be Heard Drug company lobbyists are inundating the Senate to prevent the prescription drug importation bill from becoming law. Consumer groups are intimidated by the FDA’s baseless assertions that imported drugs are somehow dangerous. The FDA has preyed on fear and uncertainty for decades, while American consumers are extorted into paying the highest prices in the world for their prescription drugs. This is not just an issue for individuals to be concerned with. There are dire predictions of severe economic upheavals in the United States if a solution is not found for the high cost of prescription drugs. Some of the largest corporations in America cannot afford to fund health insurance benefits for current and retired employees. Health insurance companies are going bankrupt because of astronomical drug prices. Medicare itself is predicted to become insolvent in the not-too-distant future. The United States has been economically deteriorating as prescription drug prices skyrocket. In order to counter the influence peddling of the pharmaceutical behemoths, American consumers must become politically active. Consumers vastly outnumber drug industry lobbyists. Regrettably, ignorance and apathy have silenced many Americans and enabled drug money to create laws that favor outlandish pharmaceutical company profits at the expense of the consumer. I encourage every patriotic American to enlighten their two Senators about the need to support the Pharmaceutical Market Access Act of 2003. If this bill is passed into law, it will liberate the American consumer from being an economic serf to the pharmaceutical cartel. The next page provides a form letter that can be mailed or faxed to your two Senators. For longer life, William Faloon.
References 1. Ghoumari AM, et al. Mifepristone (RU486) protects Purkinje cells from cell death in organotypic slice cultures of post natal rat and mouse cerebellum. Neuroscience, 2003 Jun,100:13: 7953-7958. 2. Koide SS Mifepristone. Auxiliary therapeu tic use in cancer and related disorders. J Reprod Med, 1998 Jul;43(7):551-560. 3. Mattson MP, et al. Activation of NF- kappaB protects hippocampal neurons against oxidative stress-induced apoptosis: evidence for induction of manganese super oxide dismutase and suppression of perox ynitrite production and protein tyrosine nitration. J Neurosci Res, 1997 Sep;49(6):681-697. 4. McCullers DL, et al. Adrenocorticosteroid receptor blockade and excitotoxic challenge regulate adrenocorticosteroid receptor mRNA levels in hippocampus. J Neurosci Res, 2001 May;64(3):277-283. 5. McCullers DL, et al. Mifepristone protects CA1 hippocampal neurons following trau matic brain injury in rat. Neuroscience, 2002 Jan; 109:2:219-230. 6. Pedersen WA, et al. Corticotropin-releasing hormone protects neurons against insults relevant to the pathogenesis of Alzheimer's disease. Neurobiol Dis. 2001 Jun;8(3):492- 503. 7. Willerson James T, et al. Stem cells improve heart function of seriously ill heart failure patients. Cir J Am Heart Assoc. 2003 Apr;22 | ||||
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| What You Can Do to Fight High Drug Prices We are asking all Foundation members to write a short personal letter to their two Senators. The letter on the following page is an example of what you might want to write to urge your Senators to pass the House's version of The Pharmaceutical Marketing Access Act of 2003 (H.R. 2427). If this bill is passed into law, the cost of prescription drugs will be drastically reduced. Corrupt bureaucracies will trample basic human rights as long as the citizenry remains passive and apathetic. Please write a letter in support of this bill and mail it to your two Senators. To find your two Senators, call the U.S. Capitol Switchboard at 1-202-225-3121. If you want to discuss this with your Senators, you can be connected to their offices directly. Date: Please confirm to me in writing that you will vote YES for the drug importation bill (The Pharmaceutical Market Access Act of 2003). Name: SUMMARY: Americans Deserve World-Class Drugs at World Market Prices! THE PROBLEM: Two years ago, Congress passed and the President signed into law the Medicine Equity and Safety (MEDS) Act. It was the intent of Congress to allow Americans to import wholesale quantities of lower-cost prescription drugs into the United States. But the promise of this legislation has gone unfulfilled. Even though the FDA largely wrote the bill, it has not implemented the law. What has been the result? Americans continue to pay drug prices that are 30-300 percent more than in European and other industrialized nations. Even HHS Secretaries Shalala and Thompson admit that Americans should not have to pay higher prices so that the "starving Swiss" can pay less for the same prescription drugs. This price disparity is wrong. Despite a second vote in the House in favor of opening pharmaceutical markets (Amendment #150 passed 324 to 101 on 7/11/2001 as part of H.R. 2330), prescriptions continue to go unfilled because prices are too high in the United States. Worse yet, the FDA holds a legal dagger over the heads of those Americans seeking better health who attempt to import FDA-approved drugs. Fortunately, Congress has another opportunity to do the right thing and codify America's right to open pharmaceutical markets. Market Access: Those countries are limited to: the European Union, Australia, Canada, Iceland, Israel, Japan, Lichtenstein, New Zealand, Norway, Switzerland, and South Africa. Note: Mexico is NOT included. Safety: The Pharmaceutical Market Access Act strengthens America's commitment to maintaining the safest pharmaceutical drug market in the world. This bill requires all prescription drugs produced at home and abroad to use counterfeit-resistant packaging, similar to the technology used by the U.S. Department of the Treasury. If the technology is good enough to secure U.S. currency, it's good enough to secure our pharmaceutical chain-of-custody. Safety: The Pharmaceutical Market Access Act requires the FDA to implement this program within 180 days of enactment. This frees Americans from an environment where patients forgo pharmaceutical treatments, at risk to their own health, because their prescriptions are too expensive. STATUTE: |
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