DRUGS THE FDA SAYS YOU CAN'T HAVE
Americans suffer and die even though effective drugs to treat their diseases are approved in other countries. The public is generally aware that novel drugs are sold in Europe and Japan, but intense lobbying by the pharmaceutical industry has blocked the wide-scale availability of these better medications.
Drug companies don’t want Americans to shop the world for more effective therapies. They prefer the current FDA-protected system where large companies enjoy a virtual monopoly over the American marketplace. This archaic system earns record profits for drug companies at the expense of U.S. citizens, who pay inflated prices for the medications the FDA does allow them to have.
The FDA deceives the public and Congress into believing that drugs approved in other countries are somehow “dangerous,” despite having no evidence to support this. What the FDA conveniently ignores is the fact that drugs they say are “safe” kill over 106,000 Americans every year.(1-3)
Thalidomide still kills
Proponents of today’s drug approval system have to go back 41 years to the thalidomide debacle to find an example of an offshore drug causing a serious side effect. Thalidomide still kills because the FDA is using this old issue as an excuse to embargo life-saving drugs that are approved by health ministries in other countries. Furthermore, these drugs have been used in other countries for years without serious side effects.
Few people remember that it was not the FDA who discovered the thalidomide problem. It was a German scientist who identified thalidomide’s dreadful power to halt limb development in the early stages of pregnancy. The FDA’s sole contribution to avoiding this problem in the United States was a delay by a junior FDA officer in reviewing the original application.
There is tragedy on the other side of the thalidomide ledger, too. Thalidomide has been shown to halt the proliferation of blood vessels, an effect that may help starve certain cancers and protect against blindness induced by wet macular degeneration. In 1998, the FDA finally approved thalidomide to treat a complication related to leprosy. That means that doctors can legally prescribe thalidomide to patients with other diseases. The FDA, however, has put up so many restrictions on its off-label use, that few physicians or patients are willing to fight the red-tape.(4)
The rare disease the FDA approved thalidomide to treat only occurs in about 50 Americans every year. The FDA, however, says the company that makes thalidomide cannot promote its use in treating cancer and macular degeneration. Recent First Amendment losses the FDA has suffered in the courts may enable thalidomide to be advertised,(5) but that would mean the company making the drug would incur the wrath of the FDA and be subjected to retaliation against other drugs it might want to get approved.
Fearing FDA retaliation
The FDA has taken science out of the practice of medicine and replaced it with an incompetent and biased bureaucracy. To win FDA approval of a new drug, it takes a lot of political influence.
The FDA has put up so many restrictions on its off-label use, that few physicians or patients are willing to fight the red-tape
The committees who advise the FDA whether or not to approve a new drug are largely comprised of individuals who are beholden to the pharmaceutical giants.(6) Small biotech companies who cannot afford to put their own people on these advisory committees are at a significant disadvantage. There are FDA-staffers who appear unusually friendly to large drug companies, but find every excuse imaginable to delay the approval of novel drugs from smaller companies.(7-12)
The FDA intentionally delayed the approval of ribavirin for decades while this anti-viral drug was saving lives in just about every civilized country on earth. The company who made ribavirin committed the terrible “sin” of holding a press conference to extol the virtues of this drug before the FDA approved it. Another victim of FDA retaliation was the immune-enhancing drug isoprinosine. While isoprinosine has been prescribed by doctors throughout the world for nearly two decades, the FDA will never approve it here because the manufacturer helped promote the fact that Americans could import it from other countries for their own personal use. The sad fact is that when effective drugs are not approved because of FDA retaliation, American citizens die.(13,14)
Life-saving offshore drugs
An example of a drug that may never be approved in the United States is thymosin alpha-1. In 1981, we wrote a headline article about the multiple benefits of this immune boosting agent produced in the thymus gland.(15) Unfortunately, the small company making the drug lacked the resources to win FDA approval. Thymosin alpha-1 did gain approval in Europe. Published studies show that when used in combination with cancer chemotherapy, it helps mitigate bone marrow toxicity.(16,17) When thymosin alpha-1 is combined with interleukin-2 or alpha interferon, it enhances immune response against cancer cells and the hepatitis C virus.(18-23) Thymosin alpha-1 should be available to Americans, but the FDA says no!
Another drug that could be of benefit to hepatitis C and certain cancer patients is polaprezinc. This ultra-safe Japanese drug has been shown to reduce viral load and induce complete response in Type 1b hepatitis C (when combined with interferon).(24) It may also be effective as an adjuvant therapy in cancer cells that up-regulate a growth factor called nuclear factor kappa beta. If you don’t live in Japan, it is very difficult to obtain polaprezinc, a unique compound of carnosine and zinc.
Neurodegenerative diseases such as Alzheimer’s have no effective treatment. A drug called memantine may delay the progression of Alzheimer’s and Parkinson’s disease. Memantine works by a different mechanism than current FDA-approved drugs such as Aricept and Tacrine. Memantine has been used in Germany for the last ten years, but it remains bogged down in FDA-mandated clinical trials. Four million American Alzheimer’s disease patients anxiously await.(25-33)
A prime example of a drug that should have been approved by the FDA years ago is a COX-2 inhibitor called nimesulid. Americans suffered from arthritis pain and cartilage degeneration while nimesulid was long-ago approved in other countries. Americans now pay outrageously high prices for FDA-approved COX-2 inhibitors and American cancer patients are dying because this class of drug is not yet approved to treat cancer. Nimesulid was patented way back in 1971, but Americans had to wait for another COX-2 inhibitor called Celebrex to be approved in December 1999. Some studies indicate that nimesulid is safer than Celebrex or Vioxx. Nimesulid may also be more effective in the adjuvant treatment of cancer than Celebrex or Vioxx. It costs about $125.00 a month for Celebrex or Vioxx, yet nimesulid can be obtained in Europe for only $22.00 per month. It is unconscionable that U.S. citizens were denied access to COX-2 inhibitors for so long and now have to pay an average of five times more for this class of medication.
It’s time to revolt
Today’s flawed system of drug approval needs a major overhaul or Americans will continue to perish while effective therapies exist in other countries.
As more Americans learn that they are not getting the best that science has to offer, we believe the citizenry will rebel against the medical establishment, who place their monopolistic profits ahead over the well-being of the patient.