OCR Text |
Show The National Enterprise , February 9, 1977 byDeanAlsup Enterprise Staff Writer Mention the Federal Page three market in the early 1980s. If they encounter difficulties, it may not be released until the late 1980s. Drug Administration to drug One of Three Breakthroughs owners of drug research companies, and their response is likely to border somewhere between lewd and down-rigribald. Through their bungling bureaucratic red tape, the FDA has managed to raise the dander of almost everyone close to the pharmaceutical industry and even some of those stricken with heretofore incurable illnesses. Why are hundreds of people crossing the border into Mexico every year for forbidden (in the U.S.) Laetril treatments? Why since 1961 has approval of new drugs slowed to a snails crawl of 15 in 1976, from 45 a decade and a half ago? Why does even the American Cancer Society want cancer research pulled out from FDA control? Simply put, why must a maze of paperwork and red tape complicate a proven drugs entry into the marketplace where it could be set to work curing illness and saving Consider the case of DMSO (dimethyl sulfoxide, a compound said to have 31 pharmaceutical uses). Originally discovered by a Russian scientist in 1866, it was nearly a century later by American researcher Dr. Stanley Jacob, at the University of Oregon. He calls it one of three major medical breakthroughs in this century. Together with Salt Lake based Research Industries, the University, and others, over $20 million has been devoted to DMSO research. Although never proven harmful to humans, DMSO was banned by the FDA in 1965 when the bureau discovered that prolonged and heavy use of the drug (one percent of body weight) could cause myopia in rabbits and monkeys. Prior to their ban, over 100,000 Americans found relief from such ailments as arthritis, skin disease, burns, ulcers, disorders of the cornea and dozens of muscular problems. The persistance of Jacob and Henry Moyle, president of Research Industries, has kept DMSO alive. Both are hopeful the FDA will apbut prove the drug soon then, theyve been dangerously hopeful for over two years. Chemex, a Riverton, Wyo. research company has also been working for about four years on a drug known generically as larrea divari- - researchers, doctors and ht lives? The FDA says theyre doing the best they can qualifying that statement, as usual, with limitations of a small, underpaid staff, and other excuses common to the species of Bureaucrati. Perhaps they are confused. Caught in a cross fire consumers activists screaming, Protect us from the evils of unsafe drugs, and Congress shouting We want results-cureits little wonder chaos rules the $11.8 billion a year industry. be-betwe- en s, Its too costly for a small company like ours to meet all the FDA standards . We re trying to avoid the bureaucratic control of the FDA in order to save time and money . what about the winder drugs? Researchers boast of many marvelous discoveries made within the past ten years. Where are they? Still in the test tubes; still under the watchful eye of the FDA; still awaiting approval. y The Drug Company has found a compound called Vincristine, which shows superior ability in fighting cancers like acute But Eli-Lill- childhood leukemia Hodgkins disease. and cata. But theyve taken the drug outside the country for testing with little hope of ever getting FDA approval and being able to market it Weve within the U.S. been forced to test abroad, Chemex president Charles Hamilton said. Its too small for a company costly like ours to meet all the FDA standards. We are trying to avoid the bureaucratic control of the FDA in order to save time and money. . The drug is not being sold in this Years of FDA country. testing block its entry to market. The Merck Drug Company, Rahw'ay, N.J., has a revolutionary compound they call MK641MK642. It has showm effectiveness on every kind of bacteria ever tested. Like penicillin, it stops the multiplication of bacteria, but covers a wider range of bacterium than penicillin. If early tests are successful, Merck expects to bring it to Nothing to Do With FDA Chemexs re- top searcher, Dr. Russel T. Jordan, claims the drug has medical potential in the Mormon settlers and American Indians. Chemex is testing the drug in cancer research in Italy and conducting other tests in Guatemala and Costa Rica. Hamilton says its unlikely the drug will ever be marketed in this country even though one compound has been proven effective in stopping the growth of eye cancer in cattle. But since the U.S. constitutes only about 10 percent of the w'orld pharmaceutical market, Hamilton believes his company will find prosperity through foreign marketing efforts. After the drug is proven effective and safe abroad, Hamilton does believe, however, the FDA will be forced to pay some Until then, he attention. says, We dont want anything to do with the FDA. Yes, the wonder drugs are there all right. Thats the point, theyre there, not here. Merck also has a wild-growi- ng approved. Daniel S. Greenberg, editor and publisher of Science and Government Report , says the American people are getting a government snow job on the progress of cancer research. Greenberg and his staff received cancer medical research records from the ACS in 1976 and wrere absolutely sk vaccine proven effective against flu, venereal disease, chicken pox and shingles. Another diuretic of theirs pulls in $30 million a year from foreign countries. The company is making headway a with another antibiotic muscle relaxant, a long term analgesic and one drug they refuse to talk about. None of these are available in the U.S., but most are being sold abroad. And in fact, most major U.S. drug companies are now doing a substantial portion of their business abroad. Merck Companys overseas sales account for 45 percent l, of their revenues. 45 percent; Eli Lilly, 36 percent; Lederle, 50 percent; Pfizer, 52 percent, and Warner Lambert, 42 percent. Of course, the costs incurred through proving a drug both safe and effective have reduced the number of new drug applications reFor ceived by the FDA. example, there were only 15 new drugs approved last year, compared to 45 in 1961 , one year before Congress added the efficacy clause to the regulatory vocabulary of the FDA. Prior to 1962, effectiveness was not a viable factor. A drug had only to be proven "safe" before it could be marketed. non-prescripti- on Richard-son-Merrel- Astronomical Costs areas of cancer, dental caries, some skin diseases and prevention of ulcers. Chemicals for the drug are derived from the cresote bush, found primarily in the arid AmeriTales of the can desert. healing pow er of the cresote bush date back to the early Since spent in research. 1948, they said, over $90 million has gone to antibiotic research alone, and they have yet to produce a single usable drug, by FDA standards. The drug companies say they can expect to spend a minimum of $12 million in getting a new drug In the past ten years, the Merck Co. has spent over $800 million on drug re- search while bringing only one major new drug to market in the U.S. They were recently forced to shelve a new drug for gout and swallow' over 520 million President of Research Industries , Henry Moyle, says over $20 million has already been sunk in research of DMSO. Cancer Society Protests And how many times has the lady from the American Cancer Society come knocking at your door for a charitable contribution? If she had her way, cancer research w'ould be yanked from the auspices of the infamous FDA. Doctors tell us accomplishments in the cancer field have come a long way, but the fact is, fewer people are dying from cancer operations since surgery techniques have been greatly improved. The actual cancer death rate has changed very little. amazed at what they learned: The survival rate of lung cancer patients has fixed itself at 8 percent since 1950. Cancer of the colon kills 56 percent of those inflicted, the same as in 1950. A 2.5 percent increase in leukemia survival has been noted, however, and female breast cancer victims have also shown slight improvement, from 89 percent survival in 1950 to 90 percent last year. The reason for slow progress in cancer research, Greenberg attributes to government, namely the FDA, who carries on the cancer Continued on page eleven |