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October 20, 2004 - There are only two companies licensed by the FDA to provide flu vaccines in the United States. One is California based Chiron Corp. with its manufacturing facility in the United Kingdom. The other is Aventis Pasteur, a European pharmaceutical manufacturer. British regulators found that the vaccines produced in the Chiron plant in Liverpool were contaminated and impounded the 48 Million doses already manufactured. British regulators and not the FDA protected the American public from contaminated vaccines.
President Bush has said that he will continue to block American access to international cost controlled pharmaceutical markets because he cannot assure the public that those medicines are safe. That ignores the fact that the medicines American patients wish to buy in Canada are manufactured by US drug companies under US safety regulations. The safety assurance justification for preventing access to medicines at reasonable prices rings hollow indeed, especially in light of the effectiveness of foreign regulation as demonstrated in the case of Chiron’s vaccines. It is just an excuse to protect the extraordinary profits of the pharmaceutical industry; from the manufacturer right down to the corner drug store. It is the drag your feet, make excuses, and do nothing approach to the crisis facing many patients who can not afford to pay for medicines they need to maintain health. Let me give you an example – a personal example. My wife suffers with scleroderma, a relatively rare chronic, progressive and inevitably fatal auto-immune condition. With aggressive treatment by talented and innovative physicians she has now outlived the typical period between diagnosis and death. This June her physician tried a new drug, one that was not labeled for treatment of scleroderma by its US manufacturer but was approved for treatment of irritable bowel syndrome – a condition that does share some symptoms with her disease. Because it was what her medical plan calls a third tier drug – an expensive medication that is covered only if the insurance company pre-approves its use – he started her out with a supply of samples he had received from the manufacturer. The result was astounding. Not only were the troublesome symptoms arrested, the damage to her lungs was actually showing signed of reversal. The insurer refused approval and the monthly cost of directly purchasing the medication is far beyond our means - even from a Canadian source. There is another similar medication manufactured in New Zealand and not approved for distribution in the United States. It is neither as effective as the US medicine nor does it reverse the damage, but it is keeping her symptoms and further destruction at bay. Her doctor gave her the telephone number of a New Zealand pharmacy that will sell her the drug. Her first three month supply came via airmail this week. It cost $35.00. Of course her importation is illegal and the President cannot assure her that the drug is safe. She can be assured that without it the progression of her disease will proceed at an increasing pace toward premature death. Neither the President’s drug cards nor his convoluted Medicare plan to insure drug company profits can help her. She is not yet 60. Linda is not alone. The prospect of premature death from orphan diseases haunts countless Americans. In her case a drug that can arrest if not reverse the disease process is out there and has proven to work for her. It hangs there just out or reach, available to John Kerry’s family; available to George Bush’s family; but not to us. In order to stay alive a little longer she must settle for a second best medicine and break the law to get it. America can do better than that. America must do better than that. |
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