Over this weekend we got good news and bad news from the FDA. Two similar regimens to treat HIV and AIDS were tentatively approved.
For the United States, a single pill per day drug was approved. This will replace the drug cocktail that HIV positive and AIDS patients have been forced to take in recent years. Here is the bad news, it will be so expensive the American public, Medicare and Medicaid will pay through the nose for this so-called breakthrough. The Medicare Drug program has a very interesting provision that prohibits the Medicare Program from competitive bidding drug purchases. It is enough to make your head spin. When I was a Purchasing Officer for the United States Air Force Medical Service Corps during the Vietnam War, we competitively bid “garden hoses.”
Here we are in 2006 as the only industrialized country on earth that does not competitively bid its publicly purchased medications. The argument is that the United States has a “big heart” and its citizens have to pay for the research and development for new drugs. What is odd about this argument is that so many of the new U.S. marketed pharmaceuticals were, indeed, developed abroad. Most drug companies are now multi-national corporations. Notwithstanding, they have a stranglehold on the United States Congress and the Executive Branch, regardless of political affiliation.
Further, what is the big deal about the science of this new single-dose drug administration? The true breakthrough was getting Bristol-Myers Squibb Company and Gilead Sciences, Inc., to cooperate in compounding existing medications manufactured by their respective firms -- specifically, Squibb’s Sustiva (efavirenz) and Gilead’s Truvada (emtricitabine tenofovir disoproxil fumarate).
What will this cost the American people, the Medicare and Medicaid program? We will find out soon. At the moment, only God knows how the American public will be fleeced to pay for existing drugs compounded and marketed only inside the United States.
Almost comically, this same weekend, the Voice of America reported that a similar approach to drug compounding has tentative approval from the FDA, but it will require two pills per day. The impact of arresting HIV and slowing down the progress of AIDS is the same. The active ingredients in this “two pills per day” regimen are remarkably similar. The drugs are sold under the trade name of Epivir, Retrovir and Viramune. The drugs are lamivudine, zidovudine and nevirapine.
This compounding will be manufactured by a company that may not “ring a bell” for you. The drug company is Aurobindo Pharma in Hyderabad, India. Following is a direct quote from the Voice of America Press Release, “This is the first time the Food and Drug Administration has approved a product like this under the plan. The decision is a tentative approval. That means the product meets all quality and safety requirements for marketing in the United States. Full approval would mean that the product could be sold in the United States. But that is not possible because of patent protections and marketing agreements.”
Wait a minute. I thought we were in support of a global economy. Why are we being denied these Indian medications? When I need to call and ask a technical question about one of my computers, the Indian engineers and technicians are good enough for me and the rest of the American people. Why can we not have the benefit of their pharmaceutical manufacturing expertise?
How about that, “. . . Cannot be sold in the United States . . . because of patent protections and marketing agreements.” In other words, the fifteen countries desperate for these drugs will receive them at reasonable prices because of the moral outrage that these drugs have largely been withheld from them to date.
Stay tuned for the following. You are going to hear a lot about what a wonderful thing this is that American people suffering from HIV or AIDS will only have to take one pill. The public relations campaign will not have much to say about how expensive the pill will cost.
You can also expect to hear how compassionate we are to make similar drugs available to the third world and reduce suffering among those poor people suffering from HIV or AIDS. You will hear less about the fact that this drug regimen will be quite inexpensive.
P.T. Barnum said, “A sucker is born every minute.” When it comes to the American people and the drug industry, you have a financial circus that would give P.T. Barnum a giggle. Do not expect any moral outrage from Washington. The United States Congress is for sale to the highest bidder. I should be clear. This is my opinion. What is your opinion?
Jan Jennings
Republished with permission with from the Hospital News Group
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