Adventist Media Response and Conversation

Saturday, May 14, 2011

Government against Healthcare

With all the talk of the government's attempt at taking over healthcare it is important to consider some of the history of how government actually increases healthcare costs.

For a number of years Colchicine has been used to treat gout flares up. A painful Uric Acid accumulation in the joints. Often the condition is caused by the overuse of doctors prescribing diuretics, at least that is what I have personally seen in various people I have known.

In 2008 the cost of a Colchicine pill was about 9 cents. Then the Food and Drug Administration (FDA) got involved. In 2009 the FDA granted Colchicine approval for the treatment of gout. As Wikipedia says: “In 2009, the FDA approved colchicine for gout flares, awarding Colcrys a three-year term of market exclusivity”. The FDA granted the exclusivity on a drug that predated the FDA. This is much different from other instances where a pharmaceutical company researches and develops a drug which they then hold the patent to for a number of years. In this case the drug was made by various companies and was for all intents and purposes a generic drug. Now, one has to wonder under what Constitutional authority the FDA has the right to restrict and grant exclusivity for a drugs of long use. It is not a safety issue or a purity issue which are under the FDA's mandate.

We all have to wonder about what kind of lobbying went on between URL Pharma and the officials at the FDA. But we have to remember that is how much of our government works now. For instance the Obama Healthcare Bill was not from President Obama. He declared all kinds of things about his plan but he never had a plan. It was not even from the Congress and Senators who claimed they were working on the healthcare bill. It was substantially put together by staffers and lobbyists. As America's Watchtower writes:

Much has been made about the politicians who voted in favor of the healthcare reform legislation without actually knowing what was in it because they didn’t even bother to read what they were voting on, but this takes the cake. Max Baucus is credited with writing the unpopular legislation but at a recent public meeting–when confronted with the question of whether or not he read the healthcare bill–Max Baucus admitted that he had not read the healthcare reform bill before voting on it.
When lobbists and money grubbing people get together the consumer is last on their list of concerns. Colcrys the Colchincine drug rose in price from 9 cents per pill to about 5 dollars per pill. Because the FDA acting as king maker gave the rights to a company and took rights away from manufacturer's. True the company did some research on dosages. Nothing that any University could not easily do for not too much money. It might be within the FDA position to issue a grant for such study but not really to hand out the right of creating the drug to one pharmaceutical company.

The New England Journal of Medicine wrote an article on this atrocity and the good folks at URL Pharma wrote a reply which is almost laughable. One of the things they write is the following:

NEJM: “After the FDA approved Colcrys, the manufacturer brought a lawsuit seeking to remove any other versions of colchicine from the market and raised the price by a factor of more than 50, from $0.09 per pill to $4.85 per pill.4 These increased prices directly affect the availability of the drug to patients with gout or FMF who have long been using colchicine safely in an evidence-based manner.”

URL Pharma Response: This statement is untrue. Our Patient Assistance Program protects virtually every patient and is one of the most generous programs ever offered by the pharmaceutical industry. It is only individuals with income greater than 600% of the Federal Poverty Level, who decide to not purchase health insurance, that are not covered for their Colcrys purchases. Also, it is false and misleading to state that we “raised the price” as there was no price for an approved colchicine product prior to Colcrys. The price of a safe, legal, FDA-approved drug, backed by research, discovery, and the financial risks and intellectual commitment to achieve such advancements, cannot be compared to that of an illegal, unapproved product. As shown above, anecdotal information cannot be relied upon as medical evidence, and doing so endangers patients. Additionally, 169 deaths, millions of cases of diarrhea, and other unnecessary toxic reactions do not constitute “using colchicine safely in an evidence-based manner.”
Of course if you check into the assistance program there are many hoops to jump through and it only works if your doctor and the pharmacist know how to do things to please the program. The pharmaceutical company is trying to appear generous with their windfall from the Federal government.

There are probably numerous such examples. I know of some things that would be changed to work more efficiently with some medically related equipment but any change in the equipment even if they had nothing at all to do with the care the patient got would have to run the whole device through the long FDA approval process again. Bureaucracies move slowly and seek to maintain their bureaucracy. If you think it will streamline or cut medical costs you are only kidding yourself. Sadly this is your government at work, not helping the consumer but the pharmaceutical company.

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