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Huffington is a medicynic.

In regard to stem cells the unholy trinity are quoted to observe:

Rev. Pat Robertson: “Before long, we’ll be harvesting body parts from fully formed people. Once you begin this…utilitarian use of cells, then everything is up for grabs.”

Rev. Jerry Falwell: “…the President was right to ban federal money going to this dangerous and unethical research.”

James Dobson: “Experiments on the blastocytes, which are fertilized eggs, has a Nazi-esque aura to it.”

Our president is planning to veto a bill which would make more stem cell lines available to research. Without research we’ll never know the possibilities of treatment and cures from this modality. What’s next, banning in-vitro technology because of the large attrition rate? Banning vasectomy oophorectomy and contraception because they artificially deny erstwhile sperm and eggs their manifest destiny?

There is nothing dangerous, unethical or naziesque about using stem cells to treat medical problems. A theocracy on the other hand is all of that.

Sadly this whole business seems to be another opportunity for politicians to posture for their base without coming to grips with real issues. From a medicynical viewpoint politicians should be more concerned with our moribund, expensive, mediocre health care system.

Conflicts of interest are apparent at every level of the health care industry. The Times July 16, 2006 describes yet another. Our so called system appears to work through bribes and rigging. Hardly an open competitive market.

The Citizen’s Health Care Working Group’s interim report provides a number of ideas on how to initiate a more rational health care system in the U.S.

Medicynic’s last post Phixing Pharmaceutical Costs noted that our so called free market system doesn’t assure access, can’t control costs and results in economic rationing. On the other hand successful national heath care programs (see this) assure access by sitting “down at the bargaining table with the government and representatives from professional associations of doctors and healthcare professionals to set exact fee structures. They negotiate strict cost controls that have prevented expenditures paid by consumers from approaching anywhere near exorbitant U.S. levels. Cost controls are essential to the success of these “shared responsibility” systems.” These negotiations extend to suppliers and pharmaceutical companies as well.

Price competition is fundamental to the capitalist system. Competition for customers leads to the right price for product and value. Such competition however is anathema to health care. Why? On one hand we have patent monopolies which allow patent holders to charge whatever they want for a product for a generation. This eliminates competition. On the other hand, we find it difficult as a society, as health providers and as consumers to place a monetary value on health care, a surrogate for life. We don’t shop for value.

We’ve focused on cancer medicines in previous posts in part because their pricing is extreme and also because patients with cancer perceive that they face the ultimate dilemma—pay or die. Cancer pharmaceutical pricing is indeed a death tax, a system that redistributes wealth rather than assures quality care at reasonable price.

The question is whether there is, or should be, a quid pro quo for a government granted pharmaceutical patent monopoly. One that will assure reasonable pricing. This article on Financing Drug Research offers some suggestions. Medicynic suggests we:

1. Require the government and pharmaceutical companies to negotiate prices for patented medications purchased for government programs and benficiaries. Including Medicaid, Medicare, the Federal Employee program and Tricare this would affect 100 million citizens (1/3 the population of the U.S.) Since we like transparancy we should make the negotiated prices public.

2. Enforce the reasonably pricing provisions of Dole-Bayh. Retrieve the taxpayer’s contribution to drug development costs (approximately 20 billion a year to basic medical research) from patent holders and use these proceeds to defray pharmaceutical prices to consumers. This would also require the disclosure of the real development costs of pharmaceuticals.

3. Prohibit direct to consumer (DTC) advertising. In a 30 second ad full disclosure as outlined below is not possible. As a result patients do not fully understand the limits and costs of any given product. Few countries allow such advertising.

4. If we don’t wish to completely prohibit DTC advertising, require full disclosure. This would include mention of the risks of treatment and a summary of proven benefits and competing approaches in clear language that a lay person can understand. The price of the medication, with estimates of monthly and yearly costs as well as a measure of cost effectiveness (cost/unit of additional survival time or other approved measure) must be also be provided to fully inform the consumer.

5. Require clinical studies to include cost data as well as a measure of cost effectiveness (QALY-Quality adjusted life year or other) in the discussion of any phase II, III or IV study reporting positive results.

6. Monitor the FDA approval process to be certain that generics come to market quickly on patent expiration.

7. The Canadian system controls patented drug prices by not allowing marketing unless the drug is priced right. A similar program could be instituted here to decrease our pricing to the level of other industrialized countries.

8. Alternatively, link the length of patents to reasonable pricing. As part of the FDA approval process the proposed price of the new medication would be compared with similar medications already on the market and with the same medication in other countries. The same process that the Canadian patent drug review board uses. If priced 10% over the comparator, the patent length would be decreased by a similar 10%–there are many ways such a link could be structured. For unique innovative drugs the cost of development could also be factored into the pricing length of patent equation. Price increases during the duration of the patent would be tied to the rate of inflation. If they exceed that rate the patent would be proportionally shortened.

The costs of medical care are staggering. This study, “Illness And Injury As Contributors To Bankruptcy,” from Health Affairs reminds us that 50% of bankruptcies are caused, at least in part, by medical expenses. “An Outcry Rises as Debt Collectors Play Rough” in the Times July 5th describes the gloves-off tactics of debt collectors today. Finally, “The Moral Burden of Bankrupcy” in the Christian Science Monitor applies religious ethics to debt,

Given the spiralling cost and chaos of our health care system system perhaps this, as noted in the the Health Affairs study, is the solution!

If the debtor be insolvent to serve creditors, let his body be cut in pieces on the third market day. It may be cut into more or fewer pieces with impunity. Or, if his creditors consent to it, let him be sold to foreigners beyond the Tiber.
—Twelve Tables, Table III, 6 (ca. 450 B.C.)

But today’s new drugs are worth much more/ounce than gold and todays alchemists don’t hesitate to take advantage. Look at this.

We’ve talked in the past week about the quality and costs of care in the United States. Our patent (government sanctioned monopoly) system is part of the problem.

Big PHARMA maintains that it is essential to have exclusive patents now up to 20-25 years in length to assure profits that will allow continued research and development of new drugs. As a result of Pharma’s effective congressional lobby, pharmaceuticals are the only uncontrolled, i.e. not open to negotiation and price setting, of the health care expense areas. Hospitalization, doctor’s fees, laboratory costs are all negotiable and discounted by the various health care payers. As a result, the rate of increase of spending on pharmaceuticals far exceeds that of other areas–13% a year since 1980. More on health care costs here and here.

Patent law has been carefully crafted to maximize profits of the drug industry. During the patent protected period drug companies can and do charge whatever they wish for a product. As a result, over the past 30 years drug prices have risen exponentially to unimagined levels and the industry has enjoyed record profitability “one example is that in 2002, the combined profits for the ten drug companies in the Fortune 500 ($35.9 billion) were more than the profits for all the other 490 businesses put together ($33.7 billion).”

When I started my medical oncology practice in the 70’s the cost of anticancer drugs averaged under $100/month. By the 90’s the pricing of new drugs broached the $1000/month, and by 2005 we were in the area of $10,000/month for some new drugs. For more look here.

It’s an unfortunate fact that in cancer therapy pharmaceutical costs have become what is essentially a death tax on the desperately ill. Your give your money or your life is on the line. Consider the number of people each year facing a life threatening illness. Consider also that the cost of many of these new drugs/year exceeds the average and median incomes in the U.S.; exceeds the cost of new automobiles; and over the lifetime of a patient the cost of a single medication can exceed the cost of the home of most americans. (see previous post on imitinib) Instead of a benevolent health care system in which access to care and restoration of health are the goals, we have a system whose main purpose is to maintain the profits of the health care industrial complex. The result is wealth redistribution rather than a fair price.

Pricing of pharmaceuticals is not sustainable and is the equivalent of a market bubble that cries out for correction.

This today. Guess who pays!

It’s hard to find anything good to say about the our health care establishment. Read here, here and here.

Even a “positive” article reports:

“I can see three patients with acute needs every 15 minutes,” she said.

The charge is $52 to $60, which is coverable by insurance and similar to prices at many of the new clinics springing up in places like CVS pharmacies and retail chains like Wal-Mart.”

Amazing stuff for a medicynic.