Medicynic

If you do all that they recommend you may not live any longer, but it will seem that way.

The editor of a prominent medical journal duped!

Conflicts of interest are unfortunately the rule not the exception in medical research. Consider the following discussion of medical progress from Medscape.

“Dr. Beer: A couple of presentations pertained to this issue, adding to the growing body of evidence from TAX 327 suggesting that modern chemotherapy can be effective for some patients. One analysis, for example, indicated that pain response is an independent predictor of survival, which is not surprising, but is interesting nonetheless.^“

“Another analysis from TAX 327 evaluated the effect of treatment on quality of life in patients with minimal symptoms. Those researchers found that quality of life improved to a greater extent following treatment with docetaxel plus prednisone compared with mitoxantrone plus prednisone for all patients, as well as for patients with minimal symptoms. We previously learned that survival was better and that prostate-specific antigen (PSA) response rates were greater with docetaxel, but in some patient subsets, toxicity was higher with docetaxel-based chemotherapy. And so it is reassuring to see that docetaxel-based chemotherapy was associated with a higher quality of life than mitoxantrone/prednisone and that the toxicity burden was not so excessive that the benefits were outweighed by side effects.

On the other hand — looking at the numbers critically — more patients experienced a deterioration in quality of life than an improvement, and I think that is a reminder that a lot more work needs to be done.” (italics medicynic’s)

Contrast the time and detail given to extolling the virtues of the treatment (docetaxel) versus the bare minimum of detail disclosing that most patients don’t respond and experience deterioration while on treatment. The fact that the survival benefit is barely two months is not all disclosed. It’s not surprising that the discussant is a paid consultant for the drug company manufacturing docetaxel.

At the bottom of the article in a location that is easy to overlook it states: “Disclosure: Tomasz M. Beer, MD, FACP, has disclosed that he owns stock, stock options, or bonds and is an inventor with rights to intellectual property created for Novacea. Dr. Beer has disclosed that he has received grants for clinical research from sanofi-aventis and Novartis. Dr. Beer has also disclosed that he has received grants for educational activities from sanofi-aventis.”

Can a paid consultant offer unbiased, unspinned information? Is disclosure enough? Medicynic doubts it.

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.