Medicynic

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.

Zocor’s patent has expired. The article in the Times describes the financial ramifications on statin manufacturers Merck, Pfizer, Schering Plough, and Astra Zeneca.

Statins (a common class of drugs to lower cholesterol) are big business, in case you ever doubted it. Lipitor generates revenue of 12 billion dollar a year while Zocor generates 10 billion. With profits of drug companies in the 15% of revenue area these drugs are cash cows.

Even considering the drug companies estimate of $800,000 (a disputed number) to develop a new drug these revenues imply excessive and remarkable profits–but that’s our system, or is it?

The drug development equation is complex with a long pipeline consisting of basic research, identification of drug candidates, testing for toxicity and efficacy and finally release on the market. Pharma, however, is rewarded with market monopoly’s for 20 years, or more; pricing that seems to have nothing to do with real development costs; and profits that are quite remarkable–see Marcia Angell’s article and book of the same name or John Abramson’s book Overdosed America (review here).

Try this.

It’s amazing that we simply roll over and watch this happen. We’ll be having a discussion of drug patents next week.

Another medicynic!

$56,000 reported here for a course of treatment with Erbitux (cetuximab), which “has not yet been proven to extend the lives of colorectal cancer patients. It does shrink tumours in some patients and delay tumour growth, especially when used as a combination treatment.”

NCI notes that the use of this drug is based on an “open-label, single-arm trial (138 patients) of Erbitux plus irinotecan and an open-label single-arm trial (57 patients) of Erbitux as a single agent. All studies enrolled patients with EGFR-expressing (75-82 percent of those screened were positive), recurrent, metastatic colorectal cancer. All patients had received prior irinotecan; two-thirds of the patients in the randomized study and half of those in the supportive study had progressed during or within 30 days of receiving an adequate course of irinotecan.

In the randomized trial, 38 percent had also received prior oxaliplatin. Determination of clinical benefit was based on evidence of durable responses without evidence of an effect on survival. In the randomized trial, the overall response rate was 23 percent with a median duration of response of 5.7 months in the Erbitux plus irinotecan arm. The overall response rate was 12 percent with a median duration of response of 4.1 months in the Erbitux monotherapy arm.

The median time to progression was significantly longer for patients receiving combination therapy (4.1 vs. 1.5 months). Comparable results were observed in the single arm studies of Erbitux plus irinotecan (15 percent Overall response rate, 6.5 months median response duration) and Erbitux monotherapy (9 percent overall response rate, 1.4 months median response duration).”

These results are real, there are no typos. We are spending $56,000 for a drug with 23%, 9% and 15% response rates in three studies–duration of response from 1.5-6.5 months. This may be progress but is it worth it? Cost effective? Can we afford it?

We live in a world in which doctors prescribe medications costing up to $100,000/patient and in which this and this and this is happening.