Ipilimumab

We’ve had some experience with melanoma in relatives – it was caught early and hasn’t returned. It’s an especially dangerous type of cancer if it “metasicizes” – that is, penetrates the protective skin layers and enters the blood stream. The cancer will quickly spread and infect other organs. It usually overwhelms the body with death shortly following.

So I was glad to read of the development of a new drug that helps people in whom the cancer has spread. It’s called ipilimumab, and is being “developed” by Bristol Myers, whose stock has responded favorably to recently released findings of clinical studies that found the drug effective.

But it is confusing. An article in Medical News Today reviews the findings of the study.

Early results of a trial found that a new drug that targets a genetic mutation found in over half of melanoma cases and some other cancers caused tumors to shrink and patients to live around 6 months longer without their disease getting worse, including those whose cancer had spread to the liver, lung and bone.

Current treatments can generally extend life expectancy around two months. Is this progress?

I suppose. And I don’t know how to read these studies. Perhaps the important point is that they have hit on an entry point into a new means of treating the cancer that will lead to an eventual cure.

Or maybe it is just hype. But it is fodder for those who tell us that large pharmaceutical companies are doing important research that is bringing real benefits to the human condition, and that this is what justifies the protection from competition that we grant them. Are we not seeing some return on investment here?

Not really. Bristol Myers did not invent the drug. A company called Medarex did. Bristol Myers merely bought Medarex.

And this is typical of the business model of large pharmaceutical companies. They take the research of others (most often, NIH) and leverage it into marketing bonanzas.

To illustrate: People often think of Nike as a shoe company. It is not. It is a marketing company. They know how to exploit sweatshop labor to make a shoe. That’s for sure. But their real talent is “adding value” to a $5.00 shoe, converting it to a $150 Air Jordan. That’s their specialty.

In the same manner, Bristol Myers markets drugs.

Take Avapro, for example, aka irbestaran. It’s a fairly modestly priced drug by PhRma standards – only about $120 a month. It is used to treat high blood pressure, and kidney problems in diabetics. It has an important side effect: It doesn’t work.

A large randomized trial following 4100+ men and women with heart failure and normal ejection fraction (>=45%) over 4+ years found no improvement in study outcomes or survival with irbesartan as compared to placebo test.*

Bristol Myers annual sales of Avapro: $1.3 billion.

Will ipilimumab be a life-saving drug for metastasized melanoma patients? Or, will it be a cash cow for Bristol Myers that buys some end-of-life time for Medicare patients? Is it yet another tap into the public health care coffers for big pharma?

The early bet appears to be marketing winning out over science. This hype around this drug, the purchase of Medivex by Bristol Myers, and the clinical trial that doesn’t seem to offer much hope beyond four month for people with a death sentence … all smells like another Pharma con game.

I hope I am wrong.
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* Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A (December 2008). “Irbesartan in patients with heart failure and preserved ejection fraction”. N. Engl. J. Med. 359 (23): 2456–67. doi:10.1056/NEJMoa0805450. PMID 19001508.

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