Healthy Skepticism Library item: 14449

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Brody H.
'Biologicals'--a Technique to Justify High Drug Prices
Hooked: Ethics, Medicine, and Pharma (blog) 2008 Oct 17
http://brodyhooked.blogspot.com/2008/10/biologicals-technique-to-justify-high.html

Full text:

The Healthy Skepticism listserv recently featured a very insightful and helpful comment from a Down Under pharmacist, Dr. Chris Doecke, of the Royal Adelaide Hospital. Though this blog is not primarily about why drugs cost so much, it is about techniques of drug marketing, so I thought Dr. Doecke’s expose of the myths surrounding the term “biologicals” might be helpful to readers:

‘I also would like to highlight another very common myth that is often promoted in the area of new pharmaceuticals generally, but particularly with cancer treatments. Unfortunately many health professional have also been sucked in that most new drugs are “biologicals”. Once said this somehow immediately justifies a $100K per year price tag without further challenge.

The quotes from the BW article were: “Because cancer treatments often consist of complex protein molecules that take years to develop, the drug multinationals left these risky products to small biotech ventures such as ImClone.” “And Roche, bowing to pressure from Britain’s National Institute for Health & Clinical Excellence (NICE), slashed the price of lung cancer drug Tarceva by $1,200 to $10,830 per four-month course of treatment.”

Point one

Tarceva is erlotinib hydrochloride, a fairly simple small synthetic chemical. It is not a protein, it is not complex. It inhibits endogenous receptors in the body to modify physiologic processes (tyrosine kinase activity) just as atenolol inhibits endogenous receptors in the body (beta adrenergic receptors). Erlotinib is presented as a simple oral film coated tablet. We are being duped into linking these simple chemicals with “biologicals” because they are use for cancer treatment. Novartis did exactly the same with imatinib for CML. A$50-75K per year per patient for a simple oral dose form.

Point two

The fact that a pharmaceutical is a proteins should NOT immediately justify a $100K per year price tag. Most are produced by using a recombinant process via a cell line. Once the process is established, cells simply spew out protein. I simplify a little, but as part of my PhD I produced active protein via recombinant techniques – hence isn’t that difficult. Finally we have had recombinant human insulin available for decades at arguably reasonable prices.

In summary, this is a subtle process that we often get sucked into. That is, that everything for cancer is “biological” and that everything biological is rare, complex and expensive. As health practitioners we need to de-bunk these myths at every opportunity.’

Thanks to Chris for giving permission to reprint his comment here, and he notes that he will be expanding the discussion for a future edition of the Healthy Skepticism Newsletter.