It is estimated that over One Million women world wide currently have breast cancer and 20-25% of them are afflicted with the Her2 version. Her2 refers to a type of breast cancer that has been found positive to carry a protein that promotes the growth of cancer cells. Its the most aggressive and deadliest type.
The drug, Herceptin, first approved by the FDA in 1998 to treat Her2 was touted as a break through miracle drug. It is made by Genentech who began charging a record $20,000 a year for its use in 1998. Today, Herceptin costs upwards of $145,000 per year or 14 times its original cost. It has helped prolong many lives, but now there is something even better in the pipeline.
It seems that the drawback to Herceptin is the body becomes resistant to it. Enter an experimental drug some are calling "super Herceptin", also made by Genentech. It works like the original drug by hunting down and interfering with the cancer cells. But this newer version, called TDM1, is Herceptin with a chemotherapy drug attached. The combination delivers a one-two punch, seeking out the cancer cells and not only stopping growth but delivering the chemo right to the cell. In trials TDM1 is saving lives big time. In addition, its supposed to be less expensive than the original Herceptin.
Genentech applied for approval on the "fast track" program of the FDA. It was turned down. In fact, it is not approved for any country. Although it is still approved for trials only, many desperate late stage cancer patients cannot get it without the general approval. And it almost lost the approval of its continued trials, which lead many people to appeal to the FDA and Genentech directly.
At the same time another drug, Adcetris developed by Seattle Genetics, was approved by the FDA for the treatment of Hodgkin’s lymphoma which only affects 1% of the worlds population. The treatment for this drug will come at a price tag of $100,000.
I am of the opinion it was turned down because no one cannot afford these high costs anymore and government health agencies don’t know how to deal with the drug manufacturers – after all, we are talking about 25 million users! How can anyone deal with the high costs of these drugs? Genentech refuses to give details to explain the high costs of its drugs, however, investors are amassing record profits.
Drug companies say many factors drive the pricing of their drugs, including the high cost of research and development, complex and expensive manufacturing processes and the value the drugs provide for patients.
”There’s not really any incentive in the system to be more rational,” said Dr. John Hornberger, an adjunct clinical professor of medicine at Stanford University and a practicing physician who studies drug costs. Drug advocacy groups are afraid to rock the boat in the event research and development could slow down.
Policy makers in the United States, unlike those in Britain and some other countries, do not measure the cost-effectiveness of new drugs, Dr. Hornberger said. The government does not control drug prices, and Medicare is prohibited from making coverage decisions based on cost; it must base its decisions solely on the drugs’ performance. The only country known to successfully negotiate a lower price for Herceptin has been Australia to date.
I say governments, bring in the negotiators, like any good business does. Just ask Australia how its done. While you’re at it bring in some hard core ethics instructors to educate the drug manufactures and the investors.
Listen to one woman’s plight to save her trials : Jeanne Sather