Hope, at $4,200 a Dose - New York Times: "Drug industry experts say Abraxane’s price reflects the fact that makers of cancer drugs can charge high prices for new medicines even if they are only marginally better than their older counterparts. That pricing dynamic is enabled by insurance, which shields patients from the full price of drugs. Without pressure from their insurers, patients have little reason to choose older treatments over expensive new therapies. Doctors, who ultimately decide what drugs to prescribe, also do not have to worry about paying for the treatments they choose. Charging $4,200 a dose for a new version of an old cancer drug has helped make Dr. Patrick Soon-Shiong a billionaire. The drug, Abraxane, does not help patients live longer than the older treatment, though it does shrink tumors in more patients, according to clinical trials. And the old and new medicines have similar side effects. An independent review of Abraxane published in December in a cancer research journal concluded that the drug was “old wine in a new bottle.”
It's easy to fool patients ! What's the point of "shrinking" a tumour if this does not allow you to love longer - or better ?
Abraxane (a taxane) is a new form of Taxol. Abraxane combines the drug paclitaxel with Albumin, a protein found in human blood. Taxol combines paclitaxel with Cremophor, a combination of castor oil and alcohol. The delivery mechanism is different, however, they are basically the same drug.
ReplyDeleteDespite its effectiveness, paclitaxel has some drawbacks. Paclitaxel targets the fastest-growing cells, but it isn't specific to cancer cells. It also kills hair cells and cells in the stomach lining, leading to hair loss and nausea that are associated with chemotherapy. It is possible for many patients to be resistant to it, and also to develop a tolerance, limiting the drug's ability to fight future occurrences of cancer.
Patients taking Taxol receive a steroid and an antihistamine to reduce the risk that Cremophor will cause harsh allergic reactions. Patients taking Abraxane do not need to take a steroid or antihistamine, and can be given at higher doses than Taxol. However, more of the women on Abraxane had numbness and tingling in their hands and feet. And more suffered nausea and vomiting, diarrhea, muscle and joint pain and anemia.
Some taxane-induced side effects are so common, and in some instances so severe, that patients and their physicians may delay treatment, reduce the dose or discontinue therapy altogether. While medications designed to prevent or treat nausea, vomiting and decreased white blood cell counts are available, there are currently no treatments for other serious taxane-induced side effects, particularly nerve damage.
Despite the broad antitumor activity of taxanes, their clinical usefulness has been limited by common side effects such as painful nerve damage, reduction of white blood cell counts, liver damage, allergic reactions, nausea and vomiting, and other toxicities (Bionumerik).
According to clinical trials, although it does shrink tumors in more patients, Abraxane does not help patients live longer than the older treatments. Dr. Ramaswamy Govindan, a Washington University professor who was co-author of a December 2006 article in the Annals of Oncology about Abraxane and other, as-yet- unapproved Cremophor-free versions of Taxol, said that none of the new drugs had shown significant advantages over the older medicine. In general, the novel formulations so far have not stood out as distinctly superior.
Shrinking tumors is a totally inadequate measure of the effectiveness of a drug. German investigators, using the CellSearch system, shown that Taxol produced the greatest degree of tumor shrinkage, but also the greatest release of circulating tumor cells, beginning the most life-threatening aspect of cancer, metastasis. With cells remaining in the circulation, this observation corresponds with results found in patients that tumor response does not mean increased survival (Oncol News Int'l, Vol 14, #5, May '05).
Then add in the price shock of the drug! Charging $4,200 a dose for a new version of an old cancer drug. Two studies have documented a clear association between reimbursement to oncologists for the chemotherapy and the regimens which oncologists select for their cancer patients. In other words, oncologists tended to base their treatment decisions on which regimen provided the greatest financial remuneration to the oncologist (Jacobson, M.,O'Malley, A.J., Earle, C.C., et al. Health Affairs 25(2):437-443, 2006) and (Patterns of Care: 2005,Vol 2,Issue 1).
U.S. Oncology played a role in getting this drug approved. U.S. Oncology took a hit in its latest SEC Form 10-K report. It reported a first-quarter net loss (oops!). They said a number of factors impacted their results, including reduced pre-tax income due to lower use of certain supportive care drugs used to treat cancer-induced anemia (F.D.A. Warning Is Issued On Anemia Drugs' Overuse), and the discontinuation of the Medicare Demonstration Project (the project HHS' inspector general's office found gave providers an extra $130 to simiply forward data that already was collected).
And one other seemingly unrelated bit of information in the SEC Form 10-K. In 2005, U.S. Oncology was subpoenaed by the U.S. Department of Justice about contracts and relationships with pharmaceutical companies. Coincidence?