Lack of Meaningful Clinical Trials

We have produced an entire generation of investigators in clinical oncology who believe that the only valid form of clinical research is to perform well-designed, prospective, randomized trials in which patients are randomized to receive one empiric drug combination versus another empiric drug combination.

What passes for a successful experiment in clinical oncology? Henderson, et al, entered 3,100 breast cancer patients in a prospective, randomized study to compare cyclophosphamide with doxorubicin alone versus cyclophosphamide plus doxorubicin with Taxol (in the adjuvant, pre-metastatic setting). The results were microscopically positive, at best, and cannot begin to justify the enormous financial and human resources expended (while making no effort at all to test and improve methods to individualize treatment).

But these results changed the face of the adjuvant chemotherapy of breast cancer. Cyclophosphamide plus Doxorubicin with Taxol became standard of care. Taxol recently went off patent. Now the thrust is to identify on-patent therapy which is microscopically better in clinical trials of one-size-fits-all treatment. Already, the community-based oncologists are migrating to Cyclophosphamide plus Doxorubicin with Docetaxel (expensive/remunerative) so what was the purpose of doing that 3,100 patient prospective, randomized Henderson study?

Some academic oncology groups have as their major ovarian cancer project, clinical trials to show that Taxotere (Docetaxel) can now be the new "standard" therapy. Patients are treated with Taxol plus Carboplatin. If (or when) Taxol plus Carboplatin doesn't work, they'll be crossed over to Taxotere, a drug which is mostly (if not completely) cross resistant with Taxol, for which the cancer clinic will collect several thousand dollars per patient from the large pharmaceutical company if and when they are treated with this drug (delaying the patient's treatment and possibly subjecting them to a horrible death).

There were a couple of recent clinical trials, one dealt with breast cancer and the other dealt with lung cancer; both of them had the drug Taxotere (Docetaxel) in their repective studies. These kind of chemotherapy studies have never yielded any kind of meaningful advance. It's being done simply because Taxotere (Docetaxel) is an on-patent drug which has a Big Pharma sponsor willing to spread around a lot of money to identify and expand indications.

We are getting an expanding list of treatments which are partially effective in a minority of patients, ineffective in a majority, remarkably effective in a few, while being enormously expensive. The fastest way to improve things is to match treatment to the patient.

All the rigorous clinical trials identified are the best treatments for the average patient. But cancer is not an average disease. Cancer is far more heterogeneous in response to various individual drugs than are bacterial infections.

The tumors of different patients have different responses to chemotherapy. It requires individualized treatment based on testing the individual properties of each patient's cancer. There are over 100 different therapeutic drug regimens which any one or in combination can help cancer patients. The system is overloaded with drugs and underloaded with wisdom and expertise for using them.