New Cancer Therapies
The development of drugs for cancer medicine is big business. Scientist commonly develop a theoretical drug and must then find investors to contribute money to test it out. The testing phase usually requires millions of dollars.
Researchers routinely begin preliminary testing on cancer cells in tissue culture or on laboratory animals. If the drug seems to be working, it will eventually reach the human testing phase, called the clinical trials. There are three phases of clinical trials.
The first of these phases is designed to determine if the treatment is safe for humans. The drug will be administered to a limited number of people during phase I. These patients are usually at very progressed stages of their disease. During this phase, physicians attempt to determine if there are any side effects of the drug or if it is toxic for humans.
Phase II involves more patients. The volunteers are often critically ill since safety is still assessed.
Phase III involves a much larger number of people, possibly hundreds. During this final phase, the drug will be assessed to determine if it has any true benefit. The patients’ progress is assessed at many different points throughout the trial and the value of the drug is determined. If the study is shown to be a success, even if it is only slight, the drug will be considered marketable and millions of dollars stand to be made.
As expected, there are laws regulating experimental drugs. The Food and Drug Administration (FDA) has a committee that helps set many of the limitations (called the Oncologic Drugs Advisory Committee). They allow experimental drugs to be administered to severely ill patients in some instances. Currently, if a patient is not eligible for a clinical trial with an experimental cancer drug, the patient may apply to get the drug by filing an individual IND application (investigational new drug). The application must be approved through the drug company and the FDA must agree that there is enough evidence to consider the drug is safe.
Unfortunately, less than a thousand patients a year get an individual IND. Drug makers do not commonly use what they call “compassionate use” programs like individual IND’s. There are many valid reasons for not wanting to distribute untested drugs, such as safety or the inability to make enough of the drug.
There have been instances where drug companies receive huge numbers of requests for their new drug. One company, Astra Zeneca Pharmaceuticals, developed a drug for non-small cell lung cancer named Iressa. They had thousands of people call begging for the Iressa trial. Due to limits with Iressa many patients were ultimately turned down and not included in the trial.
