The Problems with the Cancer Trials
Cancer cell
The controlled trials have been considered essential for proving the value of a certain medication, before they are released on the market. However, what many do not know is that in order to be able to save lives through the medications, the control trial can destroy lives.
Such is the case of Thomas McLaughlin, and Brandon Ryan, two cousins who have been identified with melanoma, which is a lethal type of skin cancer. One month before the discovery, a new drug has been created, and the drug had the capacity of stopping the disease. Both of them had the same type of tumor, which had very high chances of responding to the treatment. University of California, Los Angeles, and many other large cancer centers from the country enrolled patients for the last test which would allow the drug to be placed on the market.
This is where things start to get complicated. McLaughlin received the drug, and the effect of it was visible soon afterwards. The tumor stopped growing very soon after the drug was administered. Brandon Ryan was accepted into the trial in May but he wasn’t as lucky as his cousin. The computer lottery which chooses in what category the participants to the trial would be included chose Ryan to the control group. The control group receives the same chemotherapy drug that all the cancer patients have received in the last 30 years, and which is known for the fact that it is ineffective. It was a known fact that the chemotherapy would not be effective, but even so, he had to remain in that group, as he was not allowed to change the group in order not to change the results of the tests.
The drug which has been used in the tests for all these years is called PLX4032, and many oncologists are against it. Many of them have said that the drug should not be used since it is known that it can not help the patient. However there have been many people who have said that the control drug is essential in order to prove that the new drugs are effective. In the case of the melanoma, no drug which has provided great results in the trials has been effective later when it was released on the market. Dr. Paul B. Chapman, a medical oncologist at Memorial Sloan-Kettering Cancer Center, says that he believes that his task is to prove that the drug is effective, and that the drug can really help the people in the long run.
The main issue and the main concern of so many people is the approach which these doctors take. They say that they want to prove that the medications are effective in comparison to other drugs, but when it is a known fact that the other drug is not effective, and then what is the point? Why would they deliberately allow the death of so many patients by denying them the drug which could save them, or which could relieve them of some pain, or prolong them their lives? Dr. Charles L. Sawyers, chairman of human oncology at Sloan-Kettering believes that doctors such as B. Chapman are not actually helping the people, because they allow them to receive chemotherapy which is very harsh for the body. On top of that, he sustains the opinion of the majority which says that by not allowing all the patients from the trial to receive the new drug is a very bad thing.
He believes that the system needs to change, and so does Dr. Richard Pazdur, director of the cancer drug office at the Food and Drug Administration. Dr. Pazdur believes that the system should be based on measuring the progress of each individual, and in that case, the controlled drug would not have to be used. The main problem is that the patients depend on a roll of the dice, on a computer which chooses between possible life and death. It really is a game of luck for them, and things should not be like that. In the case of Thomas McLaughlin, the tumor he had under his left armpit started to grow again. The group which he belonged to, consisted of 31 other patients and all of their tumors shrank in the initial phase.
However, after less than one year, the tumor started to grow again, but even so, The New England Journal of Medicine, called the drug a huge success especially since these people had advanced melanoma, which in most of the cases means eight months survivability after the disease has been identified. The second trial was in the works, and the F.D.A received letters from many oncologists which pleaded them to approve the drug faster. However, the situation was not very simple, because very few people would have joined the trials if the drug would have been on sale. “It would not make sense to join a trial where you have 50/50 chances of receiving the drug when you can just buy it” said one cancer patient, who decided to remain anonymous.
Dr. Keith Flaherty, who is an oncologist at the Massachusetts General Hospital, stated that the drug should be already on the market because all the essential information about it has been gathered. He was one of the doctors who led the initial testing. He said that there is no point in giving the patients an ineffective drug, such as the one used for trial, and he said that he will never participate in such a trial ever again. The new trial will cost $100 million and it will delay the approval from the F.D.A by two more years. Many of the doctors see this as pointless. The doctors have stated that even if the drug proves to be ineffective when it comes to prolonging someone’s life, at least it is still useful because it can help that person lead a better life for 6 or 8 months. It is unknown how the situation will be solved.
