Understanding Clinical Trials

By Abraham Safirstein

Clinical Trials:  Understanding In Vitro – In Vivo

Let’s analyze why most “promising” cancer drugs never make it into the big time.

The first stage in a drug development is to try it “In Vitro”, which means in the lab in a petri dish. They take several cancer cell lines and test them against the prospective drug, and Eureka! It kills the cancer cells like flies; the little unknown detail for the poor investors is that almost anything kills cancer cells in the petri dish. Vitamin C, Vitamin D, Curcumin, Tea Tree Oil, a hammer, you name it and it kills cancer cells in the lab. The problem is that in the petri dish the cancer cell is disarmed; it doesn’t have access to estrogen, ILGF, VEGF, NFKb, blood and the nutrients it carries. All it has is glucose, so we may get a hint that it might work but there is a long distance between that and killing cancer “in vivo”.

Then they do a xenograft in rats and do all kind of tests. It may work pretty nice, but that is just a step in the right direction. If it looks good, then they may start clinical trials, and that is when the big money has to come into play.

It is very interesting to me that when I check the charts of results published by the pharmaceutical companies, they almost never compare it with placebo, always with another drug, so it is almost impossible to find out what would happen if someone decided to do nothing. In any rate, in most cases the benefits portrayed in the charts are relatively small, and that, for a nominal increase in the median and total survival times.

One thing that strikes me is that there are not many new cancer drugs approved, and I mean NEW. There are some similar to existing ones that have a little change, enough to get a new patent to keep the cash flowing. It is a shame for the wasted money and the wasted patient’s hope, and not precisely in this order. I wish they would find a cure already after so much suffering.

If one is running out of options and is offered into a trial, it is important to understand what the different phases are. Phase I is to find out the level of toxicity, which means that at that point there is no way of knowing if it even works in humans.  Chemotherapy is no candy, and the toxicity involved can itself be lethal.  Unless really desperate, I would wait at least to enter in a phase II, where the “canaries in the mine” already tested toxicity and there might be at least some information of the level of safety and success. If anything, I would try to get into a phase III trial where there should already be more solid information on which to base my criteria if it is worth it.

I would be very careful to invest the time to thoroughly review the material pertaining to the trial to weigh the information with the aid of somebody that understands the jargon, to at least do my due diligence to avoid being misled.

Even though there are many studies that point to the fact that vitamins and antioxidants are beneficial for patients doing chemotherapy and/or radiation, many doctors that are running the trials reject the use of them for two primary reasons. First, most MDs receive little training in nutrition in medical school, so they feel uncomfortable to opine on it, and second, most chemo drugs and radiation are based in oxidation.  As I explain in another page, the term antioxidant misleads them into thinking that they will protect the cancer cells (like they do the healthy ones), so their procedures may be impaired and fail. The reality is the opposite, because antioxidants cause damage to cancer cells through a different pathway as it has been repeatedly proven.

Another twist is that their goal is to find out if the therapy works, and they don’t want people to have the opportunity to cure themselves by other means and distort the trial results.

There is another misleading aspect in the way clinical trial results are reported.  When they say a new drug has a 70% success it does not mean that 70% of patients get remission.  What it means is that there is a 70% improvement over the drug with which it is being compared.  If the median survival time (MST) for the older drug is 3 months, and the new drug’s is 5 months, 70% misleads you to think that 70% of patients survived, when in reality it means they survived 2 additional months.  And that may be still misleading because what they are writing about is MST, and it may well be that the total survival time is the same.

This gives us a better perspective of whether the toxicity involved in the newer drug merits trying it or if to look for something else that may offer a greater potential for a better outcome.

 

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