Are you suffering from cancer? Here's how to know when you should and should not consider experimental therapies

Note: Molecular biologist and author Jeff Stewart has worked as a consultant for drug companies for more than 15 years, reviewing data on new cancer treatments. Last July, the 50-year-old father of seven was diagnosed with stomach cancer himself. He spent most of the next 10 months undergoing treatment while also writing the recently published book Living: Inspiration from a Father with Cancer.

His book is a compilation of life lessons and reflections that "helped me get through tough times and avoid even tougher times," he says. The book is intended as a life guide for his children, but also contains insider tips for anyone facing a cancer diagnosis. The following excerpts have been edited for length and clarity. --Editorial

As a cancer patient, I get sent many, many articles about early stage cancer treatments and alternative therapies. I think every cancer patient receives these articles. Since I'm in the public eye with my cancer, I receive them not only from friends and relatives. I also receive them from people I've never met, but who are trying to help me.

Cancer treatment isn't just a personal matter. For more than 15 years, I've consulted with pharmaceutical companies, among others, on cancer drugs. My clients have included both large pharmaceutical companies and small biotechs. I'm sure you're familiar with the names of the big pharmaceutical companies. I've interviewed hundreds of oncologists over the years. Figuring out the scientific and commercial potential of a cancer drug is just a normal day at work for me.

How do you evaluate experimental treatments? Follow the evidence

Basic rule of cancer treatments: Gain evidence. We need evidence to believe something works. This is especially true for cancer.

Step one: Is the drug approved by the FDA?

Step two: If the drug is approved, is it also recommended in cancer guidelines? If the approved drug isn't in the cancer guidelines, health insurance companies won't pay.

Step three: if the drug is neither approved nor in the guidelines, is it in the final phase of clinical testing? That usually means phase III. If so, then a cancer patient may be able to participate. If the drug isn't in the late phase of clinical trials, it's too early to help most cancer patients.

Amazing results in a test tube? Talk to me in 15 years, if I'm still here then. Phase I clinical trials in humans have just begun? Still too early to help me. Cure mice? Of all the oncologists I've asked about mouse data, at least a quarter have told me this exact punch line: "I've never treated a mouse for cancer." Yikes, yikes. Funny oncologists. It's not just snarky. Underneath their tired joke is an argument. Most of the things that cure cancer in mice don't work in humans.

The author signs copies of his new book.

Franklin Knox / Jeff Stewart

/

Jeff Stewart

The author signs copies of his new book.

It's worse than you think. Nearly every new invention that comes out of a university is too early to help someone who now has cancer. Worse, almost everything fails. If that sounds trite, I'm sorry. This is the lived reality of oncologists.

Yes, there have been great advances in cancer treatment. The really promising drugs that can make a difference in the short term are already in late-stage clinical trials. Oncologists read. They know what's coming. Anything that is early stage won't and cannot cure someone who has cancer now. I think one of the worst jobs an oncologist has is to explain to a cancer patient why a miracle drug that is still in the early stages of development has no chance of curing them.

The hard truth: most experimental cancer treatments fail

Most people who don't work in oncology don't understand this. Even the most promising cancer drugs fail. Cancer drugs have the second worst failure rate of any disease. Only Alzheimer's is worse.

Just think of the tens of millions of dollars spent to get a cancer drug from the university, through cell lines and mice, to patients to be tested in clinical trials. That's an enormous amount of work. It could take a decade. Those drugs that are tested in humans have won the biotech lottery. For a cancer drug to be tested in humans, the science has to be amazing. The scientists working on the drug believe it'll work no matter what. They may be talking about a Nobel Prize or at least the Lasker Prize. Everything seems certain to succeed. What could go wrong?

Want to guess how many of these "sure winners" end up passing clinical trials? Seven percent. That's 7% of the best drugs that emerge from the best science and are so promising that a pharmaceutical company invests $10 million to more than $1 billion to test the drugs on patients. Ninety-three percent of "winners" fail.

What about reuse of approved drugs? Approved drugs can be used by physicians outside of their approval. What if a drug for parasites could cure cancer? Why shouldn't that be taken?

Again, the question is: Where is the evidence? Cancer drugs are special. State laws require insurance companies to pay for cancer drugs if independent cancer guidelines recommend using the drug. Even if the drug isn't FDA-approved to treat the cancer, they must pay for it as long as the drug is proven to be effective.