Coley's Toxins -Clinical Trials Fraud

this is quotable!!

Why Coleys Toxins has not been widely used despite it's results

Submitted by CancerHusband on Wed, 08/18/2010 - 14:26

Back in 2008, we asked our oncologist at Stanford University about immunotherapy. My wife had completed surgery, radiation and chemotherapy. Yet, despite having gone through all that, the odds of recurrence for Synovial Sarcoma are very high, at 50%. And upon recurrence, death almost always follows shortly. Hence, we were actively looking for anything else that could give us an edge.

Our former oncologist told us that sarcomas are not immunogenic. By this, she meant that all evidence indicates that sarcomas do not respond to modern immunotherapy. By then, I had already researched Coley's Toxins to a reasonable extent and read numerous case studies of large, bulky sarcomas, melting away completely and staying away for years. Thus, I was perplexed by the apparent discrepancy.

A common misconception

Our former oncologist explained that Coley's Toxins is one of the fringe alternative therapies that have no evidence of working for sarcomas. If I remember correctly, she said that Coleys has been tried only for lung cancer, and not for sarcomas -- and even so, there wasn't any real evidence that it worked (for lung cancer).

With all due respect, her view of Coley's was incompatible with what I had researched. William Coley, after all, was head of the bone sarcoma unit at the predecessor of Sloan Memorial Hospital in NYC. He treated mainly sarcoma patients with his toxins. This contradicted our the assertion that it had been tried for lung cancer but not sarcomas.

Furthermore, Coley observed that his toxins seemed to work better for sarcomas than carcinomas. Yet another contradiction to the statement that "sarcomas are not immunogenic". To be fair, the "sarcomas aren't immunogenic" statement applies to "modern" immunotherapy used from the 1970s, 80s and 90s. Indeed, these have not been very successful. In recent years, however, immunotherapy has been making a comeback. The news is now filled with companies announcing their cancer immunotherapy products ad trials.

It would seem that our former oncologist (along with many other doctors) was not aware of the rich and extensive history behind Coley's Toxins, dating further back to the early 1890s -- a history that may yield hope and promise for some cancer patients.

Failure by our FDA. The American Cancer Society blacklist.

In fact, Coley's Toxins was used by many physicians in the US since William Coley's time until the 1950s . The critical turning point came in 1963 when the FDA ruled Coley's treatment a "new drug" and therefore made it illegal to administer in the US. The FDA refused to grandfather Coley's toxins into existing practice, as it did with aspirin and other long established products. By this time, Coley's Toxins had already been used in the US for a whopping 70 years!

The net result was a severe blow to cancer patients. Oncologists trained after 1963 eventually never heard about Coleys Toxins. This was further compounded by the American Cancer Society's absurd claim that Coley's Toxins was mere quack therapy. The ACS blacklisted it along with other alternative cancer treatments, thus dooming it into "quack-therapy land" for decades. It was only in the 90s, that the ACS finally withdrew Coley's from their blacklist -- thanks to the efforts of Dr. Lloyd Old and Helen Coley Nauts.

For some, it wouldn't be too far fetched a leap to imagine that the pharmaceutical industry lobbyists may have been responsible behind the ACS' push to suppress alternative treatments - treatments that may divert patients away from lucrative chemotherapeutic drugs. But again, this is all supposition that's impossible to prove.

This brings me to another important point why Coley's virtually disappeared and may never, ever make it back to mainstream medicine. According to this academic analysis, it takes $802 million to bring a new drug to market .

The FDA rules have GOT to change

As it stands, any drug that cannot earn a minimum of $802 million will probably not make it through FDA trials.

In order to pass the FDA trial process, the drug needs to be tested in a well controlled setting via clinical trials. While this sounds good and in the interest of the consumer, in practice, it takes LOTS of money. A friend of ours explained her perspective on this issue.

This friend works for a company that runs clinical trials for the likes of big pharmaceuticals such as Pfizer, Johnson and Johnson etc. She told us that some doctors love to run clinical trials for the money - lots of it! For example, for each patient recruited to a trial, the doctor may receive $5000 to $10,000. That's what they may receive for recruiting the patient. On top of that, whenever the patient returns to the doctor for periodic evaluation, more money is paid.

You can imagine then, if a physician is able to recruit 100s of patients, there's the potential to make serious money for that one trial. And that's only one trial site. Most trials have multiple trial sites. All this money comes from the drug company trying to get their drug approved.

Assuming all this is true, and that our friend is not misrepresenting the facts, it discourages me to think that money is the reason why something like Coley's will probably NEVER make it past the FDA clinical trial process - unless a large pharmaceutical company finds it profitable to market.

It doesn't matter if Coley's Toxins has shown compelling evidence of achieving significantly better results compared to conventional chemotherapy or radiation. It doesn't matter if it's the only modality that offers any credible evidence of being able to cause large, widespread sarcomas to melt away (and stay away), with no indication of long term toxicity. It doesn't matter if 8 out of 19 advanced stage breast cancer patients resistant to conventional treatment achieved full and complete regression of their cancers.

If it cannot be patented or protected (intellectually) to earn back more than $802 million, it ain't going to get through the FDA trial process.

That's the bottom line. Discouraging isn't it? In it's enthusiasm to protect consumers, the FDA has essentially excluded any drug or treatment that's too cheap to make . Again, a cynic might say that this dynamic has been deliberately put in place by drug companies as a protective moat around their development process.

Has modern oncology failed us?

Even more frustrating is the failure by modern oncology to see beyond these restrictive dynamics. In our personal experience, all the oncologists we have personally encountered have been extremely caring individuals. We believe they have meant only the best for my wife, and always operated in her best interest. Yet, for a disease that holds no definite cure (and one where there is often subjectivity in determining the best treatment plan) -- caring and operating in best interest is not enough. It behooves oncology to go the extra mile and step outside the box.

Consider that the "box" is essentially defined by the FDA, which in turn, is defined by financial dynamics that preclude unpatentable drugs. Failing to explore outside the box is a fatal flaw that will divert attention towards managing details (such as minimizing toxicity, balancing side effects with quality of life). This, in turn, leads to missing the big picture -- that is, adopting a whole different approach to that may offer significant benefit - or perhaps even a cure.

For many of us cancer patients, the odds are simply too high. We cannot afford to merely follow the official treatment guidelines. Following those guidelines are undoubtedly the right thing to do for a great many cases. However, there are many other cases where they are insufficient. They may be safe and convenient. But they may not be the best thing to do for the patient. When there is enough evidence that an unapproved treatment modality may offer serious benefit to a cancer patient whose prognosis is grim, isn't it then unthinkable NOT to pursue or at least investigate that modality to the utmost?

It simply isn't good enough to say "let's wait for the clinical trial process to weed out what works". Again, what if something like Coley's Toxins really does work much better than chemo (for certain cases). And yet, it will never make it through the trial process because of financial reasons?

From a moral standpoint, it simply is not right to fall behind official guidelines and wait for someone "else" to prove it. If William Coley hadn't gone scouring the tenements to track down Fred Stein, but rather, remained satisfied to stay within the four walls of his surgical ward to treat patients coming to him, the world would never have benefited from his discoveries.

Will any physician or oncologist go that far for their patient today? Will you not take up the challenge, make that mental leap beyond official treatment guidelines, and evaluate the evidence for yourself (rather than relying on potentially flawed meta-analyses)? What if infusing the patient with something so safe that it has no evidence of any long term toxicity can cure - yes CURE - your patient of cancer when nothing else works? Should you not at least take a long, hard look at it?