http://www. impactlab. com/2007/01/31/cure-for-cancer-found-but-no-one-is-talking/)
A $2 per serving cancer cure has been found by Researchers at the University of Alberta in Edmonton, Canada yet most of the media world is silent.. Since this is not a patentable drug from a major drug company with little profit potential, it has received very little coverage.
Scientists may have cured cancer last week. So, why haven’t the media picked up on it?
Here’s the deal. Researchers at the University of Alberta in Edmonton, Canada found a cheap and easy to produce drug that kills almost all cancers. The drug is dichloroacetate, and since it is already used to treat metabolic disorders, we know it should be no problem to use it for other purposes.
Doesn’t this sound like the kind of news you see on the front page of every paper?
The drug also has no patent, which means it could be produced for bargain basement prices in comparison to what drug companies research and develop.
Scientists tested DCA on human cells cultured outside the body where it killed lung, breast and brain cancer cells, but left healthy cells alone. Rats plump with tumors shrank when they were fed water supplemented with DCA.
Again, this seems like it should be at the top of the nightly news, right?
Cancer cells don’t use the little power stations found in most human cells - the mitochondria. Instead, they use glycolysis, which is less effective and more wasteful.
Doctors have long believed the reason for this is because the mitochondria were damaged somehow. But, it turns out the mitochondria were just dormant, and DCA starts them back up again.
The side effect of this is it also reactivates a process called apoptosis. You see, mitochondria contain an all-too-important self-destruct button that can’t be pressed in cancer cells. Without it, tumors grow larger as cells refuse to be extinguished. Fully functioning mitochondria, thanks to DCA, can once again die.
With glycolysis turned off, the body produces less lactic acid, so the bad tissue around cancer cells doesn’t break down and seed new tumors.
Here’s the big catch. Pharmaceutical companies probably won’t invest in research into DCA because they won’t profit from it. It’s easy to make, unpatented and could be added to drinking water. Imagine, Gatorade with cancer control.
So, the groundwork will have to be done at universities and independently funded laboratories. But, how are they supposed to drum up support if the media aren’t even talking about it?
Pretty crazy huh? Well after reading/watching this I really felt like I had to respond. Being in the pharmaceutical industry I feel like I have a pretty good grasp of the rocky landscape that exists for pharmaceutical companies that engage in the development of potential therapeutics. From the competitive pressures facing pharmaceutical companies, to the regulatory requirements/hurdles, to the ethical dilemmas executives have to face, to the political influence on pharmaceutical companies and the healthcare market, exists a lot of complexity that the general public is just unware of. The good and bad, the rhytme or reason, is irrelevant when looking the industry. The key point I am trying to make, is that it is the reality of our current system.
So, at face value how do you interpret a report that says a University has discovered a potential cure for cancer, but pharmaceutical companies are ignoring it because there is no “value” in it for them. Well, my first question is this. Do you really believe everything you hear and read from our vast, independent, quality and truth seeking media conglomerates? Last night I was watching a presidential roast with Barak Obama and John McCain and Obama even jabbed at the media for their “non-partisan, fact-finding, unbiased” journalistic stands (well, not quite as loquacious and direct as that, but it is clear that our major media outlets hardly consistently practice independent journalism). This reminds me of a nice analogy to the practice of sales and advertising. A sales professor of mine once said of the advertising executives, “advertising executives know that at least 20% of their advertising dollars are effective, the challenge though is figuring out which 20%”. I think that is a fair comparison to the mainstream media. I am sure greater than 20% of their reporting is fair and independent, but which 20%?
So when the media reports that a potential cure for cancer has been developed, but pharmaceutical companies are ignoring it, what do you really think? Well let me share another nugget with you. About 3 ½ years ago there was a news report of a San Diego-based biotechnology company that had developed a novel vaccine that had an efficacy rate of nearly 100% against the H5N1 flu strand in studies in mice. At the time the avian flu was broadcasted as the one the most dangerous potential pandemics that the world had to prepare for. Companies all over were flooding resources into potential vaccines and this San Diego based company had developed a vaccine that was nearly 100% effective in animal studies. Well, 3.5 years later there is little mention of this potential therapy and the companies stock price is hovering just about $1/share. The point is that companies all over are always researching and developing products that appear in the early stages to be potentially revolutionary therapies, however, the reality of it is that most of them end up failing. And they fail for all sorts of reason. Animal are not humans, although physiological similarities exists that prove beneficial in helping determine potential therapeutic viability, they are not the same, and often times what worked in an animal doesn’t work in a human. Safety profiles of potential therapeutics may demonstrate that in humans the required dosage for efficacy can be potentially toxic. Novel molecules can have unknown long-term side effects that have to be determined. There can be unknown pharmacological interactions between potential therapeutics. There may not be a suitable “delivery vehicle” for the product, which would require extensive development of a suitable formulation, which adds more risk and more cost.
But this news report said that this potential cancer cure is based on an existing compound, DCA, that is a chemical that is available commercially and has been used in small cases in different medical settings. I say so what. What does this mean? If the media started reporting that there was a discovery that the active ingredient in Drano cured herpes, but no pharmaceutical company would develop it because it wasn’t cost-effective, would you go and starting drinking Drano? Granted those inflicted with cancer obviously have a different perspective as they are fighting for their lives and is hardly something that should trivialized with my poor analogy; however, the point is discovering a potential therapeutic to actually properly developing a safe, deliverable and effective therapeutic is not a straight line connecting two dots. This was once the belief in the early in the 1900’s.
In 1906 consumer watchdog groups, journalist and government officials pressed for the stricter regulation on food and drug products. This resulted in the formation of the Food and Drug Administration, however, was still felt by many as inadequate. It wasn’t until 1937 that the need for strict regulation was realized. In 1937 a pharmaceutical company created a product called “Elixir Sulfanilamide”, which was comprised of a toxic ingredient called DEG. This product was essentially a flavored concoction of DEG and since no preclinical or animal studies were required, was distributed to thousands of people. However, after over 100 people died taking this “Elixir” an investigation was triggered, which then discovered that the product was essentially a poison to humans. This incident spurned the 1938 Food, Drug and Cosmetic Act, and several amendments of it have resulted in the complex, expensive and challenging regulatory pathway pharmaceutical products must undergo.
Rewatch the video clip and listen as this outraged reporter keeps talking over the research that made this discovery telling him that the findings need to be taken with a grain a salt. However, that is irrelevant to the reporter. This is a classic example of how the media loves to sensationalize their stories. Let me throw out a few things that could likely happen if in fact there was true demonstrated evidence that this was a safe and effective cure for cancer.
1) A pharmaceutical company could actually be altruistic and choose to develop this product and potentially lose millions of dollars. However, I would argue that the PR alone for a company that says they have developed a cure for cancer would surely outweigh any development costs and generic competition losses they would face.
2) The Federal Government would subsidize the further development of this product with a pharmaceutical company and grant exclusitivity rights to ensure the company could make some sort of profit. Don’t believe this could happen? Read about the Hatch-Waxman Act, which pertains to generics. This would be done. (http://en.wikipedia.org/wiki/Drug_Price_Competition_and_Patent_Term_Restoration_Act
3) The Federal Government would allow a pharmaceutical company to file this product under Orphan Drug status. In a nutshell, granting a drug Orphan Drug status fast tracks them through the FDA regulatory pathway and also provides a period of market exclusitivity. This was designed to address situations such as this one. Orphan Drug status is granted for drugs that offer potentially promising therapeutic advantages, but for diseases with a very limited market. It is designed to encourage companies to develop products in markets that would normally cost more to develop in than they would ever make-up in revenue.
4) A pharmaceutical company or foreign government would take this discovery outside to a country or region with less rigid and less expensive regulatory requirements and prove its efficacy in markets outside the U.S. If it really was the miracle drug that it was, the hurdles for approval in the US would drop and approval would likely then be sought from the FDA. Some companies already do this. There is a San Diego-based company called Artes, that recently won FDA approval for a Botox substitute that they claim is superior to Botox and actually continues to get better and better over time once injected. However, instead of tackling the US market first they first got it approved in various European countries. Being a cosmetic treatment it would not be covered under socialized healthcare plans that most European countries have that fixed prices to levels that make it almost unprofitable market products in those countries. However, as a cosmetic treatment they would have a very different market and could charge a premium. Coupled with the simpler regulatory requirements they could make a return much faster that first coming to the US.
The reality of this is that none of these options will likely happen because there is no certainty that this discovery will actually work once it goes through the clinical trials that all drugs have to go through. Sampling of animal data and some human data is hardly proof enough, especially when there are likely several other products that companies are working on that have similar results. You ask yourself, how often do discoveries such as this happen. How often to companies, universities or centers of research make discoveries that could be revolutionary?
Let me try and put this in perspective for everyone. I have worked for four pharmaceutical companies in my years in the industry. At each of these companies, products were and have been discovered that could potentially be revolutionary.
My first company had developed a purely synthetic blood substitute. It was amazing, because the safety data was spectacular; it could act as an oxygen carrier with 8x the oxygen carry capacity of hemoglobin, and was universally compatible with any blood type. Well 12 years and $500 million later the product failed during Phase III clinical trials due to an unexplainable number of patient deaths vs. the control group. My third company had been developing therapeutics based on DNA plasmids. A technology now so simple you could develop a “drug” in a matter of weeks once the DNA sequence was identified for the molecule responsible for triggering the therapeutic response. This technology was applied to a wide array of disease targets including, HIV, flu, cancer and heart disease. This is in fact the company that I referenced earlier that potentially found a vaccine for the H5N1 flu virus. Despite being a promising technology, even 3 years since my departure, the company is still trying to find traction and prove their technology. Lastly, my current company, Amylin Pharmaceuticals recently (about a year ago) presented animal data that examined a triple hormone cocktail for the treatment of obesity. In this presentation, animal data was presented demonstrating incredible results in the weight loss of rats that were injected with this cocktail. Obese rats would have drops of 25% in body weight with 0% muscle loss and 100% fat loss. This was incredible data that no other current treatment could compete with, not even gastric bypass surgery. One year later I have not heard any news on its product. But this does not surprise the company, the investors, or me because we know there are still so many unknowns and hurdles that have to be addressed before any viable product is actually developed. This is part of the reason why drugs take 7-12 years from discovery to regulatory approval. And those are for the drugs that make it. Amylin’s first product discovered was Symlin and Symlin took 18 years from discovery to market approval. And don’t forget that for every drug approved and on the market there was probably hundreds more that were at one point thought to be potential product, but never made it.
So I think it is important that we listen to these kind of news reports with a bit of skepticism and be leery of the sensationalism of media. The media is a multi-billion dollar profit driven industry that like any other industry is trying to make money and often times at the expense of their moral and ethical obligations. Ratings rule their world and controversy drives these ratings. However, despite this, an important point was still brought up, but just under a context that, although plausible, is unlikely in this scenario. The concern that he brought up is a very real concern in that, what happens when business takes precedence over the ethics of saving lives? What happens if a potential treatment just would not be profitable because the market is too small or there is no IP available to block competition and inflate prices to ensure a profit? This leads me to submit that there is an inherent flaw in the system of how drugs are developed. A system designed to protect that consumers has been infiltrated by capitalism and politics…but I will save that for another day…
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2 comments:
I've gotten in virtually this same discussion with folks over the past couple years. And I think it was over this same data even, or something very similar.
I couldn't agree more. People accuse biotech of being heartless without knowing how the business model functions. Putting research into an unpatentable technology is suicide. Morality or no morality, it just doesn't work.
I feel like in these cases, where there is a moral imperative but no profit margin due to patents, the money should come from the government, and if the public outrage towards this sort of thing were pointed in that direction, it would (not that it doesn't in a lot of cases already I suppose). But there is a vast ignorance about the whole process, and it's easier to blame the fat cats charging an arm and a leg for drugs instead of tracking the source of the problem.
Forced morality through government investment...similar to how they handle the environment (no company will become green unless it's cost effective, which usually is provided through tax breaks).
Let's quit our jobs and become lobbyists. Actually, you'd be good at that, I'd be shit. I'll take pictures of you lobbying, how about that?
Man, pharma is even more complicated than the energy industry. Thanks for the comparison by the way, I was already drawing comparisons.
This begs the question, how would and effective and ethical pharmaceutical industry be run? It seems that you need the competition of a capitalist approach in order to cast the wide net of science in order to find those small percentages of drugs that actually do work. A purely government run program would perhaps be too focused. However there does need to be some incentive for drugs that don't have a potentially huge market or low profit potential due to IP. This ties also to the lack of investment in drugs for diseases that affect mostly the poorest of our human race such as malaria.
Perhaps an Cancer X prize would be in order. Find the cure for cancer and we'll give you $1 billion dollars and more importantly, lots of prestige. I'm sure something like this exists. Also, I think the types of drugs funded by the government should be carefully examined. You mentioned the drug for obesity. It seems that taxpayer money going toward this issue would be far better spent on the prevention end from nutrition courses in school to building walking cities to get people out of their cars.
Well I'm not sure I'm getting to a cohesive point here so I'll stop now. An interesting conundrum for sure.
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