Cheap Cancer Drug Finally Tested In Humans 363
John Bayko writes "Mentioned on Slashdot a couple of years ago, the drug dichloroacetate (DCA) has finally finished its first clinical trial against brain tumors in humans. Drug companies weren't willing to test a drug they could not patent, so money was raised in the community through donations, auctions, and finally government support, but the study was still limited to five patients. It showed extremely positive results in four of them. This episode raises the question of what happens to all the money donated to Canadian and other cancer societies, and especially the billions spent buying merchandise with little pink ribbons on it, if not to actual cancer research like this."
Re:Spelling. (Score:3, Informative)
No, it works on all cancer patients who spell properly.
where does it go? (Score:5, Informative)
>> It also raises the question of where all the money donated to Canadian and other cancer societies, and especially the billions spent buying merchandise with little pink ribbons on it goes, if not to actual cancer research like this."
Answer:
http://www.preventcancer.com/losing/acs/wealthiest_links.htm [preventcancer.com]
A much better page on Science Daily... (Score:5, Informative)
http://www.sciencedaily.com/releases/2010/05/100512141909.htm
Generic Drug May Be Potential Treatment for Deadly Brain Cancer
ScienceDaily (May 13, 2010) — Medical researchers at the University of Alberta have reported evidence that the orphan generic drug dichloroacetate (DCA) may hold promise as potential therapy for perhaps the deadliest of all human cancers: a form of brain cancer called glioblastoma.
The report is published at the journal Science Translational Medicine, a journal of the American Association of the Advancement of Science.
In 2007 the U of A team led by Dr. Evangelos Michelakis, published evidence that DCA reverses cancer growth in non-human models and test tubes. The team showed then that DCA achieves these antitumor effects by altering the metabolism of cancer. By altering the way cancer handles its nutrient fuels, specifically the sugars, DCA was able to take away cancer's most important strength, the resistance to death. Since then, several independent groups across the world have confirmed the Alberta team's findings. In December 2009, the editors of "Science" predicted that cancer metabolism is one of only 5 areas across all scientific disciplines, to "watch for major breakthroughs" in 2010.
The U of A team set out to show that the way that DCA works in actual patients is the same with the way it works in the lab. In addition, researchers wanted to show whether DCA is safe and possibly effective in very sick patients with brain cancer.
By extracting glioblastomas from 49 patients over a period of 2 years and studying them within minutes of removal in the operating room, the team showed that tumors respond to DCA by changing their metabolism. Then, the team treated 5 patients with advanced glioblastoma and secured tumor tissues before and after the DCA therapy. By comparing the two, the team showed that DCA works in these tumors exactly as was predicted by test tube experiments. This is very important because often the results in non-human models tested in the lab do not agree with the results in patients. In addition, the team showed that DCA has anti-cancer effects by altering the metabolism of glioblastoma cancer stem cells, the cells thought responsible for the recurrences of cancer.
In the 5 patients tested, the drug took 3 months to reach blood levels high enough to alter the tumor's metabolism. At those levels, there were no significant adverse effects. However, at some of the higher doses tested, DCA caused nerve malfunction, i.e. numbing of toes and fingers. Importantly, in some patients there was also evidence for clinical benefit, with the tumors either regressing in size or not growing further during the 18 month study.
No conclusions can be made on whether the drug is safe or effective in patients with this form of brain cancer, due to the limited number of patients tested by the study's leads Drs Michelakis and Petruk. Researchers emphasize that use of DCA by patients or physicians, supplied from for-profit sources or without close clinical observation by experienced medical teams in the setting of research trials, is not only inappropriate but may also be dangerous. The U of A results are encouraging and support the need for larger clinical trials with DCA. This work is also one of the first in humans to support the emerging idea that altering the metabolism of tumors is a new direction in the treatment of cancer, Michelakis and Petruk said.
The research team hopes to secure additional funding to continue the ongoing trials with DCA at the University of Alberta. Further studies would include more patients with brain cancer, and test the combination of DCA and standard chemotherapies, eventually including patients from other academic health sciences centres.
One of the intriguing features of this work was that it was funded largely by public donations, including philanthropic foundations and individuals. In addition, it received strong support by Alberta public institutions, both the University of Alberta and Alber
Re:Where the money goes (Score:5, Informative)
Notice, though, that the March of Dimes didn't try to block the Polio vaccine, or lobby against it in any way.
Instead, they switched to other things to wipe out, and have apparently made great progress on all sorts of various birth defects now...
Re:Cure? (Score:5, Informative)
Well, I've been cured of cancer twice. Three times if you count the relapse.
Here are the drugs I took
http://en.wikipedia.org/wiki/Asparaginase [wikipedia.org]
http://en.wikipedia.org/wiki/Mercaptopurine [wikipedia.org]
http://en.wikipedia.org/wiki/Methotrexate [wikipedia.org]
http://en.wikipedia.org/wiki/Vincristine [wikipedia.org]
http://en.wikipedia.org/wiki/Prednisolone [wikipedia.org]
So yea, the drug companies actually cured me.
Re:Cure? (Score:5, Informative)
There is no profit in cures, just treat the symptoms and make them dependent on you.
You're missing the author's point. Your two combined statements would read as:
There is no profit in cures, except wherein the condition would result in the death of the patient.
Dead patient means no more profit. Yeah?
Re:Where the money goes (Score:5, Informative)
More like curing cancer would put the charities out of business. It's like the March of Dimes. They're goal was to wipe out Polio. When that happen, they didn't exactly fold the tents and go home.
So... you mean it's like the opposite of the March of Dimes.
Great example.
Re:Penn and Teller talked about this on "Bullsh*t" (Score:5, Informative)
Money spent on e.g. breast cancer awareness goes towards raising awareness of breast cancer, not to finding a cure or even a treatment. It's the same with every other X cancer awareness non-profit charitable organization.
Also, the amount of money for awareness isn't very large compared to the amount of money required to do human-based research. My small research lab has a relatively modest budget of USD 250k per year (*thank* *you*, NIH, and *thank* *you* to all you taxpayers out there). The total cost my institution will bill the government for my lab over the five years of the grant I have is about $2.25 million, including overhead. Now a couple of million dollars is a gob-smacking amount of money by most individual people's scales, but it's just one small biology lab. We're working with test-tubes, not humans ... at least not yet.
A hoo-ha-break-out-the-champagne fund raiser would net $1 million. That's a fantastically successful fund raiser. But it would only run my lab for about two years. If I wanted to do a Phase-I clinical trial, it would take two-to-three times that amount of money. Phase-II would be about ten times that. Phase-III is not something that could be done at my home institution alone.
So public-based fund raising for breast cancer, autism, kidney disease, coronary disease, glaucoma, what-have-you, is wonderful. But it's on the wrong scale to fund research or human drug testing. I'm deeply impressed that anyone was able to raise enough money for an independent drug trial.
Re:Cure? (Score:5, Informative)
Let's look at a case study.
There was a time when the most profitable drugs were anti-ulcer medicines. Surgeries for fixing ulcers were also big money-makers and they even developed rubber patches for peoples' stomachs to repair ulcers that didn't respond to the medicines.
Some (publicly-funded) research found that ulcers were actually caused by bacteria not stomach acid, and could be cured with an extremely cheap course of ant-biotics. The drug companies had done some basic research on this and did not publish. There was more than half a decade when drug companies knew that cheap antibiotics could cure ulcers but did nothing about it. It finally took government-funded researchers to publish and within half a year, the anti-ulcer drugs fell off the top ten, and even the top 100 of prescribed drugs.
During the time when it was known that ulcers could be cured with antibiotics, drug companies spent millions of dollars on marketing the anti-ulcer drugs to doctors, even convincing them that these drugs should be used to prevent ulcers in patients that had no symptoms. Since calcium phosphate was one of the ingredients of some of these drugs, they were pushed for osteoporosis therapy for women, even though simple calcium supplements cost pennies by comparison.
Do drug companies put profits ahead of patients? Undoubtedly. It's what happens when the ownership of a company is no longer the person who's name is on the sign, but equity owners who see their ownership in the company as a simple investment, and don't care at all about what the company does or how it does it, as long as the stock price rises. The desire for profit becomes a much stronger force than the desire to do the right thing, because corporations are not people, and will never care about the "right thing". This is the disconnect that gives the lie to any "free market" benefit to society.
If I'm the owner of the Pope Ratzo Cabinet Company, I care about the satisfaction of the customers who buy my cabinets. Along with the desire to profit is a natural desire to be known as the guy who makes the best cabinets. When I sell the company to a conglomerate, there is no longer a connection of reputation, or even the raw peer pressure I would feel if the lead paint on my cabinets were to harm someone. Now the investors are the owners, and they don't know squat about cabinets. They just know profits. Add "tort reform" and "liability limits" and suddenly there's no downside if people get hurt because the company does something wrong. It's just added to the cost of doing business.
Acquisition and consolidation creates fewer competitors. Globalization grows the scope of the remaining companies until the cost to get into the business to compete becomes so great that it's impossible for new competitors to come from anywhere but venture capital, where the "name on the sign" is pushed out of the way as quickly as possible. No responsibility, no accountability in the marketplace, since customers don't really have many options to find a competitor.
What was the last time a doctor prescribed or recommended aspirin, which is far superior to any of the more expensive "anti-inflammatory" medicines which are used for arthritis, pain, etc? I can buy aspirin, a wonderdrug, safe and effective (even perhaps beneficial) for $1.99 for a bottle of 500.
Re:Where else (Score:5, Informative)
My baby brother has autism, he's 18 and operates at a 12 year old level. He's not stupid, but he is definitely developmentally retarded.
Seriously, if you don't think that autism is a retardation then there is something really wrong with your world view.
Heck, just look up the words.
Autism == a disorder of neural development characterized by impaired social interaction and communication, and by restricted and repetitive behavior.
Impair == make worse or less effective
Restrict == restrain within bounds; to limit; to confine;
Restrain == to close within bounds, limit or hold back from movement;
Retard == cause to move more slowly or operate at a slower rate
Quit trying to convince yourself that it's not as bad as it is. Accept that it's bad, and then fix it.
Denial on your part just limits the possible solutions that you will aloow him to enjoy.
Too little, too late... (Score:4, Informative)
My wife died of a GBM (glioblastoma multiforme) in Jan 2006, 7 weeks after diagnosis - sigh. We were together for 20 years; I had hoped for many more.
By-the-way, the cutting-edge drug for this is Temodar [wikipedia.org] at a list price of $11,000 / month (for several months), but co-pay w/insurance: BCBS: 10%, Optima: $40 - go figure.
Re:where does it go? (Score:5, Informative)
That article is a bit sketchy, and way out of date. Take a look at this instead: Charity Navigator on the American Cancer Society [charitynavigator.org]
I trust Charity Navigator a lot more than thus guy. His site looks like a non-profit organization, but it seems to be just one guy looking for a way to sell his own books. All the publications [preventcancer.com] on the site are written by this one guy, Samuel Epstein. [preventcancer.com] He criticizes the ACS, but his nonprofit isn't even listed on Charity Navigator.
in 1988 the ACS held a fund balance of over $400 million...Of that money, the ACS spent only $90 million— 26 percent of its budget— on medical research and programs
That was 22 years ago! Based on Charity Navigator, they spent 6.9% on administrative expenses, and 72.8% on programs. The names he mentions in his article aren't current.
It was probably a good criticism in it's time, and it appears that the ACS has reformed -- perhaps as a result of the article.
There's no one cure for cancer. (Score:4, Informative)
The current means of "curing" cancer is to poison the cells that have cancer, which sometimes mean poisoning all of your cells and hoping the ones with cancer are more susceptible to the poison. If they die before you do, you are cured. If not, well, then you "died of cancer".
The actual cure for cancer would involve making the damaged DNA not be damaged any more. But it's not just the DNA, it's also the biological nanomachines that replicate and repair the DNA.
Personally I don't think it's impossible. But the difference between the current medicine and that kind of medicine is like the difference between splashing a bucket of paint on a wall and rendering Avatar in real-time.
We are as da Vinci in the middle ages, all imagination and no concept of technology, drawing pictures of flying machines made of sticks and sack-cloth with all the aerodynamic efficiency of a mid-air collision. The real things may be centuries off. Or maybe decades, if technology has taught us anything about accelerating technological change, and if greed hasn't so crippled the medical-research industry that it prefers maximizing long-term profit from poison to actually finding a cure.
Re:Where else (Score:3, Informative)
Let me try this again, since you obviously misread something in my post as "autism is mental retardation":
1. Autism is often linked with mental retardation. Moreover, depending on your area, autism may be classed as a form of retardation (a very general term!), or classed as whatever the current politically correct term for "retardation" is;
2. Autism describes a problem with mental ability just as retardation describes a problem with mental ability. Prejudice against the "retarded" is as bad as prejudiced against the autistic.
Re:Cure? (Score:3, Informative)
For someone so stuffed full of himself, you don't read very well do you?
Where did *I* say they don't want a cure? I said they don't want a cheap generic cure (as in something already approved for use in humans that is already made generically), they want an expensive patented one.
How's that for a fact dumb ass? (you started it :-)
Re:Cure? (Score:5, Informative)
This is the best I can do with short notice [wikipedia.org]
Note especially the timeline at the bottom of the article.
By "medical establishment" they mean "the pharmaceutical industry".
Here is what happened in 1984:
It was demonstrated that penicillin could cure ulcers as early as 1955, but it wasn't until 1994 when the patents ran out for the anti-ulcer drugs that "the medical establishment" started to pay attention to the fact that H. pylori infection was the cause of ulcers, not stress or spicy food.
Note that Warren and Marshall's research is fully funded by The National Health and Medical Research Council of Australia. In other words, "the government". Not the free market. Not the pharmaceutical industry. The Government.
In 2005, Warren and Marshall win the Nobel Prize in Medicine.
Re:Penn and Teller talked about this on "Bullsh*t" (Score:3, Informative)
It's inefficient because of how hard it is to find patients suitable for a clinical trial. Good science requires isolating variables. A hypothetical hospital may have a hundred cancer patients. Half of them are long-term smokers, but the drug is known (through test-tube experiments) to interact with the residual pollutants, so they're out of the trial. Of the remaining fifty, ten have been known to be unreliable with their medications.They're out, too. Of the forty left, thirty have the wrong kind of cancer. Only ten are left, and five of them are using other drugs that work with the same chemical as this drug, so (possibly fatal) interactions are likely. Three more have various outside-the-hospital factors that affect their ability to participate (they live next to a Superfund site, have a highly stressful life, etc). That leaves only two individuals that appear to be useful for the trial at this hospital.
If the trial needs more than those two people, the whole process has to be repeated at another hospital. When you include factors such as the cost of lawyers (to verify that personal information stays personal), plane tickets (to make those all-important face-to-face meetings), review board meetings (to ensure that the trial is actually going to be useful before patients are contacted), the monetary price goes way up.
The drug companies are well aware of how inefficient the process is, and solutions are under progress.
Re:Biochemist Zheng Cui’s funding was cut (Score:3, Informative)
Biochemist Zheng Cui’s had grants and funding while researching cancer, but after he found a very promising approach to fight cancer -- it worked so well that he planed to move to human trials -- all the money dried up.
http://www.popularmechanics.com/science/4273366 [popularmechanics.com]
Popular Mechanics is not the best source for a comprehensive report on new cancer research, but as best as I can figure out that interview he seems to be describing something that's been used for 50 years. http://en.wikipedia.org/wiki/Hematopoietic_stem_cell_transplantation [wikipedia.org]
I know about this because I had a friend with leukemia who was looking for a donor with a match. I wanted to join the donor registry myself (not for my friend, which was very unlikely, but because it was possible that somebody somewhere in the world was a match for me) but I was too old.
It would take someone who knows more about cancer immunotherapy than me to explain all the ways treatments like this have been tried before and usually failed, sometimes succeeded.
But the idea of paying $100,000 for an experimental cancer treatment unapproved by the FDA and tested only in mice is enough to raise my eyebrows. The first human study after an animal study is a Phase I study, which is done not to cure but to establish a safe (and unsafe) dose. I can't imagine how he got it through the Wake Forest ethics committee.
None dare call it a conspiracy!
You just did. But this is /..
Re:Cure? (Score:3, Informative)
http://www.csicop.org/si/show/bacteria_ulcers_and_ostracism_h._pylori_and_the_making_of_a_myth/ [csicop.org]
The bacteria causing ulcers idea has been distorted by the media. It was proven that bacteria caused ulcers, however:
1) There were in fact a lot of papers published on the subject.
2) Proving that an infectious agent causes a disease requires being able to reproduce the disease. This did not happen for a while. Even the scientist who experimented on himself didn't actually get an ulcer.
3) Many healthy people have the same bacteria but don't get ulcers.
4) The existing non-antibiotic treatments for ulcers did work. The antibiotics just prevented a relapse, and the correct treatment is to use both (i.e. not to avoid the existing anti-ulcer drugs)
5) The length of time it took for the medical community to accept the theory was reasonable, considering the steps you need to go through to prove it, the length of time required, and the research needed. Trials take time.
There wasn't any suppression.
Re:Spelling. (Score:3, Informative)
Re:Biochemist Zheng Cui’s funding was cut (Score:5, Informative)
In the US, the usual FDA process for drug approval is to go through 3 phases of human trials (then a mandatory phase 4 during which adverse event data from the wild is gathered and analyzed). There is a Fast Track [fda.gov] program at the FDA for serious diseases where there is a need for treatment options. This allows drugs to get approved faster by skipping steps and using surrogate end points instead of proving complete efficacy and safety.
I'd be interested to hear the reasons that grants were not given to continue this research. It might have something to do with there not being a specific mechanism of action identifiable in his experiments. In his interview he admits that he has no idea why it works, but it seems to work. Sciency people don't like things like that. They probably have a better reason than "it seems a little hokey", though.
Re:Cure? (Score:2, Informative)
Martin, If you dig just a little bit deeper, you'll find that this bunny burrow goes a very long way down. Hypovitaminosis D has been implicated in just about every disease under the sun (so to speak). Not surprising when you learn that our ancestors were making 5,000+ units per day in their skin, back before we all turned into residents of air-conditioned caves who smear on chemicals to "protect" us from sunshine on those rare occasions that we do venture outdoors.
The key to understanding why vitamin D is so important is to know that it's actually not a true vitamin at all, but rather a pre-hormone; the active hormone (calcitriol) is involved in a myriad of regulatory pathways all over our body, most significantly in the immune system as well as in calcium regulation. Calcitriol is also essential to normal growth, including neural development; deficiency during pregnancy is associated with autism in children.
Deficiency during childhood is associated with many autoimmune diseases including type 1 diabetes and multiple sclerosis.
Deficiency during adulthood is associated with coronary artery disease, hypertension, diabetes, dyslipidemia, vulnerability to viral infections (including influenza and the common cold, which are far more prevalent in the winter months), vulnerability to certain bacterial infections (most prominently including tuberculosis), and at least 17 different types of cancer, most notably including breast, colon, prostate, and (ironically enough) melanoma.
If you start to look into diseases that are significantly more prevalent in dark-skinned people (who are more protected against the rays of the sun but unfortunately also not so good at making enough Vitamin D outside of tropical environments), you can begin (but only begin) to understand the extent of the problem.
The current RDA for Vitamin D has somewhere between zero and nothing to do with actual human requirements for the substance; fortunately that's actively changing as the medical community gets more aware of the situation, but in the meantime you can consider current amount of Vitamin D supplementation in food to fall into the "near homeopathic dose" category.
Current official medical recommendations are to take enough Vitamin D to achieve measured serum levels of at least 30 ng/ml of 25(OH)-D (calcidiol), but a growing number of doctors who have looked into this a bit further (including myself) think that the goal should actually be somewhere in the 60-80 ng/ml range, particularly for cancer prevention.