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One Drug to Shrink All Tumors (sciencemag.org)
64 points by mynd 1456 days ago | hide | past | web | 65 comments | favorite



Some heart-wrenching comments from the page:

"Husband and father of 3, age 31, high grade spindle cell sarcoma, stage 4 with mets- help! nuclearcouple@hotmail.com or find me (spouse) on fb, Heather Cimino in Fort Myers, Fl, willing to travel anywhere, just save my husband!"

"my wife has tumor that are killing her will you hurry up and get this sorted - is there anyway one can volunteer for a trial tim.parry@xtra.co.nz"

There has got to be a way to address this need.


There has got to be a way to address this need.

Yes, there is. Fight for the right of each individual to follow his best judgement in regard to all matters pertaining to his own life. (If someone doesn't know enough to make the call, he knows enough to choose a physician who can.)

Right now, timely experimental treatments are basically outlawed. What good is it to say that there's an FDA procedure to get around the controls if you're treated too late? What right does anyone have to deprive anyone else of what might be their only shot at life?


The problem is that lay people have essentially no ability to distinguish between potential 'last shots'. And exemptions will invite snake-oil salesmen.

It can be frustrating, but the rules weren't created in some blind bureaucratic power-grab. They're responses to actual problems that existed in their absence. They aren't without their downsides, but they remain better than the alternative on balance.


Yet somehow countries that regulate drugs merely by safety tend to produce better health outcomes than countries that regulate for safety and efficacy like the US FDA does. You're just asserting that the upsides outweigh the downsides, but every study I've seen that tries to measure things quantitatively comes to the opposite conclusion.

The gullible are already getting snake-oil in the form of herbal remedies and homeopathy.


The point here is that this drug hasn't been tested for its safety, much less its efficacy. It is still at an early testing stage. The researchers seem to have a reasonable theory for why they believe it will be effective. But molecular biology is complicated and the risk for harmful effects in humans is not trivial.

Ben Goldacre's book Bad Pharma details the serious personal and social costs that come with poor drug trials. Everyone urging the abandonment of caution here seems to assume this new drug already works or, at the very least, the effects of its usage could not be worse than the grim prognosis patients already confront. But that's what proper trials are meant to establish. Snake oil can come in pill form, too. And even with the current precautions, we've ended up with a number of ineffective, expensive, and sometimes deadly drugs on the market.


I'd go further in saying that the gullible are going online where they learn of really shady solutions. From there, they go underground or to other countries to get snake-oil of a particularly strong reptilian flavor.

As with the drug war, we drive people into being basically criminals when they're in reality suffering from a medical condition.

So rather than being allowed to experiment with extremely desperate volunteers who could likely one day provide some real EUREKA therapies, we send those folks to the dark side where they're much more likely to spend a great deal of money and be taken advantage of.

That's a huge practical loss, but an even greater ethical loss. At its very core, we are throwing away people's right to choose what to do with their own bodies. Being okay with that ethical tragedy is like being okay with rape or torture for some poorly proven "greater good".


Rhetorical tip: If you seek a dysphemism for alternative therapies of which you disapprove, "snake oil" is a poor choice, given that that substance is a rich source of omega-3, the same fatty acid that so many physicians now recommend to their patients. Snake oil's nutritional profile may well account for its value to practitioners of Chinese medicine.

http://www.scientificamerican.com/article.cfm?id=snake-oil-s...


They aren't without their downsides, but they remain better than the alternative on balance.

That's not a credible claim. Tell that to either of the two people that left those comments.

Sure, there's risks inherent with experimental drugs, but these people are dying or losing loved ones. They don't give a damn, and none of us has any right to stop them from taking those risks with their own persons. Their bodies are their own, they are not yours.

And frankly, the snake-oil salesman claim strikes me as little more than FUD. People can get recommendations from multiple MDs before making up their minds.


The history of snake-oil salesmen is well documented. http://www.authentichistory.com/1898-1913/2-progressivism/8-...


Why is it OK to lump honest physicians, researchers and patients in with snake oil salesmen and their victims?

Why is it morally acceptable to have laws intended to help the people that don't care to tell the difference? Those laws come at the expense of those who do care, who take the trouble to figure things out.

Why shouldn't we live in a free society where the best within us can make a difference, and take humanity forward?


> "Why shouldn't we live in a free society where the best within us can make a difference, and take humanity forward?"

Our free society lived with the alternative. And they collectively decided "the right to be defrauded is a false liberty, this is no the way forward, let us try another way."

And you know what? We've moved further forward, faster since these regulations were put into place. When people have trust that they're not being defrauded, they participate in the market to a far higher degree. When companies don't have to compete against charlatans, don't have to balance every dollar of research with a dollar of trying to educate the public about what is and what is not medically sound, they invest far more into their research efforts.


We lived with the alternative, but could we judge the two properly? When someone dies due to an unsafe drug that makes for a very compelling story. When someone dies from something that could potentially have been cured with a faster drug approval process, well, those deaths show up only in faceless statistical aggregates and society had already come to accept that sort of death as natural.

All the drugs that turned out to be dangerous over the last few decades and had to be withdrawn spring easily to mind, but how many people know about the deaths of the people whose heart attacks could have been prevented if the FDA had allowed the first beta blockers at the same time as they came into use in the rest of the developed world? Not many, despite the death toll of the later dwarfing all the former combined.


"We've moved further forward, faster since these regulations were put into place."

Or perhaps we've moved further forward, faster in spite of these regulations being put into place.

Honestly, your position sounds like so much FUD to me, and I ultimately reject it because it boils down to this: "The US government has more of a right to determine what Heather Cimino's husband can do with his own body than he does, even should he die."

No thanks.


Straw man.

I'm not arguing for the "right to be defrauded."

(Aside: fraud is a violation of an individual's rights, by definition. Your phrase steals the concept of "rights" - it uses "rights" while simultaneously attempting to deny or undermine the very same concept of "rights.")

We need a government, and strong laws to ensure that fraud and other instances of force [including theft, murder, etc.] are identified objectively adjudicated justly, after it has been shown that someone's rights have been violated.

We shouldn't treat anyone - physicians, patients, businesses, etc. - as guilty before they've acted. That's what regulations do: they are based on the assumption that people are guilty, and that need to be stopped before they act.

I'm for treating everyone as innocent until specifically proven guilty. Why aren't you?


Representing that you have a potential cure or treatment when you have, by definition, no scientifically sound reason to believe that's correct isn't fraud? (If they had such a reason, they'd have no trouble getting clearance for human trials. You can argue about whether the current bar for evidence is too high, but that's distinct from arguing there should be no bar at all.)

> "We shouldn't treat anyone - physicians, patients, businesses, etc. - as guilty before they've acted. That's what regulations do"

No, they don't. They regulate activities, not people. They're distinct from laws only inasmuch as we recognize that while not just everyone should be allowed to do a thing (say, drive on public roads) some people should be allowed to do those things. So we don't outlaw those activities, we regulate who is and is not allowed to do those things.

Do you believe a law against murder is equivalent to treating everyone as a murderer before they've acted? How is a regulation over who can publicly make medical claims so different? If the law simply said "no-one can make medical claims", the way no-one can yell "fire" in a crowded theatre, would that be pre-judging?


I do not recognize "the collective's" right to make this decision for me.


And yet by participating in this society you are directly supporting their ability to make such decisions, whether they side with or against you on a given issue.

If you actively pursue one of the many methods available to effect change, you can only do so via the same channels that allowed others to set up the status quo. Even securing a constitutional amendment against such laws would just underscore the right and ability of others to pursue their own amendment to overturn yours.

The only way to secure your victory would be to end representative democracy. And of course no other method of government would deliver a guarantee to respect your freedom to make such decisions free from their meddling.

So all that's left is no government.


"The only way to secure your victory would be to end representative democracy."

That would be why I prefer a constitutional republic to a democracy.

Edit: to be more specific, a constitutional republic that pays actual attention to the Tenth Amendment.


"The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people."

Do you see anything in the Constitution that grants the federal government the right to tell me what medications I choose to take?

I don't.


The Constitution is a living document that provides the legal framework for testing the constitutionality of laws and a method for its amendment. It explicitly grants society, via representative government, the right to interpret, change and extend the Government's power.

To reject the power of society to, by following constitutionally-specified methods, give government this power is to reject self-government.


Why is it OK to lump honest physicians, researchers and patients in with snake oil salesmen and their victims?

The best snake oil salesmen believe in their products. There are already exceptions for allowing people to take highly experimental procedures when there likely to die without them. However, there are plenty of cases where highly trained well meaning doctors caused massive suffering without benefit to their direct patents.

As a recent example of fringe medicine, a few athletes have injected themselves with stem cells. Not to mention the modern version of doping which often involves substances that are known to be harmful or medicine has little idea what the long term effects are.


So we should treat every physician, researcher and patient as guilty, incorrect or foolish until proven innocent, correct or wise?

However, there are plenty of cases where highly trained well meaning doctors caused massive suffering without benefit to their direct patents.

No one is omniscient. The ideal in medicine can't be something impossible (i.e., medicine that cures all ills and everyone, and never has any risks or side effects). No one knows how to do that (now and for the foreseeable future), and we shouldn't deny people the best chance they have at life to chase an impossibility.


So we should treat ... researcher... as guilty, incorrect or foolish until proven innocent, correct or wise?

Yes, that's the point of peer review.


Peer review is just another thing that helps individuals decide scientific matters for themselves.

The implicit idea behind peer review can be summed up like this: "This is what I think about this work. (I have credentials X, Y, and Z, and I've published this stuff you many have heard of.) What I have to say is just another thing for you to consider. Take it or leave it."


It's more than that as it's vary possible for things to fail peer review and or be edited and resubmitted. But, also in some ways less as you as a reader don't know who did the peer review.


I'm not denying their existence.


For what its worth, I agree with you, but the other side is not so unreasonable as it seems. The risk is not to the dying. The risk is that selection bias (of the miracle survivors) might cause an ineffectual drug to creep down the chain of "desperateness" (from the truly desperate to the less so) until it possibly occludes treatments that do work.


>"lay people have essentially no ability to distinguish between potential 'last shots'"

I'm sure you mean well, but this type of thinking really bothers me.

For example, many of us here on HN, possess the critical reasoning skills to determine snake oil from a credible research lab. Given that there are almost no practicing oncologists present, we'd all likely qualify as lay people.

However the central issue is a medical doctor is not even qualified enough to choose, due to malpractice liability. On top of that even a specialist can find difficulty prescribing experimental treatment lawfully, unless it's part of an FDA trial. This is in addition to the incentives drug companies push. [1]

I speak from first hand experience dealing with Psoriatic Arthritis and establishment CYA (cover your ass) thinking. After spending $1000+ per month on Anti-TNF blockers [2], I'm doing just fine on lifestyle changes and have seen no disease progression after 3 years of being off meds. I wouldn't bother mentioning it if it weren't for the thousands of credible patient stories that point to fixing what we eat as a means to being healthy. Yet the paradigm for the last 30 years is one of treatment, not prevention.

Guess which makes more money for Pfizer, GSK etc? Hint: it's not vaccines (prevention). Chronic treatment (autoimmune, psych drugs, cvd etc) are dominating the top 10 sales charts. [3]

I would feel incredibly angry and upset if myself or someone close to me, were in a position to try an experimental cancer treatment, but were unable to, because of regulatory snakes and ladders.

I'm not saying the FDA is useless or provides no public benefit, but I would question the wisdom behind entrusting authority of one's life, to a single decision making body.

[1] http://www.nytimes.com/2011/11/25/us/payments-to-doctors-by-...

[2] http://en.wikipedia.org/wiki/Etanercept

[3] http://en.wikipedia.org/wiki/List_of_largest_selling_pharmac...


>For example, many of us here on HN, possess the critical reasoning skills to determine snake oil from a credible research lab. Given that there are almost no practicing oncologists present, we'd all likely qualify as "lay people".

The fact that you think critical reasoning can help discriminate between a quack and someone selling real medicine indicates you don't have the ability to make that distinction.

The truth is, no one does. It takes a process with many checks, and even then snake oil makes it through.

Hell, the same people who make real medicine can have a lapse of judgment and make phony medicine. No one could tell, even their peers, without verifying the experiments performed.

It's not a far-fetched scenario. Prominent researchers fall from grace several times a year. Multinational drug companies sell medicines that perform worse than placebos.


"no one has the ability to make the distinction between a quack and real medicine" (paraphrasing OP)

What utter nonsense. If someone presented you with a homeopathic dropper [1] saying it would cure cancer vs a new gold nanoparticle experimental therapy [2], "no one" would be able to tell the difference?

While the new treatment may turn out to have issues (no one was suggesting experiments were risk free), to imply it's indistinguishable from quackery, is false.

[1] http://en.wikipedia.org/wiki/Homeopathy

[2] http://bjr.birjournals.org/content/85/1010/101.full.pdf


> For example, many of us here on HN, possess the critical reasoning skills to determine snake oil from a credible research lab. Given that there are almost no practicing oncologists present, we'd all likely qualify as lay people.

Ah, how did we miss such an obvious fact! Of course we computer scientists are naturally smarter than all the other laypeople.


Snark aside, we are somewhat in agreement.

I tend to dislike elitist thinking (or though I'm still guilty of it at times), not for moral reasons, but simply because empiricism, in my admittedly subjective opinion, is routinely lauded over common sense in nerdy communities (HN, slashdot, SO etc), and is often a form of bias. Having a bias doesn't mean one is wrong necessarily, but it can be problematic too, especially if one lacks cognizance of said bias.

For example, my gf is the furthest thing from a computer scientist, but is routinely more observant socially and can spot bullshitting better than I in certain contexts (among other superior cognitive skills).

However in the past I've tried to pick too many battles in one post, and that makes it difficult for someone to upvote, as they may agree with some, or one point, but not another and creates a mixed cognitive dissonance. Hence I didn't want to launch into a large foray of intellectual elitism.

Hence the aim was, for the most part was to try to leave epistemological disputes (how do we know what we know, who knows what etc, do all groups have equally justified beliefs?), out of the debate and focus on the regulatory side of things and empowering the individual to be allowed follow their own life and death decisions.

That said, perhaps I could have left the opening paragraph off altogether in retrospect.


The problem is that lay people have essentially no ability to distinguish between potential 'last shots'. And exemptions will invite snake-oil salesmen.

So because some people will be duped, let's doom everyone to death.


> If someone doesn't know enough to make the call, he knows enough to choose a physician who can.

Unfortunately that is demonstrably not the case. There are many qualified, experienced, doctors who are happy to peddle nonsense. Even limiting yourself to conventional medicine it's hard to tell the effective medication from the less effective medication.

> What right does anyone have to deprive anyone else of what might be their only shot at life?

What right does anyone have to manipulate desperate dying people out of vast amounts of money on unregulated, useless, gambling?

I'd agree if you're suggesting that people should be able to volunteer for trials - but double blinding means they may not be getting the experimental treatment.


>What right does anyone have to manipulate desperate dying people out of vast amounts of money on unregulated, useless, gambling?

This already happens. I don't really see how allowing dying people to access experimental procedures is any worse than allowing dying people to pay for crystals, and "charged" water.


crystals and charged water don't tend to cost the same as a house.

I think I've changed my mind slightly. So long as people are properly informed - with very easy to understand information - I guess I'd let them access random experimental meds. I'd prefer that to be part of a rigorous study.


Didn't know it was this bad, but couldn't agree more. It should be entirely up to an individual what they put in their body. Monumentally frustrated right now.


People who are desperate tend not to be the best test subjects--if there is any indication that the drug isn't work, they're likely to switch to another treatment. This is absolute havok on both safety and efficacy trials, which depend on participants sticking to their regime (whether or not their regime is the tested drug or a placebo). The end result is that the drug ends up taking longer to get to market than it otherwise would, assuming that it can get through the trials.

Yes, it sucks for the people who won't survive until the drug reaches the market, but the overall outcome for society is better.

Also, at the end of the day, taxpayer money is used to pay for most EOL care. The taxpayers have a vested interest in not exposing dying people to expensive and unproven treatments which could make their conditions even worse.


There is, "expanded access" or "compassionate use". http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocat...


How many months or years does that process take?

Morally speaking, the judgement of a patient (and the physician he has chosen) must not be impeded even for an instant. The FDA renders individual judgement on these matters irrelevant, and the result is often death and slowed medical progress.


I imagine these people are desperate enough to find other means to acquire an antibody that blocks CD47. I wonder what quasi- or il- legal means are available to them? Care to speculate?

Edit: perhaps a set of crowd-sourced, extremely explicit instructions about how to manufacture, purify, and test such antibodies would be a start. With such a set of instructions, they might be able to find experts to help them under the table.


Well, you could try ordering from Fischer or any of the usual research supply places out there, but they will not ship to a non-institutional address.

Even theft isn't an option here, unless you're somehow certain that a particular lab has exactly the right antibody. (In my lab, we often have trouble keeping track of that for ourselves...)

And don't forget that you need to be able to maintain sterile conditions, and have whatever other reagents you need to dilute things, etc.


Wait - are you saying people could (were it legal) simply order this stuff from a company? Can you give me some kind of reference for this? If so, I could see people reaching out and finding others capable of placing the order.


Here's CD47, conjugated to a fluorophor (when you have a cell covered in a conjugated antibody, it fluoresces when exposed to laser light - this is done so that an instrument called a flow cytometer can identify cells).

http://www.biolegend.com/percp-cy55-anti-human-cd47-4338.htm...

Of course, to get CD47 depletion, you'd probably want an antibody that isn't conjugated (functional grade):

http://www.ebioscience.com/resources/in-vivo-use-of-antibodi...

Also, some more help on the terminology: CD47 (and most, if not all molecules that fall under the Cluster of Differention [CD] nomenclature) vary on a per-species basis. So an antibody that targets CD47 in mice is not going to stick to human CD47. "Anti-" in this context means that the antibody in question will stick to specific molecule in the species that comes after the "anti-".

Note what it says on the bottom of the page. That's there because of regulations.


Perfect, thanks for all this.


Strong word of warning! These antibodies are not human, but most likely mouse. They will illicit a strong immune response, since they are foreign to the human immune system. Furthermore, antibodies can be directed against many different locations on their target molecule (epitopes), CD47 in this case, and therefore it is very unlikely that they will compete with the ligand they are trying to block.

In brief: you will hurt people doing this and achieve nothing.


Thank you.


I'm only aware of the process because of a NYTimes (IIRC) article, which said they had a roughly two week wait for approval. Getting the pharmaceutical company to provide the med was significantly harder.


Well, the treatment is moving to Stage 1 Human trials, these people should clearly get in touch and volunteer to be a part of the trials.


Here is a link to a related trial in South Carolina currently recruiting participants to examine a role for CD47 in myeloma. It is not a trial using the antibody cited in the OP's link, but a study to examine if targeting CD47 (and some other potential targets) makes sense in a human context, rather than just in a mouse.


It bothers me to continuously see articles with headlines like this. Just look at the comments—it gives false hope to patients and their families. As the author mentioned later in the article, there is a big difference between seeing cancer cells die in a petri dish or reduction in size of a transplanted tumor in mice and it being safe and effective in humans. I hope this succeeds, but it is a long way from a Phase 2/3 clinical trial.

Cancer research is too important to use misleading, link bait headlines to attract attention.


My best friend was just put into hospice for metastasized melanoma. He's 35. Where is this stuff?

Nothing more useful to add to this comment. Sorry


Sorry for your friend.

This is the original article: http://www.pnas.org/content/109/17/6662

You can actually get the antibody yourself, FTA: "The anti-hCD47 (B6H12) hybridoma was obtained from the ATCC" [http://www.lgcstandards-atcc.org/Products/All/HB-9771.aspx]

Purifying it is easy, if you have a lab.

However... you can't use that antibody directly in humans, since it is a mouse antibody, which the human immune system will recognize as foreign. So, even if this treatment were to work, it is necessary is to first "humanize" the antibody so it won't be rejected, and then you can see what effect you get in a clinical trial. I imagine this is what the $20mil funding is for.

You can find clinical trials for new drugs here:

http://clinicaltrials.gov/


Can you use this one directly in humans? Both humans and mice are mentioned, and I do not know how to interpret the nomenclature: http://www.biolegend.com/biotin-anti-human-cd47-antibody-370...


That is a mouse antibody (viz, Isotype: Mouse IgG1, κ) targeted to the human CD47 protein, the same problem exists as for the one mentioned in the above article.


Here is a longer, more recent, (more obscure), article: http://stanmed.stanford.edu/2012summer/article7.html


Thanks for this.


The article is from 26 March 2012, over a year ago. Would be great to hear on developments that happened over last year.

May this be another 'lost' case, appeared once and never again?


"Although macrophages also attacked blood cells expressing CD47 when mice were given the antibody, the researchers found that the decrease in blood cells was short-lived; the animals turned up production of new blood cells to replace those they lost from the treatment"

That's great -- does anyone know if any other cells in the body express CD47? Especially ones that can't be replaced so easily?


No specific answer from me, but I guess digging through some top entries from pubmed can answer that. http://www.ncbi.nlm.nih.gov/gene?term=%28cd47[gene]%29%20AND... may be a good start.


Cancer evolve. In this sense it is like a new species (and it can occasionally become one).

That's why fighting it is so difficult. I highly doubt there ever can be one chemical substance that reliably fights all sorts of cancer.

And you can't really cure cancer anyway.

Our only hope at this point is genetic engineering.


I would expect that human tissue put in mice would normally be rejected by the mouse's immune system, so this treatment would just allow that to happen in the special case of cancer tissue (which has mechanisms to prevent that). I'm worried that the human immune system wouldn't be as interested in attacking its own cells that became cancerous, even with this treatment.


This was linked to by The New York Post yesterday, but the article itself is a year old.


... and in the darkness bind them? Let's hope so.


White blood cell transplant is proven to shrink (cure) cancer. However you won't see it in the USA for the next XX years. Some doctors in China is already doing it though, so if you can travel, that is an option.

See http://www.lef.org/magazine/mag2010/jul2010_Life-Extension-F...

Also, I believe there is an organization that helps cancer victims by arranging travels outside of USA for innovative treatments, LEF can refer you to them.




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