Drugs *can* be re patented for use in differenct conditions.
But the thing holding this back is not technical it's economic.
The drug mfg/regulatory eco system rewards safety and novelty not cheapness.
With predictable consequences.
A solid tumour is the perfect example of a complex adaptive system at work. It is an ecosystem with competitive and cooperative networks of cells at play. This is one of the reasons why cancer is so difficult to treat. Historically, the approach has been to blast tumours with the most toxic drugs at our disposal – cytotoxic …
Nope. That's called "off-label" use, doesn't mean you can receive another patent. What you CAN do is change something (e.g. the salt used), devise a new drug-delivery system (e.g. slow-release or liposomal) or combine with another drug and patent that, with the new indication (requires FDA rubber stamp of approval). Then you can market the patented reformulation as treating the new indication, whereas the generic cannot be marketed as such.
No, they can't be repatented. The patent is for the substance itself (and sometimes for the method(s) of synthesis and/or purification) and not for its application. Pharmaceutical companies would synthesise a lot of compounds, get patents for them and then start testing them to see what they might do. They can be registered for a new application, but this does not confer the kind of economic protection a patent does.
That was a fascinating read. I hope that said trials get underway to demonstrate or otherwise the efficacy of the approach.
As someone who has lost family and friends to cancer I really, really, hope that valuable medicines aren't being side-lined in the pursuit of profit.
this is precisely where government should step in. They don't have to do the research, nor the tests for safety etc. A short cut to a potentially viable, cheap treatment.
Of course big pharma and right wing economists will scream about market distortions and unfair competition. Well they can shut up, because this is precisely the sort of thing that shows up the limitations of the market, and might lead to us all concluding that the market has come to serve only the interests of the rich few and treats the rest as a leech treats its host.
Government "They don't have to do the research, nor the tests for safety etc"
Oh, but they do. It's the law. Now doctors can prescribe treatments "off-label" but they take full responsibility for whatever happens to the patient and can't shoulder any of the blame on the pharmaceutical manufacturer.
And no doctor will risk prescribing off-label unless they've seen the evidence that the drug in question is effective and is less likely to kill the patient than leaving the patient untreated (or using a different treatment).
(off label includes prescribing the same drug made by a different manufacturer and in a different form to that which has been approved for that treatment. eg Pharma A makes drug X in pill form and gets it approved for the treatment of Intestinal disease 'M'. Pharma B puts drug X in an injection form for the treatment of skin disease 'N'. Sticking B's syringes into your patient for his gut ache is off-label.)
I read something about a drug (I believe it was from a reputable source but not massively specific maybe there are instances it cannot be used) that basically reversed the process of decay that will never come to light because the effects on the dental industry.
but this story is exactly the point, the market does work because customers demand better cheaper alternatives to what is already out there
The customers can demand all they want. If the suppliers can't make a profit on a product, or can't make as big a profit on a new product as they are on an old one, it'll never get put on shelves. One of the downfalls of a free market is that no matter how much the people may want a vaccine for the common cold* they'll never get one because there is so much money to be made from people who get a cold every year or two.
*Yes, I'm well aware of the challenges and probable impossibility around an effective rhinovirus vaccine. I'm just using it as an example.
You're aware, of course, that in a land of Ayn Rand worshipers it wouldn't cost a half a billion dollars to get a drug approved by a governmental regulatory agency and new drugs and treatments would be available all the time. The downside is that a few dozen folks might likely die as guinea pigs the way they did a hundred years ago.
The biggest hindrance to drug approval is that everyone in the industry remembers thalidomide which started as a cancer drug and became a panacea for everything from anxiety and insomnia to nausea and morning sickness. Given the lack of testing it may not be surprising that it all didn't work out as planned. Today the unspoken motto of FDA approvers is "be like Kelsey and never be the one who approves tomorrows thalidomide". While that isn't a bad thing it also hinders companies from producing generic equivalents of drugs used for a hundred years. My sister has Hashimoto's thyroiditis which has left her hypothyroid and all the natural varieties (all made with dessicated thyroid glands of livestock, mostly pigs) of generic thyroid replacement have disappeared because the FDA won't approve the drug and switching brands is impossible because none are considered to be an equivalent dosage of the other so when the price of one rises it requires a trip to the doctor for a new prescription of today's cheapest variety.
>>"Of course big pharma and right wing economists will scream about market distortions and unfair competition"
Only the extremists. I don't judge all on the Left wing by the Socialist Worker's Party, nor are all on the Right wing unfeeling monsters. I'm fairly Right wing and I am very much in favour of the occasional government intervention in cases like this where we're trapped in a local minima.
All highly complex systems, even well-designed ones, benefit from the occasional nudge.
And I sincerely hope it ISN'T. The NHS needs repurposing, it's not fit for anything as it is. I don't trust any of these 'studies', as they're likely to have been financed by pharmaceutical companies with a vested interest.
And as for cancer cures, there's only one cure for many forms of cancer, which has been proven by INDEPENDENT research, as well as anecdotal evidence. It causes no proven adverse health events, and results are seen quickly; of course, thanks to lobbying by the UK's leading cancer 'charity', it's also still illegal.
So, folks, if you've ever fundraised for CRUK, or donated, please be aware of where most of that money is going - the prevention of the legalisation of a safe, effective and reliable cure for many cancers which are currently incurable. In fact, so determined is CRUK that it should remain illegal, that every time legalisation is up for debate, it publishes the same well-worn bullshit in the Right-wing rags, knowing the people who read them treat them like some kind of sacred text and, if you've got letters after your name, and you claim to hold the title of 'Dr', you can pretty much be assured they'll lap up every single word you say so, if you make claims that not only does cannabis not CURE cancer, but smoking it increases your chances of developing lung cancer up to twenty-fold over tobacco, then by fuck it must be true - he's a DOCTOR, FFS! Fuck the fact he could have bought his doctorate off eBay for £20!
Now, at the risk of sounding like some kind of Tea Party nutter, I AM going to go down the 'won't somebody think of the CHILDREN…?!' path, because that's my main motivation for continual campaigning for full legalisation. Many kids whose deaths are attributed to cancer actually succumb to the effects of chemo and or radiotherapy which their small bodies simply cannot handle; every dose is a game of Russian roulette, because you simply don't know if this could be the one-dose-too-many. You are subjecting a (very) small person to lethal poisons and lethal doses of radiation, which are in no way discriminatory, they'll destroy whatever they happen to come into contact with; CBD DOES discriminate, and ONLY destroys the cancerous tissue and leaves healthy tissue alone.
The thing is, Big Pharma isn't interested in curing ANYTHING - if people are truly healthy, it's not gonna be raking in the massive profits it does from its chemo poisons and toxic radiation. A 3-year-old struggling against AML isn't a PERSON, they're merely a cash cow to be milked dry. If cannabis was legalised, Big Pharma would lose BILLIONS, because patenting nature is nigh-on-impossible. CRUK is simply the lobbying arm of Big Pharma UK, disguised as a charity. If it's slogan - Together We'll Beat Cancer. Sooner - was to ring any way true, it'd be lobbying FOR cannabis legalisation, NOT AGAINST IT!
I expect this'll get down-voted from here to Uranus and back, because you must NEVER speak ill of the NHS - and speaking ill of CRUK…?! UNFORGIVABLE! But I know the truth in that which I speak, whether you want to believe it or not - that's entirely your prerogative.
And also for labelling a significant percentage of the population as "right wing" and then proceeding to construct a pantomime evil straw man that you can demolish. Who do you think your persuading with logical fallacies?
Politicans love groups and labels because it allows them to stir up arguments between groups, which allows them to divide and conquer. By promising to address one groups concerns they get support from that group, usually by promising to screw another group over. Never mind the damage this does to our society with the constant encouraged infighting between groups.
If you find this objectionable, then don't take part.
Very likely. But stop for a second and think what happens to all these cancer charities if a cure is found... boom they go out of business overnight. It's in their own interests to keep finding new treatments but never find a cure, and if they discover a cure then cover it up before anyone outside hears of it.
"And as for cancer cures, there's only one cure for many forms of cancer, which has been proven by INDEPENDENT research, as well as anecdotal evidence"
Please provide some evidence of this or we naturally will decide you are talking bollocks.
Of course, the rant-like nature of your post has raised the bar somewhat to reversing that judgement, but some of us are open to the scientific process where opinions can be changed when repeatable experimental evidence says so.
The principle is well established here in the US ... take a world full of scientific accord, and neutralize it with one self-aggrandizing US Senator standing up with a snowball in his hand, proclaiming that his opinion plus the continued existence of snow stands as proof positive of his unassailable position.
Same with the US healthcare system. People die. People have always died, and will continue to die. That's no reason to get all hysterical and undercut the world's most profitable economic enterprise (next to big oil and weapons sales.)
Antacid tablet, anyone?
Greed can work. Greed can work very well. Dreams of avarice drive the development of entirely new drugs. There are treatments for obscure diseases you've never even heard of because there is a fortune to be made in it.
Beyond that, it should be little trouble for less Ferengi nations to do the things that don't do well with Gordon Gekko types.
Dear Patient, I understand you are concerned at having xyz cancer. I also understand that many patients with xyz also have worms/ acid reflux, yada, Yada, Yada, (delete as required). I have to warn you that one side effect of this treatment is that tumours shrink/die/disappear while the heart burn, worms or whatever are being treated. Now may I ensure that you are kept free of worms heartburn whatever?
The civil service hate this approach but in my past experience in a different field they end up living with it and have even been bounced into following that approach - if the incentive is in the right place.
There is an ongoing battle over cheap and effective vs a too expensive to use treatment for if believe wet macular degeneration.
Isn't this one of the reasons why we need to be pressing for open access publication of research, rather than letting it be hidden behind paywalls? Certainly there is a strong argument that anything which has been government funded should be open access.
While it may be slightly disconcerting for GPs and other health professionals that patients might sometimes know almost as much as they do, public education is both an important component of medicine and a means to ensure that Big Pharma is to some extent held to account.
A substance, new or repurposed, is not a drug until there is sufficient knowledge about the the indication (which disease or which tumour in which patients?), effective dosing schedule(s), actual doses and duration of treatment. Buying time by partial remission is good, but complete cure is better. Studies to support generation of protocols are difficult to finance, and there are quite a few bureaucratic obstacles. Hard for all those who are not industry with their deep pockets.
Some modern treatments convert lethal diseases into chronic diseases. Quick and complete cures are less profitable for the industry and are not supported. The independent review boards might be sceptical too.
When I was diagnosed with HCL (Hairy Cell Leukaemia)*** in 2009, I was treated with a drug that is used for MS. Kudos to the team that thought this treatment up. Before this, the survival rates were poor and the incidents of it re-occurring after 5-7 years was high. Now, my prognosis is that I should be good for another 20-30 years with a just one blood test a year.
*** There are around 500 people in the UK with HCL.
A while back some work was done by (IIRC) Kanzius on using gold nanoparticles to treat solid tumors as they would absorb certain microwave-infrared (3um) wavelengths and superheat thus heat stressing the cancer cells beyond their survival point (hyperthermal)
This was based on earlier work where researchers experimenting with diathermy noticed coincidentally that nearby tumors regressed weeks later despite being quite far away from the probe(s).
Quite a few drugs used for routine conditions have an anti-cancer effect but the trick is to balance the side effects and ensure that the combination doesen't critically deplete some liver enzyme or affect kidney function.
Guys, sorry but the article is a misrepresentation of truth and this is a field where common sense is simply not good enough.
To release a medicine for use you must have solid data backing it's efficacy and safety in the disease you want to treat. Anecdotal and series review data is not good enough: MANY promising drugs have failed to show real value when put to the final clinical tests. You can argue a lot (I do), on specific issues of the regulatory system, but thinking that something with the level of evidence supporting cimetidine in cancer is more than a possibility requiring clinical testing is not true. And the cost of testing the effect of such a drug is the hundred of USD millions range (think how you would act if each time you roll the dice the bet is a few hundred USD million and your chances of success are at best 1 in 3, maybe lower).
Many companies are in the business of looking to repurpose drugs (it is much cheaper than start from 0 and you do get patents on them if you do it right), and usually their return on investment is better than to that of big pharma. If they are not interested in a drug you should think twice before believing they are stupid and you are wise (it might be the case but do not bet your house -or worse your pension -on it)
There might be a theoretical case for government to invest in developing old drugs in new indications, but before you do ask for that think twice: government is usually awful in allocating funding and the current track record of fully government funded research producing useful cancer drugs is close to nil world wide.
You may hate them, but Pharma guys know how to make sure money is spent carefully (at least much better than government)
Well said Onco guy, the only thing I would add is that pharma companies do re-purpose their own drugs all the time. We've all got adverts for Viagra in our email, and we all know what its for, but it was developed to treat pulmonary arterial hypertension, also know as blood pressure. Its licensed for erectile dysfunction and pulmonary arterial hypertension as for as I know . See http://en.wikipedia.org/wiki/Sildenafil for possible other uses of Viagra
Giving in to public pressure, having an idea of the cost of clinical trials and licensing, and knowing how much money gov agencies and waste. A 1% rise in all taxes, will all money going to anti cancer testing, should allow the gov to check about 10 drugs a year for anti cancer properties, with the first results available in about 5 years. What do you think Onco guy would that be enough money?
Honestly, 5 more drugs tested is irrelevant to given the number of compounds in clinical testing in Oncology (over 100 times that).
I think the better thingreen any National Government should do with money for Healthcare is bargaining to get the most services/drugs per USD spent. Basic research is a different thing, tough.
If you follow the link to the redo website you can get the articles for some of the these drugs. In the cimetidine case there's lots of trial evidence listed - which is why the cochrane review is mentioned. You don't get a cochrane thumbs up without some solid evidence.
Sorry again, but I do not share your respect for Cochrane review: I can only speak for the field I master real well (anti-thrombotic treatment), and the Cochrane document for that field is just a cookiecutter affair. What normal users (e.g. practising medics) should expect is that a review document spots flaws in the knowledge base so that a non-expert can understand the relative value of existing evidence. The specific review I can evaluate completely fails to realize where the evidence is weak due to design issues. I really think that after reading it a non-expert will get a false assurance in the quality of data, so it's worse than not having a review.
There is a kind of hippie feeling that only those who are free of the slightest contamination by any contact with Pharma can be our guides in the quest of drug usage advice. One of the big problems of that is you are leaving out of your expert team anyone who has broad and deep knowledge of a field (most likely if you areceiving a real expert at least Pharma has asked your advice or invited you to participate in discussions research, etc.)
There is zero chance of a repurposing of a drug in the US due to nobody being willing to pay for something that will not lead to profit. It might happen in the UK though research labs here rarely have the funds for large-scale tests. It is such a slim might that perhaps not such a great difference in the outcome of the two systems, only in how we (failed) to get there.
1) plenty of re purposing going on in medicine already, just most non-oncologists don't feel the need to write about it in quite the same "saving the world" way.
2) drug development doesn't cost $500 million, or $800 million, or whatever the current figure plucked from the air is. It's usually around $50 million, still plenty but not quite the same when you consider what blockbuster drugs make. (Top fact: atorvastatin was the first drug to make more than $1 billion profit in one year. Yes that's profit!)
3) pharmaceutical companies are not intrinsically evil, as some believe, but society has set up some appalling incentives for them. Taken forever? For a rich "lifestyle" disease?
4) treatment data is still required, and whilst safety approval is easier with an already widely used drug, you still need to prove that your purported mechanism of action is efficacious and effective. It's the phase 3 trials which are the big ones.
I mostly aggree with you but to reply to your points
1) Agreed, and oncologists probably do it too, but the ones who shout about it gets noticed and reported on
2) No, unless you made a typo it costs about $2.5 Billion, yes that's billion, to get a new drug to market. for reference see http://www.scientificamerican.com/article/cost-to-develop-new-pharmaceutical-drug-now-exceeds-2-5b/
3) Agreed, no law abiding company can be evil they may do things you don't like/agree with, and not do things you want them to do/agree with. After all you vote for the politicians who make the laws so unless you are evil and vote for evil politicians to make evil laws, companies obeying the law can not be evil. They can be bad and tricksy and find ways round the laws but then the politicians, who work for you, need to do their job and fix the laws not bitch about it
4) Agreed, trials are very expensive, and you may have to go back to phase 2 trials if you are changing the dose.
In response to point 2, from one of my previous posts (http://forums.theregister.co.uk/forum/1/2014/11/28/beyond_the_genome_youve_been_decoded_again/):
do drugs cost that much to develop? We don't have much evidence - you can read between the lines here:
Here's where the old $800million/new drug figure comes from:
http://www.ncbi.nlm.nih.gov/pubmed/12606142 (please note it is entirely from figures from the pharmaceutical industry, not publicly available info)
The $800 million was debunked at book length: http://books.google.co.nz/books?id=SKr5BDAmiMoC&printsec=frontcover&dq=the+$800+million+pill&hl=en&sa=X&ei=WLx6VJjyHoLRmwW73YLYDg&ved=0CBMQ6AEwAA
And recently(ish): "one can conclude that R&D costs companies a median of $43.4 million per new drug" from BioSocieties (2011) http://www.pharmamyths.net/files/Biosocieties_2011_Myths_of_High_Drug_Research_Costs.pdf
Apologies for long quote, but bluntly the people who made the original claim (and now amplify it every so often) about the high cost of developing drugs are those who ask for money to pay for the development of drugs. Can you see a conflict of interest?
I can't escape the feeling that this entire piece reads exactly the same as any other paranoid rant about how sugar pills, crystals and everlasting batteries would be saving the world if only big oil and pharma weren't forcing the world's lizard-run governments to suppress the research and render the scientists to the inner core of Venus etc.etc.
There is possibly a personal interest here, as someone who's lost a few close people recently, anyone saying 'ah, it's because they didn't try this particular treatment' would be wise to check there's a reasonably soft landing immediately behind them.
But overall my point is it's fine to propose any sort of reasonably-argued alternative approach to treatment that could be researched, but to do so to lay-people rather than experts in the field does not lend you credibility, and to exaggerate its potential efficacy or to claim it's being unfairly suppressed immediately discredits any rational basis for the argument.
For a start, not a single thing stated here seems to suggest a mechanism of actually destroying an existing tumour with an established blood/oxygen supply and whatever else it needs - which it will have before it is substantial enough to be detected by any current means. At best, you're talking of a potential treatment that could suppress the formation of secondary cancers once the intial case is known about, and maybe slow the growth of the original. Or a course of drugs people would have to take their entire lives 'just in case'.
Since the discussion touches upon the measures of success, may I point out (also because understanding statistics and their limitations is a good thing) that geek/techie publisher No Starch Press have an interestingly title in the offing http://www.nostarch.com/statsdonewrong
and there is a sample chapter up for viewing, it does talk about "underpowered" studies and how to spot if your wonderdrug/treatment/process isn't probably as different from the control as the inventor would like
Governments really should take a step back. There are many "non-profits" raising money to "cure cancer." For example, according to Forbes magazine, the American Cancer Society takes in USD 935 million / year; and Phase III costs about USD 40 million. I think they can well afford to test four or five drugs - that is, if all their employee salaries aren't as high as their most highly compensated employee (USD 2 million.)
Repurposing: the standard - at least in the US - for anti-anxiety prescription medicine is alprazolam (brand name: Xanax.) It's off-patent, so it's dirt cheap for insurance companies to cover. There's a non-benzodiazepine drug available that does the same thing, Lyrica, which will not be off-patent until the end of 2018, so it's still expensive. The EC approved it as on-label for anti-anxiety, but the US FDA, protecting the insurance companies (while harassing doctors for prescribing benzodiazepines) will not approve it except for its current use as a pain reliever for fibromyalgia.
Hmmm. Maybe insurance companies could fund Phase III for off-patent drugs, to save money on expensive cancer drugs...
I came across this a few years ago when my father had macular degeneration (abnormal growth of blood vessels in the eyes). Some doctors were experimenting with an off-label treatment using a drug intended for bowel cancer, injecting it into the eyeballs (yuck!). Here in Australia, the restrictions on off-label prescribing are not too onorous - the patient just has to sign a set of terrifying disclaimers. Since the alternative was blindness, he had no hesitation in signing.
The treatment proved to be extremely successful, even restoring earlier damage. The drug company responded by re-labelling and re-packaging the drug, and charging ten times the price! (Fortunately, my father gets his treatment heavily subsidised)
I understand that patients in the UK at that time were less fortunate. The cumbersome off-label regulations prevented many patients for getting the drug, or made it prohibitively expensive. I heard of an elderly couple having to decide which of them was going to go blind, because they couldn't afford enough of the drug for both of them.
I have a friend who is currently facing this nastyness - macular degeneration. Is there any way you can give more of a clue to the name of the actual drug?
(If you and El Reg staffers are OK with it, I'm happy for them to give you my email address OR they can work as an intermediary if necessary - but I would love for her to be able to get some help with this!)
Nor do the drug companies believe you can't put a value on someone's life. They do it all the time with meds costing upwards of $1,000 a dose and more for something that cost a few bucks to make. Who needs illegal drugs when the legals are even more lucrative.
Hold the downvotes and hear me out.
The research isn't there. I know this. Some valid research on cannabis as a cancer cure has been done, but the results are too preliminary and the sample groups too small to draw any real conclusions. But what we do have is enough to suggest that maybe we should be looking deeper into pot as a treatment. Not a cure on its own by any means, but as a possible companion to other treatments that may (emphasis on may) be able to increase effectiveness.
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