Aa
Eyedrops to remove eye cataracts?
I read at the link below that scientists have developed eye drops that can remove cataracts, but they are still in testing mode.
Any one have any idea as to when this will be available to the puplic?
http://www.sciencealert.com/scientists-have-developed-an-eye-drop-that-can-dissolve-cataracts-from-eyes
Any one have any idea as to when this will be available to the puplic?
http://www.sciencealert.com/scientists-have-developed-an-eye-drop-that-can-dissolve-cataracts-from-eyes
Best Answer
My claim is based on basic logic that I explained. I noted that they might not actively block the treatment, but that there is no rational argument why any insurance company would spend money lobbying in favor of FDA approval of a cheaper treatment for cataracts.
Business people don't spend their businesses money with not only no foreseeable return on their investment, but in fact a reduction in their bottom line. Unless you can provide a counter argument to my point, then it is your claim which seems out of touch with reality and contrary to business 101. It is your claim that doesn't cite evidence or logic which is more akin to the poorly reasoned conspiracy theories out there that aren't supported by logic or evidence.
The fact that I linked to articles that might be a couple of years old is irrelevant when there is no indication that anything has changed that I have seen or that you can post. I could post lots of other articles on the topic but hadn't seen reason to take time collecting more when no rational counter argument is offered, merely deriding a conclusion that you don't seem to wish to believe despite credible sources to the contrary. I am posting on a topic I know something about and have researched in detail. I am posting on a topic I was personally impacted by because I expended effort to go to Europe to get a lens the FDA hadn't approved.
Business people don't spend their businesses money with not only no foreseeable return on their investment, but in fact a reduction in their bottom line. Unless you can provide a counter argument to my point, then it is your claim which seems out of touch with reality and contrary to business 101. It is your claim that doesn't cite evidence or logic which is more akin to the poorly reasoned conspiracy theories out there that aren't supported by logic or evidence.
The fact that I linked to articles that might be a couple of years old is irrelevant when there is no indication that anything has changed that I have seen or that you can post. I could post lots of other articles on the topic but hadn't seen reason to take time collecting more when no rational counter argument is offered, merely deriding a conclusion that you don't seem to wish to believe despite credible sources to the contrary. I am posting on a topic I know something about and have researched in detail. I am posting on a topic I was personally impacted by because I expended effort to go to Europe to get a lens the FDA hadn't approved.
Bring up all the 2 year old articles you want to cloud the issue.
Your claim that insurance companies will block new treatments ("Therefore it is in their financial interest to not see cheaper treatments approved.") is definitely in the realm of conspiracy theory.
Your claim that insurance companies will block new treatments ("Therefore it is in their financial interest to not see cheaper treatments approved.") is definitely in the realm of conspiracy theory.
Oops, I meant of course Stanford's Hoover Institution, not Administration :-). I think I'd written about Hoover's administration before and muscle memory kicked in. They should let you edit your own comments to fix typos.
An American doctor writing in Cataract and Refractive Surgery Today (a mainstream publication, not some conspiracy newsletter):
http://crstoday.com/2013/02/why-i-left-the-united-states-to-practice-medicine
"Why I Left the United States to Practice Medicine
... In summary, my decision to move to the United Kingdom has meant that I have had access to the best technology at least 2 to 5 and sometimes 10 years or more before it became available in the United States. ...
Complication repair is the most common reason for American patients to come to my clinic, as their surgeons in the United States are unable to offer them the best treatment options, and many of these patients are actually referred to us surgeons in Europe by US surgeons for this reason."
Dr. Mark Packer, a nationally prominent surgeon who is often quoted in the literature, wrote this a few years ago:
http://tinyurl.com/qc3keel
"FDA: For Development Abroad
What an interesting geopolitical puzzle modern medicine has become. The US remains the center of innovation, yet it is those living elsewhere who are the early beneficiaries of our success. The US FDA sets the highest standards in the world for the evaluation of new technology, but the barriers to entry have become so high that the likelihood of useful devices from outside the US getting approval here are rapidly diminishing. And CMS, facing budgetary constraints, continually devalues the procedures by which this new technology is applied, making the economic model even less appealing to innovative medical technology companies....
Long story short, I’m thinking about opening a clinic overseas. "
Unfortunately he didn't open that clinic. The Tufts Center for the Study of Drug Development, the major source of such figures, notes:
http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study
"Developing a new prescription medicine that gains marketing approval, a process often lasting longer than a decade, is estimated to cost $2,558 million, according to a new study by the Tufts Center for the Study of Drug Development. ...
The $802 million, equal to $1,044 million in 2013 dollars, indicates that the cost to develop and win marketing approval for a new drug has increased by 145% between the two study periods, or at a compound annual growth rate of 8.5%."
An article from Stanford University's Hoover Administration by NYU law professor RIchard Epstein, considered one of the most cited and influential legal scholars:
http://www.hoover.org/research/tale-how-insulin-came-market
"I have attended countless meetings of doctors and research scientists in which the role of the FDA was discussed. The uniform view is that the FDA slows down medical progress by about three to five years. These doctors, however, are not willing to state this publicly for fear of administrative revenge. "
A Wall Street Journal piece (not exactly a fringe publication) on:
http://abigail-alliance.org/WSJ%20OP-ED%20FDA's_Deadly_Track_Rec%2008-14-07.pdf
"The FDA's Deadly Track Record"
Two GMU economics professors have a website on the topic:
http://www.fdareview.org/index.shtml
"Is the FDA Safe and Effective?"
The issue is the speed of approval and costs and standards. I went to Europe to get the Symfony lens which isn't approved here yet, and there are a number of lenses that have been available in Europe for years that no one seems to be even trying to get approved within the US. The issue doesn't require some sort of belief in a secret coverup, it is no secret that these lenses aren't available here but are available overseas.
There is a vast difference between silly fantasies of covering up 100 MPG vehicles where there isn't credible evidence and the claims are scientifically implausible and only a tiny fringe group accepts the claims, and an awareness of the realities of how the political process works and issues with the FDA that have been written about by numerous sources and are concerns shared by a large number of people in the industry and economists.
I referred above to nobel laureate economist James Buchanan who won his prize for the field of "regulatory capture" which studies how governments should be expected to operate in the real world, and evidence of how they do, "politics without the romance" vs uninformed wishful thinking about them. Economists in the field have published many critiques of the FDA.
http://crstoday.com/2013/02/why-i-left-the-united-states-to-practice-medicine
"Why I Left the United States to Practice Medicine
... In summary, my decision to move to the United Kingdom has meant that I have had access to the best technology at least 2 to 5 and sometimes 10 years or more before it became available in the United States. ...
Complication repair is the most common reason for American patients to come to my clinic, as their surgeons in the United States are unable to offer them the best treatment options, and many of these patients are actually referred to us surgeons in Europe by US surgeons for this reason."
Dr. Mark Packer, a nationally prominent surgeon who is often quoted in the literature, wrote this a few years ago:
http://tinyurl.com/qc3keel
"FDA: For Development Abroad
What an interesting geopolitical puzzle modern medicine has become. The US remains the center of innovation, yet it is those living elsewhere who are the early beneficiaries of our success. The US FDA sets the highest standards in the world for the evaluation of new technology, but the barriers to entry have become so high that the likelihood of useful devices from outside the US getting approval here are rapidly diminishing. And CMS, facing budgetary constraints, continually devalues the procedures by which this new technology is applied, making the economic model even less appealing to innovative medical technology companies....
Long story short, I’m thinking about opening a clinic overseas. "
Unfortunately he didn't open that clinic. The Tufts Center for the Study of Drug Development, the major source of such figures, notes:
http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study
"Developing a new prescription medicine that gains marketing approval, a process often lasting longer than a decade, is estimated to cost $2,558 million, according to a new study by the Tufts Center for the Study of Drug Development. ...
The $802 million, equal to $1,044 million in 2013 dollars, indicates that the cost to develop and win marketing approval for a new drug has increased by 145% between the two study periods, or at a compound annual growth rate of 8.5%."
An article from Stanford University's Hoover Administration by NYU law professor RIchard Epstein, considered one of the most cited and influential legal scholars:
http://www.hoover.org/research/tale-how-insulin-came-market
"I have attended countless meetings of doctors and research scientists in which the role of the FDA was discussed. The uniform view is that the FDA slows down medical progress by about three to five years. These doctors, however, are not willing to state this publicly for fear of administrative revenge. "
A Wall Street Journal piece (not exactly a fringe publication) on:
http://abigail-alliance.org/WSJ%20OP-ED%20FDA's_Deadly_Track_Rec%2008-14-07.pdf
"The FDA's Deadly Track Record"
Two GMU economics professors have a website on the topic:
http://www.fdareview.org/index.shtml
"Is the FDA Safe and Effective?"
The issue is the speed of approval and costs and standards. I went to Europe to get the Symfony lens which isn't approved here yet, and there are a number of lenses that have been available in Europe for years that no one seems to be even trying to get approved within the US. The issue doesn't require some sort of belief in a secret coverup, it is no secret that these lenses aren't available here but are available overseas.
There is a vast difference between silly fantasies of covering up 100 MPG vehicles where there isn't credible evidence and the claims are scientifically implausible and only a tiny fringe group accepts the claims, and an awareness of the realities of how the political process works and issues with the FDA that have been written about by numerous sources and are concerns shared by a large number of people in the industry and economists.
I referred above to nobel laureate economist James Buchanan who won his prize for the field of "regulatory capture" which studies how governments should be expected to operate in the real world, and evidence of how they do, "politics without the romance" vs uninformed wishful thinking about them. Economists in the field have published many critiques of the FDA.
Since cataracts are mostly seen in those of us who have reached a certain (mature) age, I would think that Medicare Insurance would be the primary driver in promoting something that would reduce the costs.
Suggesting that such a treatment would be covered up seems a lot like those 100 plus MPG carburetors that GM and Ford have supposedly kept hidden through the years.
Suggesting that such a treatment would be covered up seems a lot like those 100 plus MPG carburetors that GM and Ford have supposedly kept hidden through the years.
re: "IF (and its a very big if")"
Yup, agreed that is a very big "if" at this point. Though I guess I see reason to be hopeful it may be at least somewhat helpful for some cataracts (which in much of the world is far better than the non-treatment they have now). I'm hopeful though it will lead to research into related chemicals (which of course may be patentable and high cost to develop and hence may be high cost at first, justifying expenditure for FDA approval.. but where eventually the patents will expire and competition will drive the price down so eventually it will be low cost).
re: "it will be the insurers providers that will drive the usage"
On the surface that would seem logical and most people I suspect would think so if it reduces costs. However the situation is unfortunately more complicated than it appears on the surface. The profit insurers make tends to be a certain % of their revenue (in fact laws attempt to limit that %, medical loss ratio rules, though they have unintended consequences I won't go into). The higher the healthcare costs they pay out are, the higher the premiums are and therefore the higher their profits are. If *all* insurers need to pay for an expensive treatment, it is factored into all their rates and they benefit from the treatment being expensive.
An individual insurer won't pay out more on a particular hospital bill than they need to, but the industry as a whole benefits from higher healthcare costs and from not having cheaper treatments approved. If a cheaper treatment is FDA approved, of course they will cover it since their competition will so they don't wish to lose business by not covering something and by having higher than needed premiums to pay for a more expensive treatment.
Therefore it is in their financial interest to not see cheaper treatments approved. They may not actively work against approval, but they may at least not to lobby to try to force them to be approved which is more likely the case in this instance. Many people won't actively work to do something bad like prevent a cheaper cure, but will see no reason to contribute effort to push for a cheaper treatment that will cost them money. (though they may rationalize that they consider it "risky", motivated reasoning to help them believe they are doing the right thing even if its motivated by personal interest). Also of course most people try to do good by the world (or at least not do bad things), but a subset of people are mercenary and driven by money and the realm of lobbying tends to draw in such people even if they are the minority. Often the "squeaky wheel" gets the attention in the realm of lobbying, special interest groups have more motivation to lobby than the general public. (except in this case there is a vast enough number in the general public that are impacted by cataracts that they are likely to counteract special interest influence).
Yup, agreed that is a very big "if" at this point. Though I guess I see reason to be hopeful it may be at least somewhat helpful for some cataracts (which in much of the world is far better than the non-treatment they have now). I'm hopeful though it will lead to research into related chemicals (which of course may be patentable and high cost to develop and hence may be high cost at first, justifying expenditure for FDA approval.. but where eventually the patents will expire and competition will drive the price down so eventually it will be low cost).
re: "it will be the insurers providers that will drive the usage"
On the surface that would seem logical and most people I suspect would think so if it reduces costs. However the situation is unfortunately more complicated than it appears on the surface. The profit insurers make tends to be a certain % of their revenue (in fact laws attempt to limit that %, medical loss ratio rules, though they have unintended consequences I won't go into). The higher the healthcare costs they pay out are, the higher the premiums are and therefore the higher their profits are. If *all* insurers need to pay for an expensive treatment, it is factored into all their rates and they benefit from the treatment being expensive.
An individual insurer won't pay out more on a particular hospital bill than they need to, but the industry as a whole benefits from higher healthcare costs and from not having cheaper treatments approved. If a cheaper treatment is FDA approved, of course they will cover it since their competition will so they don't wish to lose business by not covering something and by having higher than needed premiums to pay for a more expensive treatment.
Therefore it is in their financial interest to not see cheaper treatments approved. They may not actively work against approval, but they may at least not to lobby to try to force them to be approved which is more likely the case in this instance. Many people won't actively work to do something bad like prevent a cheaper cure, but will see no reason to contribute effort to push for a cheaper treatment that will cost them money. (though they may rationalize that they consider it "risky", motivated reasoning to help them believe they are doing the right thing even if its motivated by personal interest). Also of course most people try to do good by the world (or at least not do bad things), but a subset of people are mercenary and driven by money and the realm of lobbying tends to draw in such people even if they are the minority. Often the "squeaky wheel" gets the attention in the realm of lobbying, special interest groups have more motivation to lobby than the general public. (except in this case there is a vast enough number in the general public that are impacted by cataracts that they are likely to counteract special interest influence).
IF (and it's a very big if) this proves to actually work it will be the insurance providers that will drive the usage.
At this point, the only benefit is to the spam internet floater removal eye-drops, which now have another phony benefit to promote to the gullible.
At this point, the only benefit is to the spam internet floater removal eye-drops, which now have another phony benefit to promote to the gullible.
I should add that of course FDA approval is costly (another reason for high drug costs initially in the US), which may be an impediment to an eye drop being available in the US even if it is proven effective and available elsewhere. Some companies now with proven treatments overseas don't even bother to try to get their devices approved in the US due to FDA costs.. Hopefully overseas trials and approvals will be able to be taken into account in the future to streamline approvals, I know that is an issue being debated, there are folks trying to improve the FDA process. Given the prevalence of cataracts, it seems likely if an eye drop is proven effective and available elsewhere, that somehow it'll eventually wind up being available in the US at a decent price. Politicians are often older and more in the demographic at risk of cataracts themselves :-), or old enough to be aware of how many of their constituents have to deal with them, and the cost issue will come into play if it is cheaper.
I was mostly pessimistic about the political process and those who engage in it. I wasn't pessimistic about most researchers and doctors, who typically aren't involved in the political process and are focused on finding the best ways to treat people. I said most doctors I assume care more about helping people than about their careers. There are however a minority that are politically driven, as are some in the support businesses for cataract surgery. Also doctors are human and can have subconscious biases at work influencing their evaluation of things when their livelihood may be at risk even if they would prefer to be immune to such things,.
There is limited funding for medical research (though I suspect this type of research is trivial in cost compared to many areas), but as you acknowledged earlier this may potentially save money and so from an investment point of view it seems likely the return on investment would be large. Perhaps it isn't appropriate for government to fund it (I think most such research should be funded by private means, including charities), but many private individuals will find it a worthwhile goal. I could see people who may have early cataracts personally deciding its worth crowdfunding studies and participating in them.
Dr. Robin's opinion makes assumptions about things such as the cost of the eye drops, being pessimistic about what that might be, and that isn't a medical issue. Although in theory its possible he is right in his concern, I'd say the odds are extremely high it could be a more cost effective approach. Even if in many places like the US cataract surgery may be available and cost effective, that isn't the case in much of the world, where:
https://www.wikiwand.com/en/Cataract
"Cataracts are the cause of half of blindness and 33% of visual impairment worldwide. "
So if there is any chance eye drops may be a more cost effective treatment it seems worthwhile from a humanitarian point of view, and given the potential for it to be cheaper even in developed countries it seems worthwhile from an investment point of view. The idea that surgery is good enough and there is no need to investigate a potential pharmaceutical cure is strange, to say the least.
I've been in the entrepreneurial world for decades and know something about business, including now the supply chain world in healthcare. Looking up the current cost to labs of lanosterol shows that even in small quantities currently its cost by itself should add little to the cost of a basic eye drop like lubricant drops or allergy drops which are very low cost now when subject to competition. (and in bulk quantities for production the cost for lanosterol should drop).
The reason some medical treatments are costly is due to patent protection and lack of supplier competition and due to the need to recoup the costs of trying many different treatments. In this case the candidate substance is already known, and likely to be safe given it is present in the body. In the case of a natural substance it is unlikely they can find a way to patent protect it since such things aren't usually protectable (though granted some variant chemical that performs better might be, the research suggests that even the natural substance by itself might be sufficient). Given the cost of many OTC eye drops, and the potential for competition, to me it strains credulity to think eye drops would be comparable to the cost of cataract surgery.
Obviously he is right that even if the drops work, the side effect and complication profile will need to be compared with cataract surgery to determine which approach is better for those that can afford the cataract surgery option. However without research it isn't clear how that will turn out, and it is of course better than nothing for those that can't get surgery in some parts of the world. Obviously eye drops can have issues, but the level of concern he is expressing prior to research seems a bit much (especially given even cataract surgery as I noted may lead to the use of eye drops afterwards, including extended use for those who wind up with dr eye problems as a side effect of surgery).
Although doctors participate in the system, the issue of approval is less about medicine than about politics. More relevant than medicine are the economics of "public choice theory", the application of economic principles to politics to examine the incentives of the parties involved. Its initial proponent James Buchanan won a nobel prize and who termed it "politics without the romance". (and about "regulatory capture theory", whose inventor George Stigler also won a nobel prize, which explains that regulators tend to be captured by the industries they regulate by default and regulations working more for their benefit than for the public's).
I wasn't pessimistic about the eventual outcome since enough private people around the world are interested in finding cures, and because the existence of political opposition doesn't mean it will succeed, merely that it will delay things. The issue of political opposition to new treatments is apparent to those who study the history of the FDA and drug approval costs and times for approval rising drastically over the years. That is in part because bureaucrats like all humans respond to incentives (as public choice theory details), and they tend to be punished more for releasing a drug/device that causes any harm than they are for holding back a treatment that might have helped people. Those who are harmed by a side effect are easily seen, those who weren't helped are often unaware they weren't helped. In addition the existing companies with products on the market don't like competition, and as regulatory capture theory explains they often use the regulatory process to try to limit competition by driving up the costs and red tape for competitors to enter the market.
There is limited funding for medical research (though I suspect this type of research is trivial in cost compared to many areas), but as you acknowledged earlier this may potentially save money and so from an investment point of view it seems likely the return on investment would be large. Perhaps it isn't appropriate for government to fund it (I think most such research should be funded by private means, including charities), but many private individuals will find it a worthwhile goal. I could see people who may have early cataracts personally deciding its worth crowdfunding studies and participating in them.
Dr. Robin's opinion makes assumptions about things such as the cost of the eye drops, being pessimistic about what that might be, and that isn't a medical issue. Although in theory its possible he is right in his concern, I'd say the odds are extremely high it could be a more cost effective approach. Even if in many places like the US cataract surgery may be available and cost effective, that isn't the case in much of the world, where:
https://www.wikiwand.com/en/Cataract
"Cataracts are the cause of half of blindness and 33% of visual impairment worldwide. "
So if there is any chance eye drops may be a more cost effective treatment it seems worthwhile from a humanitarian point of view, and given the potential for it to be cheaper even in developed countries it seems worthwhile from an investment point of view. The idea that surgery is good enough and there is no need to investigate a potential pharmaceutical cure is strange, to say the least.
I've been in the entrepreneurial world for decades and know something about business, including now the supply chain world in healthcare. Looking up the current cost to labs of lanosterol shows that even in small quantities currently its cost by itself should add little to the cost of a basic eye drop like lubricant drops or allergy drops which are very low cost now when subject to competition. (and in bulk quantities for production the cost for lanosterol should drop).
The reason some medical treatments are costly is due to patent protection and lack of supplier competition and due to the need to recoup the costs of trying many different treatments. In this case the candidate substance is already known, and likely to be safe given it is present in the body. In the case of a natural substance it is unlikely they can find a way to patent protect it since such things aren't usually protectable (though granted some variant chemical that performs better might be, the research suggests that even the natural substance by itself might be sufficient). Given the cost of many OTC eye drops, and the potential for competition, to me it strains credulity to think eye drops would be comparable to the cost of cataract surgery.
Obviously he is right that even if the drops work, the side effect and complication profile will need to be compared with cataract surgery to determine which approach is better for those that can afford the cataract surgery option. However without research it isn't clear how that will turn out, and it is of course better than nothing for those that can't get surgery in some parts of the world. Obviously eye drops can have issues, but the level of concern he is expressing prior to research seems a bit much (especially given even cataract surgery as I noted may lead to the use of eye drops afterwards, including extended use for those who wind up with dr eye problems as a side effect of surgery).
Although doctors participate in the system, the issue of approval is less about medicine than about politics. More relevant than medicine are the economics of "public choice theory", the application of economic principles to politics to examine the incentives of the parties involved. Its initial proponent James Buchanan won a nobel prize and who termed it "politics without the romance". (and about "regulatory capture theory", whose inventor George Stigler also won a nobel prize, which explains that regulators tend to be captured by the industries they regulate by default and regulations working more for their benefit than for the public's).
I wasn't pessimistic about the eventual outcome since enough private people around the world are interested in finding cures, and because the existence of political opposition doesn't mean it will succeed, merely that it will delay things. The issue of political opposition to new treatments is apparent to those who study the history of the FDA and drug approval costs and times for approval rising drastically over the years. That is in part because bureaucrats like all humans respond to incentives (as public choice theory details), and they tend to be punished more for releasing a drug/device that causes any harm than they are for holding back a treatment that might have helped people. Those who are harmed by a side effect are easily seen, those who weren't helped are often unaware they weren't helped. In addition the existing companies with products on the market don't like competition, and as regulatory capture theory explains they often use the regulatory process to try to limit competition by driving up the costs and red tape for competitors to enter the market.
I don't share that pessimism. There are always exceptions to everything but all medical researchers are essentially trying to put themselves out of business. The current ad MD Anderson says it wants to get rid of cancer completely. Do you or anyone really think that they are other than fully committed to curing cancer even though if there were no cancer there would be no MD Anderson Cancer Hospital?
Dr. Robin's opinion is valid even if you do not agree. There is limited money, time and talent to do medical research. Which would be the better use of precious research dollars. Prevent cataracts where there is a fabulous treatment or glaucoma or macular degeneration cure where a huge amount of blindness is caused with not very good treatment ?
JCH MD
Dr. Robin's opinion is valid even if you do not agree. There is limited money, time and talent to do medical research. Which would be the better use of precious research dollars. Prevent cataracts where there is a fabulous treatment or glaucoma or macular degeneration cure where a huge amount of blindness is caused with not very good treatment ?
JCH MD
re: "huge expense for insurance companies and government health systems such as NHS and Medicare/Medicaid. If there were any simple, inexpensive way to prevent, reverse or clear cataracts without surgery that would be investigated and studied by these organizations. "
I agree that many private organizations will attempt to research potential treatments, so that if a treatment has potential it will be validated. I'll just note that there may be political pressure for government research not to fund this and to be cautious about approvals. Unfortunately while most eye surgeons I'm sure wish to help people even if it impacts their careers, there are some that will let their personal self interest influence their views on this and their lobbying. There was a letter to the editor already in the Baltimore Sun where a eye doctor, actually a professor, argues against money being spent to research the drops:
http://www.baltimoresun.com/news/opinion/readersrespond/bs-ed-cataracts-letter-20150728-story.html
I found the arguments to be misguided and illustrative of the potential roadblocks that might arise if there is a viable drug treatment.
I agree that many private organizations will attempt to research potential treatments, so that if a treatment has potential it will be validated. I'll just note that there may be political pressure for government research not to fund this and to be cautious about approvals. Unfortunately while most eye surgeons I'm sure wish to help people even if it impacts their careers, there are some that will let their personal self interest influence their views on this and their lobbying. There was a letter to the editor already in the Baltimore Sun where a eye doctor, actually a professor, argues against money being spent to research the drops:
http://www.baltimoresun.com/news/opinion/readersrespond/bs-ed-cataracts-letter-20150728-story.html
I found the arguments to be misguided and illustrative of the potential roadblocks that might arise if there is a viable drug treatment.
I'll add that while the absence of evidence that something works (the carnosine drops) is *not* evidence of the absence of a therapeutic effect, it does suggest skepticism that the drops are useful. There are vast numbers of people with cataracts around the world, many of whom can't afford surgery. There are animals with cataracts to conduct tests on. Conducting tests on such drops should be a rather trivial sort of clinical trial since there are many potential subjects out there and since people often go for months without treatment it should be possible to ethically give people an inactive control substance in a randomized blind clinical trial before they get real treatment of whatever sort.
Some might worry that an eye surgeon wouldn't conduct such trials since they would lose money if eye drops worked. However in this case that isn't an issue since there are optometrists out there who can't perform eye surgery so they don't lose money if an eye drop proves to work well, but who can diagnose and grade cataracts, so there should be no barriers to finding doctors willing to participate in trials.
When an easily testable treatment has been proposed for several years, and is being sold, but there are no trustworthy clinical tests out there, it suggests the treatment isn't actually effective. Or perhaps its occasionally effective, but isn't something to get your hopes up about. It is also something to be cautious of whether there are safety tests that have been done to ensure it doesn't cause any troubles, I haven't had reason to check on that.
Some might worry that an eye surgeon wouldn't conduct such trials since they would lose money if eye drops worked. However in this case that isn't an issue since there are optometrists out there who can't perform eye surgery so they don't lose money if an eye drop proves to work well, but who can diagnose and grade cataracts, so there should be no barriers to finding doctors willing to participate in trials.
When an easily testable treatment has been proposed for several years, and is being sold, but there are no trustworthy clinical tests out there, it suggests the treatment isn't actually effective. Or perhaps its occasionally effective, but isn't something to get your hopes up about. It is also something to be cautious of whether there are safety tests that have been done to ensure it doesn't cause any troubles, I haven't had reason to check on that.
The above eyedrops are completely worthless, unless of course you are the person selling them and that is where that link leads to. An uncontrolled study on 3 people proves nothing.
The above poster has it completely wrong. Cataract surgery is a huge expense for insurance companies and government health systems such as NHS and Medicare/Medicaid. If there were any simple, inexpensive way to prevent, reverse or clear cataracts without surgery that would be investigated and studied by these organizations.
TV everywhere is filled with all kinds of wrong, misleading and fraudulent information as is the internet.
Anyone interested in preventing cataracts: don't use tobacco or cannabis; don't use alcohol in excess; protect the eye from sunlight exposure; don't get obese and diabetic; eat a great diet, above eye trauma with proper protection, avoid steroid use.
JCH MD
The above poster has it completely wrong. Cataract surgery is a huge expense for insurance companies and government health systems such as NHS and Medicare/Medicaid. If there were any simple, inexpensive way to prevent, reverse or clear cataracts without surgery that would be investigated and studied by these organizations.
TV everywhere is filled with all kinds of wrong, misleading and fraudulent information as is the internet.
Anyone interested in preventing cataracts: don't use tobacco or cannabis; don't use alcohol in excess; protect the eye from sunlight exposure; don't get obese and diabetic; eat a great diet, above eye trauma with proper protection, avoid steroid use.
JCH MD
Actually those are definitely *not* the drops referred to in the study. In fact the drops you refer to are an example of why some are skeptical of the optimism of this paper since there were early claims of promise with carnosine drops that were then never replicated in further better studies in humans, and there is suggestion the good results may have been due to bias on the part of a researcher with a financial interest in the outcome. The reactions I see suggest others think the research in the recent Nature paper indicates far more promise than the carnosine drops. Here is a clip from the PBS link I gave above talking about the carnosine drops:
http://www.pbs.org/newshour/updates/eye-drops-clear-cataracts/
"Horowitz’s skepticism stems in part from prior natural compounds that have been falsely marketed as cures for cataracts, such as the antioxidant carnosine (or N-acetylcarnosine).
'Carnosine is snake oil,' he said. 'It isn’t approved by the FDA. It isn’t approved the Eye Institute. And only one group showed that it could deaggregate lens proteins,' Horowitz said. 'But it’s a natural product, so people can buy it in a health store.' "
An article in the Review of Optometry notes:
http://www.reviewofoptometry.com/content/d/clinical_care/c/35158/
"Our literature search of peer-reviewed publications relating to NAC found that virtually all information on the subject had been published by Dr. Babizhayev and his colleagues. Interestingly, the publishers are not only the research scientists who discovered and patented the formulation of NAC, but they also have disclosed interests in Innovative Vision Products, the manufacturer of Can-C. With this in mind, one may recognize the potential bias that may exist, leaving the scientific and medical community with an interest in further evidenced-based research investigating the efficacy of NAC. ..
To date, no human trial has conclusively displayed clinically significant, reliable data that any one treatment or combination of treatments can produce a delay in onset, reduction in progression, or reversal of signs or symptoms of ARC."
From the wiki entry on this (some of its source links are broken, but the Royal College statement link can be found on archive.org which archives old web content, just give it a broken link and it'll find old copies):
https://www.wikiwand.com/en/Acetylcarnosine
"The Royal College of Ophthalmologists issued the following public statement about NAC as of August 2008:
The evidence for the effectiveness of N-acetyl carnosine eye drops is based on experience on a small number of cases carried out by a Russian researcher team [Babizhayev]. To date, the research has not been corroborated and the results replicated by others. The long-term effect is unknown. Unfortunately, the evidence to date does not support the 'promising potential' of this drug in cataract reversal. More robust data from well conducted clinical trials on adequate sample sizes will be required to support these claims of efficacy. Furthermore, we do not feel the evidence base for the safety is in any way sufficient to recommend its use in the short term. More research is needed.[11]
Babizhayev and colleagues, of the US-based company Innovative Vision Products (IVP), which markets NAC treatments, published another human clinical trial in 2009. They reported positive results for NAC as well as arguing "only certain formulas designed by IVP..are efficacious in the prevention and treatment of senile cataract for long-term use."[12]
In a 2010 book on ocular disease, the current state of this subject is summarized as follows:
Carnosine (β-alanyl-L-hystidine), and its topical prodrug formulation N-acetylcarnosine (NAC), is advertised (especially on the internet) to treat a range of ophthalmic disorders associated with oxidative stress, including age-related and diabetic cataracts. No convincing animal studies or masked clinical trials have been reported.[13]"
http://www.pbs.org/newshour/updates/eye-drops-clear-cataracts/
"Horowitz’s skepticism stems in part from prior natural compounds that have been falsely marketed as cures for cataracts, such as the antioxidant carnosine (or N-acetylcarnosine).
'Carnosine is snake oil,' he said. 'It isn’t approved by the FDA. It isn’t approved the Eye Institute. And only one group showed that it could deaggregate lens proteins,' Horowitz said. 'But it’s a natural product, so people can buy it in a health store.' "
An article in the Review of Optometry notes:
http://www.reviewofoptometry.com/content/d/clinical_care/c/35158/
"Our literature search of peer-reviewed publications relating to NAC found that virtually all information on the subject had been published by Dr. Babizhayev and his colleagues. Interestingly, the publishers are not only the research scientists who discovered and patented the formulation of NAC, but they also have disclosed interests in Innovative Vision Products, the manufacturer of Can-C. With this in mind, one may recognize the potential bias that may exist, leaving the scientific and medical community with an interest in further evidenced-based research investigating the efficacy of NAC. ..
To date, no human trial has conclusively displayed clinically significant, reliable data that any one treatment or combination of treatments can produce a delay in onset, reduction in progression, or reversal of signs or symptoms of ARC."
From the wiki entry on this (some of its source links are broken, but the Royal College statement link can be found on archive.org which archives old web content, just give it a broken link and it'll find old copies):
https://www.wikiwand.com/en/Acetylcarnosine
"The Royal College of Ophthalmologists issued the following public statement about NAC as of August 2008:
The evidence for the effectiveness of N-acetyl carnosine eye drops is based on experience on a small number of cases carried out by a Russian researcher team [Babizhayev]. To date, the research has not been corroborated and the results replicated by others. The long-term effect is unknown. Unfortunately, the evidence to date does not support the 'promising potential' of this drug in cataract reversal. More robust data from well conducted clinical trials on adequate sample sizes will be required to support these claims of efficacy. Furthermore, we do not feel the evidence base for the safety is in any way sufficient to recommend its use in the short term. More research is needed.[11]
Babizhayev and colleagues, of the US-based company Innovative Vision Products (IVP), which markets NAC treatments, published another human clinical trial in 2009. They reported positive results for NAC as well as arguing "only certain formulas designed by IVP..are efficacious in the prevention and treatment of senile cataract for long-term use."[12]
In a 2010 book on ocular disease, the current state of this subject is summarized as follows:
Carnosine (β-alanyl-L-hystidine), and its topical prodrug formulation N-acetylcarnosine (NAC), is advertised (especially on the internet) to treat a range of ophthalmic disorders associated with oxidative stress, including age-related and diabetic cataracts. No convincing animal studies or masked clinical trials have been reported.[13]"
These are the eye drops you are referring to; http://www.ethosvision.com/nac-carnosine-eye-drops/ These are the actual drops that were featured on UK TV with great success on 3 people with varying cataracts. Should have gone mainstream news but I guess there's a lot of money in cataract operations so we know why it didn't! Good luck!
Oops, I should have said that clear lens exchange, CLE (sometimes referred to as refractive lens exchange, RLE) is currently a smaller market for lenses than the cataract market, presumably it has the potential to eventually be used by anyone with presbyopia once the quality, safety and cost are improved enough. So hopefully the prospect of a cataract cure won't put a damper on investment in developing new lenses and better surgical equipment.
The scientific approach behind this appears solid. But as to when the product might be available? That depends on how much funding any researchers get--and funding isn't thick on the ground--plus investors, plus repeated clinical trials, which can take years, plus how many stockholders drop out because of the length of time involved for testing and the results of testing.
If you get Nature Magazine or follow scientific news, you will be able to follow this developing story--but I wouldn't bet on fewer than five years.
If you get Nature Magazine or follow scientific news, you will be able to follow this developing story--but I wouldn't bet on fewer than five years.
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It looks very promising, though it is an early study that needs to be replicated to confirm the results (though I suspect there will be many people inspired to try to confirm the results quickly in their own animal trials around the world). Many media outlets report early results that are never confirmed or are overturned since the claim gets them an audience. In this case it looks like there is reason to be optimistic this is a major breakthrough that will lead to a treatment.
I'll note that the PBS story on the topic mentions in part:
http://www.pbs.org/newshour/updates/eye-drops-clear-cataracts/
"And since lanosterol is a naturally-occurring compound in our bodies, the side effects might be minimal in future human trials, he said.
So that’s it…case closed…cure for cataracts found, right? Not so fast. Some outside experts are remain skeptical. ...
'Not all cataracts are the same, and it is not a single disease,' UCLA ophthalmologist Joseph Horowitz said. "
Even on animals it didn't work on all cataracts, and those it worked on it didn't always eliminate completely. They will of course now study related chemicals to see if there is something that works even better. Another article also notes the reason to be hopeful, though some critique of the study
http://cen.acs.org/articles/93/i30/Cholesterol-like-Molecule-Suggested-Possible.html
"Leo T. Chylack, emeritus professor of ophthalmology at Harvard Medical School, points out that the animal experiments did not have adequate controls and did not involve standard protocols used by many in the cataract field, including how to properly photograph eyes to grade the severity of cataracts."
However I'd guess that even if the critique is on target that it merely calls into question the quantitative assessment of the effect, rather than its existence, but I hadn't read the Nature paper to confirm that assumption.
I'll also note that despite the various references to it taking a few years for human trials, in the case of something like this I suspect there are people in countries with less rigorous rules regarding safety testing before clinical trials who will run studies, or people who will run illegal studies. *If* it does work there will be lots of political pressure on the FDA to approve it quickly, but then there will be pressure from surgeons to take a long time to approve it. I suspect that if it does work it'll be approved outside the US first and either lead people to go overseas or people to use it in an illegal fashion in the US. I don't know how the politics would play out if it does work, if there would be cries from surgeons to limit access in the US to lanosterol (available for other purposes) until its officially approved and lead to a black market for it, or if the government would just let people make their own choice about using it in an unapproved fashion.
I wonder how the stocks of companies depending on cataract related products will do in the near future. Though in the long run its likely people will be getting more clear lens exchange to address presbyopia, that is smaller than the cataract market. Hopefully if this does work it won't impact the development of future better replacement lenses since they will be used for such voluntary lens replacement, or for whatever cataracts can't be treated with this.