Wow. The entire premise of the article aside, for me the idea that medical treatments can be made with physics and not medicine was an incredible, incredible revelation.
This man (not a doctor!) has invented a method to neutralize sperm in a way that would never have occurred to me. He uses the most basic principles of physics (magnetic charge) to neutralize sperm!
Realizing that sperm is negatively charging, he simply coats a short section of the inside of the vas (tiny tube going from testes to the penis, located in the scrotum) with a positively-charged polymer. As sperm travels in this coated tube, the ionic attraction causes damage on a cellular level in the sperm, the pull effect effectively destroying the sperm "tail" and preventing it from fertilizing a female but without hormonal/medical methods!
For me, as an engineer, this was a true revelation.
As a physicist, I have been, on odd occasions of boredom and quarter-life-crisis, tempted to go into medicine. But the only type of medicine I'd be interested in is radiology.
Walk in, cure a patient with physics, walk out, earn $600K a year. Sounds pretty sweet!
What's that? You have cancer? No worries, I have radioactive beams! Zap! You're cured!
Unfortunately you gotta go through many years of the more usual, squishy form of medicine before they'll let you become a radiologist, so I stuck with my existing career path.
In its report, the WHO team agreed that the concept of RISUG was intriguing. But they found fault with the homegrown production methods: Guha and his staff made the concoction themselves in his lab, and the WHO delegation found his facilities wanting by modern pharmaceutical manufacturing standards. Furthermore, they found that Guha’s studies did not meet “international regulatory requirements” for new drug approval—certain data was missing. The final recommendation: WHO should pass on RISUG.
Is this an example of why health care is so incredibly expensive in this country?
Do these "modern pharmaceutical manufacturing standards" actually buy us extra safety?
Do these "modern pharmaceutical manufacturing standards"
actually buy us extra safety?
Yes, but we pay a price:
* Evaluations take a really long time. So it's hard to get the drugs into the hands of people.
* Development is now extremely expensive. That forces just about everyone except the largest drug mega-corporations out of the market.
* Drugs that would be a net benefit to the world sometimes never make it through the entire process because the ROI isn't good enough, or the associated side effects are deemed too harsh. (We would likely not have aspirin today if it hadn't been developed prior to the modern way of drug development... it has too many high-risk side effects)
--
On the plus side:
* The drugs you do get are generally far safer and better understood than they otherwise would be
* You can feel safe that each batch of the drug was made the same way, using the same process, and ends up having the same strength/effectiveness as every other batch of the same drug... even when made by a different company. (We take that for granted now... but it's actually a really big deal if you look at medication from a historical perspective.)
* We have far fewer snake-oil salesmen ripping people off for cures that are, at best, useless and at worst, cause the condition to get worse, or cause birth defects, or some other harm. If we do find the drug doing harm, it gets pulled off the market
It's difficult to assess the situation without having the WHO report or an inspection.
The long and short of it is YES. There are regulations regarding the quality and reproducibility of pharmaceutical manufacturing processes (the CMC - chemistry, manufacturing and controls portion of an IND/NDA) that go a long way to ensure the safety of patients here in the US. Yes, they can be expensive to comply with. But current Good Manufacturing Process (cGMP) regulations are a necessary component to not only protect patients, but also to ensure the validity of the clinical data collected. Without these controls, changes in formulation, lack of reproducible drug substance (Active pharmaceutical ingredients, or APIs), and finished drug products (including container-closure systems), there is no way to be sure what the patient is getting is equivalent to what was used to obtain approval (NDA/BLA/PMA/510k) or consistent across the marketplace.
There was a big push to get manufacturing and studies done "on the cheap" in India, China, SouthAmerica, and Eastern Europe. But over the past few years, many companies have pulled back development in these areas (unless they were planning to launch products in these regions) due to lack of oversight and poor quality of production and study conduct at clinical sites. And rightly so.
If the WHO conducted a thorough audit of his processes and found that they weren't up to par with the FDA or EMA(Europe's FDA) then we should all hope that any development in the US or Europe be conducted in accordance with OUR guidelines and regulations. The India trials could (and should) be used as a benchmark and built upon, but not relied upon out of hand without more diligence and reproducible results across multiple clinical studies (and in various ethnic populations, age groups, and other factors).
The inventor has a duty to obtain results using the most controlled and reproducible manner possible. For all of our sakes.
I'm sure it's not as black and white as that. There's a certain level of safety requirements, and we could probably relax them with only a small percentage of people suffering or dying as a result. We could also raise them, and decrease that number. Etc, etc., it's all a numbers game, and I'm already boring myself with this argument.
Regulation costs account for 90% of bringing a drug to market, on average $1 billion and 10 years of clinical trials for each new drug [1]. Of course, a mere 10 years of clinical trial cannot catch all long-term side effects, and we would be safer if the FDA was more stringent. The flip side is that we would have fewer and more expensive health care options. For better or worse, our regulatory structure is heavily biased towards fewer deaths from approved treatments, very long clinical trials, and expensive health care.
In general, the word "agile" and the health industry have nothing to do with each other.
[1] yeah, yeah, citation needed. I pick facts up by listening to The Economist podcast on the way home, you go find a hyperlink.
This process may be a preferable alternative to condoms, but it does not stop the spread of STDs. From the WHOs perspective there's no obvious benefit.
I suspect this may be the real cause of their lack of interest.
This is presented as though it's an instance of regulatory capture - which it may be - but I don't think we really have enough information to draw that conclusion.
It's entirely possible that there was concern for contamination or the like in the methods used, which would be a fair concern. On the other hand, the current manufacturing methods don't strike me as sufficient reasoning to pass on the concept as a whole, if that's indeed what the final recommendation means, as the article seems to imply.
> Do these "modern pharmaceutical manufacturing standards" actually buy us
> extra safety?
They certainly buy us jobs for bureaucrats. Recently the FDA confiscated all of
the birthing pools (related to the surge in popularity of water births).
Apparently inflatable pools should be classified as 'medical devices.' To quote
the FDA, "pregnacy is an illness and birth is a medical procedure."
My thoughts exactly. All the objections seem to sidestep the revolution that this drug could be. If the science is there, but some more studies are needed, why didn't the WHO back better lab conditions and make a go for it?
Either they thought it was not a viable theory for a drug, or they were avoiding it for profit/political reasons.
The world has been promising male birth control for decades now and the techniques (There are several that all work at almost 100% and are fully reversible) are proven (numerous long term trials, I can think of two from a decade ago off the top of my head, one in Washington state and one in Australia, in their final stages, with fewer side-effects, complications and failures than female birth control) and much more effective than female birth control (100% in most cases). I've been reading about it actively since I was 15 and now I'm 30 and I'm still reading about how it's 5 years away. I want this so bad it hurts, but no one is bringing it to market.
The problem is there isn't (enough of?) an incentive to actually put out these treatments. I guess the money just doesn't compare to female birth control.
The problem is there isn't (enough of?) an incentive to actually put out these treatments. I guess the money just doesn't compare to female birth control
One issue is that public health authorities are (probably quite legitimately) concerned that improved male birth control methods will lead to a decrease in the use of condoms and an increase in STDs.
Looks like the future of space, medicine, and technology belongs to the countries that have not yet hobbled themselves with lawyers and bureaucrats to the point that something must be perfect if it is to exist at all.
Totally agree. If they continue without all the lawyers they will be far more advanced in 20 years.
If this or some offshoot ever makes it to the US, we should see a dramatic decrease in family law, Federal subsides for child support, and could lead to dramatic decrease in crime.
That is, if it becomes as available as womens birth control.
For those who aren't interested in seeing a picture of a scrotum being operated on, the technique described is a polymer that is injected into the vas deferens. As sperm pass the polymer, their membranes and tails are damaged. The technique can be reversed using a solvent.
A 100% effective, low maintenance, reversible birth control method could have an incredible effect on the future of the species. I'm guessing the benefits of fewer unwanted children will be incredible. The possible downsides include a dangerously low birth rate and forced temporary sterilization, but I think the long term effects will be very positive.
That's because you've got a physical identifier of this concept in your mind. Does the idea of a pacemaker feel bad? Probably not, because your "heart" is an abstract idea--you'll probably never see it with your own eyes. A lot of professors teaching dissection have noted your feelings, girls in general don't have a squeamishness to overcome in testicular dissection since they don't have that externality of organs.
I would sign up for this procedure in a heartbeat, but it still doesn't get around the (albeit not perfect) STD protection condoms can provide. If this takes off, people probably won't wear condoms most of the time, and the number of people being diagnosed with STD's will skyrocket.
If this takes off, people probably won't wear condoms most of the time, and the number of people being diagnosed with STD's will skyrocket.
I don't understand this thinking. To me condoms have always been about STD protection and not pregnancy prevention. I'd like to think for most people this idea will not change. I mean if you barely know a girl and she tells you that she's on the pill so you don't need a condom that should be a giant, screaming in your ear red flag to put your clothes back on and run home. I don't see how this will be any different if a guy tells a girl the same thing.
Could be. The question you suggest is then: do we keep this off the market to protect humanity from itself? Should we retract oral contraception on the same grounds? There are many inferences that could be hand-waved here, but, fundamentally, RISUG increases the range of options related to reproductive choice, no more.
Will this cause an increase in sexually transmitted diseases? If straight men don't have to wear condoms for pregnancy-avoidance, and straight men & women don't like to pretend/boast that they've had lots of sex (unlike gay couples), then the pressure to go bareback (without a condom) increases and there might be more HIV/AIDS/STIs
>straight men & women don't like to pretend/boast that they've had lots of sex (unlike gay couples), then the pressure to go bareback (without a condom) increases and there might be more HIV/AIDS/STIs
If I'm reading this right, you're under the impression that a condom protects you against the vast majority of STIs, correct?
Yeah no. Condoms are primarily preventative towards towards diseases that are spread via Semen, vaginal fluids, and skin to skin contact only on the area it covers. Syphilis, Herpes( which can also be spread via oral sex ), Genital Warts, and crabs as a loose example ( There's more ) are not prevented by a condom. Aside from HIV/Aids ( in which case African American women are the highest rate of infected ) that quip was pointless as was this post.
Probably not. Insurance already covers vasectomy since it's much cheaper than paying for a pregnancy/childbirth/child medical expenses/etc and it doesn't seem to have resulted in increase in STD.
Odds are, if you have medical insurance, you can get a vasectomy for a co-pay of $20 and the procedure only takes about 15 minutes.
I'm fairly sure that Planned Parenthood in the US also does it cheaply.
My gut tells me that the guys who are responsible enough to get vasectomies if they really don't want kids are also responsible enough to wear condoms. The converse is likely also true!
Yet another illustration about how broken the health care system is in the US. Pharmaceutical and medical device companies are disincented to produce cost effective treatments, it's really an outrage. Medicine in the US is geared towards costly treatments that are needed on a recurring basis; we're inundated with marketing and profit driven medicine. IMO, the NIH and FDA should be promoting a research-rewarded system that promotes cost effective and potentially society-shifting treatments such as RISUG.
i always wonder why dont we have atleast one country on this planet that has some kind of fast-track approval process for this kind of research and solutions ???
also it shouldn't be costing millions - something like this should be self funded by the govt. ... tax payers are made to pay for many stupid things but research like this should be treated as "Too Big To Fail" !!!!
>“If it’s no longer a crazy Indian idea and it’s something that’s working in India and in rabbits in Ohio and in the first 20 men in the US,” Lissner says, “then there’s got to be a point where there’s just no excuse for a Gates or a Buffett not to get on board.”
The words "crazy Indian idea" hit me as offensive at first. But I guess that's just the way the world perceives us and its up to us to change that.
[+] [-] ComputerGuru|15 years ago|reply
This man (not a doctor!) has invented a method to neutralize sperm in a way that would never have occurred to me. He uses the most basic principles of physics (magnetic charge) to neutralize sperm!
Realizing that sperm is negatively charging, he simply coats a short section of the inside of the vas (tiny tube going from testes to the penis, located in the scrotum) with a positively-charged polymer. As sperm travels in this coated tube, the ionic attraction causes damage on a cellular level in the sperm, the pull effect effectively destroying the sperm "tail" and preventing it from fertilizing a female but without hormonal/medical methods!
For me, as an engineer, this was a true revelation.
[+] [-] hugh3|15 years ago|reply
Walk in, cure a patient with physics, walk out, earn $600K a year. Sounds pretty sweet!
What's that? You have cancer? No worries, I have radioactive beams! Zap! You're cured!
Unfortunately you gotta go through many years of the more usual, squishy form of medicine before they'll let you become a radiologist, so I stuck with my existing career path.
[+] [-] growt|15 years ago|reply
magnetic charge? really? I don't think so.
[+] [-] haberman|15 years ago|reply
Is this an example of why health care is so incredibly expensive in this country?
Do these "modern pharmaceutical manufacturing standards" actually buy us extra safety?
[+] [-] Sukotto|15 years ago|reply
* Evaluations take a really long time. So it's hard to get the drugs into the hands of people.
* Development is now extremely expensive. That forces just about everyone except the largest drug mega-corporations out of the market.
* Drugs that would be a net benefit to the world sometimes never make it through the entire process because the ROI isn't good enough, or the associated side effects are deemed too harsh. (We would likely not have aspirin today if it hadn't been developed prior to the modern way of drug development... it has too many high-risk side effects)
--
On the plus side:
* The drugs you do get are generally far safer and better understood than they otherwise would be
* You can feel safe that each batch of the drug was made the same way, using the same process, and ends up having the same strength/effectiveness as every other batch of the same drug... even when made by a different company. (We take that for granted now... but it's actually a really big deal if you look at medication from a historical perspective.)
* We have far fewer snake-oil salesmen ripping people off for cures that are, at best, useless and at worst, cause the condition to get worse, or cause birth defects, or some other harm. If we do find the drug doing harm, it gets pulled off the market
[+] [-] briggsbio|15 years ago|reply
The long and short of it is YES. There are regulations regarding the quality and reproducibility of pharmaceutical manufacturing processes (the CMC - chemistry, manufacturing and controls portion of an IND/NDA) that go a long way to ensure the safety of patients here in the US. Yes, they can be expensive to comply with. But current Good Manufacturing Process (cGMP) regulations are a necessary component to not only protect patients, but also to ensure the validity of the clinical data collected. Without these controls, changes in formulation, lack of reproducible drug substance (Active pharmaceutical ingredients, or APIs), and finished drug products (including container-closure systems), there is no way to be sure what the patient is getting is equivalent to what was used to obtain approval (NDA/BLA/PMA/510k) or consistent across the marketplace. There was a big push to get manufacturing and studies done "on the cheap" in India, China, SouthAmerica, and Eastern Europe. But over the past few years, many companies have pulled back development in these areas (unless they were planning to launch products in these regions) due to lack of oversight and poor quality of production and study conduct at clinical sites. And rightly so. If the WHO conducted a thorough audit of his processes and found that they weren't up to par with the FDA or EMA(Europe's FDA) then we should all hope that any development in the US or Europe be conducted in accordance with OUR guidelines and regulations. The India trials could (and should) be used as a benchmark and built upon, but not relied upon out of hand without more diligence and reproducible results across multiple clinical studies (and in various ethnic populations, age groups, and other factors). The inventor has a duty to obtain results using the most controlled and reproducible manner possible. For all of our sakes.
[+] [-] pavel_lishin|15 years ago|reply
[+] [-] jacoblyles|15 years ago|reply
In general, the word "agile" and the health industry have nothing to do with each other.
[1] yeah, yeah, citation needed. I pick facts up by listening to The Economist podcast on the way home, you go find a hyperlink.
[+] [-] zemaj|15 years ago|reply
I suspect this may be the real cause of their lack of interest.
[+] [-] T-R|15 years ago|reply
It's entirely possible that there was concern for contamination or the like in the methods used, which would be a fair concern. On the other hand, the current manufacturing methods don't strike me as sufficient reasoning to pass on the concept as a whole, if that's indeed what the final recommendation means, as the article seems to imply.
[+] [-] pyre|15 years ago|reply
[+] [-] lhnn|15 years ago|reply
Either they thought it was not a viable theory for a drug, or they were avoiding it for profit/political reasons.
[+] [-] solarmist|15 years ago|reply
The problem is there isn't (enough of?) an incentive to actually put out these treatments. I guess the money just doesn't compare to female birth control.
[+] [-] hugh3|15 years ago|reply
One issue is that public health authorities are (probably quite legitimately) concerned that improved male birth control methods will lead to a decrease in the use of condoms and an increase in STDs.
[+] [-] puredemo|15 years ago|reply
[+] [-] noonespecial|15 years ago|reply
[+] [-] jgervin|15 years ago|reply
If this or some offshoot ever makes it to the US, we should see a dramatic decrease in family law, Federal subsides for child support, and could lead to dramatic decrease in crime. That is, if it becomes as available as womens birth control.
[+] [-] Aloisius|15 years ago|reply
[+] [-] w1ntermute|15 years ago|reply
[+] [-] thasmin|15 years ago|reply
[+] [-] jcromartie|15 years ago|reply
[+] [-] sudont|15 years ago|reply
[+] [-] deskamess|15 years ago|reply
sudonts response below is also noted, and agreed with.
[+] [-] grantbachman|15 years ago|reply
[+] [-] matwood|15 years ago|reply
I don't understand this thinking. To me condoms have always been about STD protection and not pregnancy prevention. I'd like to think for most people this idea will not change. I mean if you barely know a girl and she tells you that she's on the pill so you don't need a condom that should be a giant, screaming in your ear red flag to put your clothes back on and run home. I don't see how this will be any different if a guy tells a girl the same thing.
[+] [-] hoprocker|15 years ago|reply
[+] [-] city41|15 years ago|reply
[+] [-] unknown|15 years ago|reply
[deleted]
[+] [-] rmc|15 years ago|reply
[+] [-] Wickk|15 years ago|reply
If I'm reading this right, you're under the impression that a condom protects you against the vast majority of STIs, correct?
Yeah no. Condoms are primarily preventative towards towards diseases that are spread via Semen, vaginal fluids, and skin to skin contact only on the area it covers. Syphilis, Herpes( which can also be spread via oral sex ), Genital Warts, and crabs as a loose example ( There's more ) are not prevented by a condom. Aside from HIV/Aids ( in which case African American women are the highest rate of infected ) that quip was pointless as was this post.
[+] [-] HeyLaughingBoy|15 years ago|reply
Odds are, if you have medical insurance, you can get a vasectomy for a co-pay of $20 and the procedure only takes about 15 minutes.
I'm fairly sure that Planned Parenthood in the US also does it cheaply.
My gut tells me that the guys who are responsible enough to get vasectomies if they really don't want kids are also responsible enough to wear condoms. The converse is likely also true!
[+] [-] spidaman|15 years ago|reply
[+] [-] ph0rque|15 years ago|reply
[+] [-] bakbak|15 years ago|reply
also it shouldn't be costing millions - something like this should be self funded by the govt. ... tax payers are made to pay for many stupid things but research like this should be treated as "Too Big To Fail" !!!!
[+] [-] unknown|15 years ago|reply
[deleted]
[+] [-] rrrazdan|15 years ago|reply
The words "crazy Indian idea" hit me as offensive at first. But I guess that's just the way the world perceives us and its up to us to change that.
[+] [-] shawndumas|15 years ago|reply
[+] [-] KeyBoardG|15 years ago|reply
[+] [-] jonsantana|15 years ago|reply
[+] [-] hippich|15 years ago|reply
[+] [-] r00fus|15 years ago|reply
Infertility is a complex problem with multiple possible causes.
[+] [-] BasDirks|15 years ago|reply
[+] [-] saool|15 years ago|reply
[+] [-] jjclarkson|15 years ago|reply
[+] [-] unknown|15 years ago|reply
[deleted]
[+] [-] armored|15 years ago|reply