21 replies to this topic

[Elus]

I found this 2 minute video about just how difficult it is to develop drugs for the human market. I wonder if anything can be done to make this process easier.

Edited by Elus, 08 March 2012 - 05:11 AM.

[Mind]

Allow more people to take risks. Right now the FDA will not allow you to cook up your own drugs in your basement and take them to cure a disease that you have, even though you are fully aware of the risks and accept all consequences. Try to give the your drug to someone else with the same disease and you will probably end up in prison. There are many terminally ill people very willing to take experimental drugs that haven't been through the incredibly expensive multi-year sometimes multi-decade process of FDA approval. but they are not allowed to, even if they accept all risks and consequences.

[niner]

Allow more people to take risks. Right now the FDA will not allow you to cook up your own drugs in your basement and take them to cure a disease that you have, even though you are fully aware of the risks and accept all consequences.

Yes, this would be a start. One of the consequences that people would have to accept is that society wouldn't want to pick up the tab if they injure themselves. There should be some sort of 'drug experimentation insurance' they could buy to cover such contingencies.

It would also help if people could essentially sign up for trials with no ability to sue if something horrible happened to them, perhaps in exchange for a cash payment. Interesting ethical dilemma: cash payment causes poor people to be guinea pigs for the well off. No one ever said life was fair, right?

Another thing that would change the drug market would be to work out a non-profit drug development model, since the desire for the huge cash bonanza drives a lot of secrecy, misallocated funding, and focus only on diseases with large, affluent markets.

[Mind]

I guess my key point here with risky experimental treatments/drugs was "terminally ill". That removes the rich/poor exploitation aspect. Most serious diseases (cancer, what-not) do not follow income inequality all that closely.

[niner]

I guess my key point here with risky experimental treatments/drugs was "terminally ill". That removes the rich/poor exploitation aspect. Most serious diseases (cancer, what-not) do not follow income inequality all that closely.

I think there are some allowances made for terminal patients ("compassionate use" exceptions), but yeah, that could be opened up some more. Cancer, heart, and metabolic disorders tend if anything to fall more on the well off, but there are a number of third world diseases that afflict huge numbers of people and get very little if any attention from Big Pharma. This appears to be slowly turning around, catalyzed perhaps by people like Victoria Hale, who started a non-profit to bring modern drug development technology to bear on third world diseases, and people like Bill Gates, who has funded a lot of that.

[Ampa-omega]

argh i just wrote my text and lost it..

ok, well,

i was just thinking about this yesterday and IMO the scientific process is screwed up! it is inefficient in terms of a informational management perspective, biology is too complex and the current research paradigm is too outdated, we need a faster way to test biology then mice ( but mice so far seem the best option), and we need a way to make all scientific information free, accessible and then we need to converge the information, we need a better and faster way to do science, categorize the information into a computer database, use current knowledge of Artificial intelligence to have automated research software running and working to categorize the information and find new discoveries. and greed must be removed from science period.

Edited by Ampa-omega, 08 March 2012 - 10:36 PM.

[zeroskater6979]

pharmacogenomics is the next big step

[niner]

we need a faster way to test biology then mice ( but mice so far seem the best option),

We have faster ways, like cell assays, worms, flies, and fish.

and we need a way to make all scientific information free, accessible

That's for sure. We could start by blowing up the journal publishers who hold hostage the information that was paid for with public money and given to the journal company for free. All public funds going to research should be tied to a requirement that results be published only in open access journals.

and then we need to converge the information, we need a better and faster way to do science, categorize the information into a computer database, use current knowledge of Artificial intelligence to have automated research software running and working to categorize the information and find new discoveries.

When someone finally gets this going, it will revolutionize science. Biology is too complex, and the flood of papers is too great for one person to understand it all. An AI is needed here.

and greed must be removed from science period.

Hoo Boy. Good luck with that. Seriously though, greed shouldn't be the ONLY way that we fund drug development or new therapies. Greed is the reason we get a bunch of me-too SSRIs and statins instead of the new breakthrough compounds we really need. We're happy to give the Pentagon a TRILLION dollars a year to "protect" us from non-existent threats, but try and spend a few billion to defeat, y'know, death from aging? The thing that really will kill each and every one of us? (unlike al qaeda, Iran, the North Koreans, or China) Well, that would just be beyond the pale.

[Ampa-omega]

we need a faster way to test biology then mice ( but mice so far seem the best option),

We have faster ways, like cell assays, worms, flies, and fish.

and we need a way to make all scientific information free, accessible

That's for sure. We could start by blowing up the journal publishers who hold hostage the information that was paid for with public money and given to the journal company for free. All public funds going to research should be tied to a requirement that results be published only in open access journals.

haha, niner you have good humor. we definably have other ways, then mice, forgot about that but things really need to be sped up is where i was just getting at, i was thinking about factories of robots and petri dishes for a sec, i don't know if that would work yet but it was a interesting thought. we still need a fast and reliable way to test for agents that is closer to human biology, which mice seem to be for now, who know what the crazy future holds when we could grow human organs in the lab and make research super automated.

Edited by Ampa-omega, 09 March 2012 - 05:25 AM.

[niner]

i was thinking about factories of robots and petri dishes for a sec, i don't know if that would work yet but it was a interesting thought.

The pharmaceutical industry is doing this now, in a process known as High Throughput Screening. These kinds of technologies are beginning to be used for anti-aging research. We need more of it. Here's a picture of an automated pipetter with what I think is a 96 well plate. There are more dense plates with 384 wells. Typical assays use microliters of sample compound solution. It's now common to screen hundreds of thousands of compounds, or even a million or more in a given assay.

 htsa.jpg   95.76KB   2 downloads

[mikeinnaples]

and then we need to converge the information, we need a better and faster way to do science, categorize the information into a computer database, use current knowledge of Artificial intelligence to have automated research software running and working to categorize the information and find new discoveries.

When someone finally gets this going, it will revolutionize science. Biology is too complex, and the flood of papers is too great for one person to understand it all. An AI is needed here.

Wasn't IBM looking at enhancing the 'Watson' software for a purpose very similiar to this?

[CaptainFuture]

Another problem of the current approval process is the fact that the FDA has no incentives to approve drugs. It's always better for them to delay drugs or not approve them at all. If they approve a harmful drug, the media and public will be all over them and they can be sued. If they don't approve a drug or delay a drug, this can cause millions of premature deaths and lots of suffering for the patients but the FDA is fine. As long as people are too stupid to understand that only personal liberty promotes maximum welfare, lots of people are gonna pay a high price.

[niner]

Another problem of the current approval process is the fact that the FDA has no incentives to approve drugs. It's always better for them to delay drugs or not approve them at all. If they approve a harmful drug, the media and public will be all over them and they can be sued. If they don't approve a drug or delay a drug, this can cause millions of premature deaths and lots of suffering for the patients but the FDA is fine.

When it's clear that lives are at stake, the FDA approves drugs very quickly. They call those 'fast track' approvals. They would be more likely to drag their heels on a me-too SSRI or something like that. The FDA just reflects what the public demands. The public demands risk aversion, so the FDA is risk averse. Maybe we need to create a new class of "no-litigation drugs". If the drug hurts you, tough. You aren't allowed to sue. On the other hand, you get the drug years sooner, for less money. The chickens can wait for the full-tort version, and pay a lot more for it. Of course, by the time it's available, it wouldn't be necessary because of post-marketing surveillance on the no-sue version. Maybe they could both come out on the same day, at different price points.

[tham]

Countless drugs, including lifesaving ones in cancer and other
terminal diseases, which have been around in the rest of the world
for up to decades, are still not available in the US because of
your "Gestapo" FDA.

As I told Bill when he was still alive, your country has an idiotic,
cumbersome, longwinded, extremely expensive (money politics
obviously heavily involved) and red tape-tangled system of drug
procurement.

Quite a number of tragic, avoidable deaths, particularly children,
all due to this.

Had he been given access to amrubicin, Bill might well still be
alive to this day. Amrubicin had been tried and tested in Japan
years ago. Why the plain stupidity, beating around the bush for another
silly, pathetic three more longwinded phases of trials over there, just
to satisfy the red tape of "proving" something which has already
been long proved ?

Tantamount to trying to prove that sugar tastes sweet.

[CaptainFuture]

The problem is the logic behind FDA action: We prevent death through not approving drugs that could potentially be harmful. Nobody looks the other way round and estimates how many millions of people have died because certain drugs are not made available because of our present system! Another huge problem is the fact that this highly inefficient, highly expensive and highly time consuming process of developing, testing and getting a drug approved, PREVENTS new companies and smart brains from entering the market. Even if fast-track is granted this reduces the approval process from 13 to about 6 months but that's all, drug development procedures and required testing is not touched by this.

[niner]

The problem is the logic behind FDA action: We prevent death through not approving drugs that could potentially be harmful. Nobody looks the other way round and estimates how many millions of people have died because certain drugs are not made available because of our present system! Another huge problem is the fact that this highly inefficient, highly expensive and highly time consuming process of developing, testing and getting a drug approved, PREVENTS new companies and smart brains from entering the market. Even if fast-track is granted this reduces the approval process from 13 to about 6 months but that's all, drug development procedures and required testing is not touched by this.

Good analysis, Cap'n. The problem isn't entirely the FDA. The problem is US. "We", the broad American public, are highly risk averse, and we are also a very litigious society. The public wants the FDA to guard them from any and all risks, and everyone in the medical supply chain, from pharmas to drug stores, wants a bullwark against litigation.

Funny how, after all this, we still have as much risk as we do in our pharmacopeia.

[CaptainFuture]

Good analysis, Cap'n. The problem isn't entirely the FDA. The problem is US. "We", the broad American public, are highly risk averse, and we are also a very litigious society. The public wants the FDA to guard them from any and all risks, and everyone in the medical supply chain, from pharmas to drug stores, wants a bullwark against litigation.

Funny how, after all this, we still have as much risk as we do in our pharmacopeia.

Ye, absolutely true and the problem is not specific to the USA or the FDA. You will find this kind of risk aversion, laziness and government intervention in nearly all first world countries, especially in Europe, although there still is some diversity in the health care field of the different European states. It's interesting that the European dept crisis is a useful mean for politicians to promote more centralization in Europe, while it was this centralization in the beginning (the introduction of the Euro against the will of many Europeans) which causes the biggest problems now. Less freedom means less welfare unless you have brilliant politicians which nearly no country has.

I don't think that it's "us", who are responsible for the current situation. I certainly didn't vote for this degree of government intervention in my life and there are many people who also oppose it. The problem in my eyes lies in democracy. As Thomas Jefferson said:

“A democracy is nothing more than mob rule, where fifty-one percent of the people may take away the rights of the other forty-nine.”

Government and media can do a lot to influence the opinion of their people. The more dependent you make your citizens and the more you indoctrinate them, the less likely it is, that they will vote for more liberty. Government and media play a huge role in promoting this false believe of salubrious government intervention. Politicians play savior during crises, that they created themselves. Who gives a healthy person the right to dictate a cancer patient what drugs he is allowed to take and what not?

I really hope that the situation improves with personalized medicine.

[PGN]

Countless drugs, including lifesaving ones in cancer and other
terminal diseases, which have been around in the rest of the world
for up to decades, are still not available in the US because of
your "Gestapo" FDA.

As I told Bill when he was still alive, your country has an idiotic,
cumbersome, longwinded, extremely expensive (money politics
obviously heavily involved) and red tape-tangled system of drug
procurement.

Quite a number of tragic, avoidable deaths, particularly children,
all due to this.

Had he been given access to amrubicin, Bill might well still be
alive to this day. Amrubicin had been tried and tested in Japan
years ago. Why the plain stupidity, beating around the bush for another
silly, pathetic three more longwinded phases of trials over there, just
to satisfy the red tape of "proving" something which has already
been long proved ?

Tantamount to trying to prove that sugar tastes sweet.

The problem is the logic behind FDA action: We prevent death through not approving drugs that could potentially be harmful. Nobody looks the other way round and estimates how many millions of people have died because certain drugs are not made available because of our present system! Another huge problem is the fact that this highly inefficient, highly expensive and highly time consuming process of developing, testing and getting a drug approved, PREVENTS new companies and smart brains from entering the market. Even if fast-track is granted this reduces the approval process from 13 to about 6 months but that's all, drug development procedures and required testing is not touched by this.

I've personally lived through this madness, having experienced the pressure to take FDA "approved" drugs for cancer which are toxic poisons and having seen what small biotech companies have to go through to get promising new medical treatments to market. One company I know has a very promising natural substance that repairs surgical adhesions in a matter of months. It's made from a fruit that has been eaten for hundreds if not thousands of years, so there are no side effects or toxicity. Even so, they don't have the money to go though the laborious, expensive FDA drug approval process. There is no other drug for adhesions but they can't fast track it because it's not life-threatening, though adhesions are sometimes extremely painful. Surgery to remove it, just encourages regrowth. So the only thing they could do was to market it as a nutriceutical. However, nutriceuticals by FDA guidelines as of today cannot conduct clinical trials, cannot publish data or market using any data, cannot publish testimonials with medical claims, cannot post medical claims on public forums. You are almost guaranteed to be shut down in an instant if you violate any of these FDA guidelines. Small biotech companies, who are the real innovators, not the big drug houses, are basically gagged from saying anything about medical claims unless you file for New Drug App even if they have scientific proof it works. If your company can't afford to file a NDA, or doesn't want to sell it as a drug, you are basically left hoping the public accidentally discovers your supplement works for medical conditions through word of mouth, public forums, blogs, etc. The people who need it the most, will never know about it because mainstream media won't usually report about medical benefits from nutriceuticals. All they report on are promising new "drugs" that may take up to a decade to get to market.

The public has been misled to believe the FDA is only interested in protecting them from dangerous substances, when in large part the drug process protects Big Pharma's bottom line. For example, if you could pay $60 for a supplement that does the same thing as a drug that cost $1000, with no toxicity or side effects and years of proven efficacy as a food substance, wouldn't you want the supplement? Of course you would, and everybody would know about it and buy it. But if you could prevent the little supplement company from ever making med claims, guess who wins, Big Pharma. Not the consumer obviously. They end up waiting years and paying more for the drug. The FDA drug process is not a very fair or efficient system. It doesn't promote innovation at all, it just hinders it and stifles any incentive for research by small biotech firms. They need to seriously rethink this system, but with state of politics in the US now, I don't see that happening anytime soon.

Edited by PGN, 30 May 2012 - 02:57 PM.

[niner]

It's made from a fruit that has been eaten for hundreds if not thousands of years, so there are no side effects or toxicity.

Once you take it out of the fruit, concentrate it, and consume it in large quantities there is no longer any guarantee of safety or lack of toxicity.

However, nutriceuticals by FDA guidelines as of today cannot conduct clinical trials, cannot publish data...

Sure they can. No one stops them from running a trial and publishing the results. What they are stopped from is making health claims. Too many supplement companies want to make health claims on the basis of meaningless in vitro or invertebrate experiments, and those are almost always misleading. Testimonials are essentially worthless, as they will be cherry-picked if used in marketing. Just this morning I bought a nutraceutical that was tested in a huge clinical trial, the results of which were published. There is a nearly-identical prescription version that costs 22 times as much, which I have no intention of using.

mainstream media won't usually report about medical benefits from nutriceuticals. All they report on are promising new "drugs" that may take up to a decade to get to market.

The mainstream media will report on anything that they think will catch peoples' eyes. They report on supplements all the time, and are usually as out to lunch on them as they are on all health coverage.

But if you could prevent the little supplement company from ever making med claims, guess who wins, Big Pharma. Not the consumer obviously.

If you prevent the little supplement company from making false or misleading claims, which they are famous for, then the consumer does win. I agree that drug regulating bodies the world over could use reform, but the public demands safety and efficacy, so a return to the patent medicine / snake oil period isn't likely.

[PGN]

Once you take it out of the fruit, concentrate it, and consume it in large quantities there is no longer any guarantee of safety or lack of toxicity.

They did toxicology tests of the substance at Eli Lilly already. People have been taking it internally in their own in vivo tests for years, No demonstrated side effects or toxicity has been shown.

Sure they can. No one stops them from running a trial and publishing the results. What they are stopped from is making health claims. Too many supplement companies want to make health claims on the basis of meaningless in vitro or invertebrate experiments, and those are almost always misleading. Testimonials are essentially worthless, as they will be cherry-picked if used in marketing. Just this morning I bought a nutraceutical that was tested in a huge clinical trial, the results of which were published. There is a nearly-identical prescription version that costs 22 times as much, which I have no intention of using.

That is not what they told me. In the past this was true, nutriceutical could perform trials and publish them, but in recent months it's all changed. They planned to do clinicals on adhesions and had even started doing this in conjunction with doctors who had patients with adhesions. This company has been working with the FDA in getting the nutriceutical to market, They wanted to make sure they would not be shut down, like many other supplement companies had been in recent months. When the FDA told them any clinicals would imply it was drug status and they would have to file NDA, they stopped their trials. They wanted to test this substance for telomerase markers, again FDA denied their request.


The mainstream media will report on anything that they think will catch peoples' eyes. They report on supplements all the time, and are usually as out to lunch on them as they are on all health coverage.



If you prevent the little supplement company from making false or misleading claims, which they are famous for, then the consumer does win. I agree that drug regulating bodies the world over could use reform, but the public demands safety and efficacy, so a return to the patent medicine / snake oil period isn't likely.

I agree, but how will they show it's not snake oil if they aren't even allowed to do clinical trials and be subject to scientific review like drugs? There are plenty dangerous supplements out there that do nothing, but there are some really legitimate ones that could save many lives. They are all lumped into this category of nutriceuticals which is so restricted in what they can claim or test, how can we identify the good from the bad?

[niner]

That is not what they told me. In the past this was true, nutriceutical could perform trials and publish them, but in recent months it's all changed. They planned to do clinicals on adhesions and had even started doing this in conjunction with doctors who had patients with adhesions. This company has been working with the FDA in getting the nutriceutical to market, They wanted to make sure they would not be shut down, like many other supplement companies had been in recent months. When the FDA told them any clinicals would imply it was drug status and they would have to file NDA, they stopped their trials. They wanted to test this substance for telomerase markers, again FDA denied their request.

It sounds like they're caught in an argument about whether it's a "drug" or not. This is something that's come up recently, and if this is the way it's playing out, then that really sucks. If an academic group wanted to do a trial of a compound that they had no interest in selling, I wonder what would happen there? It seems pretty unlikely that the FDA would put up such a barrier to pure research. It hasn't traditionally been this way. It's possible that there's more to the story.

[PGN]

It sounds like they're caught in an argument about whether it's a "drug" or not. This is something that's come up recently, and if this is the way it's playing out, then that really sucks. If an academic group wanted to do a trial of a compound that they had no interest in selling, I wonder what would happen there? It seems pretty unlikely that the FDA would put up such a barrier to pure research. It hasn't traditionally been this way. It's possible that there's more to the story.

The NIA conducts research on anti-aging therapies which can be anything, natural substances, nutriceuticals, drugs, gadgets, etc. on rats. So, they plan to submit their substance for inclusion in next year's NIA study. At least they will have that research published in 2 years (assuming they get chosen). It's not specific to adhesions, but it will validate some other properties this substance is known to have.

http://www.nia.nih.g...ing-program-itp

I'm sure they would welcome independent research on this compound to verify or disprove their assertions. But they're not about to contact any researchers to do research on their behalf. They are extremely careful not be caught in a situation where the FDA can accuse them of conspiring to get around regulations. It has to be totally transparent, initiated by unaffilated outside parties, and done independently with no active participation by the company. Then the FDA would have no recourse but to let the research be published, right?