Why are drugs so hard to make and take so long to come out on the market?

I know there is a lot of people complaining no cure for ALS ,MS, Parkinson’s ,HIV , motor neuron disease , dementia , alzheimer’s ,autoimmune diseases and cancer.

Well some cancers have much higher cancer survival rate than other types of cancers.Well Pancreas , Liver ,Bile duct , Esohagus , Lungs , Bronchus ,Stomic , Mutiple Myeloma , Brain and Leukemia have a very bad survival rate. And about 40% of people will get cancer in there life time.Well 1/2 people who have cancer will die.

Incidence, survival and mortality : Cancer Research UK : CancerHelp UK
http://www.cancerresearchuk.org/about-cancer/cancers-in-general/what-is-cancer/statistics/incidence-survival-and-mortality
I hear three theories explaining this why drugs are so hard to make and take so long to come to the market.

1.Government retriction , once a chemists finds a computer model that shows results and you doctor prescribes medication add 10 to 15 years to it.All running lab rats tests after tests ,clinical trials and testing. You wont it faster , have people sign up for guinea pigs and lower the testing and you will get 5 year mark than 10 to 15 year mark.

2.The easy diseases have cure and now on to the hard to cure diseases.

  1. Drugs have site effect.It is very hard to make a drug that has little to no site effect or does not harm the body.

I hear that new faster computers will allow chemist to bring out new drugs faster. And if we had a quantum computer we will have cure for almost every thing in 10 years…

My son is working on leukemia and myeloma research right now. Thanks to computers they can run hundreds of tests at a time. Computers, however, do not speed up the time it takes for a tumor to develop, or the time it takes to shrink.

You can get one woman pregnant and have a baby in nine months, but you can not get nine women pregnant and have a baby in one month.

As for having people be guinea pigs and reduce testing, have you ever heard ofThalidomide?

  1. Science takes time. You’re looking for cures that don’t yet exist.
  2. Some problems are easier to cure than others, and some that look similar have different causes. “Cancer” refers to a multitude of cellular mutations.
  3. Drugs need to be tested to be sure they don’t kill people. Ideally, this includes longitudinal studies. They need to be tested for next generation effects, too. My mother was offered thalidomide, which, fortunately, she declined.

While computer modeling capabilities have grown almost exponentially in the past decades they are far from 100%. We have really only scratched the surface of how the human body functions at the cellular level and below. Until we do, computer simulations are a best guess option.

We still have to run all the test in real time and observe the effects over time. No way to speed that up.

The “guinea pig” idea has (at least) two problems with it.

First, in order to test it properly, half of them have to be given ineffective placebos, but pretty much nobody wants to be involved unless they can have the actual drug.

Second, if there is an unknown side effect, don’t you think the victim’s family will sue the company for millions (plus an extra 50% to cover the lawyers’ 1/3 cut)?

Some side effects may not become apparent for years.

NPR has been running a series on the sharpdecline in funding for biomedical research. That doesn’t help…

(I’ve been doing fine since my nice TV was stolen. I’ve got 2 little TV’s with DVD’s & a Roku & an antenna I haven’t tried to attach. Who needs the morning local TV news with the latest crimes & car wrecks? NPR has local news & weather–& details on far more depressing stories.)

So what do you think is the **major slow down **why there is no cure for ALS ,MS, Parkinson’s ,HIV , motor neuron disease , dementia , alzheimer’s ,autoimmune diseases and cancer yes cancer very hard.Some some cancers have much higher cancer survival rate than other types of cancers but cancer still very hard to cure.

1 Testing takes too long
2 Computers are not fast enough
3 Drugs have site effects. It is very hard to make drugs with little to no site effects.

Well you got the part about low-hanging fruit, but to elaborate on that:

Bacteria were fairly easy to kill with antibiotics, but they are evolving immunity, and some were always harder to kill, or target areas of the body where it is difficult to deliver the antibiotics, like the brain or sinuses. Penicillin and Sulfa drugs dramatically reduced death from bacterial infections.

Viral diseases are harder because viruses mutate so quickly. Anti-virals are few, mostly we rely on training the immune system to kill them through inoculation.

HIV is hard because it targets and hijacks the immune system.

Cancers and many other diseases are a result of malfunctioning of the body’s systems or processes. You have to figure out what is going wrong, why, and how to stop or repair the damage.

Nonsense. Although they do have significant applications in biomedical (including drug) research, computational methods are a relatively small part of the story, and faster computers will not speed things up all that much. Even if you can use computers to design promising molecules, you still have to figure out how to make those molecules, which can be very difficult, actually make them (which may not be easy - especially making the stuff in large enough quantities to be commercially viable), and then test them, first in vitro and on animals, and then on humans, to see if they actually work and do not have side effects worse than their benefits. Lack of computing power does not come close to being the most significant bottleneck in drug research.

If our understanding of human biochemistry were complete and perfect, then, maybe, all drug design could be done on computers, but our knowledge is very far from being complete and perfect, and computers are not going to help with that. That takes actual experiments, and they take time, expertise, and money.

Okay, I’m reposting this from an old Pit thread because I don’t feel like having to type it all out again. I will just add that, while I like and respect the computational chemists I’ve known over the years, just showing that a molecule should dock into a receptor site in a computer model is no guarantee that it will even hit the receptor in real life. And it’s “side effects” damn it. It’s not “site effects”.

Beginning reposting:

Oh boy, it’s time again to try to disabuse people of the notion that the NIH and academic labs are really behind all new drugs. Here is Derek Lowe’s list of postings on the topic. To try to summarize:

  1. A target is not a treatment. In other words, just because it appears that hitting receptor A has an effect on B doesn’t mean it will actually work in animals or humans.

  2. A hit is not a drug. A hit may not even be a lead. Any number of molecules can give a response in an assay. It doesn’t mean that they will all work for any number of reasons.

  3. Lots of analogs of the lead need to be synthesized. You always want to have something else to try in case your first lead goes down. This takes people and money, even if the syntheses are pretty convergent. You’ll need to make a reasonable amount on small scale as well for testing.

  4. Once you’ve finally narrowed it down to a single molecule, you still need to make more of it. Lots more. There’s lots of studies before you even get to Phase I in humans. And unless you’ve gotten extremely lucky, it’s unlikely that the original synthetic route will scale to the amounts required and even less likely that it would be fine for plant production. So now your target comes to me and chemists like me.

  5. I get the fun of trying to turn whatever your original route was into something we can do on a large scale. Large scale may only be 100 g at one point in time that can be made in my hood or a larger amount in our kilo lab. Or it could be making sure we have a route that can go into small-scale GMP and eventually the plant. Developing a suitable process can take months or years. In the meantime, the formulations people are coming up with ways to make a single compound into a useable form, the analytical chemists are coming up with ways to make sure that we can always test that the material meets spec, we’re making sure that the chemistry can be performed safely, and the chemical engineers are making sure that the process can work in their equipment.

  6. You’ve got your material, it’s made it all the way through pre-Phase I testing, and you’re ready to go into humans for the initial studies on blood levels and tolerability. In the meantime, you still need to be sure that you’ll have a good enough route and trusted suppliers to supply materials going forward.

  7. Pass Phase I? Great. Now it’s time to give it to sick patients in Phase II. Will it actually do in the human body what you want it to do? If it doesn’t, be glad you failed right now and not in Phase III.

  8. Pass Phase II? Great. Here’s the last set of studies with Phase III before the FDA and other agencies will let you sell it. Better pray you don’t fail now. Phase III trials are huge and hugely expensive. A failure in Phase III represents most of a decade of work going down.

  9. Congratulations, you have a drug. It’s taken probably a decade of work, lots of people, gobs of money, and you’ve beaten the odds. Better hope it makes enough cash to recoup all the costs and doesn’t wind up being pulled off the market for reasons that were not seen in Phase III but were observed over time in the general population (say, for instance, the COX2 inhibitors.)
    Reply With Quote

Thing is, your basic premise is incorrect. Medicine has been moving very quickly over the last 100 years.

About 90 years ago, Calvin Coolidge, Jr. died from a blister. Sulfa hadn’t yet been developed. About 65 years ago, penicillin went into trials and, since that time, many of us who would otherwise have died did not. When one of my friends was diagnosed with AIDS in 1992, he was expected to live 6-24 months but beat the odds by living 29 months. Now with the same presentation but better medications, he could live for decades. When my family member was diagnosed with Hepatitis C in about 1993, the treatment had a 16% success rate, when another was diagnosed in about 2006 it was 50%, and now it’s a pretty good bet that Hepatitis C will be cured. I’d be dead of TB by now (if not killed earlier by strep or bronchitis or asthma). The plague, syphilis, TB, and other bacterial diseases look easy to cure because we can cure them. We’ve made good inroads on viruses, but they’re trickier. We’ve made good inroads on a lot of cancers as well.

Okay so the big bottleneck is how to make molecules that dock into a receptor site or problem with side effects or testing? Or All three?

susan I thing two things.
Why some of us the public things like that.:eek::eek:
1.Hollywood makes it look easy.

  1. Electronics and computers changing very fast. Just 5 years ago we had no ipad , no iwatch. No Ultra-high-definition TV.

On the September 5 they said a 4-K Blu-ray Disc will be licensed in the spring or summer of 2015 and 4K Blu-ray Disc players have an expected release date of late 2015.

Also technology like plasma TV ,LED and LCD that so advance now than 10 years ago. Not so say ultra flat thin is around the corner in two or three years out.

Like electronic paper ,electronic newspaper.Also very thin flexible tablet computers a paper-thin flexible tablet computer ,paper-thin flexible roll up maps like.

http://cnet4.cbsistatic.com/hub/i/r/2009/01/29/4f9643c6-f4d6-11e2-8c7c-d4ae52e62bcc/resize/370xauto/edee6963c0b2f77973cc7f2b28caa335/ASU_Flexible_Display_mock-up.jpg

http://www.8164.org/wp-content/uploads/2009/03/ms3.jpg

So people think medicine should change that fast the rate of Electronics and computers.

Why is that? Is it they don’t understand enough how molecules that dock into a receptor sites?

Computer models of proteins come from the PDB, which is a database of protein crystal structures. First off, crystal structures are only so accurate (there’s always a little uncertainty). Secondly, the organization of a protein under the conditions required to obtain a crystal structure is not necessarily the same as the actual organization under biological conditions.

Even if your model is the world’s greatest, everything else I wrote still holds. Your molecule may not actually hit the target receptor. It may hit the receptor but not have the desired effect. It may be rather promiscuous and hit other, undesired targets as well. The pharmacokinetics may be terrible. The synthesis may be impossible, at least on any reasonable scale.

Electronics are easy. We basically design it all from scratch. Biology is hard. We have to deal with millions of years of evolution with no user manual.

Everybody knows that the drug companies already have the cures to all known diseases. But if they cure everything then they couldn’t make any money. In order to protect the conspiracy they allow friends and loved ones (and even themselves!) to die of the diseases they could cure.

My SO is in pharmaceutical research. I hope she sneaks me a cure if I ever get sick.

It is not “difficult” to make a drug that works but has no side effects. It is impossible to make a drug that works but has no side effects.

Saying “this treatment has no side effects” is synonymous with saying “this treatment has no effect”.

Aspirin treats headaches and has the side effect of occasional stomach problems. Penicillin kills bacterial infections and has the side effect of occasional allergic reactions and diarrhea. Current treatments can sometimes cure cancer but have all kinds of side effects.

TANSTAAFL.

Regards,
Shodan

:eek::eek: indeed. I have no idea what you’re trying to say. When come back, bring English.

But when they do come up with a cure to a nasty disease, a cure that is both cheaper than the long-term treatment (hospitalizations and liver transplant) and much has fewer adverse effects than the current medications (Interferons), they get slammed for “gouging” consumers.

And that the main reason why cancer is very hard to cure.It is very haed to cure because it like having a fish tank full of fish and trying to only kill the blue fish not the red fish.So you could add toxic or bleach but you kill every thing.Trying to get drug to only go after the blue fish is really hard.
cancer for example , it is easy to come up with chemotherapy very easy !!! But very hard to come up up with chemotherapy that works but does not kill you or make you very ill.

So what will speeds things up? And more cures for cancer and other diseases? Better computer models? You make it sound computer models and computers are not the bottleneck.

Why

Because if side effects or testing is the main bottleneck all the money or young people going to school to be medical researchers are not going to speed things up.

And unfortunately people will die and there will not be a cure for those things I talked about in 10 to 20 years from now.

The main bottleneck are side effects and testing.So even if some one had trillions of dollars it not going to help or speed things up.