I worked as a scientist in the public sector for about seven years. I left because nomatter what “groundbreaking” research I did, it was never going to go anywhere. I published papers and got patents that were never going to lead to any sort of therapeutic. The best case scenario was that we hoped that a company would want to buy the patent, which never happened because the patents were, in retrospect, silly.
It’s simple, really. Public universities have no infrastructure to take ideas into the clinic. They have no idea how it is done, and they don’t have the money to do it. You can try throwing money at it, but I assure you that it won’t work. The people who stay in academia are not all that geared toward the sort of work that is required to get a therapeutic made. I collaborate with academic labs, and the mindset is completely different.
I moved to an “evil” pharmaceutical company. And, believe it or not, I still do groundbreaking research, and now I actually have hope of one of my ideas being put into development next year. It was an idea I came up with. I didn’t steal anything from academic labs to come up with it. My company let me play with the idea in my spare time. As it gained steam, they saw what I had and gave me more and more free time with it until it is now 90% of my time. Why exactly would you want to keep me from doing that?
Your alternative universe would end up with a bunch of scientist vying to have the brightest peacock feathers at the conferences, with brilliant research that no one would have the ability to bring to fruition. If you’re getting your ideas of how preclinical (and god forbid, clinical) research is done from movies, I assure you that it’s a bit more complicated than finding a plant in the Amazon, extracting something in your hut, and putting into a rat and claiming to have cured cancer.
I don’t want to delve into personal insults, but some of the ideas I hear around here are pretty insane. It’s like they believe that all problems would be solved if you just let the government run everything.
What exactly has the government run so well that you think they should apply that model to all sectors of the economy?
Again, to reiterate I do not favor banning private pharma companies. However the question in the OP was what would happen and I said “medicine and pharmaceuticals would be better”. My reasoning for this was the belief that the incentive system for R&D and distribution in a public system would be more in line with the goals of medicine (to provide the most health benefits with the fewest side effects to the most people at the lowest cost) than they would be in private enterprise.
If I had $9,000 in debt and someone said ‘what would happen if you had $7,000 in debt instead’ my response would be ‘that would be better’. However better and ideal are not the same thing. I believe if R&D were done totally by the public and non-profit systems then we’d be better off. However it is not ideal to ban private enterprise since private investment also needs to play a role. I don’t know enough about the subject to say what is ideal with any certainty, but no I don’t support banning private enterprise. But I do believe the public system’s incentives (promote economic growth domestically and internationally, slow medical spending, win public accolades, increase productivity) are more in line with the goals of medicine (most health to the most people with the fewest side effects at the lowest cost) than the incentives of the private enterprise system (sell the most expensive drugs you can to people who can afford them).
However, the incentives of the private industry again are to make money. You make money by marketing products to people who can afford to buy them. The problem is that with health the people who need help may not have money.
As to the subject of european R&D, my understanding/impression is that R&D is still going to be done by private corporations in Europe. If anything Europe spends less on R&D than the US. The US spends about 2.5% of GDP on R&D and the EU spends about 1.8%.
I do not know how much is public or private. However the US does spend more on R&D so naturally we will probably see more advances.
And according to Marcia Angell a reason pharma companies want to set up shop in the US is because we have such an advanced public research infrastructure which private industry can use. So if the R&D centers are located here, it could be in part to take advantage of our tertiary educational system and other publicly funded research orgs.
Since the United States is the major profit center, it is simply good public relations for drug companies to pass themselves off as American, whether they are or not. It is true, however, that some of the European companies are now locating their R&D operations in the United States. They claim the reason for this is that we don’t regulate prices, as does much of the rest of the world. But more likely it is that they want to feed on the unparalleled research output of American universities and the NIH. In other words, it’s not private enterprise that draws them here but the very opposite—our publicly sponsored research enterprise.-Marcia Angell
Algher I know, and that is great that Merck is giving the drug away. However ivermectin is almost 30 years old. On top of that a new drug (which you reference) is being tested. So that is 2 drugs for a serious disease in a 30 year time span. We have 9 types of statins as well as various OTC supplements for cholesterol.
For erectile dysfunction there are at least 5 treatments. Testosterone, viagra, cialis, levitra & alprostadil.
If your argument in favor of private enterprise is that private enterprise has 2 treatments for river blindness, my response is that it has 5 treatments for impotence. Not to pick on people with ED, but the fact that a serious disease that disables communities has 2 treatments and erectile dysfunction has 5 drugs doesn’t make me impressed by the incentive system of the free market when it comes to medicine.
Neglected tropical diseases do not really offer much chance to profit since the people who have them usually make $2/day or less. So there is little incentive by the private system since the profit motive isn’t there.
However the public system does have an incentive. Fighting these diseases can improve our national security.
Heck, you don’t have to ban the pharma companies. Just stop passing laws that are designed to work in their favour. Allow full importation of equivalent Canadian drugs, for starters.
Banning pharmaceutical companies would be a bad idea. At the very least the private sector is probably going to be more efficient at manufacturing and distributing drugs. What I think is worth considering is a massive increase in public funding for pharmaceutical research which is then placed in the public domain where private companies can use it. This would likely lead to a steep decline in drug prices. The public sector research would be focussed on treatments for the major diseases so there would still be niches like lifestyle medicine where the pharma companies could continue to do research and receive patents.
I think that if you want more effective drugs against more diseases, you have to start accepting certain toxicity parameters.
Right now, if I make a drug for a serious, life threatening disease that cures 100,000 people per year, but, unfortunately, it kills 10 people per year in an unpredictable manner, then that drug is likely a no go. Personally, I think that is not the right way to go, but that’s the way that the FDA rules are written because the public wants 100% safe drugs.
Now, I can see that you don’t want your erectile dysfunction drugs killing people, but there are quite a few people that would take those odds for debilitating illnesses. I would.
So, as a scientist, my hands are often tied by toxicity. Which makes companies wary of delving into brand new drugs and toward “me too” drugs where the dangers are known.
My 2 cents. Allow for certain toxicities for serious conditions. The human body is complex, and it is impossible to determine how every single person will react to a drug. If a drug company, through no fraudulent means, has a drug that turns out to have toxicities, then there shouldn’t be ability to sue. If those toxicities are outlined to the patients, and the patients decide to take the chance, then that should be fine.
But, if you want 100% safe, 100% effective drugs, then you’re going to get people unwilling to take chances and spend the hundreds of millions of dollars to bring something brand new to the market.
Hmm yeah, I guess there’s no good reason I know of to make publicly-funded medical research entities and private pharmaceutical companies mutually exclusive. I suppose my problem with private pharmaceutical companies has been that they’re only interested in treating illness where they can make a profit, and as a result, many diseases are seemingly ignored. What’s the solution to that situation?
As private companies operate for profit, it’s somewhat inane to complain that they only focus on drugs (doctors treat, pharma develop drugs) where they can make a profit. Yes?
The profit motive drives in general a great deal of efficiency. Leaving aside Wesley’s dataless stereotyping, we’ve already seen what pure state medicine looks like in the Soviet bloc. It did not look good and was not effective in developing consistently new therapies for even core diseases. (Note when I say state medicine, I am not talking about government support for general access to treatment, state insurance schemes, etc, I am talking Soviet style complete nationalisation)
Private pharma (and contra the strange stereotypes, there are big private pharma groups in Europe, rather evidently have a bit of state involvement in health care isn’t itself a disaster) is good overall at therapy development.
But some items do get orphaned by the market. Rather than shrieking hysterically and throwing the baby out with the bathwater, a rational response would be to dedicate public funds - directly or via subsidy to private research - to non-profitable areas.
No sir, I mean it literally. I mean that what you said was outright madness: it was wholly and utterly againt any and all evidence. And I don’t even say that about atheists and Mormons. I have no other appropriate or proper word for it than “insane,” because it to hold this belief requires the absolute refutation of known evidence in favor of a theoretical model not validated and in fact invalidated by experience.
This has not happened. Public R&D is principally done on a much higher-order effects by academics testing concepts. It has nothing to do with actually creating a workable drug people can use. This is why you do not commonly hear about university research scientists curing diseases.
Aside from the fact you still don’t recognize that said 40% of funding (I will assume your figure is corrrect) goes into theoretical grant-based research. It does not, and cannot, create a practical product because that’s not what those people do. And if you want to create practical products, you have to do exactly what all those researchers in pharma companies do. Furthermore, that governments do not, in fact, use this miraculous power to produce better drugs tyou think they have, and never have, and show no inclination to try, is rather a good indication they can’t.
Second, creating knockoff drugs with a slightly different chemical structure would do nothing if the drug doesn’t actually produce better long-term results. The company can claim it’s better, but unless they have something to back it up, it’s meaningless (and they will be sued, as the FDA looks rather dimly upon that).
Wait - you consider the fact that drug companies focus their research on the conditions that people want to pay money to fix as a bad thing? You consider the fact that they grab the easy problems and fix them first a bad thing? You think that the same rational allocation of resources which every human being has engaged in since the dawn of time is a bad thing?
And you wonder why I think you mad.
So, in other words, you made huge unwarranted assumptions, simplified the technical problems and practical issues of politicians handing out vast sums of money to fix public health problems, and then substituted your own wants and desires for those of all other humans.
Yeah, you’re right. I was wrong. That’s not insane at all. Yup, height of sanity. No crazy there. None. Nada. Not a bit. Clarity itself. Dunno why anyone would think it wrong, really.
The drug market has been heavily distorted by the FDA. The FDA requires drug certification not only for safety, but for efficacy. The efficacy requirement is extremely expensive and takes a long time - it can cost upwards of a billion dollars and a decade of time to take a drug from initial research through FDA certification. The result of the explosion of regulatory cost means the drug companies can not afford to research and certify drugs that only apply to a small percentage of the population.
One of the best things the U.S. could do right now to get drug costs in line would be to drop the efficacy requirement from FDA testing, and test for safety only. This would immediately lower drug certification costs, and would also get drugs into the hands of doctors and patients faster. Faster cycle times means more lives saved, it means more time in the market for the drug to remain under patent, which means the drug manufacturer can sell each dose for less money.
The efficacy requirement is useless anyway - once the drug is certified, doctors are free to use it for whatever purpose they deem fit. This is called ‘off-label’ use. Some drugs are rarely even used for the purpose they were certified for, which means the majority of prescriptions for the drug are for ailments for which efficacy was never even tested. So why do it?
I’d go even one further and say that the FDA should become an advisory-only body, and that drugs must be clearly labeled as to whether they have passed FDA certification for safety, and for efficacy. Then let the market and insurance companies decide. Doctors would be legally free to prescribe non-FDA certified drugs, but their insurance companies might prohibit the use of non-certified drugs for doctors holding malpractice insurance with them. This would open the door to drug certification outside the government, such as we already have with Underwriters Laboratories and the various insurance company driven auto certification and testing facilities.
The high cost of drugs is largely driven by the high cost of R&D and FDA certification. That’s where to look for reform.
Why would you want to change it? The areas where they can make the most profit are the areas that affect most people and therefore have the biggest potential market.
Would you have them work instead on isolated illnesses that affect far less people?
I actually think that efficacy should be a requirement. But they need to loosen the reins a bit. There is currently a drug (Provenge if you want to look it up) that everyone agrees is safe and nearly everyone agrees is efficacious but has been waiting years for approval because the analysis was a post hoc analysis. I agree that this isn’t ideal but the FDA independent panel recommended approval years ago and yet it is still not available.
It costs an insane amount of money to get a drug on the market. Again I will use my project which is very early stage preclinical and has already cost tens of millions of dollars. Once things go clinical, forget it. It’s astronomical.
I agree with a lot of the thrust of what you’re saying here, but its undermined by this bollox you’re talking about safety and efficacy. It is impossible to decouple safety and efficacy - they’re two sides of the same coin and one cannot assess the therapeutic index / safety window of a drug without reference to efficacy. Fiveyearlurker put it better upthread, we (as Joe Public) need to re-assess our attitude to risk if we are to continue to enjoy pharmaceutical solutions to disease, and the FDA should in turn reflect this adjustment.
‘Low hanging fruit’ is now a cliche in pharma - all of the easy targets are taken care of, it is increasingly difficult to come up with druggable solutions to things like Alzheimers, mental illness, cancer etc. It’s almost certain that regulation will need to be relaxed if we’re to get usable drugs onto the market in these areas (not cancer so much - already stands alone in terms of toxicological requirements).
How? Pharmaceutical companies aren’t charities and if there isn’t going to be money in pursuing a treatment for an illness, they’re not going to go for it.
Researching and treating all illnesses should be the goal of society, not just the most profitable ones. Of course this is the real world and we don’t have unlimited resources, I know, but having money as the sole driving force behind a lot of medical research doesn’t seem to be the ideal situation (to me at least).
Your post is correct if you qualify it with ‘in the west’, which is part of the OPs point. Tropical disease such as malaria, schistosomiasis, chagas disease etc kill millions of people each year and won’t make 10p for a pharma company. Non-critical conditions in the West such as premature ejaculation, obesity, anxiety, insomnia etc can be massively profitable. So should a pharma company invest R and D into premature ejaculation, or malaria?
There are pharma companies that are non-profit and work towards their goals for other reasons. Many people don’t get into this industry just for the minuscule money that most of us make. There are also different areas of pharma that are different from one another. PET drugs are a whole different ball of wax than aspirin.
There are thousands of drug companies out there, very few of them resemble GSK.