Searching for Drugs
The biggest story about health care this morning appears in the business pages, not the political section, of the New York Times. It is headlined “A Rising Hospital Threat: Infections Unfazed by Antibiotics Become More Common.” A new category of bacteria is “already killing tens of thousands of hospital patients each year.” These “Gram-negative” germs apparently beat out even the more widely known drug-resistant “methicillin-resistant Staphylococcus aureus” – or MRSA for short – in their immunity to virtually every sort of treatment. And no relief is in sight, the article suggests, “for a combination of business reasons and scientific challenges.”
To find out about the business reasons, you have to turn to a sidebar headed “Deadly Germs Largely Ignored by Drug Firms.” Even there, you read through five paragraphs of medical information before getting to this: “The difficulty of killing Gram-negative germs is not the only reason for the dearth of new drugs. Another is that many big drug companies have scaled back or abandoned antibiotic development. Antibiotics are typically taken for a only a week or two, after which the patient is cured. They are simply not as lucrative as drugs for other diseases that are taken for a long time to manage a long-term condition.”
My reflections on this article went in a half-dozen directions, including several having to do with mortality in general and the false hopes we place in modern medicine. But it also reminded me of the false hopes we place, when it comes to health care, in the market. I became convinced of that in the 1970s when I spent considerable time studying health-care systems and economics. My conviction was refreshed a few years ago by a reading of Medicine and the Market, a major comparative study of health-care systems by Daniel Callahan and Angela A. Wasunna.
Still, the development of new drugs was one area where the market model actually made some sense, certainly compared to the idea that when my physician recommends a CAT scan or MRI to investigate a sudden onset of double vision I’m going to shop around for the best scan for a buck in the New York area. Of course it has been long recognized that drug research and development are skewed toward the needs of the well-to-do while those of the impoverished remain neglected. A few compensatory measures have been set into place. And now here is a new distortion, the lack of incentive to develop drugs that might actually cure, and cure quickly, rather than keep you drug dependent. Is there a solution?
‘Is there a solution?’
An organized, militant, ‘not taking a no’ group did wonders for AIDS hiv treatment..
We need An organized, militant health care reform group finding a way to put fire in the belly of people like myself who [up to now] have good health care. Political leaders would not be welcome in the group I would see being worthwhile.
If Tea party ‘Know-nothings’ can be somewhat effective why not the overwhelming people in the middle getting militant about health reform?
Maybe the universities could be enlisted to help. They’re doing other sorts of research on patentable materials. According to Alasdair MacIntyre’s new book the universities are all now money-making corporations anyway.
A vivid example of fratricide being committed by the “free market.” We have always known that modern medicine is geared towards treating illness rather than preventing it because there is not that much money in prevention. The insurance companies have been taking it on the chin in the last few days. The comeuppance for the drug companies is long overdue.
Sadly, most people who have shares in drug companies are more concerned about share price than curing patients. If we could encourage drug shareholders to push for drugs for health above drugs just for profit a lot of good can be done. This is a huge ethical question. You will find Catholic organizations pushing annuities and other financial services that have a Catholic name but not necessarily Catholic values. Certainly something to consider instead of the false issues that are too often touted. How many Christians will vote for health over profit who own drug company shares?
How about a National Institute of Health–the name is not important– that acts as a nonprofit pharmaceutical company sponsoring research but holding a patent on the results?
How about ‘Catholics For Reconciliation’ ? Bishops would dare not oppose such a group.. :0)
Prof. Gannon — NIH already does a great deal of basic research, but it doesn’t patent it. That is another of the ironies of the health care system — the citizens pay for it and the corporations get the results free.
My last post wasn’t exactly right. NIH does research and funds research at universities and hospitals. Wikipedia says that in 2008 it was responsible for 28 percent of the total funding of biomedica research. But i don’t think it actually produces finished products that would be patentable. However, according to Wikipedia,
” It also found that of the 21 drugs with the highest therapeutic impact on society introduced between 1965 and 1992, public funding was “instrumental” for 15.[14]”
NIH just might be the answer. But would the Constitution allow it to compete with the pharmos?
Actually, the universities are now part of the problem, having been more or less coopted by the same incentives that are found among for-profit manufacturers. It has to do with changes in the law made in the early 80s that allow universities to profit from research and patents to a much greater degree than they had previously. As a result, they look for profit potential just like manufacturers do.
Several ideas would be: more rigorous FDA scrutiny of what is currently being approved — new drugs are more expensive, not necessarily better, and if manufacturers weren’t so able to profit from marginal medications, they might once again actually look for “break through” drugs.
Second would be to allow antibiotics to remain on patent longer.
Third would be to have a government funded office of antibiotic research.
Fourth would be to impose much stricter controls on the use of current antibiotics and to require a system of rotation (Danish researchers found that pulling antibiotics out of use for as little as two years could re-establish their effectiveness against many infections.)
Fifth would be to significantly restrict the use of important antibiotics for agricultural use (not proven but highly suspected as aggravating the problem).
Sure, there are lots of things we can do.
” — overwhelming people in the middle getting militant”
The reason they are in the middle is that they are not militant.
The use of antibiotics at sub-therapeutic levels in livestock feed is a multifaceted mess. The low doses increase growth rate in feed-lots, perhaps by stacking the deck just a bit more in the animals’ favor, perhaps especially when they’re kept in execrable conditions. IMO, you don’t need to pull antibiotics from agricultural use generally, but restrict their use to medical indications, and eliminate their use in feed. In (probably the same) Danish experience noted above, cutting out antibiotics in feed led to an increase in medical use. Even so, it’d benefit to ban non-medical use: 1. sub-therapeutic use is pretty much an ideal means of making antibiotic-resistant bugs, while proper medical use is less likely to. 2. animals on medicinal doses of antibiotics are kept out of the food chain–that’s an economic pressure on farmers to improve living conditions that lead to illness.
The basic business model of maximizing profits at the lowest possible cost is a big part of the problem. That can work well where there is real competition. Hospitals are to blame also since they operate on the same business axiom. They complaine when Medicare restricts them but they are not as liberal where they have free reign like ordering unnecessary tests and medicine where there is no need nor any hope of a cure.
So perhaps a lot more exposure of how drug companies work so the public can become aware. The exposure/education has to be across the board showing how every step of the laddder colludes to creating greater cost.
There are solutions. The drums just have to beat louder for reform.
For what it is worth……excellent article that points out the gaps and needs in a health care system that relies completely upon the free market.
We simply need the will power to offer the best private/federal approach we can pass with 51 votes:
- require coverage for almost all who live in the US (repeatedly supported by church social justice statements)
- remove all limits, pre-existing conditions, exclusions after you have insurance, etc. (if this means government co-ops that cross state lines; so be it since the public option seems to be dead)
- make the system such that “cadillac” and wealthy ERISA plans are taxed and redistribute this so that those who make 200% of less of a family of four of poverty level have money to cover them and change the system so that coverage is portable and not tied to employers
- begin to implement plans to move from FFS to payment for outcomes and to a team approach for treatment
- Limit all MLRs to 85% or higher …….this regulates how much profit a free market insurance plan can make;
- incent big pharma to spend a % of all R&D on needed medications not just profitable drugs. If pharma is unwilling to do this, open up the US to receive drugs from overseas that meet US standards/oversight (now that is true competition)
- require that these total changes be as revenue neutral as possible
- lower the age for eligibility for Medicare
all of these steps are pro-life in the truest sense of catholic social justice practice and theory.
I was surprised that more was not said in the article along these lines:
Tens of thousands of Americans die every year from infections they acquired because doctors and nurses in hospitals don’t follow simple cleanliness rules. It’s been over 150 years since Semmelweis, and doctors still aren’t washing their hands.
There is an aggressive campaign by the National Business Group on Health called LeapFrog. It is basically a report card by hospital; by treatment of diseases, by surgeries – success rates; etc. in many of our major metro areas.
The push is to enlarge these report cards to cover the complete US and drive improvement.
MRSA rates and decreases are one of the top initiatives.
Just a grateful thought: The Times has done so many useful investigative reporting pieces in the lsix months or so, in the health care area, especially. It’s almost as if they are trying to prove why they are needed, or desperately trying to do something really significant. while they have the resources.
Bill DeHaas and Barbara have mentioned incentives that may get Big Pharma more focused on the growing (and scary) microbial resistance problem. Lisa also highlighted the misuse of antibiotics at the sub-therapeutic level. Another thing to remember about antibiotics is that many are largely unchanged in molecular structure at the time they are excreted from our bodies, They can thus make their way into rivers, aquifers, etc. and eventually into drinking water. It’s not too much hyperbole to say that we are awash in antibiotics, and it’s no wonder, for example, that resistant TB bacillus, MRSA, and VRE (vancomycin-resistant enterococcus) are on the rise.
Somewhat ironically, increased research on vaccines could have the salutary effect of combating the increase in antibiotic-resistant bacteria. A significant number of antibiotic prescriptions are for respiratory illnesses, many of which are viral in origin and therefore not responsive to antibiotics. Every antibiotic prescription, especially unnecessary ones, increases the likelihood of bacterial mutations that result in increased resistance. Doctors sometimes feel the pressure to “do something” when a patient presents with an uncomfortable respiratory malady. Isolating the culprit–bacteria or virus–can take days, and though a doctor may suspect that the illness is viral in origin, the doctor will often take a default position and prescribe an antibiotic. With the ongoing development of technology that will more quickly isolate the culprit, targeted treatment should become more of a reality. In addition, DNA sequencing techniques are becoming both more sophisticated and faster, thus allowing scientists access to the genomes (i.e., the complete DNA sequences) of harmful micro-organisms. With such blueprints in hand, and with the resulting knowledge about the chinks in a harmful micro-organism’s armor, new and more effective treatments can be fashioned.
Eight or 9 years ago I worked for a Co. doing antibiotic drug research. The post notes the “false hope we place in modern medicine”, and I think that’s a true and important point. Barbara and others mentioned non-drug ways to address the problem, like handwashing and the agricultural use of antibiotics. Also, the article linked says: “It is likely to be several years before new drugs to treat Gram-negative infections are available.” The prognosis is worse for diseases like diabetes, any mental illness, many cancers. But okay, we do need new antibiotics.
Complaining about the cost of drugs may have some validity, but it certainly doesn’t address the problem of drug-resistant bacteria. If any of you paid attention to the pharmaceutical industry, you would know that there have been huge layoffs in R&D recently. New drugs have been very hard for the industry to make, at any price. For antibiotics, some kind of public/private collaboration, i.e. early R&D by universities or the NIH and development by a pharmaceutical company, is already being tried, but it’s by no means a sure thing. A recent industry estimate says it costs $1.5 billion to develop a new drug. The research and development costs are $975 million. Of that, $725 million goes to study drugs that ultimately fail, and $250 million is spent directly on the successful drug. Companies are not foolishly wasting money on dumb ideas: it’s just very, very hard to find new drugs or predict which approaches will succeed early in the process. So, most attempts to make drugs fail, at enormous expense. Imagine the NIH trying to defend what appears to be pouring money down a hole to legislators/taxpayers.
Ed Gleason: HIV is an interesting example of the industry coming up with lifesaving drugs, one to be proud of . The first HIV drugs, AZT and the like, were terribly toxic, but people were dying, so they took them, and researcher learned. The next generation of drugs, HIV protease inhibitors, target an enzyme that is closely related to an enzyme involved in blood pressure regulation for which an approach to making inhibitors was known. This was a very lucky coincidence. A crisis, and a lot of luck.
What William Collier says is true, in theory, but even so, it’s hard to make a good safe (cheap) antibiotic, and it may be that until we face another devastating epidemic like HIV, neither the public nor the industry will take the risks or spend the money to really attack this problem.
Thank you everyone for a very useful discussion.
My main interest in this, apart from the desire never to get sick, is understanding how markets fail in medicine. Or succeed.
That is why I mentioned that the development of new drugs struck me as an area where the market might actually work better than in many other aspects of health care. As Kathleen Mortell points out, development of a new drug can be a big gamble that probably wouldn’t sit well on the taxpayer’s dime, but may be privately undertaken in hopes of significant profit.
Still, I believe that the new HIV/AIDS treatments wouldn’t have emerged absent a concerted campaign. Certainly that was required to make them available in poor nations in Africa and Asia. And what do I recall about so-called “orphan drugs,” needed to treat relatively rare diseases that, without special incentives like extended patents, did not constitute a sufficiently large and therefore profitable market?
But what struck me as more than passing strange is that here was a potentially large market with relatively affluent buyers (people who avail themselves of hospital care in nations like ours), and the reason why new drugs were not being actively pursued seemed to be that the damned things might actually work, i.e., provide a cure in relatively short order rather than years of dependency.
It is too easy or perhaps just too boring to beat up on Big Pharma but am I right in thinking that this is one of the most profitable industries, year after year? Maybe laying off R & D employees has something to do with that.
Mr. Steinfels -
Somebody on one of the threads said that the pharmos are not among the most profitable corporations. But what does that mean? Some businesses have outrageous profits.
The fundamental and apparently intractable ethical problem is, it seems to me is; what is a fair profit? a fair price? It’s not of much interest to ethicians these days. Keynes was interested but had no good answer.
However, it seems to that until we reach some rational answer to those questions we will be saddled with a capitalist system that assumes that a fair price for drugs is whatever the sellers can extort from the buyers Yes, in the case of drugs that is exactly what the pharmos do — charge as much for life-saving drugs as people are willing to or can afford to pay. Yes, for life=saving drugs that have no competition pricing is indistinguishable from extortion..
Hi Peter Steinfels,
I think this is a really interesting subject, and I could go on about it until everyone else gets tired! Ann Oliver, you know little about making drugs, but you do understand logical arguments, and Peter asks: “here was a potentially large market with relatively affluent buyers” and if so, why aren’t the pharma companies taking the opportunity to make antibiotics and extort money from people?
The short answer is that the market is actually not large. At present there are a range of effective antibiotics available; cheap and safe enough to be handed out to children. They are arguably the best drugs in the pharmacopeia (they were created by other microorganisms, mostly, not drug researchers) and they set a very high bar. Fairly healthy people can beat the drug-resistant bacteria using a less-than fully effective antibiotic plus their own immune system. Very frail people sometimes can’t clear an infection even with the right drug. The numbers of people who would be helped by new antibiotics are currently small, and it costs a huge amount of money to do the experiments to know whether a drug works and is safe. The public will not accept drugs that are not very safe, even in a trade-off with significant benefits, and that weighs heavily in the decisions companies make about which drugs to pursue. A similar issue exists in diabetes and obesity research; the competing treatment is diet and exercise. It is very hard to make a drug that is safer and more effective than diet and exercise. I agree with Peter in theory that in these types of cases, we could see a crisis coming and start working on treatments that the market hasn’t “chosen” to pursue. In practice, we actually do that, in an imperfect way. Universities do basic research that (hopefully) lays the groundwork for developing drugs in areas of need, and grant money goes to these researchers based on arguments about importance, not profit. (Barbara wisely does not want universities in the for-profit drug-making business.) This is not a perfect system, but with the amounts of money involved, I’m not sure there’s a better one.
About drug pricing: as Unaguidon has pointed out about insurance, it makes no sense to expect for-profit companies to give stuff away. Drugs are cheaper in European markets because large buyers can negotiate prices. The people who oppose health care reform are the ones who are responsible if pharma is gouging you. It doesn’t get you anywhere to curse a rock for being a rock; curse the guy who put it in your shoe.
To add to what Kathleen Mortell said: Bacteria are life forms and they will always evolve to try to resist any drug we can make. It’s not clear that we need so many more antibiotics, as much as we need to leverage the assets we already have more wisely.
There is a lot more room for improvement in reducing the rate of resistant infections, many of which are found in hospitals, and which has the benefit of being much more cost effective, and helps to avoid the problem of resistant antibiotics, in addition to keeping patients healthier. In short, a preventive, public health approach is probably superior to an approach that looks for ever better and more expensive treatments after an infection has started.