Bad news makes more headlines than good news. Some people even make a good living pointing out all the problems in certain industries (some of whom either make money in the exact same industry, or made all their money and now feel compelled to point out all the industry’s flaws). And nobody is a bigger magnet for critics than the thriving pharmaceutical industry.
But Reason Magazine, a bastion of libertarian thought, has an interesting article in its just-published October 2007 issue (which won’t be online for a few months) about the “overrated risks and underrated benefits of pharmaceutical research ‘conflicts of interest'” (Is Industry-Funded Science Killing You? by Ronald Bailey).
Now, the bias in this article is clear as well — it appears in a magazine where its publishers believe the free-market is best left alone, and government intervention kept to a minimum. So you’d expect that if Reason is going to publish an article about pharmaceutical research, it’s going to take the side of free markets — that is, the existing industry of pharmaceutical companies working with academia, for-profit journals, and other organizations that conduct clinical drug trials. They’d like to see the government stay out of the fray.
The article is a well laid-out argument for the status-quo, pointing out that the industry adapts to meet the needs of changing government and disclosure requirements. And that while there are some big-headline cases that occasionally make the news, the vast majority of clinical trials and drug research is conducted ethically and without safety problems. CenterWatch, which tracks clinical trials, estimates that more than 40,000 clinical trials are now in process, involving more than 20 million people. CenterWatch president Ken Getz says in the article, “The vast, vast majority of clinical trial participants ahve very positive experiences.”
What about all those conflicts of interest that bring otherwise unworthy drugs to market, as some claim? In 2005, Tufts University Center for the Study of Drug Development found that faster drug approval times do not correlate with more frequent drug withdrawals, and the data speak for themselves — the withdrawal rate in the 1980s was 3.2%, 3.5% in the 1990s, and 1.6% so far for this decade.
How do patients feel about researchers who might have some sort of ties to a drug company conducting research for them? Well, not all of them see it as a bad thing. That article points to a 2006 survey (published in NEJM) of cancer patients participating in five research trials, more than 80% thought it was ethical for researchers to receive speaking or consulting fees from the company. Most patients also said they would oppose a ban on relationships between researchers and drug companies, according to the article.
What about docs just being pushed to prescribe newer drugs that basically do the same thing as their older, less expensive counterparts? I would ask, Are doctors simple pushovers that are always looking to prescribe the latest, greatest drug? Or are there some real benefits (or perceived benefits) from such prescriptions, such as better side effect profile, less life-altering side effects (e.g., sexual side effects), or a quicker treatment response? According to the article in a 2002 study for the National Bureau of Economic Research, researcher Frank Lichtenberg estimated that, “on average, ‘reducing the mean age of drugs used to treat a condition from 15 years to 5.5 years […] increases prescription drug spending by $18, but reduces other medical spending by $129, yielding a $111 net reduction in total health spending.'” The reductions in other medical spending include less hospital and office visit expenditures.
Newer drugs are also the result of the type of society we live in — a free market society that values competition amongst competing firms to drive innovation and new treatments.
As I said, the Reason article is bound to make a good argument, as that is the point of such articles. But I still think it’s a good read for people who believe that pharmaceutical companies are all evil and just in it to make a buck. They’re not, and the articles makes a good argument for the system that is in place is flexible enough to adapt to meet the changing needs and demands of society. Is it perfect? No system designed by humans and with significant monies for all parties involved (even non-profits) is going to be perfect. Could it be better? Maybe, but I have yet to see any solution that demonstrates we’re in need of significant change, given that the vast majority of clinical trials and drug research is run ethically and responsibly.
6 comments
I don’t think that drug companies are ‘all evil’ but I do think that they are in it to make a buck – that is the ethos in a ‘survival of the fittest’ western mentality of what companies are all about.
> the vast majority of clinical trials and drug research is conducted ethically and without safety problems.
There could be problems here is the business interest goes some way towards determining what the ethical restrictions are and what constitutes a safety problem.
> What about docs just being pushed to prescribe newer drugs that basically do the same thing as their older, less expensive counterparts? I would ask, Are doctors simple pushovers that are always looking to prescribe the latest, greatest drug? Or are there some real benefits (or perceived benefits) from such prescriptions, such as better side effect profile, less life-altering side effects (e.g., sexual side effects), or a quicker treatment response?
Placebo response can be considerable. If you take a group of people and tell them they are taking the generic drug that was developed 10 years ago and compare that group with people who are told they are taking the ‘latest and greatest and newest drug with considerably less side-effects’ and you give them the same drug what do you think would happen? How much should people have to pay for a placebo response? Should a doctor be ethically obliged to prescribe a more expensive medication to a less expensive medication with knowledge that the difference in treatment response is due to the expense of the medication? A lot of people (doctors included) think ‘yes’.
> Newer drugs are also the result of the type of society we live in — a free market society that values competition amongst competing firms to drive innovation and new treatments.
Do you mean that newer drugs couldn’t develop in a society that wasn’t free market? Do you mean that there would be less newer drugs if the society wasn’t free market? Newer doesn’t necessarily mean better and there is surely a trade-off between new drugs and progress that is not merely placebo…
I think that there need to be many changes to the current system.
I think that the companies should be required to disclose ALL their experimental results. If 96 out of 100 studies show that drug x is no more effective than the previous drug then we should hear about all 100 studies and not just the 4 studies that show the drug to be more effective. What is particularly concerning about the companies being able to withold such information is that 4 out of 100 studies isn’t even statistically significant (which is to say that the findings don’t adequately rule out chance being responsible for the positive finding).
What is hard about the drug companies having an investment in the academic and other supposedly ‘independent’ research is that they have a hand in the methodology that is used for drug trials (which enables them to do such things as ‘fail to support a hypothesis’ rather than ‘show that the drug is more harmful than alternatives’). If you run studies that show that drugs are harmful then you can kiss career prospects in pharmaceutical companies goodbye – and, when drug companies have an investment in academia – you can probably kiss an academic post goodbye too.
The absense of regulation means that quality and ethics are comprimised. I understand that people put a lot of hope in the pharmaceutical industry to cure whatever ails them but I do think that this hope is something that the pharmaceutical industry profits from significantly. That hope can blind people to problems with the current system. It is frightening for many people to think that there are such significant problems. If there are such significant problems then… What is going to cure them?????
According to the article, in 2004, the International Committee of Medical Journal Editors (ICMJE) adopted a policy that requires, as a condition of consideration for publication in their journals, registration of clinical trials in a public registry. Since such publications are a requirement for getting FDA approval, this along with the 2004 announcement by the Pharmaceutical Research and Manufacturers Association of creating an online registry for all clinical trial results (from 2002 on), should go a long way to addressing the concerns of negative or non-significant results. This has long been a concern of mine as well, since nobody, not even researchers outside of pharma, rarely bother to publish nonsignificant findings.
I would agree with the article’s main thesis, that there are already plenty of regulations around these studies and their publication that is driven by changes in expectations, academia, etc. — not by government. I think government regulation is great to ensure we get a house that won’t fall down, but I have a lot less optimism when it comes to even more regulations in this arena.
I do believe drug research thrives in a competitive world that places a concrete value on innovation. That is why the U.S. is where most new drugs are developed. Could it be supplanted with a not-for-profit model? It would be one of the nation’s biggest shifts of an entire industry in our history and I’m not sure it could be constructed in a way that saves innovation without giving something valuable up in the process. Given that the current model is largely working (and that drug withdrawal rates for safety reasons have largely stayed the same in the past 30 years), do we really need to scrap something for a few bad apples?
Or do we need to find better ways of catching those who would “game” the system in order to increase their profits?
I’d argue the latter would be much better for society in the long-run.
> I do believe drug research thrives in a competitive world that places a concrete value on innovation. That is why the U.S. is where most new drugs are developed.
Yes. There has been a lot of innovation with the development of new drugs. What concerns me, however, is whether those new drugs have been adequately tested such that they really are an improvement on the old drugs. More drugs doesn’t necessarily mean better drugs and I’m interested in the trade-off between less new drugs on the market (which of course means less profit for pharma) but the consequence that those new drugs on the market really are an improvement on the drugs already on the market.
Similarly to how happiness isn’t a function of how many brands of spaghetti sauce you have to pick from in the supermarket (more brands actually tends to lead to LESS happiness) better health isn’t a function of how many brands of drugs you and your doctor have to pick from.
I’m interested in the quality / quantity trade-off and I’m concerned that pharma sacrifices quality for quantity because quantity means profits.
So who restricts pharma to ensure that the latest and greatest brand of drug really is an improvement on the last brand of drug?
I guess that I think that independent scientists should develop the methodology for testing because they are the ones that are most likely to develop methodologies that get at reality rather than profits. It can be hard to find truely independent scientists, however, because of the pharma influence in supposedly ‘independent’ research environments.
I guess that I think that there need to be independent bodies that determine the methodology, ethical restrictions, and so forth. I guess it doesn’t really matter to me whether those independent bodies are governmental or non governmental bodies. It just matters that they are independent. I suppose I think ‘government’ because where I’m from the government tends to have some involvement with those independent bodies (in the sense that the government prosecutes deviations from the restrictions imposed by those independent bodies). And because… Researchers tend to get the majority of their funding from the government rather than from sources like… Drug companies (or subsideries thereof).
Well, if you need proof, look at how many people are/were prescribed tricyclic antidepressants (the old standard for depression treatment) versus SSRIs (the “new” standard for depression treatment). After 1990 or so, the amount of prescriptions for antidepressants skyrocketed when SSRIs became commonplace.
Why?
Well, they generally have better-tolerated side-effects (until the sexual side effects became more publicly known and understood). Outside of the sexual side effects, though, these new set of drugs had overall less severe side effects than those they replaced.
>> So who restricts pharma to ensure that the latest and greatest brand of drug really is an improvement on the last brand of drug?
Well, the FDA sets the regulations in the U.S. about efficacy and safety, so if you have an issue about the *degree* of efficacy, you can already take it up with your existing governmental bodies. The FDA isn’t supposed to approve drugs that don’t show some improvement over an existing drug.
I think in the vast majority of pharma clinical trials, independent scientists do develop the methodology and in a reliable, ethical manner. Sure, it becomes a “don’t bite the hand that feeds you” phenomenon, but at the same time, no scientist would ever want to be labeled as simply feeding from the hand of pharma. Well, a few don’t mind, but most do.
I wouldn’t mind more non-profit oversight of the process, rather than government oversight. I believe once you involve too much government in things, you involve a lot of unnecessary costs and bureaucracy.
The antipsychotics of the 1960s versus the antipsychotics of today are a world of difference. Ask anyone who has taken large amounts of thorazine and has to deal with tardive dyskinesia. So yeah, there’s definitely been improvements. The question is, could these improvements occurred in a system other than the one in place today in the U.S.?
Maybe, but the answer isn’t more clear than that.
SSRI’s don’t do much better than placebo, but they result in how much profit for pharma? Similarly, anti-psychotics don’t do much better for psychosis than other forms of tranquilisation, but they result in how much profit for pharma?
> After 1990 or so, the amount of prescriptions for antidepressants skyrocketed when SSRIs became commonplace.
Yes… But how much did people actually benefit from those prescriptions? How much harm is done to people who suffer through withdrawal syndromes from those prescription medications? Depression in increasing in prevalence because our concept of depression has expanded. Because of the development of SSRI’s more people are being diagnosed with depression than ever before. People are considered to have depression now when they wouldn’t have been considered to have depression in the past. THis isn’t to say that it is being over diagnosed now or that it was being under diagnosed before. It is to say that pharma has an interest in mental illness being prevalent as do clinical psychologists as do psychiatrists as do people who are trying to reduce the stigma of being mentally ill. it is a win win situation except for… people who are harmed more than helped by those drugs.
> The FDA isn’t supposed to approve drugs that don’t show some improvement over an existing drug.
I’m concerned that there isn’t enough testing of side-effects (think thalidomide (sp?) and the sexual side-effects and other sorts of withdrawal syndromes from SSRI’s (effexor, for example) that pharma is still denying). And why would pharma choose to measure side-effects? It isn’t in their interests to do so. They simply aren’t going to do so until the FDA or whoever requires them to do so. Similarly, there has been some criticism of the drug companies testing medications against inert placebos because the person can work out they are taking placebo by the lack of taste etc of the tablet. THis means the double blind is broken and hence the results of the study aren’t valid.
Er… Is the FDA independent from pharma interests / funding?
> no scientist would ever want to be labeled as simply feeding from the hand of pharma.
I disagree. Pharma hires scientists to develop their medications and to conduct their testing on those medications. If you work for pharma you are paid significantly more than if you work in a university environment. Not all scientists want to work in academic, many aspire to earn a high income working for pharma or some other private sector.
Academic scientists tend to look down on it, to be sure. But that being said they are happy to have their flights paid for by pharma and they are happy to go to that pharma funded conference and take their courtesy xanax pen and notepad paper. Doctors similarly are happy to attend conference talks where pharma reps present all the latest positive pharma findings and hand out free samples of the latest drugs.
> I believe once you involve too much government in things, you involve a lot of unnecessary costs and bureaucracy.
I’m not sure if that is inevitable… But I guess I’m not exactly wedded to the idea that the government specifically should restrict pharma. I’m not exactly sure that government counts as not having pharma interests, either 😉
The ‘improvements’ in modern anti-psychotics are controversial. One of the ‘improvements’ seems to be that Dr’s are prescribing less of a dose than they used to. Less dose = less side-effects. Is that an improvement in medication? It is controversial whether the newer generations are increasing cognitive degeneration much like how the older ones increased motor degeneration. Not sure that counts as an ‘improvement’.
> The question is, could these improvements occurred in a system other than the one in place today in the U.S.?
So… I’m not sure these are cases of genuine improvement. And as for the clearer cases of genuine improvement… I’m not at all convinced that those developments couldn’t have occured in a significantly modified or alternative system. At present… All drug companies are subsidieries of… How many major US pharma? Perhaps there is something of a monopoly on pharma that prevents alternative companies setting up shop in alternative locations (for example). Perhaps the US pharma’s have less restrictions than pharms’s would have in other developed western nations and as such it is impossible (financially) for alternative pharma’s to get going…
I don’t know a great deal about this… But I am wary of psychiatric medications in particular. And the fact that pharmas make such considerable profits and yet restrict their life saving medications to people who can pay for them (rather than selling them at cost to people in the third world etc) shows that it is indeed profits before people. Just feel sad is all 🙁