Bad Science Blog Highlights The Harm Done By Pharma Patents

from the it's-a-start dept

CG was the first of a bunch of folks who sent in a link to Dr. Ben Goldacre from the always excellent Bad Science blog taking on the issue of the harm done by pharma patents:

Ignoring patent and licensing issues has allowed Dr Yusuf Hamied, director of Cipla, to innovate: even though each drug is officially owned by a different company, he could put a common combination of three treatments (Stavudine, Lamivudine and Nevirapine) into one simple, single combination pill. This increases treatment compliance -- it's easier to take your medication correctly -- and that keeps you alive longer, while reducing the emergence of resistant strains.

Hamied calls his pill Triomune (he also offers "Antiflu", a copy of Tamiflu for the developing world, and many more). In 2001 he was selling to MSF clinics for $350 per person per year, more than 30 times cheaper than the official versions of these drugs. Triomune is now only $87 a year. This is amazing. Hamied is a hero.

Richard Sykes, head of GlaxoSmithKline (and now retired rector of Imperial College London) disagreed. He called Hamied a "pirate" and described the quality of Indian generic drugs as "iffy". Hamied says GSK is a "global serial killer" for charging high prices for their medication. So who is right?

From there, Goldacre runs through the traditional arguments both in favor of and against pharma patents, and concludes:

If the global $550bn pharmaceutical industry are trying to make an economic case for patents in the developing world, then they must argue that the benefit to drug development from the financial incentives in these tiny corners of the world market is so significant -- so vital, the final link in the incentive chain -- that it is more important than millions of unnecessary deaths. I am not a health economist, but I doubt that is a fair swap, and this is not what patent laws were invented for.

Indeed. I'm glad to see Goldacre take on this issue, though I hope that he'll spend some time exploring the work done by many before him that goes much more deeply into the problems with pharma patents. For example, in explaining why pharma patents can be "good," Goldacre trots out the line "It takes about $800m and 10 years to bring a drug to market," but that's been widely debunked. If Goldacre (or anyone else) is interested in the subject, they should check out Merrill Goozner's detailed and thorough analysis of this claim in his book, appropriately entitled The $800 Million Pill, which thoroughly debunks the notion that it costs a pharma company $800 million to bring a pill to market.

On top of that, he should look at the some of the work done by Nobel Prize winning economist Joseph Stiglitz in detailing how patents harm innovation in the drug process. Or, hell, he can look to the US government itself. The GAO put out a report a few years ago, noting that patents appeared to be hindering, not helping, the development of new drugs. Another great source of detailed information is the chapter in David Levine and Michele Boldrin's book, Against Intellectual Monopoly, that directly deals with the case of pharma patents (pdf). It goes through the history of different patent laws in different countries and totally debunks the idea that patents create true incentives for pharma. There's plenty of evidence of harm, but very, very little true evidence that patents create actual incentives for innovation.

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The Placebo Effect: Things Pharma Prefers You Not Worry About

from the here,-take-this-sugar-pill dept

There's a fascinating article in the latest issue of Wired about the placebo effect and pharmaceutical companies. It's fascinating for a few reasons: First, because it shows the thought process of pharma firms and why "what's best for pharma" is often not what's best for your health (which is a line often trotted out by those who believe in protecting pharma). Second, because it suggests that some (potentially significant) parts of pharmaceutical science -- the stuff we hear over and over again is so important to protect via patents -- is bunk. And, finally, just because it may surprise you to know just how powerful the placebo effect appears to be -- and that it's only getting stronger.

The critical point is that final one. Basically, the placebo effect (the impact had on a patient taking a sugar pill under the false impression that it's medicine) seems to be quite real and, at times, quite powerful and lasting. Even more surprising is that, over time, the placebo effect has only become stronger and stronger.

Now, if pharmaceutical companies were actually interested in your health, then this would be a ripe area of study, well worth exploring to see if the placebo effect could be better understood and somehow harnessed to make people healthy. But, of course, you can't patent a sugar pill, so pharma research dollars have gone into drugs that can be patented.

However, a serious problem has arisen: with the placebo effect getting stronger and stronger, these "wonder drugs" that pharma has been spending millions of dollars "developing" have increasingly been failing clinical trials, because they can't out-perform placebos. The theory behind testing against placebos is that if a drug doesn't outperform the placebo, you have to question what good the actual drug is and why it should be approved. So, if a drug fails to outperform a placebo, then (the thinking goes) the drug is useless. But that's partly based on the idea that the effect of taking a placebo is weak.

This leaves out an important part of the equation: If the placebo is really effective in dealing with certain issues, then why not examine how to utilize that fact to make people healthy? Some in the pharma world have been pushing for this for a long time, and have repeatedly asked the big pharma companies to release their data on clinical trials, in order to better understand the impact of placebos and to see if there's a way to harness their power. But the pharma companies have resisted and don't want to release the data -- in part because they're scared to death of what this all means. If sugar pills are effective, that's a very different business, and the claims of all of the drugs that are on the market would be called into serious question. Instead, they've apparently spent their time writing out detailed marketing plans that convince doctors to prescribe medicine that doesn't work any better than alternatives.

Now, let's be quite clear here: I am not saying that drugs don't do any good. There are plenty of pharmaceuticals that certainly help deal with certain conditions, and there are plenty of people who lead better lives (or are alive at all) solely because of modern medicine. But, these findings about the placebo effect certainly suggest that -- at least in many cases -- rather than dumping chemicals into the human system via a pill, your brain may actually be a lot more effective at concocting the proper chemicals itself.

If we had a healthcare system built on incentives to actually keep people healthy -- rather than just to sell more pills -- this would be the beginning of a very important field of study. Instead, it's been resisted and the data has been hidden away for years.

The incentive system is clearly screwed up. It's based on patents and hoarding information, rather than on actually keeping people as healthy as possible. If you could craft a healthcare system that actually rewards those who keep patients healthy, then perhaps we'd actually know a lot more about the placebo effect and, beyond it, our own brains' ability to produce important, potentially life-saving or life-improving chemicals on its own. In fact, in such a system, the incentives would be less about hoarding information, and more about sharing it, since, through collaboration, it would be more likely that more people could be kept healthier, allowing greater overall profits. The problem today is that the system is based on incentives that are misaligned... and thus, it's a struggle to get anyone to care about the fact that the placebo effect actually seems to help some people.

Update: As pointed out in the comments, Skeptic Magazine recently had an article that provides some more thoughts on placebos.

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Big Pharma Abusing Patent Laws To Seize And Destroy Legal Indian Generic Drugs

from the helping-the-needy dept

The deeper you look at how pharmaceutical companies use and abuse the patent system, the worse it looks. It's much more horrifying than what's happening in the tech industry in many ways (especially since lives are often at stake). The latest such example highlights the desperate lengths that Big Pharma will go to, in attempts to stamp out perfectly legal competition. India has a legal and thriving generic drug market that was built up initially via a ban on pharma patents in India (which, as an aside, shows again that a ban on patents can actually help create a thriving industry). More recently, India was forced, almost entirely against its own wishes, to implement patents on drugs. Even so, many of its generics are not covered by patents, and there are a number of developing countries that also do not recognize patents on certain drugs. Thus, it should be perfectly legal for Indian generics to ship those drugs from India to developing nations. And... it is. Except that pharma companies have convinced EU trade officials to seize and/or destroy such shipments that pass through EU borders in transit to these developing nations.

Thus, if a legal Indian generic drug maker has a shipment of those drugs to Peru, where the same drugs are also perfectly legal and not blocked by patent law -- those drugs might still get seized because en route to Peru, they may pass through some European countries, where Big Pharma has used its lobbying clout to get customs officials to search for and confiscate any such medicine, claiming they are violating patents in the EU. Because of this, the Indian firms need to spend a lot more money and ship via other means.

To deal with this, India is looking to file a complaint with the WTO, and at least according to the experts in the WSJ article above, India has a strong likelihood of winning. Big Pharma and the border patrol folks are defending their actions, claiming it's to stop counterfeit drugs, but that's not what's happening here at all. These drugs are not counterfeits. They're legal generics, not intended for the EU at all, and they're being confiscated for no good reason other than the fact that Big Pharma doesn't want to compete.

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Patents Not Enough Of A Monopoly, According To Biotech Firms

from the say-what? dept

Apparently, a bunch of big biotech firms feel that the patent monopolies they already have over certain drugs aren't enough, and they are demanding Congress enact laws that also stamp out any competition from similar drugs (known, back here in the real world, as competitors). You would think that after centuries of understanding how bad monopolies are for the market that the gov't wouldn't kowtow and simply hand over such things -- but it is. Of course, the biotech firms already have patents, so it's questionable why they also need an additional gov't granted monopoly period to block out "biosimilar" drugs, other than the fact that they don't like competition.

They claim, of course, that they need this exclusivity to recoup their costs in developing the drug. However, the deeper you look at the details, the less true that really is in practice. Much of the really core biotech work is done under gov't grants anyway, and often at research institutes. These private firms pick up the trail later in the game in a lot of cases -- but still get full patent rights. The actual cost of developing these things has been massively overstated, often lumping in marketing costs to R&D. It is true that clinical trials are crazy expensive and a huge burden on biotech and pharma companies, but that's a separate issue. There are numerous proposals about ways to take the clinical trial burden expense away from pharma. Lumping those mandatory gov't induced expenses into basic R&D is misleading. Furthermore, even in the face of competition, time and time and time again, we've seen that the original provider still commands a large and noticeable premium, from which it can easily recoup its costs. This is nothing more than blatant monopoly rents with a Congress too clueless about basic economics to resist.

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Surprise, Surprise: Pharma Abusing IP Laws To Prevent Competition

from the live-by-ip... dept

The deeper and deeper you look into the pharmaceutical market and the way those firms use patents, the worse and worse it looks. There's little evidence that pharmaceutical companies really need the kind of exclusivity that patents provide, but it's become so established an idea, that some actually believe that pharma would disappear without patents. However, the truth is quite different. The chemistry industry -- the precursor to the pharma industry -- actually fought against patents in the early days, knowing that robust competition was what drove innovation and profits. Patents only allowed the leaders to stomp out competition and limit the overall market, increasing their own profits, but slowing innovation and product development.

Thus it should come as no surprise at all that a new report has found that pharmaceutical companies are regularly abusing patents for anti-competitive purposes (thanks Rob Hyndman for the link):

Pharmaceutical companies are manipulating the intellectual property rights system and are "actively trying to delay the entry of generic medicines onto their markets," a top EU official said of an EU inquiry into the pharmaceutical sector released Wednesday. As a result, there has been a decline in the number of innovative medicines getting to the market, it says.

In other words, contrary to the popular myth, patents are actually being used to hold back innovation in the healthcare market.

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