Are patents going to impact how doctors treat a patient?

Today Ars Technica reported on a case before the US Supreme Court and how the court is assuming that the usage of scientific data, which has been publish, is a valid patent. This is a pretty scary scenario. What do you mean? Well, the patent is related to how the levels of some chemical impact the dosage of a drug. That’s it. If you have level X in your blood you should have dosage Y. The patent holder created a device to test the level of the chemical in your blood which then suggests a dosage level. The Mayo clinic developed their own test and  have been administering the test on their own without paying anything to the company. The arguments in the court essentially assume that this is a valid patent.

Should this patent be valid though? Seems like something that could be patented. Based on what is considered patentable, this should fall under mathematical formulas. Essentially, this is a matter of correlation and basic regression analysis. During a drug trial you can determine a correlation between the impact of a dosage of a drug on the current level resulting in a lower level of the chemical. This is really how all medicine works. If you can reduce costs by creating your own tests and administering it yourself then that’s great. Hospitals should be encouraged to do this if they are large enough.

This is what Doctors do. They read literature about the medicine the condition it’s supposed to impact and what sort of connection there is with the dosage levels and the response rate within the patients. Every doctor has to use a test to determine the level of a chemical or some condition. This can be the pulse (irregular heartbeats), blood pressure (pressure cuffs), blood sugar (A1 test) and the list goes on. In each case the doctor is able to assign a proper dosage prescription based on the study of patients. If a doctor was required to pay a licensing fee for each and every case of this our currently exorbitant costs of health care will seem cheap. Like when we used to complain about $1.50/gallon for gas.

The other problem with patenting something like this is that it’s likely to be highly unenforceable except for when a large institution like the Mayo Clinic. Individual practitioners will be safer than large clinics, but they could be impacted as well. If they are required to use an extremely expensive proprietary testing methodology rather than have the ability to use any testing method it will drive up prices and may put doctors out of business.

If the court rules on this as if these types of patents are valid, we will need to push to have patent law changed again. The last change moved things in general, in the right direction but a lot more work needs to be done.

Ethics in Science III

I’ve been doing a series on Ethics in science, part one, part two, because there’s been a lot of public issues in the UK about the behavior of scientists. Any suggestions, or laws put into affect would have far reaching impacts. As any scientist in the UK would be required to follow them and any scientist that wishes to publish in a journal headquartered there. I believe Nature is. Nature is THE journal to get published in.

There are some different suggestions on what should be done, including ethics review boards and independent verification of results. The UK’s investigation of fraud led to this result:

In the same way that there is an external regulator overseeing health and safety, we consider that there should be an external regulator overseeing research integrity,” says the committee’s report. “We recommend that the government set out proposals on the scope and powers of such a regulator and consult with the research community and other relevant parties to develop them.

I understand what they are going for here. They want to prevent another vaccine debacle or prevent another cold fusion lie. I think they also plan to prevent another “Climate gate.” While these are noble causes, I can’t help but fear that politics will get involved in this process. If a scientist is found of committing true fraud their career is over. There just isn’t the right incentives to commit fraud in MOST sciences. Yes, it happens, but it’s more likely to be a mistake than true fraud. Which is something that peer review might catch. However, even this is difficult without the initial data set, or recordings of how the experiment was carried out. Scientists are pretty brutal when going through the peer review process. They question everything and you have to have a satisfactory answer to all their questions if you want the results to be published. The true best way to improve scientific debate is to provide incentives to publish articles that have debunked previous research. This will fix more problems than a regulatory board for most of the sciences.

However, then we come to medical sciences. Here there are much greater incentives to commit fraud or intentionally mislead. Why? Well, for a blockbuster drug they can sell Billions in revenue a year. If a drug company thinks that they have a blockbuster on their hands they will try to get it to market sooner. In most cases they have patent protection for at most 10 to 15 years. But you’ve said patents are for 20 years. That’s true, however, it typically takes drug companies 10 years to get a drug to market. After the last ten years they are able to request a 5 year extension.

Why is the system set up like this? Well, the drug companies test a lot of different drugs and not all of them can be blockbuster drugs. A lot of them don’t make it through the rigorous testing process either. The drug companies have to pay for all of that as well as make a profit. So, they charge a lot for these blockbuster drugs. They actually do have some different prices to try to help the poor out as well though.

So, in clinical trails there is more incentive to commit fraud or with hold important results. What can be done about it? Well Bernie Sanders (US Senator) has proposed a prize competition for developing different kinds of drugs, which as a stipulation of getting the prize the US government would own the patent. The government would license the patent out so drugs could be cheaper. However, this prize would have to be huge which would again provide more incentives to defraud the government. It would have to be in the billions to allow for the drug companies to recoup their expenses. It could force much stronger restrictions and oversight on the drug trials though. Which could reduce the ability to commit fraud. The prize committee could potentially be made up of scientists that are part of the NIH (National Institute of Health) which would do the data analysis for each of the “Blockbuster” trials thus forcing impartiality into clinical trials.

This could work. Additionally there could be sanctions put on the fraudulent authors, where they are unable to publish for a year, at any level. Where they lose their grants, or are unable to hire new graduate students until they show they have been reformed. This would certainly kill their career. However, this should happen.

Finally, I think that scientists should be required to add any conflicts of interest in the publications as well as sources of funding. In many cases this already happens as the funding agencies require it, however making it an explicit part of the publication process will make it more transparent. Transparency is vital to science.

Science isn’t perfect, but it’s our best tool for understanding the world around it. Committing fraud on the scientific community and the world as a whole is a horrible crime and should be treated as such.

Ethics in Science II

Yesterday I discussed some of the ethical concerns within the Medical science field. This case most likely has the most frequent cases of fraud and unethical behavior. Why? Because there’s a ton of money involved. Clinical trials relate to drugs, which is a multibillion dollar industry. Additionally, there is no requirement by the National Institute of Health to list any potential conflicts of interest. According to Nature there was a plan in the works to require this. However, it got scuttled. In business people go to jail for these types of things.

However, medical science is not the only place where fraud happens. As this ethic blog notes there are a lot of several different kinds of fraud. Some are intentional, others are less intentional. The biggest problem is intentional fraud. Where the author makes up some result. There are two pretty big examples of this. The first is the fake human clone from South Korea by a scientists named Dr. Hwang Woo Suk. This  guy was rather quickly outed as a fraud. However, this wasn’t until there was a HUGE debate in the mainstream media about the ethics of cloning human stem cells. This helped push the US and much of Europe to ban cloning of human embryos.

The second most famous case of fraud is the case of cold fusion. What is cold fusion though, why would people want to make claims of making that happen? Well, fusion is what the sun does, if we could manage to do that on earth without burning ourselves up that would be pretty awesome. Basically, as the PopSci article states, is that with fusion you get more energy than what you put into it. It basically would solve all world energy problems. The first person that does it would basically be a savior to the human race. So, it’s something that people really want to do. There’s debate if it’s even possible, it’s theoretically possible, but physically possible is still up for debate.

So, accidental fraud comes about from introducing a personal bias or from misinterpreting data. Both of these happen fairly often in science. Why? because we’re human, and this is what the scientific method is supposed to eliminate over time. Before publishing results you typically need to have been able to reproduce them and show that there is a trend that is consistent over time for the phenomena that you are studying. This is one of the biggest requirements for science. Which is why in clinical trials there are at least three stages to ensure repeatability of the data.

The other good thing about the scientific method is the fact that other people can take your results and findings and test them. IF the results are different they can be published and used to dispute the previous findings. This happens all the time in regular scientific discourse. In fact there’s a great example of this going on right now. This debate has been going on for about a hundred years now or so. Recently a group debunked Gould’s bias argument. Basically a guy back in the late 1800’s measured a big set of skulls to see if there were any size differences. Stephen Jay-Gould, basically the Richard Dawkins of his day, re-analyzed the data because he felt there was bias in it, and found that there was in fact bias! Well, this recent group actually remeasured the skulls and found out that it was Gould that was biased and that if anything the original sample was more correct.

Science is supposed to be totally objective. As we can see from this discussion it’s not, and cannot be. Why? We’re human. However, the system works really well as a whole. In my next blog I’ll discuss some of the ways we can address issues of fraud other concerns that I’ve mentioned over the past two days.

Ethics in Science

So, right now the UK is in a big uproar about ethics in science. There have been parliamentary hearings which have deeply concerned scientists. In one opinion piece from the guardian the author argues that it’s been too long going that the scientific community has been able to function without some sort of regulation. Scientists of course object to this. Because there is a method to the manner in which they work. Many, from the tone at the hearings, feel this is another assault on the scientific community.

However, it maybe that there’s some scientific work that is more likely to have fraudulent activity in it. Today the Guardian published an article about scientific ghost writers. Scientific Ghost writers can come in two forms. The first is harmless where the author is really the person that got the funding. Depending on the journal these authors are either the second or very last author on the paper. This is normal, as typically you’re working in that person’s lab and they are paying you. So they should get some credit for the work done as they may also have had an advising role. The second kind of ghost writing is much worse. These writers were in no way associated with the research and their names are put on the article to give it weight, or if they were the ones supposed to be doing the research and some one else did it. In the Guardian article they are focusing on clinical trials for medicines.

This isn’t the only country where fraud, exaggerating claims or ghost writing occurs. Although, the UK has had one of the most famous cases with the retracted article linking MMR vaccine to Autism (meaning it was fraud). This also happens in the US and in many clinical trials. In fact a Greek doctor has made it his mission to unearth clinical trial fraud and really understand what was going on there. The Atlantic had a great write up about this in November of 2010. The doctor  Ioannidis has been making a career out of debunking claims as well as researching the causes of these problems. He argues that the double blind clinical trial isn’t giving us the best results we could possibly be getting in medical science. Although, he doesn’t offer a huge amount of alternatives. 

The New York Times also ran a story about in September of last 2010 about some of the ethics behind clinical trials. This article discusses how two cousins ended up in the same trial and one cousin was given the treatment and the other was not. It was a story that was really questioning the ethics of the clinical trial, because it was obviously working. However, pushing through these treatments without fulling testing them can be just as dangerous. Granted these people were near the end as it was. The cousin that didn’t receive the new treatment died from only getting the chemo.

One the one hand we want to get promising medicine out as fast as possible. However, we want to ensure we are properly testing these medicines to ensure safety. This leads to a great deal of ethical concerns. For promising medicines do we make exceptions? Do we allow fully untested medicine into the wild? These are difficult questions. From an ethical and moral standpoint allowing a patient to die because of a randomized test is very questionable, which is what happened in the case above. However, in some cases rushing through medicines like these end up causing deaths in other manners. In the case of Vioxx this is exactly what happened. In many people it reduced the risk while in others it out right killed them. Where is the balance? I think this is why the UK is pushing for more oversight in these cases.

*Note: my dad, a nurse practitioner pointed out that i was slightly wrong about Vioxx. He’s correct. There were more ethical problems than the fact it was a bad drug. Simply the creators of Vioxx hid the fact that it impacted african americans differently than white americans. If Vioxx hadn’t done this it wouldn’t have been a problem for the drug to stay on the market. If you want to read more about Vioxx there’s a chapter in the book Denialism By Michael Specter

In my next blog I’ll discuss scientific fraud and ethics in other fields.