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Monday, May 15, 2006

A Well Funded Cult

Working with the scientific method can be tough. Nature has a way of frustrating us human beings. To get around our ignorance we have created religions and we have created science. In between these two extremes there are varying degrees of getting the world to do what we want it to do. Say for example, you have cancer and you want it to go away. You could pray and it might go away. If it does you attribute the disappearance of the cancer to the praying. Likewise you could take a drug that is on the market. Again, if the cancer goes away, it's because of the drug. The problem is that we are only guessing. It could have gotten worse. What then becomes of our beliefs on prayer or the drug industry?

When drug companies run clinical trials they have many options for obtaining the best possible results. Like religion, they can work around evidence that detracts from their hypothesis. What can we do as consumers to varify if the drug companies are operating in a less than honest manner? We can use the scientific method.

TUESDAY, May 16 (HealthDay News) -- In a revealing look at the impact of funding on medical research, a new study found that clinical trials funded by drug companies and other for-profit entities were more likely to report positive findings than similar trials funded by nonprofit groups. ...according to background information in this article, surveys of randomized trials conducted in the 1990s found that for-profit trials were more likely to report positive findings. Those surveys raised questions about the design and conduct of industry-funded clinical trials. A study published earlier this year found that industry is paying for more and more medical research, with a full half of studies now funded solely by the private sector.

In this paper published in JAMA, May 17 2006, they looked at the data from 324 consecutive superiority trials of cardiovascular medicine published between January 1, 2000, and July 30, 2005, in JAMA, The Lancet, and the New England Journal of Medicine. The question was whether or not the trend of for-profit funded trials providing favorable results continued from 2000 to 2005. Since it is known that industry is paying for more and more research, we might want to take a closer look at the studies that are being conducted. If the drug companies are going to pay for the studies, we have to study the studies. We have to question the questions they are asking.

It's difficult to take a random sampling and come up with an exact description of what you've got. Say you you want to measure handfuls of dirt. You hire people all over the world to pick up a handful of dirt and analyse what they get. In China people have smaller hands than people in France. The French might report that their dirt weighs more than Chinese dirt. In Palm Springs where dirt is very dry they say that their dirt weighs less than the dirt in Nebraska. So already we've got problems in measuring the weight of a handful of dirt. How do we account for factors such as hand size and moisture content?

One way to analyse the results that get published is to look at who is doing the study. Do they want the dirt to weigh more or less? Maybe the French have already reported on the correlation of the weight of dirt and the annual production of crops. Lets say that an increase in the weight of dirt corralates with an increase in crop production. Palm Springs has a desire to introduce farming into their economy. The French make a pitch to sell them their dirt as do the Nebraskans. The Palm Spring folk see that the dirt from each group is roughly the same based on their studies. The Nebraskans protest with a study that they funded indicating that the French cheated by only using data from dirt picked up by men. Men have larger hands than women. The French tout a study that they conducted where the dirt in Nebraksa was picked up by Chinese women. Of course they don't mention that part of the study. The Nebraskans go after the scientific integrity of the French. Who do you believe? All this science is just so confusing.

As you can see, this can get out of control. The real issue that we've forgotten is whether or not the weight of dirt has anything to do with growing a crop. What is the crop anyway? Cactus? In order to get to the bottom of an issue in nature it is important to know what you are looking for. It is critical that the questions asked are non-biased.

In the same issue of JAMA there is a study on the cancer risks in taking HUMIRA and Remicade, both monoclonal antibodies against TNF alpha. The drugs are prescribed for treating rheumatoid arthritis. One of the authors, Eric L. Matteson, MD, MPH, is getting paid by the makers of another TNF alpha inhibitor (Enbrel) to do a similar analysis on Enbrel alone. The reason Enbrel was left out of the trial was because Enbrel differs at the molecular level. HUMRIA and Remicade are antibodies whereas Enbrel is a modified TNF alpha receptor. Should that really matter? Was this study fair? Before the article begins perhaps factors such as Dr. Mattesons relationship with the makers of a competitors drug should be divulged.

Dr. Matteson may or may not publish a similar article on Enbrel. The effects of this corporate study will be people switching from HUMIRA and Remicade to Enbrel. That's just a guess. To be fair however Enbrel needs to be put up to the same rigors of the HUMIRA/Remicade study. Ultimately we might find out the effects of TNF alpha levels. It is complicated but drug company motives are not. Study the studies. Look at what they are doing and make decisions based on their own research. Use their data to draw conclusions that they never intended you to draw. The more we learn about corporate science the better we'll be able to gauge their conclusions.

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