Drunk With Conflict


Leonard Zwelling


If there is one person you do not want to get a letter from, it is Senator Charles Grassley (R-IA).

He recently sent one to Dr. Francis Collins, the Director of the NIH. It was about a large clinical trial. Apparently the National Institute on Alcohol Abuse and Alcoholism was doing a study to measure the possible beneficial effects of a single alcoholic drink per day. The problem is that the costs of this “government” study were being defrayed to the tune of $67 million (out of the total $100 million price tag) by the alcohol industry. The funds were garnered by the NIH scientists who suggested to the industry that there might be a benefit to a single drink per day in warding off cardiovascular disease, strokes, diabetes and cognitive problems. Hey, wouldn’t you have jumped on board if you had stock in the alcohol company?

It will come as no surprise to anyone that the study is centered at Harvard and that the local IRB approved all of this.

Senator Grassley would like to know how the integrity of the trial data is to be guaranteed given the interest the sponsor has in the outcome. He also wants to know why the scientists were raising the money from the alcoholic beverage industry for a trial aimed at upping the value of the company stock and whether any of this undermines federal policy.

But think about it. Is this any different than an industry-sponsored study of a new drug? I think not.

Much of the clinical research in the United States is paid for by corporate entities with vested interests in the outcome of the trials. Stop that and you stop research. What the scientists who generated the money for the alcohol study did is no different than what many academic faculty do in encouraging pharma industry sponsors to perform critical drug trials at the universities where the faculty work under the auspices of those faculty some of whom also give paid presentations for the industry sponsors. This is the dance that academia has been compelled to do since the federal government cannot support these very costly trials.

The only way to fix this is to grant the NIH a whole lot more federal money in the budget to defray the cost of all the needed clinical research or prevent those doing the research from having anything to do with raising the money for it. It also helps, as appears to be the case here, that an independent data safety monitoring board is in place to evaluate the data. These board members should have nothing whatever to do with the trial or with the trial sponsors. That’s probably as good as one can do. There simply is not enough government money to support the level of research society would like to see done. The private sector is going to be involved and without it, research would halt.

Thus the firewalls must be up between those acquiring the data and those paying for the research. That may not have been the case here. We shall see what the two NIH investigations into the integrity of the study design and the manner in which the funding was secured show.

From here it looks like some of the NIH personnel started the study on themselves while not considering the consequences of their behavior with regard to the sponsors of the research.

From my own personal experience being rejected from a position on Senator Grassley’s committee because I worked at MD Anderson when he was investigating that institution, I can assure you that the Senior Senator from Iowa is not someone from whom you wish to get a letter. He has never seen a conflict of interest in academia that he cannot exploit for political purposes. This one seems like no exception.

Leonard Zwelling