Last week, the Senate Finance Committee targeted yet another academic for failing to fully disclose potential conflicts involving research funding provided by drugmakers and other financial holdings. The example, which singled out Stanford University'sAlan Schatzberg, is part of a larger investigation into academics who receive funding from both the NIH and pharma for possible violations of federal regulations. At issue are whether universities and NIH are adequately policing disclosures in an effort to maintain scientific integrity and objectivity. In response to the probe, the NIH disclosed it would tighten oversight, but the story is just beginning. Eric Campbell, an associate professor at the Institute for Health Policy, Massachusetts General Hospital and Harvard Medical School, who studies the relationship between academia and industry, explains why...
Pharmalot: Why is this issue important? Campbell: It matters because patients rely on the advice and the wisdom of their doctors in making health care decisions. And they rely on the fact that their doctor has their best interests at heart and that academic science is true and unbiased and not influenced by commercial pressures. So when conflicts of interest exist, it brings into question the basic trust and value of these relationships. It's important for Americans that institutions take these relationships very seriously, and that they're disclosed and watched and monitored. Remember that not all academics, but many are opinion leaders in medicine - they lead a specialty, head a professional association and are well known. If one of them makes a presentation about a beneift of a drug, it can influence the reaction of doctors in the audience and the doctors they know. So it's important to know the nature of these relationships. Disclosure becomes a necessary step but it's not a sufficient step.
Pharmalot: But not every academic is a so-called key opinion leader. Campbell: Distinctions about the realm or scope of one's influence is difficult to make, but because one isn't nationally known doesn't mean they can't have influence in a certain sphere. One could argue why doesn't anyone care about a physician practicing in rural Minnesota, but the issue is to apply the principal broadly and make sure it's adhered to broadly. We shoud treat everyone the same but paying particular attention to the most influential is important.
Pharmalot: How pervasive is this problem? Campbell: I think the data are very clear that relationships with industry are ubiquitous in medicine and research. They exist at the individual level and also at the institutional level. At this point, the question si how good are the disclosure policies that currently exist? Are these well known by faculty? Does faculty take them seriously? How well do people disclose? Are there penalties if they don't?
The problem is that every institution has its own disclosure form. There's no national form. And so every institutino defines things differently. Some have to disclose conflicts, some only relationships, and then only those that meet certain financial threshhold. Sometimes, it's not very clear what relationships with industry qualify and thus need to be disclosed. There's also the potential for non-disclosures to be unintentional due to ambiguousness in the disclosure system.
Pharmalot: Why isn't is possible for universities to police their faculty? Campbell: It's impossible to police faculty. The only way to check is to check tax returns and see what's been declared to the federal government. And there are all kinds of way these relationships can go on. You could set up a non-profit foundation that takes company money and pays fauculty that way. You could run these things through university foundations so it looks like a gift or donation, but it's filtered through the university. Short of getting tax information, they have no way to know. You have to rely on faculty to be open and honest. Perhatps the majority are, but we also know from Senator Grassley (who initiated the investigation) there are people who aren't. Some could be deliberately hiding things. Some could be bad accountants.
Pharmalot: How do we solve this? Campbell: There are a couple of ways we could go about this. You could have a national database by faculty and institution that receives funding from NIH. Submit disclosures on a singlee form to a database that's collected by the government. Failing to dslcose then has more weight. And then there's what Senator Grassley is proposing, which is have drug companies tell the government what they've given to which researchers and check that way. A database would allow institutions to check what faculty disclosed and if that matches what drug companies say they gave those faculty. The devils is in the details, though. There are still ways around everyting and have to rely on people to be honest and forthright.
The issue of trust is very important. The important thing is to illuminate the truth of these relationships. Many are necessary and not at all wrong. They have positive benfits for faculties, universities, patients and society, so they're important and we need to preserve them. A relationship with industry is not bad in and of itself. But at the same time, these carry risk and we need a way to minimize risk, implement a dislocosure system, and educate the public about benefits and risks. In my opinion to automatically assume they're all wrong and all bad is completey short sighted. In the end, people have to disclose and forms have to be clear and unambiguous, and there should be real penalties when people fail. And institutions have to make decisions about these things based on policies and principals, and not on the person who failed to disclose.