This is Why Nobody Trusts the Pharmaceutical Industry, Part 2: A few days ago, I
posted in response to a Wall Street Journal article concerning clinical trials for a blood substitute developed by Northfield Labs. The crux of the story is this: in an earlier (though not recent, as I initially said) trial, 10 of 81 patients who received the fake blood suffered a heart attack within seven days. As current trials proceed, however, “several hospitals have told community meetings that previous trials showed PolyHeme to be safe, failing to mention the 10 heart attacks in their printed materials.”
It was—and remains—my position that pharmaceutical companies should adhere to the ethical principle of informed consent, which means that they have an absolute moral obligation to share any information regarding fatalities in a previous clinical trial with patients. In this case, patients are generally in extremis when treatment is required, and unable to give their consent at that time. So that means the companies have an absolute moral obligation to share the information proactively with the community, so that people can opt out, if they wish.
The article provoked an interesting response from at least two readers, both of whom—doubtless they have their reasons—elected to remain anonymous.
The first provided examples of the information being shared with the communities in two trial centers, presumably in an attempt to rebut my argument that they were not fully informed. In fact, the community information is worse than I had imagined. Not only is there no mention of the 10 in 81, there’s no mention of the word death. The language used—“serious cardiovascular adverse experiences”—is so vague, the only reasonable conclusion is that it’s deliberately misleading.
This deception is explained—if that’s the right word—with the information that “the company involved, the surgeons involved, and the FDA concur that the blood substitute was NOT responsible for the cardiac problems.” By all means, share those conclusions with the patient population. But those conclusion are not an excuse to refuse to provide them with the facts. One of the hallmarks of a democracy, and of true free markets, is that regulators (and companies) do not presume to decide what is good for us and what is not. People should be given the facts and then trusted to make those decisions for themselves.
Even more telling are the words of the second anonymous poster, who writes that I must be “caught up in the angry, self-righteous anti-pharmaceutical company mood” of the times. Leaving aside the fact that I have been accused of being an apologist for the pharmaceutical industry far more often than I have been accused of being a critic, I have always believed that this kind of ad hominem attack (the word “self-righteous” pops up three times in one paragraph) tell us more about the writer than they do about his (or her) subject.
A strong subset within the pharmaceutical industry is so convinced of its goodness that it is impervious to criticism. It sees the world in black-and-white terms and its thinking runs something like this: “We make products that save or improve lives. We are therefore the good guys. Anyone who criticizes the good guys must be a bad guy. Therefore, all critics are bad guys. Therefore all criticism is necessarily wrong.”
I now understand why my friends in the pharmaceutical PR industry are so frustrated. They offer sound public relations advice. They counsel greater openness and honesty. They suggest that when it comes to disclosure, the pharmaceutical industry should err on the side of providing too much information rather than not enough. They provide advice designed to improve the industry’s image—which is exactly what I did. And they are accused of being angry and self-righteous.
The difference is, they’re being paid to save the industry from its deceptive, authoritarian and arrogant impulses. I’m not.