More Questions About Nonprofit Groups And Industry Support

In response to my article about commercial funding of nonprofit organizations from the manufacturers of the PCSK9 inhibitors, Joshua Knowles wrote an eloquent and heartfelt defense of the FH Foundation, which receives some funding from industry. But I think he fails to address the fundamental underlying issues I wrote about in my piece.

Knowles writes that “FH is a devastating disease with huge individual, family and societal costs… [that] too often leads to early, aggressive heart disease. FH affects 1 in every 200 to 500 people – over 1 million individuals in the U.S…. we know that when FH is diagnosed and treated early enough, its adverse effects can be ameliorated.”

But Knowles fails to address a key problem here: is it possible or even desirable to find and treat all of those patients? The broad range– is it 1 in 200 or 1 in 500?– makes clear that this is not an easy problem to resolve. It is inevitable that by increasing the sensitivity of screening methods we will also decrease the specificity. Inevitably there will be some people who will be diagnosed with a frightening disease and who will receive therapy– some, perhaps, even the new, expensive and unproven PCSK9 inhibitors, as I discussed in my article– who would otherwise have not been diagnosed.

One thing disease advocates almost never discuss is the problem of medicalization, of turning people into patients, and the often traumatic effect on quality of life of the new “patient” and his or her relatives, who now learn that they have a disease. Too often previously happy and apparently healthy people are told that they’re living on borrowed time and have a ticking bomb inside them. These are scare tactics.

Let me emphasize: I am not saying that efforts to identify new FH patients should be halted, but I do think we need to think more carefully about these sort of problems. I am concerned that all the money and resources is on the side of aggressive screening and treatment. One are of particular concern (though not the only one) is the role of industry money in helping to decide who we screen or how we treat people. It is simply obvious that industry has a very definite interest in selling as much of their products as possible.

In addition, let’s not forget that those expensive new drugs, the PCSK9 inhibitors, have not yet been shown to have any clinical benefit. Most experts believe that these benefits will be proven in a few years, and I see no reason to disagree with them, but in the meantime I think we need to be extremely cautious.

Knowles notes that the FH Foundation board is made up of people who have FH and the doctors who treat them. I have no doubt that they are admirable and well meaning. I am moved by his characterization of the FH foundation’s works as “a labor of love.” I have no doubt this is true. But I don’t think it is demeaning or even disrespectful to point out that FH patients and the doctors who specialize in treating them are not necessarily the most objective about this condition or that they should decide how overall healthcare resources should be allocated to this disease.

Knowles states that the FH Foundation modeled itself on the highly successful CF (cystic fibrosis) Foundation. But he doesn’t consider the differences between CF and FH.  When the CF Foundation was started nearly all CF patients died in childhood or very early adulthood. FH is a terrible problem, but it does not have the same urgency as CF, as evidenced by Knowles’ own statement that the average person is not diagnosed with FH “until almost age 50” and that more than 25% of them have heart disease at the time of diagnosis. Once again, I don’t want to diminish the significance of FH, but we should acknowledge these differences.

I do not mean to single out the FH Foundation. I believe that these problems are ubiquitous. Nonprofit medical groups, from the tiny FH Foundation to the enormous American Heart Association or American Cancer Society, have an “institutional imperative” to stay alive. Funding– whether from drug manufacturers or Coca Cola– can be very difficult to turn down. The temptation is too great.








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