A Memo to my Boss: "We can do our small part"

Time for change

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Sun Sep-10-06 03:03 AM
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A Memo to my Boss: "We can do our small part"

As a liberal Democrat who works for a federal agency that is part of the George Bush administration, I have often found my work atmosphere stifling and repressive. And though I would not admit this to my fellow workers, I�m sure that that at least partially explains why I find writing posts for DU to be so much more interesting and enjoyable than the work that I get paid to do. The bottom line is this: The issues that I read and write about on the DU are generally of crucial importance to our country and to the world � whereas the Food and Drug Administration (FDA) that I work for is emblematic of many of the serious problems that the we DUers typically write about and which typify the Bush administration.

I have written about those problems before and won�t dwell on them here, except to link you to my discussions of the anti-science and pro-corporate aspects of today�s FDA. This is a very serious problem because in order for the FDA to effectively accomplish its mission of protecting us against dangerous foods, drugs, biologicals and medical devices it must emphasize a scientific and a pro-people approach � approaches that the Bush administration has disdained ever since it grabbed control of our country in January of 2001.

Fortunately, due to a dedicated core of FDA scientists/public health workers, the infiltration of the Bush point of view into the FDA has not been complete. However, indoctrination of the Bush philosophy into upper level management at FDA has been quite successful, which is not surprising given the fact that most upper level managers are political appointees.

Recently I had an opportunity to vent some of my opinions on these issues when my boss asked each of the epidemiologists working under her to give her our ideas for a conference which our office is planning to sponsor within the next few months. The stated purpose of the conference is to discuss better ways to evaluate the safety and effectiveness of medical devices after they have been marketed. But as with all such activities that the FDA has been involved with in recent years, it appears that our upper management is planning to invite the manufacturers of the devices to the conference, with no representation for the public.

Bush philosophy has so infiltrated the FDA that many FDA workers, and probably almost all of its upper level management have forgotten (if they ever knew) that the purpose of the FDA is to protect the public, rather than the corporations that manufacturer the foods, drugs and devices that the FDA is supposed to be controlling in the public�s interest. With that in mind, here is the memo that I recently wrote to my boss on that subject:

I realize that this is politically controversial at the FDA, but I feel strongly that we should have consumer representation at the conference, as I believe that currently consumers have too little of a voice in FDA policy and manufacturers have too great of a voice.

The original purpose of the FDA, and the purpose that it still claims on its websites is to protect consumers against unsafe products. That is why it is funded primarily by U.S. taxpayers. The manufacturers are the ones who we are supposed to be regulating for the protection of the consumers. And yet, it seems that the FDA in recent years spends a lot more time consulting with manufacturers and asking for their advice, and almost no time seeking the advice of consumers or consumer representatives (In fact I�m not aware of a single instance where it has sought the advice of consumers or consumer groups in the past few years.)

Furthermore, allowing the manufacturers to dictate policy to the FDA seems to me to constitute a serious conflict of interest. I�m not saying that we should not listen to what they have to say. But we need to always keep in mind that their first priority is to make a profit. We have seen many instances in the past where manufacturers have put profits ahead of safety, the one that I�m most familiar with being the time where Medtronic convinced our Commissioner to pull my article on AneuRx after it had already been accepted for publication and was about to be published.

Here are some quotes by Dr. Sidney Wolfe, of Public Citizen, from an interview with Amy Goodman on this subject:

We did a survey of FDA physicians, the physicians who review new drug applications. And these are what the findings were in our survey. They identified 27 drugs that they thought were too dangerous to be approved, but which were approved over their objection. They identified 14 instances where they were told not to present information adverse to a drug at a public FDA advisory committee hearing because it might prejudice the advisory committee against the drug. Not to mention that the drug company at the same hearing does everything to prejudice the committee in favor of a drug. So, the climate at the FDA even back in 1998 was silencing criticism, people were leaving the FDA in droves, scientists, physicians and others, and that has continued. The FDA did an internal survey after ours which came pretty much to similar conclusions. And then the third survey, the inspector general one in 2002, reached the same conclusion. So Dr. Graham is not alone. There are a large number of people in the FDA, who are there trying to protect the public health as part of the public health service, but being pushed around, I think, because of the influence, the undue influence of the drug industry, to sign off on drugs that they know are too dangerous.

Now that the Epidemiology Branch is presumably taking over responsibility for post-market issues, it seems to me that this provides an excellent opportunity for us to do something about re-arranging priorities.

I understand that we want to make this a reasonably small conference so that we can get some work done. But if that is our goal then I think that we should invite consumer representatives instead of manufacturers, and then we can always obtain the manufacturers� opinions later.

Lastly, I have to say that in recent years this problem has not been confined to the FDA by any means. We have energy executives writing government energy policies; we have the oil industry and the automobile industry dictating policy on the fuel efficiency of cars; we have pollution generating industries dictating policies to our Environmental Protection Agency. The list goes on and on. The hallmark of a Fascist state is a too close relationship between government and corporations. We can�t stop that process by ourselves, but we can do our part within our own realm of responsibility.

Tim F. Chang

I got a little bit carried away with that last paragraph. I guess that I must have felt as if I was writing for DU. It was a bit of a mistake to do that because we are not supposed to express political opinions in the course of our work at FDA.

Nevertheless, it felt good, and the memo received a very positive response, both from my fellow workers and from my boss, who promised to do what she could to get upper management to agree to have consumer representation at the conference. Now we�ll have to wait and see what upper management has to say about it.