The FDA is supposed to protect Americans against unsafe drugs — drugs with bad side effects, for example. According to this interview with Ronald Kavanaugh, a former FDA employee who worked there 10 years, that is not what actually happens. Here are excerpts from the interview:

I think most people would be shocked at how malleable safety data is. Human studies are usually too short and the number of subjects in them too small to adequately characterize [= detect] the most dangerous risks.

Human clinical pharmacology trials are typically done in Europe, yet clinical pharmacology reviewers at FDA have been barred from analyzing this information prior to studies being conducted in the US.

If reviewers say things that companies don’t like, they will complain about the reviewer or they will call upper management and have the reviewer removed or overruled.

When you do raise potential safety issues, the refrain that I heard repeatedly from upper management was‚”where are the dead bodies in the street?” Which I took to mean that we only do something if the press is making an issue of it.

FDA’s response to most expected risks is to deny them and wait until there is irrefutable evidence postmarketing, and then simply add a watered down warning in the labeling.

Which is why bad side effects are sometimes discovered after FDA approval.

Thanks to Anne Weiss.

Mark Bittman writes about food for the New York Times. If he covered health instead of food, would he have dared to write this?

When I was growing up, drinking milk at every meal, I had a chronic upset stomach. . . . In adolescence, this became chronic heartburn, trendily known as GERD or acid reflux, and that led to . . . an adult dependence on Prevacid, a proton-pump inhibitor. Which, my gastroenterologist assured me, is benign. (Wrong.)

Fortunately my long-term general practitioner, Sidney M. Baker, author of “Detoxification and Healing,” insisted that I make every attempt to break the Prevacid addiction. Thus followed a seven-year period of trials of various “cures,” including licorice pills, lemon juice, antibiotics, famotidine (Pepcid) and almost anything else that might give my poor, sore esophagus some relief. At some point, Dr. Baker suggested that despite my omnivorous diet I consider a “vacation” from various foods.

So, three months ago, I decided to give up dairy products as a test. Twenty-four hours later, my heartburn was gone. Never, it seems, to return.

His gastroenterologist (and probably several other doctors) failed to tell him that his digestive problem might be due to eating the wrong foods. It is as if an astronomer fails to understand — or at least tell his students — that the earth is round.

It is equally interesting that someone smart enough to write for the New York Times fails to figure this out for himself. How strange that a food writer would not connect food and health — someone else had to draw his attention to the possibility. Although Bittman praises Dr. Baker, you are not going to figure out what foods are bad by adding things, such as licorice pills, to your diet. Dr. Baker failed to understand this obvious point, which Bittman still fails to see, apparently. Bittman should be utterly astonished by this mountain of avoiding the obvious, including his own.

In a later column he feels “frustration” and begins to notice how big the problem — self-serving avoidance of the obvious by doctors and the rest of mainstream health care — is:

Experiences like mine with dairy . . are more common than unusual [huh?], at least according to the roughly 1,300 comments and e-mails we received since then. In them, people outlined their experiences with dairy and health problems as varied as heartburn, migraines, irritable bowel syndrome, colitis, eczema, acne, hives, asthma (“When I gave up dairy, my asthma went away completely”), gall bladder issues, body aches, ear infections, colic, “seasonal allergies,” rhinitis, chronic sinus infections and more. (One writer mentioned an absence of canker sores after cutting dairy; I realized I hadn’t had a canker sore — which I’ve gotten an average of once a month my whole life — in four months. Something else to think about.)

Although lactose intolerance and its generalized digestive tract problems are well documented, and milk allergies are thought to affect perhaps 1 percent of the American population, the links between milk (or dairy) and such a broad range of ailments has [have] not been well studied, at least by the medical establishment.

Yet [wrong word] if you speak with people who’ve had these kinds of reactive problems, it would appear that the medical establishment is among the last places you’d want to turn for advice. Nearly everyone who complained of heartburn, for example, later resolved by eliminating dairy, had a story of a doctor (usually a gastroenterologist) prescribing a proton pump inhibitor, or P.P.I., a drug (among the most prescribed in the United States) that blocks the production of acid in the stomach.

Finally he turns to emotion:

There is anger as well as surprise, because you’d think that with a grapevine’s worth of anecdotal stories and at least some studies linking dairy to physical problems, few people began this kind of self-testing at the suggestion of their doctor — unless, that is, their doctor was in the “alternative” camp. [he is so angry he gets confused?]

So I got mail saying things like, “When I think back to all the things I’ve missed because I had a migraine, it makes me a little angry that the solution for me was so simple.” When a lifetime of suffering, medical visits and prescription drugs can be resolved with a not especially challenging dietary change — one that, when it works, has rewards well worth the sacrifice — a certain amount of retroactive frustration seems justifiable.

The big trip begins with the small step. Maybe Bittman will begin to wonder at the dystopic miracle of a healthcare system in which respected gastroenterologists fail to grasp that digestive problems are often caused by food. No one else in prestige media has managed to notice this, as far as I can tell.

Thanks to Lisa Wiland.