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This piece was originally slated to appear in Third Coast Press, the newspaper, and will eventually appear at Third Coast Press, the web site. If the images on this page aren't loading, I recommend switching to using Firefox as your browser. If you don't want to bother, though, don't worry--the images are all just pullquotes from the article.

If you haven't been living in Antarctica for most of the past year, you've heard a lot about the Food and Drug Administration (FDA) lately. Vioxx and heart attacks; Zoloft and suicides; mad cow disease--all these are tied up in the business of the FDA. In Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat, Fran Hawthorne, a veteran reporter of politics, industry, and healthcare, takes us inside the FDA in much the same way that The Jungle--the book often credited for inspiring Teddy Roosevelt to get the government involved in food safety--took readers inside the meatpacking industry.

Unlike Upton Sinclair's novel, however, blame in Inside the FDA is rarely assigned in a simple way. There are doctors who read drug labels carefully and doctors who hand out prescriptions for whatever is the newest drug on the market. There are scientists committed to finding treatments for cancer and scientists looking for anti-wrinkle drugs. There are Type I mistakes, where a drug is released too soon and previously unknown side effects cause injury or even death, and Type II mistakes, where drugs that might help fatally ill patients are held back by testing. There are Congress members and lobbyists. And above all, there are mounds and mounds and mounds of paper. (Although drug applications are now usually submitted electronically, it was not unusual in the past for a company to hire a truck to transport the 300 or so volumes that it takes to make a new drug application).

Those looking for easy answers on food and drug policy will not find them here. What they will find, however, is an invaluable education on how drugs get from test tubes to medicine cabinets and food from genetic labs to grocery shelves, and where the pressure points are along the way. Recently, Fran Hawthorne spoke by telephone to Third Coast Press about her book and about what those concerned with food and drug safety could and should do.

TCP: What got you interested in writing a book about the FDA?

FH: Several things. I have done a lot of writing about healthcare from many different angles. I had just written a book called The Merck Druggernaut--which is about the drug company Merck--and using that as a way to look at the pharma industry. I've written a lot of articles for a lot of different publications about health care from point of view insurance coverage, from the point of view of consumers, from the point of view of companies offering health plans.

My first love is really covering politics, which I've also covered in my long and varied career. The FDA is just a great way to put together so many areas of experience and interest to me, and it is such a major topic. But I have to say I lucked out. When I started this, I got the contract almost two years ago. I knew it was important, I knew there were many issues, I had no idea it was going to explode in the way it has in the past six months or so.

TCP: Yeah, as I was reading it I thought, "Wow, this is just straight out of the headlines!"

FH: Well, I was scrambling throughout last fall to keep up with the news. They kind of had to tear the pages out of my hand and get them printed.

TCP: People who've seen me reading [Inside the FDA] are like, "Whoa, is that an expose?" And I say "Well, not exactly; it's just more of a look at the workings of the FDA." Did you have you have a particular view of the FDA when you started, and has that changed over the course of doing the book?

FH: I think I started out with mixed view of FDA, as I think many people do. You're kind of vaguely aware that it's out there protecting you; you know it does something with food. Because I've done so much reporting, I had been bombarded by questions from both sides and had felt the anger of both sides--the anger of the drug companies because of the nitpicking bureaucratic obstacles; the anger of consumer groups who see it as the lap dog of industry. You kind of get these gut instincts as a reporter. You know that likely the two extremes of anger are based on some facts and a lot of exaggeration. I knew that it was a mix of all these, but I didn't know where it was going to fall down. . . .

It would be a lot easier to talk to you and to do the public speaking I'm doing. . . if I could come out and say "This is an exposé because the FDA is corrupt and totally controlled by industry." But I'm stuck being [gasp!] an honest reporter!

TCP: One theme that runs through Inside the FDA is the graying of the Baby Boomer generation. Over and over again, you learn that Boomers are getting older and will need more medicine; pharmaceutical companies are looking for drugs to market to affluent, aging Boomers; Boomers are veteran protesters who know how to get what they want. It seems like there's a real tension between the idea that Boomers are socially responsible and want to see what's best for everyone and the idea that Boomers are retiring and they just want a great sex life and what's best for them. Which side do you think will win out?

FH: Well, first of all, how can one generalize about 76 million people? There's also one other aspect now that we're generalizing, anyway. There are several things that have defined the population of boomers--one is this social activism that you've mentioned, this concern for other people--we don't just take what's given to us; we question authority. I think more broadly true than the first generalization is that there is this desperation among Boomers to be forever young, because we saw ourselves as the vanguard, we didn't trust anyone over thirty, and we're still clinging to that. There are good aspects of that because we're not just going to sit back at 65 and go retire and go play golf in Florida. We take care of our bodies and we try to stay healthy. So there are good things, but there is also something kind of bad and silly, and this is where frivolous drugs come in: Propecia and Botox and all of this. . . a lot of money is wasted on this, a lot of brain work is wasted. On the other hand, there seem to be some other effects of Botox that may be beneficial, and Viagra may help with a very serious kidney disease. So you think "Well, wait a second. . . ." I think the issue of the Boomers is a major trend, because the drug industry is so much catering to this generation which has dominated society for years.

TCP: I was just curious if it was something you were conscious of writing about or if it just happened.

FH: I have to say that was not one of the narrative threads that I was conscious of intentionally, but I know it was a major part of my Merck book, and it is kind of unavoidable when you write about health. Balancing risk versus access to drugs--if you have only one point to make about the FDA, that is the major issue that always has been and always will be. ThatÕs where the criticisms are, thatÕs the issue that deals with everything.

The other area that I write about that I kind of stumbled on by accident is this whole issue of political manipulations resulting from Erbitux that led to reorganization of the FDA, which I think is seriously going to hurt the FDA's ability to keep up with new research and science. I'm very concerned that the FDA is losing its historical tradition of having a good chunk of scientists who do real original research so they know what they're talking about, so they understand the drugs they're getting. They're losing that because of this bureaucratic maneuver that was probably politically influenced, and I think it's going to hurt. And this is one place where some people in the industry are unhappy, too.

TCP: I was fascinated to learn about the complexity and interwoveness of food and drug monitoring by different government agencies. There's a whole chapter in the book about this: for instance, if you buy a frozen cheese pizza, the FDA is responsible for its safety, but as soon as you add a slice of pepperoni, it becomes the responsibility of the USDA, which oversees meat. Is that kind of entanglement inherent, or will it change and become simpler?

FH: I had fun writing that chapter. That one I got a little carried away sometimes with my puns or joking, but to some degree it's so ridiculous you just have to laugh, or groan, or whatever.

To some degree it's inherent, because, you know, government is famous for being a bureaucracy and these things weren't all invented at once. It wasn't like the Constitution was written and then every single department and agency was created right away. Government grew as whole concept grew that government does have responsibility to proactively reach out and help provide basic, minimal levels of security. First it's armies, then it's social security, then this got tacked on and this got tacked on. To some degree it's sort of inevitable that it's going to be haphazard. Microwave ovens get invented, and then where do we tack them on? But it's not completely inevitable. Government does get reorganized all the time. Things get changed. Government officials could sit down and look at this in a more reasonable way. It absolutely could be organized more reasonably.

Many consumer groups, especially the ones focused on food, have been trying for years to reorganize and get all the food put in one place. . . it hasn't been a high priority for the government to do this, but they do need to sit down and look at all the things the different agencies oversee. And you could do it. You put things that are not medicine in one place, things that are medicine in another, food in another, devices in another, et cetera.

TCP: It seems like Food and Drug Administration is one area where there isn't a clear path for progressives. We all want to see better health care, but we can't seem to agree on what that consists of how to achieve it. Has writing this book given you any insights on what kind of path progressives should follow?

FH: Progressives and consumer activists are often on different sides of same issue. You look at it and youÕre torn, because you've got friends on both sides. This comes up so much with the FDA. I've been to these committee meetings where you've got heartrending stories from people on both sides. Antidepressants are a great example, where you've got the parents who come up and say, "My kid took Zoloft and hanged himself," and on the other side you see the parents and the psychiatrists who say, "There is nothing else, and we have these kids who need medical help, and there is no other drug."

There are things that people can do and should do. One thing is that if there is an issue you're concerned about, read a lot about it, obviously. What you need is a strong consumer point of view in addition to the industry point of view. The industry has a lot of money to get its point of view across. The consumer point of view may in fact agree with the industry view at times. This is an industry that by-and-large creates good products--sometimes they're frivolous and silly and unnecessary, but sometimes they save lives, so it's not necessarily bad if a drug company is trying to get a drug approved by the FDA. They're not bad guys necessarily.

What you need is a strong consumer/patient point of view to be an honest advocate to the FDA, as strong and well-funded as industry, which it never will be. One thing for your readers to take away is to hook up with other consumer groups and really know what you're talking about. The scientists at the FDA tend to be dismissive of consumer groups as ill-informed, and sometimes that is true. There have been times I've sat in on meetings and listened to people talk and just cringed. You have to know what you're talking about, because you are talking to scientists who are experts in their field. What you want is new drugs thoroughly analyzed as fast as possible, which takes money, so it is important for the FDA to be fully funded, and you can lobby for that.

The thing that Congress is very aware of now is post-market monitoring of drugs. Vioxx made people very well aware that there's not enough done on that score.

On the issue of food, the FDA really dropped the ball on that about 20 years ago when genetically modified foods were first created. The FDA had the chance then, because there were no laws. Nobody knew what to do. The FDA could have said "These are not natural products. These are additives, and we need to study and approve them in some way"--but they didn't, and nothing is done now. GM food has not killed anybody, but you really don't know what you're getting into, and I think it behooves the FDA to take a better look at them for the sake of public safety, because nothing is being done now. A tomato is a tomato, no matter how it's been modified. As long as it's recognizable as a tomato, you can sell it.

What needs to be done now to get more authority for the FDA is for Congress to pass a law, and in fact there is a bill that's been introduced in the Senate by Richard Durbin which would set up approval process for GM foods.

TCP: Hey, that's our senator! How fitting!

To learn more about Senator Durbin's proposals for food safety, visit http://durbin.senate.gov/issues/foodsafety.cfm.

copyright 2005 by Laura Crossett