Tuesday, September 29, 2009

Part Three: The Relationship Between the Level of Regulation under the FDCA and the Health Status of a Product’s Targeted Population

[From BioLaw/AgLaw]

An Introduction to the History of Quack Medicine

In the late nineteenth and early twentieth centuries there was a remarkable growth in the marketing of sham products to treat and cure disease.

At that time, the rate at which quack medicines were being introduced into the market far outpaced the development of the science necessary to establish the efficacy and identify the risks associated with each new product. This scientific lag time created a period when there was an information void that
predatory commercial interests were quick to use to their advantage. As the FDA carried the burden of proof to show that a product did not work or was unsafe in order to remove the product from the market, during this lag time predatory commercial interests were able to profit from scientific uncertainty to the detriment of public health.

During this long period in U.S. history, the curative claims of the predatory sham medicine salesmen were limited only by the gullibility of their targets. In many cases, the degree of gullibility was proportional to the level of desperation of the individual for a cure. The more dire the condition, the more vulnerable an individual was to the ‘flim flam’ of the greedy snake oil salesman. And the more dire the condition, the greater the degree of harm when the sham medicine did not work, causing injury over and above the original illness and/or causing a delay in seeking effective medical treatment. Thus, this lag time between initial marketing of a sham product and the development of the science necessary to resolve uncertainties over the new product’s safety and effectiveness was very costly in terms of human suffering and loss of life. Slaying the Hydra: The History of Quack Medicines
In 1962, after a series of highly publicized public health crises, legislation was passed to close this ‘space between’ created by scientific uncertainty by switching the burden of proof for safety and effectiveness from the FDA and onto product manufacturers.

Read the rest here...

Thursday, September 24, 2009

Great video on sustainability in the wine industry.

In particular, I really enjoyed the shot beginning at the 2:49 mark.

Tuesday, September 22, 2009

Part Two in AgLaw/BioLaw's series on the FDA

I tried to put up a comment last week asking the author what she thought about the rather tenuous link between high cholesterol and heart disease, but it wasn't approved. That's splitting hairs, though, because the point is not whether high cholesterol really does cause heart disease but whether products can claim that they can lower your cholesterol without subjecting themselves to FDA regulation.


Tuesday, September 22, 2009

Post Two of a Series: The Relationship Between the Level of Regulation under the FDCA and the Health Status of a Product’s Targeted Population

The first post of this series began by asking whether functional foods should be regulated as drugs if they claim to treat abnormal health conditions. For example, was it appropriate for the FDA to characterize Cheerios as a drug as a result of its advertising claim that “you can Lower Your Cholesterol 4% in 6 weeks?” An abnormally high level cholesterol level is a serious risk factor for disease and those with high cholesterol levels are in an abnormal state of health. By virtue of its claims to help this group of unhealthy consumers with their struggle to return to a normal state of health, should the manufacturer of Cheerios be required to undergo the FDA's premarket approval process to show that eating Cheerios is effective in lowering cholesterol as claimed?

The answer to this question may become more apparent by looking at another category of products that claim to help unhealthy people return to a normal health status – weight loss products.

Click here to read the rest.

Friday, September 18, 2009

Wednesday, September 16, 2009

From BioLaw/AgLaw


Tuesday, September 15, 2009
Post 1 in Series: The Relationship Between the Level of Government Regulation under the FDCA and the Health Status of a Product’s Targeted Population
Cheerios -- a Drug?

This past May, the FDA issued a warning letter to General Mills stating that the claim on Cheerios cereal that “you can Lower Your Cholesterol 4% in 6 weeks” turned the Cheerios from a food into an illegally marketed drug. When bloggers heard the news, posts ran from scolding the FDA to “grow-up,” to those which lauded the FDA’s action.

Who is correct? Is targeting a cereal one of those cases where, as one blogger suggested, the FDA has its priorities wrong? A look at one recent food trend may help answer this question.

By making its cholesterol lowering claims, Cheerios is entering the growing market for functional foods. In 2008, functional foods -- which are defined as foods that claim to have health benefits over and above the delivery of nutrients -– were a $30.7 billion dollar market. This market is predicted to grow by 40% over the next several years.

Examples include: probiotics in salsa and ketchup; omega-3 fatty acids in orange juice, eggs and peanut butter; pasta enriched with calcium; heart healthy ginger ale infused with green tea; ‘energy’ drinks with amino acids for joint health. The list goes on and on. One never knows what might pop up in a favorite food.

And now a new category of functional foods is cropping up which industry is calling cosmeceuticals -– foods that are being marketed to enhance appearance. (A bit confusing because that term is commonly used to describe drugs that are being marketed as cosmetics. Perhaps cosmefood would be better?). One example of a cosmeceutical for skin beauty is a product on the market that consists of marshmallows infused with allegedly skin-boosting collagen.

Fortified foods are not new. Iodine has been added to salt since 1924 to reduce the incidence of goiter. Grains have been fortified with niacin, thiamin, riboflavin and iron since 1943, a public health move that almost eliminated brain/skin degenerating pellagra within a decade. However, present day functional foods are flooding onto the market before the science exists on the effectiveness of many of their associated health claims.

Where should the FDA draw the line on regulation? Should the level of product regulation be linked with the health status of the product’s targeted population? While not stated explicitly, it appears that this is the strategy that the FDCA has followed since its inception. See Van Tassel, K., Slaying the Hydra: The History of Quack Medicine, The Obesity Epidemic and the FDA's Battle to Regulate Dietary Supplements, 6 Indiana Health L. J. 203-251 (2009).

Traditionally, the greatest amount of regulatory protection under the Food Drug & Cosmetic Act (“FDCA”) has been applied when products are targeted at vulnerable, unhealthy populations and claim to aid in an individual’s struggle to return to normal health. Examples of products that fall into this category by making health remedy or recovery claims include drugs and devices. For these products, the modern FDCA establishes a premarket enforcement process that places the majority of the cost and burden on the product manufacturer to establish safety and efficacy through the clinical trial process prior to distribution to the public. Without premarket approval from the FDA, these products will be deemed both adulterated and misbranded as a matter of law.

Conversely, the FDCA requires less regulatory protection when products are targeted to healthy populations to maintain or improve a normal state of health. Examples of products that fall into this category are traditional foods, and (until recently) a very limited number of functional foods and (once again, until recently) a similarly narrow category of dietary supplements. For these products, the FDA carries the burden of removing an unsafe or ineffective product by proving that it is adulterated or misbranded.

Currently, far too many functional foods and dietary supplements are being marketed to the unhealthy and vulnerable by making health recovery or remedy claims without demonstrating through premarket approval that their products are both safe and effective. It appears that Cheerios is just one product of many that are making these claims.

An abnormally high cholesterol level is a serious risk factor for disease and those with high cholesterol levels are in an abnormal state of health. Cheerios is claiming to help this group of unhealthy consumers with their struggle to return to a normal state of health. As one commentator remarked, it is possible “that some people with high cholesterol will see eating breakfast as a clinical treatment, perhaps even offsetting a more pressing need to cut back on French fries.” Consequently, by sending its warning letter to Cheerios, it appears that the FDA is heading down the right path.

The merits of the FDA’s position on Cheerios specifically, and functional foods more generally, may become more apparent by looking at another category of products that claim to help unhealthy people return to a normal health status -– weight loss products.

The next in this series of blog posts will provide a general introduction of the current problems with the claims being made by weight loss products, particularly in the context of the obesity crisis. The focus on the example of weight loss products will provide a structure for the following posts which will take a look back through the history of the relationship between the FDCA, the FDA and predatory commercial interests. Through this exercise, regulatory patterns will be identified that appear to link the level of product regulation with the health status of the product’s targeted population.

The goal of this series is to take lessons from the past and apply them to assist in the analysis of current regulatory issues involving food, functional food and dietary supplements. This first series will provide the ground work for the second series which will delve into the use of nanaotechnology in consumer products for direct and indirect human consumption -- including food (directly and through the food production process), food supplements, cosmetics and sunscreens.

Tuesday, September 15, 2009

Thursday, September 10, 2009

Pollan on health care reform

Why forcing health insurance companies to stop denying coverage on the basis of chronic diseases or pre-existing conditions could help turn the tide on reforming the farm bill.


Big Food vs. Big Insurance

Published: September 9, 2009

Berkeley, Calif.

TO listen to President Obama’s speech on Wednesday night, or to just about anyone else in the health care debate, you would think that the biggest problem with health care in America is the system itself — perverse incentives, inefficiencies, unnecessary tests and procedures, lack of competition, and greed.

No one disputes that the $2.3 trillion we devote to the health care industry is often spent unwisely, but the fact that the United States spends twice as much per person as most European countries on health care can be substantially explained, as a study released last month says, by our being fatter. Even the most efficient health care system that the administration could hope to devise would still confront a rising tide of chronic disease linked to diet.

That’s why our success in bringing health care costs under control ultimately depends on whether Washington can summon the political will to take on and reform a second, even more powerful industry: the food industry.

According to the Centers for Disease Control and Prevention, three-quarters of health care spending now goes to treat “preventable chronic diseases.” Not all of these diseases are linked to diet — there’s smoking, for instance — but many, if not most, of them are.

We’re spending $147 billion to treat obesity, $116 billion to treat diabetes, and hundreds of billions more to treat cardiovascular disease and the many types of cancer that have been linked to the so-called Western diet. One recent study estimated that 30 percent of the increase in health care spending over the past 20 years could be attributed to the soaring rate of obesity, a condition that now accounts for nearly a tenth of all spending on health care.

The American way of eating has become the elephant in the room in the debate over health care. The president has made a few notable allusions to it, and, by planting her vegetable garden on the South Lawn, Michelle Obama has tried to focus our attention on it. Just last month, Mr. Obama talked about putting a farmers’ market in front of the White House, and building new distribution networks to connect local farmers to public schools so that student lunches might offer more fresh produce and fewer Tater Tots. He’s even floated the idea of taxing soda.

But so far, food system reform has not figured in the national conversation about health care reform. And so the government is poised to go on encouraging America’s fast-food diet with its farm policies even as it takes on added responsibilities for covering the medical costs of that diet. To put it more bluntly, the government is putting itself in the uncomfortable position of subsidizing both the costs of treating Type 2 diabetes and the consumption of high-fructose corn syrup.

Why the disconnect? Probably because reforming the food system is politically even more difficult than reforming the health care system. At least in the health care battle, the administration can count some powerful corporate interests on its side — like the large segment of the Fortune 500 that has concluded the current system is unsustainable.

That is hardly the case when it comes to challenging agribusiness. Cheap food is going to be popular as long as the social and environmental costs of that food are charged to the future. There’s lots of money to be made selling fast food and then treating the diseases that fast food causes. One of the leading products of the American food industry has become patients for the American health care industry.

The market for prescription drugs and medical devices to manage Type 2 diabetes, which the Centers for Disease Control estimates will afflict one in three Americans born after 2000, is one of the brighter spots in the American economy. As things stand, the health care industry finds it more profitable to treat chronic diseases than to prevent them. There’s more money in amputating the limbs of diabetics than in counseling them on diet and exercise.

As for the insurers, you would think preventing chronic diseases would be good business, but, at least under the current rules, it’s much better business simply to keep patients at risk for chronic disease out of your pool of customers, whether through lifetime caps on coverage or rules against pre-existing conditions or by figuring out ways to toss patients overboard when they become ill.

But these rules may well be about to change — and, when it comes to reforming the American diet and food system, that step alone could be a game changer. Even under the weaker versions of health care reform now on offer, health insurers would be required to take everyone at the same rates, provide a standard level of coverage and keep people on their rolls regardless of their health. Terms like “pre-existing conditions” and “underwriting” would vanish from the health insurance rulebook — and, when they do, the relationship between the health insurance industry and the food industry will undergo a sea change.

The moment these new rules take effect, health insurance companies will promptly discover they have a powerful interest in reducing rates of obesity and chronic diseases linked to diet. A patient with Type 2 diabetes incurs additional health care costs of more than $6,600 a year; over a lifetime, that can come to more than $400,000. Insurers will quickly figure out that every case of Type 2 diabetes they can prevent adds $400,000 to their bottom line. Suddenly, every can of soda or Happy Meal or chicken nugget on a school lunch menu will look like a threat to future profits.

When health insurers can no longer evade much of the cost of treating the collateral damage of the American diet, the movement to reform the food system — everything from farm policy to food marketing and school lunches — will acquire a powerful and wealthy ally, something it hasn’t really ever had before.

AGRIBUSINESS dominates the agriculture committees of Congress, and has swatted away most efforts at reform. But what happens when the health insurance industry realizes that our system of farm subsidies makes junk food cheap, and fresh produce dear, and thus contributes to obesity and Type 2 diabetes? It will promptly get involved in the fight over the farm bill — which is to say, the industry will begin buying seats on those agriculture committees and demanding that the next bill be written with the interests of the public health more firmly in mind.

In the same way much of the health insurance industry threw its weight behind the campaign against smoking, we can expect it to support, and perhaps even help pay for, public education efforts like New York City’s bold new ad campaign against drinking soda. At the moment, a federal campaign to discourage the consumption of sweetened soft drinks is a political nonstarter, but few things could do more to slow the rise of Type 2 diabetes among adolescents than to reduce their soda consumption, which represents 15 percent of their caloric intake.

That’s why it’s easy to imagine the industry throwing its weight behind a soda tax. School lunch reform would become its cause, too, and in time the industry would come to see that the development of regional food systems, which make fresh produce more available and reduce dependence on heavily processed food from far away, could help prevent chronic disease and reduce their costs.

Recently a team of designers from M.I.T. and Columbia was asked by the foundation of the insurer UnitedHealthcare to develop an innovative systems approach to tackling childhood obesity in America. Their conclusion surprised the designers as much as their sponsor: they determined that promoting the concept of a “foodshed” — a diversified, regional food economy — could be the key to improving the American diet.

All of which suggests that passing a health care reform bill, no matter how ambitious, is only the first step in solving our health care crisis. To keep from bankrupting ourselves, we will then have to get to work on improving our health — which means going to work on the American way of eating.

But even if we get a health care bill that does little more than require insurers to cover everyone on the same basis, it could put us on that course.

For it will force the industry, and the government, to take a good hard look at the elephant in the room and galvanize a movement to slim it down.

Wednesday, September 9, 2009




Recently I was reading last month’s Rolling Stone article about the Democrats caving on all the meaningful parts of health care reform. It paints a convincing picture that if they give up on the public option then the plan won’t help much, could even make things worse, will hurt the Democrats politically and hurt the chances of real reform happening any time soon. I thought jesus, what is wrong with these people, we elected them for “change” and now the opportunity to do what we asked them to do makes them run around in a panic, peeing on the floor like a dog on the 4th of July. (Another American reference for you there.) Are they really all in the pocket of insurance companies? They have the majority, they have the majority of the people. You really worried those dumb fuckers at the town hall meetings are gonna be mad if you give them cheaper health coverage? I don’t think that’s worth losing sleep over.

You flash back to a few years ago when the Republicans controlled everything, had everything they wanted, including two wars and all kinds of rampant butt play in their overseas prisons, and still saw themselves as victims. They overplayed their hand. The Democrats are doing the opposite, they have the chance to do something great for their country and their children and grandchildren, they would rather do nothing at all. They’re folding their cards too early. Fuck you motherfuckers. Why can’t somebody cut the shit and stand up for what is obviously right?

mp_bulworthAll that was on my mind but also I had recently watched SOUL MAN so my solution was to watch another well-meaning but racially questionable satire, BULWORTH. Starring and written and directed by Warren Beatty, BULWORTH speaks to alot of this anger I have, but it does it in a way that makes me cringe. And I don’t think this is supposed to be uncomfortable comedy like THE OFFICE or something.

Beatty plays Senator Jay Bulworth, a Democrat who’s on the eve of his re-election campaign and hasn’t eaten or slept in days. When an insurance lobbyist (Paul Sorvino, KNOCK OFF) bribes him to kill a reform bill, Bulworth takes out a huge life insurance policy and hires an assassin to kill himself. He’s stressed and has nothing to lose so he just starts Telling It Like It Is at his campaign stops. For example at a black church he tells them that the Democratic Party doesn’t care about them because what are they gonna do, vote Republican? At a Hollywood industry party he says “my people aren’t stupid, they always put the big Jews on the schedule,” then starts flipping through his notes saying, “They must’ve put something bad about Farrakhan in here somewhere.”

bulworthIn South Central two young (very stereotypical) black women are so impressed by his candid statements that they volunteer for him, which means they follow him around cheering him on, snapping at people and gossiping. He goes to a club with them and, unfortunately, learns about rapping. And starts doing it. Throughout the rest of the movie.

Most of the ideas behind the movie are admirable, and there are other things I like about it, which I’ll get into. But there is no way to get around the rapping. He freestyles horrible nursery rhyme type lyrics and says them slowly, syllable by syllable, in a bizarre style that’s part out-of-touch-white-guy-attempting-to-co-opt-what-he-believes-to-be-black-slang, part speech impediment. He makes Vanilla Ice seem like Rakim or Slick Rick.

Late in the movie, after Bulworth rhymes to Don Cheadle and a gang of underage crack dealers in South Central, one of the kids asks, “Is that how white people rap?” It’s the movie’s only acknowledgment that he’s horrible at it. I mean, I never thought we were supposed to think he was good, but his entourage acts like he is, and nobody ever cringes or runs away like you want to do at home watching the fucking thing. The main joke, definitely, is that all these stuffy white people have to hear rap, and listen to The Truth from this guy, who by the way is on a spiritual quest assigned to him by a homeless street preacher played by the controversial poet Amiri Baraka.

But I guess if you look at ISHTAR (to be honest I’ve never seen the whole thing) it’s clear that Beatty finds something really funny in people performing awful songs. Still, I’m not sure he understands just how painful it is to watch this one.

I remember I read somewhere that Warren Beatty was hanging out with Suge Knight when he made this movie, as research. But I’m not sure he found the authenticity he was looking for. He kind of makes it seem like most black people are selling crack or working for crime lords, but have the potential to do good if only they would decide to get it together. Perhaps when nudged to do so by a white politician. And it’s a little painful to see Halle Berry trying to act “street,” saying “yo” and acting tough. She does look good with dreadlocks though. I can see why Bulworth goes for her. I would think the rapping would actually be a dealbreaker though. This was before Eminem raised people’s standards for white rappers, but I still don’t think anybody is gonna forgive how this guy raps. I sure won’t. Ever. Never forget.

What I do like about the movie is that it comes from a left wing point of view but criticizes the Democratic party as compromised and sold out. From my point of view most Democrats are too centrist, but the mainstream media usually doesn’t acknowledge that point of view. They offer Democrats as the furthest left you can get without being a communist (or sometimes they consider them actually to be communists). Senator Bulworth has sold out his values, promoting himself as more conservative to try to get votes. With Halle Berry he talks reverantly about the Black Panthers, but on TV he complains about welfare being “out of control.”

Usually in a political movie you’re either gonna have one side as the good guys and one side bad, or all politicians bad. In this one Republicans don’t even really figure into it. It’s not about the right wing at all. The blame is on the Democrats, arguing that they are the ones who believe in health care as a right, they’re the ones that should be doing something about it, but they never do because they’re more worried about campaign money than about their constituents and their country and the human race and things that are good. And that’s why BULWORTH is relevant now (despite the rapping), because we have the same thing going on now. Republicans just want to stop health care reform because they want to make Obama look bad, and as a bonus they get to cause the deaths of many poor people, which is a hobby many of them enjoy. But it’s not in their court, it’s up to the Democrats. They could and should do it and would do it if they weren’t mostly a bunch of dumb assholes.

The opening scene is actually a really good one. It’s a montage of Bulworth in his office watching all the different variations on his new TV spots, repeating the same bullshit about welfare and “the new millennium.” And then he just starts to cry. It’s a really effective scene because the commercials seem pretty real and you just have to hear the same phrases over and over and over, not only showing you what empty slogans they are but showing you how he must feel having to say the same shit every time. He just feels like a phony. Because he is a phony.

Believe it or not the movie is scored by the great Ennio Morricone. But then it also uses some great hip hop songs like “100 Miles and Runnin’” by NWA and “The N**** You Love To Hate” by Ice Cube. It’s a bizarre combination, but strangely appropriate. When I reviewed ORCA a few months ago I talked about how Morricone’s music seemed to infuse the whole thing with depth, make it seem profound and poetic. Here’s an even better example of how fucking good the guy is. At the end, Bulworth embraces gorgeous young Halle Berry. As a viewer I’m still thinking this movie is ridiculous and what the fuck would she see in him and no way would this ever happen and neither of them (especially her) are particularly three-dimensional characters, but somehow, with the music, it seems kind of touching, like we have watched these two teetering on the edge of falling in love and invested ourselves in them and now we are relieved to finally see it coming to fruition. Completely unearned by the movie, but collected in full by Morricone.

And the end credits are really cool – a suite of Morricone music with hip hop songs by Ol’ Dirty Bastard and others occasionally fading in and playing for a bit and then drifting away as the orchestra continues.

Yeah, I guess I mainly just like the opening scene and the end credits.

Tuesday, September 8, 2009

Djokovic v. McEnroe: How can you not love this?

I almost feel bad about all those times I called him Quitter or Chokovic.