The Right to Eat Unfortified Foods and Health Care Reform

Scientists have begun to question the benefits of consuming too much folic acid. Potential risks relate to new estimates on how long it takes the liver to convert folic acid (“56 times slower than previously thought”); its ability to mask particular types of anemia; and an increased risk in “accelerating the growth of existing cancers.” Unlike strained arguments for health care reform, this really is an issue that affects us all: The FDA requires folic acid fortification in staple foods like breads and cereals.

The FDA’s original report on the matter (from 1999) reasons that folic acid fortification prevents neural tube defects among pregnant women. Even if the risks of over-consuming folic acid are all made up, the logic still escapes me for why everyone’s daily bread has to be modified.

The controversy regarding folic acid is just unfolding, and in all fairness it remains on the fringes of mainstream medicine. But you can feel a strong uneasiness on both sides of the issue: The conventional medical opinion says that folic acid fortification is a miracle of public health and you shouldn’t scare the public into believing half-truths. The opposing view, well, implies that poor regulations actively poison us through our food.

It’s too soon to jump to conclusions, but the fear of scaring the public with new info is almost always unfounded. We’re smart enough to figure things out for ourselves. If there is true skepticism about the benefits of folic acid, then we need to hear it. Afterall, we’re the ones who are being forced to consume it.

The debate raises more fundamental questions however about medical regulation, the role of government, medical science, and the rights of food consumers. It is somewhat ironic that we scrutinize new prescription medications given to subsets of the population, and yet gloss over widespread regulations such as this one, which asks the entire population to eat a synthetic diet as if they were all expecting babies.

As the health reform debate rages on, expect similar shortcut solutions, which attempt to lower health care costs through such non-conventional interventions. Already we are seeing calls to increase vitamin D and folic acid in our diet, while decreasing other ingredients that medicine deems harmful, at least at the current moment. Such actions need to be scrutinized carefully and at all levels of action, including the chance that fortification will help those who need it most, and that it'll insure that the vitamins and minerals are actually metabolized. Large-scale epidemiological studies need to make sure that negative health correlates to low levels of vitamins and minerals aren't confounded by low consumption of products like orange juice and enriched flour.

In fixing health care, there's a strong push-and-pull between ensuring that patients have the personalized attention they need, and treating everyone the same. The solution however needs to err on the personalized approach, because treating everyone the same is no way to give people what they need. Indeed, the more we try to treat everyone the same – be it by putting us all on the same medical plan, or force-feeding vitamins and minerals – the more unintentional consequences will result.

-KJ

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Media (in order of appearance)

Photo: (1)[Wonder Bread], 02/21/2009, Werklife; (2)Big Brother, 01/03/2008, Ian Geldard; (3)Vitamin water + energy, 05/25/2007, Ryan. Sphere: Related Content

Healthcare: Time, Money, and Details

Capitol Hill is filled with buzz about Obama’s rushed health care proposal, intended to overhaul the current system. But as politicians portray healthcare with broad rhetorical brushstrokes, they continue to overlook a plethora of details that unnecessarily inflate its cost. A less publicized news item from last week was the annannouncement that the FDA will delay their final decision on Ampligen – the leading drug for the treatment of Chronic Fatigue Syndrome (CFS) – until this fall. The FDA announced that the delay was due to staffing problems.

Submitting Ampligen’s application is Hemispherx, a small biotech company that has researched the drug for nearly 3 decades. Like a handful of similar companies, their future solely depends on the FDA’s forthcoming decision. All of the clinical trials are complete. The drug’s application was accepted for review just over a year ago, which would make the FDA’s turnaround time over a year and a half. Judging from Hemispherx’s annual operating costs, the FDA’s delay by itself will cost them a total of approximately $15 million.

The FDA’s mission is largely to protect the public from harmful drugs, however critics demonstrate that their overcautious ways do more harm to the public than good. Their delays have cost the public thousands of more lives than they have saved, along with making them unpopular among most practicing physicians.

Even if you believe in the FDA’s mission, then it is hard to overlook the sheer inefficiency and waste that they introduce to healthcare. Clinical trials for new drugs take about 10 years, but even after all the data is in – as is the case with Ampligen – it often takes up to 1 more year for them to make a final decision. FDA delays are not-too-unexpected, but they have still hit Hemispherx hard.

Following each FDA delay, Hemispherx announced new efforts to raise more cash. Currently they are operating like a bear in hibernation, placed on life-support.

Given the millions of dollars lost due to FDA "staffing issues", one strategy might be to give them more staff. They might have applicants pay directly for these staffing issues, but the FDA already receives hundred of millions of dollars worth of fees; supplemented with more money by Congress, fees from private companies consist of half of their drug approval budget. Why these fees aren't enough to reduce the decision time to under 12-months isn't clear.

But the real problem, as discussed above, is with the structure of the FDA and the responsibilities placed on them. As drugs like Vioxx prove to be more dangerous than people could have guessed, the FDA has taken part of the blame; in response they have received more money and power, but this hasn’t led to marked improvement, accuracy, or efficiency.

Determining the safety of drugs can be particularly tricky, but there is only so much that you can ask for: Did the clinical trials meet their endpoints? Were there side-effects? Is there any reason to believe that there might be additional risks? Even if it takes 10 years of research to answer these quesitons, it should not take an additional year to intrepret the results: Either the end points were met or they weren't; there are side-effects or there aren't; there are reasons to consider additional risks or there aren't. These questions are not black-and-white, but following 10 years of required research (and often more), an additional year to make the decision - supposedly filled with heated internal regulatory debate - is not likely to find anything new.

As with most jobs, the problem lies not so much with the staffing, but with the structure of the organization. The main question is whether their mission – to approve and oversee every single drug (and many foods) on the marketplace – would be feasible, even if they had a large army of scientists at their disposal.

Science, like anything in life, obeys laws of diminishing returns: Beyond a certain threshold, the more you study one particular thing, like a drug, the less return in greater knowledge you'll receive for your efforts. Going back to the Voixx example, how many more years of clinical trials, and how much more power and money granted to the FDA, would have better assured its safety?

The assumption being placed on the FDA is that more research and regulation is better, regardless of the specific types of research and regulation being carried out. This is the same mistake that has been applied to the SEC for years, whose added regulations over the years tends to favor red tape, paper work, and superfluous committee-creating over investigatory manpower.

Currently drugs like Ampligen wander through a maze like patients lost in the healthcare system, knowing where they want to go but not being able to get there. And likewise they incur quite a cost – in the case of Ampligen, an added 18 months and about $15 million, assuming, of course, that the drug is even accepted. On top of decades of research and piles of paperwork, does it really take an additional 18 months and $15 million to judge a drug? The frustrating part is that much of this could be avoided either by cutting back on new drug requirements; somehow lowering the cost to big pharma of drug approval; or at least greasing the FDA's wheels in any manner that would make them more - not less - efficient. As it is, patients along their way are forced to pay for these costs, which are often more attributable to regulatory stuckiness than to added value.

Any improvement in healthcare requires us to look at the factors driving up its cost, rather than further re-distributing costs that already exist. In this environment, small companies like Hemispherx - who can survive 30 years researching just one drug - exist not because of the current healthcare system, but in spite of it. Indeed, in what other private industries is it common for a company to go decades without a product? Such gargantuan human efforts are testament to our need for better healthcare, not for better government intervention.

-KJ

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Note: Long position held in HEB.

Media (in order of appearance)

Photo: (1)Day 20, 1/20/2009, Richard; (2)Ampligen PR; (3)Healthcare, hospital, doctor, 04/22/2009, Anoto Group; (4) corridor, 04/10/2005, sumit. Sphere: Related Content

Complexity vs Simplicity...and Specialization

Since I was a kid I’ve had an ongoing debate in my head about whether the world is complicated and hard to understand or whether it’s actually quite simple and straightforward.

I know, it’s a silly question, and of course, the answer is relative to your perspective, or to the question you’re asking, or to what you’re trying to get out of things. Still, though, whenever my head goes down that road of thought – the one that deems the question silly – it’s clearly coming from the analytic – maybe read complex – part of my brain that wants to break everything down and attach qualifiers to everything it sees. That’s the pro-complex side in the debate talking. It deems not only that the world is complex, but, more importantly, that this is whole question is worthless and unfocused because we have to get back to work and figure more things out.

Nonetheless, this little debate has stayed with me for quite some time – almost in a nostalgic sense, like a pop song that you like when you’re young, and as you return to it throughout life it takes on new meanings. I’m not sure what’s fueling it. I think it’s a nagging feeling that life is pretty simple, but we just make things artificially complicated for ourselves. That’s the pro-simple side of the debate. Recently I’ve been erring towards the simple side. Maybe it’s because I need to think less and do more.



But as I think about it more, the problem seems to be that when you look into phenomena, you can either raise more questions or consolidate phenomena. On some level many of us are familiar with both of these outcomes, and at times they go hand-in-hand. The ability to raise more questions is what drives knowledge – it’s that section at the end of a research paper that states future directions for your research; more importantly, it’s that intuitive feeling that the more you learn, the more you discover you don’t know.

And yet we’ve all had that feeling where we solve a problem, life is better, and, well, that’s that.

Although if the drive for knowledge ever became complacent in its footsteps – as if it were to accomplish some new feat, and say to itself, “That’s just what I was looking for. We’ve made such great progress that I feel like I can take a break for a while and bask in the glory of my achievements” – well, then it would have stopped a long time ago.

At the same time, this endless drive forward produces a more fragmentary and disconnected picture of things, where further endeavors become more exacting and less relevant. We’re back at the complicated side of things.


The saving grace is that all of these bits of explanations will eventually be consolidated, somehow sometime. The individual study of such disconnected areas as the color of pigeons, speciation of dogs, beaver dam-building, and barnacles might leave one with an incoherent view of things, but it left Darwin with the puzzle pieces to propose evolution by means of natural selection. For every system of Ptolemaic complexity I presume there must be a Copernican revolution waiting on the other end to fix things. It’s just that the turnaround time can be slow, and that the whole thing only becomes obvious in retrospect.
Most importantly however different fields are more or less open to change, and this is where that nagging pro-simple feeling – that we’re making the world artificially complex – returns. On the one hand, the modern sub-division of scientific fields might actually reflect true scientific progress along with the real nature of the things. On the other hand, there may be artificial or economic reasons for keeping things so complicated. Afterall, the time-consuming credentials required to practice science or medicine inherently pushes those professions towards further specialization. This specialization might not be a bad thing, as per Adam Smith the modern economy is based on it, but it can become suspect when – unlike private or less regulated areas – the costs of entry are greater than the out-going benefits, creating diseconomies of scale like our health care system (or, more questionably, like science...I'll have to think on that one some more).

From another perspective, the pro-simple side of me keeps wondering what that Copernican revolution – or even just a bit of genuine scientific consolidation – would look like in various fields. Its benefits I’d think would have to outweigh the pressures pushing towards specialization.

-KJ

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Media (in order of appearance)

Photo: (1), (2), Metamorphosis series by MC Escher; (3) S'more Peeps!, 03/03/2008, by Rory Finnerman;

Video: (1)Music video, from The Beatles 56 Channel, of the song "We Can Work it Out" by The Beatles, released as a 1965 single. Sphere: Related Content

Restoring Science

Many who work in research implicitly agree that the truth will set you free. And in one way or another this has driven a lot of us to science. But it's counterintuitive - the truth being thought to be objective and all - that the truth is so different depending on who's asking for it.

What then are we to make of Obama’s repeated desire to “restore science to its rightful place”? Josh Witten (over at Scientific Blogging) wrote a stimulating piece in which he contrasted a recent finding from efforts in federal Chinese science with Obama’s treatment of science. The former employed data on social disturbances, which was generously – almost surprisingly – released by the Chinese government. Looking at 51,000 social disturbances in 2007, sociologists were able to find patterns in the disturbances, which allowed them to successfully predict future ones.

Witten brings up the poignant question, to what end?. Would they use it for good in order to prevent civil unrest? Or would they use it to suppress their billion-plus citizens?

This concern, although hypothetical, is certainly valid for a government with such a corrupt history as China’s. In contrast, our government’s corruption - although not as oppressive as China’s and much smaller in degree - is more implicit and hidden. It's decentralized, just like the structure of the government - hidden away in an infinite amount of special interests, which collectively serve to chip away at the general interest. Indeed, to what end? is the question that we must ask about our own government’s science as well.

Conflicts of Interest

If economics has taught us anything, it’s that people respond to incentives. Almost anyone these days would be quick to point that out when discussing privately funded research. And over the past decade, scientists and academics have become sensitive about their own sources of funding. Scientific conflicts of interest these days are thought to arise mostly from private funding, in the form of corporations hiding negative findings so that they can profit at the public's expense.

But what about publicly funded research? Certainly it still abides by these same incentives, only they’re coming from the government. Hidden agendas in public research are not as explicit – there’s no CEO or central board pulling the strings – but this can make them all the more dangerous.

For instance, you can be certain that environmental scientists who have thought hard about global warming, and don't believe that it's man made, aren't going to receive much in the way of public funding, particularly under Obama’s new administration.

Or what about medical researchers who disagree with the CDC? Many claim that studies on the links between vaccines and autism are marred by confirmation bias - namely their conclusions are simply attributed to the objectives of the authors rather than to good science. Furthermore, vaccines are widely supported by public health officials who are associated with the government. Why would they fund any researchers who genuinely wanted to assess the negative effects of vaccines, when they not only disagree with them, but have everything to lose should their hypotheses be supported?

Every scientist has a unique perspective on the world, but how can we be assured that committees of them who disseminate funding aren't forcing their views onto others? If a researcher concludes in a study that government intervention in his field is ineffective, how is he going to be funded in the future?

A concrete example I recall is from a Chronic Fatigue Syndrome (CFS) researcher I once heard. To give a brief background, the CDC & NIH combined have espoused the view that CFS is no different from depression, although this has produced little in the way of useful research. The researcher was of the opinion that CFS wasn't very related to depression, and he wanted to run a well-devised study comparing different patients' etiologies. The study was eventually funded by the NIH - and his hypotheses were supported - but only he said, because after his grant application was rejected a few times, he re-focused it as if the study was meant to show that CFS was the same as depression, which was more in line with the opinions of the lead researchers at the NIH. It was a funny little anecdote when he told it, but then in all seriousness he said he would probably never receive NIH funding again.

The Doublespeak of Special Interests

Many people in the scientific community are joyful about Obama’s promises to science. And with good reason, because this gives them renewed vigor, along with added job security. But Obama’s vows to the scientific community are at best your average appeal to another special interest and at worst a hint at a more centrally planned scientific future. The web of the conflicts of interest portrayed above are not unique to science. They arise whenever the government overreaches into any special interest area.

Take the phrase “restore science to its rightful place”, and replace the word science with any other political buzzword: religion, agriculture, education, national highways, mail delivery, broadcast television. In this context, the statement’s meaning slowly becomes hollow to ears jaded from meaningless political promises. It does imply that money will be taken from other areas for the sake of science, but that’s about it.

But society thrives on science, where would we be without it? is the retort coming from a few people at Scientific Blogging, and I think it's the feeling generally shared by the scientific community. Once again, however, this argument rings hollow when you consider how many people have said that exact same thing – but for everything in addition to and on top of science, usually covering fields that they work in. Just the other day I heard a reporter say that federal mail service is integral in a democracy, as if to imply that we’d fall apart without it. This is essentially the same argument being espoused by the scientific community for more public science.

Any rigorous argument in favor of more public funds for science has to go beyond its import to society, and cover why it's more important than other specific areas that the government funds. Lobbyists and politicians, of course, act as if you can spend money on everything at once. When that power is abused society as a whole feels the ramifications, either directly through taxes or indirectly through poor monetary policy. Imagine for one moment that the government, just like a person or corporation, really did have a limited budged. Sure it would be necessary to spend money on some things, but why science and not some other thing?

The answer very well might be to spend on science, but it needs to be answered ahead of time and in this format (eg, in terms of opportunity costs). It can't just be assumed that the benefits outweigh the costs because science is good - or even because it's really super good. In the event that science is not the best thing to spend money on, then society as a whole loses (and at the expense of well-paid scientists). Even if all of those funds lead to very fruitful discoveries later, it doesn't automatically prove that they were still worth it, or that they were better than other investments. You would think that such fans of objectivity as scientists would embrace objective assessments like cost-benefit analysis. And they often do, but not always when it comes to their own work.

Well they're already cutting us the check, so why complain?

Academics and scientists feel they have an enlightened view of the world, and in a sense I agree. That's why it bothers me all the more that somehow many of them fail to see that the dirty politics and doublespeak of special interests applies to their discipline as well.

Free-market economist Milton Friedman argued that special interests tear apart the moral fabric of society. They're particularly dangerous because of the covert nature of their corruption: They don't lead to an outright abuse of power, but they create the incentives for many smaller ones. Take from the individual examples above - the scientist who is skeptical about man-made global warming, the doctor who wants to thoroughly assess vaccines, or the CFS researcher who disagreed with the NIH - none of these examples alone attests to the extent to which government funds can harm science. You have to look at the combined effect of such individual missteps, across every field affected, and multiplied over time. The overall picture is not unlike communism in its waste, inefficiencies, moral decay, and potential for corruption, the only difference being that the process is slower and more subtle - but nonetheless real - in regards to special interests.

Even with its extra funding, what is science’s rightful place anyway? Is it just to be well-funded? What does this place look like? Will we shuffle our focus in science - alternative energy for a while, then say obesity - just like 5-year plans in Soviet Russia? Obama strikes me as confident and intelligent, but there's a subtle Orwellian tinge to his promise, if only because science is so important and can be used for so many different ends. Unfortunately this is the last question people seem to ask of Obama’s promise - to "restore science to its rightful place", alright, but to what end?

-KJ

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Media (in order of appearance)

Photo: (1) Essay: Elevating Science, Elevating Democracy(New York Times), 01/26/2009, MashGet; (2) "We need a president who believes in science.", 03/21/2008, Snil Garg; (3) Crowd Policing, 08/12/2006, by Dom Dada; (4) Poster from the 2006 documentary about global warming, An Inconvenient Truth; (5) USPS Logo; (6) Rockefeller Research Building: Example of a building constructed over a highway, 01/01/2008, by Zachary Korb; (7) Berlin Wall, 03/20/2006, by David Hunter; (8) 柏林墙 - The Berlin Wall - Berliner Mauer, 11/12/2007, by siyu. Sphere: Related Content