Stossel's latest on Health Care Reform

John Stossel of ABC's 20/20 covered Health Care Reform again recently... see the video on YouTube. Not much new insight or material here, but he's always provocative in his style.

On the Need for a National Food and Shelter Plan

See this posting from Philosoblog, "National Food and Shelter Plan: A Proposal". This funny and clever, but there is an important argument from analogy and reductio ad absurdem provided here.

Shikha Dalmia On the Myth of Free Market Health Care in America

Shikha Dalmia at Forbes.com wrote a good opinion piece on "The Myth of Free Market Health Care in America". She notes similarities between our current system and that of France and Germany, and argues that we do not in fact have a "free market system". A truly free market system would look very different from what we have today -- too bad it isn't even being considered.

On Five Freedoms in Jeopardy

See the article from CNNMoney.com entitled "5 Freedoms You'd Lose in Health Care Reform". The author, Shawn Tully, describes these five:

1. Freedom to choose what's in your plan
2. Freedom to be rewarded for healthy living, or pay your real costs
3. Freedom to choose high-deductible coverage
4. Freedom to keep your existing plan
5. Freedom to choose your doctors

(As always, thanks to FIRM and Dr. Paul Hsieh for providing this link.)

On Healthcare Not Being a Right

Dr. Paul Hsieh has authored another good, short (two page) posting that explains that health care is not a right: The Federal Health Care Muggers. Health care is not a right, just as food, shelter, jobs, etc. are not rights. Paul states this nicely:

Rights are freedoms of action (such as the right to free speech), not automatic claims to goods or services that must be produced by another. Attempting to guarantee an alleged “right” to health care must necessarily violate actual rights.

He then proceeds to describe just how various actual rights will be violated should various health care mandates being discussed these days be put in place. While there are very good economic arguments against national health care schemes, the more fundamental objections are the moral, rights-based ones.

On Rationing vs. the Free Market

I hate it when professional philosophers and other academics, who you'd think would know better, can so muddle and obfuscate important issues by poorly defining their concepts. This happens a lot, with a recent example being an article written in the NY Times by Princeton philosopher Peter Singer, regarding the drive for universal health care in this country. See the concise and very clarifying response by Don Watkins, that clearly defines the difference between rationing and the free market, and obliterates the contradictory concept of "rationing by price". See also Paul Hsieh's posting on this at FIRM (includes link to original article by Singer, which requires NY Times login). As Paul nicely sums up at the end:

By drawing the proper distinction between free markets and rationing, Watkins shows that it is only the free market can create a morally just distribution of goods and services. Only the free market protects the rights of the producers who create those goods in the first place to trade with willing consumers on terms they find mutually acceptable.

If you still aren't convinced, let me ask you this: do you consider all pricing, of all goods, to be the same thing as "rationing" of those goods, that is, on a par with a system where government bureaucrats determined who could have what products? Consider for example children't toys. Is it unfair that you can't afford a particualr toy for your child? Is that "rationing"? Is that the same as if the government decided your family could have toy #1, but your neighbor could have toy #2? Or use any other commodity or service in this example taht you like: cars, homes, food, whatever. Is it "rationing" that you can't afford caviar or the nicest restaurant in town? Is it rationing that you can't afford a BMW? or a trip to Hawaii? or a bigger house? Clearly these are not examples of "rationing" -- there is an essential difference between you not being able to afford something you want, and the government controlling the distribution of a type of product or service and making decisions as to who can have what.

Always keep this essential distinction -- between the free-markets and rationing -- clearly in mind while considering the current debate about health care systems.

Hopefully Washington will Learn the Lessons from TennCare

See this good article summarizing what went horribly wrong with TennCare, the programs adopted by Tennessee in their attempt to provide universal health care for their citizens. Four key points made are (read this short article for the explanation of each):

• "Free" Care Is Expensive
• Employers Prefer "Free" Care to Private Care
• There Is a Difference Between Access To Care and Availability Of Care
• Government Control Puts More People In The Exam Room Than Just You And Your Doctor

There are many flaws in our current health care system, though opinions differ on exactly what those flaws are. Hopefully the politicians in Washington will heed the warnings from the history of TennCare -- alas, I'm not holding my breath!

Sally Pipes on Canada's Health Care System

I know I've been blogging about this a bit lately, but here is another good video on the healthcare debate: another one noting flaws in the Canadian model. This is a video of part of a talk that Sally Pipes gave at a Cato event recently. She manages to pack a lot into less than eight minutes, noting several stories of the common issue of rationing services, and the stunning hypocrisy of the government leaders in Canada who make use of the "escape valve": coming to the US for services. Something to keep in mind if the US goes down a path that is patterned, in relevant respects, on the Canadian model: what will our escape valve be?

Undercover Video Exposing Government Health Care in Canada

I've seen lots of videos and read lots of articles that criticize the government-run health-care in Canada. There are of course many who praise that system too, including of course many in our government who are urging the US to move more towards a system like Canada. So the average person can be left wondering who to believe in light of such contradictory reports.

But this video, Crowder on Canada, is one of the best I've seen on the subject. The host is a bit annoying in that he is trying so hard to be entertaining. But the value of the video comes from the "undercover" camera segments, in actual government health care facilities in Canada. Plus some of the things that the government employees, and others, have to say, is also quite damning.

I urge everyone to see this video!

On Health Insurance and Health Care: Some Alternative Perspectives on Reform

The majority of stories in the media these days are naturally reporting, and often times cheerleading, the Obama administration and the Democrat-led congress in their march towards "health insurance/care" reform. Given their control in Washington, aspects of their plan seem inevitable at this point, even while they still debate some of the finer points and negotiate on some details.

In this posting I am going to provide a collection of links to criticisms of this direction, warnings of what is likely to happen if anything akin to what is being proposed are made law. These don't get even a fraction of the media coverage that the plans of the political left do, since they amount to calls for truly free-market reforms -- things that the left despises. So I've been saving up links for a few months, and now want to share them with you as an archive of good material. Several years from now, when most everyone has health coverage, but health care costs are skyrocketing, health care rationing is a reality, health care innovations are in decline, health care trips abroad are increasingly popular, and health freedoms and rights are finally recognized as having been seriously limited by the "reforms of 2009/2010"... you won't be able to think back and say silly things like "Well, the system was broken, we had to do something, and there were no other ideas out there from Republicans or libertarians or Objectivists or anyone else, so we all jumped on the only reform bandwagon in town."

Here are some links to alternative, free-market viewpoints, criticisms of both proposed plans and government plans in states, Canada, Europe, and more. Not meant to be comprehensive, just some highlights from what I've read in the past several months.

• Health Care Reform vs. Universal Health Care (Paul Hsieh, M.D.)
• National Health Preview: The Massachusetts debacle, coming soon to your neighborhood (WSJ)
• Mandatory Health Insurance: Wrong for Massachusetts, Wrong for America (The Objective Standard)
• When Doctors Opt Out: We already know what government-run health care looks like (WSJ)
• The 'Public Plan' Would Be the Only Plan (WSJ)
• Don't Doc American Health Care (Steve Forbes)
• Competition Would Save Medicine, Too (John Stossel)

And then here are more items, all brought my way by We Stand FIRM (Freedom and Individual Rights in Medicine), where Paul Hsieh, M.D., provides outstanding analysis and commentary along with the links (original sources he comments on given in parentheses below):

• How US Health Care Stacks Up (IBD)
• Four Myths About Universal Coverage (University of Illinois law professor David Hyman)
• Canadian Cost Controls (Financial Post)
• Gratzer on Socialism and Cancer (David Gratzer, M.D., in The New Atlantic)
• Rhoads: Force is not Competition
• Pipes on Canada (Washington Examiner)
• More Waiting in Massachusetts (Boston Globe)
• Schwartz on MassHealth
• Medicare is Unsustainable
• How ObamaCare Will Affect Your Doctor (WSJ)

Granted, these are all short articles and opinion pieces -- they are not 500-page legislative documents that propose entire health insurance and health care reform packages. But numerous free-market think tanks and advocacy groups have documented such overall reform plans for years (they just aren't of any interest to the majority of leaders in Washington). My purpose in providing this collection of links was just to inform readers of that good alternative thinking does exist in this arena.

Health Care Reform: Real Ideas for a Free Market Alternative

Michael Tanner wrote Sunday in the LA Times a good article that provides several free-market steps that could be taken to reform our healthcare system. His article is available at the Cato website and is titled: Obama Doesn't Have the Only Prescription for Healthcare Reform.

The two major things he supports are:

• Change the tax code to move us away from employer-based health insurance to individual-controlled health insurance. This makes the insurance "portable", and stops hiding the real costs of healthcare from consumers.
• Allow us to purchase out-of-state insurance. He gives a good example that compares the cost of insurance in NJ vs. Kentucky, with the former being more expensive due to mandates and regulations. Making this change would allow people to, in effect, "purchase the regulations" of the state that fit their needs best. This change would encourage competition between companies in different states, and even between politicians in each state.

A third item he supports is to encourage greater competition in who provides healthcare -- by rethinking the licensing laws. He writes: "Nurse practitioners, physician assistants, midwives and other non-physician practitioners should have far greater ability to treat patients. We also should be encouraging such innovations in delivery as medical clinics in retail outlets."

Tanner concludes with:

The choice facing us now is not between Obama's plan for healthcare micromanaged by the government or doing nothing. Rather, it is a choice between government control, regulation and rationing on one hand, and free markets, choice and competition on the other. That is the real healthcare debate.

Health Care Reform and Drugs That Save Lives

Virginia Postrel wrote an outstanding article for the The Atlantic, titled and subtitled as: "My Drug Problem" -- The cancer drug Herceptin saved the author’s life. It also cost $60,000. Would health-care reform put it, and other expensive new drugs, out of reach?

A provocative question. The article is well worth reading in full, but here is a key excerpt:

Not everyone in similarly rich countries is so lucky—something to remember the next time you hear a call to “tame runaway medical spending.” Consider New Zealand. There, a government agency called Pharmac evaluates the efficacy of new drugs, decides which drugs are cost-effective, and negotiates the prices to be paid by the national health-care system. These functions are separate in most countries, but thanks to this integrated approach, Pharmac has indeed tamed the national drug budget. New Zealand spent $303 per capita on drugs in 2006, compared with $843 in the United States. Unfortunately for patients, Pharmac gets those impressive results by saying no to new treatments. New Zealand “is a good tourist destination, but options for cancer treatment are not so attractive there right now,” Richard Isaacs, an oncologist in Palmerston North, on New Zealand’s North Island, told me in October.

A more centralized U.S. health-care system might reap some one-time administrative savings, but over the long term, cutting costs requires the kinds of controls that make Americans hate managed care. You have to deny patients some of the things they want, including cancer drugs that are promising but expensive. Policy wonks dream of objective technocrats (perhaps at the “independent institute to guide reviews and research on comparative effectiveness” proposed by Barack Obama) who will rationally “scrutinize new treatments for effectiveness,” as The New Republic’s Jonathan Cohn puts it. But neither science nor liberal democracy works quite so neatly.

She then goes into some detail regarding the situation with New Zealand's Pharmac and the drug Herceptin, the political turmoil it has caused, and the difficult situation the egalitarian leftists find themselves in. Towards the end she summarizes with:

The good thing about a decentralized, largely private system like ours is that health care constantly gets weighed against everything else in the economy. No single authority has to decide whether 15 percent or 20 percent or 25 percent is the “right” amount of GDP to spend on health care, just as no single authority has to decide how much to spend on food or clothing or entertainment. Different individuals and organizations can make different trade-offs. Centralized systems, by contrast, have one health budget. This treatment gets funded, and that one doesn’t.

And if you'd like more of Virginia Postrel's excellent writing along these lines, see her follow-up article where she responds to many who commented on her article. (Thanks to Paul Hsieh at FIRM for the links.)

On Altruism and Health Care

My favorite blog for health-care industry analysis and commentary is We Stand FIRM (Freedom and Individual Rights in Medicine). However, I was introduced recently to another good blog, ReasonPharm, via this posting that notes the impact of the call for greater altruism in medicine and the health care industry. I'm definitely adding this blog to my regular reads.

American Health Care System: 10 Surprising Facts

Here is a nice list of 10 Surprising Facts about the American Health Care. These aren't surprising to me of course, they are "surprising" in the sense that they are seriously under-reported in the media. We all hear, everyday it seems, about various flaws -- real, debatable, and imagined -- in the US health care system. But we don't very often hear about its positives, the good things about it. And it is exactly those good aspects that are threatened by trying to reform our system in the direction of say Canada's or Great Britain's.

For the record, I agree changes to our system are needed, but not the kind of changes that those on the political left are calling for. I support the views found at FIRM: Freedom and Individual Rights in Medicine.

Warnings For the Health Insurance Industry

Paul Hsieh has written a great two-part (still quite short) essay entitled "Health Insurance Industry Sells Its Soul to the Devil". An important read for those who want America to move to a single-payer, "universal healthcare" model like many other countries have.

On Our Not-So-Private Health Care System

Don Watkins makes some excellent points in his posting What Free Market in Health Care? Keep those in mind the next time you hear calls for government-run health-care: what they should say is government run to a greater extent than it already is. And ask yourself: if you don't aspects of our current system, what is the root cause of those negative aspects -- a truly free-market, or the various government interventions over the past many decades?

More on Canada's Health Care System

The Feb. 9th issue of the Wall Street Journal had an excellent piece by Nadeem Esmail, titled 'Too Old' for Hip Surgery. This provides several examples of the perils of government-run/national health care systems -- and notably gives horror stories from Canada, one of the countries that politicians love to point to as a system that the US should emulate. Read this brief article and remember its lessons the next time you are told how wonderful such a system would be: where will you go when you are faced with similar wait lists and rationed care here in the US? If every country adopts such a system, there won't be anywhere for folks like those in this story to escape to for timely life-saving care!

The FDA and Health Care's Future

The Dec. 30th issue of the Wall Street Journal had two excellent opinion pieces about health care in the US:

• Obama Will Ration Your Health Care, by Sally Pipes
• The FDA Is Killing Crohn's Patients, by Gideon Sofer

The first gives a good summary of what we are likely to see coming soon in the US, given the selection of Tom Daschle as a key part of Obama's health care reform team. The second is yet another indictment of the horrible FDA, and yet more reason that the organization should be significantly reformed and preferably dismantled altogether.

A Step in the Right Direction for Organ Donation?

See the Dec. 17th WSJ opinion piece Wait-Listed to Death. This article discusses the work Arlen Specter (R, Pa.) is doing to re-write the provision of the 1984 National Organ Transplant Act that bans any incentives for people to donate bodily organs.

I'd much rather see us make more dramatic changes than what Specter is pushing for -- such as creating a market for organs to really boost supply and save many lives and improve the quality of life for so many more. But short of that, I think what Specter is pushing for is a good first step. There are many unintended consequences of the currently law, such as this:

The impact of the federal statute is as appalling as it is ironic. Kidney transplant recipient Sally Satel has noted that burial and cremation expenses can be provided when a body is donated to science -- as long as it isn't used to save the life of a current patient.

Even if you don't agree with me that people's families should be able to be paid in order to encourage organ donation upon death, or that people should be able to be paid in exchange for donating a kidney while alive, who could argue with changing the law to end the above ridiculous situation? In that case, the benefit only covers some of the costs of the death -- burial and cremation expenses -- it doesn't provide any additional benefit to the surviving family. So even a desperate poor person wouldn't think of suicide to aid his family, because this revised law wouldn't receive any real financial benefits from it -- they just wouldn't have the added cost of burial/cremation brought about by the suicide.

This is a no-brainer, and it could help increase the number of people who agree to be organ donors upon their death -- something the thousands of people dying and suffering on organ waiting lists desperately need!

On Paying Organ Donors

I was pleased to see an article in the October 8th issue of the Economist about the need to allow for payments to organ donors (in the case of a kidney) or their families in the case of donation of organ donation upon death.

Here are my previous blog postings on the need for a market for organ donations (esp. for kidneys):

• On Why We Need a Market for Human Organs (7/27/2008)
• The Need for an Organ Market (12/23/07)
• Repugnance Shouldn't Be a Standard (8/4/07)
• Market for Kidneys... Guess Where? (11/26/06)
• 10-person Domino Donation at Johns Hopkins (11/26/06)
• Sounds Good, But How About Really Helping? (10/29/06)
• Consequentialist Bioethicist is Proud of Efforts to Restrict Organ Donations (9/15/06)
• A Good Sign for Change to Organ Donation Policy (8/5/06)
• Equal Opportunity to Suffer and Die (6/18/06)
• Market for Organs (5/20/06)

On How Portion Sizes Have Grown

Here is an interesting slide show that clearly indicates how portion sizes in the US have grown in just the past few decades. Anyone who has been paying attention "kinda knew" this, but this slide show gives you some numbers and images to concretize it. Yikes!

Want more? Here is a second slide show that gives more educating examples.

Increasing Obesity in the USA

Yikes! Everyone has heard about, and most of us can plainly see, the rising levels of obesity in this country, and with it the many health problems that follow (heart disease, diabetes, etc.). But this animated graphic map of the USA does a nice job of showing just how badly this is increasing in recent years. The site that provides this, weight.com, states that "The data is based on the Behavioral Risk Factor Surveillance System (BRFSS), a random-digit dialed telephone survey of adults in the United States. This data is courtesy of the Center for Disease Control (CDC)."

On Why We Need a Market for Human Organs

Its been a while since I've blogged about the desperate need for a market solution to the issue of kidney donation. So I wanted to note this good opinion piece in the May 16 issue of the WSJ, by Sally Satel: "Why We need a Market for Human Organs". She makes many great points, and even responds to some critics by noting how such a regulated system could be put in place so that the poor would not be taken advantage of. In addition to the more fundamental philosphical arguments that one could give (e.g., we have a fundamental individual right to sell one of our kidney's if we want to), Satel's arguments and reasons are strong ones and hopefully will one day help to change policy on this issue.

As I've blogged on this subject a lot in the past, I've decided to gather the links to those postings in one place. So here they are, with the oldest ones last:

• The Need for an Organ Market (12/23/07)
• Repugnance Shouldn't Be a Standard (8/4/07)
• Market for Kidneys... Guess Where? (11/26/06)
• 10-person Domino Donation at Johns Hopkins (11/26/06)
• Sounds Good, But How About Really Helping? (10/29/06)
• Consequentialist Bioethicist is Proud of Efforts to Restrict Organ Donations (9/15/06)
• A Good Sign for Change to Organ Donation Policy (8/5/06)
• Equal Opportunity to Suffer and Die (6/18/06)
• Market for Organs (5/20/06)

On Complementary and Alternative Medicine

I want to thank R. Barker Bausell (professor of research methodology in the School of Nursing at the University of Maryland at Baltimore) for his excellent essay "Placebo Effect" in March 14 issue of The Chronicle Review. He makes several outstanding criticisms of so-called complementary and alternative medicine, and the call for more testing and studies. He argues instead that there should be less such testing and research, primarily because most such things haven't even passed the basic threshold to warrant rigorous testing by scientific methods. Read his essay for some clarity on an issue that we are often mentally clouded with vague and tricky claims.

Some Video Clips on Canada's Health Care System

On the Fence Films has created several short videos on the Canadian "single-payer" health care system. These are three stories of course -- many more are out there that should give pause to everyone pushing for a government single-payer system in the US. Check these short videos:

• Two Women
• A Short Course in Brain Surgery
• The Lemon

Sad stories... but what will be much worse will be what happens if we adopt a similar system and get the inevitable rationing and lengthy wait-times. If today people in other countries with such systems (not just Canada) come to the US and pay for health care to save their lives or eliminate horrific pain... where will they go when they can't come here anymore? And... where would we go? No where.

The Need for an Organ Market

I meant to blog about this weeks back, but it slipped through the cracks. A great letter to the editor was published in the Chicago Tribune in November about the need for a market for organ donors. It doesn't get much more succinct and powerful than this:

Thousands have died through the years waiting for transplants because the National Organ Transplant Act forbids the sale of human organs. To significantly decrease the shortage of organs, this murderous law must be repealed and the trade in organs decriminalized. If the law recognizes our right to give away an organ, it should also recognize our right to sell an organ. And if the law recognizes our right to pay for a life-saving medical treatment, it should also recognize our right to pay for a life-saving organ for transplant.

Those able to pay for organs would benefit at no one's expense but their own. Those unable to pay would still rely on charity, as they have done to this day. Moreover, those able to buy organs would drop out of the waiting list, increasing the chances of those remaining to obtain the organs they need.

If the legitimate rights of potential buyers and sellers of organs were protected, many of the 95,000 people waiting for organs would be spared much suffering and escape an early death. How many? Let's find out.

Health Care and the Free Market

Two weeks ago the ARI put out a short opinion piece titled "Be Healthy or Else!". It nicely summarizes a free-market viewpoint rarely found anywhere else.

But even better, because it gives real-life examples, is John Stossel's recent "Medical Competition Works for Patients". In this column, Stossel gives numerous examples of areas of the health care world where free-market principles still thrive, where competition and pricing are not being altered by government regulation or even insurance company's policies. And the results? Quality in those areas continues to go up, and prices continue to go down. Quite the opposite of what we see across most of the health care world in recent years, eh? To get some great examples of the free-market at work in health care, this column is must reading!

And just as good is his previous column that details how Whole Foods ditched the traditional health insurance game in favor of HSAs -- Health Savings Accounts -- for its employees. The results, and Whole Food CEO John Mackie's understanding of the principles involved, are impressive and instructive. Also must reading!

We Should Have Less Health Insurance, Not More

John Stossel makes some outstanding points in his column Our Crazy Health-Insurance System. Government intervention, perverse incentives, vicious cycles... it has all led the current mess that is the American health-care system -- or rather, the way we pay for our health-care. I could quote many great bits from this column, but instead I'll just strongly encourage you to read it yourself -- it isn't long!

Government Enforced Diets are Coming

Do you think it a ridiculous idea that the US government might one day enforce healthy habits on us citizens? Things like determining everyone's healthy diet, disallowing smoking, and so on? Seem far-fetched? Maybe not... consider this ARI press release criticizing a proposal in Britain that would force Britons to:

to adopt a government-prescribed "healthy lifestyle" or else be denied certain medical treatments. Britons who improve their health by, for example, quitting smoking or losing weight would receive "Health Miles" that could be used to purchase vegetables or pay for gym memberships.

If this is an accurate characterization of the proposal, then it is quite striking. So, you overeat and become obese, or you spend years smoking, and rather than suffering the consequences fo your actions, you are forced by the government to change your behavior, and in exchange you will be rewarded with free food and other goodies, taken from others through taxation of course. I have to agree with Yaron Brook, to me this is a "reductio ad absurdum of nanny-state paternalism".

Any takers on bets on how long it will be before proposals like this are suggested in the USA? And any wagers on how long such proposals get approved?

FDA: Definitely not "First, Do No Harm"

A vital phrase for those in the medical profession, "First, do no harm", goes back to the ancient Greeks (though, contrary to popular belief, it is not found in the Hippocratic Oath).

The following paragraph from the Wikipedia entry for this phrase (Primum non nocere) does a nice job summarizing its importance:

It is one of the principal precepts all medical students are taught in medical school. It reminds a physician that he or she must consider the possible harm that any intervention might do. It is most often mentioned when debating use of an intervention with an obvious chance of harm but a less certain chance of benefit.

I mention this important precept in relation to the WashingtonPost story, Teen Suicides Up Sharply For First Time In Years. (Thanks to John Enright for the link.) And what is the speculated reason in this news story as to the likely cause (or the biggest reason) for this increase in teen suicides? The actions of the FDA.

How so? Well, remember several years ago when the FDA got wind of studies that indicated that some anti-depressant medications (e.g., SSRIs) could have increased rates of suicides in the young, especially during the first few weeks of taking the medications as the body and mind adjusted to them? Their reaction to this was to further regulate such medications, and do so in scare-tactic fashion, by forcing the companies producing them to put big black box suicide warnings on them, targeted at teenagers specifically.

So what happened? Well, surprise, surprise: use of such medications declined dramatically amongst teens. But it is exactly these medications that are credited with helping to reduce the rate of suicide for many years previous. I mean, the biggest cause of suicide is no doubt severe depression, right? And what do people take for depression? Anti-depressant medications. So scaring people away from the medication that will help them... real bright, FDA, real bright.

Did the FDA factor this inevitable outcome into their decision process? I suspect not, or at least not well enough. The FDA has a pattern of reflexively regulating drugs based on studies (particularly big noise-making ones) that show or suggest (more or less well) negative side-effects from taking those drugs. After all, history in the US has thus far shown that no one will get fired at the FDA, nor will budgets be slashed, when thousands or millions of people die because the latest life-saving drugs are held up by FDA rules, regulations, and bureaucracy. But failing to regulate something when there is a shred of evidence that some people might have a negative side-effect -- they can't let that happen!

And this is not something the FDA can simply tweak and get better at doing. The FDA, or any such regulating body, simply can't do a very good job of weighing the personal benefits of new drugs against the possible personal negative side-effects for those same people or others. The benefits are too personal: each individual would have a different value hierarchy, meaning for one person it might worth the increased risk of heart attack to be rid of some other ailment they have, but for someone else it would not. A drug that could save millions from one killer ailment, is held up because it might increase the risk of some other ailment for those same people or others. Rather than leave it alone, regulation keeps the drug from the people who need it and want it. By what moral right does the FDA do this, by what moral right do they get to make these value decisions?

In the current case of the teen-suicide warnings, did the FDA consider the externalities of this decision? Did they weigh the harm that such a policy would do against the supposed good it could do? At first glance, one might see nothing wrong with informing people about studies on a drug that indicate a greater statistical chance of suicide amongst a population. But in addition to the above points, there is a crucial difference that complicates this case that doesn't complicate other drug studies. Unlike medications that cure one ailment but might lead to increased heart-attack risk, here we are talking about suicide -- so free will comes into play. Even if full free-will is somewhat inhibited when severe depression develops, this greatly complicates any studies in this area (in a way that doesn't arise for studies on the pancreas), making studies and aggregate statistical analysis far more difficult.

All of that said, and while I'm no expert on this, as I have said before (see my posting on this) I am prima facie doubtful of the studies indicating increased suicide as an effect of using SSRIs or other anti-depressants. Often people start taking these medications after their first visit to a doctor for depression, and because they take a while to take effect, the depression can continue to get worse before the medications help the people help themselves and begin to get better. But this is not the fault of the medication! The person was likely going to keep trending downward for a while regardless, and if they had waited until they pretty bad off before seeing the doctor, well, they might be suicidal or nearly so already.

Further, a person might become increasingly depressed when they first start trying an SSRI and don't see immediate results -- especially if their doctor didn't impress on them how the drugs work (the time needed, etc.). They might conclude "This isn't even helping? So nothing will, and I can't bear it!". But again, this is not the fault of the medication!

Do the studies the FDA relied on to require the warning boxes for teens take into account all of these kinds of points? I wonder. I don't know either way, but I wonder.

What is obvious about the track record of SSRIs and other anti-depressants (from what I gather from this article and elsewhere) is that they have been a major factor in decreasing suicide rates. Until, that is, the FDA got involved, scared teens (and their doctors) away from the medications, and the rates apparently went sharply up again. Take away a major weapon in one's battle against depression, and surprise, surprise, more people will become increasingly depressed and commit suicide. That should have been obvious to FDA regulators, but apparently it wasn't.

Btw, I've written a few posts on the FDA here at Philosopher Stone. Check them out!

• August 11, 2007: The FDA Ranges from Annoying to Deadly
• August 11, 2007: A Possible Future: Prescription Drug Disaster
• July 5, 2007: On the Costs and Benefits of Health Care Regulation
• June 3, 2007: Walter Williams on the FDA
• May 3, 2007: Depressed About Anti-Depressant Warnings
• September 26, 2006: FDA Should Retire at Age 100
  

Why Don't Miracles Ever Grow New Limbs?

Recently blogger Ergo Sum posted some comments about Mother Teresa. In that post, he note the following observation that he came across on an atheist website:

If there're so many miraculous cures occuring even today, how is it that we never hear of an amputee growing out a new, fully developed, and healthy limb?

This is an important question! Anytime you hear about miracles or someone praying for a cure to an ailment, it is always something that can have any number of things happen to improve the situation, cure the disease, etc. Often the people getting the miracle cure are in third world countries with less high-tech science and medical care available. But not always of course. The point is that the thing prayed for, or the miracle delivered, is always for something internal in the body that people don't perceptually see the cause and effect relationship for (not without instruments, tests, etc.). So it just seems like: I prayed, and a week later I got better. Or the miracle-worker did some ritual, and a week later I felt better.

Well, if miracles can really happen, or if prayers are really effective, then why don't miracles ever grow back an arm or a leg, and why don't people pray for such things to happen? I think that is very telling: both about supposed miracle-workers, and for people who pray for something to happen in their lives.

How about Foodcare?

In late June, George Reisman posted a great piece by Gen LaGreca about the proposals for so-called "universal healthcare". In it she paints a scary picture of what "Foodcare" would very likely be like. A very effective argument by analogy.

More Great Stuff From Stossel on Health Care

John Stossel has been on a roll lately in his writings on health care. He has been responding to Michael Moore's ridiculous "Sicko" movie, and in his latest column he explains several problems with some of the underlying rankings that Moore relies on. There are so many great bits here, I won't quote any of them... just go read his column!

A Possible Future: Prescription Drug Disaster

I recently blogged about how generic drug prices are soaring in Canada.

The flip-side of this is that brand-name drugs are of course cheaper in other countries like Canada. Here is a great ARI item that explains why that is. The crucial question is "Why?" and the answer is price controls in such countries. But the only reason this doesn't cripple the R&D efforts of drug companies -- and hence their ability to create new, life-improving and life-saving drugs -- is that people in countries like Canada free-ride on the prices paid by Americans. Creating drugs is extremely expensive: not only is the R&D rightly expensive and time-consuming, but it is made much worse because of the onerous regulation of the FDA and other government bodies. Other major costs include advertising/marketing to get the word out about new or improved drugs to doctors and patients.

This ARI item gives voice to a pro-consumer argument that you will hear almost nowhere else, as it ends as follows:

It is only because the American market is free from price controls that drug companies are able to recoup their enormous R&D costs, and thus find it profitable to sell additional units of the drugs at a lower cost in other, price-controlled countries. Should America impose price controls either directly or by proxy, the house of cards will collapse. We should protect the rights of pharmaceutical companies--and the welfare of consumers--and demand an end to price controls, direct and indirect.

The FDA Ranges from Annoying to Deadly

My local Rochester paper yesterday ran a brief AP story titled "FDA Checks 2 Popular Heartburn Drugs". Here is a link to a slightly longer version of the same article at the LA Times, and here is the item on this from the FDA website. The story is that some new data might indicate a connection between using two AstraZeneca heartburn drugs (Nexium and Prilosec) might increase serious heart-related problems. The new data doesn't seem to add up to much, as the FDA's position is "At this time, FDA's preliminary conclusion is that collectively these data do not suggest an increased risk of heart problems," and also "Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of these products at this time."

So such downplaying makes me wonder a bit why this is a story worthy of being in the newspaper. But then you have to wait till the end of the article for this:

A higher number of patients taking either one of the drugs suffered heart attacks, heart failure or sudden heart-related death, the FDA said. But the studies involved only a few hundred patients, a relatively small number, and larger research studies showed no indication of heart problems.

So why is this news? Sounds like at best it is some counter-evidence to larger studies that indicate no such cause-and-effect problems for heart-attack, etc. for these drugs.

While that was the last paragraph in the article in my Rochester paper, the LA times version adds this final paragraph:

In the study involving Prilosec, 17 patients taking the medication had serious heart problems, compared with eight in the group that had surgery, AstraZeneca said. However, the Prilosec patients appeared to have been in poorer health to begin with. Six of the Prilosec patients had had previous heart attacks, compared with none in the group that had surgery.

Well, that makes it even worse! So the studies in question are not only smaller than the others, but they seem to have rather important problems with how they were conducted, factors that weren't ruled out, and so on.

All of that is bad enough -- a seeming waste of our taxpayer money chasing down unlikely side-effects based on small, poorly conducted studies. But that is merely annoying compared with the truly deadly effects of the FDA's and other federal regulations on drugs and health care. First, see my recent post about two articles from the Economist that explains the often hidden costs of such regulation. Then see the recent ARI press release, The Deadly FDA, which really puts a sting into the FDA. It begins:

The Court of Appeals for the District of Columbia Circuit recently ruled that terminally ill patients do not have a right to take medicines that have not been approved by the FDA.

"Barring individuals from choosing what medicines to take is immoral and destructive," said Dr. Yaron Brook, executive director of the Ayn Rand Institute.

"The decision about what drugs to put in one's body rightfully belongs to each individual, not to FDA bureaucrats. To deny individuals this right is to impose a death sentence on those who, in the face of certain death, would rationally choose to accept the risks of an experimental treatment, but are barred from doing so until the urgently needed drug completes the FDA's onerous, years-long approval process. Indeed, this case was initiated by a group founded by the father of a girl who died after she was denied access to an experimental anti-cancer drug the FDA later approved.

"Individuals, in consultation with their doctors, should be free to assess the evidence of a drug's effectiveness and safety, taking into account their own personal context (such as their unique risk factors, or the fact that they are certain to die without the treatment). Some people may take ineffective or harmful drugs, but FDA approval does not eliminate such risks. The individual always assumes some level of risk when deciding on a course of treatment, and it is capricious--and too often deadly--for the FDA to usurp the individual's right to decide which risks it is in his interest to accept.

The rest of the press release is just as damning of the FDA as the above, and also gives brief responses to objections to this kind of view of drug regulation.

A Union for Bloggers? Huh?

My wife Susan sent me a link today and prefaced it with "This is not a joke article from the Onion." That certainly got me curious, so I read the blog posting at Rational Jen that was itself a response to the Forbes.com piece "Bloggers Consider Forming Labor Union" (my friend Chris also mentions this on his new blog here). As a story about bloggers, no doubt this is being much talked about around the Blogosphere -- alas, I don't have time right now to look around for others' comments on this story.

Assuming this isn't a joke, I'll comment on a few bits from the Forbes article:

In a move that might make some people scratch their heads, a loosely formed coalition of left-leaning bloggers are trying to band together to form a labor union they hope will help them receive health insurance, conduct collective bargaining or even set professional standards.

Huh? Who will they receive it from? Who are they going to be collectively bargaining with? They are not employed by anyone! This is bizarre. The only thing I can imagine here, with regard to health insurance premiums, is that a very large number of bloggers banded together in some sort of way that insurers recognized, then they could be considered a "pool" the way large companies are, and this can lower insurance rates somewhat. Is that what they are hoping for? Other than that, I don't know where they are going to be magically given health care from or with whom they plan to bargain collectively.

Organizers hope a bloggers' labor group will not only showcase the growing
professionalism of the Web-based writers, but also the importance of their roles in candidates' campaigns.

Its not clear to me how these benefits will derive from having a union. Again, being as charitable as I can, are they thinking that they will do someting like MSM columnists who have their content aggregated on larger sites and thereby reach an audience they would have difficulty reaching as lone writers? If so, then they should just write for group blogs, or use RSS to aggregate their blog postings on particular sites. I don't see what role a "labor union" will play here.

Others see a blogger coalition as a way to find health insurance discounts, fight for press credentials or even establish guidelines for dealing with advertising and presenting data on page views.

That first issue I addressed above -- I think they must mean the insurance pool idea. I can see the value of press credentials, but can't bloggers just get together and write guidelines for various things? What role does an actual "labor union" play here? Is this just semantics that is throwing me off?

"It would raise the professionalism," said Leslie Robinson, a writer at ColoradoConfidential.com. "Maybe we could get more jobs, bona fide jobs."

How would forming a labor union "raise the professionalism"? And why don't such bloggers -- if they actually want "real" jobs as writers -- go get them? Don't big bloggers love being on the outside of the MSM? Are they now saying they want real jobs as writers afterall? I don't get the desire here, nor how forming a "labor union" is the answer -- afterall, most employers would rather not have to deal with labor unions, not to mention a labor union composed mostly of ultra-leftist folks -- which it seems is mostly the type of bloggers who are interested in forming a "labor union" for bloggers.

"The blogosphere is such a weird term and such a weird idea. It's anyone who wants to do it," Hopkins said. "There's absolutely no commonality there. How will they find a commonality to go on? I think it's doomed to failure on any sort of large scale."

I think what you could get is some banding together of bloggers -- but we already have that. We have group bloggers. We have aggregators. A blogger union on a large scale? Like this person, I don't see it.

Madrak hopes that regardless the form, the labor movement ultimately will help bloggers pay for medical bills. It's important, she said, because some bloggers can spend hours a day tethered to computers as they update their Web sites.

"Blogging is very intense - physically, mentally," she said. "You're constantly scanning for news. You're constantly trying to come up with information that you think will mobilize your readers. In the meantime, you're sitting at a computer and your ass is getting wider and your arm and neck and shoulder are wearing out because you're constantly using a mouse."

Just a thought... maybe you should get some balance in your life then! Its no one's fault but your own if you are "tethered to your computer", if your "ass is getting wider" from sitting too long, and your body is "wearing out because you're constantly using a mouse". Get some exercise! Break up your day with other activities.

If readers of these blogs enjoy their writing so much, then they can help pay for the medical care needed to keep them at their computers 19 hours a day. That is their choice. Put out a special Tip Jar or PayPal button for that purpose! Good luck!

Repugnance Shouldn't Be a Standard

Over the past several years I've read more and more from bioethicists and others who argue against some regulation, policy, or law based primarily on the grounds of "repugnance". I've read this on the issues of stem cell research, cloning, euthanasia, and others.

This is absurd. One's subjective emotional responses -- whether discomfort, repugnance, apprehension, joy, elation -- are not a proper grounding for moral evaluation of an action, or a prospective regulation, policy, or law.

And yet this charge of "repugnance" surfaces time and again, perhaps most commonly in connection with the dire situation with the lack of kidneys available for transplant. There are no where near enough donors relative to the number of those who need a kidney -- people are suffering for years for lack of a kidney, and many die waiting for one.

And yet this problem could be solved in a relatively short time if a market for kidneys were allowed to develop and flourish. In such a market, individuals could be given cash payments for one of their healthy kidneys, or their beneficiaries could be given cash payment in exchange for kidney donation after death. The former is what would really fix the shortage, but even the latter (which seems like a no-brainer) would help. But neither of these are allowed today in the US. Although regulation of a market, generally speaking, interferes with that market and creates a suboptimal result, even a regulated market is better than no legal market at all. So in this case, as with many other non-violent acts that are currently prohibited, I definitely support a move from prohibition to a regulated market for kidneys.

The BBC recently did a special on this subject. This summary, after mentioning the "repugnance" or "disgust" viewpoint (I won't even call it an argument), quotes a Bishop whose position is that cash payment for a kidney negates the act's moral worth. His position apparently is that simply donating a kidney to a stranger or loved one is a good thing, but not if you are paid for doing so. This is, in part, the common ethical bias against money, commercial exchange, and best put -- the trading of a value for a value. This is a basic -- and common -- ethical error the Bishop is making here.

Here is a great clip from this article:

Yet others argue that what really counts here is not the motive, but the results.

American writer Virginia Postrel has been campaigning for it to be legal in the US to pay cash for a kidney from a live donor.

She said: "People want to keep it as a heroic, uncompensated act because it makes them feel good.

"Never mind that tens of thousands of people are dying for your right to feel good about other people's heroic acts."

Postrel's criticism sounds cynical, but she isn't the cynic she appears to be. She donated a kidney to a sick friend, became interested in the idea of a market for kidneys because of her experience with donation.

"The reaction is completely disproportionate to the actual risks involved. People do act like you're completely nuts."

Italics mine... what a great line!

Generic Drugs More Expensive in Canada

The Frasier Institute in Canada has done study which shows that the prices for generic drugs in Canada have been skyrocketing, and that Canadians now pay significantly more for generic drugs than we do here in the States. It is of course well known that we pay more for brand name drugs than Canadians do. Both of these results are because of government interference in the market. Here is a brief news item on this study.

The Waiting Lines in Canada

I regularly hear about the long waiting-lines for health services, especially things like surgery, in countries like Great Britain and Canada. Hearing that from angry patients is one thing -- that is just anecdotal evidence and could easily be quite biased: who doesn't want faster service? So actual data on this is what is needed. And fortunately, the Frasier Institute in Canada has put out an annual report of health care waiting-lines in Canada for 16 years now. Check out the 2006 version of their Waiting Your Turn publication, which is 90 pages of data and analysis on this issue. Just a quick scan of the graphs at the back show a general trend that is not positive. And here are a few paragraphs taken from their Executive Summary section:

Canada-wide total waiting time increased slightly in 2006 (continuing to hover near the 18-week mark)--and its level is high, both historically and internationally. Compared to 1993, waiting time in 2006 is 91 percent longer. Moreover, academic studies of waiting time have found that Canadians wait longer than Americans, Germans, and Swedes (sometimes) for cardiac care, although not as long as New Zealanders or the British.

The promise of the Canadian health care system is not being realized. On the contrary, a profusion of research reveals that cardiovascular surgery queues are routinely jumped by the famous and politically connected, that suburban and rural residents confront barriers to access not encountered by their urban counterparts, and that low-income Canadians have less access to specialists, particularly cardiovascular ones, are less likely to utilize diagnostic imaging,
and have lower cardiovascular and cancer survival rates than their higher-income neighbours.

This grim portrait is the legacy of a medical system offering low expectations cloaked in lofty rhetoric. Indeed, under the current regime--first-dollar coverage with use limited by waiting, and crucial medical resources priced and allocated by governments--prospects for improvement are dim. Only substantial reform of that regime is likely to alleviate the medical system's most curable disease--waiting times that are consistently and significantly longer than physicians feel is clinically reasonable.

According to them, average waiting times in Canada have increased by 90% since 1993... and waiting times are even longer in Great Britain! Ouch... no pun intended.

Our health care system in America is very flawed, no doubt about it. But the debate is not on that general question, but rather what should be done to improve it. The next time you hear folks arguing that we should move to a socialized medicine regime, consider all of this data provided by FI on waiting lines in Canada. And then consider that those in countries like Canada and Great Britain, who avoid those waiting lines by coming to the USA and paying for faster health services, won't be able to do so any longer if we have a system similar to theirs. The waiting lines in Canada and Great Britain would then become even longer (and or the wealthy and powerful would work harder to jump the lines). Even worse for Americans though would be this question: where would we then go to obtain faster, perhaps life-saving, health services when we most desperately need it? Nowhere it would seem.

John Stossel Responds to Michael Moore

Several recent columns by John Stossel refer to an interview he had with Michael Moore for an upcoming 20/20 piece on health care. In these columns Stossel responds to several of Moore's claims and views, and as always he makes some great points and does so in an enlightening way. The three columns are: Live and Let Live, Freedom and Benevolence Go Together, and Michael and Me. All three are good reads. I'll quote a just a few bits here:

Michael Moore may not have thought about it, but there are only two ways to get people to do things: force or persuasion. Government is all about force. Government has nothing it hasn't first expropriated from some productive person.

In contrast, the private sector -- whether nonprofit or a greedy business -- must work through persuasion and consent. No matter how rich Bill Gates gets, he cannot force us to buy his software. Outside government, actions are voluntary, and voluntary is better because it reflects the free judgment of creative, productive people.

The italics there are mine... what a great line that is! This was from the first column linked above, which doesn't actually spend much time responding to Moore. This is from the second column linked above:

Moore added, "I watch your show and I know where you are coming from. ..."

He knows I defend limited government, so he tried to explain why I was wrong. He began in a revealing way: "I gotta believe that, even though I know you're very much for the individual determining his own destiny, you also have a heart."

Notice his smuggled premise in the words "even though." In Moore's mind, someone who favors individual freedom doesn't care about his fellow human beings. If I have a heart, it's in spite of my belief in freedom and autonomy for everyone.

Doesn't it stand to reason that someone who wants everyone to be free of tyranny does so partly because he cares about others? Wishing freedom to one's fellow human beings strikes me as a sign of benevolence. But Moore and the left don't see it that way.

Moore thinks respecting others' freedom means refusing to help the less fortunate. But where's the connection? All it means is that the [advocate of capitalism] refuses to sanction the use of physical force (which is what government is) to help others. Peaceful methods -- like voluntary charity -- are the only morally consistent methods. I give about a quarter of my income to charities because I've seen that private charity helps the needy far better than government does

That was a good catch by Stossel... the smuggling use of "even though". Stossel continues on, and catches Moore with another smuggled premise:

Surprisingly, he did show an understanding of the importance of the libertarian philosophy to America. "John, your way of thinking actually was great for this country. I mean it; it helped to found the country. It helped build us into one of the greatest nations, perhaps the greatest nation, that the earth has ever seen. Limited government, pull yourself up by your bootstraps, every man for himself, forward movement, pioneer spirit. That's why a lot of people in these other countries really admire us, because there's this American get up and go."

I interrupt here to point out another smuggled premise. Did you catch that "every man for himself" line? America was never about every man for himself. A free society is about voluntary communities cooperating through the division of labor. [A free society] is far from "every man for himself."

After acknowledging that limited government helped make America great, Moore went on to say, "But I don't think that what you believe is what's going to allow us to survive."

He means that if government does not assure people health care and food, our society will disintegrate.

But why would a philosophy that was good enough to build a successful society be unsuited to sustaining that society? Individual freedom, with minimal government, made it possible for masses of people to cooperate for mutual advantage. As a result, society could be rich and peaceful. As the great economist Ludwig von Mises wrote, "What makes friendly relations between human beings possible is the higher productivity of the division of labor. . . . A preeminent common interest, the preservation and further intensification of social cooperation, becomes paramount and obliterates all essential collisions."

Freedom and benevolence go hand in hand.

And then the third column includes this excellent bit of Moore-refutation as well:

America's medical system has problems, but profit is the least of it. Government mandates, overregulation and a tax code that pushes employer-paid health insurance prevent the free market from performing its efficient miracles. Six out of seven health-care dollars are spent by third parties. That kills the market. Patients rarely shop around, and doctors rarely compete on price or service.

Moore told me, "Government can do things right. ... My dad gets his Social Security check every month. Comes not only every month, it comes on the same day through the so-called 'dilapidated' U.S. mail. ... [A]sk your grandparents what they think of Medicare. Although it has its flaws, although it may be underfunded, it's a much better program than the HMO that somebody has."

Underfunded? Medicare has a 75-year $34 trillion unfunded liability! Its costs are growing faster than inflation.

Social Security has a 75-year $5 trillion unfunded liability. These are Ponzi schemes that will be bankrupt before Moore reaches retirement age. The U.S. mail manages to deliver his dad's checks, but compare its performance to FedEx or UPS. The Post Office said it wasn't possible to deliver packages overnight.

I want FedEx health care: innovation, new cancer treatments, hip replacements and pain relief. We get that from private-sector competition, not government lethargy.

Moore said, "You don't introduce profit into your city water department."

He's wrong about that, too. As I wrote in "Give Me a Break", Jersey City, New Jersey's water tasted foul and failed safety tests. City workers said there wasn't much they could do. In fact, water prices would have to be raised ... just to maintain the lousy service they had.

So Jersey City turned its water system over to a for-profit company. Within months it had fixed the pipes government workers said couldn't be fixed, and for the first time in years, Jersey City's water met the highest cleanliness standard. Taxpayers saved $35 million.

The private company could do it better and cheaper because their skills were honed by constant competition.

Private competitors innovate or die. Government workers do what they did last year. That's why I want the private sector to provide my health care. Pursuit of profit will give us our best medicines and medical devices.

I love the very specific New Jersey water example here, as that is a direct response to Moore's rhetorical jab. And then the comparison between the private sector and government employees, which I've marked with italics, is a nice line too.

On the Costs and Benefits of Health Care Regulation

The latest issue of The Economist has both an editorial and then a one-page article on America's health-care system, and the costs and benefits of the tangled maze of regulations we have. The editorial begins by noting that Milton Friedman argued that the FDA was unreformable and hence should be abolished. While I agree with that, those at the Economist do not. But their editorial does go on to make some interesting and sensible reform suggestions:

The starting point is that the FDA and its counterparts across the world need to move from a risk-obsessed, "one size fits all" approach to a more flexible system that considers the risks and benefits of new therapies. Rather than asking drugs to undergo many years of costly trials in the vain pursuit of medicines that are safe for all in all circumstances, regulators should allow speedier conditional approvals. This is especially true for the growing number of targeted therapies, such as several excellent new cancer treatments, made possible by advances in genomics--a science that identifies which genetic groups will benefit from a drug.

If initial tests and sophisticated computer modelling show promise, innovative new drugs should proceed to small human trials. Ultimately, the drug could be approved for use by a wider part of the general population deemed (through genetic testing and other screening methods) to be at relatively low risk or more likely to benefit from the therapy.

Safeguards can counterbalance this relaxation. Faster approval of new drugs in humans should be matched by more rigorous post-launch testing and surveillance. At the moment, the FDA does not have the money or authority to do this properly. Scores of post-launch studies of drugs safety have been requested by regulators, but remain undone or ignored by firms. And yet there is reason to think such post-launch surveillance, if bolstered by the use of electronic records and "data mining" techniques, could save many lives. When Vioxx, a blockbuster pain remedy made by Merck, turned out to be dangerous for some patients, private health-management organisations with excellent electronic patient records spotted the problem months before the FDA did. The second safeguard is for all drugs trials done anywhere in the world--failed or successful--to be made public and the data published online. Consumers would have the information they need to choose whether to take a drug, weighing benefit against risk. Companies would benefit from a cheaper and faster approvals process, and a lower risk of litigation.

By cutting the costs of approval, lighter regulation should help move the industry away from blockbusters towards niche products. A reformed FDA might thus speed the arrival of the long-promised age of personalised medicine. Even if it survived, Friedman would surely approve.

The article in this issue then discusses three recent studies that give real evidence that Friedman's view of the FDA is correct: namely that it does far more harm than good. And we are talking about real physical harm here folks: people's lives would be saved if the FDA didn't do the things it did. See the graph in this article that indicates the total costs and benefits for five major areas of regulation of the US health care system: medical torts, the FDA, insurance regulation, and the certification of health professionals, and health facilities. It even indicates the components of the costs that come from State vs. Federal regulations. In all five of these areas, the costs outweigh the benefits. While medical tort and insurance regulation have greater total costs, this graph indicates that the relative costs vs. benefits are worst for the FDA.

Citing a second reference (a forthcoming paper by Michael Cannon of the Cato Institute), the article notes the important problem with the FDA:

Citing the best evidence to date on the costs and benefits of FDA regulation, Mr Cannon argues that the agency "is too slow and demands too much testing", ultimately harming consumers. He points out that drugs regulators can make two broad types of errors. First, they might approve a drug too quickly, only to find out after its launch that it is dangerous or even deadly. Second, they could delay the launch of a highly innovative drug by demanding onerous or unnecessary trials and thereby deny many needy patients a new therapy.

Proper regulation requires balancing these two risks, but the pitch may be queered by bureaucratic self-interest. If the regulator allows even one drug to slip through the approval process that later proves harmful to some people some of the time, a hue and cry is sure to follow. Look no further than the recent public backlash against the FDA after several deaths were linked to Vioxx, a blockbuster pain remedy made by Merck.

And yet the second (and probably bigger) risk of leaving people untreated because of restrictions on drugs rarely gets the regulators into trouble. As Mr Cannon puts it, "no FDA official has ever been fired or faced a congressional inquiry for delaying the approval of a promising new drug, however unjustified the delay." What is more, he speculates, big drug firms may quietly acquiesce to this burdensome red tape because it acts as a barrier to entry against newcomers without the cash or lobbying power to navigate the FDA.

That is a key point. I'd love to see FDA officials grilled by members in Congress with questions like "Because you took five years to approve drug XYZ, it is estimated that 10,000 people died that would have otherwise lived. How can you defend your slow bureaucracy?" That would be precious... but I'm not holding my breath.

I hope that the FDA will be reformed for the better, though I fear it won't be or that changes will only make the situation worse.

On the Right to Assisted Suicide

During the week that Dr. Jack Kevorkian was released from prison, The Ayn Rand Institute had both a press release, and an op-ed "The Right to Assisted Suicide" Thomas Bowden. Both are excellent.

From the Op-Ed:

What lawmakers must grasp is that there is no rational, secular basis upon which the government can properly prevent any individual from choosing to end his own life. When religious conservatives use secular laws to enforce their idea of God's will, they threaten the central principle on which America was founded.

The Declaration of Independence proclaimed, for the first time in the history of nations, that each person exists as an end in himself. This basic truth--which finds political expression in the right to life, liberty, and the pursuit of happiness--means, in practical terms, that you need no one's permission to live, and that no one may forcibly obstruct your efforts to achieve your own personal happiness.

But what if happiness becomes impossible to attain? What if a dread disease, or some other calamity, drains all joy from life, leaving only misery and suffering? The right to life includes and implies the right to commit suicide. To hold otherwise--to declare that society must give you permission to kill yourself--is to contradict the right to life at its root. If you have a duty to go on living, despite your better judgment, then your life does not belong to you, and you exist by permission, not by right.

For these reasons, each individual has the right to decide the hour of his death and to implement that solemn decision as best he can. The choice is his because the life is his. And if a doctor is willing (not forced) to assist in the suicide, based on an objective assessment of his patient's mental and physical state, the law should not stand in his way.

And then commenting on Oregon, the one state that has "provided clear procedures by which doctors can end their dying patients' pain and suffering while protecting themselves from criminal prosecution", Bowden continues:

Religious conservatives' opposition to the Oregon approach stems from the belief that human life is a gift from the Lord, who puts us here on earth to carry out His will. Thus, the very idea of suicide is anathema, because one who "plays God" by causing his own death, or assisting in the death of another, insults his Maker and invites eternal damnation, not to mention divine retribution against the decadent society that permits such sinful behavior.

If a religious conservative contracts a terminal disease, he has a legal right to regard his own God's will as paramount, and to instruct his doctor to stand by and let him suffer, just as long as his body and mind can endure the agony, until the last bitter paroxysm carries him to the grave. But conservatives have no right to force such mindless, medieval misery upon doctors and patients who refuse to regard their precious lives as playthings of a cruel God.

Secular and rational state legislators should regard the occasion of Dr. Kevorkian's release from jail as a stinging reminder that 49 of the 50 states have failed to take meaningful steps toward recognizing and protecting an individual's unconditional right to commit suicide.

Walter Williams on the FDA

Walter Williams makes some good points in his article FDA: Friend or Foe? In particular, he notes the following tension:

Some drugs are highly beneficial to certain patients but pose an unacceptable risk to others. ... So if you're an FDA official, what are your incentives in terms of whether to approve or disapprove the marketing of a drug that has a tremendous benefit to some patients and poses a health threat to others?

Former FDA Commissioner Alexander Schmidt hinted at the answer when he said, "In all our FDA history, we are unable to find a single instance where a Congressional committee investigated the failure of FDA to approve a new drug. But the times when hearings have been held to criticize our approval of a new drug have been so frequent that we have not been able to count them. The message to FDA staff could not be clearer."

There's little or no cost to the FDA for not approving a drug that might be safe, effective, and clinically superior to other drugs for some patients but pose a risk for others. My question to FDA officials is: Should a drug be disapproved whenever it poses a health risk to some people but a benefit to others? To do so would eliminate most drugs, including aspirin, because all drugs pose a health risk to some people.

He also notes that the FDA lately has been rejecting drugs because they aren't unique enough from what is already on the market. To which he responds:

According to the FDA's literature, its mandate is: "Once a new drug application is filed, an FDA review team — medical doctors, chemists, statisticians, microbiologists, pharmacologists, and other experts — evaluates whether the studies the sponsor submitted show that the drug is safe and effective for its proposed use."

Nothing in the FDA mandate requires that a drug has to be better than what's currently available in order to win approval.

Henderson and Hooper argue that in the worst-case scenario where Arcoxia is no better than existing drugs, it would compete with those drugs. Two centuries of economic theory and evidence show that competition is good. A new drug that competes with existing drugs would moderate drug prices and cause competitors to stay on their toes.

Depressed About Antidepressent Warnings

For a while now I've heard about how certain anti-depressents, the SSRIs I believe in particular, are said to "increase the risk" of suicidal thoughts and/or suicide itself in teenagers and children. I've been quite skeptical of any studies that are reported as supporting these contentions. Now today the news is announced that the FDA is expanding this warning for anti-depressents to include "young adults" as well -- those 18-24 -- during the first month or two of treatment.

Now, granted I'm not a doctor. Nor a scientist involved in such medical studies. Nor someone who is otherwise an expert in this area.

Having said that, I think I have good reason to be suspicious. First of all, I think we should all be pretty skeptical of much of what the FDA says: as a large government bureaucracy, and one that causes (or are at least morally responsible for) a great deal of harm and death by holding back helpful drugs for years and years, they don't inspire confidence generally speaking.

But even if you do hold the FDA in high regard... I must ask: have you yet heard reports on this issue that make any sense? They always speak in very vague terms about "increased risk" and so on. When you read further or dig into the underlying data, you find out that the "risks" are still very low.

More importantly, the word "risk" is tossed around as implying that some sort of actual causation has been shown -- of if not proven (which it hasn't been at all), then at least a strong statistical effect has been determined. But I am highly skeptical of this, and here is why. How would studies be done on this in a rigorous scientific way? From what I understand of SSRIs, they are slow acting -- meanings days and weeks, not hours. An increasinly depressed person, who actually gets to a point where they visit their doctor and are prescribed an SSRI, are likely going to continue to get worse before they get better -- caused by the depression itself, not from the drugs they've been prescribed!

Another reason to be skeptical here is that many times I've read of extreme cases of actual suicide or violence for new patients on SSRIs, but often when you dig into those you find out the person didn't follow the prescribed amount. With SSRIs you are supposed to slowly ramp up your dosage (and then slowly ramp it down when you are coming off of it). If you take five times the amount prescribed, then it is easy to see how that could cause problems.

And lastly, the FDA is the organization behind regulating and demanding all those ridiculously long listings of supposed "side effects" for every drug ad you see on TV or in magazines (if you can even read them, as they are often filled with legalese and printed in 2-pt font). Some instances of this are better than others, but I think their definition of "side effect" is likely wrong-headed, their ability to interpret statistics dubious, and their understanding of real, scientifically valid causation nearly non-existent. Its gotten to the point where comedians now are making fun of such side-effect listings for the jokes they often are. And then there are the high-profile court cases where people sue for heart attacks from this or that medication, many of which quietly get decided later in favor of the pharma company because the person was obese pounds and had every other actual heart disease risk known to man.

Prescription drugs can do harm, no doubt. And I consider it logically possible that SSRIs are actually causing increased suicidal thoughts in young people during their initial weeks or months taking them. But I am not at all convinced that we have any actual evidence of this at all, and I find it much more plausible that what is really happening is that people who are increasingly depressed and start taking the medications continue to get worse -- from their depression -- before the positive benefits of the drugs kick in.

So the next time you read or hear a news item speaking vaguely of studies that indicate "side effects" or "increased risks", and especially if the FDA is touting it, dig a little deeper, and ask if there is evidence of actual, proven causation -- or just some fairly weak, and perhaps grossly misunderstood statistics?

Neurosurgeons Shrug

The Jan. 29 - Feb. 5 issue of Us News and World Report had an interesting article "Get me a Neurosurgeon, Stat!". It details the increasing reasons that high-end medical specialist, such neurosurgeons, are opting out of the traditional hospital on-call systems. Examples are given that indicate this is a life-and-death issue -- if a specialist is not available at a hospital, or if one is located too late, people die.

While the reasons for specialists leaving the profession -- or at least adjusting how, when, and where they are willing to work -- are many and complicated, the summary of the problems is given as "too much work, too little pay, and the fear of malpractice lawsuits." At a more detailed level, the article notes that the 1986 federal Emergency Medical Treatment and Active Labor Act, which was enacted to prevent "discrimination" against the poor, has had the effect of requiring specialists of all kinds to be on call all the time. It also led hospitals to pressure doctors to provide these services for free, in exchange for being given facilities to perform their for-pay practices. But as more and more doctors can now do their paying practices in their own facilities, they no longer need to be attached to hospitals -- and so many are opting out.

The malpractice lawsuits aspect is interesting too. When a doctor builds up a history with a patient, there is much lower chance of getting sued. But with complete strangers as patients in the ER, and the often frantic nature of the ER, the odds of lawsuits arising from mistakes is much higher. So many doctors have decided to stop taking ER calls, or they might limit the types of calls they'll take -- e.g., a neurosurgeon who will not do brain surgery but who focuses on the spine instead.

The final paragraph is thereore not surprising:

Experts believe things are likely to get worse before they get better, with emergency docs continuing to scramble—they grimly call it "dialing for doctors"—to find specialists to help people like Elsie Bishop. Says Taylor: "The American public has no idea how dangerous it has become to get sick or injured at the wrong time."

Cures from Light?

The normally extremely-light reading newspaper supplement USA Weekend had an interesting one-page item this past Sunday titled "Light that can cure you". It discusses the good, and potential, still being tested good, that various forms of light-therapy can have for our health. Four types of light are covered: Near infrared light, Red light, Blue light, and Ultraviolet light. This is not something I knew anything about, but some of it sounded quite promising.

Mercury in Fish Another Overblown Issue

Today I read two somewhat contradictory stories in my local paper about mercury levels in fish, and to what extent this is a health hazard for us. The first (originally from Washington Post, but see it here) describes a recent report that suggests some areas are more susceptible to mercury pollution than others, describing these areas as mercury "hot spots". As a report about a report, it seemed like a fine article I suppose. But what it lacked was any mention of why we should care much about the issue. It just took it for granted that everyone knows that mercury-in-our-fish is a bad thing. And that is probably making a safe assumption on the part of readers, since we have been bombarded with stories of how dangerous mercury found in our fish diets can be for our health.

But the story gets very much complicated by the second, shorter article I read today. In the USA Weekend supplement to my local paper, the "Eat Smart" column by Jean Carper was titled "Phony Fish Scare?". Here it is in full:

Don't let a mercury scare keep you from eating fish, says William Lands, Ph.D., formerly with the National Institutes of Health and a leading expert on the benefits of fish oil. He says virtually all fish, even those high in mercury, are safe.

"Mercury is toxic in the absence of selenium," Lands says, "but fish is loaded with selenium that neutralizes the danger." A new University of North Dakota study shows that common fish, including grouper, swordfish, tuna and salmon, have much more selenium than mercury. Even albacore tuna (high on the government's hit list) has 15 times more selenium than mercury, making it perfectly safe, in Lands' view.

Is there any fish Lands would avoid because of high mercury? No, except maybe the pilot whale, not seen in U.S. markets.

So that was eye-opening for me. Selenium, which is common in fish, counter-acts the dangers from mercury.

So I did a little looking around the web, and I found several interesting things. The first was this article, which has an interesting excerpt including a graph showing the relative levels of mercury and selenium in various types of fish, and also in pilot whale -- the mammal mention by Lands above. Very interestingly, there are far greater levels of selenium than mercury in all the fish species shown: sole, flounder, salmon, tuna, pollock, halibut, cod, snapper, grouper, and swordfish. But in the case of pilot whale, the relative amount of selenium is much lower than in all the types of fish listed.

The info in the article was taken from materials at mercuryfacts.com, which seems to be the same site as fishscam.com. This site has lots of interesting materials, including critical comments about prominent scientists and environmentalists who are promoting fear of mercury in fish. As just one item on their site, see "The Flip Side of Mercury". One also discovers that much of the health concern over mercury in fish comes from a study that involved... guess what... pilot whale. See also the Mercury Myths page, which details problems with the following common claims:

• The amount of mercury in our environment (and in the fish we eat) is dangerously increasing.
• Mercury in fish presents a serious health risk to Americans.
• The health risk from mercury outweighs the health benefits of eating fish.
• You can get mercury poisoning from the amount of fish you might consume in a given week or month.
• Every year in the United States, 630,000 children are born with mercury levels in their blood that put them "at risk" for neurological disorders later in life.
• Eight percent of American women of childbearing age have unsafe levels of mercury in their blood.

Apparently there is good reason to doubt each of these claims.

Richard Epstein on Big Pharma as Over-Regulated

Richard Epstein had a recent piece in the LA Times that argues that the big pharmaceutical companies are actually over-regulated, and that the call for cost controls for prescription drugs is ill-advised. After detailing the increasing pressures that these companies face, and the effect this has had on the number of new drugs being created (down significantly in recent years), Epstein eloquently writes:

All these developments spell higher costs for the companies. Simultaneously, regulatory attacks on the industry's pricing model, including recent proposals to have the government negotiate rates for all senior citizens covered under Medicare Part D, threaten its revenue stream. The pharmaceutical industry operates in a high-fixed-cost and low-margin environment. It costs, on average, more than a billion dollars to get the first pill to market. All subsequent pills, however, can be made and marketed for only a few additional dollars or cents. Of course, no user ever wants to pay the big bill for that first pill. Instead, each fervently hopes to pay as close to marginal cost for the subsequent pills.

The problem with that is that unless someone pays for developing that first pill, there's no second pill to take. The central challenge to drug pricing is to figure out, quite literally, who swallows (and in what proportions) that huge front-end cost. Unfortunately, no company has a precise method to fairly, reasonably and palatably allocate the cost of drug development among the varied classes of subsequent consumers — large HMOs, hospitals, full-service pharmacies and Medicaid for starters. Each buyer has a strong incentive to push as many of those costs as possible onto someone else.

The upshot is a rough-and-tumble bargaining game in which drug prices vary substantially across different market segments. But the corner drugstore doesn't have the same leverage to play one drug manufacturer off against another, so it usually pays higher prices for its wares than a large HMO. The resulting confusion leads to loud calls for equitable, industrywide price controls. But price controls would have the same dire consequences as they would in any other industry. Investment dollars will quickly move elsewhere if the regulatory system does not allow manufacturers to maximize their revenues over the useful life of the drug (which, incidentally, never exceeds the 11 or so years of patent protection).

Repeated studies, both domestic and foreign, have shown that price controls dull the incentives of pharmaceutical companies to develop new drugs. Even talk of price controls depresses investment.

Because of its high-fixed, low-variable cost structure, the drug industry will never reach perfect competitive equilibrium. But in our second-best world, ponder carefully the different consequences of two strategies. The first seeks to expand supply by avoiding regulation and encouraging the entry of new companies into the business.

The second seeks to hold down prices by direct controls. The second approach leads to low prices today but systematic shortages tomorrow, while the first leads to greater innovation today and greater choice tomorrow. We must be careful not to mistake price controls for a cure when they are in fact a disease. Let our new reformist Congress beware.