Tuesday, May 26, 2009

Elisabeth Edwards Interview with Jon Stewart

It's on Hulu, and it's a bit funny. Skip past the second commercial point; the interview is towards the end of the show. Edwards is hocking her book Resilience, which is mostly about her husband cheating on her, but the interview manages to focus on health care in America.

Sunday, May 24, 2009

Mandatory Private Insurance - Why It's Stupid

The Washington Post has a very flattering article about Senator Baucus today. I am going to just focus on one sentence, though.

"Baucus is committed to delivering universal coverage and getting more and better care from health dollars, and he is seriously considering an individual mandate -- requiring adults to have health insurance -- and taxing employer-provided health insurance."

If he's considering an individual mandate, he is clearly not committed to getting more and better care from health dollars. This is very similar to McCain's proposal. Let's start with the setting. We have now about 50,000,000 people with no insurance, almost entirely because it is too expensive. We have tens of millions more people with inadequate insurance, who still go bankrupt if a major health complication occurs. We have companies offering less and less in the way of health benefits because prices are rising so much.

* Making health insurance mandatory for people who can't really afford it is going to require spending federal money on subsidies. It is flat out less efficient to give this federal money to private insurance companies with their high overhead than to just expand Medicare or Medicaid. This is just Congress's way of unnecessarily giving our tax dollars to insurance company stakeholders as a "thank you" for all the campaign contributions.

* Individual insurance customers have no negotiating leverage. Large employers get discounts on insurance prices because they can pool risk and threaten to take their big group contract to a competing insurer. Individuals can't negotiate to reduce insurer's profits, so they get gouged. Unless the government is going to really meddle with private insurance rates and practices, making private insurance mandatory is going to lead to an even higher percentage of health dollars going to profits instead of care. Depending on how the subsidies are worked out, this will either unnecessarily hurt the lower class, unnecessarily rip off taxpayers, or both.

* We will still have huge problems with underinsurance. Even with subsidies, even when it's mandatory, consumers with lower incomes are going to get the insurance plans with the lowest premiums. These plans may have high copays, high deductables, and poor coverage. We are still going to see bankruptcies due to medical costs. Unless the government meddles extensively with what insurance plans are offered, but that doesn't seem to be on the table.

* Regarding taxing health insurance from employers, that will result in a further reduction of coverage by employers, higher costs to individuals, poorer coverage overall, and further weakening of our ability to compete in the global market. What would eliminate all of these problems is a public, single-payer option, which would reduce everyone's costs, increase coverage, and let our industries be more competitive.

Saturday, May 23, 2009

HR 676 - The Good and the Bad - Part 4

Continued from Part 1, Part 2, and Part 3.

Health care delivery facilities must meet regional and State quality and licensing guidelines as a condition of participation under such program, including guidelines regarding safe staffing and quality of care.

This is a measure to appease people who oppose federal involvement in state affairs.

Some states insist on having unnecessarily low standards. "Best Practices" is the idea that everyone should do what has been shown to lead to the best outcomes. We are constantly measuring health care outcomes related to different policies, and it blows my mind that there are factions out there who refuse to do what is best for the people in their care. Mississippi's quidelines for quality of care are not the same as Connecticut's, and Mississippi has significantly worse health care outcomes. A single-payer has a great opportunity to use its leverage to require uniformly high standards instead of allowing states to choose whether or not they will slack off. Residents of Mississippi are still Americans, and the American government has a responsibility to them.

Participating clinicians must be licensed in their State of practice and meet the quality standards for their area of care. No clinician whose license is under suspension or who is under disciplinary action in any State may be a participating provider.

Pretty standard.

Same as above about variance in state standards, but with an added gripe. It is a pain in the tuchas for clinicians to move from one state to another because licensure requirements are all different. Clinicians who live near a border are either stuck working in one direction, or have to go through multiple licensure procedures. I don't know if this constitutes an undue burden on interstate-commerce or what, but it is ridiculous. There should be at least the option of satisfying a single, high standard that would allow clinicians to move without getting a new license. There is a similar situation with gun laws, and many states accept a Florida license because it is more difficult to get than their own. Some states are easier to move to than others.

The complaints in this post are about our current system, and not about HR 676 in particular. It is just that HR 676 is accepting of these problems, and they are included in the bill. Causing as little turmoil as possible will help the bill's progress, though our system really does need some improvements.

Friday, May 22, 2009

Health Insurance Reform - Conflicts of Interest

It's been in the news for a week now that Senator Baucus's Finance Committee hearings are a total sham. With 59% of Americans asking for a single-payer system, it is absurd that the Senate would only meet with representatives from the industries that profit from the existing, inefficient private system. How could Baucus overlook representatives from single-payer supporting groups? The unfortunate and obvious answer is money.

Baucus has received "... from the insurance industry, $1,170,313; from health professionals, $1,016,276; pharmaceuticals/health-products industry, $734,605; hospitals/nursing homes, $541,891; health services/HMOs, $439,700" over his career.

"According to the report, Senator Baucus received $183,750 from health insurance companies and $229,020 from drug companies in the last two election cycles."

Insurance companies and drug companies have lots of money to spend on lobbying and campaign contributions (legal bribes). People who cannot afford health insurance also cannot afford lobbying or campaign contributions. The only way to get representation in government decision-making processes is to pay the people who get to make the decisions.

But wait... where did those figures come from? Some searching on news.google.com has only given me more blogs and op/ed pieces that cite DemocracyNow! or the 13 protesters who were arrested, heavily biased sources of information. Where can I find something more legitimate? A few seconds with Google gives me OpenSecrets.org. Let's look up our friend Max Baucus.

Three of his top 5 contributing industries and their contributions since 2005:
Insurance - $545,225
Pharmaceuticals/Health Products - $493,313
Health Professionals - $492,641

Individual contributers include Aetna, Amgen, Blue Cross, and Kindred Healthcare. For the billions of dollars these companies have riding on Baucus's actions, they are getting a pretty sweet deal. Baucus isn't alone, though. These companies donate to pretty much everybody to make sure their interests are taken into account more than the citizens of this country who do not make large financial contributions.

Something else that is interesting is that pharmaceutical companies gave 2-3 times as much money to Republicans as to Democrats until 2008. This may just reflect that we had a Republican majority in Congress until recently, but also that the Republican party values big corporate profits more than social welfare, relative to the Democratic party. Big Pharma would want to finance Republican campaigns in closer elections, but resort to just getting some leverage with Democrats in a year in which more Democrats were going to win anyway. I would like to hear other ideas.

I am glad that organizations such as OpenSecrets help give us transparency, but why isn't this information in the mainstream media? When CNN runs a story with politicians giving their policy views, it could easily and briefly mention each politician's conflicts of interest. Most people just don't know what's out there unless it's given to them, and it is the media's responsibility in a democracy to give the public relevant information.

Monday, May 18, 2009

HR 676 - The Good and the Bad - Part 3

Continued from Part 1and Part 2.

No institution may be a participating provider unless it is a public or not-for-profit institution.
Investor-owned providers of care opting to participate shall be required to convert to not-for-profit status.
The owners of such investor-owned providers shall be compensated for the actual appraised value of converted facilities used in the delivery of care.
There are authorized to be appropriated from the Treasury such sums as are necessary to compensate investor-owned providers as provided for under paragraph (3).
The conversion to a not-for-profit health care system shall take place over a 15-year period, through the sale of U.S. Treasury Bonds. Payment for conversions under paragraph (3) shall not be made for loss of business profits, but may be made only for costs associated with the conversion of real property and equipment.

Okay, this is a bit confusing, and not something that's been covered much in the media compared to the prior points. Fifty-nine percent of America’s non-federal hospitals are not-for-profit (Government Accountability Office (2008)). With a single-payer system, hospitals and other service providers will be practically forced to obey the requirements of that payer in order to stay in business. For-profit service providers will either shrink and offer only premium services at high cost to private payers (uncovered procedures or immediate procedures without waits), or they will have to make this conversion to not-for-profit status.

What do they have to convert? A common difference between for-profit (FP) and not-for-profit (NFP) hospitals is the presence of an emergency room (ER). ERs are expensive and tend to lose money, but are required for NFP status. The trade off is providing a lot of uncompensated emergency care instead of paying taxes. To work with HR 676, many FP hospitals would have to build ERs. The bill would have Treasury Bonds sold to pay for this construction, along with any other conversion costs, though I am not sure what else would be involved. They have 15 years to convert.

NFP hospitals are generally more efficient than FP hospitals. It sounds like the government will pay FP investors for the conversions. 15 years is a fairly long amount of time for conversion. After transition, we will have a more efficient system overall that cares more about health care provision and less about profit.

Everyone who currently profits from their FP facilities is going to fight the bill. They will not be compensated for "lost profits". FP facilities and private insurance companies will suffer immediately as many of their customers switch insurance. NFP facilities may not be able to accommodate a sudden rise in customers. There will be a stormy transition in which we do see a temporary increase in wait times for people with the federal insurance, which the opposition will capitalize on in their complaints, and an increase in misinformation as providers and private insurance providers compete.

Thursday, May 14, 2009

Drug Samples - The First One's Free

There is a new article on Free Drug Samples in the Public Library of Science.

Summary: Drug samples are bad. Doctors are people, and are subject to manipulation by marketers the same as anyone else. The multi-billion dollar pharmaceutical companies give out samples in ways that make them more money, increasing awareness of expensive new drugs, irrespective of the effects on national health. These companies lobby the government to make sure they can keep doing this, even though it is bad. Samples are not used to help the poor, and are often used by the doctors or given to friends since they are not monitored. Lack of monitoring and involvement of pharmacists also leads to negative drug interactions and a lack of consumer education. Socialized health care systems are relatively impervious to manipulation by samples.

If you follow the link, also read the comment by Ken Johnson, Senior Vice President of Communications for the Pharmaceutical Research and Manufacturers of America. Obviously biased, he presents some data that does not really contribute to his argument. He supports the idea that drug samples give people treatment for their problems, ignoring that the main article already discussed this, and how poorer patients often discontinue these drugs cold-turkey when the freebies run out. Ken argues that most prescriptions are still for generics, which is a distraction from the problem that still more expensive new drugs are being prescribed than should be. His argument is like saying that it's okay to set some houses on fire because most houses will still not be on fire. Was the KRC survey of prescribers? Of course they don't think they're influenced by marketers over journal articles and clinical formularies. Ken goes on to point out that drug expenditures have gone down, and payers influence prescription decisions, both of which may be true, and neither of which counters the points of the main article. Then he says that 75% of physicians report using samples to reduce costs for patients, which combined with the main article means that they're reducing costs mostly for non-poor patients. Remember that the samples also work as a hook to get people using who can actually pay for more. Finally he repeats that free drugs are good, again ignoring long-term ramifications of only temporary and undermonitored, underexplained free drugs.

HR 676 - The Good and the Bad - Part 2

Continued from Part 1.

The health insurance benefits under this Act cover all medically necessary services, including at least the following:
(1) Primary care and prevention.
(2) Inpatient care.
(3) Outpatient care.
(4) Emergency care.
(5) Prescription drugs.
(6) Durable medical equipment.
(7) Long term care.
(8) Mental health services.
(9) The full scope of dental services (other than cosmetic dentistry).
(10) Substance abuse treatment services.
(11) Chiropractic services.
(12) Basic vision care and vision correction (other than laser vision correction for cosmetic purposes).
(13) Hearing services, including coverage of hearing aids.

All medically necessary services are covered. One of the cost containment measures may be to reduce unnecessary testing and procedures. A huge problem with our US system is unnecessary services, also known as "defensive medicine" because they protect doctors from getting sued. People need to accept that even best practices don't always work, and it's not malpractice. Doctors should be protected from lawsuits as long as they follow best practices. This will reduce costs without disproportionately reducing quality of care. It is also good that HR 676 explicitly includes mental health and substance abuse treatment, which both have cascading effects on health and quality of life over time and generations.

"Medically necessary" will still usually mean "whatever a doctor says". Many doctors fall prey to biases in their decisions that reduce quality of care in the face of current medical research, but doctors as a group refuse to let anyone else question them, no matter how much data suggests they do something different. Large payers have had varying success controlling service provision by controlling payments per diagnosis ("prospective payment" for "diagnostically-related groups" (DRGs)), but also have had trouble spotting shenanigans like hospitals "upcoding" patients to more severe diagnoses to justify additional treatment.

Chiropractors? Seriously? They seem to have had good lobbyists since at least the early 1970's. What an unnecessary waste.

Such benefits are available through any licensed health care clinician anywhere in the United States that is legally qualified to provide the benefits.

Totally standard.

No deductibles, copayments, coinsurance, or other cost-sharing shall be imposed with respect to covered benefits.

No financial barriers to treatment means that everyone can afford health care. Fewer poor people avoiding basic and preventative care means fewer poor people in the ER increasing our costs and reducing their productivity.

This is an obvious lesson we should have learned from other socialized health care systems, and from experiments within the US: cost-sharing is good. When health care is completely free, people go to the doctors when they don't really need to. This is when the lines and waits get unnecessarily long. This is when practitioners' time is wasted. Even the poorest people can scrape together a $10 co-payment if they really need a doctor, and just $10 will make people think twice before running to the doctor every time they sneeze. This is not about the money as much as it is about disincentivizing waste.

We should also charge for missed appointments. Years of working providing services in poor communities has given me much experience with no-shows and last-minute cancellations. This population has many reasons for missing appointments: no transportation, the health complication itself, being unable to better schedule other necessary conflicting appointments, but often they are just not motivated to do things. The linking factor between their poor health and poverty is often that they are characterologically immediately-gratifying and avoidant of putting forth effort or exposing themselves to additional stressors such as discussing problems with a doctor. For a number of etiological reasons, they are compelled to sit at home, watch TV, eat junk food, smoke, complain, and have kids that they don't raise effectively. These behaviors lead to both poverty and health problems, and perpetuate the problems through generations. I am not saying that this describes all poor people. This is just a common issue among the poor. Service providers of Medicaid recipients are lucky to have show rates over 60%. My current clinic has instituted a number of measures to improve the show rate, and is happy to report consistent rates between 70% and 75%, and we do not get paid when the clients don't show. We use phone call reminders, and we discharge anyone who misses two consecutive appointments, but we have no cost-sharing at all. I am privy to an experiment conducted by a dental practice that serves a poor area. They tried different charges for no-shows or same-day cancellations. They found that clients were more cooperative when the charges were used for a specific and known purpose (toys and magazines for the waiting room). They also found that $20 was the sweet spot for motivating attendance. Anything less than $20, and the clients would rather stay at home and pay it. Anything over $20 and the clients would never come back. $20 kept clients on the list and coming in for appointments. Take advantage of the people's desire to avoid stressors. Make the possible loss of money more stressful than the trip to the doctor.

Charging some money makes the system more effective and efficient than making everything free.

Wednesday, May 13, 2009

Infant Mortality Determinants in the US

I have to apologize for suggesting earlier that giving uninsured women health insurance would improve prenatal care and reduce infant mortality. That seems like an intuitive prediction, but it is questionable. I have been playing with GapMinder, and it is a very helpful tool for identifying probable correlations and tracking them over time. Gapminder shows:

* No discernable relationship between percent of a state's population without insurance and infant mortality. Infant mortality has been steadily decreasing while the proportion of uninsured decreased, then increased.

* Possible relationships between infant mortality and income, education, life-expectancy at birth, and geography.

* Less clear possible relationships between infant mortality and murder, robbery, and divorce.

* Washington DC is a crazy outlier on nearly every measure.

How does this information fit together to explain our infant mortality rates?

The southern states are typically more rural and politically conservative, demanding minimal government intrusion. They have a prevailing culture of deregulation, which has led to the highest pollution rates and the lowest education standards. There is a "brain drain" phenomenon in rural areas that high academic achievers move to cities, perhaps in other states such as California and New York. There is natural colinearity among the variables GapMinder showed may associate with infant mortality. Low education -> low income. Living in the south -> low education and low income.

The Northeast has different attitudes, favoring government involvement, having high standards for education. This region is more progressive, trying new things to see how to make improvements, instead of following traditions.

Some pieces are missing from this puzzle that GapMinder doesn't have.

I would like to see drug addiction data mapped with the rest of this data. I think it is a key link between the health insurance and infant mortality discrepancies between the US and other industrialized nations. Drug addiction increases infant mortality. Across the US, people with drug problems end up in jail at very high rates. Across other industrialized nations, people with drug problems end up in rehabilitation programs more often than in the US. Many US health insurance programs cover some drug rehab, but not all and not very well. Medicaid covers a lot more, but only covers people who qualify for Medicaid.

Does the South have more drug problems than the Northeast? Is it more likely to send addicts to jail than the Northeast? Is it less likely to provide rehabilitation than the Northeast? Using murder and robbery rates as an estimate of drug problems, it looks like the South (plus Nevada) is worse off than other US regions.

A socioneuropsychological unification theory:

Fearful, angry people are more easily overwhelmed by novelty and complexity. Their brains simplify input their whole lives, causing them to miss nuance and detail. Their relationships are poor, their learning is poor, and they are drawn to simple, concrete, black-and-white ideas. They are also drawn to each other in order to feel more secure in a predictable and simple social environment. They also raise fearful, angry kids (though yelling, shaming, rigidity, overcontrol, and abuse), perpetuating these problems generation after generation. With lower education, worse income prospects, less hope, and a baseline physiological disregulation, drug use can be a pleasant liberation. There are also genetic components to all of this, but they are not nearly as important as environmental factors except for predisposition to drug dependence. Let's include cigarettes and alcohol as drugs. Besides drug use, other self-soothing behaviors such as overeating would be common. GapMinder does not show obesity rates, but it does show that the South has the worst life-expectancy in the US. The South has about equivalent uninsured rates to the West, but worse health outcomes because of behavior. Nicotine, alcohol, and other drugs during pregnancy are associated with low birth weight, among other developmental problems. During fetal development, the frontal lobe is the last part of the brain to get blood and oxygen. When there is a problem with getting proper nutrients to the fetus, this part of the brain is generally affected the most. This is the part of the brain involved in behavioral planning and inhibition. Smokers and drug users give birth to kids that are impulsive, and who are then more likely to do things like use drugs, not take care of themselves, and have kids at younger ages. We are observing a cycle over generations that is changing the distributions of neurologically and behaviorally healthy people across geographic regions. They do not care for themselves, their developing fetuses, or their children as well as normal-functioning people.

What is up with Washington DC?

DC has many well-paid government employees and contractors, giving it the highest average income by far. It also has a large population of urban poor, contributing to the highest per-capita murder rate (some competition with Philadelphia) and highest HIV rate. Rampant drug use and unhealthy behavior among the urban poor population of DC increase its infant mortality rate.

What should we do?

Whether its covered by health insurance or not, we need better drug rehabilitation services, comparable to other industrialized nations. We also need uniformly high standards for educating our children, especially in how to raise healthy children themselves. It is going to be a long and difficult task to undo the damage done by generations of poor habits, and the beliefs and impulsivity and poor self-awareness that perpetuate them.

Tuesday, May 12, 2009

HR 676 - The Good and the Bad - Part 1

HR 676 is a popular attempt to expand Medicare to all Americans. It is greatly supported by unions and health care professionals. It is greatly opposed by insurance company executives and shareholders, as well as free-market ideologists. Based on the outcome data from the "real world experiment" of other industrialized nations implementing similar systems, it is relatively clear that HR 676 has some good and bad attributes. I will start discussing these attributes in this post, but will probably have to finish in subsequent posts.

"All individuals residing in the United States (including any territory of the United States) are covered under the USNHI Program entitling them to a universal, best quality standard of care. Each such individual shall receive a card with a unique number in the mail. An individual’s social security number shall not be used for purposes of registration under this section."

This is the basic summary of the whole bill. This entitles everyone in the US to health care. No more 46,000,000 uninsured Americans. No more millions of bankruptcies due to medical bills (half of all personal bankruptcies). Fewer people waiting for acute conditions then going to the ER, which means better work productivity and lower health care costs per person.

Notice also that this includes Guam, Puerto Rico, and potentially illegal residents. Though there is evidence that illegal residents use less health care than citizens, they still use health care (usually the ER), often without paying for it. This may provide an incentive for them to use basic care and preventative care instead of emergency care, which will save us all money in the long term.

Speaking of the long term, I am compelled to point out that giving poor women access to prenatal care, and poor children access to basic and preventative care, may save our society billions in services for kids with chronic conditions. Babies born underweight tend to have so many more problems in their lives than healthy babies, and that is typically preventable.

One possible problem is that people that are currently dying (the US has the worst infant mortality among its industrialize cohorts) may instead survive with chronic conditions. That would increase long-term costs and lower net quality of life (drastic effects on caregivers, reducing mothers' lifespans by up to a decade due to stress), but I cannot confidently predict what the rates would be. Also, some people believe in keeping everyone alive as long as technologically possible despite quality of life, so this point has a very subjective and controversial value. How to weigh this into the decision-making is difficult and unclear.

"Individuals and families shall receive a United States National Health Insurance Card in the mail, after filling out a United States National Health Insurance application form at a health care provider. Such application form shall be no more than 2 pages long.

Individuals who present themselves for covered services from a participating provider shall be presumed to be eligible for benefits under this Act, but shall complete an application for benefits in order to receive a United States National Health Insurance Card and have payment made for such benefits."

So, the first time you show up, you get services under the assumption that you qualify, and you fill out a 2-page form to get your card for the future.

Unless service providers are checking that patients' identification cards match the application forms, there is little to prevent fraud. Oh, wait, what would be the motivation for fraud? Everyone gets free care in this system.

To be continued...

Acupuncture - A Study with Toothpicks

I came across this article today reporting on a study comparing four types of lower back pain treatment over 7 weeks: individualized acupuncture, standardized acupuncture, "sham" acupuncture using toothpicks, and a control group that just used painkillers and anti-inflammatories (all groups were allowed to use drugs). Though I don't have the original journal article (May 11 Archives of Internal Medicine), the sample size seems large enough that the effect size mentioned should be statistically significant. 40% of the control group reported "significant improvement in disabilities brought on by back pain", and 60% of each of the other three groups reported the same. What might this mean for recommended treatments and third-party payment?

First, keep in mind that the participants all knew that this was a study on acupuncture treatment in order for the study to get informed consent. Only people willing to receive acupuncture were involved, which means the study had self-selection biases. Then they were randomly assigned to the four groups. So, the control group knew it was not getting the treatment that the study was testing. This would definitely have led to expectation biases in reporting disability. This study compared people willing to try acupuncture who got what they were told was acupuncture to people willing to try acupuncture who were then not given it. The chances that the effect seen is due to the placebo effect are very high.

The placebo effect is real and practically significant. It is really amazing how thoughts and beliefs, activity in the pre-frontal cortex, affect other parts of our brains and bodies, stimulating immune response (or inhibiting it) among other phenomena. What is also nifty is that we can intentionally generate these effects in ourselves without being tricked. Once we understand that a placebo effect exists, we can mimic the effect on purpose through mindful concentration or meditation. Recent studies using MRI, PET, and SPECT scans have revealed many brain processes that we can harness to benefit ourselves.

Jonah Lehrer, in How We Decide, cited research that reported that 90% of cases of non-specific lower back pain go away with just 7 weeks of rest. That would make rest far more effective than acupuncture or drugs. Perhaps having an active treatment encouraged these participants to continue physical activities that aggravated their back problems. With the expectation that they would be better with acupuncture or drugs, maybe they pushed themselves harder than they should have.

Based on this information, and in the interest of best practices, it seems that the answers to our questions are that Doctors should prescribe seven weeks of rest before moving on to other treatments, and that third-party payers still have little to no call to reimburse for acupuncture. The evidence is not compelling that acupuncture works according to its theories, and the high likelihood of a placebo effect suggests that similar benefits could be achieved through optimism, which is free.

I am interested in any well-done, valid, peer-reviewed studies demonstrating real benefits to acupuncture beyond a placebo effect. Since one in twenty studies may fall prey to a type I error (alpha is usually 0.05), meta-analyses are preferred. Send them my way if you've got 'em.

Tuesday, May 5, 2009

Single-Payer Health Care

I am sure this is only the first of many times I will write about single-payer health care. I will try to keep this to a brief overview.

Free-market Capitalism or Libertarianism generally support the idea that outcomes are best when companies are free to do whatever they want, and consumers are free to do whatever they want. Demand from consumers will control what companies offer and at what prices. Companies succeed that satisfy consumers the best.
Socialism generally supports the idea that consumers are best served when the government applies more control to companies to sell what the government thinks is good for the consumers.

The Current US System: We have many different private insurance companies, plus Medicare for the elderly (and ESRD), plus Medicaid for the very poor, plus S-CHIP for kids in not-rich families. The many private companies compete with each other for customers by advertising and offering different insurance packages at different prices. The US private insurance system is mostly free-market capitalist, but also has various regulations at the state and federal levels. The private insurance industry heavily lobbies congressmen and makes substantial campaign contributions to ensure that legislation is not passed that would hurt its profits. People who cannot afford insurance also cannot afford lobbyists. Politicians are not required to understand economics, ethics, or health care systems, and most don't. They often end up voting how they are told, which gives us things like Medicare Part D that explicitly prohibits Medicare from negotiating for lower drug prices.

Foreign Systems: The other industrialized nations that we usually compare the US to (European countries, Japan, Canada, Australia) are far more socialized. They can all be said to have single-payer systems, though their systems vary, because citizens have the right to most health care treatments and the government pays. The government is the single payer (a couple countries involve the government distributing funds to a handful of insurance companies based on citizen-chosen enrollment). As a single-payer, the government has great leverage that it uses to demand quality and efficiency from service providers.

Outcome comparisons: No one should ever make decisions based on belief in ideology when there is data from measured outcomes that demonstrates which system works best. The US system results in generally comparable health outcomes for the people who get health care to those in our socialized counterparts. Unfortunately, we pay about twice as much money for those comparable outcomes, and tens of millions of our citizens don't get any basic health care at all because they can't afford insurance or care. In the absence of affordable basic care, our uninsured and underinsured citizens wait until they have acute problems that cost devastating amounts of money, often causing bankruptcies and home foreclosures. Nearly half of the home foreclosures that precipitated our economic collapse were due to medical bills. This simply does not happen in single-payer systems. Money is wasted in our system on advertising and bureaucracy. If Medicare were offered to all Americans, the overhead savings would pay for the health care of our currently uninsured. With this health care, acute health problems would be reduced, and our nation's productivity and economy strengthened. America currently has the worst infant mortality rates among industrialized nations because uninsured and underinsured women cannot get effective prenatal care.

Each system does what it is designed to do. The US system is designed to make money for insurance companies that in turn give money to lobbyists and campaigns, and deny basic health care to tens of millions of people, increasing infant deaths, weakening our whole economy and bringing down quality of life. Single-payer, socialized systems are designed to give everyone adequate health care, resulting in stronger, healthier, more productive and functional nations.

Saturday, May 2, 2009

Homeopathy - A Political History in the US

This is not what I expected would be my first topic, but it is getting a lot of current exposure on scienceblogs.com and sciencebasedmedicine.com. Both of these sites are slamming homeopathy, and the support given to homeopathy by the Huffington Post. Though they make valid attacks on the effectiveness of homeopathy, readers still lack much of the history and politics of homeopathy in America. Here I will present a brief summary of a longer paper I wrote a few years ago on herbal and homeopathic products, and why they should be regulated by an empowered Food and Drug Administration, if not outright banned. Most of the paper was about herbal products, but I will save that for another time. Note: this content is several years old, and does not take into account any new laws or regulations passed after 2005.

Executive Summary: Homeopathy as a field has sanction to regulate itself, which it hardly does at all. The FDA does not have the resources to take action against homeopathy products that make false claims. Homeopaths make a great deal of money selling products and services to people who do not realize that homeopathy is only as effective as a placebo at treating or preventing any health problems.

History: Homeopathy was invented by Samuel Hahnemann in the 1790s. It is based on two theories: the law of similars, which states that substances which elicit the same symptoms as a disease will help the body cure itself of the disease, and the law of infinitesimals, which states that drugs are more powerful the more that they are diluted. Homeopathic medicines, despite frequently involving poisonous substances, are blanketly considered safe by virtue of their ingredients being diluted so much. Some are even diluted to the point that a purchase will contain no molecules of the key ingredient, but some practitioners insist that the medium retains a "spirit" or "vibration" of the active substance, and will still function as a remedy.

Regulation of homeopathic medicines has changed over time. In 1934, Senator Copeland, himself a practicing homeopath, drafted a bill (S 2000, later S 2800) intended to protect American citizens from quacks by making medicines illegal that were not listed in the United States Pharmacopœia, National Formulary, and Homœopathic Pharmacopœia of the United States (HPUS). Copeland's bill, enacted in 1938, made all HPUS drugs legal, and regulated by the FDA under the Federal Food, Drug, and Cosmetic Act. The Durham-Humphrey Amendment in 1953 made all homeopathic medicines prescription-only, but the FDA often did not enforce this rule due to its view that these medicines were useless. The Kefauver-Harris amendments in 1962 further regulated that homeopathic medicines added to the HPUS after 1938 be tested and accepted by a governing body of experts, which homeopaths did not like since they had so many different opinions about what treatments were effective. The 1988 Compliance Policy Guide (CPG) finally allowed many homeopathic medicines to be sold over the counter (OTC), as long as they were indicated "solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment" (FDCA, sec 400) such as colds or headaches. The sudden flood of OTC products upon enactment of the CPG in 1990, labeled with legal claims of treatment as indicated by the HPUS, resurrected the homeopathic industry and set it growing. Changes to the HPUS are under the control of the Homœopathic Pharmacopœia Convention of the United States (HPCUS), a non-governmental, non-profit organization, and occur once or twice per year since 1998.

HPCUS, therefore, has the power to decide what is a drug by law, and whether it has OTC or prescription-only status. The HPUS has over 1,300 drugs, about 440 of which are prescription in some potencies, and about 20 of which are prescription-only. The organization's requirements for deciding are not particularly stringent. Besides requiring proof of safety (easy to accomplish with enough dilution), new drugs must satisfy only one of the following four conditions:
● The therapeutic use of a new and non-official homeopathic drug is established by a homeopathic drug proving and clinical verification acceptable to the HPCUS.
● The therapeutic use of the drug is established through published documentation that the substance was in use prior to 1962.
● The therapeutic use of the drug is established by at least two adequately controlled double blind clinical studies using the drug as the single intervention; the study is to be accompanied by adequate statistical analysis and adequate description of the symptom picture acceptable to the HPCUS which includes the subjective symptoms and, where appropriate, the objective symptomatology.
● The therapeutic use of the drug is established by a) data gathered from clinical experience, or b) data documented in the medical literature.

For the purpose of these requirements, a "proving" is just a trial that shows that the substance elicits the same symptoms as the problem it is purported to treat, and "medical literature" includes any source the HPCUS decides to accept for the case. Anything documented as in use before 1962 gets grandfathered in. Though the third option is preferred by scientists, and most resistant to criticism, it is the most difficult to satisfy, and is easily bypassed by meeting one of the other requirements, such as anecdotes from personal clinical experience. Also, adherents to the philosophy of similars will probably accept almost any "clinical verification" that accompanies a proving. In addition to these means of having a drug accepted into the HPUS, HPCUS cites a clause that allows non-official drugs to be marketed providing "the manufacturer to produce a proving or sufficient clinical data for the FDA to make a determination as to whether the drug was in fact homeopathic."

Each state has further authority over who can gain licensure to prescribe homeopathic medicines that require prescriptions. Though a national license is available through the National Center for Homeopathy for anyone who meets its requirements (MDs, PAs, naturopathic physicians, etc…), states may limit the practice to MDs only or any selection at their discretion. The National Center for Homeopathy (NCH) reports that Minnesota became the first state to allow unlicensed practice of homeopathy in 2001. Also, Pennsylvania has not recognized the HPUS as an arbiter of legal drugs since 1972, and Texas since 1985.

The overwhelming evidence is that homeopathy is founded on extremely flawed theories, and maintained by believers who rely on anecdotes, subject to availability heuristics and confirmation and expectancy biases. Consumers are being scammed out of money, and many are not getting the effective treatments that they need because they think homeopathy is enough. Homeopathy should be banned by the government in order to protect consumers who do not have the education to protect themselves. Let us not value the profits of an industry over the welfare of our citizens.