Bigness: The Health Care Reform Criticism That is Always Made and Never Explained

March 29, 2010 at 10:48 PM 1 comment

Written by Lewis D. Eigen

With all the histrionics over Health Care Reform, throughout the entire process, it was easy to miss some of the very important issues of the debate. One, in particular, got entirely lost for a very interesting set of reasons. It was the Bigness issue. But there was hardly a Republican who did not complain about Bigness. It was mentioned hundreds of times each day throughout the more than a year of debate. How could it be lost?

It was “lost in plain site”. There are few citizens who do not know that one of the criticisms of the Health Care Reform Bill was that there would be a large, centralized, system running American Health Care instead of the smaller decentralized status quo. But very few people indeed can recall any discussion of WHY bigness would be bad–for our health delivery system and for the nation. That is what was missed. And that is where the Republican political tacticians could have done a much better job.. In their choice of tactics to defeat Health Care Reform, they failed to communicate and explain the, admittedly complex, issue of Bigness in American history and public policy. Had they done so, Health Reform probably still would still have passed, but it might look quite different from the present law. This article is the first of a series that discusses what the debate missed: Why bigness in our nation’s health system might not be very good.

Why Bigness Was Complained About But Never Explained

During the over one year of debate, the country was reminded hundreds of times each day by Republicans (and a few others) who warned of a Federal takeover of one-sixth of the economy. However if we analyze the Republican effort, it would seem that they had a de facto rule that all the Republicans obeyed:

“Always complain; never explain.”

One of the reasons that this issue was never joined and never explained is that the Republican Party, in addition to becoming much more conservative in the last two decades, has also become more anti-intellectual. The solid intellectual roots of Conservatism (Burke, Hyack, and Rand for example) have given way to a bizarre logic which has argued that since a majority of university people, media folk, entertainers and other intellectuals have statistically tended to be anti-conservative (some would say “liberal”), that Conservatives should not play in the home fields of the enemy. Instead, they opted for a type of populism where public passion and suspicion against “pointy headed intellectuals” tends to have been the tactic of choice. Actually the two parties have flip-flopped since the turn of the last century. Few except historians recall William Jennings Bryan running three times as the Democratic Party Presidential Candidate and railing against the “Godless Republicans” , the Ivy League and other Universities and others of the intellectual class. Some even argue that after the Democrats passed the Civil Rights Bill and the Republicans played the Southern Race card, the most anti-intellectual people in American society just switched parties and anti-intellectualism became Republican where it had been a bastion of the Democratic Party–particularly the South.

Another reason is that the Republicans have been relatively successful at continuous repetition of simplistic slogans and sound bytes–usually negative about what or who they are against. Some Democrats also used the approach, but they were no where near as skilled as the Republicans at this political technique. The Republicans reached the pinnacle of political effectiveness when an unknown Republican Candidate (Saxby Chambliss) for the U. S. Senate defeated incumbent Max Clealand be accusing Clealand of being unpatriotic and not supporting the military and the troops. Chambliss had this charge stick by repeating the mantra over and over again and never explaining or demonstrating where or how Cleland was unpatriotic. Clealand was a heroic, wounded, combat military veteran who returned from Vietnam without his two legs and one arm. His Republican “patriotic” opponent, had not only never served a single day in the military but had asked for and obtained two deferments from having to serve in Vietnam. John McCain, Chuck Hegel, Bob Dole and some other Republican stalwarts (and veterans) condemned the unethical technique, but success speaks more loudly than morality in politics. McCain was himself the victim of that kind of campaign in the South Carolina Primary for the Republican Presidential nomination. Health Care Reform was as important as a policy argument gets in America, and the Republican leadership went to their most effective political strategy. However as we will see, the technique that may be most effective for winning a short term political election for a seat in Congress or the State, is not necessarily effective arguing an issue that has been with us for decades and even after passage will be have to be dealt with many times over in the next decades. The law that Obama, Pelosi and other Democrats passed was the beginning of Health Care Reform, just like the Social Security Bill of 1936 was just the beginning of what the program has become over the years. Up to this point with respect to Health Care Reform, most of us never heard the details of Bigness argument–either side of it.

Instead of making a serious intellectual foray, the Republicans chose a classic political populist strategy of taking reality to an extreme and telling the public the consequences of the extreme. If there were not enough potentially negative extrapolations, a little creative fabrication was used as with the infamous “death panels.” However, there are some very important consequences and issues of size that were judged either not dramatic enough of too complicated. On these, there was only Republican silence, much to the chagrin of some of the “intellectual” conservatives and ironically, some “intellectual liberals” who are equally concerned about the issue of Bigness in our society in general and government in particular.

All eggs in the single basket

So what are the potential problems of Bigness? First, is what I call the “All eggs in the single basket” argument. It is a risk management issue of which most Americans have unfortunately become acutely aware as a result of the relatively few giant institutions that dominate banking and Wall Street making the same monolithic, terrible errors of judgment. Had the financial industry been disaggregated like women’s clothing or pizza, the companies who made the mistake would have gone under and those more sensible would have survived. As a result of the Bigness–in this case “too big to fail”–the few companies who made the errors, took almost everyone else down with them. For all the rest of us to then survive, we had to first rebuild the erring banking institutions and pay the very executives who “screwed up” the institutions that had to be bailed out. That was done at all our expense, so that the rest of us might have a chance to also recover. A majority–Democrats and Republican–members of Congress and the Executive Branch mostly all held their respective noses and voted for TARP. While the very people who made the errors were collecting their million dollar bonuses, 10% of the Americans who paid to bail the banks out were now themselves out of work and losing their homes and health insurance coverage.

Bigness Precludes Normal Solutions to Problems

Although there were many causes, it was the Bigness problem that precluded the normal, usual and more fair modes of dealing with the economic meltdown problem. Normally, our very system of decentralized government is a substantial hedge against problems of Bigness. Americans do not think about it much, but most foreigners are astounded to find that in Boston, for example, the Police who protect them and the public are not only not National police, but the Federal Government has almost nothing to say about policies and practices of the police department in Boston or almost anywhere else. And then the visitor to America finds that the laws in Boston can be quite different in New York, or Chicago. A crime in Pennsylvania may not be a crime in Arizona. In France, there is only one set of criminal laws and that is enforced by national police. (There are local police for traffic regulation and such, but only Federal police have the power of arrest.) The Frenchman looks at the FBI and discovers that it is smaller than one of the three shifts of the New York City Police Department.

American Historical Distrust of Government

The United States was created in an atmosphere of distrust not only of English government but Government in general. Americans did not want to put all their law enforcement eggs in a single basket, but the same was also true about every other facet of society including even the military. One of the hottest political issues was whether or not we should even have a standing army. If that was inadequate, the whole nation would be at risk. With 13 separate state militias, the feeling was, we would be safer.

Germany traditionally always had a strong national police. However, the Nazi’s in the 1930’s got control of the national police and that put them in good position to control the whole country. In reaction to WWII, today’s German Constitution not only vests the states with the law enforcement powers but specifically prohibits any national police at all. The Germans now keep their eggs distribted.

After the Eisenhower national highway system was introduced, most highway money has been federal, but it is not the feds who actually build the roads. States, counties and cities have that authority and responsibility. A number of years ago, all but one of the County Commissioners of Kentucky were indicted for corruption in road building contract letting and supervision. Substandard roads dotted Kentucky, but the roads of Iowa of Ohio were not negatively affected. If there were a single national authority that oversaw all road building in the country and 16 of its 17 members were taking bribes, the entire nation’s roads would be a mess instead of just Kentucky’s.

The FBI Crime Laboratory

One of the most dramatic examples of this Bigness issue is the FBI Crime Laboratory, which is though of by many as a national crime laboratory. Police in many jurisdictions send their evidence to the FBI for analysis and assistance. The FBI lab under J. Edgar Hoover had developed a wonderful reputation as the cutting edge of scientific analysis of evidence. However, there were two unfortunate realities. First, the lab was never as good as Hoover had touted it–nothing could be that good, and Hoover was one of the best promoters who ever served in a government agency. Second, since Hoover, the FBI lab has gone down hill to the point where it has been officially judged as seriously inadequate. It is perhaps incorrect to say that the FBI lab has declined; rather, it has stayed pretty much the same during the 50 years of the greatest growth in the development of basic science the world has known. The world discovered that they were way behind in understanding and use of laser and DNA technology, their vautned fingerprinting identification was quite unreliable, and their science of associating bite marks and bullet jackets with perpetrators was junk science, little better than coin flipping.* Cases all over the country are being re-litigated and called into question. Fortunately, most of the forensic analysis in the country was not done in the FBI lab despite the fact that there was no charge to the local police. But there had been efforts, when many thought the FBI lab was the gold standard of forensic science, to require that all police departments use the FBI lab. Fortunately, the effort failed.

A Big Health Mistake: Breakfast

In the field of health and medicine we have had many examples of putting too many eggs in the same basket–plus some very close calls. In the 1940s until relatively recently Americans were told that breakfast was the most important meal of the day, and it should ideally consist of two eggs (usually fried in butter of bacon fat) with bacon and toast. This health regimen was pushed not only by the Federal, State and Local Health Departments, but the Educational Authorities and the Federal and State Departments of Agriculture as well. Today, we know that such a regular breakfast is counter-indicated for almost all Americans. Cholesterol, polyunsaturated fats, excessive calories all are now seen in a totally different light. In this example, it was a lot easier to get the Departments of Health, the Schools and the Agriculture Departments to push the old “healthy breakfast” than it was to get all the physicians and nurses in the country to do so. It always takes longer for a decentralized system to adopt something new than a monolithic, centralized one. This is the argument in favor of Bigness and centralization. And there are many examples to justify that point of view.

When Lack of Bigness in Medicine Cost Lives

When penicillin was first used in medicine it was injected. The miracle drug was just that. However, a number of patients were allergic to the drug and went into anaphylactic shock. Many died–from the penicillin itself . Soon, oral tablets were developed. They generally had the same therapeutic effect in non-emergencies, but far fewer people had negative reactions. Pills were a big life-saver. But it took the American physicians, as a whole, over a decade to stop injecting penicillin and proscribe pills instead. There were then no Federal agencies that could mandate the pills, and malpractice cases were almost impossible for a patent to win as there was an unwritten rule that prohibited any doctor from testifying against another in a malpractice case. Then, the one institutional advantage of malpractice suits over and above justice for the victim–intimidating professionals to reform practices–was not even functional. There was no way to rapidly produce needed change and reform.

Polio Illustrates Both Sides of the Bigness Question

Perhaps the best example–one that illustrated both sides of the Bigness and control issue in health and medicine, involves polio. It was the development of the polio vaccine at a time when polio was by far the most feared disease in America. There were two scientists, Salk and Sabin, both working on the problem of developing such a vaccine but taking very different approaches. Salk was a young man who saw polio as the major enemy of America. Like the Nazis, it had to be defeated. Sabin was an established, older scientist, who was the leading virologist in the world. For him, this was a scientific effort, where passion and emotion should have no part. Sabin was trying to develop a vaccine that used dead polio cells, as any live cells might actually transmit polio and not protect against it. Salk however viewed Sabin’s method as being too slow. He counted the numbers of children and adults who would be paralyzed for life or die waiting for Sabin’s method to possibly bear fruit. He went the live virus route.

Soon Salk had a live vaccine the seemed to work with monkeys and did not transmit the disease. He tried it on himself and his own family and children. Then, he tried it with a couple of hundred children in an orphanage with the consent of the orphanage physician. In those days we had very small government in health. Salk needed no approval from FDA to clinically try a new vaccine. He did not have to follow any NIH ethical guidelines for informed consent. If he were so required, he would not have obtained it. Sabin, the much more influential scientist, tried to appeal to any who would listen that the Salk trials were irresponsible and immoral and ought to be stopped. But with no Big Government in health there was no one who had the authority to stop the effort. When the orphans fared well with the vaccine, Salk, with the financial and other assistance of the March of Dimes–a private charity, embarked in the largest clinical trial that had ever been attempted in the history of human medicine–over a quarter of a million children. No government agency approved the study; none was asked to do so; no approval was required. Nor was there any required approval by the AMA or even the University of Pittsburgh where Salk was doing the work. Several private laboratories were contracted with to make the vaccine to Salk’s specifications. Sabin was apoplectic claiming Salk was going to create a major polio epidemic. Many government authorities were terribly worried but there was no mechanism for government involvement. Before long the data was coming in: The vaccine was clearly protecting the children from polio and there were no cases of contracting the disease from the live virus vaccine. Salk was hailed the world over and for a while was the most famous person in the world of science–second only perhaps to Albert Einstein. The few politicians who had been persuaded by Sabin to try and slow down the effort were now desperately to get a photo opportunity with the savior of the children, Jonas Salk. Sabin was ignored as a hysteric.

Salk in the midst of his media celebrity received the terrible news. Some children who had been inoculated with his vaccine had none-the-less contracted polio. A few had died. What had gone wrong? Were the injections not being given correctly? Was there a new strain of polio developing? Salk left the media and buried himself in data. Soon he realized that the situation was worse than he feared. There were hundreds of dead children. Sabin explained that this was bound to happen with a live virus vaccine and he and others called on Salk and the March of Dimes to stop the clinical trials. Salk was ambivalent. Statistically, even with the hundreds of deaths, he and others could prove that there were far fewer children dying than if the normal proportion would get polio. Instead of being unusually effective, the vaccine was only partially reliable. Sabin went to the politicians and to the Department of Health Education and Welfare. He begged the Surgeon General, as the nation’s chief physician, to order the clinical tests stopped. The SG was ambivalent. This role had never before been filled by a Federal official–deciding who was right and who was wrong in a technical, scientific dispute. How could a Government do this? He didn’t understand the science himself and there were no others in the Federal Government who had relevant competency. As the data kept coming in, it appeared that Sabin was right in one respect. The children who contracted Polio did not get it from a new strain; nor were there any deviations in the injecting process. The disease was coming from the vaccine itself!

There has never been more pressure on a Surgeon General. Children were dying daily from a vaccine that was protecting many more. Over all, the combination saved more lives than it took, plus it eliminated the many cases of paralysis that polio brought. When the death rate appeared to be going up, for the first time in American History, a Federal Official, issued an order stopping all use of the new polio vaccine.

If American’s think that there was heat and anger over the 2010 Health Reform debate, it was nothing compared to the fighting over the Polio vaccine. Physicians were being bribed by anxious parents who realized that their children had better odds with the now illegal vaccine than without it. Other Americans insisted on a halt until it was better understood and the scientists know what was happening and why. But most Americans obeyed the law.

One problem was that it was not clear at all that the Surgeon General even had the authority to issue such an edict. Who was he to come between America’s doctor’s and their patients? Who had the right to decide about a child’s risk alternatives–the parents or the Federal Government? Health Car Reform damage was potential and unrealized. With the vaccine, children were dying every day.

Now it was Dr. Sabin who became something of an American hero. He had predicted the problem, warned everyone, but was not heeded. Now he was vindicated, and he argued that we should wait for a killed virus vaccine–the proper and safe kind–which was being developed in his laboratory. Salk and the March of Dimes were now on the defensive.

One difference between the killed and live virus vaccines is that the live virus vaccine could be reproduced and manufactured very quickly where the killed virus would take many more months if not years to develop and another year or so before it could be manufactured in sufficient numbers–remember, “sufficient” at the time meant EVERY child. Many more children would die if the ban on the Salk vaccine continued. He and supporters appealed to the Surgeon General. At the time, the SG was a distinguished physician. His research experience and knowledge was limited and now Salk and his supporters were making arguments that did not depend on medicine as practiced at the time but depended on the science of epidemiology and the mathematics of statistics. How was he to judge?

Luck intervened! To this day, no one knows who suggested the idea, but someone thought that perhaps all the dead children might have been inoculated with the same batch of virus–perhaps a faulty batch. That is not exactly what had happened, but it was close. One of the 4 manufacturing companies, trying to increase their profit margin, modified one of Salk’s required manufacturing procedures and some of the batches were actually being sent out with full strength live Polio virus. When that company’s vaccine was discounted, there were NO OTHER DEATHS. The fix was easy. However that was the scientific and manufacturing fix. The political remedy was not so easy. Sabin and many of his supporters insisted on maintaining the status quo and waiting for a killed virus vaccine–“do not take any chances with a proven killer.” Salk and his supporters wanted to save hundreds of thousands of lives and eliminate paralysis due to polio. Most members of Congress then, and many do today, have in the words of Sargent Shriver–the Peace Corps and Anti Poverty Agency founder–“have the courage of a wet noodle!” All of a sudden, members of Congress who had had so much to say to the press a few weeks earlier decided that it was a complex scientific matter that should be left to the Surgeon General who was then left “holding the bag.”

After considerable thought the SG reversed himself and withdrew the ban. The mass vaccinations continued and there was not another death. There is however an important post script to use this classic case to assist us in the issue of government control and influence over health in America. The Salk vaccine was expensive to deliver. A nurse or doctor had to do the injections. And no one knew, including Salk, how long the immunity would last. Early tests indicated that it might be only a few years. Sabin’s killed virus was designed for oral administration–no medical supervision required, Teachers could do this in schools. And there were good reasons to believe that the Sabin vaccine, when it was ready, would offer much longer protection. When the Sabin vaccine was finally ready a few years later, Salk was the first one to advocate switching, and it is the Sabin technique that we use today.

American Polio in Retrospect

Physicians, researchers, scientists, ethicists, philosophers, and politicians still study the Polio vaccine case. In a scientific sense, both Salk and Sabin were right. By today’s ethical standards both would have been wrong. Scholars of government point out that if the same science were developed today, hundreds of thousands if not millions of American children would be dead and paralyzed while our present FDA and NIH processes would be navigated. In the era–not very long ago–of very small government involvement in health, Jonas Salk and the March of Dimes had their human lab trials and clinical trials which involved over 1 million children and eliminated the most dreaded disease in America and most other industrialized countries. This was done in less time than it would take to prepare an application for and get approval for the first human trial. In the time if would take to get the clinical trial approved, the entire Salk research and been completed and other nations were already saving their children. Hospitals were telegraphed findings of the first inoculations, and agreed to participate and were themselves inoculation children in less than a week. Today, there is no hospital in America which could even get an opinion from their lawyer in a week much less go though their boards and committees to allow the experiment. Today, it would cost more money and time to get a parent’s informed consent than it did to pay for the vaccine, the transportation, the training, the professional labor–all that was needed to completely protect the child in Salk’s clinical trial all over the country.

Many would see this case study as a strong argument for very small government involvement. However, that is because to the serendipity of the scientific facts. Every scientist and medical research knows that we “lucked out” with polio. Not that there was any luck involved in the brilliant effort of Salk and also of Sabin. Where we lucked out was with the political structure of our health system. Consider the following possibility. The live virus vaccine that the one company let loose not only gave polio to many children, but also created a mutant strain of more virulent polio that not only was not protected by the vaccine and those children with that mutant strain became carriers. And the new strain was totally resistant to the drugs of the time which had a moderate effect. Consider that instead of a small minority of children who acquire polio being paralyzed, it was the majority who were paralyzed. And the new strain was more communicable and deadly as well. Polio is a virus and just as we have SARS and different forms of flu virus, the same thing would have happened. Under the Sabin research plan, that would probably have been caught before there was an epidemic or pandemic let loose. But Salk moved so quickly that just as he eliminated polio in America in a few year, who might have spread a pandemic of a more deadly disease in the same few years.

And what might have happened if after the deaths with the bad vaccine, the Surgeon General had left his ban in place. There would be no polio protection for another few years and there would be tens of thousands of children dead or in iron lungs–the best amelioration for severe paralytic cases.

Or to go back to the other side, suppose Sabin was right at the beginning and the SG issued his order, but the Federal Courts ruled that he did not have the authority to do so. It is the view of many attorneys, the SG did not have the authority at the time and may well have lost such a suit.

Clearly, if nothing else, the polio vaccine case, illustrates the complexity of the bigness issue with health in America. 40 years ago most people studying this issue would have tended to agree that with more government centralization and larger responsibility for health care would enable faster and more universal change when needed, either to stop a useless or dangerous procedure or enable a better process. The risk would be do we want all our eggs in the same basket. If there is a mistake might we be better off with smaller decentralization. Is the clear benefit in situations like penicillin pills worth the risk of our whole population in the same dangerous situation?

However, today, the speed issue assumption has also come under more scrutiny. Size, we have learned, does not always correlate with speed and efficiency. Indeed the correlation might be negative. The large organization usually takes longer to make a decision. If the organization is a governmental one, it almost certainly will average more time. If it is a democratic governmental organization, still longer. So here is a possible model for a new health practice. If the FDA or other Federal agency decides that a practice change is desirable, it will take 3 years for it to get the word out and have say 90% of all physicians using the new practice.

If the Federal Government were not involved and the change in practice were just made by one of the Medical Academies (eg American Academy of Pediatrics) , it might take 6 years to reach a 90% compliance rate. However, if after the research is done, it takes the Academy 1 year to reach a decision, the total time to reach 90% compliance would be 7 years.

However if your government agency would decide in the same 1 year period, they would produce the 90% compliance in only years 4 years–a much better result for the country. However, what if it tool the Federal Agency 5 years to reach a decision? It would then take a total of 8 years to reach the same compliance level. The Federal agency would be inferior to the private agency.

Five years seems an excessive time to reach a decision assuming all the research is in. But there are a number of areas that become so politicized that they have taken many years. Approving the “Morning After” contraceptive-abortion pill (depending on one’s point of view) took many years. There the issue was morally hot. But there are many decisions where a drug company might deliberately stall and slow down a process so that it gets more years of no competition for their drug from a generic drug that would compete with it.

So in considering Bigness in American health, we have to factor in not only the quality of the decision that would ensue, but the time that the Bigness in government might take for the public to derive the benefit. Beyond the risk of too many eggs in a single basket, we have to consider the quality of the decision that might be reached and the time that it might take to reach whatever decision is made. That is the next article: Time and Quality of Decisions of Government Regarding Health

 

End Notes:

* Tainting Evidence: Inside the Scandals at the FBI Crime Lab by John F. Kelly and Phillip K. Wearne, The Free Press, 1998

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Entry filed under: Health & Medicine, History, Politics. Tags: , , , , , , , , , , , , , , , , , , .

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1 Comment Add your own

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