Volume 67, no. 7 July 2011
The Accountable Care Act (ACA) expands and rigidifies the trend to practice medicine by the numbers. Drug ads exhort patients to “know their numbers.” With interoperable electronic health records (EHRs), insurers and government agencies will know them also. Health information technology (HIT) will enable the czars to evaluate compliance with various disparity and quality metrics, and to calculate permitted payments. It will also provide the data set for “comparative effectiveness research” (CER).
Like the Fourth Book of Moses, the new ACA bible is full of enumerations, categorizations, rules, and penalties. ACA, however, does not lead to a Promised Land or to the fulfillment of a covenant, but rather to nowhere (utopia) and to the destruction of the patient-physician relationship and existing medical institutions. If ACA is not stopped, we will not be wandering in the wilderness for a mere 40 years. The Soviet Union took 75 years to fall, and the society destroyed by Communism may never recover.
Stats.con
Government policy is justified by citing endless statistics. Yet the numbers are not necessarily the key to knowledge, as British physician and clinical researcher James Penston shows in his book Stats.con (see review in J Am Phys Surg, summer 2011). George Orwell warned repeatedly that statistics are an instrument of the state to control our thoughts and actions. In Orwell’s shadow world, truth and falsity were alien concepts; figures were manipulated, distorted, or even fabricated to produce a view favorable to those in power. And in the real world, Winston Churchill cynically remarked: “When I call for statistics on infant mortality, what I want is proof that fewer babies died when I was Prime Minister than when anyone else was Prime Minister.”
Politics aside, Penston states that notions of truth and falsity have no place in statistics. When medical science fell under the spell of statistics shortly after the end of World War II, the revolution in thinking went mostly unnoticed. As statistics triumphed, physicians’ freedom became severely restricted; British physicians function under the diktat of government agencies and the Royal Colleges. Yet, Penston writes, “any impartial judge would find it hard to conclude that statistics-based medical research is anything other than a failure.” It has not discovered many causes of disease, or produced many drugs that have materially altered patients’ lives.
Penston dares to challenge the sanctity of the randomized controlled trial (RCT). Correlation doesn’t prove causality, he notes—and neither does a statistically significant difference between groups in an RCT. Large trials are needed because expected benefits are so small—and because researchers have such a limited understanding of the mechanisms of drug action that they cannot predict which individuals are most likely to benefit. Statistical significance has nothing to do with clinical importance.
The “frequentist” approach has insoluble problems, especially when trying to apply results for the “average” population to individual patients, Penston believes—even if researchers are totally honest, a dubious assumption. There is no reliable way to confirm the results of individual RCTs.
The RCT resembles science, but there are fundamental differences. “Bacon and Galileo must be turning in their graves.” With science, “causal relationships are visible, palpable. There’s no need for any debate.” But then, “statistics arrives with data as malleable as warm wax, to be shaped into anything that the powerful and influential want.” It fits in well with the new authoritarianism, which requires “constant surveillance to ensure that [professionals] are acting in line with the current orthodoxy.”
Penston deconstructs the RCT gold standard. The problems with data mining—CER—are far worse.
Forensic Statistics
While claims from RCTs fail to replicate about 20% of the time, the problem with epidemiology is so bad as to constitute a crisis, writes S. Stanley Young (“Everything Is Dangerous: a Controversy,” National Institute of Statistical Sciences, June 2008, www.niss.org). Fewer than 20% of nonrandomized trials replicate; i.e. 80%-90% of epidemiologists’ claims are false.
More than $1 billion in grant/tax money flows to institutions with reproducibility problems, Young states. A fundamental flaw in their methodology is to ask multiple, often hundreds to thousands of questions, of the same data set. It’s like playing “maverick solitaire”: given 25 randomly selected cards from a deck of 52 playing cards, the probability of being able to arrange them into 5 “pat hands” (e.g. a full house) is 98%.
Since data miners are good at concealing their footsteps, critics need full access to the raw data and the code used for the statistical analysis—often not forthcoming.
The EHR software that is supposed to support all this “research” and to guide medical treatment also needs a forensic evaluation, writes Scot Silverstein, M.D., of Drexel University (see http://hcrenewal.blogspot.com). He cites such an evaluation of the Cerner FirstNet system used in New South Wales, Australia, done by Prof. Jon Patrick. The authoritarian implementation processes of the governmental HIT “support” staff were familiar to Silverstein, such as disenfranchising the clinical staff and failing to acknowledge the validity of complaints.
“Healthcare reform” demands acceptance because it claims to be based on science. But then, so did Communism.
A Comparison of Two NJ Charities
The following figures were compiled from IRS 990 forms by AAPS president-elect Alieta Eck, M.D., for Plainfield Health Center, a federally qualified health clinic (FQHC), in 2008, and Zarephath Health Center, a private charity , in 2009:
Racial Disparity
To document achievement of the goal of eliminating “healthcare disparities,” the race/ethnicity of the patient must be determined. In a study of race as a risk factor for neonatal hyperbilirubinemia, the race documented in the medical record frequently did not match self-reported race. Of 145 mothers classified as white, only 64% self-reported as white: 13% said they were Hispanic, 3% Middle Eastern, and 11% of two or more races. Of 427 classified as black, only 70% self-reported as black, with 23% describing themselves as mixed race. For Asian and Middle Eastern categories, there was only 35% and 50% agreement, respectively (Pediatrics 2006;117:1618-1625).
Transforming Medical Education
Physicians must stop viewing themselves as “nonintegrated, dedicated artisans” and become “leaders of a system that values wise standardization, meaningful measurement, and respectful reporting.” The curriculum must include health disparities, CER, HIT, and models of management and control (NEJM 2/24/11).
The Prophets: Hsaio, Gruber, Dartmouth
Physicians are definitely outside the tent, in the view of Dr. Atul Gawande: They need to accommodate to being members of the pit crew (“Cowboys and Pit Crews,” New Yorker 5/26/11). The perennial experts are designing the system in which they must work. The newly enacted Vermont single-payer plan has two principal authors. William Hsaio of Harvard previously did untold damage to Medicare with his Resource-based Relative Value Scale, and Jonathan Gruber of MIT was a key designer of RomneyCare.
The primary force behind the Obama Administration’s dedication to accountable care organizations (ACOs), Elliott Fisher, is an author of the Dartmouth Health Atlas, which shows geographic variation in medical treatment. The latest map focuses on end-of-life care for people with chronic illnesses.
“The authors do their usual job of putting vast amounts of data into very colorful maps, which add up to absolutely no understanding of what is going on,” writes Greg Scandlen. They assume that adjusting for age, race, sex, and illness eliminates any population differences that might explain, say, the proportion of people who die in hospital rather than at home. Might there be other differences between Ogden, UT, and New York City, he asks? Family structure, religion, home ownership, crime rate? Like most health policy researchers, Scandlen writes, Fisher et al. “view patients as slabs of flesh to be pushed around rather than as…adult human beings” (http://healthblog.ncpa.org 4/26/11).
The new system in Medicaid, likely a model for all of medicine, will make primary care physicians on the pit crew interchangeable with advanced practice nurses, who will be paid the same (transcript of public meeting of Medicaid and CHIP Payment and Access Commission [MEDPAC] 5/19/11).
New AMA CEO Has Ties to White House
The AMA’s new CEO James Madara, M.D., an academic pathologist, has not been a highly visible member of the AMA. Formerly CEO of the University of Chicago Medical Center, he worked with First Lady Michelle Obama and senior White House advisor Valerie Jarrett before resigning amid controversy. His Urban Health Initiative, which re-directed less severely ill patients to community hospitals and formed new affiliations with federally qualified community health centers, was criticized by doctors in the hospital and sparked calls for congressional hearings. He then served as senior advisor with a health consulting firm started by former HHS Secretary Michael Leavitt (HealthPolicyNewsStand 6/2/11 and AMA press release). He’s the “perfect fit for those who want a patient-system relationship,” writes David McKalip.
AAPS Calendar
Aug. 6. Doctors’ Town Hall, Nashville, TN.
Sep 28-Oct 1. 68th annual meeting, Atlanta, GA.
Oct 4-6, 2012. 69th annual meeting, San Diego , CA
ACTION OF THE MONTH
Does your state have a chapter? Check at http://www.aapsonline.org.
If not, you could be the state coordinator!
Contact Jeremy Snavely, [email protected].
ACA Takes and Discriminates, AAPS Argues
AAPS filed an amicus brief in the U.S. Circuit Court of Appeals for the D.C. Circuit in another case challenging the Patient Protection and Affordable Care Act, Seven-Sky v. Holder (No. 11-5047). AAPS v. Sebelius is still pending in the D.C. District Court.
AAPS asks the Court to consider the Fifth Amendment’s Takings Clause, as well as its clause protecting against federal discrimination: “No state shall make or enforce any law which shall…deny to any person within its jurisdiction the equal protection of the laws.”
The ACA’s insurance mandates and penalties constitute unlawful takings, AAPS argues, by compelling the healthy to subsidize the unhealthy through higher insurance premiums, so that the unhealthy may enjoy lower insurance rates. It is a long-accepted principle that “the sovereign may not take the property of A for the sole purpose of transferring it to another private party B, even though A is paid just compensation.” Moreover, the idea that the ACA provides something valuable is simply false for self-insured persons or those with catastrophic insurance.
The Act is “either per se unconstitutional for taking private property for private use, or it is unconstitutional for taking property for public use without compensation.”
The mandates violate the equal-protection principle by imposing greater burdens on those who choose to self-insure or maintain high-deductible catastrophic insurance. The government argues that its own decision to require emergency rooms to treat the public regardless of ability to pay somehow justifies acting against those private citizens who will not burden the federal fisc. Here it “seeks to redress an entirely self-inflicted injury.”
It is precisely to avoid equal-protection arguments and injuries that states typically allow alternatives—such as posting a bond—if they condition the privilege of a driver’s license on maintaining minimum insurance for third-party liability.
How Far We’ve Come
The “reform” scheme is to create a “market” structure in which “no one can ever again be turned down for health insurance,” writes Mark A. Hall, J.D. But something “went wrong on the way to the courthouse” (NEJM 1/27/11). Hall notes that reverting to the original meaning of the Commerce Clause “would entail reversing generations of established precedent and undoing massive and firmly ensconced regulatory regimes”—such as the FDA. It would be much more palatable to conservative justices simply to stop the Commerce Clause from expanding further.
Still, “the acknowledged undesirability, if not impossibility, of banning medical underwriting without a requirement to purchase insurance is the government’s strongest defense,” he writes. Some rationale other than the Commerce Clause might be found. After all, “no one even asserts that economic liberties are constitutionally guaranteed.” All we need is something that is merely “convenient” or “rationally related” to a constitutional power.
Jefferson Davis, the only president of the Confederate States of America, was imprisoned 1865-1867 and indicted for treason in 1866. The case, however, was dropped, and he was denied the trial he demanded to argue the constitutionality of the South’s actions in 1860-1861. In 1867, Salmon P. Chase, Chief Justice of the U.S. Supreme Court, wrote: “If you bring these leaders to trial, it will condemn the North, for by the Constitution, secession is not a rebellion. His [Jefferson Davis’s] capture was a mistake. His trial will be a greater one. We cannot convict him of treason.”
Government Transparency
Rep. Michael Burgess, M.D. (R-TX), requested records pertaining to a May 2009 agreement in which a group of industries promised to trim $2 trillion from healthcare spending. White House counsel Bob Bauer claimed executive privilege. The Administration then claimed not to have any records pertaining to major aspects of the creation of the law.
“Two trillion dollars, and no one even jotted down a note on the back of an envelope?” Burgess asked.
And a number of floppy disks turned over by key members of the Clinton Task Force on Health Care Reform were blank.
Look up “transparency” in your Newspeak dictionary.
Biotech Firms Warned to Shut Up
Scott Harkonen, former CEO of InterMune, has been sentenced by a federal judge to 6 months of home confinement and a $20,000 fine—for issuing a press release suggesting that an off-label use of an approved drug might be useful in some patients. Most sales of Actimmune, approved for chronic granulomatous disease, are for treating idiopathic pulmonary fibrosis. A large trial seeking approval for this indication failed to show that the drug slowed progression, but patients with mild to moderate forms seemed to live longer. Of course, more rigorous trials are needed.
Much softer statistical standards will, however, be used in government-funded CER to inform federal treatment guidelines and determine Medicare payment policies. And at least $100 million will be spent to publicize results (Wall St J 6/6/11).
Harkonen is appealing on First Amendment grounds.
Lawsuit Immunity
In Brueswitz v. Wyeth, the U.S. Supreme Court ruled that vaccine makers are immune from lawsuits charging that the design of a vaccine is defective.
In 1992, Hannah Brueswitz suffered seizures after her third dose of Tri-Immunol, containing whole-cell pertussis vaccine, followed by a residual seizure disorder and developmental disability. Since this effect had recently been removed from the table of injuries compensable under the National Childhood Vaccine Injury Act (NCVIA), the family sued the manufacturer for not developing a safer vaccine. At that time, company representatives had concluded that the acellular pertussis component, now standard in DTaP, was “not worth it for the total market.” Wyeth removed Tri-Immunol from the market in 1998.
On the basis that they are “unavoidably unsafe products,” legal experts agree that vaccines should be exempted from strict liability. However, a decision for the plaintiff in Brueswitz could have, according to Pfizer and other vaccine manufacturers, opened the door to a flood of lawsuits and jeopardized the supply of vaccines. Notably, the FDA does not usually consider whether a safer design exists in deciding whether to keep a product on the market (NEJM 4/21/11; Reuters 2/22/11).
Correspondence
A New Gag Rule Equivalent. A physician contacted me about receiving a report in which he was labeled an “outlier” based on patient surveys. Mental health counseling was recommended to make him more “affable.” He suspects that an HMO conducted the survey but does not know the questions asked, nor the criteria for defining an “outlier.” This could be a method for HMOs to evade accusations of illegal gag rules as they obstruct patients from obtaining timely care. Patients dissatisfied with the procedures may take out their frustrations on their physicians in satisfaction surveys. Suppose the doctor tells an angry patient that his frustration is because of HMO procedure, and he can do nothing about it. If the patient complains, he may be asked to fill out a survey on his physician’s care. The negative data may be used to punish the physician; being forced to have counseling will have very negative consequences and will have to be disclosed forever. Physicians will learn to be “affable”: they should always say nice things about the HMO, never tell the truth about delays or denials of necessary care, and wear a silly smile at all times.
Lawrence R. Huntoon, M.D., Ph.D., Lake View, NY
AMA Membership. In December 2010, the AMA had 215,854 members, of whom 21.9% were students and 14.4% residents. That means 137,499 practicing physician members. In the U.S., there are 1,144,282 physicians and medical students; 942,999 practicing physicians after subtracting the 8% who are medical students and 9.6% who are residents. Thus, 14.6% of practicing physicians were AMA members in 2010. The loss of practicing physician members has accelerated. The drop from 21.8% to 17.4%, roughly a 20% loss, took 4 years. The further drop to 16.4%, a 16% loss, took only 2 years.
Stuart Gitlow, M.D., Woonsocket, RI
The Role of Patients. Harvard economist David Cutler, who played a key role in crafting “healthcare reform,” and who thinks ACA could “turn out to be the most successful health care legislation ever,” wrote an article in which he used the word “patient” exactly four times (“The Simple Economics of Health Reform,” The Economists’ Voice, Berkeley Electronic Press). There’s “patient information,” which the government gets; “patient outreach,” in which patients are told what to do; “follow-up care for patients,” which capitated payments are supposed to cover but won’t; and “bundling payments for patients,” rather than letting patients decide what to buy on their own. In short, these “patients” are little Lego people that Plan architects get to push around.
Linda Gorman, Ph.D., Independence Institute, Golden, CO
Crashing Insurance. With insurance, we have risk on one side and an bet on the other side that the risk will be covered by spreading it around over people with comparable risk. Actuaries have a highly developed math for doing this. Not taking pre-existing conditions into account is stupid raised to some higher power. To offload that stupidity onto the market and say you have done no harm is idiotic. It is saying I have the power to do anything so I will just do it.
A politically incorrect story: early in the AIDS epidemic, one of a gay couple, knowing he had a death sentence, would load up on life insurance. Actuaries noticed an increase in young males dying with new, massive insurance policies. Insurance companies went to the California insurance commissioner saying, if we are required to pay, we are bankrupt, and all the people who are not gaming the system will be left high and dry. A system a lot of people depended upon would die. The commissioner ruled that the condition was pre-existing, and insurers did not have to pay.
Architects of ACA want to crash medical insurance in the U.S. so only the government is left to insure. The issue is government versus private contracts. Actually rather simple.
S. Stanley Young, Ph.D., Natl Institute of Statistical Sciences
About Those “Benefits.” While defenders of ACA chatter endlessly about people who are uninsured because of a pre-existing (it turns out there are only 12,500 of them), half of the newly insured (16 million of them) will be forced into Medicaid, where they will effectively be denied the right to buy any private insurance—whether they have a pre-existing or not. And while ACA defenders boast about the removal of annual and life-time private insurance benefits, few notice that we’ll be putting 16 million people into plans that routinely limit benefits—regardless of pre-enrollment promises.
John Goodman, Ph.D., National Center for Policy Analysis
The Problem Is Not Luddite Docs. Complaints about health information technology (HIT) are not from old dogs not wanting to learn new tricks. If Boeing produced aircraft with malfunctioning engines, broken seats, defective flaps, tires that blew on landing, and rust right out of the factory, one might suspect that the development and manufacturing environment might be substantially problematic. For years, I have suspected chaos in the HIT software engineering process, with inadequate attention to rigor, fine detail, resilience engineering, and other practices essential in the development of mission critical technology of any type.
Errors are likely to be spasmodic (unpredictable), and the patient who hits the mis-processing jackpot could die.
Scot Silverstein, M.D., Lansdale, PA
