AAPS News November 2012 - Guinea Pigs
Nov 1, 2012
Volume 68, no. 11 November 2012
Every medical student will probably hear a patient say that he doesn’t want to be a “guinea pig.” Many patients, however, are eager to be experimental subjects in a clinical trial of a new treatment that may help them, or simply to receive an “off label” treatment for which a formal trial is not available.
The difference is uncoerced informed consent—an absolute necessity. Additional requirements under the Nuremberg Code:
“The experiment should be so designed and based on the results of animal experimentation and knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.”
“No experiment should be conducted, where there is...a priori reason to believe that death or disabling injury will occur….”
“Proper preparations should be made...to protect the experimental subject against even remote possibilities of injury, disability, or death” (http://tinyurl.com/794hahy).
“Do no harm” is the general principle, and inevitable risks must be balanced against potential benefit. Beyond the formal experimental trial, we now face society-wide, compulsory impositions of medical, economic, or social measures without a control group, proper data analysis, or means to terminate the trial if harm is occurring. Serious harm may come to individuals, or eventually to the entire fabric of society.
In a laboratory that tests the strength of building materials, steadily increasing pressure is applied to a new type of concrete. It appears that nothing is happening—until the block suddenly shatters, notes Jim Powell. “My biggest worry is that all of the overstrained systems are interconnected” (GCOR, September 2012).
The basic principles of central planning and socialist redistribution have been widely tested, both abroad and in dozens of utopian communities in the U.S.—and fail, catastrophically.
Certain aspects, such as the effort beginning in 2009 with the HITECH Act to “reengineer” the way health information is collected, stored, and used, are “unprecedented.” Results so far are not very good. Clinicians frequently say, “I work for my EHR [electronic health record] instead of my EHR working for me.” EHR-caused errors can even threaten patient safety. Still, “over the long term, the success of HITECH seems inevitable, in part because its failure is unimaginable,” writes David Blumenthal (NEJM 12/15/11 and 12/22/11).
Accountable care organizations (ACOs) are a “guess,” acknowledges Donald Berwick. They “make sense”—“as an experiment” (JAMA 9/12/12). Gail Wilensky also notes that ACOs might have made more sense as a pilot project (NEJM 10/12/12).
ACOs are not just “1990s managed care redux,” writes Ezekiel Emanuel. This time, we might get care redesign instead of service denial, because of EHRs and “better data, guidelines, and metrics.” Then there’s the government’s strong incentive to succeed: “looming, significant price reductions have a way of focusing efforts and bringing people together” (JAMA 6/6/12).
Another mechanism essential for operation of the Affordable Care Act (ACA) is the national system of Health Insurance Exchanges. It is not only untested, but undefined. “We have gotten little bits of information here and there about how the federal exchange might operate,” said Linda Sheppard of the Kansas Insurance Dept. (http://tinyurl.com/9wyzz9m). According to PwC’s Health Research Institute, “state-based exchanges will create an irreversible shift in the insurance market that ultimately changes the way medical care is sold in the U.S.” [emphasis added] (http://tinyurl.com/8fycypf).
The single biggest failing of Obama health policy, writes John Goodman, is failure to recognize that medical care is a complex system, and that such systems cannot be accurately modeled (http://tinyurl.com/9ggfutq). Conceding that “components of complex systems interact nonlinearly over multiple scales and produce unexpected results,” Lewis Lipsitz still asserts that CMS is applying “simple rules” that will work (JAMA 7/18/12).
“Prevention,” Guidelines, and Mandates
“Prevention is the key to cost control and improving the quality of health care,” writes Ezekiel Emanuel (Science 9/21/12). “The approach begins with interventions that transform medical care: entrusting care to multidisciplinary teams that share a common electronic health record with a single care plan.”
This untested herd medicine approach is propounded just as we are learning the effects of the widespread, long-term use of a treatment included in many quality metrics: Beta-blockers, for which 200 million prescriptions were written in 2010 alone, may be less effective than thought, even useless (JAMA 10/3/12).
Favored methods may be applied population wide with minimal animal studies, unbeknownst to patients. The effect of vacuum aspiration abortion on outcome of future pregnancies has never been tested in animals. The effect of repeated influenza immunizations has never been tested in animals—yet health workers may be subjected to them on pain of losing their job. Gardasil’s long-term effect on animal fertility is unknown—despite attempts to mandate this vaccine in children.
Physicians can do harm—one patient at a time. Central planners can harm vast numbers simultaneously with treatment protocols, or the entire populace with “prevention” or social measures.
Just the Numbers, PleaseThe Fiscal Gap. The difference between projected spending and revenue for the U.S. (“unfunded liabilities”) is about $223 trillion. That is about the same as the capital markets of the entire world. Hyperinflation, which lasts months, not decades, is useless for dealing with 75-year, intergenerational promises (James Cook’s Market Update, Mid-October 2012).
The Budget Gap. Total federal revenue, $2.5 trillion; total spending, $3.8 trillion; mandatory spending (interest, Social Security, Medicare, TARP, pensions, etc.), $2.5 trillion. Funds for the military and all other government functions are borrowed (http://tinyurl.com/d626xv7).
Entitlement enrollees: 119 million. Full-time workers: public sector, 18 million, private sector 95 million.
Global “Prevention”In an issue devoted to “prevention” (Science 9/21/12), Richard Smith of the London School of Hygiene and Tropical Medicine writes that “effective prevention of noncommunicable diseases requires changes in how we live.” The solution calls for a global, “comprehensive and integrated economic approach.” He admits that we do not know which countries will be positively or negatively affected by the changes, or by how much.
Vaccine UpdatesAAPS receives many calls about mandatory flu vaccine (see action item). This policy is spreading despite an extensive 2010 Cochrane Review that concluded: “Influenza vaccines have a modest effect in reducing influenza symptoms and reducing working days lost. There is no evidence that they affect complications, such as pneumonia, or transmission” [emphasis added]. Moreover, “reliable information on influenza vaccine is thin but there is evidence of widespread manipulation of conclusions and spurious notoriety of the studies” (http://tinyurl.com/9d9ro9z).
AAPS fought against mandating vaccination against a sexually transmitted disease, human papillomavirus or HPV, for 11-year-old girls as a condition for school attendance (AAPS News, March 2007). The vaccine is now recommended for boys as well. Premature, irreversible ovarian failure, likely owing to Gardasil, has been reported in a 16-year-old Australian girl. Her menses, regular when she was vaccinated, became scant over the following 2 years and then stopped (BMJ Case Reports doi:10.1136/bcr-2012-006879). She declined to take hormonal contraceptives, which were used by many in the clinical trials and would have masked the problem. Rat fertility was not impaired, according to the package insert, at least not short-term, but ovaries were not examined.
Dale F. Webb, M.D., (1931-2012), R.I.P.Dale F. Webb, M.D., a thoracic and cardiovascular surgeon from Yuma, AZ, died suddenly during our annual meeting. In addition to his medical accomplishments, Dr. Webb stood for physicians’ rights. His successful litigation against the Arizona licensure board in 1999 improved the due process accorded to physicians (http://www.aapsonline.org/judicial/webb.htm).
AAPS 69th Annual MeetingIn San Diego, Juliette Madrigal-Dersch, M.D., of Austin, TX, was installed as President, and the following officers were elected:
President-elect: Thomas Kendall, M.D., Greenville, SC
Secretary: Lawrence Huntoon, M.D., Ph.D., Lake View, NY
Treasurer: W. Daniel Jordan, M.D., Atlanta, GA
Directors: Richard Amerling, M.D., New York, NY; Robert S. Emmons, M.D., Burlington, VT; Adam I. Harris, M.D., San Antonio, TX; G. Keith Smith, M.D., Oklahoma City, OK; and Melinda Woofter, M.D., Granville, OH.
Two resolutions were passed, on the CME monopoly and the Enrollee Hold Harmless Clause:
RESOLVED: that AAPS promote state legislation to end the ACCME/AMA (Accreditation Council for Continuing Medical Education/American Medical Association) monopoly on defining CME (continuing medical education) requirements for licensure.
RESOLVED: that AAPS educate employers, insurance subscribers, and physicians about the significance of the Enrollee Hold Harmless Clause.
Flashback: Medical PoliticsIn an article entitled “New England Journal, Selective Voice of Medicine,” Harry Schwartz of Columbia Univ. wrote that in addition to its medical articles, NEJM publishes many articles on “the economics and politics of medicine, an area in which randomized, double-blind experiments are rare, and where an author’s bias often shines out brightly.” Then-editor Arnold Relman had no patience with fee-for-service medicine. Canada and Britain were depicted as “virtual medical Utopias,” bearing no resemblance to the systems described in The Lancet and the BMJ. NEJM complained of high administrative costs in the U.S., but never about the reason for them: third-party payment (WSJ 3/17/1988).
U.S. Down to 18th in Economic FreedomOn world economic freedom rankings, the U.S. has plummeted from third place, behind Hong Kong and Singapore, in 2000, to 18th, falling 8 places in just the past year (http://tinyurl.com/8ldjq77). Free nations are more prosperous, and there are other benefits, as John Goodman points out. Life expectancy is 20 years longer in the top fifth compared with the bottom fifth, and infant mortality is ten times higher in the countries with the least freedom. Equality of incomes is unrelated to degree of freedom, but the poorest in free countries earn 8 times as much as the average in the least free (http://tinyurl.com/9yq8wan).
AAPS CalendarFeb 1, 2013. AAPS v TMB hearing; regional meeting, Austin, TX.
Sept 25-28, 2013. 70th annual meeting, Denver, CO.
ACTION OF THE MONTHMany hospitals are forcing medical staff to take annual influenza immunizations, or lose privileges. Please go to https://aaps.wufoo.com/forms/z7w6q9/ and take the survey.
Data Dredging: Green Jelly Beans Cause AcneData are collected by the petabyte (1018 bytes) today, information flow having increased at a nearly exponential pace, but we are still in the Dark Ages when trying to utilize it, writes Richard Byyny, M.D. Designing experiments to confirm or disprove hypotheses is “a process in many ways the antithesis of data mining” (Pharos, spring 2012).
Data mining lends itself to observational studies, which can easily lead to conclusions, with “95% confidence,” that green jelly beans (but not pink or mauve ones) are linked to acne, explain S. Stanley Young and Alan Karr (http://tinyurl.com/9qbfp2l).
Extremely costly regulations may be based on such fallacies.
EPA’s Human ExperimentsHaving imposed multi-billion dollar costs on American industry based on epidemiological evidence that, it claims, shows 200,000 deaths per year from air pollution, the U.S. Environmental Protection Agency (EPA) is exposing vulnerable patients to such pollutants at up to 21 times the regulatory level in an apparatus resembling a gas chamber.
PM2.5s, or particulate matter of diameter less than 2.5 microns, such as found in diesel exhaust, can lodge deep in the lungs. EPA has told Congress that there is no safe level, and that people can die within hours of exposure. Nonetheless, in 41 experiments, subjects were not told that they might die. They were only warned about minor airway irritation.
So far, the EPA has not found any results that might justify its cost:benefit calculations, but it did publish one case report of a woman who developed atrial fibrillation, likely coincidental.
The American Tradition Institute filed suit, alleging violation of ethical standards for human research. Alternately, EPA has been grossly misleading Congress (Washington Times 10/18/12).
A federal court denied, without prejudice, a request for a temporary restraining order on further experiments.
FDA Impedes Use of Patient’s Own Stem CellsIn U.S. v. Regenerative Sciences, the U.S. District Court for the District of Columbia upheld an injunction brought by the U.S. Food and Drug Administration (FDA) against the use of patients’ own stem cells to treat cartilage and joint injuries (see J Am Phys Surg, summer 2011), claiming that a “manufacturing process” is involved. The company plans to appeal (Nature 8/2/12).
The FDA has repeatedly blurred the line between manufacturing medical products and practicing medicine whenever new techniques emerge, write Scott Gottlieb and Coleen Klasmeier.
“If the FDA’s victory is upheld on appeal, then conceivably nothing done as part of clinical practice is beyond the agency’s reach.” Most science for using adult stem cells for regenerative medicine has moved to Britain, Israel, or Singapore (WSJ 8/8/12).
“Socialism is...not the pioneer of a better...world, but the spoiler of what thousands of years of civilization have created. It does not build; it destroys.
“A society that chooses between capitalism and socialism does not choose between two social systems; it chooses between social cooperation and the disintegration of society.”
Ludwig von Mises, Socialism
AAPS Fights to Uphold Sanctions on ProsecutorAAPS has filed an amicus brief asking the U.S. Supreme Court to grant certiorari in the case of Dr. Ali Shaygan. After Dr. Shaygan was acquitted of all 141 counts related to allegedly dispensing drugs outside the scope of his medical practice, the trial court awarded him $600,000 to partially cover his legal fees. The Eleventh Circuit Court of Appeals reversed the award.
If allowed to stand, the Court’s ruling removes even the modicum of protection against prosecutorial abuses provided by the Hyde Amendment, a loser-pays model that applies when a federal prosecution is “vexatious, frivolous, or in bad faith.”
AAPS describes the case as a “publicity-driven prosecution of a minority physician.” Instead of accepting the developing facts when its case fell apart, the prosecution “engag[ed] in extensive wrongdoing in an attempt to seek a preordained goal” of a mandatory 20-year prison term. In reprisal for the defendant’s exercise of his rights, the prosecution engaged in “charge stacking,” inflating the original 23 counts to an absurd 141.
As the mens rea requirement is vanishing in federal prosecutions, “the Hyde Amendment is the only external check against prosecutorial misconduct,” writes AAPS General Counsel Andrew Schlafly (http://tinyurl.com/92t8y8k).
On Aug 21, The New York Times also asked the Supreme Court to hear the case, “to reaffirm that a prosecutor’s duty is to seek justice, not victory at all costs.”
New Era of Anti-fraud and ComplianceProviders can expect a major increase in the number of Medicare and Medicaid claims audits as a result of ACA, according to Robert Freedman of Hayes Management Consulting. A compliance officer at a major academic medical center said that 80% of his time was spent defending against audits. But even if a provider wins an audit appeal, it could still face enforcement sanctions since the Office of the Inspector General (OIG) does not have to honor decisions of an administrative law judge. Short-stay claims are a particular risk because CMS refuses to supply clear guidance; it gets a greater impact on payment by keeping rules vague.
As part of a new compliance mandate, private health insurers are expected to do the government’s work on some fraud investigations. “If insurers do not do a good job of fighting fraud committed by others, the insurers may face their own government investigations, under the False Claims Act or otherwise,” states attorney Kirk J. Nahra (BNA’s HCFR 10/3/12).
EHR Fraud TargetedThe use of EHRs has been accompanied by higher charges, especially for evaluation and management (E/M) services. Hospitals and physicians generally say that the software enables more accurate documentation of services that were previously undercharged. The OIG will study “chart cloning” and overuse of cut-and-paste functions. The fraud squad is mailing a 54-question survey to hospitals that received a “meaningful use” bonus.
“Healthcare professionals grumble that they are being hassled for using the very technology that the federal government has encouraged them to adopt through incentive payments.” One survey recipient said, “It feels like whiplash” (MedScape10/25/12).
CorrespondenceDriving out Independent Physicians. The true goals of ObamaCare are being revealed. Health Savings Accounts are quietly being excluded from the Exchanges under development. The core infrastructure is the ACO—bundled payments with strict government controls. A few Councilors of MSSNY report having received notifications from their health plan carriers “cautioning them about referrals of patients to out-of-network physicians.”
A letter from the AMA to the Senate Finance Committee, co-signed by most state medical associations and virtually all specialty societies, basically endorses ACOs as the model they believe doctors should pursue as a replacement for the sustainable growth rate (SGR). Once the specter of the SGR is vanquished, doctors can “invest...in care re-design” (http://tinyurl.com/cqulfcy).
Lawrence R. Huntoon, M.D., Ph.D., Lake View, NY
Vichy Capitalists. The difference between crony and Vichy capitalists is that cronies try to keep quiet about their thieving relationship with their kept politicians. Vichy are cheerleaders for the winning side, even if Joe Stalin is running things. They angle for the federal contracts and profit at the expense of taxpayers. Here, for example, is an article on 11 ways to profit from health care reform (http://tinyurl.com/cprfb4w). I’m surprised it doesn’t call for the creation of a new medical specialty, euthanology, as the demand of these skills will be evident soon enough. It’s a growth industry! But making money doesn’t make it right.
G. Keith Smith, M.D., Oklahoma City, OK http://www.SurgeryCenterOK.com
Vaccinating the Herd. Doctors are now the property of the hospital. Their bodies may be poked and pricked, and if there are any objections, temporary suspension papers will be drawn up. Last time I asked, papers for objecting to influenza vaccination had not been drawn up yet.
Kenneth Christman, M.D., Dayton, OH
Death by Degrees. This essay from an ebook entitled Bad Education (http://tinyurl.com/8qlmk7y) relates to the history and fallacy of accreditation. In 605 A.D., the Chinese emperor Yang Guang established the world’s first meritocracy, based on a new system of imperial examinations. Test prep academies proliferated. As the number of degree-holders increased, exams were made more difficult. A man crazed by failure on the test gathered an army that began the bloody Taiping Rebellion.
The authors suggest that “systems of accreditation do not assess merit; merit is a fiction created by systems of accreditation.”
Ron Benbassat, M.D., Beverly Hills, CA http://www.changeboardrecert.com
A Set-up for Sham Peer Review. The Physicians’ Bulletin at my local hospital included an article by Dr. Lucian Leape of the Harvard School of Public Health highlighting why a “culture of disrespect is harmful…[and] its effect on public safety makes it a matter of national urgency…. Behaviors [including] a subtle pattern of disrespectful behavior can… undermine and inhibit compliance with and implementation of new practices [emphasis added]. Dr. Leape is telling hospital administrators to keep tightening the noose.
S. Clarke Smith, M.D., Anaheim, CA
Single Payer = No Self Pay. A single-payer system cannot allow individuals to pay for their own medical care. It goes against the envy-driven mentality behind the whole idea of universal care…. Getting treatment outside the system will be seen as bribing a public official. Socialism not only eventually kills the free market; the free market kills socialism. It is a fight to the death. One system or the other must prevail; they cannot both survive.
David J. Shedlock, caffeinatedthoughts.com
No Patient Protection. ObamaCare will homogenize the delivery of care, with “stakeholders” determining the who, what, when, where, and how care is provided. To date, the only thing that has stood between patients and stakeholder-mandated rationing of care has been the ethical compass of physicians. Now even that is under attack by those who view the Oath of Hippocrates as inconvenient or outmoded.
Robert Sewell, M.D., Southlake, TX http://www.spiritofhealthcare.com
Need Is Not a Claim. Without acceptance of this proposition, ethical reasoning is impossible. There are at least 5 billion people in the world who are less well off than most Americans. How could you cope with getting up in the morning if all those people had a claim on your daily activities? If helping others is a public good, as in the proverbial case of the lighthouse, we need ethical principles to guide coercive collective action. One might be that the coercive cost to each citizen is less than the resulting benefit (http://tinyurl.com/8mu3k9p).
John Goodman, Ph.D., National Center for Policy Analysis http://healthblog.ncpa.org/
Enough Carrot, Time for the Big Stick. CMS will be auditing up to 20% of physicians who received an incentive payment to participate in the Medicare electronic health records program. Participants will need to show paper or electronic documentation that supports their attestation of meeting the meaningful use requirements and that they used a certified EHR system.
Joseph M. Scherzer, M.D., Scottsdale, AZ