Frederick Banting discovered insulin in 1921 and didn’t want to profit off of such a life-saving drug. Fast forward to 2019, and the price of insulin continues to increase year over year. Why is that?
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Reforming U.S. Healthcare: Even Research Statistics Are Rigged
To paraphrase Elizabeth Barrett Browning, How do I rig thee? Let me count the ways.
Even research statistics are all too often rigged, according to a commentary in this month’s Journal of the A.M.A. These rigged statistics are being applied to clinical studies of new drugs, devices, and treatments to put them just far enough over the line of “significance” to win Food and Drug Administration approval.
And to win big dollar profits for research companies and the researchers themselves – my claim, not the Journal’s.
This goes beyond what Mark Twain called “lies, damned lies, and statistics.” Twain was referring to “spinning” legitimate statistics to show results in a favorable light.
But Stanford’s John P. A. Ioannidis MD, ScD, calls out statisticians-for-hire for actually cherry-picking, distorting, and manipulating post-hoc the statistical analyses themselves in scientific publications, in the service of Big Pharma.
Ioannidis’s Observations
Here are some of his observations:
- Some policy makers have an exaggerated sense of certainty about research results based simply of a P-value less than 0.05 (P-value is a statistical construct that estimates the probability that an observed difference between the study group and control group is a true difference rather than a coincidental difference caused by random factors alone.)
- Some policy makers hype results based on statistical differences that are technically correct but weak at best
- Some policy makers focus on “statistical significance” only and fail to consider “clinical significance” as well as other practical considerations when interpreting study results
- “Some fields that claim to work with large, actionable effects (eg, nutritional epidemiology) may simply have larger, uncontrolled biases.” That is, just because a study appears to have a robust statistical effect does not mean the conclusion is iron-clad. An observed difference might have another hidden explanation that contradicts the study conclusion.
- “Absent pre-specified rules, most research designs and analyses have enough leeway to manipulate the data and hack the results to claim important signals.”
- “Studies have shown that unless an analysis is prespecified, analytical choice (eg, different adjustments for covariates in nonrandomized studies) may allow obtaining a wide range of results.”
- “In a recent survey completed by 390 consulting statisticians, a large percentage perceived that they had received inappropriate requests from investigators to analyze data in ways that obtain desirable results.”
- “Passing the threshold of “statistical significance” … such as P < .05 is typically too easy…”
- “Clinical, monetary, and other considerations may often have more importance than statistical findings.”
Ioannidis’s Solution
Dr. Ioannidis’s offers a solution to keep honest statisticians honest: Require researchers to post in advance, such as at ClinicalTrials.gov, not only the overall research design but also detailed descriptions of
- numbers of subjects to be studied (since cohort size affects the “power” of the statistical analysis)
- which statistical methodologies will be used
- advance definition of subgroups designated for separate analysis
- specification of the threshold for statistical significance (choice of P value)
- criteria for altering statistical methods in the face of unexpected problems occurring during the course of a study
- plans to post raw data for all to see and analyze.
Comment:
Prestigious medical journals could adopt Ioannidis’s solutions without waiting for comprehensive reform of the whole health system. But the Journal’s surfacing of issues around abuse of research statistics illustrates the extent to which that system has fallen under the pall of profits, the depth to which the system has been rigged, and the degree to which Hippocratically-pledged professionals have been coopted. And this means that the full weight of our society, government and nation will be needed to fix it.
Take Action
Now, take action.
Ex-MetroHealth COO sentenced to 15 years for defrauding hospital
The former chief operating officer of Cleveland-based MetroHealth System was sentenced to more than 15 years in prison for his role in a conspiracy to defraud the health system through a series of bribes and kickbacks, according to the Department of Justice.
Five things to know:
1. The sentencing came after former COO Edward Hills, DDS, and three co-defendants — all dentists at MetroHealth — were found guilty of criminal charges in July 2018. The four men were indicted for the crimes in October 2016.
2. According to court documents presented by the Justice Department during the trial, Dr. Hills and two of his co-defendants engaged in a racketeering conspiracy from 2008 through 2016 that involved a series of bribes, witness tampering and other crimes.
3. Federal prosecutors alleged Dr. Hills solicited cash, checks and expensive gifts from the two co-defendants beginning in 2009, and in return took actions on their behalf allowing them to operate their individual private dental clinics during regular business hours while receiving full-time salaries from MetroHealth.
4. Dr. Hills, who also served as interim president and CEO of MetroHealth from December 2012 through July 2013, allowed the co-defendants to hire MetroHealth dental residents to work at their private clinics during regular business hours and did not require them to pay wages or salaries to residents. He allowed the three individuals and others to solicit bribes from prospective dental school residents, which amounted to at least $75,000 between 2008 and 2014.
5. Dr. Hills’ co-defendants are scheduled to be sentenced later this month.
Cartoon – Problem with Team Players
Cartoon – A Good Idea?
Cartoon – Word of Mouth Marketing
Cartoon – Blood Testing
NC hospital system tries another megamerger
Atrium Health struck out a year ago when it attempted to merge with in-state rival UNC Health Care, Bob reports. Now, the hospital system has inked a new deal to combine with Wake Forest Baptist Health, which is 90 minutes away from its headquarters.
Why it matters: Research overwhelmingly shows these kinds of regional hospital mergers lead to higher health care prices (and, consequently, premiums) because providers gain negotiating leverage and make it harder for health insurers to exclude them from networks.
Between the lines: The primary hook that Atrium and Wake Forest are selling is that they would build a new medical school in Charlotte. Because who could be against more doctors and research?
- The organizations didn’t mention how, or if, they would try to keep costs and prices down.
- The combined system would have almost $10 billion of revenue, which is roughly the size of Boston Scientific.
How “Medicare for All” changes health care financing
Sen. Bernie Sanders’ “Medicare for All” plan would drastically change not only how health care is paid for, but who ultimately pays for it.
- While the wealthy and the poor usually pay the same premium for today’s employer-based insurance, Sanders’ plan would beef up insurance coverage for everyone and pay for it by increasing taxes on the wealthy.
Driving the news: As part of yesterday’s rollout, Sanders released a white paper with several “options” on how to raise the additional revenue it would take for the government to pay for everyone’s health care without any premiums or out-of-pocket costs.
- While most people’s taxes would go up, the wealthy would pay for a much greater portion of the nation’s health care system than they currently do.
- A 4% “income-based premium” for workers who make more than $29,000 and a 7.5% “income-based premium” on employers (exempting the first $2 million in payroll) are two of the financing options. Most economists assume that the employer tax would get passed onto employees through lost wages.
- Other options include increasing the individual tax rate on high earners, taxing “unearned” income at the same rate as earned, and establishing a wealth tax.
What they’re saying: Even if all of these payment options were implemented, they still wouldn’t cover the total cost of Sanders’ plan, said the Committee for a Responsible Federal Budget’s Marc Goldwein.
- He said there could also be unintended consequences of such high taxes on the wealthy, such as discouraging investment.
The bottom line: “More progressive tax-based financing of health care is a feature, not a bug, of Medicare for all,” the Kaiser Family Foundation’s Larry Levitt said.
- “The idea of financing health care through taxes rather than premiums and out-of-pocket costs would be fairer in some people’s minds, but also disruptive,” he said.
HENRY KOTULA 