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Per Congressional mandate, the FDA has submitted a report to Congress on the state of the CBD marketplace.

The report outlines studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years. As predicted in my testimony at the FDA’s June 2019 Part 15 hearing, there is significant inconsistencies between cannabinoids concentrations that are listed on labels and what the products actually contain.  Some relevant verbatims from the FDA report:

“FDA recognizes the significant public interest in CBD products,” the agency wrote. “However, there are many questions about the characteristics of currently marketed CBD products because the Agency lacks significant information on what CBD-containing products are on the market and there are little data available on those products themselves.”

“FDA believes that understanding the characteristics of marketed CBD products is critical to making informed decisions about how best to protect public health in the current marketplace."

“Of the 102 products that indicated a specific amount of CBD, 18 products (18%) contained less than 80 percent of the amount of CBD indicated, 46 products (45 percent) contained CBD within 20 percent of the amount indicated, and 38 products (37 percent) contained more than 120 percent of the amount of CBD indicated.”

Only one of 133 samples had potentially hazardous materials.

Well – that’s reassuring.

FDA is undertaking a more extensive CBD product testing effort that will involve using “a sampling methodology to create a representative, random sample of the current CBD product marketplace.”

“The Agency is purchasing data on brands, product categories, and distribution channels for CBD products.” The FDA is also “in the process of developing its own comprehensive list of brands operating in the CBD market space by assembling data from targeted internet searches and analytics. FDA intends to leverage both data sets to randomly sample products across brands, product categories, and distribution channels, while favoring products with a higher market share.”

The sampling is expected to cover cannabis tinctures, oils, extracts, capsules, powders, waters and other beverages, food items, cosmetics, personal lubricants, tampons, vape cartridges and products sold for pets.

It is unlikely the FDA’s bark will be worse than its bite.

Per the FDA, “Together, this information will provide the Agency with a better understanding of product characteristics in the current CBD marketplace and will help protect and promote public health.”
 
A new study out of the Bay State regarding the importance of copay assistance programs and the downside of accumulators. 

The Massachusetts Health Policy Commission (HPC) examined copay accumulators and the use and impact of prescription drug coupons in Massachusetts.  (The Massachusetts HPC is an independent state agency charged with monitoring health care spending growth in Massachusetts and providing data-driven policy recommendations regarding health care delivery and payment system reform.)
 
Of note, the study finds that, “Continued growth in high deductible plan enrollment, coupled with increasing drug prices, suggests that patient affordability challenges will only increase. Eliminating the availability of coupons at this time – without substantial protections for patient affordability – would likely create serious challenges for many patients in the Commonwealth.” 
 
As to copay accumulators, “they are unlikely to encourage patients to use lower cost alternatives. Copay accumulators shift costs from the payer to the manufacturer and patient, potentially resulting in lower premiums. However, copay accumulators may preserve the affordability challenges that patients originally faced in their plan design, which could lead to lower access and adherence. In addition, these programs may increase administrative complexity for payers and PBMs and add confusion to patients navigating an increasingly complicated health care system.”
 
Facts are stubborn things; and whatever may be our wishes, our inclinations, or the dictates of our passion, they cannot alter the state of facts and evidence – John Adams
 

The QALY is Discriminatory

  • 06.23.2020
  • Robert Goldberg

Real Clear Health

Should Our Health Care System Place a Dollar Value on Lives?
By Charles Camosy & Robert Goldberg
June 22, 2020
The COVID-19 pandemic is proving to be a catalyst for a long-overdue discussion in this country about our health care system and whether some lives should be considered more valuable than others. Are some Americans comparably more expendable and less deserving of measures to save or extend their lives?

Earlier this month, Oklahoma provided the nation what we believe is the only just answer: it banned state agencies from deciding who gets treatments based upon a bureaucratic measure of the value of life called a QALY.


Those who haven’t heard of the acronym QALY should get to know it. It stands for Quality Adjusted Life Year and it is a scoreboard that divides our population into health care winners and losers. QALYs are used to prioritize the use of ventilators and hospital beds for the younger and healthier and able-bodied—while denying care to those with lesser physical or mental capabilities.

And it’s used by policymakers to decide who should get new medicines, including those to treat COVID-19. Increasingly, unelected and unaccountable organizations such as the Institute of Clinical and Economic Review (ICER) are being used by policymakers, government health programs and insurers to ration care. ICER’s use of QALYs in making these recommendations is inherently discriminatory and may even violate the federal civil rights of the elderly and disabled to be treated equally in medical facilities which get federal funds.

As if this huge moral and legal problem with using QALYs wasn’t bad enough, there are other problems. For instance, ICER arbitrarily decided that an additional year of healthy life is worth $50,000. This dollar value was established in 1982 to determine how much kidney dialysis would be needed to keep someone with kidney failure alive. This while the EPA assumes an additional year of life is worth up to $3 million.

Further, the QALY benchmark inherently assumes people with disabilities or older or harder to treat are worth less. People with disability or your underlying illness – be it heart disease or diabetes – your QALY score is lower and the value assessment scorekeepers will likely recommend that insurance coverage simply isn’t warranted. And if you are someone with a rare disorder such as ALS or Parkinson’s your worth is lower still.

Further, ICER claims that no matter how valuable a drug is — even if it cures — we should only spend $1 billion a year on it. Their rationale: since new drugs might be needed to be taken for a long time, the people who use them might live longer if they stay on a medicine, then total health care spending will increase. By comparison, as ICER states, medicines that help people who are healthy are more ‘cost-effective.’

Recently ICER rushed out a price recommendation of $4300 for remdesivir, the new drug that treatments people hospitalized with COVID-19. In making that assessment, ICER ignores circumstances that any ethical person would consider.

Remdesivir, at the very least, reduces the amount of time people spend in the hospital with COVID-19 by four days. $38,755, depending on the cost-sharing provisions of their health plan.  That doesn’t include post- COVID-19 cost or the fact that for every additional day in the ICU, readmission and death rates post hospitalization climb. It also doesn’t include that fact that if Remdesivir had been available before the pandemic, we wouldn’t have had the overflow of ICU patients.  Cutting length of stay by four days would have increased hospital bed turnover, freeing up enough ICU and non-critical care capacity.  And that would have meant not shutting down the economy.

And yet the talk is about rationing drugs like Remdesivir. Incredibly, those that would be harmed most by rationing are precisely the people who suffered most because of the policies designed to free up hospitalization. Rationing would target the frail veterans who were herded into nursing homes where they died and those whose care was already delayed despite the very people at greatest risk of COVID-19.

The pandemic exposed the fact ICER’s justification for rationing has little to do with scarcity and lot to do with protecting a set of relationships and institutions that support a culture who discards the most vulnerable.

This throwaway culture has a primary value: maintaining a consumerist lifestyle. Proponents of this kind of rationing claim that health care spending – particularly money spent on those with the greatest unmet need – will not be as economically efficient. In an example of brutal honesty, then, groups like ICER want to obtain good outcomes by excluding care and other resources for those who need it the most.  

The QALY systematically deprives those who have been marginalized the same right to health and those of us who are more privileged take for granted. It makes a mockery of our nation’s founding claim that all of us are created equal.

As we move into – and beyond – this new phase of the pandemic, we should follow Oklahoma’s lead. We should reject a discriminatory culture reinforced by QALY-based policies. And we should support a counterculture in which the marginalized are encountered, embraced, cared for, and protected in the fullness of human equality before the law.

Charles C. Camosy is Associate Professor of Theological and Social Ethics at Fordham University and author of “Resisting Throwaway Culture: How a Consistent Life Ethic Can Unite a Fractured People, New City Press”, 2019.  Robert Goldberg is Vice President, Center for Medicine in the Public Interest and co-cost of the Patients Rising podcast.

The Young and the COVID Restless

  • 06.21.2020
  • Peter Pitts
Big h/t to Scott Gottlieb:

Bernstein Research shows a correlation between mobility trends and COVID-19 outbreaks; predicts states like Arizona, Arkansas, Alabama, Mississippi, North Carolina, South Carolina are likely to see intensification in the epidemic on top of recent increases. Google mobility data shows that areas of “high-mobility” (states in more advanced stages of “opening) and lower levels of testing most at risk.

Conclusion – Smart opening must be matched with enhanced personal responsibility. What messages are most useful and impactful for un-masked youth?
 

Silencing Science

  • 06.11.2020
  • Robert Goldberg
It is all well and good for everyone to set aside time to reflect on the death of George Floyd and determine what we can do to ensure that such occurrences continue to become increasingly rare. 

So, I have no problem when two leading scientific publications -- Science and Nature -- devote one day of tweeting to focus on the tragedy. 

I do have a problem when such publications allow themselves to be bullied and hijacked by individuals and groups demanding that publications scrap the scientific method because, they claim, it reinforces something called white privilege and systemic racism. 

We have seen what subverting and enslaving science to ideologically and racially warped ideologies produces: Repression, slavery and eugenics. That triad of tools has been used by totalitarian regimes and unhinged movements throughout history. When the institutions and cultural constructs that defend freedom of thought, expression and action cower or cave to such forces, human dignity is debased at the very least.  At the worst, it leads to censure and coercion as both ends and means. 

Science and Nature may have opened the door to a disaster created by forces that are racist and anti-Semitic, forces that crave control without any justification except the fervent belief that they – not you or me – should be in charge.  My guess is that other publications will engage in online virtual signaling and more to demonstrate how woke and guilty they really are.  

Increasingly I am reminded of something Jacob Bronowski, a mathematician and defender of science said in his PBS series entitled, The Ascent of Man.  Here is a link to the video.

“There are two parts to the human dilemma. One is the belief that the end justifies the means. That push-button philosophy, that deliberate deafness to suffering has become the monster in the war machine. The other is the betrayal of the human spirit. The assertion of dogma closes the mind and turns a nation, a civilization into a regiment of ghosts — obedient ghosts, or tortured ghosts.

It’s said that science will dehumanize people and turn them into numbers. That’s false — tragically false.

Look for yourself.

This is the concentration camp and crematorium at Auschwitz. This is where people were turned into numbers. Into this pond were flushed the ashes of some four million people. And that was not done by gas — it was done by arrogance, it was done by dogma, it was done by ignorance.”

When people believe that they have absolute knowledge, with no test in reality, this is how they behave. This is what men do when they aspire to the knowledge of gods.”



 
Health Economic Research Study Presented at ISPOR, and Published in the Journal Value in Health, Demonstrates Reduction in Total Cost of Care with Increased Use of New Medicines for Treatment of Patients with Pancreatic Cancer

More effective, better tolerated oral therapies for pancreatic cancer may lead to further reduction of burden on the healthcare system
NEW YORK--(BUSINESS WIRE)-- Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism based therapies (CMBTs™), announced the results of a health economic outcomes study demonstrating that the therapeutic benefit of increasing the use of novel medicines is so great that it is driving a decrease in the actual total cost of healthcare. The supporting data from the study are being presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Virtual Meeting held from May 18 to May 20 and published in the Society’s peer-reviewed journal value in Health.

Health technology assessment programs are increasingly using real-world, longitudinal patient data to assess the effect of new medicines on total cost of care. This study analyzed such data to measure the impact of new pancreatic cancer therapies on other, non-drug medical expenditures.

“Our study looked at treatment inflation-adjusted expenses per patient for pancreatic cancer care between 2009 and 2016 and found that for every additional $1 spent on medicines for pancreatic cancer in 2016, there was a reduction in non-drug spending of $8 – $9,” said Robert Goldberg, Ph.D., Vice President and Co-Founder of the Center for Medicine in the Public Interest. “The value of advancing and accessing next-generation novel therapies is apparent from our total cost of care analysis looking at both medical and pharmacotherapy costs.”

The study showed that between 2009 and 2016, average inflation-adjusted per patient spending on pancreatic cancer care declined from $37,000 to $10,000. Prescription drug spending increased during the same time period from $2,200 to $6,100 per person (inflation adjusted). In effect, for every additional dollar spent on disease-altering therapies for pancreatic cancer between 2009 and 2016, there was a reduction in non-drug spending of $8 – $9.

Furthermore, there was a decline in the length of stay in hospital settings and a decrease in hospital deaths for this cohort of patients with pancreatic cancer. From 2009 to 2016, the mean length of stay decreased by 1 day. The proportion of deaths in hospitals during that time period also decreased by 2.8%.

The analyses also evaluated hemorrhage complicating a procedure, including Whipple surgeries. Hemorrhages are estimated to occur in 7.2 to 8.5% of those patients who have undergone a pancreatectomy and are associated with longer and more expensive hospital stays. Patients who were discharged from inpatient settings after being diagnosed with a complicating hemorrhage appeared to be routed to less intensive settings of care. In particular, the proportion of those discharged into home health care, as opposed to short term hospital care or another institution, increased by 1.2% between 2009 and 2016.

The study analyzed longitudinal patient-level data from the Medical Expenditure Panel Survey (MEPS, 1996 – 2017). The study evaluated 80 patients who had a diagnosis of pancreatic cancer and available prescription data. Individual age and employment status were accounted for as covariates. Notably, the data revealed that while prescription medicine expenses have increased as part of the total cost of treating patients with pancreatic cancer over the last ten years, the overall healthcare cost of treating pancreatic cancer patients has gone down.

All analyses were performed using R version 3.6.1 on Ubuntu 19.04. Means and standard deviations were computed for the raw and inflation-adjusted total health care costs excluding drug spending. Study averages were computed for the total health care costs, including prescription medicine costs for the period between 2009-2016 which included approval and/or use of novel treatment approaches such as Abraxane® (nab-paclitaxel), FOLFIRINOX and erlotinib. The prescription medicines expenses, and proportion of healthcare spending were also plotted along with a LOESS curve using the same parameters. All expenditures are adjusted for inflation using 2012 U.S. Dollars.

As a result of this health economic outcomes study, further analysis of a larger, longitudinal set of patient-level data is needed to more fully explore the relationship between spending on medical innovation, and reduction in total cost of patient care, as well as improvements in quality of life.

Details of this study are being presented at the ISPOR Virtual Meeting held from May 18 to May 20. For more information on ISPOR’s virtual program please visit the conference website at: https://www.ispor.org/conferences-education/conferences/upcoming-conferences/ispor-2020.

The health economic outcomes poster on pancreatic cancer presented at the ISPOR virtual conference is as follows:

Title: Using longitudinal patient level data to assess the value of new pancreatic cancer treatments on total health spending.

Authors: Robert Goldberg1, Michele Korfin2, Giuseppe Del Priore2, Semmie Kim2, Vincent J. Picozzi3, M Mandelson3, Victoria G. Manax4

Institutions: Center for Medicine in the Public Interest, NY, NY1,Tyme Technologies, Inc., NY, NY2, Virginia Mason Medical Center, Seattle, WA3, Pancreatic Cancer Action Network, Manhattan Beach, CA4


CSI Update 2

First Vaping, Then Smoking Subject of Media Coverage of COVID-19

Last week, after The Food and Drug Administration, allowed a spokesperson to claim that e-cigarette use increased the risk of COVID-19, the agency revised its advice two weeks ago to acknowledge that the relationship is currently unknown. As Bloomberg News reported, an advisory from the American Cancer Society notes that there “is currently no evidence supporting a direct connection between e-cigarette use and getting COVID-19” and there is “very little direct evidence that e-cigarette use affects COVID-19 outcomes.”

While the “vaping increases COVID-19” meme has died down somewhat, it has been replaced by the “smoking might treat COVID-19” angle.

The rationale behind this effort is explained in one of the thousands of pre-publication articles being published on COVID-19.  The paper: " A nicotinic hypothesis for Covid-19 with preventive and therapeutic implications" collected data “from 480 patients tested positive for COVID-19. Out of that 350 patients were hospitalized and only 4.4 percent were regular smokers with an average age of 65. Out of people who did not hospitalize 5.3 percent were smokers with an average age of 44. They

The authors surmise that nicotine competes with the virus for the ACE2 receptor on cells: “The epidemiological/clinical evidence and the in-silico findings may suggest that Covid-19 infection is a nAChR disease that could be prevented and may be controlled by nicotine. Nicotine would then sterically or allosterically compete with the SARS-CoV-2 binding to the nAChR. This legitimates the use of nicotine as a protective agent against SARS-CoV-2 infection and the subsequent deficits it causes in the CNS. Thus, in order to prevent the infection and the retro-propagation of the virus through the CNS, we plan a therapeutic assay against Covid-19 with nicotine (and other nicotinic agents) patches or other delivery methods (like sniffing/chewing) in hospitalized patients and in the general population.”

Other small retrospective studies show that COVID-19 rates are lower in smokers than non-smokers.  It could very well be that other factors – including genetic – that explain the difference. And we will need much large data sets to establish a cause and effect or statistically reliable association.  

One reason that the “smoking might treat COVID-19”  has gotten traction is that the evidence for claiming  “Smoking increases COVID-19 risk” is pretty thin as well.  The most interesting stab at identifying a possible relationship is presented in an article entitled:

ACE-2 Expression in the Small Airway Epithelia of Smokers and COPD Patients: Implications for COVID-19

The author looked at the lung tissue of people with COPD and compared cells from those smoked and those that didn’t.   The researchers concluded: “active cigarette smoking and COPD up-regulate ACE-2 expression in lower airways, which in part may explain the increased risk of severe COVID-19 in these populations. These findings highlight the importance of smoking cessation for these individuals and increased surveillance of these risk subgroups for prevention and rapid diagnosis of this potentially deadly disease.”

As we have noted, there are many good reasons not take up smoking or use e-cigarettes and for quitting both.  The contribution of smoking to COVID-19 is not one of them.  The evidence of the possible impact of smoking on COVID-19 risk or transmission consists finding ACE2 gene and protein expression increases in the airway epithelium obtained from cytologic brushings of sixth to eighth generation airways in individuals with and without COPD.  As the authors noted: the study had several limits:

“First, the study was cross-sectional and as such, we could not determine whether interventions such as inhaled corticosteroids or bronchodilators (for those with COPD) could modulate ACE-2 gene expression in the airways. Second, the precise attributable risk (for coronavirus infections) imposed by cigarette smoking and COPD is uncertain. Third, although the airway epithelia is the major source of entry for COVID-19, the virus can gain host entry through other ports including gastrointestinal mucosa, which was not evaluated in this study. Fourth, we did not have access to upper airway tissues, which may also become infected with SARS-CoV-2.

To which we add a fifth: COPD is a result of long-term lung damage and itself may be a risk factor independent of ACE-2 gene expression.  Using that data to implicate e-cigarettes is a stretch.

What Do We Know and What Don’t We Know?

1. We know that smoking is harmful to health and a leading cause of death.
2. We don’t know if either smoking itself or the diseases that it causes can be shown to cause an increased risk of COVID-19 or increased severity of COVID-19. All we have now are studies of lung tissue from patients with COPD.
3. We don’t know if nicotine has a protective effect and if so, in what patients.  All we have is a plausible mechanism derived from retrospective observational case reports that are now being tested in vivo or invitro.

The Commonsense Perspective

A plausible hypothesis is based on data the suggests a causal relationship between the use of a product and specific biological changes. More important, that hypothesis should be testable.  To our mind, the nicotine-COVID-19 connection should be regarded as more substantial – because of the data already generated in humans -- than a conjecture about what happens to humans-based studies of cell cultures.  We hope media coverage of research on nicotine, tobacco, e-cigarettes and COVID-19 is less sensational and more informational.

As CMPI President Peter Pitts recently told the media:  “Smoking is the world's #1 preventable health crisis. While anecdotal evidence does show that a small cohort of cigarette smokers and e-cigarette vapers have had better responses to COVID-19, the plural of anecdote is not data. However, it does point to yet reason why e-cigarettes are a far safer alternative to combustible smoking.”



About the Commonsense Science Institute (CSI)

CSI is a clearinghouse for expert commentary and research evaluating the net public health benefit of alternatives to smoking.  You can follow CSI commentary on the drugwonks.com blog.

About the Center for Medicine in the Public Interest (CMPI)

The Center for Medicine in the Public Interest is a nonprofit, nonpartisan research and educational organization that seeks to advance the discussion and development of patient-centered health care.You can obtain more information about CSI and CMPI by contacting:
Dr. Robert Goldberg:  rgoldberg@cmpi.org   862-216-5731 @drbobgoldberg

 



April 30, 2020, New York City. The Center for Medicine in the Public Interest (www.cmpi.org) urges the Food and Drug Administration to grant Gilead’s remdesivr an emergency use authorization. Under an EUA, the FDA does not grant formal market approval to a product.  Instead, as it has done with several diagnostics and drugs such as hydroxycholoroquine, EUA allows doctors to provide access to products with early data showing clinical benefit for whom a clinical trial is not available, or participation (in a trial) is not feasible.

Further, the FDA, NIH and integrated health systems should be collecting real world data on how patients are doing on remdesivr through a parallel-track system.

As noted in a recent CMPI article: “AIDS activists wanted to expand the evaluation of other potential HIV drugs beyond people who were enrolled in clinical trials. In 1990, they "collaborated with Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases (NIAID) to come up with a plan called "parallel track."  Under the parallel-track system, patients could receive drugs if they were unwilling or unable to participate in the typical clinical trial.

Formal clinical trials for remdesivir as well as hydroxychloroquine can be conducted while the community studies are taking place.

To facilitate the establishment of parallel track studies, CMPI recommends the following:

Paying physicians, accountable care organizations, Medicare advantage plans, urgent care centers an additional $50 per patient per month to provide care and enter data related to the use of remdesivir, hydroxychloroquine and other modalities, separately or in combination. 
The Patient-Centered Outcomes Research Institute, NIH, FDA, DARPA, BARDA, along with biopharmaceutical companies, insurers, health information companies should fund the establishment of an open source data repository that can be accessed by researchers, patient organizations, clinicians, etc.  The federal government, along with the funders of an open source data repository, should grants to community-based researchers that establish a parallel track study program.  Additionally, any data collected must be stored consistent with recent HHS regulations that allow patients access to their medical information.
Further, consistent with FDA guidance, the collection and analysis of real-world data, should demonstrate that a treatment effect is present and predictable. As Janet Woodcock has noted: The question FDA must answer is ‘can you make a causal inference’ from the data?  
As an incentive to support the parallel track process, the FDA should provide approval for use based on the evidence of treatment effect.  Health plans should pledge not to use step therapy, prior authorization or cost sharing to delay access to those products approved under a parallel track pathway.  Pharmaceutical companies should pass any discounts or rebates directly to patients or price products to ensure patients have no out of pocket cost for their products.
Remdsivir studies show no new safety signals and positive impact on those hospitalized with serious manifestations of COVID-19. An emergency use authorization is the right and sound decision for the FDA.
 
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Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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