Latest Drugwonks' Blog
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.”
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
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.
Important new paper from the American Action Forum on insulin pricing:
The most “shocking” finding in the paper (per AAF President Douglas Holtz-Eakin) is that the net price – the price received by manufacturers after paying rebates – of the most common insulin products has fallen recently. For example, Eli Lilly released data showing that “the list price of Humalog increased 27 percent from 2015 to 2019, while the net price decreased 14 percent. Sanofi’s latest pricing report shows that since 2012, the average list price for all its insulin products increased 126 percent by 2018, while the average net price has decreased 25 percent.”
* Diabetes cost the United States $327 billion in 2017, becoming the most expensive chronic disease in the nation.
* Insulin costs, before accounting for any rebates or discounts, comprise an estimated $48 billion (20 percent) of the direct costs of treating diabetes; after rebates, insulin accounts for 6.3 percent of costs.
* The average list price of insulin increased 11 percent annually from 2001 to 2018, with average annual per capita insulin costs now nearing $6,000.
Because patients’ out-of-pocket costs are typically based on list price, their expenses have risen substantially despite the decrease in net price for many of the most commonly used insulin products over the past several years.
If the trends of the past decade continue, gross insulin costs in the United States could reach $121.2 billion in total spending (or $12,446 per insulin patient) by 2024, but if more recent trends of much slower price growth prevail, insulin spending could total $60.7 billion in 2024 (or $6,263 per patient).
The full paper can be found here. It’s an important read.
The most “shocking” finding in the paper (per AAF President Douglas Holtz-Eakin) is that the net price – the price received by manufacturers after paying rebates – of the most common insulin products has fallen recently. For example, Eli Lilly released data showing that “the list price of Humalog increased 27 percent from 2015 to 2019, while the net price decreased 14 percent. Sanofi’s latest pricing report shows that since 2012, the average list price for all its insulin products increased 126 percent by 2018, while the average net price has decreased 25 percent.”
* Diabetes cost the United States $327 billion in 2017, becoming the most expensive chronic disease in the nation.
* Insulin costs, before accounting for any rebates or discounts, comprise an estimated $48 billion (20 percent) of the direct costs of treating diabetes; after rebates, insulin accounts for 6.3 percent of costs.
* The average list price of insulin increased 11 percent annually from 2001 to 2018, with average annual per capita insulin costs now nearing $6,000.
Because patients’ out-of-pocket costs are typically based on list price, their expenses have risen substantially despite the decrease in net price for many of the most commonly used insulin products over the past several years.
If the trends of the past decade continue, gross insulin costs in the United States could reach $121.2 billion in total spending (or $12,446 per insulin patient) by 2024, but if more recent trends of much slower price growth prevail, insulin spending could total $60.7 billion in 2024 (or $6,263 per patient).
The full paper can be found here. It’s an important read.
Center for Medicine in the Public Interest Launches Commonsense Science Initiative
FOR IMMEDIATE RELEASE
New York, New York– The Center for Medicine in the Public Interest has launched the Commonsense Science Initiative (CSI) to provide strong, science-based policy, public discussion and public engagement on tobacco harm reduction innovation, primarily focused on the United States but with global reach.
According to Peter Pitts, President of CMPI and former Associate Commissioner for External Affairs at the Food and Drug Administration noted: John Adams famously said: “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.
In the same spirit, CSI will promote awareness of bad science and set the record straight about the impact of alternatives to smoking on public health, well-being, and the environment.”
As part of that mission, CSI will issue rapid response fact sheets and launch a regular blog post on drugwonks.com to call attention to US media coverage of reduced risk smoking alternatives that is incomplete, methodologically flawed, non-reproducible and outright misleading.
The CSI blog will combine original content, summaries of scientific papers, as well as re-publication of articles and speeches given by harm reduction experts.
FOR IMMEDIATE RELEASE
New York, New York– The Center for Medicine in the Public Interest has launched the Commonsense Science Initiative (CSI) to provide strong, science-based policy, public discussion and public engagement on tobacco harm reduction innovation, primarily focused on the United States but with global reach.
According to Peter Pitts, President of CMPI and former Associate Commissioner for External Affairs at the Food and Drug Administration noted: John Adams famously said: “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.
In the same spirit, CSI will promote awareness of bad science and set the record straight about the impact of alternatives to smoking on public health, well-being, and the environment.”
As part of that mission, CSI will issue rapid response fact sheets and launch a regular blog post on drugwonks.com to call attention to US media coverage of reduced risk smoking alternatives that is incomplete, methodologically flawed, non-reproducible and outright misleading.
The CSI blog will combine original content, summaries of scientific papers, as well as re-publication of articles and speeches given by harm reduction experts.
The effective response to a pandemic requires limiting and slowing the spread of a virus. That in turn requires providing people with sound, evidence-based information about what causes coronavirus transmission. Above all, it is essential that health care professionals and institutions are able to focus their time and resources on those with the greatest medical need.
Spreading misleading information about what could increase the risk of virus-caused respiration infections can and has led people to panic and seek medical care they don’t need at the expense of those that do.
In particular, several media outlets and public health organizations have promoted the fear that vaping causes or increases the risk of COVID-19, an assertion first made by New York City Mayor Bill DeBlasio.
Most recently, Bloomberg ran a story: “Vaping Could Compound Health Risks Tied to Virus, FDA Says.” People with underlying health issues, such as heart or lung problems, may have increased risk for serious complications from Covid-19,” Michael Felberbaum, an FDA spokesman, said in an email Friday in response to questions from Bloomberg. “This includes people who smoke and/or vape tobacco or nicotine-containing products.”
“E-cigarettes can damage lung cells,” Felberbaum said.
Focusing on vaping when much the population is still seeking certainty about social distancing, testing and other introduces confusion where clarity is needed. Spreading unsubstantiated claims that vaping will increase the risk of COVID-19 is uncalled for. Especially by the FDA.
The fact that the FDA allowed such an unqualified and unscientific statement is puzzling. There was no scientific study or evidence accompanying the statement. In particular, the blanket assertion lacked any context, conflating vaping, smoking and heart or lung problems as equally at risk. Relative to other health related factors such as diabetes, heart conditions and COPD, how much additional risk does vaping generate? Should people who vape as a way to reduce smoking stop vaping? Should they switch from vaping to smoking?
Further, the FDA spokesman’s claim that vaping damages lung cells was unqualified and stated in the absence of any supporting data. This too sows panic about the relative contribution of smoking or e-cigarettes to the risk or severity of coronavirus.
The fact that a press spokesman made a scientific assertion ( “E-cigarettes can damage lung cells”) and was reported without contextual information as medical advice from the FDA is both dishonest and dangerous.
To be clear, the National Academy of Sciences report: Public Health Consequences of E-Cigarettes concluded there was substantial evidence that e-cigarette aerosols can induce acute endothelial cell dysfunction and promote the formation of reactive oxygen species/oxidative stress.
But the same study also made clear that the “generation of reactive oxygen species and oxidative stress induction is generally lower from e-cigarettes than from combustible tobacco cigarette smoke” and that the long-term consequences and outcomes on these parameters with long-term exposure to e-cigarette aerosol are uncertain.
Indeed, the FDA spokesman and Bloomberg – like many other media accounts and statements fail to distinguish between long- and short-term risk, between research conducted on mice or human tissue samples and real-world data, gathered from human beings. Rather, articles singling vaping out as a risk factor for COVID-19 applies the “linear no-threshold hypothesis” which presumes that toxic “causation is a linear process, meaning that there is no safe dose and that damage occurs at a constant rate as exposure increases.”
For example, a New York Post article entitled “Vaping May Be A Cause of Coronavirus Cases in Young Americans”, quotes a blog by Stanton Glantz, director of the Center for Tobacco Research Control & Education at University of California San Francisco: “Vaping affects your lungs at every level. It affects the immune function in your nasal cavity by affecting cilia which push foreign things out...[T]he ability of your upper airways to clear viruses is compromised.”
Glantz, whose research on the link between e-cigarettes and heart disease has been retracted, fails to make the distinction between short term and long-term exposure or between smoking and e-cigarettes on what is called nasal mucociliary clearance. Again, these distinctions are important, especially when deciding what public health messages should be conveyed.
The distinction is important for two reasons. First, it is well known that years and decades of chronic smoking are needed for the development of lung diseases. And even among smokers, it takes at least a decade or longer of consistent smoking for COPD to develop. Most studies conclude that "prolonged tobacco use is associated with respiratory symptoms and COPD after controlling for current smoking behavior."
One recent study found that e-cigarette (ECs) "use may aid smokers with COPD reduce their cigarette consumption or remain abstinent, which results in marked improvements in annual exacerbation rate as well as subjective and objective COPD outcomes." That was followed by another analysis in 2018 that concluded, "EC use may ameliorate objective and subjective COPD
outcomes and that the benefits gained may persist long-term. EC use may reverse some of the harm resulting from tobacco smoking in COPD patients.
Finally, most young adults are switching from cigarettes to e-cigarettes. Few non-smokers are starting to vape. Rather, the decline in smoking tracks with the increase in the use of e-cigarettes. As for the so-called gateway effect (vaping being the first step to smoking), a recent study concluded that less than 1 percent of young people who have vape then go on to smoke regular cigarettes. If anything, young vapers are less likely to go on to smoke regular cigarettes than their peers who try out other tobacco products first. Even if long term use of vaping does contribute to health problems, having people who would otherwise smoke us e-cigarettes, is likely to reduce the overall risk of diseases associated with more serious COVID-19 complications.
E-cigarettes are an alternative to smoking cigarettes. They are less harmful than combustible tobacco. The vast majority of young adults who use ECs are using them to reduce the amount they smoke. Such a shift is associated with reduced exposure to the biomarkers that, over the long term, increase an individual’s risk of cancer, heart disease, and COPD.
With regard to COVID-19, the relative contribution of smoking as a factor is unclear. Smoking is associated with a higher risk of being hospitalized for or dying from complications related to COVID-19. But high-risk patients are also more likely to be over age 70 and have a history of diabetes, heart disease or COPD. Research clearly shows that e-cigarette use reduces the consumption of chemicals contained in combustible tobacco that lead to such health problems.
The FDA’s statement was irresponsible and can lead people to believe that vaping is a significant risk factor for COVID-19 at the expense of other habits clearly related to the risk of transmission or severity of disease.
If a pharmaceutical company actively promotes one of its products for conditions other than those approved by the Food and Drug Administration, it’s considered “violative behavior” and often results in what’s known in the regulatory world as a “warning letter” -- official correspondence from the FDA ordering the firm to cease and desist from such communications. But can the FDA send a warning letter to the President of the United States?
President Trump keeps championing the drug chloroquine as a potential cure for COVID-19. While there is anecdotal evidence that this drug might help ameliorate the symptoms of the coronavirus, it is by no means a cure – and the plural of anecdote isn’t data. Trials to actually collect scientifically valid evidence about the effectiveness of chloroquine are only just beginning. These programs can be expedited but they mustn’t be rushed.
So, what’s wrong with the President sharing some potential good news? Nothing as long as it’s in the proper perspective. That’s what was missing from the President’s remarks, perspective. False hope has many unintended consequences. There are already reports of people hoarding chloroquine causing shortages for patients who, for example, must use it regularly to manage their rheumatoid arthritis. And unfortunately, but not unexpectedly, there have been reports of over-dosing and death.
Proper scientific trials of chloroquine and other compounds that might ease the symptoms and shorten the duration of COVID-19 must be fast-tracked – but they cannot be ignored or trivialized. Science is like that and that’s why physicians such as Dr. Anthony Fauci and FDA Commissioner Steven Hahn are such important members of the President’s task force. Information about new drugs and new uses for existing ones must be truthful accurate and non-misleading. In the Age of COVID, that’s a crucial public health trifecta.
As Rudyard Kipling reminds us, “Words are, of course, the most powerful drug used by mankind." This is precisely what the FDA reminds drug companies in its warning letters. When it comes to matters of medical and regulatory science, let the experts take the lead.
President Trump keeps championing the drug chloroquine as a potential cure for COVID-19. While there is anecdotal evidence that this drug might help ameliorate the symptoms of the coronavirus, it is by no means a cure – and the plural of anecdote isn’t data. Trials to actually collect scientifically valid evidence about the effectiveness of chloroquine are only just beginning. These programs can be expedited but they mustn’t be rushed.
So, what’s wrong with the President sharing some potential good news? Nothing as long as it’s in the proper perspective. That’s what was missing from the President’s remarks, perspective. False hope has many unintended consequences. There are already reports of people hoarding chloroquine causing shortages for patients who, for example, must use it regularly to manage their rheumatoid arthritis. And unfortunately, but not unexpectedly, there have been reports of over-dosing and death.
Proper scientific trials of chloroquine and other compounds that might ease the symptoms and shorten the duration of COVID-19 must be fast-tracked – but they cannot be ignored or trivialized. Science is like that and that’s why physicians such as Dr. Anthony Fauci and FDA Commissioner Steven Hahn are such important members of the President’s task force. Information about new drugs and new uses for existing ones must be truthful accurate and non-misleading. In the Age of COVID, that’s a crucial public health trifecta.
As Rudyard Kipling reminds us, “Words are, of course, the most powerful drug used by mankind." This is precisely what the FDA reminds drug companies in its warning letters. When it comes to matters of medical and regulatory science, let the experts take the lead.
PHARMACISTS ARE FRONT LINE PARTNERS IN PUBLIC HEALTH
EXPANDED AUTHORITY IS NEEDED TO ADMINISTER VACCINE FOR COVID-19
Scientists are working around to clock to develop an effective COVID-19 vaccine. When that vaccine is available, we will need to get it quickly to every eligible person in the United States. That’s why the American Disease Prevention Coalition is calling on states to lay the groundwork now by ensuring that pharmacists are permitted to provide and administer all Advisory Committee for Immunization Practices (ACIP)-recommended or U.S. Food and Drug Administration (FDA)-approved vaccines.
While pharmacists in all 50 states, the District of Columbia, and Puerto Rico currently have authority to administer at least some vaccinations, extending this authority to cover all vaccine types for the varying patient populations is long overdue. Pharmacists play a vital role in raising vaccine awareness, assessing a person’s immunization status; making recommendations on needed vaccines; and administering and reporting vaccines that are provided to their patients into federal and state immunization registries. The daily interaction pharmacists have with customers is critically important, especially during times of public health crisis when so many other medical providers are overburdened with an influx of patients and/or are providing care using telemedicine practices. Considering that 9 out of 10 Americans live within five miles of a community pharmacy, our nation’s pharmacists have never been more essential to delivering critical, in-person healthcare needs—including and especially vaccines.
Currently, state laws vary widely with respect to which vaccines pharmacists may administer and any associated minimum age requirements for who can receive a pharmacist-administered vaccine. For example, in Wisconsin, pharmacists are permitted to initiate and administer all CDC recommended vaccines. However, not all states provide that level of authority. For instance, in some states, pharmacists can only administer a vaccine if a doctor provides a special prescription to that effect. These variances will make it harder for certain communities where pharmacists subjected to these restrictions to provide new vaccines to patients, such as the one being developed for COVID-19.
Research shows how pharmacists can play a key role in flattening the curve of pandemics. A Johns Hopkins University study found that allowing pharmacists to dispense flu vaccinations during a severe flu epidemic would avert up to 23.7 million symptomatic cases, preventing up to 210,228 deaths, and saving $2.8 billion in direct medical costs. In fact, during the H1N1 influenza epidemic, pharmacists played a critical role in improving access to the vaccine developed to help stop the further spread of this disease.[1][2] Pharmacists have the knowledge and experience to help our nation respond to pandemics such as COVID-19.
Every state must ensure that all pharmacists can administer all FDA approved or ACIP recommended vaccines. States should make these changes now so that pharmacists can administer a COVID-19 vaccine as soon as it reaches the market. The lives of millions of Americans may well depend on it.
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6279616/
EXPANDED AUTHORITY IS NEEDED TO ADMINISTER VACCINE FOR COVID-19
Scientists are working around to clock to develop an effective COVID-19 vaccine. When that vaccine is available, we will need to get it quickly to every eligible person in the United States. That’s why the American Disease Prevention Coalition is calling on states to lay the groundwork now by ensuring that pharmacists are permitted to provide and administer all Advisory Committee for Immunization Practices (ACIP)-recommended or U.S. Food and Drug Administration (FDA)-approved vaccines.
While pharmacists in all 50 states, the District of Columbia, and Puerto Rico currently have authority to administer at least some vaccinations, extending this authority to cover all vaccine types for the varying patient populations is long overdue. Pharmacists play a vital role in raising vaccine awareness, assessing a person’s immunization status; making recommendations on needed vaccines; and administering and reporting vaccines that are provided to their patients into federal and state immunization registries. The daily interaction pharmacists have with customers is critically important, especially during times of public health crisis when so many other medical providers are overburdened with an influx of patients and/or are providing care using telemedicine practices. Considering that 9 out of 10 Americans live within five miles of a community pharmacy, our nation’s pharmacists have never been more essential to delivering critical, in-person healthcare needs—including and especially vaccines.
Currently, state laws vary widely with respect to which vaccines pharmacists may administer and any associated minimum age requirements for who can receive a pharmacist-administered vaccine. For example, in Wisconsin, pharmacists are permitted to initiate and administer all CDC recommended vaccines. However, not all states provide that level of authority. For instance, in some states, pharmacists can only administer a vaccine if a doctor provides a special prescription to that effect. These variances will make it harder for certain communities where pharmacists subjected to these restrictions to provide new vaccines to patients, such as the one being developed for COVID-19.
Research shows how pharmacists can play a key role in flattening the curve of pandemics. A Johns Hopkins University study found that allowing pharmacists to dispense flu vaccinations during a severe flu epidemic would avert up to 23.7 million symptomatic cases, preventing up to 210,228 deaths, and saving $2.8 billion in direct medical costs. In fact, during the H1N1 influenza epidemic, pharmacists played a critical role in improving access to the vaccine developed to help stop the further spread of this disease.[1][2] Pharmacists have the knowledge and experience to help our nation respond to pandemics such as COVID-19.
Every state must ensure that all pharmacists can administer all FDA approved or ACIP recommended vaccines. States should make these changes now so that pharmacists can administer a COVID-19 vaccine as soon as it reaches the market. The lives of millions of Americans may well depend on it.
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6279616/
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.
