Silencing Science

06/11/2020 12:40 PM | 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.”



   Read More & Comment...

CMPI Led Study Shows Value of New Cancer Drugs

05/19/2020 10:05 AM | Robert Goldberg

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  Read More & Comment...

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

05/01/2020 04:12 PM | Robert Goldberg

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

   Read More & Comment...

Center for Medicine in the Public Interest Urges Emergency Use of Remdesivr in Real World Settings

04/30/2020 05:55 PM | Robert Goldberg

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.
   Read More & Comment...

From Real Clear Health: Why the Left Blames Fox News for COVID Deaths

04/28/2020 02:57 PM | Robert Goldberg

Why the Left Blames Fox News for COVID Deaths  Read More & Comment...

Sugar is Sweet and so are PBM rebates – but not if you’re a patient on insulin.

04/07/2020 08:54 AM | Peter Pitts

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.
   Read More & Comment...

Center for Medicine in the Public Interest Launches Commonsense Science Initiative 

04/06/2020 01:19 PM | Robert Goldberg

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.




   Read More & Comment...

FDA and Media Spreads Fear About Fake Vape-COVID Connection

04/06/2020 12:52 PM | Robert Goldberg

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.      

   Read More & Comment...

POTUS gets a Warning Letter

04/06/2020 09:59 AM | Peter Pitts

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.
   Read More & Comment...

PHARMACISTS ARE FRONT LINE PARTNERS IN PUBLIC HEALTH EXPANDED AUTHORITY IS NEEDED TO ADMINISTER VACCINE FOR COVID-19

04/01/2020 12:21 PM | Peter Pitts

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/

   Read More & Comment...

Making America Resilient

03/20/2020 10:27 AM | Robert Goldberg

Every time President Trump takes action, the response has been predictable.  

Critics said banning travel from Europe was a xenophobic decision that "injects past grievances and prejudices into delicate scientific and political equations. In this spiraling thriller cum horror novel, Trump's emergence, full of hostility and conspiracy…heralds a darkening turn—an early indication of the power of a pandemic to infect global decision making and international relations."

That's one way of looking at it. Another approach would be to note that the President's quick decision to restrict travel from China bought us the time we need. Or that other countries quickly followed suit.  

Of course, there are other reasons people give to claim that the President's handling of the pandemic has been a total failure. For instance, critics are blaming the President for the delay in the development and distribution of coronavirus test kits. The Food and Drug Administration was too busy rejecting test kits used in South Korea and delaying approval of American made diagnostics. The Centers for Disease Control were developing the only test available. The product's rollout was botched because its components were defective. 

The White House stepped in and now we have several tests commercially available and at no charge to Americans. He has forced the FDA to move faster (when outlets like the NY Times were urging the FDA to go slower). I hope that the Trump administration has learned from this experience and takes the same approach in ensuring the availability and use of “antibody tests to detect if someone has already had coronavirus.”

As Jim Pinkerton points out in an excellent article on Breitbart: “we should seize the opportunity to create a Medical E-Verify, which would stipulate that all employers must verify the contagious health status of all employees. “  Such testing will boost confidence and allow more workers to get back to their jobs quickly. 

Vice President Biden has claimed that "he" did a better job responding to the H1NI outbreak in 2009. Not really. 

First, while rapid test kits for H1N1 were available in 2009, many of the tests were inaccurate. " The rapid influenza detection test (RIDT) (developed at the time only detected 10-70% of influenza A viruses and couldn’t distinguish between swine flu and other types of influenza A viruses.

Moreover, Trump is not the first president wrongly accused of making an outbreak worse. In 2009, the Obama administration pledged to speed up the development and production of vaccines against the H1N1 virus. As a contemporary account notes: The Obama administration fast-tracked the production of a vaccine, but it will not have 120 million doses ready by the expected peak of the season, as it had hoped. Forty-five million doses will be available in mid-October, with 20 million more available each week afterward."

The lack of adequate testing and sufficient vaccine supply was not Obama's fault back then. It's not Trump's fault now.  

Now, critics are howling Trump has failed to ensure we have enough critical care beds for the likely surge in people with COVID-19. A recent report noted: "medical staff have been told to prioritize the patients with the highest chances of survival because of the lack of the equipment."

Oh wait, that was about Italy, one the many single health payer paradises that some Trump critics claim is superior to our system. The fact is, the United States has more critical care beds per capita than any other country.  It's probably not enough to handle the surge in patients who need ICU care, but we have a better chance of doing so than any other country. 

Then there is the need for ventilators. 

Trump critics are demanding the federal government take over the manufacture and distribution of equipment. Meanwhile, the European Commission, President Ursula von der Leyen is pleading with member states to "ramp up the production of medical equipment (mostly ventilators) and share those goods within the bloc. Von der Leyen said no country had the capacity to produce on its own what will be needed to treat patients in the fight against coronavirus.

America? We have several companies ready to roll. Indeed, our manufacturers will have the ability to make enough for the entire world now that the administration has cut the red tape inhibiting ramp up. (I will discuss the threat of potential drug shortages in another piece.)

We live in an age where everyone gives their opinion instantly and endlessly. No doubt that another president, regardless of party, would also be the subject of a diarrheic stream of commentary.  How can we drown out the psychotic chatter and evaluate presidential leadership in times of trouble?

As Tevi Troy demonstrates in his book, "Shall We Wake the President? Two Centuries of Disaster Management from the Oval Office" (Lyons Press. Kindle Edition), successful presidential responses consist of enabling people to cope in a resilient fashion with dangers when they manifest themselves.  Resilience, as Aaron Wildavsky notes, "is the capacity to cope with unanticipated dangers after they have become manifest, learning to bounce back." Making America Resilient: That describes the goal of President Trump's leadership and objective during this current crisis. After a slower than ideal start, we are heading in that direction.
   Read More & Comment...

Getting RESULTs Against Coronavirus

03/18/2020 12:38 PM | Robert Goldberg

Senator Ted Cruz is at this moment introducing legislation-- the RESULT act -  that would enable the FDA to automatically approve drugs that are on the market elsewhere to treat the coronavirus.  The bill would also allow novel treatments such as cell therapy to receive conditional approval for specific high risk patient groups with phase 1 data.   

We have done both to fight infectious diseases before.  The RESULT act would provide companies, patients, researchers and the FDA an efficient framework to help the sickest and advance the battle against COVID in real time.  

You can read the bill here.

You can learn about the promise of cell therapy here.

   Read More & Comment...

Part D Rebates: Nothing but Net

03/18/2020 07:27 AM | Peter Pitts

Drug Cost-Sharing Based on Net Price Benefits Medicare Part D Patients

A new Schaeffer Center white paper finds almost half of individuals with Medicare Part D coverage would see a reduction in out-of-pocket spending if patient cost-sharing were based on the price negotiated after the rebate (or net price), rather than the pre-rebate list price.

“Drug rebates have become an increasingly significant component of the Part D program, but our analysis shows beneficiaries are not necessarily benefiting in terms of out-of-pocket spending,” explained Schaeffer Center Associate Director Erin Trish, who co-authored the analysis.

“Although rebates help keep Part D premiums low, they do so in a way that disadvantages those who rely on high cost, high rebate drugs,” says co-author Geoffrey Joyce, Schaeffer Center director of health policy. Joyce and Trish are also faculty at the USC School of Pharmacy.

The study team – which included Trish, Joyce, and Schaeffer Center Research Programmer Katrina Kaiser –used 2016 Medicare Part D claims data to conduct the analysis. To model the policy change basing cost-sharing on net price, rather than list price, they discounted the list price of each claim by the estimated rebate and calculated what the patient’s cost-sharing would have been under this alternative scenario.

The researchers found that basing cost-sharing on net price would reduce out-of-pocket spending for about 47 percent of beneficiaries who do not receive low-income subsidies. For some, the amount would be considerable: approximately 20 percent of beneficiaries would save more than $100 and almost one percent would save more than $1000 annually.

The study also suggests another important advantage to this net-price shift: it would reduce the number of consumers reaching Part D’s catastrophic coverage phase, during which the federal government pays most of the drug costs. The authors found that 36 percent fewer beneficiaries would reach catastrophic coverage, which would result in a 19 percent reduction in federal reinsurance spending.

The findings show overall savings could be substantial for many patients. The authors note that one concern blocking this reform is that it would likely result in higher premiums. However, the authors also note that that is because some beneficiaries are paying more out-of-pocket, which helps to reduce premiums for everyone. The authors urge federal policymakers to consider implementing this change to how Medicare Part D cost sharing is calculated. Either alone or in conjunction with other reforms, basing rebate amounts on net prices rather than list prices would limit beneficiaries’ out-of-pocket spending and make cost-sharing more reflective of the actual cost of the drug.

Key Takeaways

* Rebates – as a share of total drug spending – have grown considerably over the last decade.

* Because of how rebates are implemented in Medicare Part D, patient cost-sharing is based on the list (pre-rebate) price of drugs, not the net price reflecting these negotiated discounts.

* If cost-sharing were based on net price, it would reduce out-of-pocket spending for nearly half of Part D beneficiaries who do not receive low-income subsidies.

* Approximately 20 percent of these beneficiaries would save more than $100 per year and about one percent would save more than $1,000 per year.

* Basing cost-sharing on net price, rather than list price, would provide meaningful financial relief to many Part D beneficiaries.

An important paper on a crucial reform. Worth a read.
   Read More & Comment...

Playing the Spread

03/13/2020 08:40 AM | Peter Pitts

When it comes to drug pricing, some questions are easier to answer than others. Here’s an easy one – why do physicians prefer innovator biologics to biosimilars? A big part of the answer is --  because the more expensive the product, the more money they make. (Although Medicare pays the provider the same administration fee for a biosimilar and the originator biologic – that is not the case with commercial plans.) That’s Econ 101. As Adam Smith reminds us, “It is not from the benevolence of the butcher, the brewer, or the baker that we expect our dinner, but from their regard to their own self-interest.”

How can we make that “self-interest” work in the interests of lowering costs via a more robust use of biosimilars? (Hint: It’s not by making them more expensive.)
 
That’s the theory of the Increasing Access to Biosimilars Act. Its main idea is to develop a pilot program (run by the Department of Health and Human Services) to explore ways to encourage physicians to prescribe biosimilars within Medicare Part B. Since Medicare is the largest insurer in the country, any changes in its reimbursement policy will ultimately change behavior in the private insurer sector.

Better physician education as to the safety and efficacy of biosimilars? It’s in there. More education (properly scientific, balanced and vetted) is important. (This is also a legitimate focus of the joint FDA/FTC program to address the same issue.) More important, however, is the physician pocketbook strategy. Per this legislation, physicians would share in the savings. What does that mean? Simply put, it means doctors will receive a percentage of the spread between the cost of the innovator product and the biosimilar. De minimus, this will remove the perverse incentive for physicians to prescribe a more expensive product over its biosimilar cousin. Obviously, cost isn’t the only parameter in product choice – but it’s a potent counterweight to “their own self-interest.”

The proposed legislation also eradicates the need to pursue foolish policies such as the Administration’s concept of an International Pricing Index. Also, the Increasing Access to Biosimilars Act is a shot across the bow to payers who will swiftly recognize the incentives to stop using the tools of exclusionary contracting for non-Medicare Part B patients. Why? Because it will be in “their own self-interest” to do so.

More as more develops.
   Read More & Comment...

Vaping Has Its Wakefield Moment

03/12/2020 03:37 PM | Robert Goldberg

Last July, the Journal of the American Heart Association (JAHA) published an article that claimed vaping doubled the risk of heart attacks.  The research, conducted by Stanton Glantz, director of the University of California, San Francisco’s Center for Tobacco Control Research and Education was unveiled right in the middle of a wave of articles, hearings and statements by public health officials asserting e-cigarettes were dangerous.  

The Glantz article fueled fear that vaping was deadly just as Andrew Wakefield’s 1998 Lancet study linking autism to the measles-mumps-rubella vaccine triggered anti-vaccine panic that in turn led to a decline immunization rates.  We now face the possibility of millions rejecting flu shots or a coronavirus vaccine because of the fears sowed by Wakefield. 

There’s something else both articles have in common.  They were both retracted by the journals that published them. The Lancet retracted the Wakefield paper in 2010 for being untrustworthy and fraudulent.  The Glantz article was yanked for similar reasons.

However, there is a big difference.  Wakefield was swiftly condemned after the retraction by the Food and Drug Administration (FDA), the National Institutes of Health (NIH), WHO and the Centers for Disease Control and Prevention. Today these same agencies are funding Glantz and relying upon his publications to shape public perceptions and regulation of e-cigarettes. In fact, Glantz  has received nearly $50 million from the Food and Drug Administration and the National Institute of Health to “inform the FDA’s regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.”   

The JAHA article claimed that independent of other factors, e-cigarettes were as likely to increase the risk of heart attacks as smoking. When other public health researchers, including Dr. Brad Rodu, who chairs the Center for Tobacco Harm Reduction Research at University of Louisville analyzed the data Glantz used they found the majority of patients in the study who had heart attacks had them before they started vaping — by an average of 10 years earlier. 

In fact, one JAHA reviewer raised this issue with Glantz and asked him to redo the analysis by excluding people who had previously smoked or had a heart attack.  Glantz failed to do this simple calculation. Instead, he told JAHA editors that he controlled for previous heart attacks by analyzing only those people who had one five or fewer years ago. JAHA published the study and to its credit, pulled the paper after Rodu and other researchers continued to press the issue. 

This was not the first time Glantz used statistical gerrymandering to produce misleading results that aligned with aggressive anti-vaping forces.  In 2018 he published another study about e-cigarettes causing heart attacks in the American Journal of Preventive Medicine (AJPM) that has not been retracted.  Nor was it the last. In December of 2019  AJPM published a Glantz study that was hailed as the first study on the long-term health effects of electronic cigarettes finds that the devices are linked to an increased risk of chronic lung diseases

Indeed, Glantz doubled down on the link, telling the New York Post: "Everybody, including me, used to think e-cigarettes are like cigarettes but not as bad. …It turns out you're worse off. E-cigarettes pose unique risks in terms of lung disease." 

To reach this conclusion, Glantz again counted people who smoked as e-cigarette users.  Also, he didn’t control for the fact adults with asthma are 11 times more likely to develop other types of COPD (independent of smoking).   

Moreover, Glantz said it only took 3 years for e-cigarettes to trigger lung disease. That’s a remarkable finding for two reasons. First, it takes at least a decade or longer of consistent smoking for COPD to develop. Second, most clinical trials show that biomarkers of tobacco use associated with lung and heart disease decline when people switch to e-cigarettes.

The Glantz retraction raises questions not just about his other research, but the use of his research methods to influence public opinion and regulation of e-cigarettes.  As Aaron Wildavsky wrote, “when noble lies" are told in the belief that the system is so bad that any argument against it can only counteract a small part of its falsehoods, the task of the citizen is made much more difficult.”  In this case, it is now harder to determine whether restricting or eliminating e-cigarettes – which means leaving combustible tobacco products on sale, increase or reduce the 500,000 deaths a year attributed to smoking?  

After Wakefield’s fraud was exposed, the British Medical Journal wrote that “the damage to public health continues, fueled by unbalanced media reporting and an ineffective response from government, researchers, journals and the medical profession.”  Today, Glantz is still being published by mainstream medical journals, championed by major media outlets, given legitimacy by other scientists and politicians. Can we even imagine having the response to the coronavirus based on such fraudulent research?

The JAHA retraction was a Wakefield moment. Jacob Bronowski, the great science historian and mathematician observed that “no science is immune to the infection of politics and the corruption of power.”  The way to prevent such distortion is more people engaging in better science.  But when government funding supports one point of view, then it becomes easy to overrun scientific discourse, bully those with different points of view and control public policy.  The JAHA retraction can be a step back from that abyss. 

   Read More & Comment...

Occam's Co-Pay

03/12/2020 01:55 PM | Peter Pitts

Here’s the headline:

“OptumRx and UnitedHealthcare are expanding their innovative consumer point-of-sale prescription drug discount programs to apply to all new employer-sponsored plans, making medications more affordable and improving health outcomes.”

Translation: Lower out-of-pocket costs result in higher medication adherence rates.  And this equals many good things – not the least of which is – better patient outcomes!

According to a new paper from the Progressive Policy Institute, Progressive Policy Institute on point of sale (POS) rebates:

* POS clarifies the true cost of prescription medications and allows consumers and physicians to make better cost-benefit trade-offs.

* POS reduces the incentive for companies to raise their list prices while offering bigger rebates to insurance companies and pharmacy benefit managers (PBMs).

* And, perhaps most important,  passing the manufacturer rebates through to consumers helps the high spenders, who would be able to take better advantage of discounts and rebates.

Per the OptumRx/UnitedHealthcare press release, “UnitedHealthcare’s fully insured members at the point-of-sale; consumers already seeing average savings of $130 per eligible prescription in 2019” and “Programs strengthen prescription drug adherence by up to 16%, lead to improved patient health.”

Bravo. But this welcome and appropriate bragging begs the question – why are they still pushing patient-punitive measures such as co-pay accumulators – the bleeding edge of the co-pay razor?
   Read More & Comment...

High Science

03/07/2020 03:05 PM | Peter Pitts

Last week the FDA issued its most recent thinking on CBD.

Under the title, “FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity,” it was, to anyone paying attention, a regulatory finger-wag to a still-nascent industry that still just doesn’t get it. Alas, a lot of bad science doesn’t equal even a little good science. Sometimes the view from the front of the black helicopter gets boring.

The FDA statement begins, “Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform our regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public health concerns.”

Translation: There’s no good science and we’re going to start writing enforcement letters.

The agency continues, “Today, we are providing updates on our efforts in this area, including several new steps in areas of education, research and enforcement with the ultimate goal of continuing to protect the public health and working to provide market clarity."

Translation: It’s going to be a slow process. We’re obviously going to have to help you. Ignore the need for real science at your own peril. Oh, about those claims, “… we are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two rare, severe pediatric epilepsy disorders, no other CBD products have been evaluated or approved by the FDA.” Better lawyer up, bro.

Safety issues? “There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.”

Translation: We think there may very well be safety issues such as:

“… potential liver injury, interactions with other drugs and male reproductive toxicity, as well as side effects such as drowsiness. In addition, there is still much we do not know about other potential risks. For example, other than the approved prescription drug, we know little about the potential effects of sustained and/or cumulative use of CBD, co-administration with other medicines, or the risks to vulnerable populations like children, pregnant and lactating women, the elderly, unborn children and certain animal populations. This does not mean that we know CBD is unsafe …”

Translation: … or if CBD is an antidote to COVID-19. But we have our suspicions.

“To address the questions and concerns we’ve already raised, we’re seeking reliable and high-quality data.”

Translation: We don’t have it because it doesn’t exist.

“This includes data on, among other things: the sedative effects of CBD; the impacts of long-term sustained or cumulative exposure to CBD; transdermal penetration and pharmacokinetics of CBD; the effect of different routes of CBD administration (e.g., oral, topical, inhaled) on its safety profile; the safety of CBD for use in pets and food-producing animals; and the processes by which “full spectrum” and “broad spectrum” hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products.”

Translation: You guys had better hire some pharmacologists.

“Given the importance of answering these questions, we’re exploring a number of ways to address the data gaps as quickly as possible. This includes encouraging, facilitating and initiating more research on CBD, providing venues for industry and researchers to share new data with the agency and identifying opportunities to further collaborate with our federal partners at Centers for Disease Control and Prevention, Substance Abuse and Mental Health Services Administration and National Institute on Drug Abuse on this important issue.”

Translation: We’re going to hold meetings!

But there is also good news:

“Importantly, the Agriculture Improvement Act of 2018 … has opened significant new opportunities for research, and as that body of research develops and grows, there will be considerably more information available. In particular, there’s been an increased interest in drug development from CBD and other compounds found in cannabis and we are working to support drug development as much as possible.”

Translation: Goodbye IPO dreams and hello CRO expenses and academic research grants that don’t care a brass farthing about marketplace needs and schedules.

Comrades, it’s going to be a long and winding road.

“In the coming days we are re-opening the public docket we established for our May 2019 public hearing. The docket provides a valuable conduit for submission of scientific data on CBD to the agency, so we have decided to extend the comment period indefinitely to allow the public to comment and to share relevant data with the agency. As the agency continues to move forward to explore viable pathways for CBD products outside the drug context, this extension will allow stakeholders to continue to provide relevant data as research in this area evolves.”

Translation: Key word, “indefinitely.”

And in conclusion:

“We recognize the significant public interest in CBD and we must work together with stakeholders and industry to develop high-quality data to close the substantial knowledge gaps about the science, safety and quality of many of these products. We are committed to working efficiently to further clarify our regulatory approach to these products – as always, using science as our guide and upholding our rigorous public health standards.”

Translation: Stop moaning and groaning, take off the tin foil hats and science-up.
   Read More & Comment...

World Health Organization Worries More About Vaping Than the Coronavirus

02/09/2020 06:47 PM | Robert Goldberg

 

 
At the same time the World Health Organization (WHO) was dithering about the dangers of the coronavirus, it was perpetuating another public health threat of greater magnitude. 

Specifically, WHO took to Twitter to claim, in the middle of the epidemic that it was slow to recognize, that “e-cigarettes increase the risk of heart disease and lung disorders and pose significant risks as they can damage the growing fetus”.

These claims are false. People using non-combustible sources of nicotine have better lung function and fewer attacks. Quitting reduces death from lung and heart disease. In fact, "Quitting smoking before age 40, and preferably well before 40, gives back almost all of the decade of lost life from continued smoking."

As for damaging the growing fetus, pregnant women use to nicotine patches to stop smoking. In fact, compared to infants whose mother smoked infants born to women who used nicotine patches had higher rates of 'survival without developmental impairment’. Additionally, "nicotine patch replacement therapy also decreased the risk of prematurity and small for gestational age."

Indeed, while the WHO has bungled its response to the coronavirus, SARs, Avian Flu, Ebola, and tuberculosis outbreaks, it has waged an aggressive, unscientific campaign against e-cigarettes. It regards e-cigarettes not as less lethal alternative to smoking, but as a Trojan Horse built by tobacco companies to enslave billions more to nicotine. 

The WHO's latest act of fearmongering was prompted by the Phillip Morris Inc., UnSmoke Your Mind"campaign. The effort is designed to get people to stop smoking and providing people who can't quit a technology-based solution to reduce the harms of cigarettes. 

PMI developed and markets a smoke free product called IQOS which heats the tobacco without combusting, In application to the Food and Drug Administration, (which designated the product as a modified risk tobacco product) PMI demonstrated that lower temperature and lack of combustion reduces the levels of chemicals released compared to those released in cigarette smoke. 

As part of the Unsmoke initiative, PMI wants to get 40 million people who use cigarettes but are unlikely to quit smoking to switch to a smoke-free product. In fact, the IQOS is rapidly reducing cigarette sales in Japan, at the expense of PMI cigarette brands such as Marlboro. That's consistent with US data showing that a decline in smoking was 2-4 times fast after 2014 as vaping became more prevalent.  As for claims that people are trading one addiction for another, a recent randomized trial found that 18% of those assigned to use e-cigarettes were smoke-free after a year, compared with 9.9% of using other nicotine replacement therapies such as patches and gum. 

Yet the WHO claims the Unsmoke effort, along with the e-cigarette generated decline in cigarette smoking, is part of a well-funded covert Big Tobacco strategy that has the “goal of weakening tobacco control." In addition to peddling falsehoods about smoke free products, the WHO is also planning to push for vaping bans around the world this coming year.  To help lead the fight, the WHO’s agency for developing such proposals – the Framework Convention on Tobacco Control (FCTC) -- elected Iran (who the WHO may not realize is a state sponsor of terror) as its chair. Indeed, Iran and WHO appear to take the same approach to truth in their crusade against smoking: The Iranian Anti-Tobacco Association claimed that PMI is a Zionist company smuggled Marlboro cigarettes into Iran laced with pig blood and nuclear material. 

The WHO's sluggish response to epidemics and its fearmongering against e-cigarettes reflect the values and politics of the agency as well as the fact that it functions mainly as a launching pad for the pet agendas of donors and public health technocrats.  As an article in the Independent notes: "WHO has moved from being a global health ambassador to a pernickety lifestyle watcher, campaigning on subjects like sugar taxes, obesity and (via the Framework Convention on Tobacco Control) for a global ban on e-cigarettes, for plain cigarette packaging, and against the effects of smoking in films. At an anti-tobacco conference last year, it left itself open to accusations of censorship after banning the press."

Pandemics cause hundreds of thousands of deaths each year.  Nearly 8 million people die from smoking-related diseases in same time period. Telling people e-cigarettes are as lethal as smoking is like saying that vaccines being developed to prevent the coronavirus are as dangerous as the disease itself.  The WHO war of misinformation against vaping, much like its tardy response to the coronavirus, can be deadly.

   Read More & Comment...

AARP Can Stop Rx Greed By Not Screwing Seniors

02/06/2020 12:20 PM | Robert Goldberg

In advance of the 2020 election, AARP has launched a Stop Rx Greed campaign that is demanding elected officials and candidates “crackdown on price gouging and the greedy practices that keep prices artificially high.”

That’s a noble objective.  But if AARP wants to crack down on such behavior, it should start with its own profiteering. 

AARP is a for-profit financial juggernaut with $4 billion in assets (including $365 million in cash) that generates nearly $1 billion a year in fees and royalties from marketing Medicare Part D prescription drug and health plans for United Healthcare.
  
 AARP- United Healthcare Medigap plan (insurance that covers certain drugs and other expenses not covered by the traditional Medicare program) currently serves 4.9 million seniors nationwide through various Medicare Supplement products in association with AARP. With 34 percent of the market, AARP is the largest Medigap insurer in the country. That’s three times the share of its closest competitor Mutual of Omaha.

Anyone who buys Medigap insurance knows,  premiums keep climbing.  Yet AARP doesn’t use its buying power to help offset such increases. Instead, nearly 60 percent of AARP’s total revenues— $940 million - comes from a 4.95% rebate paid to them by United Health Care and other insurance companies who license the AARP name to sell Medicare supplemental plans and other insurance products.  In fact, the 4.9% rebate is the single largest expense of United’s Medigap program and more than double the 1.85% profit that UnitedHealthcare makes on the insurance product.

Next, AARP also collects premium payments for United Healthcare.  It holds the payments for 31 days. During that time, AARP invests the money in real estate, hedge funds, bonds and stocks before transferring the money to United. All told, AARP collected $11.8 billion in premium dollars in 2018. It has used that money to build a portfolio of about $4 billion in net assets that generate about $300 million a year in cash, tax-free.

AARP also gets a flat fee for sponsoring United HealthCare  Medicare part D  and Medicare Advantage plans.  Both forms of insurance have the largest share of their respective markets. Such plans get cash rebates from drug companies in exchange for covering specific medicines. Those rebates don’t reduce the out of pocket cost of drugs patients take.  Indeed the biggest portion of rebates come from expensive new drugs used by people with life-threatening conditions such as cancer, autoimmune diseases, and HIV.   Patients taking such medicines don’t get to use rebates to reduce their spending.  Indeed, AAPR plans require them to pay up to 40 percent of the retail cost of such medicines.   

And the rebates don't reduce premiums either: While the Stop Rx Greed campaign claims drug prices are skyrocketing rebates reduced net brand drug prices by 52 percent between 2014-2019   Meanwhile, AARP Medicare Part D premiums jumped by 68 percent during the same time period. 

The campaign criticizes the rising price of insulin medications.  But AARP plans do not cover Basaglar a less expensive biosimilar version of brand-name insulin’s, Lantus.  The retail price of Lantus has increased, but the net price has fallen due to rebates, which the AARP part D plans pocket.  It covered Neulasta, a drug that boosts the immune system of cancer patients, that retails for $6100 a month but not biosimilars  Udenyca and Fulphila which retail for $4100. 

Even when they cover generic versions of high-priced brand drugs,  AARP plans still have seniors pay up to a third of the retail price of medicines. AARP plans cover a brand drug for  versions hepatitis C called Epclusa as well as its generic formulation. It turns out that the post-rebate prices of these drugs are about the same.  As a result, AARP plans will maximize the spread between list and net prices even when generics are available.

You would think that AARP and its campaign support passing rebates dollars to patients.  Think again.  AARP aggressively lobbied against government regulations that would have required part D plans to use rebates to reduce out of pocket costs.  Then again, AARP makes billions from plans that profit by forcing the sickest patients to pay the most. Perhaps before campaigning against price gouging, AARP should first stop screwing the consumers they claim to represent.   



   Read More & Comment...

Follow the Money

01/14/2020 07:50 PM | Peter Pitts

Nearly 50% of Brand Medicine Spending Goes to the Supply Chain and Others

Nearly half of total spending on brand medicines – the sum of all payments made at the pharmacy or paid on a claim to a health care provider – went to the supply chain and other entities in 2018, according to a new analysis from the Berkeley Research Group (BRG). This transformative research shines a spotlight on the misaligned incentives in the supply chain and underscores the need to fix the rebate system.

BRG found that hospitals, health insurers, pharmacy benefit managers, the government and others got nearly 50% of what was spent on brand medicines in 2018, up from 33% five years prior. By contrast, innovative biopharmaceutical companies that research, develop and manufacture medicines retained just 54% of total point-of-sale spending on brand medicines.

According to the analysis, the share of total spending on brand medicines that biopharmaceutical companies retain has been steadily declining as rebates and discounts have increased. Between 2015 and 2018, the amount innovative biopharmaceutical companies retained from the sale of brand medicines increased, on average, 2.6% annually, in line with inflation. In this same timeframe, companies brought nearly 200 new innovative treatments and cures to patients.

Meanwhile, nearly half of the increase in the total amount spent on brand medicines went back to payers during this same time period. And 20% of the overall increase went to hospitals, pharmacies and other health care providers, which is the same amount that went to biopharmaceutical companies that research, develop and manufacture medicines.
The amount hospitals, pharmacies and other health care providers retained on the sale of brand medicines nearly doubled between 2013 and 2018, increasing from $24.7 billion to $48.6 billion. This trend was primarily driven by unprecedented expansion in the 340B drug pricing program. In fact, the amount hospitals and other 340B entities retained from the sale of brand medicines purchased through the 340B program was 9 times larger in 2018 than in 2013.
We are committed to ensuring patients benefit from significant discounts and rebates at the pharmacy counter, and this analysis reaffirms the need to look at the entire supply chain to fix misaligned incentives. We must work to fix the broken rebate system, as well as programs like 340B, to lower out-of-pocket costs and solve patient affordability challenges.

The full study from BRG can be viewed here.
   Read More & Comment...