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Latest Drugwonks' Blog

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.
 
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.




 

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.      

 

POTUS gets a Warning Letter

  • 04.06.2020
  • 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.
 
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/

 

Making America Resilient

  • 03.20.2020
  • 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.
 

Getting RESULTs Against Coronavirus

  • 03.18.2020
  • 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.

 

Part D Rebates: Nothing but Net

  • 03.18.2020
  • 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.
 

Playing the Spread

  • 03.13.2020
  • 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.
 

Vaping Has Its Wakefield Moment

  • 03.12.2020
  • 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. 

 
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Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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