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Harm-Reduction

Narcos 3.0: Mexico declares War on Vaping and repeats old prohibitionists mistakes

When Mexico’s far-left President Andrés Manuel López Obrador (or short AMLO) ran for office in 2018, he and his platform promised an end to the decade-long war on drugs in Mexico. He acknowledged that prohibitionist policies cause more harm than they do good. Ironically that same President issued a surprise presidential decree on February 19 banning the import of e-cigarettes, vapes, and heated tobacco products. The order even forbids the import of nicotine-free vaping liquids.

The Presidential decree relies heavily on scare tactics, invoking the U.S. “vaping crisis” to justify Mexico’s ban. But even the U.S. CDC and AMLO’s decree concede the “vaping crisis” was actually caused by illicit black market vaping liquids. Pushing Mexican vapers to the black market will exactly cause what the order claims it is trying to prevent: more lung diseases.

Even before this decree, Mexico had opaque vaping regulations, that had to be clarified by a supreme court ruling and allowed at least certain manufacturers to sell e-cigarettes to the country’s roughly 1.2 million vapers.

These vapers are now being left alone with no access to nicotine products that are less harmful than conventional cigarettes, and that in times of lockdowns and people spending most of their week at home thanks to COVID. Two scenarios are most likely to happen if the decree does not get annulled:

  • Narcos 3.0: Mexico has a well developed black market for illicit substances, and, as regular Netflix viewers know, it serves as a massive transit hub for the global drug trade. It wouldn’t take much for organized crime to either smuggle legal vaping products from neighboring countries into Mexico and sell them on the black market or (even more concerning) sell counterfeited vaping liquids to Mexican vapers. The vaping crisis in the United States, which the Presidential decree instrumentalizes for its ban, was caused by illicit black market vaping liquids. Pushing Mexican vapers to the black market will exactly cause what the order tried to prevent: More lung diseases. 
  • Back to the ciggie: Even is the more dramatic scenario of a booming vaping black market might not come true (mainly due to the low margins on nicotine products compared to Cannabis or Cocaine), we would still see over a million vapers left behind. It is more likely that most of them will switch back to smoking regular cigarettes instead of switching to nicotine patches or entirely quit. That, in turn, would also lead to worse public health outputs.

We can see that AMLO’s decree will have serious, negative unintended consequences contrary to its own objectives.

Perhaps the most concerning is that the World Health Organization lauded Mexico’s vaping ban as a public health achievement, it fails to recognize that Mexico’s anti-vape stance will keep smokers and nicotine consumers locked in with combustible cigarettes. This policy deprives them of the choice to switch to the 95% less harmful vapes. The Consumer Choice Center’s interactive vaping map shows that up to 3.3 million additional Mexican smokers could switch to vaping if the government would emulate the UK’s progressive and science-based vaping laws.

 

Better vaping policies could help millions of Mexicans

So instead of cracking further down on vaping, Mexico should embrace tobacco harm reduction. Due to COVID and the parliamentary schedule, the Mexican Congress is currently out of session. Still, there is a window for legislative action when Congress returns to operation in the fall.

Consumer groups, vaping advocates, and the scientific community need to use this window of opportunity to explain more Mexican politicians and regulators the benefits of vaping and help busting myths around the United States’ vaping crisis. Initial protests against this misguided decree started already in March. This multi-lingual paper on the Myths and Facts on Vaping, written by my colleagues Yael Ossowski and Bill Wirtz explains the reasons behind the perceived vaping crisis in the US and is also available in Spanish. Probably an essential message in this paper for politicians is this one:

“MYTH #3: VAPING IS THE CAUSE OF RECENTLY REPORTED RESPIRATORY ILLNESSES

Much cause for concern of late has been a flurry of reports of illness and hospitalizations blamed on traditional vaping devices and liquids. The CDC has reported nearly 380 cases of lung illnesses related to vaping. Sensational headlines and opinion articles have convinced leaders in several states and even President Donald Trump to consider banning vaping flavors outright.

But careful analysis of the reported cases reveals that a vast majority of the patients with symptoms were found to have used illicit vape cartridges mixed with the cannabis compound THC. 

A study in the New England Journal of Medicine that examined cases in Illinois and Wisconsin found that 84% of hospitalized patients report using illicit THC vaping cartridges prior to their illness. No illnesses have yet been tied to store-bought vaping pods or liquids containing nicotine.

To that end, two Wisconsin brothers were recently arrested in connection with a multi-million dollar operation that mixed various chemicals (including Vitamin E) with THC in cartridges meant for vaping devices, which they then sold illegally. Authorities have identified this large scheme spread across much of the Midwest as a culprit in the recent lung illnesses there.

What this reveals is that illicit vaping products sold on black markets, rather than licensed retailers, have actually caused the most severe of the lung illnesses reported in the media. 

As such, a ban on regulated devices and liquids, whether with flavors or not, would not address the problem as it currently exists.

By pushing vaping into the black market and Mexican vapers going back to the cigarette, AMLO will (despite the thunderous applause from the World Health Organization) further weaken Mexico’s public health outputs. If he is passionate about fighting lung diseases he should make access to legal and safe ways of consuming nicotine easier and not harder. Everything else is just a stimulus program for organized crime and lung specialists.

Western Standard

Alberta’s new vape laws will discourage smokers from making the switch

For every vape pod not purchased, 6.2 extra packs of cigarettes were purchased instead.

Alberta’s new vaping regulations are a huge step backwards for harm reduction, and ultimately public health. This week, Health Minister Tyler Shandro announced that Alberta – in an attempt to curb youth vaping – will move to regulate vaping in the same manner as cigarettes, which includes age restrictions, restrictions on where consumers can vape, where advertising can be displayed, and possibly a ban on flavours.

It should be clearly said that vaping products are harm reduction tools for adult smokers, and that curbing youth access is a noble and worthy cause. That said, beyond the age restriction, Alberta’s approach to vaping is bad public policy.

First off, the provincial government has now shown that it is incapable of regulating based on the risk associated with a product. We know from credible public health agencies like Public Health England that vaping is at least 95 per cent less harmful than smoking. Because of that, vaping should be regulated in a different manner, one that recognizes the continuum of risk. Regulating vaping like smoking is problematic because it sends the wrong signal to adult smokers, primarily that vaping and smoking are of equivalent harm. By sending this false message to consumers, it can be expected that fewer smokers will make the switch to vaping, which is a net negative for public health, society at large, and more importantly, adults who are trying to quit cigarettes or consume nicotine in a less harmful way.

Take in store displays for example. In Alberta, cigarettes are purchased (mostly) at convenience stores where they are behind a screen so that products cannot be seen. Unfortunately, Alberta’s new regulations apply that same restriction to vaping products. Allowing for modest forms of in-store display will help prompt and inform adult smokers that reduced risk products exist, and will increase the likelihood of them making the switch. In order to encourage smokers to make the switch they have to know that these products exist, and the best way for them to acquire that information is at the point of sale where they traditionally purchase cigarettes. By placing all vaping products out of view, they will largely be out of mind for the 15.8 per cent of Albertans who currently smoke.

The same goes for the prospect of a flavour ban, which Alberta is now paving the way for with its new regulations. A ban on flavours, while done under the banner of curbing youth access and use, would hurt adult ex-smokers the most. Harm reduction research on the usage patterns of adult vapers – who were former smokers – shows that the availability of flavours is a significant factor in their decision to switch from smoking to vaping. In evaluating the purchases of over 20,000 American adults who vape, researchersconcluded that prohibiting non-tobacco flavoured vapes would significantly discourage smokers from switching.

While these arguments may seem like hypotheticals to some, figures from the UK have shown us in real time, the impact a harm reduction approach has on smoking cessation. The United Kingdom is arguably the leader in embracing vaping as a harm reduction tool and as a means to steer adults away from smoking. So much so that over1.5 million people in the UK have completely switched from smoking to vaping. In addition to that, 1.3 million people in the UK used vaping as a means to quit smoking, and no longer vape or smoke. Because of the UK’s harm reduction approach, 2.8 million British have switched away from cigarettes, or quit altogether.

These regulations are further compounded by Alberta’s misguided 20 per cent vape tax, which further discourages smokers from switching. Supporters of the tax will argue that an increase in the price of vape devices will reduce the amount of people who vape. This is true, however it also has the consequence of increasing the amount of people who smoke cigarettes.  Research from theNational Bureau of Economic Research, evaluating 35,000 retailers, showed that every 10 per cent increase in vaping price resulted in a 11 per cent increase in cigarette purchases. In terms of product sales, this means that for every vape pod not purchased, 6.2 extra packs of cigarettes were purchased instead. This is exactly the opposite of what public health officials should be encouraging via public policy.

While youth vaping is a problem – and one that needs to be addressed – it is important that the government doesn’t sacrifice adult smokers trying to switch or quit in the process. Regulating vaping like cigarettes ultimately means that more Albertans will continue to smoke, which certainly isn’t anything worth celebrating.

Originally published here.

The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

Western Standard

NEWSUCP brings in new law aimed at vapers and smokers

The UCP government is cracking down on smoking and vaping after consulting with more than 10,000 Albertans.

Bill 19, the Tobacco and Smoking Reduction Amendment Act, follows a review of the Tobacco and Smoking Reduction Act led by MLA Jeremy Nixon in response to the increase in vaping, smoking and tobacco use in Alberta. 

Alberta is the only province without vaping legislation.

Teen vaping rates (used in past 30 days) surged from eight per cent in 2014-15 to 22 per cent in 2016-17 and to 30 per cent in 2018-19 (Grades 10-12).

“The proposed act specifically addresses youth vaping, and would add enforceable restrictions on the possession, promotion, display, sale and use of these products, in alignment with tobacco laws. It would also include the expansion of smoke and vape-free areas, especially at places frequented by children and youth,” the government said in a release.

Albertans who smoke or vape also appear to be at higher risk of developing more severe symptoms if they contract COVID-19. The government didn’t provide any medical evidence to back up that statement.

The proposed new legislation says:

  • Minimum age for purchasing, possessing or using vaping products would align with tobacco products (18 years and older).
  • In convenience stores and gas stations, vaping displays, advertisements and promotion would need to align with tobacco restrictions.
  • Aligning places where vaping and tobacco products can not be used will reduce confusion for the public and law enforcement. New places where vaping and smoking will not be allowed include:
    • on hospital, school or child care properties
    • on playgrounds, sports or playing fields, skateboard or bicycle parks, public outdoor pools or splash pads, zoos and outdoor theatres
  • Restrictions on the locations of vaping product sales will align with tobacco restrictions, and include:
    • health facilities
    • public post-secondary institutions
    • stores where pharmacies are located
    • vending machines or temporary facilities
  • Alberta’s proposed legislation will establish the authority to consider restrictions on flavoured vape if it is not covered by potential federal legislation.

“This proposed legislation sends a strong message to youth, and anyone who thinks it is OK to supply them with vaping products – there will be fines for possession and consumption. Selling or giving these products to minors will have consequences. Reducing health harms by keeping vaping products out of the hands of youth is a priority for both me and this government, and it’s what Albertans asked us to do,” said Health Minister Tyler Shandro.

But the moves were slammed by David Clement, the North American Affairs Manager for the Consumer Choice Center.

“Alberta’s regulations are a huge step backwards from the perspective of harm reduction. Simply put, regulating vaping on par with cigarettes shows that the government is incapable of regulating based on the risk of each product,” Clement told the Western Standard.

“We know, from credible health agencies like Public Health England, that vaping is 95 per cent less harmful than smoking, which is why the rules around vaping should not be as strict as cigarettes. More importantly, regulating vaping like smoking discourages adult smokers from making the switch and quitting cigarettes, which is a net negative for public health.”

Addiction to tobacco products is the leading cause of preventable illness, disability and death in Alberta and yet the prevalence of smoking in Alberta is second highest in Canada.

Health costs for Alberta as a result of the use of tobacco products are estimated at $6 billion over the next four years.

In 2018-19, 15.6 per cent of Albertans aged 18 or older indicated they smoked cigarettes daily or occasionally.

“We thank the Alberta government and the Minister of Health for introducing legislation to help curb the youth vaping epidemic. Effective vaping legislation will be aligned with existing tobacco legislation to the greatest extent possible in order to provide maximum protection for youth. The Tobacco and Smoking Reduction Act has contributed to achieving the lowest smoking rates among adults and youth on record in Alberta,” said “Les Hagen, executive director, Action on Smoking & Health.

In October, Nixon was tasked by Shandro with reviewing Alberta’s smoking and vaping laws.

“Thank you to everyone who participated in our consultations, wrote in, or completed our survey. Your insights and solutions were truly inspiring. Bill 19 reflects the feedback we received and ensures that we are taking the right steps to protect our youth from both the known and yet-to-be-known harms of vaping,” said Nixon

In February, the government put a 20 per cent tax on vaping products.

“This legislation is long overdue and serves as an additional deterrent to limit young people’s access to harmful vaping products. School boards across Alberta welcome additional restrictions that will keep our children safer and healthier at school and in their communities,” said Lorrie Jess, president, Alberta School Boards’ Association.

According to Budget 2020, the goal of the tax is to discourage usage, especially among youth who will hopefully see the increased cost as a deterrent from either picking up or maintaining their vaping habits.

Alberta will became the fourth province in Canada to tax vaping products, along with with Nova Scotia, B.C. and Saskatchewan.

Officials have said every 10 per cent hike in the price of tobacco, researchers have noted an eight to 12 per cent decrease in use among youth.

The government expects the new tax will not only discourage youth vaping, but also net the province $4 million in 2020-21 and a total of $8 million by 2022-23.

Originally published here.

The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

In light of COVID-19, what does banning flavored vaping achieve?

The nation is focused on containing a virus of mass proportions and mitigating the disastrous economic consequences of lockdowns.

But that didn’t stop Gov. Andrew M. Cuomo from cheerily pushing his flavored vape ban in the state budget passed a few weeks ago in Albany.

This follows Cuomo’s September 2019 emergency ban on vaping flavors, excluding tobacco and menthol, later struck down by the State Supreme Court because the governor “exceeded” his authority.

Now passed by the State Legislature, the new measure prohibits the sale of tobacco and vaping products in pharmacies, bans online sales, and restricts vape shops from selling any vaping liquid but tobacco flavor.

Move over drug dealers, flavored vapes are the new hot product to sling on the streets.

At a time when New York’s hospitals are overburdened with coronavirus patients, is this really the time for a ban that effectively creates a novel black market for unregulated flavored vaping products?

Demand for flavored vapes by responsible adults, the majority of whom are former smokers trying to consume nicotine in a less harmful way, may disappear from storefronts, but it’ll easily be replaced and sourced by street dealers with a new customer base.

The governor and his allies claim the measure was necessary to prevent teen vaping and lung illnesses, but that’s false on two counts.

First, this measure punishes adult smokers who’ve found alternative products to protect kids who seek out risky products — as they’ve always done. Mind you, the state hates flavored vapes, won’t dare touch alcohol ice cream cones, and is considering legalizing cannabis in the next few months. The hypocrisy is blaring.

Shops selling vapes to kids were already breaking the law but not getting penalized. Rather than outsourcing the product to the black market — where dealers don’t ask for ID — we should implement harsher penalties on shops that sell to underage kids. Simple.

When it comes to lung illnesses caused by vaping, the CDC has repeatedly stated this was the result of illegal vape cartridges containing THC, not nicotine. This is like banning Bud Light in hopes of tackling the running of moonshine.

By banning nicotine vaping flavors, New York is inviting yet more bad actors to produce their own products, beyond the purview of regulations and safety. Could we see a new wave of lung illnesses due to these bootleg products already found on the street?

Perhaps the state would focus more on the very real pandemic it is facing rather than trying to crack down on products that responsible adult users depend on to quit smoking.

As late as February, Cuomo was lauding his anti-vaping efforts as “leading the nation in confronting this new and deadly epidemic.”

Little did he know he’d be consumed with a global pandemic of this magnitude just weeks later.

If you want to uphold public health, we must continue to fight for the legal production and sale of flavored vaping products.

Yaël Ossowski is deputy director of the Consumer Choice Center.

This article was originally published in Newsday

The Myth of the Vaping Crisis is Sparking a New War on Flavored Nicotine Products – And That Harms Consumers

Washington, D.C. – In the lull after impeachment, members of the U.S. House are pushing a bill to eradicate entire categories of flavored nicotine products.

This sweeping ban would target menthol tobacco, flavored cigars, snus, and vaping products.

Yaël Ossowski, Consumer Choice Center Deputy Director, said “The goal is to significantly reduce or eliminate youth use of these products, which is a noble pursuit. But unfortunately, the proposed bill would fall short.

“The proposed law comes in the wake of the much-hyped “vaping crisis” that transpired over the summer, in which thousands of individuals suffered lung damage from inhaling vapor products.

“In the end, the culprit was revealed to be illegal cannabis vaping cartridges loaded with Vitamin E acetate and not nicotine vaping products, according to the Centers for Disease Control,” said Ossowski.

“Despite those facts, the bill uses the debunked narrative on vaping to push a ban on unrelated items such as flavored cigars and smokeless products, and would outlaw menthol products that are used primarily in minority communities.

“This comes as both youth and adult-use of tobacco are at an all-time low. New harm-reducing technologies and education are already bringing down the use of tobacco in our country, and this bill does nothing but chase ghosts and punish responsible adult consumers,” said Ossowski.

Originally published here.

The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

The Myth of the Vaping Crisis is Sparking a New War on Flavored Nicotine Products – And That Harms Consumers

In the backdrop of a very busy Congress, members of the U.S. House are pushing a bill that would eradicate entire categories of flavored nicotine products.

This sweeping ban would directly harm consumers who use menthol tobacco, flavored cigars, snus, and vaping products by outlawing the products they use and pushing them to the black market.

The proposed law comes in the wake of the much-hyped “vaping crisis” that transpired over the summer, in which thousands of individuals suffered lung damage from inhaling vapor products, also called e-cigarette, or vaping, product use-associated lung injury (EVALI).

In the end, the culprit was revealed to be illegal cannabis vaping cartridges loaded with Vitamin E acetate and not nicotine vaping products, according to the Centers for Disease Control.

Read the Consumer Choice Center Policy Primer: Myths and Facts on Vaping: What Policymakers Should Know

Though scientific experts correctly identified the cause of the injuries – black market THC cannabis vape cartridges – that hasn’t stopped legislators from using that pretext to introduce new prohibitions on flavored tobacco products used responsibly by adult consumers.

H.R. 2339, named the Reversing the Youth Tobacco Epidemic Act of 2019, proposes several sweeping changes to flavored consumer products and is expected to soon hit the House floor for a vote.

The bill would outlaw the following:

  • Menthol products
  • Flavored cigars and cigarillos
  • Flavored smokeless tobacco, known as snus or dip.
  • Some flavored vaping products

The goal is to significantly reduce or eliminate youth use of these products, which is a noble pursuit.

But youth smoking is at an all-time low

Fewer young people than ever are using traditional tobacco products – less than 2.3%. That’s a significant decline since the year 2000, where nearly 15% of minors smoked cigarettes, according to the CDC.

  • This represents a public health victory, and one that has been achieved with sensible education, regulation, and innovation. The same is true for adult smokers. Just 13.7% of adults currently smoke, the lowest number ever recorded.
  • The latest CDC figures show that 20.8 percent of high schoolers have vaped at least once in the last 30 days. But 7 to 8% of those were vaping cannabis rather than nicotine.
  • A total flavor ban on all tobacco products and vaping products for adults would do little to curb use among youth.
  • It may even exacerbate the problem and only punish lawful adult consumers and deprive them of their choice, not to mention devastate the communities that rely on tobacco taxes to fund important social programs.

What’s more, by categorizing non-tobacco vapor products as tobacco products, House members are attacking the very innovation that has led to the lowest-ever figure of recorded tobacco use.

Prohibition Hasn’t Worked

The 100-year anniversary of the passage of Prohibition of alcohol took place last month.

  • All these years later, we know that outlawing certain consumer products does not eradicate their existence. Rather, it moves them from the legal, regulated market to the illicit and unregulated black market.
  • This makes the products themselves less safe, and the trade around those products even more dangerous.

After an entire nation had awoken to the disaster of Prohibition, it was successfully repealed in 1933.

Minorities are more likely to use menthol products

According to the CDC, African-Americans who use tobacco are 90% more likely to favor menthol products and represent the vast majority of consumers in the flavored tobacco market.

  • A ban would create an illicit market without regulations or ID checks
  • Such bans would then force police officers to crack down on illicit menthol cigarette trade, further straining relations between the African-American community
  • As seen in the case of Eric Garner, who was choked out by a police officer and later died in New York City for selling loose cigarettes on the street, bans and restrictions that create illegal markets can lead to devastating consequences.
  • If a law bans menthol and flavored tobacco products, the demand wouldn’t disappear.

Rather, it would be pushed into the unregulated market, siphoning away tobacco taxes and incenting police officers to use their power to enforce laws in minority communities.

Age-restriction by law is a powerful means of dissuading youth use

By penalizing convenience retailers that sell to minors, regulators have already created a significant barrier to youth access.

  • This allows law enforcement to prosecute bad actors and focus their efforts on illicit markets where dealers don’t ask for ID.
  • Recently, Congress’ raising of the age to purchase tobacco and vaping products to 21 years old also dissuades youth use, ensuring no high schooler will be able to legally purchase these products.
  • Nearly half of tobacco and vape shops don’t ID young customers.

Enforcing existing laws on youth access, including prosecuting shops that don’t check ID, are a powerful means of keeping youth away from tobacco products.

Bans Deny the Science on Harm Reduction by Vaping and Smokeless Products

For many adult smokers looking to quit, vaping products have been proven key to harm reduction.

  • About 4.4% of adults, nearly 11 million, are now using vaping devices
  • National health bodies around the world, including Public Health England, the New Zealand Ministry of Health, and Health Canada have endorsed vaping as a smoking cessation method.
  • The U.K.’s top health body has repeatedly said that vaping and e-cigarettes are 95 percent less harmful than smoking.
  • Bans that include flavored vaping products would deprive adult smokers of a less harmful method of consuming nicotine

We all have an interest in eliminating the number of young people who take up smoking. But counterintuitive bans would make that goal harder, not easier to achieve.

And depriving adult consumers of harm reducing technologies like flavored vaping products will reserve the decades of public health successes.

Let’s hope our members of Congress consider these facts before they vote on H.R. 2339.

Download the full policy note here.

Yes, The FDA Is In Trouble, But The New York Times’ Prescription Would Make It Worse

The FDA’s failures are a result of too much regulatory dithering and bureaucracy. Yet the Times’ prescriptions for change would just increase the dose.

A recent New York Times editorial about the Food and Drug Administration (FDA) reflects a systematic weakness at the once-venerable Gray Lady: The members of the editorial board often rely on sloganeering and popular wisdom instead of substantive evidence.

The editorial was headlined, “The FDA Is in Trouble. Here’s How to Fix It.” The agency is in trouble. But it’s due to the very kinds of “fixes” the Times recommends.

The FDA is highly bureaucratic and risk averse, leading to a slow and expensive drug approval process—at last count, more than $2.5 billion to bring a new drug to market. Yet the armchair quarterbacks at the Times want to slow it down even more and increase the cost and risks of innovating.

Supposedly, too many drugs are being approved “with too little data on how safe or effective they are,” according to the editorial. More specifically, regulators have supposedly made “compromises” by accepting “surrogate evidence” of efficacy.

In fact, there are good reasons that the clinical testing of new drugs can be accomplished with fewer and smaller trials. We are entering the era of precision, or personalized, medicine, the mantra of which is “the right dose of the right drug for the right patient at the right time.”

It reflects that treatments are gradually shifting from a relatively imprecise one-size-fits-all approach to a more personalized one, so patients can be matched to the best therapy based on their genetic makeup, the specific characteristics of their illness, and other predictive factors. This enables doctors to avoid prescribing a medication that is unlikely to be effective or that might cause serious side effects in certain patients.

How Smaller Trials Can Be More Accurate

The editorial ignores that those factors make possible drug testing in smaller, better-targeted populations. That is not a completely new concept. Under appropriate circumstances, the FDA has long used fewer and smaller clinical trials as the basis for approval.

What makes that possible is that medical research is increasingly discovering biological indicators, or “biomarkers”—such as variants of DNA sequences, the levels of certain enzymes, or the presence or absence of drug receptors—that can dictate how patients should be treated and to predict the likelihood that the intervention will be effective or elicit dangerous side effects.

Using biomarkers enables drug companies to better select patient populations for clinical trials to demonstrate efficacy. The reason is related to the statistical power of clinical studies: In any kind of experiment, a fundamental principle is that the greater the number of subjects or iterations, the greater the confidence in the results. Conversely, small studies generally have large uncertainties about results—and that is where biomarkers can make a difference.

By better defining the experimental groups, such as limiting the trial only to patients with a certain mutation in their genome or tumor, they can help drugmakers design clinical studies that will show “a high relative treatment difference” between the drug and whatever it is being compared to (often a placebo, but sometimes another treatment).

For example, a 2018 study of patients with certain rare pancreatic or gastrointestinal cancers found that analyzing the “protein-signaling networks” in the tumors could identify regulators of tumor survival. The researchers were then able to test the effect of various drugs on these regulators. That enabled them to predict in many patients which drugs would be effective in the tumors—the kind of precision oncology that makes possible smaller clinical trials.

Whiffing on Needed Critiques of the FDA

The Times editorial faulted the FDA for “its roles in the opioid epidemic (regulators allowed too many opioids on the market without properly flagging them as addictive or deadly),” but, in fact, the regulators did ensure that the drugs were safe and effective when used according to the labels, which do, in fact, warn about addiction potential. Analogously, can the Bureau of Alcohol, Tobacco, Firearms and Explosives be blamed for many Americans suffering from alcoholism?

Criticizing the FDA for its handling of e-cigarettes is easy. But the Times editorial even got that wrong, echoing the calls of prohibitionists to ban the sale of these products to adult smokers, rather than aggressively enforcing the existing ban on sales to minors.

The Times could have landed a powerful science-based critique of the agency for perpetuating the activist-created myth that nicotine e-cigarettes had anything to do with the past year’s lung disease outbreak, which was caused by adulterated THC oils, not nicotine vapes. By incorrectly blaming e-cigarettes for the illnesses, the FDA’s misinformation prevented countless adult smokers from switching to a truly less harmful alternative. The Times failed to hold the agency accountable for not telling the truth when it mattered most.

The Times editorial accuses the agency of having become “too susceptible to outside pressure,” which most FDA-watchers find to be groundless. If FDA has favored any special interests, they are “progressive” ones, including the organic food industry, which has systematically violated regulations concerning “absence claims” on labels (such as “GMO free”), and by acceding to the demands of “public health advocates” who reject harm reduction policies toward e-cigarettes. The remedy for such failings is better, smarter management.

The FDA Needs a Diet, Not More Money

The Times editorial claims the FDA “has too few resources and too little power to fulfill its key responsibilities.” The facts argue otherwise. According to the Congressional Research Service:

Between FY2015 and FY2019, FDA’s enacted total program level increased from $4.507 billion to $5.725 billion. Over this time period, congressionally appropriated funding increased by 21%, and user fee revenue increased by 35%. The Administration’s FY2020 budget request was for a total program level of $5.981 billion, an increase of $256 million (+4%) over the FY2019 enacted amount ($5.725 billion).

More important than the raw numbers is how FDA’s resources are being used. The agency has become extremely top-heavy, with ever more boxes appearing at the top of the organizational chart, even though the vast majority of day-to-day oversight and regulatory actions are taken at the level of FDA’s various “centers”—the Center for Drug Evaluation and Research, Center for Food Safety and Nutrition, and so on. The FDA needs to be put on a diet, not to have additional “resources.”

The Times editorial endorsed a recent proposal to convert FDA from a component of the Department of Health and Human Services to an independent agency. That would be a prescription for disaster. Political meddling with the agency’s decisions has been extremely rare in recent years, and the genuine calamities in which the FDA has been involved have been self-inflicted wounds that might have been avoided with more, not less, accountability and oversight.

Three distinguished former federal officials presented in the journal Health Affairs compelling procedural arguments against making FDA an independent agency. As an independent agency, they said, FDA would not be bound by the policies of the Department of Justice, potentially leading to inconsistent positions being taken by different parts of the government on issues that could include foreign policy.

Furthermore, they point out, applying a consistent approach to rulemaking as required by working within Health and Human Services and Office of Management and Budget strictures is a useful check on highly expensive or wrong-headed regulation. “It’s also a way that Congress and the president can ensure consistency across government in the application of expertise in regulatory policy,” they wrote.

The FDA’s failures are a result of too much regulatory dithering and bureaucracy. Yet the Times’ prescriptions for change would just increase the dose.

Originally published here.

The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

E-Zigarette: Dem süßen Dampf eine Chance geben

E-Zigaretten und „Heat-not-burn“-Produkte erlauben weniger schädliche Wege Nikotin zu konsumieren, geraten allerdings zunehmend unter politischen Druck. Von unserem Gastautor Bill Wirtz.

Sie sehen aus wie USB-Sticks oder Feuerzeugasbehälter, riechen oft süß und stoßen manchmal große weiße Wolken aus. Viele Ex-Raucher machten den Sprung weg vom Glimmstängel zu E-Zigaretten. Dieses dampfende Produkt profitiert von motivierten Befürwortern und leidet unter uninformierten Politikern. Die Frage im Vordergrund bleibt, ob diese Alternative besser für Raucher ist.

Die Aussage, dass E-Zigaretten 95% weniger gesundheitsschädlich als konventionelle Zigaretten sind, stammt nicht aus einer Werbung von den Produzenten selbst, sondern von Public Health England (PHE). PHE ist Teil des britischen Gesundheitsministeriums und beschäftigt sich täglich mit den Gesundheitsfolgen von Konsumgütern.

Neuere Ergebnisse, die in den Annals of Internal Medicine veröffentlicht wurden, zeigen, dass langfristige E-Zigaretten-Nutzer, umgangssprachlich auch gerne Dampfer genannt, einen zwanzigmal niedrigeren Wert an krebserregenden Bestandteilen aufweisen. Dampfer zeigen auch viel niedrigere Werte für weitere tabakspezifische Giftstoffe, die zwei bis fünfmal unter denen der konventioneller Raucher liegen. Wer als Raucher Angst vor den möglichen Risiken einer Zigarette hat, kann E-Zigaretten-Flüssigkeiten (“e-liquids”) kaufen die lediglich Nikotin enthalten.

Doch wissenschaftliche Fakten schaffen es nicht immer in die öffentliche und politische Debatte. Für viele Gesundheitsaktivisten ist klar, dass auch bei diesen risikomindernden Produkten ein starkes Zeichen gesetzt werden muss. Resultat: Obwohl E-Zigaretten gänzlich andere Produkte sind, werden sie zunehmend wie Tabak reguliert. Der Kabinettschef des EU-Gesundheitskommissars Vytenis Andriukaitis, meint die Regulierung für E-Zigaretten in der Europäischen Union sollte gleich sein, wie die gewöhnlichen Tabaks. Er sagt dazu:

„Wir werden mit Fragen über gesündere Möglichkeiten etwas in die Lunge zu inhalieren bombardiert. Eine fremde Substanz in die Lunge zu bekommen, ist einfach nicht gesund.“

Oft wird bei Menge und Einnahmemedium kein Unterschied gemacht. So fallen ironischerweise auch die tabakfreien elektronischen Zigaretten unter die EU Tabakdirektive.

Bei der UN Welttabakkonferenz, die letztes Jahr in Genf stattfand, wurden E-Zigaretten explizit nicht als Alternative gepriesen. Ganz im Gegenteil, Anne Bucher, EU-Generaldirektorin für Gesundheit, sagte dort ebenfalls, dass es keinen Unterschied zwischen E-Zigaretten und konventionellen Zigaretten gibt.

Aus dem Nanny State Index on Nicotine des Institute of Economic Affairs geht hervor, dass Schweden, Großbritannien, Tschechien, Deutschland und die Niederlande die liberalste Politik gegenüber E-Zigaretten betreiben. Die Schweiz hingegen schneidet sehr schlecht ab, vor allem durch das Verbot gegen nikotinhaltige E-Zigaretten. Der Verkauf ist nicht erlaubt – importiert werden dürfen nur 150 ml alle 60 Tage. Norwegen wird diese Produkte demnächst erlauben (die Gesetzgebung ist hier bereits in Arbeit) und damit wird die Schweiz das einzige europäische Land sein, das ein komplettes Verbot pflegt.

Natürlich kann man sagen, dass man am Besten einfach ganz mit dem Rauchen aufhört. Doch komplette Abstinenz ist für viele Raucher einfach nicht möglich. Entweder weil sie es nicht wollen, oder weil die Aufgabe von Nikotin zu schwierig ist. Sogar in extremen Situationen, wie die erzwungene Einstellung des Rauchens im Gefängnis, zeigt sich, dass Inhaftierte auch nach mehreren Monaten in Haft, in der Freiheit wieder mit dem Rauchen anfangen. Wenn man „einfach aufhören“ könnte, würde die Empfehlung einen Arzt zur Rauchentwöhnung zu befragen (so wie es heute auf vielen Zigarettenschachteln steht), nicht sonderlich viel Sinn ergeben. Wir wissen inzwischen ebenfalls, dass das “vaping” bei der Rauchentwöhnung besser abschneidet als konventionelle Methoden wie z.B. Nikotin-Pflaster.

Wer nikotinhaltige E-Zigaretten verbietet, muss damit rechnen, dass Raucher wieder auf die normale Zigarette umsteigen. Und das kann ja nicht das Ziel moderner Gesundheitspolitik sein. Verbote von E-Zigaretten führen dazu, dass viele Verbraucher sich wieder dem altbewährten Glimmstängel zuwenden. Gerade Großbritannien zeigt, dass eine liberale Dampfpolitik die klassische Zigarette besser abgewöhnt. Zwischen 2011 und 2017 ist die Raucherzahl in Großbritannien von 19,8% auf 14,9% gesunken. Gleichzeitig stieg die Zahl der E-Zigaretten Nutzer: Fast die Hälfte dieser Verbraucher nutzen E-Zigaretten als Mittel zur Rauchentwöhnung.

Der Markt bietet Rauchern nun eine Alternative, die bezahlbar und angenehm ist und zudem noch weitaus geringere Risiken mit sich bringt. Anstatt alles zu tun, um diese Alternative mit Überregulierung zu überschütten, sollte die Politik Verbrauchern erlauben Zugang zu diesen innovativen Nikotinprodukten zu haben.

Originally published here.

The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

Trump’s Vape Pod Ban is Just Another New Year’s Hangover

Washington, D.C. – As millions of Americans awoke on New Year’s Day, we learned the Trump Administration and the FDA will soon present a ban on all flavors except tobacco and menthol in pod-based vaping devices.

Though the ban is not as sweeping as first rumored, it will still deprive millions of adults of the harm-reducing flavors they have enjoyed to switch away from using cigarettes.

Yaël Ossowski, deputy director of the D.C.-based Consumer Choice Center, said a ban of this magnitude is still bad public policy, and deprives adults of more options for harm reduction.

“To be clear, the new policy is less egregious than a blanket ban or a ban on the open systems favored by advanced vapers. But it still denies the science on harm reduction and the reality of using flavors to convince adults to switch to less harmful methods of consuming nicotine,” said Ossowski.

“Pod-based devices are popular among former smokers because they’re portable, easy to maintain, and provide just the right amount of nicotine and taste to keep them away from normal combustible cigarettes. Flavors are instrumental to that equation.

“The debate on flavors has been framed by the radical tobacco control groups who need a new enemy. It’s unfortunate that vaping, which has been proven to be 95% less harmful than smoking, will now become less available to the people who need it the most.

“The facts are on the side of those who champion harm reduction and consumer choice. And in this case, because of the myths peddled by well-funded tobacco control groups, an innovative technology that has saved and will save millions of people has been demonized.

“We have a system in our country to age-prohibit certain goods like alcohol and tobacco. Rather than taking away options from adult consumers, we should investigate why kids are getting their hands on their devices and pods in the first place, and concentrate resources there instead of resorting to outright bans.

“It’s more a question of enforcement than a question of whether flavors should exist at all.

“Yet more prohibitions will only embolden sellers and dealers on the black market, who were the main culprits in the much-hyped vaping “crisis” of last year, and unlike traditional retailers and vape shops, don’t ask for ID.

“We need to continue fighting for effective harm reduction, and that won’t end here,” said Ossowski.

Originally published here.

Trump’s Vape Pod Flavor Ban is Just Another New Year’s Hangover

Trump’s Vape Pod Flavor Ban is Just Another New Year’s Hangover


Washington, D.C. – As millions of Americans awoke on New Year’s Day, we learned the Trump Administration and the FDA will soon present a ban on all flavors except tobacco and menthol in pod-based vaping devices.

Though the ban is not as sweeping as first rumored, it will still deprive millions of adults of the harm-reducing flavors they have enjoyed to switch away from using cigarettes.

Yaël Ossowski, deputy director of the D.C.-based Consumer Choice Center, said a ban of this magnitude is still bad public policy, and deprives adults of more options for harm reduction.

“To be clear, the new policy is less egregious than a blanket ban or a ban on the open systems favored by advanced vapers. But it still denies the science on harm reduction and the reality of using flavors to convince adults to switch to less harmful methods of consuming nicotine,” said Ossowski.

“Pod-based devices are popular among former smokers because they’re portable, easy to maintain, and provide just the right amount of nicotine and taste to keep them away from normal combustible cigarettes. Flavors are instrumental to that equation.

“The debate on flavors has been framed by the radical tobacco control groups who need a new enemy. It’s unfortunate that vaping, which has been proven to be 95% less harmful than smoking, will now become less available to the people who need it the most.

“The facts are on the side of those who champion harm reduction and consumer choice. And in this case, because of the myths peddled by well-funded tobacco control groups, an innovative technology that has saved and will save millions of people has been demonized.

“We have a system in our country to age-prohibit certain goods like alcohol and tobacco. Rather than taking away options from adult consumers, we should investigate why kids are getting their hands on their devices and pods in the first place, and concentrate resources there instead of resorting to outright bans.

“It’s more a question of enforcement than a question of whether flavors should exist at all.

“Yet more prohibitions will only embolden sellers and dealers on the black market, who were the main culprits in the much-hyped vaping “crisis” of last year, and unlike traditional retailers and vape shops, don’t ask for ID.

“We need to continue fighting for effective harm reduction, and that won’t end here,” said Ossowski.

Check out the CCC’s Top Myths and Facts on Vaping here.

CONTACT:
Yaël Ossowski
Deputy Director
Consumer Choice Center
yael@consumerchoicecenter.org

###

The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. 

We represent consumers in over 100 countries across the globe and closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org.

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