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  1. Full story will be broadcast tonight Sunday 6/28/20 7PM ET/PT CBS 60 minutes 6/25/20 Federal officials allowed distribution of COVID-19 antibody tests after they knew many were flawed
  2. Recently, the sale and distribution of e-cigarettes without FDA approval was banned in San Francisco. The ban is expected to go into effect early next year and will also affect other flavored tobacco products. The ordinance will make it illegal for tobacco shops to sell any flavored tobacco products or electronic cigarettes that have not been approved by the FDA. According to Ned Sharpless, who became Acting Commissioner of Food and Drugs in April of this year, “There are no authorized e-cigarettes currently on the market.” Beverly Hills also passed a similar law in early June, which will go into effect in 2021. Historically, California has blazed the trail for other states on tobacco-related bans. They were the first to prohibit indoor smoking in public places more than two decades ago. However, tobacco companies remain vehemently committed to gaining new customers no matter the cost. While the 2009 Family Smoking Prevention and Tobacco Control Act restricts marketing to youth through advertising and adding flavors in combustible cigarettes (except menthol), e-cigarette companies found themselves in the comfort of a gap in regulation. In fact, they can concoct any flavor imaginable. Despite claiming to market to adults, many flavors appear to be designed to tempt young users and particularly appeal to those willing to try for the first-time. Using data from the 2016 National Youth Tobacco Survey, the Centers for Disease Control and Prevention and the Food and Drug Administration found the “availability of appealing flavors” was one of the top self-reported reasons for using e-cigarettes among middle and high school students. It is very reminiscent of the old tactics tobacco companies used for decades prior to the development and enforcement of regulations. Juul, the largest e-cigarette company has always positioned itself as anti-tobacco. In fact, the company’s mission is “to improve the lives of the world’s one billion adult smokers by eliminating cigarettes.” They go a step further stating, “We don’t want anyone who doesn’t smoke, or already use nicotine, to use Juul products. We certainly don’t want youth using the product. It is bad for public health, and it is bad for our mission.” (Juul website) E-cigarettes are often marketed to help individuals wean off combustible cigarettes, which aligns with Juul’s mission. However, as the old adage says, actions speak louder than words. And e-cigarette companies are behaving strikingly like well-known tobacco giants. Juul spent more than $1 million dollars in marketing their products on the internet, according to one research study. They focused on YouTube, Instagram, and Twitter which promoted ads conveying having fun, relaxing, sex appeal, and being cool with those who use Juul. In fact, the strategic campaign to drastically increase their social media presence equated to growing their Juul-related tweets from 765 (on average) per month in 2015 to 30,565 per month just two years later. And it worked. The number of tweets highly correlated with retail sales enabling Juul to control more than half of the e-cigarette market share by the end of 2017. Additionally, the gap in regulation allows e-cigarette companies to sponsor music festivals and sporting events, something that is strictly prohibited for cigarettes and smokeless tobacco. However, thanks to the loophole, sponsors can set up vaping rooms, charging stations, samples, and even host surprise guest appearances from performers to lure in a bigger crowd. E-cigarette companies have gone as far as offering college scholarships to teens in exchange for essays. It’s a way for the companies to get their brand name on college websites which looks to many like an endorsement. Some of scholarship topics seem innocuous while others outright ask for students to write about the benefits of vaping or why people still choose to smoke. If all e-cigarette companies strictly market to adults and primarily existing smokers, why would teens applying for college be in that demographic? Even when their mission statement claims they are not targeting teenagers, their actions are telling a much different story. Juul, which touts one of their core values is “mission first” still ironically claims, “Switching adult smokers and eliminating cigarettes are at the center of all we do.” Yet, in December of 2018, Altria (owner of Marlboro) invested $12.8 billion in Juul. In fact, the deal made them owners of 35 percent of the company. It appears like a large investment to place in an e-cigarette company who claims to be on a mission to eliminate your primary product and revenue. Consequently, another mask emerges for tobacco companies to hide behind. E-cigarette companies proclaiming to the public that their product will improve their health by helping them quit smoking. Akin to the disturbing marketing images that were used to peddle tobacco products plastered in print and television through the 1950s. Despite e-cigarettes being marketed only to adults, the U.S. Surgeon General has declared that vaping by teenagers is at epidemic levels. We know that nicotine is as addictive as heroin, and once young users are addicted, they will likely become long-term users. Still when surveyed, many users feel e-cigarettes are harmless, simply because they are a heat not burn method like combustible cigarettes. Unfortunately, this myth is pervasive. E-cigarettes produce an aerosol by heating a liquid that contains nicotine, flavorings and other chemicals. Users and second-hand bystanders inhale harmful substances directly and deeply into their lungs through the aerosol that include nicotine, ultra fine particles, flavorings such as diacetyl (known to cause popcorn lung), heavy metals (nickel, tin, and lead), cancer-causing chemicals and volatile organic compounds like benzene, ethylene oxide, acrylonitrile, acrolein, and acrylamide. The recent bans in California should lead the way for other cities and states to pass similar policies. I urge you to contact your local representatives and advocate for proposing similar legislation in your state to hold e-cigarette companies accountable to the same regulations as cigarettes and smokeless tobacco. Without such action, we will likely find ourselves repeating history with the newest face of tobacco companies once again padding their pockets as the public pays the heavy price of preventable health conditions.
  3. On Saturday, April 27, 2019, participating communities will partner with law enforcement for the National Prescription Drug Take-Back Day. The ‘no questions asked” event is hosted by the U.S. Drug Enforcement Agency (DEA) in April and October of each year. Collection sites are set up in cities throughout the U.S. for the safe disposal of prescription medications people have at home. Dropping off unused or expired medications is free to the public and no questions are asked about the medications, including opioids. The DEA launched the take-back event in October of 2010 and since that time 5,439.5 tons of medications have been collected. The October 2018 event collected 457.12 tons of medications. To put this amount into perspective, compare 457 tons to four blue whales with each weighing approximately 100 tons. The Strategy of No Questions Asked Opioid abuse continues to be a public health concern and remains at epidemic levels in the U.S. The CDC reports 46 people die everyday of overdose related to prescription medications. In 2017, more than 35% of all opioid overdose deaths involved prescription opioids. Methadone, oxycodone and hydrocodone are the most common cause of opioid overdose deaths. Unused prescriptions discarded in the garbage can be retrieved, abused or sold illegally. The strategy of “no questions asked” is to promote safe disposal through anonymous means without consequences. Children are especially at risk for accidental exposure to prescription medications. Approximately 60,000 emergency department visits are made due to children under the age of 6 finding and ingesting medications when unsupervised. Children age 1-2 years old represent over two-third of all ED visits for accidental medication exposure and approximately 20% require hospitalization. According to the American Academy of Pediatrics, the number of children hospitalized for opioid poisoning increased 3x from 1997 to 2012 with toddlers and preschoolers representing the largest overall increase. Take-Back Day is an opportunity to discard medications to help prevent misuse, accidental exposure, overdose and possibly death from dangerous drugs. Take Back Events Do Not Accept Some Items The following items are generally not accepted at the collection site: Needles and other sharps Inhalers Mercury thermometers Iodine-containing medications Illicit drugs or substances (this includes marijuana which is a schedule 1 drug under federal law), and any prescriptions medications obtained illegally. *Individuals can call the collection site ahead of time to determine what items are not accepted. No Take Back Collection Site Nearby? If disposal instructions are not given on drug labeling and no prescription drug take back program is available, then follow these directions to discard in your home trash: Scratch out any identifying information on the prescription container to protect your identity and personal health information. Remove the medicine from its container and mix it with a substance that would make it undesirable to ingest (kitty litter, coffee grounds, dirt). Do not crush tablets or capsules before mixing. Place the mixture in a bag (sealable) or other container to prevent the medicine from leaking out of the trash bag. The FDA recommends disposing of fentanyl patches immediately after removing by folding the patch in half (sticky sides meet) and then flushing it down the toilet. Children and pets can find fentanyl patches if disposed in trash. Instructions for disposal can be found in the product medication guide. If disposal by the above method is not possible, one option is to flush the medication down the sink or toilet. Keep in mind- some communities may prohibit flushing medications out of concern of trace levels of the drugs found in rivers, lakes and drinking water supplies. Be sure to comply with the communities regulations and laws concerning medication disposal. Do not flush medications in the toilet or sink unless prescription labeling or patient information instructs you to. Locate available year round disposal locations here. Do you plan to take advantage of National RX Drug Take Back Day? Want to know more? Check out these links: Locate a local take back collection site here Read the DEA’s Disposal Act here Center for Disease Control- Healthy Water/ Prescription Drug Take Back Day
  4. Brenda F. Johnson

    Has Medication Advertising Affected Drug Intake?

    Before the FDA gained control of how networks can air medication commercials, several doctors did some research and wrote if their findings in, "Television Advertising and Drug Use", by Barry Peterson, Ph.D., et al. They take the stance that advertisements of over the counter drugs contributes to public misconceptions and encourage drug use. "In promoting OTC drugs for the relief of everyday symptoms such as pain, nervousness, or lethargy, drug companies may deceive the public into thinking that drugs are an easy way out of everyday discomfort". That was 42 years ago, but the same concern is echoed by doctors in 2001. In the article, "Ban TV ads For Prescription Drugs?" it tells us that the American Medical Association would advocate for banning prescription drugs ads from television, newspapers, and magazines. They feel that the misinformation is causing problems with the patient population. They also say that these ads undermine their credibility. Doctors find themselves in a quandary when patients demand a medication they saw advertised, but the doctor feels another medication would better fit the patient's problem. Dr. Angelo Agro, an ear, nose, and throat doctor says this about medication ads, "Ads by their nature are biased and compressed and are driven more by drug companies' financial concern than by concern for the patients' best interest". Although there were doctors meeting to lobby against the drug companies advertising, there were also doctors who felt that a ban would violate free speech. The latter group of doctors that felt the ban was unnecessary and made it known to the committee that they saw medication advertisements as a positive because they may encourage patients to see their doctor, even those who wouldn't normally seek medical treatment. They also felt that these ads help to take the stigma out of certain conditions such as depression. Present day research is related in the article written in 2018, "Coverage By The Media Of The Benefits And Risks Of Medications", by Roy Moynihan B.A. et. al. They discuss how news stories need to cover adverse effects as well as benefits, and often research is focused on the results to favor the company. They found that out of the 207 newspapers and television stories they looked at exhibited shortcomings in their reporting. Moynihan reported that only 15 percent of the media outlets presented relative and absolute benefits; 83 percent gave information in relative terms only which can be misleading. Declaring only absolute or relative benefits does not tell the full story. 53 percent did not talk about potential harms, and 70 percent did not mention cost. Cost can be a deciding factor for many patients in whether they will choose a particular medication. Disclosure was an issue also. Scientific literature underreports the ties between research results and industry. They conclude that the news media should "focus" more. They suggest an educational program for journalists that would help them to focus on the reporting and interpretation of clinical findings. The FDA states on their website under the title "Background on Drug Advertising", the following: The FDA oversees the approval and marketing of prescription drugs through the law, "Federal Food, Drug, and Cosmetic Act". We have a lot of regulation in regards to getting medications on the market compared to other countries. The mid-80s saw more involvement of the media in direct to consumer advertising instead of only to doctors and pharmacists. You have probably noticed that there are some commercials that are really vague, and others that go into great detail. There are several classifications of drug ads: Product Claim Advertisements - These are the only ads that state the benefits and risks of a drug Reminder Advertisements - These ads give the name of the drug, but not the drug's uses. Help-Seeking Advertisements - These describe a disease or condition but do not suggest a specific drug. Ex. are ads for allergies, asthma, or erectile dysfunction. I have noticed an increase in advertisements for medications, especially on television and in magazines. Ever since the FDA approved advertising for medications years ago, the number per commercial break has skyrocketed. According to the article, "Think You're Seeing More Drug Ads on TV? You Are, and Here's Why" by Joanne Kaufman, 771,368 medication ads were shown in 2016. She states that it is "an increase of almost 65 percent over 2012". Not only has the number increased for medical advertising, but the class of drugs as well. Years ago, we saw ads for allergy medication or reflux, but now we see chemo drugs, cardiology drugs, and insulin. The marketing is towards those who are older (and still watching TV), rather than the younger generations. The professional opinions are varied in regards to advertising of drugs, some have reasons they are for them, and those opposed have their thoughts. Research shows that the average consumer can be misled by these advertisements. This misinformation can cause issues between the caregiver and the patient. The doctor may have several reasons why a particular medication may not be right for their patient but the patient feels that it is the best choice for them. Cost is another factor, especially with new medications. Insurance may not pay for a new drug, and the patient is left with a large bill or having to go back and ask the doctor for another alternative. Some patients are more pill driven than life-changing driven in regards to treatment and end up on a long list of medications. Should drug companies be allowed to advertise at all? Should the government be involved? It's difficult to turn back federal regulation, and advertising is money driven. What would you like to see happen regarding the advertising of medications? References "Background on Drug Advertising". www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising. 20 July, 2018. Web. "Ban TV Ads For Prescription Drugs?". CBS News. 18 June, 2001. 20 July, 2018. Web. "Basics of Drug Ads". www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising. 20 July, 2018. Web. Bell, Robert A. Phd, Kravitz, Richard L. MD MSPH, Wilkes, Michael S. MD PHD. "Direct to Consumer Prescription Drug Advertising and the Public". 14(11)651-657. Journal of General Internal Medicine. 14 Nov, 1999. 20 July, 2018. Web. Kaufman, Joanne. "Think You Seeing More Drug Ads on TV? You Are, and Here's Why." The New York Times. 24 Dec. 2017. 20 July, 2018. Web. Moynihan, Ray B.A. et al. "Coverage By The News Media Of The Benefits And Risks Of Medication". The New England Journal Of Medicine. Vol. 342 Nu. 22, 11 July, 2018. 20 July, 2018. Web.
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