Tag Archives: Pittsburgh Post-Gazette

09/21/18

Naloxone Works If You Can Afford It

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The CDC has an interactive presentation of data on drug overdose death counts at: “Provisional Drug Overdose Death Counts.” The data visualization is based on current mortality data in the National Vital Statistics System. You can choose between dashboards showing drug overdose deaths from December of 2014 (47,523) to December of 2017 (70,467); or you can examine state-by-state reports on drug over dose deaths between December 2016 and December 2017. You can also see a dashboard showing drug overdose deaths by drug or drug class, which indicated that 47,705 people died from opioid overdoses in a 12-month period ending in December of 2017. If naloxone had been administered to them, 93.5% might have survived and 84.3% of those survivors could have still been alive a year later. Naloxone works.

The above predictions were based on a research study reported in a CNN article. The lead author of the study was Dr. Scott Weiner, an emergency physician at Brigham and Women’s Hospital in Boston. Pessimists might point out the study also found there was a 1 in 10 chance of those individuals not surviving a year (the title to the CCN article itself contained the phrase: “many recipients don’t survive a year”). Thirty-five percent of those deaths were from another opioid overdose. However, Weiner said: “The lesson learned is not that naloxone is failing; it’s working.” Naloxone works, but it doesn’t treat the underlying problem, he added.

The U.S. Surgeon General issued a public health advisory on April 5, 2018, urging more Americans to learn to use and carry naloxone. He encouraged individuals to learn the signs of opioid overdose; to get trained to administer naloxone in the case of a suspected emergency; and to talk to your doctor or pharmacist about obtaining naloxone. Prescribers, pharmacists and treatment providers were urged to learn how to identify patients at high risk of overdose; prescribe or dispense naloxone to individuals who are at elevated risk for opioid overdose and to their friends and family. He also said:

Increasing the availability and targeted distribution of naloxone is a critical component of our efforts to reduce opioid-related overdose deaths and, when combined with the availability of effective treatment, to ending the opioid epidemic.

Caroline Engelmayer reported in the Pittsburgh Post-Gazette how David Lettrich was one of these individuals who carried naloxone; knew how to use it and learned the signs of opioid overdose. Along with another person, Stuart Fisk, who was walking down the street to get coffee, he was able to administer CPR and Narcan—a brand-name version of naloxone—to the unconscious man and he save his life. David Letterich is the founder and director of Bridge to the Mountain, a nonprofit organization serving the homeless and addicted individuals in Pittsburgh. Stuart Fisk is a nurse practitioner with Allegheny Health Network, but their particular interests and skill sets weren’t relevant to what they accomplished. Anyone can carry and be trained to administer naloxone.

The Post-Gazette article pointed out how increased availability of naloxone is essential. Alice Bell, the coordinator of Prevention Point Pittsburgh’s Overdose Prevention Project, said: “In 2017 there is easily twice as much naloxone given out to the community as there was in 2016.”  Increased availability means multiple doses can be distributed to residents. “While a single dose of naloxone revives some people, others sometimes require up to six or seven doses.” David Lettrich said: “The only way naloxone works is if it can be distributed in surplus.”

But there is a problem; the price of naloxone and naloxone-based products has skyrocketed. “In 2009, one vial of naloxone sold by the pharmaceutical company Amphastar cost roughly $20. By 2016, its price had nearly doubled, to $39.60.”

Naloxone used to be a “very cheap” generic drug that cost a dollar or two per dose, Mr. Fisk said. Now, an intranasal device with two doses costs $150, according to Mr. Fisk, and an automated naloxone machine that speaks instructions on how to administer the medicine sells for over $600.

The Bill of Health, a Harvard blog of the Petrie-Flon Center, provided some helpful background information on naloxone. Naloxone was first developed and patented in 1961 as a medication to reverse constipation in opioid patients. The FDA approved its use to reverse opioid overdose in 1971. And naloxone comes in several forms. It can be administered as an intravenous or intramuscular solution and as a nasal spray. It also can be given in tablet form as an abuse deterrent (ReVia). And it comes as an extended-release injectable, also as an abuse deterrent (Vivitrol).

Naloxone has been historically inexpensive and pharmaceutical companies really didn’t care much about it. Only six pharmaceutical companies even made the drug prior to 2014. It wasn’t until the onset of the opioid epidemic, and public health initiatives that allowed public access to this drug, that prices began to soar.

Naloxone’s wholesale generic cost is around $20 for a single dose. The nasal spray product, known as Narcan, costs $133 to $160 for a two-dose kit. A top-of-the-line two-injector kit known as Evizio that talks you through injecting the naloxone starts at $3,758. The Evzio price is a 680 percent increase over its original price in 2014. “These price increases came when the opioid epidemic was at its peak, and they came without any explanation.” There have been actions taken by several states to limit these increases, but little done in the way of federal regulation to enforce them.

The “patented” delivery systems seem to be the justification for the exorbitant cost of Narcan and Evizio. But decongestants and topical steroids use delivery systems similar to Narcan and these methods cost no more than $10 to $20 dollars per unit, not $160. “An atomizer device that can be just as efficacious a means of drug-delivery sells for around $7.00.” Auto-injectors, around since the 1970s to deliver anti-nerve agents, consist of little more than plastic casing, a pressure activated spring and a needle. Remember the outcry over the unjustifiable cost of the EpiPen, a similar delivery system to Evizio costing ($630)?

The exorbitant cost of these drugs crosses an ethical boundary as well. Ethical sales principles ensure that the cost of an item can be justified, and that the buyer is not being exploited. There has been no evidence to date to support the increased cost of either naloxone product. Furthermore, any parent with a child, any spouse, friend or even a neighbor of someone with substance abuse disorder would pay any price to save their loved one’s life. To take advantage of that is simply unethical and detrimental to society.

Naloxone has gone from a $21 million per year industry before 2014 to $274 million per year since 2015. “There is no doubt: pharmaceutical companies are making money off the opioid epidemic. Additionally, those who need this drug the most, often don’t have access to it. They are the under- or uninsured, so waving a co-pay is moot.”

According to the Pittsburgh Post-Gazette, a potential solution to the exorbitant cost of these drugs is to develop an over-the-counter naloxone product. Harm Reduction Therapeutics is currently raising money and preparing for a clinical trial for its own over-the-counter naloxone product. Michael Hufford, the co-founder and CEO of Harm Reduction Therapeutics, “aims to sell naloxone at the lowest possible cost to increase access to the drug.” If you know any venture capitalists, tell them about Harm Reduction Therapeutics.

Dr. Hacker, director of the Allegheny County Health Department supports the idea of an over-the-counter version of naloxone and mentioned it to some federal legislators. The risks associated with the drug are incredibly low. Dr. Hufford wants to make naloxone widely available at minimal cost. He said: “Just like you can go anywhere and buy Band-Aids and Tylenol, we think naloxone should be that available.”

The question is will Harm Reduction Therapeutics be able to successfully navigate the gauntlet of competing lobbyists with the FDA and  federal government from Endo Health Solutions, which manufactures Narcan and Kaleo, which manufactures Evzio. Naloxone works, but only if you can afford it. Let’s see if we can make that true for the next 47,705 people dying from opioid overdoses.

03/30/15

Killer Caffeine

© : Santi Sinsawad | 123RF.com

© : Santi Sinsawad | 123RF.com

I knew of a woman who had a dual addiction to marijuana and caffeine. Yes, caffeine. She drank several pots of coffee throughout the day along with smoking marijuana. While a resident in a long-term rehab for women, she repeatedly denied that she had caffeinated coffee. But the staff “knew” she was somehow getting it and using it because of the coffee stains on the rug in her room. Several room searches were done to no avail. Finally she was busted. What the woman had done was smuggle a Melita filter and caffeinated coffee into the facility when she out for an appointment. In all the years I’ve worked with substance use/abuse disorders, this was the only time I’d ever seen such classic addictive behaviors with caffeine.

The last several years have seen the marketing of energy drinks with high caffeine content, and the use of products like 5-hour ENERGY “shots.” Many of the individuals I meet in early recovery are drawn to energy drinks, so I’ve been watching for news and research on them. I’ve heard of some concerns about their safety. And recently I heard about powdered caffeine. Just one teaspoon contains 3,200 mg of caffeine.

So let’s start with some basic information about caffeine before we get to the reported deaths from using caffeine powder. According to Wikipedia, caffeine is the world’s most widely consumed psychoactive drug. It is legal and unregulated in most countries worldwide. In North America, 90% of adults consume caffeine daily. I am one of them. A seven-ounce cup of coffee contains 80 to 175 mg of caffeine, depending upon how it is prepared (drip, percolation or espresso). Toxic doses of caffeine for an adult are over 10 grams—twenty times higher than the average consumption of 500 mg per day.

Caffeine’s positive effects have to do with reducing fatigue and preventing drowsiness. It can even stimulate faster and clearer thought flow, increased focus and better general body coordination. Consistent with this last effect, moderate doses of caffeine can improve athletic performance, but the improvements are not usually substantial. There can be some undesired effects, such as mild anxiety, insomnia, and jitteriness. Although there are caffeine-induced disorders in the DSM-5, caffeine use is usually not considered to be addictive.

Caffeinism can occur when 400 to 500 mg at one time, or 1,000 to 1,500 mg per day or more of caffeine is consumed. Winston et al. noted that the symptoms that occur (restlessness, agitation, excitement, rambling thought and speech, and insomnia) overlap with those of several psychiatric disorders. Extreme overdose can result in death. The estimated lethal dose in humans is estimated to be equivalent to 150 to 200 milligrams per kilogram of body mass; the caffeine in roughly 80 to 100 cups of coffee for an average adult. You can read further about caffeine in a 1981 article, “Caffeine: Psychological Effects, Use and Abuse.” As always with psychoactive substances, you can also see what Erowid has to say about caffeine.

Now, let’s look at caffeine powder. In May of 2014, 18-year-old Logan Stiner died after ingesting 23 times the amount of caffeine found in a typical cup of coffee. Given the above noted information, Logan would have consumed 1,850 to 4,025 mg of caffeine.  While the estimated lethal dose given above would seem to be higher than Logan’s intake of caffeine powder, he still clearly consumed roughly four to eight times the dose needed for caffeinism. Several reports have indicated that a teaspoon of caffeine powder, the equivalent of 25 cups of coffee, can be lethal. Logan’s use of caffeine powder did approach that level. Caffeine powder is a pure chemical. And as Mary Clare Jalonick reported:  “the difference between a safe amount and a lethal dose is very small.”

The FDA has warned against the use of powered pure caffeine. They are particularly concerned about Internet sales of bulk bags of it. “Pure caffeine is a powerful stimulant and very small amounts may cause accidental overdose. Parents should be aware that these products may be attractive to young people.” Michael Landa, the Director of FDA’s Center for Food Safety and Applied Nutrition, reported having a December 2014 meeting with Logan’s parents and the parents of a 24-year-old who died after ingesting powdered caffeine. He said:

I cannot say strongly enough how important it is to avoid using powdered pure caffeine. The people most drawn to it are our children, teenagers, and young adults, especially students who want to work longer to study, athletes who want to improve their performance, and others who want to lose weight.

The FDA doesn’t have the legal authority to just pull these products off the shelf. Caffeine powder is sold as an unregulated dietary supplement—unlike caffeine added to soda and other drink products. This is a common way of getting around regulation with several other potentially harmful psychoactive substances (see Krypton Can Kill You; Kava is not a Magic Bullet).

Michael Taylor, the FDA’s deputy commissioner of foods, said it was inherently irresponsible to market such a potentially dangerous product. “I would hope that people would get the message that they just ought to stop selling it.” So far, they don’t seem to be getting that message.

David Templeton, of the Pittsburgh Post-Gazette, reported that six senators have sent a letter to the FDA urging them to ban the retail sale of caffeine powder. The letter stated that pure caffeine is unsafe. Overdosing is easy and virtually unavoidable. Powered caffeine sold in bulk was said to be markedly different than other caffeine products, on the market, such as energy drinks, energy shots and others. “Because of the risk powdered caffeine poses to consumers, these products merit swift and significant action by the FDA.” The Council of Responsible Nutrition, a trade association for the supplement industry, recently stated their support for an FDA ban against the retail sale of caffeine powder. NutraKey, a major online marketer of caffeine powder did not respond to requests for comment.