12/12/17

Greed with OxyContin is NOT Good

© Linda Bucklin | 123rf.com

The health insurer Cigna announced that effective January 1, 2018, it will no longer cover OxyContin as a preferred medication. The company is in the process of notifying customers with current OxyContin prescriptions and their doctors of the upcoming change. Individuals who have begun using OxyContin for hospice care or cancer treatments will continue to be covered through 2018. If a doctor believes the use of OxyContin is medically necessary, Cigna will consider approving coverage. Needless to say, Purdue Pharmacy, the manufacturer of OxyContin, disagrees with the Cigna decision.

Cigna will offer an oxycodone equivalent medication with abuse deterrent properties, Xtampza ER with Collegium Pharmaceuticals. Collegium signed a “value-based contract” with Cigna, which will hold the company financially accountable if average daily dosage strengths of Xtampza ER prescribed for Cigna customers exceed a specific threshold. If the threshold is exceeded, Collegium will reduce the cost of the medication. “Linking financial terms to dosage metrics may encourage more education to prevent overprescribing.”

The Fix reported a Purdue spokesperson said there were few differences between OxyContin and Xtampza ER. “Unfortunately, Cigna’s decision limits the tools prescribers can use to help address the opioid crisis as both products are formulated with properties designed to deter abuse.” Cigna responded by saying the point is to change prescription practices. “The insurer hopes that doctors will begin to prescribe drugs like Xtampza ER ‘in lesser quantities and for lesser amounts of time.’”

Cigna’s decision comes in the midst of increasing pressure on Purdue Pharmacy for their aggressive, and at times illegal marketing practices of OxyContin. The pharmaceutical company came under scrutiny partly because of a series of investigative reports by the LA Times that noted a series of issues. The issues including how Purdue Pharma knew pain relief with OxyContin did not last the 12 hours as it claimed; but the company continued to insist the drug did last, in part, to protect its revenue. When doctors complained about the duration, Purdue instructed them to prescribe stronger, not more frequent doses. “OxyContin’s market dominance and premium price hinge on its 12-hour duration.” Purdue allegedly knew of this issue for more than twenty years.

For years, Purdue Pharma lied to federal regulators and the public about the addictiveness of OxyContin and countless patients got hooked on this deadly painkiller. We need to know if Purdue once again lied about the longevity of OxyContin’s pain-relieving properties and hold Purdue accountable.

Additionally, Purdue knew OxyContin was being overprescribed and illegally trafficked, but in many cases, did nothing about it. With one such operation, Lake Medical, Purdue did not stop supplying OxyContin and did not tell authorities what it knew for several years until the clinic was out of business and its leader indicted. By that time, 1.1 million pills has been put on the street.

A Los Angeles Times investigation found that, for more than a decade, Purdue collected extensive evidence suggesting illegal trafficking of OxyContin and, in many cases, did not share it with law enforcement or cut off the flow of pills. A former Purdue executive, who monitored pharmacies for criminal activity, acknowledged that even when the company had evidence pharmacies were colluding with drug dealers, it did not stop supplying distributors selling to those stores.

In 2015 Kentucky received $24 million from Purdue to settle the state’s 2007 against the company over their allegedly illegal promotion of OxyContin. As is usual in cases where pharmaceutical companies settle outside of court, they requested the records gathered in the court case be sealed and destroyed. In this case, there were 17 million pages of documents, including a deposition of Dr. Richard Sackler, the former president of Purdue Pharma and a member of the family who owns the privately held company. As part of the agreement, the Kentucky attorney general destroyed its copies of the documents provided by Purdue. However, copies of several key documents, including the Sackett deposition, filed under seal at the Pike County court, were not destroyed.

STAT News learned of the existence of these documents and filed a motion in March of 2016 to unseal the documents. In May of 2016 a Kentucky judge ordered that the documents be unsealed by June 12th. The judge said he would stay the release of the records if there was an appeal filed before then.  As of June of 2017, the documents were still not released. Purdue appealed the ruling to the Kentucky Court of appeals and although the appeals court said it expected to rule on the matter by the end of August, there was still no announcement by the middle of October.

The President of the Kentucky state Senate planned to file a motion to support the efforts by STAT to unseal the documents, saying that shielding the records from public view was “inappropriate.” He acknowledged his request to intervene could be unsuccessful, and it seems that it was. He thought the documents could help evaluate whether the $24 million payment from Purdue was a good settlement for Kentucky. “Two prior attorneys general valued the case at between $100 million and $1 billion.” Senate President Robert Stivers was concerned the state settled for “pennies on the dollar.”

Purdue was already pivoting to go overseas with its marketing strategy by 2011. With the growing concern over the opioid crisis in the U.S. and the awareness of the role OxyContin played in it, prescriptions fell by almost 40% since 2010, meaning billions in lost revenue for Purdue. Again, the LA Times documented this market expansion by Purdue in a December 2016 article, “OxyContin Goes Global.” Using a network of international companies owned by the Sackler family, Purdue Pharma is moving rapidly into Latin America, Asia, the Middle East, Africa and other regions. “In this global drive, the companies known as Mundipharma, are using some of the same controversial marketing practices that made OxyContin a pharmaceutical blockbuster in the U.S.”

In 2011, operations were started in China, Russia, Turkey, Hong Kong and South Africa. 2013 saw activity in Indonesia, Vietnam, Thailand and Taiwan. Dubai, Brazil, Columbia and Spain came on board in 2014. Lebanon and Portugal opened operations in 2015; Argentina in 2016. Chile, Ecuador, Peru, Uruguay and Venezuela plan to launch operations in the near future.  There is an interactive map on “OxyContin Goes Global” that graphically illustrates this expansion.

In Brazil, China and elsewhere, the companies are running training seminars where doctors are urged to overcome “opiophobia” and prescribe painkillers. They are sponsoring public awareness campaigns that encourage people to seek medical treatment for chronic pain. They are even offering patient discounts to make prescription opioids more affordable.

Like the initial marketing of OxyContin in the U. S., some Mundipharma representatives and promotional material minimize the risks that patients will become addicted to opioid medications. While U.S. public health officials were warning of the growing pain killer threat in 2015, a Mundipharma executive in Seoul South Korea was saying doctors there worry too much about addiction: “Many studies have shown that it’s almost impossible for those with chronic or severe pain to become addicted to narcotics, as long as the drug is used for pain relief.” The opioid problem in the U.S. is said to be largely due to recreational abuse of the drugs.

“That is exactly the same thing they were teaching U.S. physicians when they launched OxyContin in this country,” said Sharon Walsh, an addiction expert who advises the FDA on risks from pain medications.

Mundipharma uses consultants (referred to as thought leaders in the U.S.), as did Purdue and other pharma companies, to overcome this opiophobia among doctors reluctant to prescribe narcotics. Top company officials have said their success in new markets depends on defeating this mind-set.

In Spain, Mundipharma used a series of actors, musicians and models in a campaign against chronic pain. “Ebélate contra el dolor (Rebel against the pain).” The ads did not recommend a specific medication, but urged viewers to seek out a healthcare professional (call your doctor?).  “The campaign is part of a strategy to redefine back pain, joint aches and other common conditions as a distinct malady — chronic pain — that doctors and patients should take seriously.” Mundipharma sales were up seven-fold since 2007.

Around the world, Mundipharma companies cite statistics suggesting there is a great unmet need for their products. Opening an office in Mexico in 2014, Mundipharma officials declared that 28 million citizens were suffering from chronic pain. In Brazil, the company cited a figure of 80 million. In Colombia last year, a company news release said 47% of the population — about 22 million people — were afflicted by ‘this silent epidemic.’”

Meanwhile, back in the US, the lawsuits against Purdue Pharma just keep on coming. In May of 2017 the NYT reported Purdue and three current and former executives pleaded guilty in federal court to criminal charges “that they misled regulators, doctors and patients” about the drug’s addiction risk and potential for abuse. In order to resolve criminal and civil charges stemming from the drug’s “misbranding,” Purdue agreed to pay $600 million, one of the largest amount ever paid by a drug company in such cases. Three executives, including its president and its top lawyer pleaded guilty as individuals to misbranding, which is a criminal violation. “They agreed to pay a total of $34.5 million in fines.”

Purdue Pharma acknowledged in the court proceeding today that “with the intent to defraud or mislead,” it marketed and promoted OxyContin as a drug that was less addictive, less subject to abuse and less likely to cause other narcotic side effects than other pain medications.

Reuters reported that New Hampshire announced in the beginning of August of 2017 that it was suing Purdue for engaging in deceptive marketing practices. The lawsuit followed similar cases against Purdue and other pharmaceutical companies by Oklahoma, Mississippi, Ohio and Missouri and several cities and counties in California, Illinois, Ohio, Oregon, Tennessee and New York.

A week later, South Carolina filed suit against Purdue Pharma, according to Reuters. Again the company is accused of unfair and deceptive marketing of opioid painkillers. South Carolina had been part of a 2007 settlement when Purdue and three executives pleaded guilty to federal charges of misbranding OxyContin. In the August 2017 lawsuit, “South Carolina claimed that since the 2007 settlement, Purdue has continued to engage in misleading opioid marketing practices rather than reforming them to conform with the law.”

In the 1987 movie Wall Street, Michael Douglas as Gordon Gekko famously said, “Greed, for lack of a better word, is good.”  He went on to claim that greed captured the essence of the evolutionary spirit. “In all of its forms; greed for life, for money, for love, knowledge has marked the upward surge of mankind.” At the end of his speech, he was applauded. The greed of Purdue Pharma and the Sackett family, which privately owns Purdue Pharma and OxyContin, is not good. Their unrestrained greed has contributed to the current opioid epidemic in the U.S., despite the denials of the company. And now they want to export the same drug and marketing strategy to the world.

12/8/17

Room for Differences on Creation

© michaeljayfoto

Tim Keller stepped down as the Senior Pastor for Redeemer Presbyterian Church in New York City in July of 2017. Redeemer also split into multiple congregations, “actualizing our long-stated plan of shifting from being a single large church with multiple congregations to becoming a family of smaller churches.” Keller said his new role would be as a teacher and trainer for the next generation of leaders and pastors within the Redeemer family of churches. “The gospel is a living force, always sending and giving—and as I am sent in a new way now, so is every member of Redeemer, to love and serve this great city.” And yet he has been smeared as having such a low view of Scripture, “that he goes out of his way to promote the false doctrine of theistic evolution.”

The above is the stated opinion of E.S. Williams in “Keller’s false gospel” on The New Calvinists website. Williams has also written a book titled The New Calvinists, which critiques Keller and others. Williams claims in the subtitle of his book these pastors are changing the gospel. In another article on The New Calvinists bashing Keller (there are several), “Keller’s theistic evolution,” Williams distorts Keller’s position by saying he believes the Bible must be made to conform to the ‘truth’ of science. “Keller does this by asserting [in The Reason for God] that the first chapter of Genesis is a poem.” He is certainly not the only critical source of Keller on his understanding of Genesis one and whether theistic evolution can be affirmed by those with a high view of Scripture.

Ken Ham, the founder of Answers in Genesis (AiG), has also been critical Tim Keller. He said: “It is so sad to see a great Bible teacher like Tim Keller promote belief in evolution to the church.” Ham’s contends Keller and others have misunderstood what he and Answers in Genesis are saying in relation to the loss of biblical authority. According to Ham, this is the result of “contributing to undermining the authority of the Word of God by accommodating man’s ideas of evolution or millions of years into Genesis.” He believes there has been “an increasing generational loss of Biblical authority because so many in the church have opened the door to compromise beginning in Genesis.”

Within a document, “Where Do We Draw the Line?,” AiG said it is made up of “Christians who unite to defend the authority of the Bible in today’s secular culture.” That is what they say they are about—“the authority of the Bible, often in Genesis.” An example of how the issue of Biblical authority is understood by AiG has to do with the age of the earth.

For example, the secular world has been teaching that the earth is billions of years old. The Bible, based on genealogies recorded throughout the Scriptures and the context of the Hebrew word yom (day) in Genesis 1, reveal that the earth is thousands of years old. So, this question becomes a biblical authority issue. Is one going to trust a perfect God who created all things (Genesis 1:1), has always been there (Revelation 22:13), knows all things (Colossians 2:1–3), and cannot lie (Hebrews 6:18), or trust imperfect and fallible humankind who was not there and speculates on the past?

In the original AiG article, you can see links that elaborate their understanding of “genealogies,” the “context” of the Hebrew word yom (day), and whether the earth is “thousands of years old.” There is also a chart that lists “a sampling of biblical authority topics” such as the age of the earth, evolution and whether or not Noah’s flood was global or local as issues of biblical authority. AiG said the Bible does not teach the earth is millions of years old; that man was specially created from dust and the woman from the man. An evolutionary worldview says humanity came from an ape-like ancestor. And Genesis 6-8 affirms the Flood was global, covering the highest mountain by over 15 cubits. “Those appealing to a local Flood trust secular authorities who say that the rock layers are evidence of millions of years instead of mostly Noah’s Flood sediment.”

Additional examples of topics on biblical authority in the chart include the Trinity and racism. The article went on the say: “Basically, AiG is involved when any issue impacts the authority of Scripture—especially when human claims run counter to what God teaches.” What seems clear is that AiG’s position is that any Christian seeking to affirm the authority of Scripture necessarily has to acknowledge an understanding of Genesis that aligns with its own position. AiG believes the age of the earth is in the neighborhood of thousands, not millions, of years; that there was a global flood covering the highest existing mountains of the time of Noah; and that humans were specially created out of dust. Tim Keller and other Christians who allow for or teach any views that do not agree with this understanding of Genesis are therefore undermining the authority of the word of God.

The weight given to these positions is seen clearly in the AiG Statement of Faith, last updated on August 10, 2015. In order to preserve the function and integrity of the ministry “in its mission to proclaim the absolute truth and authority of Scripture,” employees and volunteers should abide and agree to the AiG Statement of Faith. Board members for the AiG ministry must hold to the following six tenets:

  • Scripture teaches a recent origin for man and the whole creation, spanning approximately 4,000 years from creation to Christ.
  • The days in Genesis do not correspond to geologic ages, but are six [6] consecutive twenty-four [24] hour days of creation.
  • The Noachian Flood was a significant geological event and much (but not all) fossiliferous sediment originated at that time.
  • The gap theory has no basis in Scripture.
  • The view, commonly used to evade the implications or the authority of biblical teaching, that knowledge and/or truth may be divided into secular and religious, is rejected.
  • The view, commonly used to evade the implications or the authority of biblical teaching, that knowledge and/or truth may be divided into secular and religious, is rejected.

While Ham and AiG does not go as far as E.S. Williams in claiming Keller and others are promoting a false gospel, Ham and AiG do seem to believe that if Keller and others disagree with the AiG understanding of Genesis on creation, the age of the earth, and whether the Noachian Flood was local or global, they have a low view of Scripture. A recent origin for humans and creation (approximately 4,000 years from creation to Christ), six 24 hour days for creation, and a global, Noachian Flood are non-negotiable beliefs about creation, according to AiG.

The Gospel Coalition (TGC), an evangelical ministry founded by Tim Keller and Don Carson, posted a video discussion between Tim Keller, Ligon Duncan and Russell Moore on what is necessary to be believed; what are the non-negotiable beliefs about creation. Both Duncan and Moore are council members for TGC.

Keller led off the dialogue on the essentials of what has to be believed about the Bible when talking to nonbelievers. Keller said the relationship of God to the creation—the Creator/creation distinction—should be stressed. He said nonbelievers may want to talk about creation as a religion versus science battle, but he suggested to not go there. “The relationship of creation to evolution isn’t the heart.” There are at least four, five or six orthodox Christian views of evolution, according to Keller. “But let’s not go there at first.”

Duncan said he’d want to tell the skeptical, intelligent unbeliever that Christianity and science are not in conflict. Protestant Christianity laid the philosophical foundation for the rise of science.

Within the church, Duncan thought the essentials or boundaries of what we have to agree on in order to recognize each other as orthodox are: creation ex nihilo, the goodness of creation and the special creation of Adam and Eve. By creation ex nihilo, Duncan meant there is a Creator-creature distinction—God was the Cause of everything else. Adam and Eve have to be acknowledged as the fountainhead of humanity to support the federal headship of Adam to have the Adam-Christ parallel for the gospel.

Keller said he would want to talk first about the first two points, the Creator-creature distinction and the goodness of creation, with a nonbeliever. With a Christian, he said he would discuss Adam and Eve, saying there are a lot of different understandings about how old the earth is, what the days are in Genesis 1, and to what degree evolution was a part of how God created things. “But where I would stop is, with Adam and Eve.” Keller said there had to be an actual Adam and Eve, otherwise he doesn’t understand how the Pauline view of salvation in Romans 5 works.

He acknowledged that the consensus, even among Christian scientists, is that all human beings were not genetically related to a human couple. It had to be a little group of people somewhere in sub-Saharan Africa. “But when I read the text … it sure looks like it’s saying that God created Adam and Eve. And he didn’t just adopt … a human-like being and put in the image of God.” Keller said the text said he created them out of the dust of the ground. He thought he had to let his reading of the text correct his understanding of the sciences.

 Science is a way of telling me truth. And the Scripture is a way of telling me truth. But if they are clashing, even though I know the science might show me I’m reading the Scripture wrong, and that has happened in the past, where the science came in and said “Are you really … does the Bible really teach that the sun revolves around the earth? So it’s possible for the science to make you ask, “Did you read the text right?” But if you go back and read the text and you come to your conclusion, that as far as you can say before God “I’m trying my best to read this as I think what the Scripture says.” Right now it says to me, … and everyone came from Adam and Eve and they were special creations. And so even though I don’t have an answer to my science friends, that’s where I stand.

I don’t think Tim Keller compromised biblical authority in what he said; nor did he preach a false gospel. I do see him saying belief in the authority of the Bible has room for differences on how to interpret Genesis 1 and whether the age of the earth is 6,000 years. It may even have room for some form of evolution. AiG and E.S. Williams vehemently deny this possibility. AiG has linked a denial of evolution, a localized flood, and an age for the earth and creation around 6,000 years with the Trinity and racism as key issues of biblical authority. So it doesn’t seem they would stand with Keller or any other Christian—which includes me—who won’t affirm their understanding of Genesis.

12/5/17

Pick Your Poison: Diabetes and Psych Meds

© klenova | stockfresh.com

The American Diabetes Association said 30.3 million Americans, 9.4% of the population, had diabetes in 2015. There are 1.5 million news cases of diabetes diagnosed each year. It is the 7th leading cause of death in the U.S. with 79,535 death certificates in 2015 listing it as the underlying cause of death. A total of 252,806 death certificates listed diabetes as an underlying or contributing cause of death. If the number of deaths from diabetes were equal to 252,806, it would be the third leading cause of death in the US, according to the CDC … and psych meds increase the risk for diabetes.

SSRIs have been associated with an increased risk of diabetes, as Yoon et al. noted in “Antidepressant Use and Diabetes Mellitus.” The researchers ruled out depression itself as a potential confounding variable in the relationship between antidepressants and diabetes. Their findings suggested that antidepressant drug treatment and not the depression increased the risk of diabetes mellitus (DM). “Given the widespread use of antidepressants, the implications of the increased risk are serious.”

The authors noted that while there is disagreement as to the reason for the association between antidepressant use and DM risk, some studies “propose that antidepressants may bio-pharmacologically affect glucose homeostasis and insulin sensitivity.” In “Use of Antidepressants Linked to Diabetes,” Peter Simons of Mad in America noted a study that has supported that hypothesis. A study led by Raymond Noordam and published in The Journal of Clinical Psychiatry, found the use of SSRIs in nondiabetic participants was associated with lower insulin secretion and an increased risk of insulin dependence in type 2 diabetes in older adults.

It is biologically plausible that SSRIs decrease insulin secretion and that this might, therefore, be a mechanism underlying the previously observed association between SSRIs and increased risk of type 2 diabetes. Consequently, type 2 diabetes patients treated with SSRIs might also have a higher risk to develop insulin dependence, a condition associated with an increased risk of mortality.

The researchers also found that participants already diagnosed with diabetes who were taking antidepressants were twice as likely to start insulin treatment than those who did not take antidepressants. They said: “our data might suggest that progression of type 2 diabetes during the use of SSRIs is accelerated.” Simons commented how the higher mortality rate for individuals who require insulin treatments made this “a particularly alarming finding.”

This new study provides additional convincing evidence that although SSRIs are commonly believed to have fewer risks of adverse effects than TCAs, they still carry significant risk. This appears to be particularly relevant when it comes to patients with diabetes. Whenever antidepressant medication is considered, patients and prescribers should carefully weigh the potential risks and benefits.

There was an updated meta-analysis published in PLos One, “The Risk of New-Onset Diabetes in Antidepressant Users.” Their meta-analysis found an increased risk factor of 1.27 between exposure to antidepressants and new-onset diabetes. When they restricted the analyses to higher quality studies, the relative risk was higher. The researchers noted their findings were in line with tow previous meta-analyses that reported “a 1.5-fold increase of diabetes among AD [antidepressant] users.” In an interview with Endocrinology Advisor, the lead investigator of the study extrapolated that given a 13% prevalence rate of antidepressant use in the US, a 1.3-fold increase in diabetes risk would translate to over 1 million cases of diabetes that could be due to concurrent antidepressant use.

Pharmacy Times reported in “Atypical Antipsychotic-Induced Type 2 Diabetes” that patients with schizophrenia were at an increased risk of developing metabolic disorders like type-2 diabetes mellitus (T2DM). Schizophrenic patients had a number of risk factors for T2DM, including family history, increased body mass index (weight gain), a sedentary lifestyle and the use of atypical antipsychotics. There have been several proposed mechanisms for the association of diabetes and atypical antipsychotics, one being the weight gain associated with the medications.

A 2006 study by Alvarez-Jiménez et al. found that 78.8% of patients taking atypical antipsychotics experienced a weight gains greater than 7%, the cut off for clinically meaningful weight gain in the study. In 2004 the FDA required a warning be placed in the medication guides of all atypical antipsychotics warning of the increased risk of hyperglycemia and diabetes.

 Patients with schizophrenia are at increased risk of developing metabolic disorders like type 2 diabetes. This is due to a number of factors, including the treatment of schizophrenia with atypical antipsychotics. There are several potential mechanisms behind antipsychotic-induced diabetes, including the weight gain associated with these medications, the effects on pancreatic receptors and/or glucose transporters, or some other cause not yet discovered. Most likely, it is a combination of these effects. Of the atypical antipsychotics, clozapine [Clozaril] and olanzapine [Zyprexa] are associated with the highest incidence of metabolic dysfunction, whereas ziprasidone [Geodon] and aripiprazole [Abilify] are considered to be the least risky.

In “Antipsychotic-Induced Diabetes Mellitus” published in U.S. Pharmacist, Chhim et al. reported there are several metabolic consequences with antipsychotic use, including weight gain, hyperglycemia (abnormally high blood glucose) and dyslipidemia (an abnormal amount of triglycerides, cholesterol and/or fat phospholipids in the blood). The association of type 2 diabetes mellitus (T2DM) and antipsychotic use is supported by retrospective epidemiologic studies as well as post-marketing assessment. Data indicate the prevalence of diabetes and obesity is 1.5 to 2 times higher in people diagnosed with schizophrenia or affective disorders than the general population.

The authors noted that diabetes was reaching epidemic proportions worldwide, and the contributions of medications to the development of hyperglycemia and other metabolic problems was getting more attention.  “Pharmacists are in a unique position to counsel and encourage appropriate self-monitoring in patients receiving certain drugs, such as antipsychotics, that can contribute to the development of weight gain, hyperglycemia, and dyslipidemia.” They can encourage patients to report adverse events to other health care providers and seek therapeutic substitutions, counseling, and/or treatment for the adverse events.

Another resource addressing these concerns, one that was cited in “Antipsychotic-Induced Diabetes Mellitus,” is the “Consensus Development Conference on Antipsychotic Drugs and Obesity and Diabetes.” This is a joint consensus statement from the American Diabetes Association, the American Psychiatric Association, the American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity to help reduce the risk of developing diabetes, cardiovascular disease, and other complications of diabetes.

There was a large longitudinal study done in Denmark by Rajkumar et al. that found in addition to the high risk for diabetes conferred by schizophrenia on individuals, “the risk is further increased by both first-generation and second-generation antipsychotics.” Reporting on the study for Mad in America, Bernalyn Ruiz said the authors said the prevalence of diabetes was 4 to 5 times greater in people diagnosed with schizophrenia. “After adjusting for potential confounders, the risk was elevated threefold compared to those without a schizophrenia diagnosis.” No differences were seen between first-generation and atypical antipsychotics.

This large nationwide study confirmed endogenous risk for diabetes among individuals diagnosed with schizophrenia, with risks increasing significantly when antipsychotics are prescribed.

The bottom line is that in addition to their other adverse effects, there is credible scientific evidence that antidepressants and antipsychotics increase the risk of diabetes among individuals taking them. So when you’re advised to use one of these classes of psychiatric medications, it’s a bit like being asked to pick your poison.

12/1/17

Snorting Chocolate

© deandrobot |stockfresh.com

You probably won’t see any of this product in your kids Trick or Treat stash, but keep a lookout for a tin of Coco Loko in their rooms just in case. Yes, you read that correctly. Coco Loko is snortable chocolate powder. Marketed by Legal Lean, the Florida-based company founded by Nick Anderson, Coco Loko is the first product of its kind in the US. Similar products have been available in Europe for several years. After ordering and trying one, Anderson decided to create his own “raw cacao snuff.” So he invested $10,000 with an Orlando-based supplement company and created Coco Loko.

The Washington Post quoted Anderson as saying the effect is “almost like an energy-drink feeling, like you’re euphoric but also motivated to get things done.” He said he uses his product as an alternative to drinking and at music festivals and in “those types of social situations when you feel anxious.” Rolling Stone reported that Coco Loko promised a “30-minute buzz,” that would lift moods, reduce anxiety and give you a surge of energy. “Legal Lean claims Coco Loko will cause a rush of endorphins and serotonin, boost energy, and bring about a sense of calm. But the company hasn’t provided concrete research to back up those claims.”

However, the company website now refers to its product as “Coco Snuff” and the overt claims noted in Rolling Stone and other media write ups just after its release and attributed to Legal Lean are now not directly attributed to Coco Loko/Coco Snuff. Legal Lean makes no such claims anymore about Coco Snuff. You learn about endorphins, that a serotonin rush produces “an elevated mood and a state similar to the feeling of ecstasy [not the drug ecstasy]. This is the feeling that will make the music sound better and overall happiness.” Gee, isn’t that why the drug ecstasy was used at raves?

Raw cacao is said to give you a steady rush of euphoric energy that helps party goers “Dance the nigh away without a crash.” Then it claims raw cacao can give you a “calm focus,” reducing the chatter in your brain. “It is also known to help with anxiety and to reduce stress.”

The revisions to product description are likely the result of action taken by Senator Chuck Schumer where he called on the FDA to formally launch an investigation into “Coco Loko.” He said the product was a “brazen example of ‘narcotic marketing.’” He said it was like cocaine on training wheels. Schumer, The Washington Post and others (like The Fix) have reported it contains caffeine, guarana and taurine, which are ingredients commonly found in energy drinks. You won’t find that information on their website.

This suspect product has no clear health value. It is falsely held up to be chocolate, when it is a powerful stimulant. And they market it like a drug – and they tell users to take it like a drug, by snorting it. It is crystal clear that the FDA needs to wake up and launch a formal investigation into so-called Coco Loko before too many of our young people are damaged by it. ‘Coco Loko’ isn’t even pure chocolate at all. Instead, it is chock full of concentrated energy drink ingredients masked and marketed under the innocence of natural and safe chocolate candy. Parents and doctors don’t want kids snorting anything at all, especially not dangerous stimulants proven to wreak havoc on the bodies and brains of young kids and teens. That’s why the FDA must formally investigate this dangerous ‘party goer’ fad before it hurts our kids, not after.

The Washington Post reported in July of 2017 the FDA had not decided on how or whether to regulate the product. An FDA spokesperson said: “In reaching that decision, FDA will need to evaluate the product labeling, marketing information, and/or any other information pertaining to the product’s intended use.” Thus the changes in product effects on the website. The company is trying to keep under the FDA’s radar A representative for the DEA said he was not aware of any agency concerns with chocolate inhalants. According to reports mentioned by Schumer, the Legal Lean said the effects were “equal to about two energy drinks.”

Anderson said he didn’t consult any medical professionals when he created Coco Loko, “nor have scientists tested the snortable snuff before it was released to the public,” according to Rolling Stone. A company spokesperson said they used research data on the market in Europe. “There are no health issues … everyone seems fine. . . . It says not to do more than half the container, I think everything is self-explanatory, there are warning labels on it and I don’t think I would be responsible.”

There have been previous concerns raised about the health effects of energy drinks containing the ingredients reported to be in Coco Loko— caffeine, taurine and guarana. There can be increased blood pressure or heart palpitations. Those effects could be magnified when someone inhales these stimulants. The director for the John Hopkins Sinus Center said as yet, there is no data reported on health consequences, but he did have a few concerns.

First, it’s not clear how much of each ingredient would be absorbed into the nasal mucus membranes. And, well, putting solid material into your nose — you could imagine it getting stuck in there, or the chocolate mixing with your mucus to create a paste that could block your sinuses.

Another sinus specialist, Dr. Jordan Josephson, said you could expect more pulmonary problems like asthma or bronchitis. Blocked sinuses could lead to snoring and even sleep apnea, which in some cases could be fatal. There are multiple social media and online reports of trying snortable chocolate products like Coco Loko.

Hopefully, this product will go the way of Palcohol, a powered alcohol product that Senator Schumer took on in 2015. As with Coco Loko, his concern was it would be marketed to teens. One of the voiced concerns then was that powered alcohol could be snorted. According to The Hill, the manufacturer of Palcohol fought back by saying: “Listen, people can snort black pepper … so do we ban it? No, just because a few goofballs use a product irresponsibly doesn’t mean you ban it.” The company reported that although its product was approved on March 10, 2015 for legal sale in the US, it would not be manufacturing Palcohol. Rather, it would be “auctioning off the secret formula and manufacturing process.” Let’s hope Coco Loko ends up with a similar fate. For more on Palcohol, see: “Hype Over Powered Alcohol” or “Down For The Count?”