Ethical Considerations in Studying Drug Safety — The Institute of Medicine Report

The New England Journal of Medicine

Health Law, Ethics, and Human Rights

Ethical Considerations in Studying Drug Safety — The Institute of Medicine Report

Michelle M. Mello, J.D., Ph.D., Steven N. Goodman, M.D., M.H.S., Ph.D., and Ruth R. Faden, Ph.D., M.P.H.

N Engl J Med 2012; 367:959-964 

September 6, 2012 

DOI: 10.1056/NEJMhle1207160

 

The tumult arising from revelations of serious safety risks associated with widely prescribed drugs, including rosiglitazone (Avandia, GlaxoSmithKline), rofecoxib (Vioxx, Merck), and celecoxib (Celebrex, Pfizer), has led to widespread recognition that improvement is needed in our national system of ensuring drug safety. Notwithstanding federal legislation in 2007 that strengthened the authority of the Food and Drug Administration (FDA) in the postmarketing period,1 critical weaknesses in the national system persist.

Central to these weaknesses are dilemmas surrounding not only the science but also the ethics of drug-safety research,2 many of which came to the fore in the heated public debate about the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial, which compared the cardiovascular outcomes of long-term treatment with rosiglitazone with those of pioglitazone (Actos, Takeda) in patients with type 2 diabetes.3 At the request of the FDA, an Institute of Medicine (IOM) committee, on which we served, was convened to examine the ethics and science of FDA-required postmarketing safety research. In this article, we review the key ethics findings from the committee's May 1, 2012, report4 and offer some reflections on the challenges ahead.

Lessons from the TIDE Trial

In May 2008, the FDA ordered the manufacturer of rosiglitazone, GlaxoSmithKline, to conduct a trial in response to evidence from meta-analyses that rosiglitazone was associated with a higher risk of myocardial infarction and death from cardiovascular causes than placebo or medications that were not based on nonthiazolidinedione comparators.5,6 Other studies suggested that pioglitazone, an alternative thiazolidinedione, was not associated with such risks.7,8 Before enrollment began, some argued that the evidence of the inferior safety of rosiglitazone was strong enough to make the trial ethically unjustifiable. Two FDA epidemiologists wrote in a 2008 memorandum that a head-to-head trial “would be unethical and exploitative” and that even a robust informed-consent process could not overcome the problem.9 This was not the consensus FDA view, which was that the uncertainty regarding the cardiovascular risks associated with rosiglitazone, as well as those associated with pioglitazone, was sufficient to justify a trial.10
 
These concerns triggered a February 2010 letter from members of Congress to the FDA demanding a justification for the trial and alleging that the consent form did not provide adequate risk information.11 In response, FDA Commissioner Margaret Hamburg expanded the FDA investigation of the safety of rosiglitazone, obtained advice from an FDA advisory committee, and asked the IOM to convene our committee.6 Although the FDA advisory committee recommended that the TIDE trial be continued if rosiglitazone was permitted to remain on the market, in September 2010, the FDA halted the trial and placed stringent new restrictions on the availability of rosiglitazone.12,13
 
The TIDE experience made the FDA appreciate the need for greater attention to the ethics of postmarketing research. First, it posed questions about what standard of evidence about drug risk justifies a decision by the FDA to require postmarketing research, particularly randomized trials, as well as what evidence could render such trials unacceptable. Second, it raised questions about what ethical obligations the FDA has to patients who participate in these studies. Finally, it highlighted a potential FDA role in ensuring that institutional review boards (IRBs) are completely informed in their efforts to protect study participants. Although major deficiencies with the TIDE consent form were identified by some FDA scientists and, later, by the IOM committee (Table 1Table 1


  


Major Deficiencies in the Informed-Consent Form for the TIDE Trial.),4,9 the TIDE investigators countered that it had been approved by “480 ethics committees and IRBs.”14 However, the language of the consent form, the trial design, and the materials supporting the justification of the trial raised a question for the IOM committee about whether these bodies adequately understood the nature of the evidence that gave rise to the trial. The IOM committee proposed a framework for evaluating the ethics of FDA-required postmarketing research15 and made a number of ethics findings and recommendations.4

Ethical Responsibilities of the FDA

The IOM committee began by noting that the public health mission of the FDA gives rise to potentially competing ethical obligations “to protect the public's health by having strong science on which to base regulatory decisions” and “to protect participants in research that it requires.”4 Requiring a postmarketing study is an ethical decision, reflecting a weighing of these values.

The committee described the conditions that must be present to justify a decision to require a postmarketing study. The FDA should require postmarketing research only when, first, the uncertainty about the benefit–risk balance of a drug is so great that a responsible decision about its regulatory status cannot be made on the basis of existing evidence; second, the research will reduce this uncertainty; third, the FDA will use the research results expeditiously to make a regulatory decision; and fourth, sufficient protections for research participants can be ensured.

The committee argued that when the FDA requires a postmarketing study, it assumes a measure of ethical responsibility for the welfare of the study participants; exercise of that responsibility cannot be handed off to contractors or the industry sponsor. The responsibility is particularly strong when the patients' treatment is determined by the study, such as in a randomized trial, linking any adverse outcomes directly to a regulatory decision to require a study of that type. This determination led to one of the most important recommendations from the IOM committee: the responsibilities of the FDA to research participants mean that it should mandate a randomized design only if the FDA “has concluded that an observational study could not provide the necessary information [to help answer the important public health question at issue], that an RCT [randomized, controlled trial] is likely to generate the information within the necessary timeframe, and that the necessary RCT is ethically acceptable.” This recommendation comports with but adds some further conditions to the current legal authority of the FDA under the FDA Amendments Act of 2007, which empowers the agency to require a randomized trial if it cannot obtain the data it needs from an observational study.1
 
In light of the critiques of the TIDE trial as inherently unethical, the committee addressed the justifiability of trials in which participants may encounter a net increase in risk, as compared with ordinary clinical care, but no realistic prospect of personal benefit. It argued that such trials can be justified only if they are necessary to answer a critically important public health question, if the potential risk is acceptable and minimized, and if special safeguards are in place, including a highly explicit informed-consent process to ensure that patients understand that they are potentially shouldering additional risk solely to contribute to the public good.
Specific actions that the FDA should take to meet its ethical obligations include specifying the study design, title, end points, and primary analyses; identifying design features that it views as ethically and scientifically indispensable; and, for clinical trials, specifying a safety-monitoring scheme. The committee recommended that the FDA routinely communicate with IRBs about required postmarketing studies — for example, by issuing a letter to accompany IRB applications that conveys information that is material to the IRB's determination of the ethics of the research, as well as providing additional communications over the life of the study as warranted by new information about the drug or by changes in professional practice. The committee also believed that the FDA was ethically obligated to actually use the findings from required studies to make timely regulatory decisions.

Informed-Consent Process for Required Postmarketing Trials

The IOM committee emphasized that the adequacy of the informed-consent process is only one element in the ethics of FDA-required postmarketing research. Other central, and indeed prior, features include ensuring that the selection of participants is equitable and that the level of risk to which they are exposed is acceptable. The committee also recognized, however, that there are challenges to achieving meaningful informed consent in postmarketing trials of drugs for which there is a signal indicating the possibility of drug-related harm. In such cases, there is a suspicion that the benefits of the drug may not justify its risks and often that it may have a worse benefit–risk profile than alternative drugs available to treat the same condition. The committee concluded that for postmarketing trials of such drugs, there are “heightened obligations to ensure that potential research participants understand the risks posed by study enrollment.”4 This was of particular importance for rosiglitazone, because the cardiovascular problem it appeared to cause was the same outcome that good diabetic control was supposed to improve — in other words, if this elevation in risk were real, there could be little offsetting benefit.

The committee recommended several measures to strengthen the consent process in order to maximize patients' understanding of the context in which the trial is being conducted, including what is already known about the risks associated with the drug. The report discussed both specific disclosures in the informed-consent form and special efforts that could be made to ensure adequate comprehension of complex information regarding risks (Table 2Table 2

  

Mechanisms for Strengthening the Informed-Consent Process for Postmarketing Drug-Safety Studies.). To assist IRBs, the committee recommended that the FDA issue guidance interpreting current informed-consent regulatory requirements in the context of required postmarketing studies.

Strengthening Postmarketing Research and Its Governance

Because a true picture of the benefit–risk profile of a drug only emerges over time, two different IOM committees have stressed the need for the FDA to fully embrace a “life-cycle approach” to drug regulation, in which its obligations to protect public health are taken as seriously once a drug is on the market as they are before approval is granted.4,16 Postmarketing regulatory oversight is assuming heightened importance as the FDA accrues additional authority to fast-track drugs for approval on the basis of more limited evidence than was previously required in order to address unmet medical needs and accelerate innovation.17-19 This changing landscape raises several challenges for ensuring the ethical conduct of research with approved drugs and balancing societal interests in drug innovation and drug safety. We highlight two of these challenges here.

First, not all postmarketing research is ethically equivalent. The TIDE trial represented an iconic kind of postmarketing study: an FDA-required randomized trial to study a drug whose benefit–risk profile was under a cloud of suspicion and at a time when alternative treatments were available, albeit not all well studied. The risks to patients of participating in the trial probably outweighed the prospect of direct benefit. By contrast, when the FDA requires an observational study that uses previously collected data, the clinical experience of the participants is unaffected, the risks incurred are not at the behest of the FDA, and ethical concerns are largely confined to confidentiality and the right to control one's medical information.

Both of these scenarios can be distinguished from the context in which a phase 4 trial is required as a condition of an accelerated drug approval and is initiated soon thereafter. Here, the trial requirement is not imposed because of a newly emerging concern about a drug already in clinical use but because additional evidence is needed to confirm the initial judgment that the benefits of a new drug are likely to outweigh its risks. Often, this initial judgment is based on the use of a surrogate end point for drug benefit, not on the clinical outcomes that matter most. Especially when the new drug targets an unmet medical need, it may be in the patients' best interest to take it, pending further timely research. The ensuing trial is undertaken to confirm the improvement in clinical outcomes predicted by the surrogate — a different epistemic and ethical situation than that in which substantial evidence suggests that the surrogate is misleading or that other harms might offset a known clinical benefit.

The volume of phase 4 and other research with FDA-approved drugs is increasing, not only because of the expanded authority of the FDA to require such research but also because of the growing volume of comparative-effectiveness research. In some cases, there may be no or little ethical difference between FDA-required postmarketing research and comparative-effectiveness research initiated by academic investigators. By contrast, a comparative-effectiveness study of two widely used drugs that is not occasioned by heightened concern about the risks of one drug relative to the other is markedly different, ethically, from a study required by the FDA to pursue a safety signal that is already of such concern that practice patterns are shifting, even if both studies use randomized designs.

These differences highlight the need for IRBs to be sensitive to the place where a study falls within the life cycle of a drug and to the reason for the research. Depending on who is initiating the research, for what reasons, and when, the same study design may have very different ramifications for the benefit–risk balance of the study and what patients need to know in order to provide meaningful informed consent. Trials that may be regarded as unethical late in the life cycle because of accumulated evidence can be much easier to initiate earlier if the need for additional research is anticipated and planned at the time of initial approval. In the case of rosiglitazone, this need could have been anticipated from preapproval data showing an adverse effect on serum lipids as well as the use of a surrogate end point (glycemic control) for a first-in-class drug.5,20
 
Second, the experience with rosiglitazone underscored the fragility of our current system of discovering risks associated with drugs. This system relies heavily on drug sponsors and FDA scientists to conduct safety analyses on the basis of data from clinical trials, some or all of which are not publicly available, and to release findings to the public. It has been shown repeatedly that the published record can misrepresent evidence known to the FDA.21,22 In the case of rosiglitazone, scientists from GlaxoSmithKline and the FDA had information from 42 clinical trials, of which only 7 were published and the others were inaccessible. Triggered by concerns expressed by the World Health Organization in 2006, GlaxoSmithKline conducted and shared with the FDA a meta-analysis of the safety of rosiglitazone that used these data, confirming a possibly elevated risk of ischemic events, but neither these results nor the primary trial results were shared with the public until an unrelated court settlement forced GlaxoSmithKline to release its complete clinical-trial data.23 This access led to the published meta-analysis by independent researchers that made these data and concerns public in 2007.5
 
It is often the work of independent scientists that has highlighted critical safety problems with approved drugs.5,24-29 Yet currently, data from premarketing studies that are submitted as part of a new drug application or a supplemental new drug application are largely shielded from release to external scientists and the public owing to concerns about a competitive disadvantage to drug sponsors.30,31 The IOM committee stopped short of calling on the FDA to increase public access to such data but recommended that the agency initiate a process to determine ways to “appropriately balance public health, privacy, and proprietary interests to facilitate disclosure” of relevant data.4 Greater transparency would better equip independent scientists to investigate early safety signals.31 Consideration should be given to making drug-safety data from clinical trials available to the public on request once the FDA has reached a decision regarding a new drug application or a supplemental new drug application or once the manufacturer has abandoned the application, unless the manufacturer can articulate a persuasive reason why it would result in competitive harm and the FDA determines that this harm outweighs the public health benefits of releasing the information.

Conclusions

The experience with rosiglitazone and the TIDE trial offers a lesson in how our current approach to the oversight of drug-safety and postmarketing research can fail both the public and the research participants. Although terminating the TIDE trial was justifiable, it left regulators with highly suggestive but nondefinitive data on the relative safety of rosiglitazone and the closest clinical alternative, pioglitazone.32
 
Reactive policymaking is tempting but problematic. The history of regulation of human subjects research suggests that rules that are “born in scandal and reared in protectionism”33 often fall short of providing meaningful protections to research participants and that, once adopted, regulations can ossify and become difficult to dislodge. Nevertheless, the IOM committee's report makes a number of actionable recommendations that the FDA can implement under its existing authority.34 In addition, appointment of an independent ethics advisory board would strengthen the decision making of the FDA as it confronts emerging ethical challenges — both those arising from required postmarketing trials and those stemming from powerful new drug surveillance systems, such as the FDA's Sentinel Initiative. As the pace of the translation of discoveries from bench to bedside continues to intensify, so too does the imperative for thoughtful ethical governance throughout the life cycle of a drug.

The views expressed in this article are those of the authors and, except where noted, do not represent the official position of the Institute of Medicine or of the committee that produced the report discussed in this article.

Drs. Faden and Goodman chaired, and Dr. Mello was a member of, the Institute of Medicine committee that produced the report discussed in this article.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article was published on August 22, 2012, at NEJM.org.

We thank the other IOM committee members for contributing to some of the ideas discussed.

Source Information

From the Department of Health Policy and Management, Harvard School of Public Health, Boston (M.M.M.); the Departments of Medicine and Health Research and Policy, Stanford University School of Medicine, Stanford, CA (S.N.G.); and the Berman Institute of Bioethics, Johns Hopkins University, Baltimore (R.R.F.).

Exchanging Partners for Recreational Sex

Look At It This Way

Seeing old things in new ways.

by Stephen Mason, Ph.D.

Exchanging Partners for Recreational Sex

Swingers-R-Us

Published on June 20, 2010 by Stephen Mason, Ph.D. in Look At It This Way

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Since I'd just given a talk at the Whole Earth Expo, I wasn't surprised when The Lifestyles Organization called and asked me to be their keynote speaker. I assumed it was yet another health food group and that they too would like to hear all about the latest research involving Life Extension. Not so. It seems this was to be the world's largest gathering of Swingers and they wanted something a little sexier. Eventually, I found myself in front of a few thousand couples at a Vegas resort explaining the ins and outs of: "Ten Perversions in 30 Minutes." This turned out to be such a fun convention that I decided to work with the group on all their subsequent events and thus began a long and rewarding relationship.
So you can imagine my surprise when radio talk-host Dr. Dean Edell, whom I knew didn't travel in such circles, mentioned Swingers. His program was just before mine so, as an admitted hypochondriac, I'd always tune-in on my way to the studio figuring that if I don't already have any of the diseases he was discussing that day...it was only a matter of time. But what could the good Doctor possibly know about the Lifestyle? It seemed that he'd just read an article published in the Archives of Sexual Behavior.

The piece began with a definition of Swingers as "married couples who exchange partners solely for sexual purposes" and then went on to review what the medical literature had to say about this group. The notion going in, of course, was that this one bit of behavior (swapping mates) was so bizarre as to almost guarantee that it would color every other aspect of their lives. The study concluded, however, that this was not the case. Significant differences between Swingers and their straight neighbors were simply not to be found. Compared to the population at large, about the only thing the researchers could find was that Swingers tended to be more from the upper middle class and tended to be more from the Conservative end of the political spectrum.

Neither the social class nor the social views would come as any great shock to those familiar with the group. Indeed, the higher educational and income levels along with a staunch support of upper middle class values are almost a given at Lifestyle events. The few areas where Swingers do differ from their more monogamous peers all involve - as you might suspect - sex. Swingers are typically more liberal when it comes to premarital relations, divorce, homosexuality, abortion and pornography; areas where, presumably, Swingers have had more experience than non-Swingers. And speaking of non-Swingers, the article went on to say that they were convinced "wife swappers" had to be heavy drinkers and users of heavy drugs. Again, anyone familiar with the group knows that alcoholic consumption is typically far below that found at most country club soirees and the NO DRUGS admonition at most Swing parties is something of a mantra. They would also know that the term "wife swappers" is never used because, in, fact, you might just as well call them "husband swappers." Dr. Edell concluded with: "The article dashes a stereotype that we may have about this particular group we think we know."

So here's an honest, open-minded guy presenting the facts and avoiding even a hint of prejudicial condemnation. That said; imagine my dismay when I later visited Multiple Sexual Partners on the Internet. I was shocked! The site was devoted to dozens of headings which include: cervicitis; cervical erosion and genital warts; gonorrhea; pubic lice; syphilis and urethritis. In short, everything that might possibly go wrong - gone wrong. Is there no up side to sex...no joy, no beauty, no healing? What could Mother Nature have been thinking when she attached so many nerves to our sex organs, filled our blood streams with sex hormones and devoted vast tracks of our brains to thoughts of sex? Must we be doomed to a choice of either denying the mental anguish of abstention or suffering the physical deterioration of decadence? Boy! She sure screwed us!
Or did she? Actually, we live in a time and place where, in so far as sex is concerned - Accentuate the Negative has become the Golden Rule. There is nothing, the conventional wisdom goes, so dangerous to your home and family, your town and country, your health and well-being as S-E-X. Is it any wonder that 31% of males and 43% of females now suffer one or more symptoms of sexual dysfunction?

So who is responsible for this appalling perversion you ask? The answer is really quite simple. The most obvious sign of neurosis is an overpowering need to control. The neurotic feels adrift amidst conflicting emotions and irrational beliefs. The only option is to hang on for dear life. Get a grip on yourself and as many of those around you as you possibly can. And that, dear reader, is the motivating force behind those who would censure and condemn all that they themselves can't handle.

How A Big Drug Company Inadvertently Got Americans Hooked On Heroin

Huffpost Business

Jillian Berman  Jillian.Berman@huffingtonpost.com

How A Big Drug Company Inadvertently Got Americans Hooked On Heroin

Posted: 02/24/2014 7:53 am EST Updated: 02/25/2014 8:59 am EST

Heroin Addiction Best of HuffPost Heroin Abuse Prescription Painkillers Heroin Epidemic Heroin Painkillers Heroin Phrmaceutical Industry Prescription Pain Killer Abuse Prescription Painkillers Addiction Business News
 

When she was 18, Arielle would come home every day and embark on what she calls an “Easter egg hunt." She wasn’t looking for candy. Arielle was hunting behind stairwells and inside closets in her suburban Long Island home for the OxyContin bottles her cousin brought home from work at a pharmacy and was hiding from her mother around the house.

“I found them one day, and I wanted to try them because all of my friends were already hooked,” said Arielle, who asked that her last name be withheld to avoid hurting her chances of getting a job. “I would see [my cousin] nodding out on the couch and not really being present, and that was how I wanted to feel. My best friend had just passed away, so I was numbing out the feelings.”

It took about a year before Arielle moved from prescription painkillers into the illegal drug that killed her best friend: heroin. She snorted it for the first time after tagging along with a friend who was going to buy some. "I was like, 'I love it,'" she said. Heroin was cheaper than prescription pills -- about $10 a bag, compared to $60 to $80 per pill -- and gave her a more potent high.

Her friend helped her inject the drug. “It was a feeling that I don’t think anyone should experience. Because once you experience it, you want to experience it over and over again,” she said. “ Next thing I know, I’m addicted.”

Arielle landed in a Long Island jail last year after she was caught breaking into a house and stealing money to buy drugs. Now 26 and living at a substance abuse treatment center, she says she's all too aware that her story isn’t unique.

Between 1996 and 2011, the number of people who ended up in substance abuse treatment centers in Suffolk County, where Arielle lives, as a result of heroin jumped 425 percent, according to a 2012 special grand jury report from the county’s Supreme Court. During the same period, the number of people who landed in substance abuse treatment for opioid pill use spiked 1,136 percent, the report found.

Long Island is one of many areas of the country where heroin addiction is reaching harrowing levels, according to Gregory Bunt, the medical director at Daytop Village, a New York-based substance abuse treatment center. The crisis is getting renewed attention after actor Phillip Seymour Hoffman died last month from an apparent heroin overdose. The rise in heroin use mirrors a decade-long spike in abuse of prescription opioids -- painkillers that are a medical cousin to heroin, but are legal as long as they’re prescribed by a doctor.
In recent years, more prescription drug abusers have started turning to heroin for a cheaper high as the price of pills skyrockets on the black market, Bunt said. Two factors have contributed to the cost increase: opioid addiction boosting demand and doctors becoming more cautious about prescribing opioids, decreasing supply, Bunt said.

Another reason for the price increase: The Drug War, according to a January 2012 report from Radley Balko. Government crackdowns have made it difficult for even reputable doctors to prescribe pain pills. To fill the void, doctors and others looking to make a buck off the prescription pills created so-called "pill mills" -- offices that prescribe pain medication in high volume and often serve people addicted to the drugs.

The result: Nearly four out of five people who recently started using heroin used prescription painkillers first, according to a 2013 study from the Center for Behavioral Health Statistics and Quality.

“A lot of people who got in trouble with the prescription opiates are switching over to heroin, and they get more for their buck, so to speak,” Bunt said. In his experience, he added, much of the heroin available today is laced with other additives, like additional painkillers -- making it more dangerous.

“Once you inject the heroin that’s available today, you’re at very high risk for fatal overdose,” he said.

See full-size image here.



Infographic by Alissa Scheller for The Huffington Post     For decades, opioid painkillers, like oxycodone, hydrocodone and morphine, had been used successfully to treat conditions like intense pain at the end of life for cancer patients and acute pain after an injury like a broken bone.

But everything changed when OxyContin -- and the marketing campaign that came with it -- started in the 1990s, experts say. The drug, developed by Purdue Pharma, had a time-release mechanism that spaced out its effects over a longer period of time.

In dozens of seminars in ritzy hotel conference rooms across North America, the company sold doctors on the idea that the time-release function made OxyContin perfect for a population of patients who were suffering from chronic pain. Representatives also argued that the drug's spaced-out effects made it less likely that patients would get addicted -- which was the main factor deterring many physicians from prescribing opioids for chronic pain.

“This campaign focused on convincing doctors that they shouldn’t worry about addiction, so the medical community was taught to believe that addiction to opiates was relatively rare,” said Andrew Kolodny, the director of Physicians for Responsible Opioid Prescribing.

The pitch was convincing, Kolodny said, because no doctor wants to believe that they’re keeping a patient in pain unnecessarily. By 2001, OxyContin had exceeded more than $1 billion in sales, and by 2003, nearly half of the doctors prescribing OxyContin were primary care physicians, according to a 2004 report from the Government Accountability Office.

“As prescriptions began to take off, it led to an epidemic of opioid addiction,” Kolodny said. “We all became much more likely to have opioids in our homes, so it created a hazard.”

“We have now this incredibly unusual public health crisis that’s essentially caused by physicians, caused by the health care industry,” said Meldon Kahan, the medical director of substance use services at the Women’s College Hospital in Toronto.


  Chart via the Harvard Kennedy School.
In 2007, Purdue and three of its top executives pleaded guilty to misleading doctors, regulators and patients about OxyContin’s risk of addiction. The company agreed to pay more than $600 million in fines. In 2010, Purdue developed a version of the drug that was harder to crush and snort or inject than the original, aimed at deterring abuse. In April, the FDA banned the original OxyContin and all of its generic versions from hitting the market.

Purdue Spokesman Raul Damas wrote in an email statement to The Huffington Post that “like any public health issue, opioid abuse is the result of many factors, not just one drug or one company.” Brand-name OxyContin represents a small share of oxycodone-based drugs on the market, and Purdue has taken steps to curb the addiction epidemic, like paying for addiction hotlines and working with law enforcement to help them better identify pills that are frequently abused.
“The recent increase in heroin abuse is an unfortunate result of many different factors, and what often gets lost is that prescription opioids play an important role in helping patients and physicians address the very real issue of chronic pain.” Damas wrote. “Purdue has led the development of abuse-deterrent opioids, but these efforts need to be complemented by public education and treatment, so that we address demand, as well as supply.”

People typically become addicted to the prescription pills in one of two ways, Kolodny said. The majority of younger users, like Arielle, find the pills lying around at home or at friends’ houses. But the other demographic suffering from prescription painkiller addiction -- middle-aged Americans -- typically get the pills from their doctors for things like chronic back or head pain. Once their bodies adjust, their doctors have to up the doses to mitigate the pain.

Betty Tully experienced this phenomenon firsthand. She went to her doctor in January of 2001, looking for a fix for the pain that had plagued her lower back for decades. Tully’s doctor said he had just the thing, a new “miracle drug” that could help her pain without putting her at risk of addiction. He started her on 20 milligrams of OxyContin. Soon, she was asking for more, so he upped her doses.
“By June, I was an absolute zombie. I couldn’t work anymore, I couldn’t drive my car anymore. I left my car running one day on the street,” the former real estate agent said. “I was calling his office and screaming that I needed this medicine.”

By the end of 11 months, Tully was on 280 milligrams of OxyContin per day. The mother of two, who had held down jobs since she was 12 years old, refused to leave the house for fear she’d miss a dose and go through terrible symptoms of withdrawal like nausea and profuse sweating. When she decided to get clean, it took her six years to completely get off the drug, and she says she’s lucky she was able to finally kick the habit. Indeed, according to Kolodny, "middle-aged women getting pain pills from doctors" are dying from overdoses at some of the highest rates in history. In 2010, 40 percent of U.S. drug overdose deaths were women, many of whom died from abusing prescription pills.

“I should be among those statistics,” Tully said. “There’s not many people that can take that much and be breathing every day.”


CORRECTION: Language was changed to clarify that while 40 percent of drug overdoses in 2010 were women, not all of them died from taking prescription pills.

Hadacol, the Last of the Medicine Shows

 

Hadacol, the Last of the Medicine Shows

 

Miss Cellania

 

filed under: History, medicine, Miss Cellania

 

 

Advertiser-supported entertainment is nothing new. Since medieval times, people could see free entertainment right in their hometown as long as they listened to a sales pitch for dubious remedies along with the singing, dancing, and side show acts. Sales of snake oil and other patent medicines paid for the show and then some. Like other forms of traveling entertainment, the medicine show lost its luster when people gained the opportunity to go see movies instead. The medicine show had one last hurrah during the 20th century in the form of Hadacol.




The story of Hadacol is the story of Dudley LeBlanc. A born entrepreneur, LeBlanc put himself through college in Lafayette, Louisiana by running a clothes pressing business. Then he put four brothers and two cousins through college as well. LeBlanc sold shoes, tobacco, patent medicine, and funeral insurance. He also ran a funeral home, which benefitted greatly from insurance sales. LeBlanc served as state senator and in the Louisiana Public Service Commission. In 1932, he ran for governor of Louisiana against Oscar Allen, who had the support of Huey Long. It was a particularly nasty campaign that LeBlanc lost. He also ran unsuccessfully for governor in 1944 and 1952. LeBlanc served as state senator for four non-consecutive terms between 1940 and his death in 1971. In the midst of his political career, he also made millions selling Hadacol.

LeBlanc ran into some trouble with the FDA over the patent medicines he was selling in 1941. Rather than deal with defending products that weren't all that profitable, he stopped making Dixie Dew Cough Syrup and Happy Day Headache Powders. Then he came up with something better. The story LeBlanc told was that he was suffering from pain in his big toe, and the only doctor who could help him wouldn't share the recipe for the medicine he used. So LeBlanc stole some from an inattentive nurse and research the ingredients on the label. From that information, he developed Hadacol. The name was short for Happy Day Company, with an L for LeBlanc. However, many years later when someone asked how he named the drug, LeBlanc said "Well, I hadda call it something."




Hadacol was a mixture of vitamins B1 and B2, iron, niacin, calcium, phosphorous, honey, and diluted hydrochloric acid in 12% alcohol. The alcohol content wasn't all that high, but the hydrochloric acid meant it was delivered through the body faster than it would be otherwise. The mixture really made people feel better, although it wasn't a cure for the many diseases it was advertised for: high blood pressure, ulcers, strokes, asthma, arthritis, diabetes, pneumonia, anemia, cancer, epilepsy, gall stones, heart trouble, and hay fever. And that was only the beginning.





What made Hadacol a success was LeBlanc's advertising ingenuity. He explored ways to promote his product that took the public by surprise -and worked. He kept supplies low in some pharmacies to create demand. He paid people for their testimonies, which sometimes crossed the line to ridiculous.

"Two months ago I couldn't read nor write. I took four bottles of Hadacol, and now I'm teaching school."

Hadacol was everywhere, on radio, on billboards, in newspapers and magazines, and at the local pharmacy. It was even sold in liquor stores and bars. People paid $3.50 for a 24-ounce bottle even if they had no food in the pantry. The hope for a better tomorrow trumped common sense in those days, just as it does now. LeBlanc pushed Hadacol on his radio show, which he broadcast in French. He published a medical pamphlet extolling the wonder of his elixir. He gave away swag featuring the name Hadacol on it, including water pistols and a comic book for children with stories drawn from glowing testimonies. LeBlanc wrote a jingle called "The Hadacol Boogie" which was recorded by several artists including Jerry Lee Lewis. He gave out Hadacol tokens, good for 25 cents off a bottle. LeBlanc had to expand his factory, then build more factories. Hadacol use spread from Louisiana across the nation. Millions of bottles were sold every year.

The Food and Drug Administration objected, not to Hadacol itself, but to LeBlanc's claims that it cured cancer, epilepsy, asthma, and other diseases when it clearly did not. Wanting to avoid trouble, LeBlanc pulled those claims, but the damage was done. The new health claims were vague, but he couldn't do anything about the testimonies consumers gave. Without specific diseases, Hadacol became a cure-all for whatever people hoped it would cure. And no matter what was wrong, the medicine made people feel better -and that was all that mattered. LeBlanc instigated rumors that Hadacol was good for sexual potency, a tip that was slyly alluded to in the medicine shows. Hadacol was said to be recommended by doctors, although the only doctor named was Dr. L.A. Willey, who later turned out to be a Californian convicted of practicing medicine without a license. To enlist doctors for endorsements, LeBlanc offered free samples and a payment for each patient a doctor could recruit for research.




In 1950, LeBlanc took the show on the road. The Hadacol Caravan of 130 vehicles played one-night stands throughout the South. Thousands of people paid admission with Hadacol box tops each night and enjoyed entertainment from Carmen Miranda, Mickey Rooney, Bob Hope, Lucille Ball, George Burns and Gracie Allen, Roy Acuff, Minnie Pearl, and other big names. The band played, chorus girls danced, circus acts performed, and LeBlanc sold millions of bottles of Hadacol. the caravan then headed west and recruited the talents of Groucho Marx and Judy Garland. In 1951, LeBlanc toured using a 17-car train called the Hadacol Special. The shows featured bicycle giveaways, beauty contests, and clowns selling Hadacol. Jack Dempsey, Milton Berle, Jimmy Durante, and Cesar Romero joined the show, which played for a month straight in Los Angeles. Hank Williams played the final act of the show and brought people to their feet every night.

At the time, Hadacol was the second biggest advertiser in the US, right after Coca-Cola. As the caravan headed east, there were hints that all was not well with LeBlanc financially. The company head was spending more in advertising than he was bringing in. He announced that he was selling the company to the Maltz Cancer Foundation, but would stay as a sales manager. The actual buyers included Dr. Maxwell Maltz, a plastic surgeon who ran a "private research project." Then news then came that LeBlanc was in trouble with the IRS. The caravan tour laid off some performers, then cancelled before the end of the schedule. Some performers were stranded without pay. The group that bought Hadacol was stunned to find how far in debt the company was, and declared bankruptcy even before paying the entire $8 million selling price to LeBlanc. Still, LeBlanc had the last laugh, as the company's debts were no longer his. Later that year, LeBlanc appeared on Groucho Marx' TV show You Bet Your Life. Marx asked him what Hadacol was good for. LeBlanc quipped "It was good for about"¦ 5 and a half million dollars for me last year."

Old Medicine Shows: Outrageous Cure Alls to Give You Chills

Old Medicine Shows: Outrageous Cure Alls to Give You Chills

Article by Marc, filed under Vintage & Retro in the Technology category.

In the 19th century, science was king. Everyone thought we’d reached the pinnacle of human invention and knowledge, and we would soon be living in a utopia. Doctors were held in unquestioned regard, and when they came out with a new cure, it worked! Because why would anyone lie about something like that? Before governments decided it would be a good idea to truly regulate claims made by medicine makers, sleazy snake oil peddlers and medicine showmen traveled the world selling tonics that would make fantastic claims. Looking back on some of the products even the most mainstream companies created is a bit… unsettling.

(Images via boston, opiated, daddytypes)

The scariest part of wildly untested drugs are the ingredients that we now know have very intense effects. For example, Victorian parents used to administer drugs containing opium to their children to help quiet them down when they went away to work. Nefarious ingredients were slipped into soothing syrups for teething children, or to help settle down a child’s cough.

(Images via digitalsinz, zmescience)

The road to hell is paved with good intentions, and let’s hope intentions were pure when companies were creating such obviously (now) bad ideas as cigarettes to help soothe asthma. Interestingly enough, Paregoric, which contains powdered opium, is still available in medications, but to a much more limited extent.

(Images via pardon-my-french, allscrubbedup, whale.to)

It’s widely known that Freud thought cocaine was a wonder drug that helped the mind, but so did the Pope! Cocaine used to be used in everything from cough drops, to wine, and even to soda (coca-cola’s original incarnation). Pope Leo XIII enjoyed Mariani’s coca wine so much that he awarded it a Vatican medal, and they used his image in their advertising. Queen Victoria and Thomas Edison were also said to be great fans.

(Images via metafilter, wikimedia, metafilter)

The packaging of medicinal products used to say it all. Package decorations varied from the most epic scenes of courage and defense, to intense, clearly very scientific diagrams, all the way down to emotional illustrations meant to grab your attention. Despite reforms, drug companies still advertise similarly; they showcase confident families and business people grinning and going about their day with a purpose that the sick just don’t have.

(Images via janeanddick, ephemeralnewyork)

The tone of vintage advertising is always interesting, but if you think ads promising weight loss are outrageous now, take a crack at these wonderful examples. Besides the fact that most people would find consuming tapeworms abhorrent, the colorful language and ridiculous imagery makes these ads a delight.

(Images via wikimedia, thevirtualdimemuseum, inventors)

You have to give old time doctors credit – they were creative. They loved to come up with long lists of ailments that sound great but are difficult to pinpoint. For example, stomach chills and nervous and chronic diseases are common ones. How many doctors today could fashion an artificial ear drum better than the real thing? Or an electric belt that has curative properties without the use of medicine? Unfortunately, these products don’t sound too far fetched for anyone who watches the occasional infomercial.

(Images via wired-for-sound, erocx1, ourkitchensink, amphetamines)

Benzedrine used to be an incredibly popular inhaler, chock full of amphetamines (known more commonly as speed), which was widely touted as increasing wakefulness and focus, with the added benefit of decreasing appetite. Amphetamines were sold under many brand names, and were most commonly used to assist weight loss.

(Images via thefullwiki, nosferajoo)

It might be surprising to dig into the past of some of our most popular drug companies, such as Bayer’s branded product “Heroin” which was touted as a non addictive substitute for morphine… until it was discovered that it actually metabolized into morphine, only on a much more powerful scale.

(Images via wikimedia, wikimedia, omglog)

We may not have changed as much as we’d like from the Victorian era, but at least the population is (hopefully) a bit more knowledgeable, and there is quite a bit more regulation. Judging from the past, this is a good thing. One thing the Victorians always did with style, however, is make some damn beautiful packaging.

Anonymous Facebook Etiquette and Saving the World from Drugs

 

HOT TOPICS: Drug and Alcohol Treatment Heroin

Anonymous Facebook Etiquette

 

Don't "like" me because I'm sober in AA. And stop outing me with your clicks. Follow these five steps toward social-networking propriety.

 

Dislike Photo via

By Bobbi Anderson

05/21/13

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• Are You Addicted to Facebook?
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• Facebook Addiction May Cause Psychosis
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• Facebook Addiction Puts Sex Offender in Prison

When you update your Facebook status to announce that you have another year’s sobriety, you accomplish two things. First, you break the 11th Tradition. Second, all of our mutual friends in the program rush to "like" and congratulate you, like moths studding the burning glass of a halogen lamp. Well, not me. Sorry, but I’m not putting my full name next to the phrase "sober." Facebook is porous. Everyone is on Facebook. If my boss is one of our mutual friends and I congratulate you on your sobriety, she may well make the leap of logic to assume that I’m "one of those AA people." And that’s none of her business.

Your alcoholism and your recovery should not be public property. When you announce your affiliation with AA online, that’s what it becomes. Thanks to a vast erosion in privacy laws, everything you say and do on Facebook is trapped in amber for perpetuity. Don’t make your AA chip your profile picture (argh)! Don’t announce that you just finished your Fourth Step. What happened to the good old days (okay, now I am officially a bleeding deacon) when we belonged to a virtual secret society that met behind closed doors and didn’t trumpet the fact that we are recovering from a deadly, highly stigmatized disease?

Okay, so you want to tell the world that you’re in AA. Fine, have at it. Re-read Traditions Eleven and Twelve and make up your own mind. But leave me—and other AA members—out of it. Review and avoid the following Facebook Crimes:

1. Outing other members blatantly

Please don’t tag me in posts about how great a meeting was or how much you “love your sober life.” Tag me in reference to how awesome your life in general is, by all means, but don’t put my name next to references about recovery.

2. Outing other members cryptically

If you come to me with a question and I suggest a page number in the Big Book to read, don’t post on my page, "Oh my God, page 69!!! You were so right!" It has my non-AA friends scratching their heads (I have close friends who I’ve never told I’m in AA) and some fellow AA members pawing frantically at their Big Books trying to get the inside scoop on what exactly you’re referring to. By the way, referencing page 69 ("we all have sex problems") in public is just as icky as posting that you’re "really enjoying" 50 Shades of Grey. Ew.

Recovery groups should be focused on recovery, not your meltdown of the week.

3. Drama, drama, drama

This tends to be a big problem in "secret" groups that are invitation-only for those in recovery. As in AA, there’s a heady mix of personalities in any online recovery community. Some of us are well, and some of us are, well, not so well. We’re all willing to cut you a little slack when you go on and on at your home group about how a barely disguised "him" (aka another newcomer sitting across the room from you) broke your heart and set your dog on fire, but when you put this info out on Facebook you’re both preserving your drama in binary code forever and issuing a virtual call to arms. In meetings you have the bylaws restricting crosstalk to help save yourself from yourself, hopefully ensuring that nobody exacerbates the drama by responding to what you say. Nor (in a perfect world) will they take your information outside the rooms to anyone but their sponsor. No such practice of "principles over personalities" can be guaranteed online, where I’ve seen members of recovery groups pick sides and greedily ask for more information. Recovery groups should be focused on recovery, not your meltdown of the week. Behavior that might be tolerated in other online groups—such as trolling/whining/shit-stirring—will get you kicked out of these "secret" groups a lot quicker than bad behavior will get you kicked out of a real meeting. Just go to a meeting. Go.

4. More drama

 

"Fuck all of y’all, I’m out of here!" Believe it or not, we want you to stay. We really do want you to stay in Alcoholics Anonymous, to find a little peace and to get sober. We know it’s not easy. And we know it’s a challenge to break a lot of those old habits, including the habit of flying off the handle and relapsing when you don’t get your way. And we know that anger can kill. When you update your status with something like—"Fuck everyone for siding with my ex! AA is nothing but snitches and bitches!"—we know it’s really tantamount to a suicide threat. And, like responding to a suicide threat, we will all try and convince you to stay. But we shouldn’t be doing that on Facebook. We should be calling you, stopping by your house and trying to take you to a meeting. Twelve-step calls should not be done on social media. That’s just lazy.

5. Photos

"Oh my God, wasn’t ACYPAA amazing? Do you remember the dance contest? How Rick dressed up like Flava Flav except instead of a huge clock around his neck he had a big AA chip? That was hilarious!" Wait, why is that picture on Facebook? Even if it is just in a "secret" group, did you get Rick’s permission to take and post his picture? What about all of the people in the background? I really doubt you asked all 40 people dancing next to Rick whether or not you could take their picture and put it online, blatantly outing them as "young and sober." Some of them might be doctors or lawyers or teachers whose careers could be jeopardized. Also, if one of our members should relapse and then post pictures of themselves with a margarita in hand, don’t embarrass them with alarmed statements about how you hope they’ll come back soon. Either they will or they won’t. Their relapse is none of your business until they call you.
I understand the temptation to weave your life on social media and your life in recovery together. Recovery is amazing. It’s natural to want to share it with everyone, to get involved and to normalize it as much as possible by broadcasting how whoop-ass your fellowship is. But it’s not just your life you’re talking about. AA is a "we" program. Recent GSO guidelines addressing this topic suggest that people do not identify themselves as members of AA on any social networking sites. That’s for everyone’s safety. Just go on and have an awesome life. I and our fellow AA members will keep clicking "like" on your snowboarding pictures or posts about how happy you are, complicit with secret smiles about how that happiness came to fruition.

Oh, and one more thing. Potential 13th-steppers: Stop profile-stalking newcomers. Newcomers, stop accepting friendship requests from sleazy 13th-steppers. Leave that shit for the meeting after the meeting, where I can steer you away from Don Juan and refer you to page 69.

Bobbi Anderson is a pseudonym for a regular contributor to The Fix.

 

HOT TOPICS: Drug and Alcohol Treatment Heroin

Why You Probably Shouldn’t Become a Drug Counselor

 

Here's a numbered list of reasons why it would be a bad idea.

 

You're not cut out for this. Shutterstock

By Bobbi Anderson

02/17/14

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• What Happens When Addiction Counselors Relapse?
• Addiction Counselor Robs Banks for Cocaine Money
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• Half of Counselors Don't Always Advise Abstinence

Hey homeslice, I was there. Three months of shaky sobriety under my belt and ready to save the world, a community college catalog in front of me. I knew more about drugs and alcohol and addiction and recovery and life skills then than I do now with six years clean. The counselors who walked me through rehab still exist in my memory as larger-than-life angels with bright hazy halos of light behind them. You know I looked up to them. But I probably shouldn’t have gone on to be an AOD counselor. And you probably shouldn’t either. Why? I’ll tell you why.

1. You’re probably not ready. 

Recovery is lot of hard work that you need to invest in yourself before you try to save somebody else. Many counseling programs don’t allow students in without a good chunk of documented sobriety, ranging from six months to two years. Ginger Olsen, a professor and veteran counselor, teaches in California where there is no such waiting period. She says that most of her students are “two steppers: one, they decide they’ve seen the light, and, two, they’re going to save the world. Very few make it all the way through.”

Take heart though, Olsen says that even the dropouts usually get something out of it.

“Whether it is the intervening 10 steps or cognitive awareness or a combination, they grow in their sobriety and become productive citizens moving on to more satisfying endeavors.”

2. School is hard. 

There are a few totally legit reasons why it’s a good idea to wait a year or so after your clean date before deciding on your life’s work. One of them is Post Acute Withdrawal Syndrome, a set of symptoms including anxiety, depression and cravings which persist months into early recovery. The most common phenomenon I saw in myself, my clients and my fellow students was a desire to do everything right away in an effort to make up for lost time. Five months ago we were lying in a gutter trying to figure out who to hit up for enough cash to make another score. Now we’re sober and bright-eyed and we need to get a job and reconnect with our family and find a girlfriend and start going to the gym again and go to school and.... It’s a lot to handle. You shouldn’t take it all on at once, because you’re going to burn out and you could relapse. I should have. Sixty hour work weeks plus being a full-time student plus every service commitment that came my way? The stress almost killed me. I was a dumbass. You don’t have to be.

3. You’re a jerk. 

Let me rephrase that: you’re going to find out some unpleasant things about yourself, and on the job is a lousy time to find them out. I found out that I’m kind of a jerk. And I found that out because I went to school instead of going to therapy. You probably need to go to therapy first, otherwise you’re going to process things through your clients, which is bad for everyone. This is known professionally as counter transference. Every demon from your past will show up in your clients—your abusive ex-boyfriend, your cold father, your drunk mother—and you need to have your shit squared away so you can actually help them instead of staging a reenactment of your childhood.

4. The people you work with will be jerks. 

The people you work with will actually be angels, except when they’re not. I had a professor warn me that every office is a dysfunctional family, and boy was he right. There are a lot of people with varying levels of emotional sobriety in the recovery field, and some of them are really going to challenge your patience. In any given counseling program there will be the cranky hardcore old-timer who thinks he’s a cop, the guilty codependent who lets her clients get away with everything, and the dry drunk deadbeat who’s making shady decisions. Some counselors relapse. Some counselors sleep with clients. Report that crap. But I’m mostly talking about the people in our profession whose ideals and techniques run completely counter to your own training. The most frustrating thing is that they usually have clients who love them, and they get results. Different strokes for different folks. Working with people you don’t agree with is part of life, period. In counseling it just happens to be magnified times ten.

5. You will not be paid what you deserve. 

The exception being if you have an advanced degree, like a masters in social work or a PhD in psychology. But the starting salary for most recently-certified counselors in my region is just a hair over minimum wage. Treatment is a low priority for funding. It’s not easy to get hired, either. School is just the first part of the process, and after that another few thousand hours of on-the-job training and an expensive certifying test are required. Considering that back in the bad old days people began “counseling” with just sobriety alone, these requirements are a good thing. Just know that in order to get the degree and the experience you need to level up to a better-paying gig, you’ll probably spend a few years making close to nothing and/or accruing student loans.

6. You will probably not be able to give your clients what they deserve. 

 There are some golden moments in this field. When the light comes on in someone’s eyes, when a group starts to bond, when a client comes in and proudly shows you their nine-month chip. They make all the crappy things about the job worth it. They do. But the moments of heartbreak far outweigh the moments of joy. You will be working with a population of people whose natural state is drunk, loaded or dead. They will arrive with a history of co-occurring disorders you’re not trained to handle. Everything about the world, from their family to the correctional system to sometimes the very program you work for will stymie their efforts to change. You will hear things and see things that will keep you awake at night, wondering if you did the right thing. You will obsess over a client for months, put them in a special place in your heart, work with them to get clean, watch them progress and cry for happiness. Then they will show up for group drunk and you’ll have to kick them out of the program. They’ll disappear back into the correctional system and you’ll feel like you’ve failed.

A friend and former colleague put it like this:

“Look, if you build a house...if you are a construction worker...you see an empty space on the ground and a few weeks later you see a house. You feel the floor, appreciate the shape, smell the labor and wood. It is very concrete. You know what you accomplished. Same with a cook, same with you, the journalist. But at the end of my day, I wonder what I accomplished and I am not certain of much.”
I’m not including my colleague’s name because her speaking publicly on the subject could endanger her career and her credentials. That brings me to one of the final things that you need to know about becoming a counselor...

7. You will need to change everything about your life. 

 I have about a month before my certification expires in California and I’m not sure whether I’m going to re-up or not. Becoming a writer has kind of decided the issue for me. A client who web-searched my name would be sure to find some unprofessional material. To be a good counselor you have to have excellent boundaries. That means that you don’t let clients into your personal life, you carefully guard your social media presence and you don’t carry a public persona that will endanger your reputation. HIPAA privacy guidelines for counselors are some of the strictest in the mental health profession. I have sat with clients as they told me their deepest, darkest parts of themselves. I’m not allowed to hug them. We cannot be friends. If I see them on the street I can’t acknowledge them first. If they go to jail I can’t visit them. If they die (and many do) I will have to mourn them privately. These are good, good rules established for good, good reasons and I’m grateful they exist. I’m a better person for having been a counselor, even for a brief time. But I had no idea what I was getting into when I started. I hope that now you do. Think hard.
Bobbi Anderson is a regular contributor to The Fix. She last wrote about Facebook etiquette.

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