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This recent Washington Post piece looks at cases where private corporate funding has influenced research done at or by the National Institutes of Health. The public tends to regard NIH as independent and unaffiliated with industry. That, the article suggests, is not always the case.

In reality, research is often prohibitively expensive. The contemporary research environment can be a fierce struggle for funding. As one veteran scientist explained, when he joined the medical faculty at a major university, he was advised to view it as a license to hunt. “They said I could keep some of what I kill.” With more than a thousand on the faculty, most were in a similar position. After ten years of fighting the good fight, he threw in the towel and took a position in the private sector doing research on commercial products. “Boring as hell, but the pay was way better. And by then, I had three kids in school.”

We get it.

I recall reading that almost half of the research done today is in the realm of medicine and health. Another quarter involves the social sciences. That leaves the last 25% for all other fields of science. It’s skewed by the enormity of financial rewards that can accompany the introduction of a new or improved medication or therapeutic advance. Many promising developments simply never make it to market. But once one does, especially a sales “hit” like Oxycontin, the company behind it will go to extraordinary lengths to keep it available for purchase.

Things are a bit different when the product is legal, like alcohol. Due to a massive public education effort, Americans are aware that alcohol isn’t exactly good for you. People choose to drink despite the risks. Still, health warnings can reduce overall consumption of alcoholic beverages. In fact, about a third of American adults consume little or no alcohol, period. Another large segment drinks occasionally.

From a seller’s standpoint, that’s not optimal. No marketer gets a bonus for selling less product.

On the other hand, if it could be convincingly demonstrated that moderate drinking was part of a healthy lifestyle, that could be used to promote consumption.

So if some enterprising MD or PhD were to show up with a proposal for research likely to demonstrate the health benefits of drinking, the beverage industry will throw money at it. Their motives are self-serving, of course, but this is business, right?

After all, the claims of the Tobacco Institute were never strong and yet Big Tobacco managed to use them, along a fleet of attorneys, public relations staff, and lobbyists, to slow the inevitable decline in US sales for decades. Quite an achievement, in a sense. Just not one America should be proud of.

We may call it criminal fraud, but the law doesn’t. And in a ‘relaxed’ regulatory climate like the current one– I’m being generous there– chances are you can get away with it. Unless some member of the public or in the media happens to make a fuss.

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The Politico website provides us with this fascinating status report on the future of opioid treatment. The Federal government is considering an infusion of cash, as much as $6 billion. As you might expect, there’s some angling for shares of the money. Big Pharma will be a major player — perhaps the major player.

So we can start there. At present, Medication Assisted Treatment (MAT) falls into two main categories:

Naltrexone injections. Naltrexone has been around for years in oral form, but compliance was poor, so much effort has gone into developing a monthly injection, and eventually, a six month implant. Naltrexone injections haven’t been around that long so we have less data on outcomes. What we do have suggests it’s effective as a continuing treatment, with the caveat that a quarter of users drop out during the required detox phase. A bill has been introduced in Congress to address this problem through a system of combined detox/ induction centers.

Opioid replacement therapy. Most of us are familiar with this option. Patients needn’t go through detox, since ORT is a continuation of physical dependence on a different opioid (methadone or buprenorphine instead of heroin etc). A monthly Suboxone injection is in the works here, as well. That should reduce diversion to the street — a common problem as Suboxone brings higher prices than heroin. There are retention issues with ORT as well, but they’re further down the line. We may eventually see implant technology used here as well.

Not coincidentally, there’s a parallel search in progress for alternatives to opioids as a pain remedy.  It won’t do much for those already “hooked”, but it would certainly help address a major pathway into addiction, and also an important cause of relapse. I’m referring to medical treatment for pain.

I do wonder how much of the $6 billion will go to Big Pharma versus counseling and other services. I hope the distribution is reasonably equitable. Narcan is great but as any first responder will attest, addicted users are prone to more ODs until and unless real change occurs. Same thing happens with ORT: without support and major changes in lifestyle, clients are prone to drop out.

It’s ironic that an industry largely responsible for creation and continuation of our current opioid epidemic could become the main beneficiary of all this new treatment funding. I guess that’s how it works. Just the other day a radio pundit referred to our patched-together healthcare system as a kleptocracy — a place where government policy is designed to benefit certain individuals or corporations rather than the governed.

Pretty cynical, isn’t it? Let’s hope he was wrong.

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Vaping is an example of what can happen when technology designed for a legitimate medical purpose finds its way into the larger population — in this instance, kids.

The whole point of electronic cigarettes was to provide another alternative to smoking for those who were unable to give it up by other means. The e-cigarette would serve as a substitute method for ingesting nicotine, but without the health hazards associated with tobacco. Think of it as a harm reduction measure. I know several longtime smokers who made the switch and seem satisfied, and several others who tried and failed.

Right from the start, however, e-cigarettes drew intense interest from adolescents. Warned against smoking from an early age, this was a way to have their cake and eat it, too. Historically, most smokers begin using tobacco in early adolescence, a time of life when it’s easier to minimize all sorts of risks.  Some kids simply assume they won’t become addicted. Others figure that even if they do, they can always quit later.

These are common misconceptions — some might call them delusions — among new users of any potentially hazardous substance. Eventually most recognize the flaws in this reasoning, but by that time, it’s too late for an easy escape.

From the business perspective, a seller’s most desirable customer is someone who genuinely needs to use your product, indefinitely. Not only wants it, but flat-out has to have it. That’s a terrific source of revenue. Smart marketers were quick to exploit the fast-growing youth market for e-cigarettes, through cute devices like the JUUL, and kid-friendly flavored nicotine with teenybopper names like Peppermint, Candy Crash, Blue Razz, and Lemon Tart. It sure seems to have worked. The absence of regulation helped. Adolescent use exploded, and here we are.

By now, this segment is absolutely key to the industry’s revenue base. With American cigarette consumption in decline, the industry is searching for opportunities to make up for the lost revenue. One involves heavy promotion of electronic nicotine delivery devices.

Experts have described the manufactured cigarette as “a crack pipe for nicotine.” The vape pen is in the same category. It’s designed to get the drug to the brain as quick and efficiently as possible, and to foster dependence in the user.

Of course, kids who do vape are at some risk to move on to smoking at some future point. Promoters of vaping are anxious to publicize research to contradict this, but to anybody who is familiar with addiction, that’s hard to believe. If you’re already physically and psychologically dependent on a drug, the main goal is always to get it to the brain as quickly and reliably as possible. It’s no longer about enjoyment. So what difference does it make in what form it arrives, so long as your brain is temporarily satisfied? Why not use whatever happens to be at hand? After all, it’s just one cigarette…

I should mention that the city of San Francisco is preparing to vote on a ban of flavored nicotine products that seem to attract kids. It won’t be easy, politically speaking. According to the Washington Post, “R.J. Reynolds Tobacco Co., which makes vape products as well as Newports, has contributed nearly $12 million to the “No on Proposition E” campaign, filling television and radio airwaves and mailboxes with ads urging voters to reject a law supervisors approved last year that is now on the June 5 ballot.”

Twelve million dollars is a whole lot more than proponents of the bill can spend. I predict a flood of TV and online ads claiming that the right to vape is a “freedom” issue for all Americans.

In reality, most nicotine addicts are anything but free. Once you’re “on” the stuff, so to speak, it’s really difficult to get off. Here’s NIDA to explain why.

So we find ourselves in the midst of yet another battle between public health advocates and a business community looking to maintain its profit margin.Not the first time, and I’m confident it won’t be the last.

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This is what I’d call an advocacy piece. It’s intended to promote use of CBD, which is fine, but drifts over into the issue of cannabis legalization, without much to justify the move.

What is CBD? The ‘miracle’ cannabis compound that doesn’t get you high

CBD (cannabidiol) and its close relatives are likely to account for almost all the medical benefits of cannabis. My guess is that THC’s value will be for its psychoactive or intoxicant properties. Accordingly, the goal should be to develop CBD medications with little or no THC content. And with specific uses, like Dravet Syndrome.

Dravet is a form of epilepsy described by the Dravet foundation as a “rare, catastrophic, lifelong form beginning in the first year of life.” How rare? Current estimates are 1 in 16,000 to 1 in 21,000 range. So medicine needs prescription meds based in CBD, for Dravet patients. But that’s not an argument for full legalization of marijuana.

That brings up a legion of other questions. This is from a neuroscientist who has no objection to legalization but is concerned about the quality of the current discussion, which she characterizes as “astoundingly naïve”.

POT HOLES: Legalizing marijuana is fine. But don’t ignore the science on its dangers.

The research on adolescent neurological development alone, she argues, should give us pause. We can’t count on age restrictions to protect kids, since we know from experience that adolescents will go right ahead and use cannabis anyway– beginning as young as 12.

It’s what many do now. It’s what happened with alcohol and tobacco. And recently, vaping.

We know Prohibition didn’t work with alcohol. It isn’t working for cannabis, either. But just as repeal of Prohibition didn’t make alcohol any safer for popular use– all these years later, it’s still a huge problem for us– neither will legalizing the stuff remove the health risks associated with cannabis. Whatever they may be.

In fact, we should be talking about and preparing for an increase in cases of Cannabis Use Disorder (CUD) and other problems related to marijuana. Developing programs for prevention, and new therapies for treatment.

Unfortunately, far as I can determine, we aren’t doing either.

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This New York Times editorial describes the case of a woman who relapsed to fentanyl  just eleven days into her probation. Her attorney argued against jail on the grounds that relapse was a medical outcome of a disease, not a crime. The prosecution apparently counter-argued that addiction didn’t qualify as a ‘real’ disease. That’s an argument that might have held up forty years ago, but not so well today. Things change.

The tendency towards relapse isn’t just a symptom of addiction — in some respects it’s the symptom. It’s the principal way we differentiate addiction from simple abuse. As in the phrase: “return to use despite adverse consequences”. It’s a pattern we look for.

I couldn’t help wondering if getting caught and sent to jail might actually have saved this individual from a fatal overdose. Where fentanyl is involved, the risk of death goes up substantially. But from a treatment perspective, a better option would have been a mandate for more intensive treatment, using a guideline such as the ASAM placement criteria. Residential rehab would be an option, or a therapeutic community. The process: a qualified credentialed clinician (QCC) assesses the individual and makes a recommendation to the judge. If s/he agrees, it’s mandated, along with other elements such as fines or restitution or community service.

In my experience, the model works well. For one thing, it helps relieve the chronic overcrowding in our jails. Pressure to turn over beds is a major cause of the ‘revolving door’ of brief incarceration followed by quick release. I suspect that actually triggers relapse. But when your community treats a correctional institution as a locked flophouse, what else can we expect? It’s “many unhappy returns”.

It’s true that incarceration does have some value for certain individuals in their journey towards recovery. I recall one woman whose cocaine use had significantly weakened her cardiac health. This is not uncommon. Dire warnings from the doctor seemed to have little effect. Then, while on probation for a drug offense, she was arrested for DWI and showed up high in Court, where she proceeded to lecture the judge on his incompetence. This resulted in a 30 day jail sentence. That was extended to 60 and then 90 days due to “persistent behavioral issues.” Having met her, I can imagine what they were.

Ten years later, clean and sober, she attributed her recovery to that experience. “Here I was 40 years old, had a law degree, and still needed to be treated like a defiant five year old,” she told me. A counselor at the jail advised her that her legal training just helped her come up with more ingenious excuses for relapse. “It had become part of the problem,” she agreed.

As long as people with addictions commit crimes, violate laws, and generally create problems for themselves and society, the criminal justice system will be involved. No way around that. Our goal should be to make sure that involvement is reasonable, compassionate, and based in a realistic understanding of addiction and recovery.

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According to this NYT story, a Justice Department investigation determined that senior executives at Purdue Pharma had been aware, as far back as the late 1990’s, of Oxycontin’s potential for abuse, and went ahead and marketed the heck out of it anyway.

I know we’re all shocked at the news.

The company could have taken steps to protect patients. Instead, they apparently decided to promote it as something it never was — a safe, less addictive remedy for chronic pain.

From the article: “Company officials had received reports that the pills were being crushed and snorted; stolen from pharmacies; and that some doctors were being charged with selling prescriptions… the company’s sales representatives used the words “street value,” “crush,” or “snort” in 117 internal notes recording their visits to doctors or other medical professionals from 1997 through 1999.”

Can’t get much clearer than that. Prosecutors, even back then, recommended felony charges for senior execs. The Justice Department instead settled the case in 2007. It was near the end of the Bush administration. The following year, Wall Street crashed, and America had other things to worry about.

Having worked with addiction patients, I could never bring myself to see Oxycontin as safe, despite near-constant promotion from the pain medicine sector. Sure, it might be less addictive than heroin, but taken over an extended period — as recommended for chronic pain– I just couldn’t see how people could avoid dependency. And it was only logical that a significant percent would experience other symptoms, such as craving, compulsion, and loss of control.

So when Bret Favre admits to having taken more than a dozen prescription opioids at one sitting, I find that entirely believable. It’s a lot but there will be many such cases.

One question I hear: what was that particular Big Pharma outfit thinking? Did their CEO really believe he could ignore all those reports and it wouldn’t eventually come back to haunt them?

Apparently, yes. Or perhaps they took a calculated risk, reasoning that even if they were caught out, they could somehow avoid the worst penalties. That’s not actually unreasonable, given what was happening with big banks during and after the ’08 Crash. Meanwhile Oxycontin would still be on the shelves, earning tremendous revenue. They could reserve some of that cash for legal fees, or to hire expensive lobbyists, in the event the feces ever did finally come in contact with the rotary device.

Corporations, like governments, are very good at keeping secrets. Just look how long it’s taken for this information, available in the ’90’s, to come to our attention.

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States are now beginning the long process of resolving claims against Big Pharma for the damage wrought on communities by widespread availability of prescription opioids, and the promotion of their use. When and if settlements are reached– as they likely will be, in most instances, although it could take a long time if the defendants fight to the wire– how much of that money will be spent on prevention and treatment of drug abuse?

Opioid court fights risk repeating tobacco’s failures

The opioid cases will involve far fewer victims and the settlements will be proportionately smaller than was the case with tobacco. Still, the damage from prescription opioids over a relatively short time is nothing short of remarkable. The Politico article cites just one Ohio county, population around half a million, that nonetheless received an average of more than 35 million opioid pills every year between 2010 and 2016.

Think about that. 67 pills for every resident. Every year.

One outcome: An unintended OD every three and a half hours. Remember, that’s just one county. Who wrote all those prescriptions? Who authorized the pharmacies to fill them? Who paid the bills?

Anyway, a major goal of the lawsuits will be compensation for damage and to prevent something like this from happening again. Logically, a huge percentage of the money awarded will be used for prevention and treatment.

Won’t it? Possibly not. That’s not what happened with the tobacco settlements.

From the article: “…over the past five years, less than 10% of the nearly $40 billion in tobacco payments went towards such efforts. That’s less than a quarter of what the Centers for Disease Control and Prevention says states need for comprehensive tobacco control.”

That doesn’t sound right, does it? Smoking has decreased, but e-cigs and vaping are on the way up — especially among younger people. Think of it as another generation of nicotine dependent people in the making. Meanwhile, tobacco still gets credit for several hundred thousand deaths annually— more than opioids.

So what are we doing with the other 90% of the settlement money? Is it being diverted to other uses? If so, how does that happen? Who votes in favor of diverting the money? Why are the CDC recommendations ignored?

I guess we should be asking our representatives. Because it could happen with the opioid money, too.

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Rehab: Last Week Tonight with John Oliver (HBO) - YouTube

John Oliver’s piece on Rehab specifically mentions a situation where the owner of a well-known treatment program also owns two major online businesses that review and rate treatment programs– including his own. That’s a textbook example of a possible conflict of interest, one that certainly should have set off warning bells.

There’s more than one definition of conflict, and the legal definitions can be quite involved. For our purposes, I’ll just pick one: Any situation in which an individual or corporation (either private or governmental) is in a position to exploit a professional or official capacity in some way for their personal or corporate benefit. Obviously, being able to give your own business a five star rating on a supposedly independent consumer website could be construed as an unfair advantage. It isn’t necessary to prove this advantage exists. It’s the presumption of advantage that matters to your customers.

How are such apparent conflicts resolved? There’s more than one way. Some examples:

  • Disclosing the relationship between the two businesses openly. Example: When an article dealing with Amazon shows up in the Washington Post, it’s usually accompanied by a note explaining that the two companies share ownership.
  • Recusal, or removing the conflict by stepping away from any involvement in one or more of the ventures. Example: The Attorney General recusing himself from involvement in the investigation of the Trump campaign. This was not popular with his boss, but it was the ethical thing to do.
  • Divesting, or removing the potential conflict by selling or separating from one of the businesses.

There are other remedies as well. Conflicts of interest can also occur in professional relationships. For instance, a clinician who works for two competing providers in the same community, thus putting patient privacy and confidentiality at risk. Many programs have a policy prohibiting this without formal approval.

During accreditation, organizations develop ethical codes that address business and contractual relationships, marketing and promotion, and related subjects. A few examples of language from same:

“Executives, Board members, and employees shall not seek to benefit directly or indirectly from the use of inside information, or to profit from a position of authority.”

“The organization shall not enter into an agreement that involves any form of fee-splitting or paying for referrals.”

“The organization shall not seek advantage through use of unfavorable information about competitors.”

“Where questions arise about possible conflicts, professionals are responsible for seeking guidance from program administration.”

When complete, these codes often run several pages in length. It’s very different from the early days in the field, when most programs got by with a list of a dozen do’s and don’ts. That no longer suffices.

Of course, a code of ethics is useless unless someone’s around to monitor and enforce it. So programs must have a clearly defined procedure for investigating and resolving ethical complaints– which can come from patients, families, employees, referral sources, visitors, business partners, and other providers. It takes planning, and once it’s done, ongoing training to make sure everyone understands their role.

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We recently learned that Green Bay Packers’ Hall of Fame quarterback Bret Favre should be included on the long list of former star athletes now in recovery. His substance use continued throughout most of his playing career, which includes three NFL Most Valuable Player awards and three extended visits to rehab.

It’s a familiar story: A month in residential to address painkillers, followed by a much longer stay for the same reason a few years later. Apparently he was very open with the clinicians regarding his desire to continue with alcohol. They warned him, and he ignored the warnings. Result: A third trip, in 1998, for alcoholism. The transition from dependence on opioids to alcohol is fairly common. Both are based on the mistaken notion that addiction can’t cross boundaries between drug classes.

Of course, that brings up the issue of performance enhancement. According to Bret, he was taking as many as 14 Vicodin at a time– technically, an overdose– during his MVP year. Why wasn’t that discovered via random drug testing? Or was it? Experts have said that Performance Enhancing Drugs (PEDs) are often of value for fast healing and the ability to play with injuries. Opioids don’t qualify?

Then again, I suspect many if not most of the players are taking prescription painkillers. Perhaps just to make it through to the next game.

But today I have a different topic in mind– my contention that many so-called “treatment failures”, meaning a return to drug use following rehab, stem not from uncontrollable compulsion or poor impulse control, but from good old-fashioned human stubbornness.

Far as I know, there’s no effective treatment for that.

And frankly, it’s a problem throughout healthcare. Always has been. Patients are issued instructions by physicians that they subsequently disregard. It’s not always the result of craving. Patients also make  conscious decisions to abandon their treatment regimen, even when it’s working.

Same’s true for many patients with heart disease, diabetes, chronic lung disorders. A patient does well for a while, then stops the medication, drops the diet, resumes drinking and/or smoking. Weirdly, often  because things were going well.

Maybe they thought they were cured. Maybe they just didn’t feel like they need to make the effort. That’s human nature, right? But it can be destructive.

We’ve come a long way in treating addictions, but we’re still not very successful at convincing a patient to stick to a treatment regimen. Many do, but others insist on learning the hard way– through trial and error.

Now that’s something we could be working on.

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Rehab: Last Week Tonight with John Oliver (HBO) - YouTube

Comedian John Oliver took on Rehab during this recent show on HBO. Oliver is from that branch of comedy that uses shock tactics to draw attention, a la Richard Pryor and Lenny Bruce. Hopefully viewers aren’t so distracted that they miss the very serious issues he brings up.

Those issues are familiar to people in the addictions field, many of whom are just sick about it.  Not least because they know they will inevitably be tarred with the same brush.

I want to address just one of the issues that Oliver brings up. I’ll return to others in future posts.

A lack of regulation of treatment providers – this deserves closer scrutiny than Oliver has time to give it. For one thing, he lumps all categories of treatment together, from inpatient all the way down to mom-and-pop recovery homes. But in reality, certain levels of care are highly regulated, while others are largely ignored.

As with so many other functions, the Federal Government has left the problem of regulation to the states. One result: some states have too few regulations and others arguably suffer from too many. I know of a number of state governments that have taken steps to improve their standards, and to make them more consistent across the board. That means changing the law, which is never easy.

The real issue, in my experience working with providers, is the absence of consistent monitoring and enforcement of those standards. In their eagerness to reduce the size of government (a frequent campaign promise), states have stripped away staff who would otherwise make onsite visits to ensure compliance. One monitor, recently retired from the state during a reduction in force, was recruited back a year later as a contractor to do essentially the same job. His Department had fallen hopelessly behind when it came to investigating complaints and monitoring  essential functions. There was a need.

I questioned him about the wisdom of this– layoffs and buyouts, followed by rehires. Didn’t that just unnecessarily interrupt the agency’s functions, and create a bunch of new problems? He readily acknowledged that. But there had been political pressure to downsize during one year, followed by a spate of critical incidents during the next. That had drawn public criticism, something all politicians wish to avoid. Faced with a crisis, the easiest solution was to rehire people who already knew the job. “Plus we don’t show up on the HR reports as regular employees,” he went on to say, “so it doesn’t look like the government is  adding positions, which would tick off the budget hawks.”

The challenge of enforcing compliance is analogous to enforcing drunk driving laws. The efficiency of the process is more important than the severity of penalties. The goal is to catch violators and impose consequences without delays. Same with treatment providers: it’s important to monitor compliance regularly and consistently, and to administer penalties as soon as possible after a violation is discovered.

To do so, you need people in the field. That means adequate staff. Which in turn means money in the budget. And that’s where politics can interfere.

In a sense, this is one if those problems that’s self-created. The remedy is a government and a political process that simply works the way it should.

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