An Opioid Study So Bad That It Disproves Itself?

https://www.acsh.org/news/2019/01/23/opioid-study-so-bad-it-disproves-itself-13753

Here’s a first. A study that might actually disprove itself. I’ve never seen anything like it.

A paper in JAMA Open Network tries to hop on the anti-opioid bandwagon but fails so badly that I had to stare at the screen in disbelief for a while. Did I really just see this? Does it mean what I think it does? Did the authors fail to realize what their own data say?

Here’s the title:

The intent of the study is obvious – to let us know that more pharmaceutical money leads to more opioid prescriptions being written, which results in more OD deaths. While this may be “intuitively obvious,” this does not make it correct. Here’s why.

The authors, mainly from Boston Medical Center, gathered prescription data from 67,507 US physicians in 2,208 counties between August 1, 2013, and December 31, 2015. They used these data to assert (Cue to “Same Old Song,” Four Tops, 1966) that the more that drug companies push opioid pills to doctors the more people died over a 2+ year period. But they may have given us cause to reach an entirely different conclusion.

Let’s start with their Table 2, which examines the association between pharma money and OD death using three different models, each of them representing a different way of measuring “money.” 

Table 2 (partial): Source: JAMA Network

There are three ways that the scientists used to measure pharma money: marketing dollars (A), the number of physician payments (B), and the number of physicians who received payments (C). In each model, there is an associated relative risk (RR) of increased deaths in those counties ranging from 1.09-1.18, which means a 9-18% increase.

ACSH advisor and expert biostatistician Dr. Stan Young is uncharacteristically understated: 

“An odds ratio, OR, of 1.000 is even odds, no effect. If an OR is close to 1.000, then any small bias could have produced the effect. An OR of 1.1 is not impressive.”

Dr. Stan Young, private communication, 1/23/19

In other words, when the increased relative risk is so low the presence of any kind of bias, for example, age, race, socioeconomic status, or the presence of other drugs, could turn the very low observed increase could turn into a zero increase. Even if we assume a perfect selection process, we are looking at an increase in deaths of about 15% at best. In other words, not much.

Now let’s look at Table 3, which shows that more pharma money results in doctors writing more prescriptions – something that can’t be a huge surprise. 

Table 3 (partial): Source: JAMA Network

But now we see that pharma money results in a large increase in the number of prescriptions written by doctors. With a higher relative risk (1.8-13.6-fold, 80-1260 % increase) the chance of bias affecting the results is quite low. 

So, let’s put these two conclusions together:

A. More pharma money leads to a very small (perhaps, zero) increase in overdose deaths.

B. More pharma money leads to a significant increase in written prescriptions.

So, it is reasonable to conclude that:

C. Despite a whole lot more written prescriptions, the rise in OD deaths is minimal, if any.

So, it’s also reasonable to conclude that:

D. Prescribed opioids aren’t causing many (or any) deaths, something that patient advocates have been screaming forever.

There are other limitations of the study that are disclosed in the paper as required. It would be rather easy to debunk the study based on these alone. But let’s not. Instead, let’s ask a question: Did the authors start out trying make a point only to end up making the opposite point instead? If so, do they realize this? Or are they just hoping that we don’t?

I have no idea. Perhaps someone can explain? Crazy.

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The DEA Thinks You Have “No Constitutionally Protected Privacy Interest” in Your Confidential Prescription Records

https://www.aclu.org/blog/national-security/privacy-and-surveillance/dea-thinks-you-have-no-constitutionally-protected

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An ‘instransigent’ Walgreens faces a shareholder proposal over managing opioid risks

www.statnews.com/pharmalot/2019/01/24/walgreen-opioids-shareholder-proposal/

As the opioid crisis intensifies, Walgreens Boots Alliance (WBA) is facing pressure from a group of stockholder activists to prepare a regular report on how it manages the risk of distributing these addictive prescription painkillers. And a pair of influential shareholder advisory firms is backing the proposal, which will be voted on Friday morning at the Walgreen annual meeting.

The proposal was filed by Investors for Opioid Accountability, a coalition of 53 state treasurers, pension funds, labor funds, and faith-based groups that collectively manage $3.4 trillion in assets. The coalition has targeted more than a dozen drug makers, wholesalers, and retailers in an attempt to change their business practices and account for the misuse and abuse of opioids plaguing the nation.

At the same time, a growing number of state, county, and city governments have filed lawsuits against many companies in a bid to recover the costs associated with overdoses, treatment, and ensuing crime. Such shareholder proposals, however, reflect a widening attempt to reach beyond management and speak directly to investors by appealing simultaneously to their pocketbooks and moral compasses.

In several instances, the coalition has succeeded in convincing boards to bolster oversight of opioid sales and distribution. Agreements have been reached with Allergan (AGN), Endo International (ENDP), Assertio Therapeutics (ASRT), Cardinal Health (CAH), and McKesson (MCK). And recently, AmerisourceBergen (ABC), in which Walgreen holds a 26 percent stake, agreed to provide a report by September.

Walgreens, however, has proven “intransigent,” according to Donna Meyer of Mercy Investment Services, the asset manager for the Sisters of Mercy. The coalition reached out to the retailer last summer and held two brief meetings last summer and fall with Walgreen executives, but the request for the board to regularly issue a report on managing opioid risks went nowhere, she told us.

Instead, the retailer filed a so-called No Action letter with the Securities and Exchange Commission, arguing why the proposed shareholder resolution was not appropriate. This is a standard maneuver when companies seek to exclude a shareholder proposal from a vote, although the company and the coalition subsequently engaged in three rounds of back-and-forth letters over the issue.

“Rather than sitting down and looking at what’s best for the company, they were resistant to taking responsibility,” Meyer told us. “And it was unusual, given that everyone recognizes the seriousness of the problem. We know that Walgreen can’t fix the problem by itself, but everyone needs to play their part in finding a solution.”

A Walgreens spokesman wrote us that the retailer, which has more than 9,500 pharmacies in the U.S., met with the coalition “on several occasions and will continue to meet with any group who wants to address this crisis.”

He also referred us to the Walgreens proxy statement for further explanation about objections to the shareholder resolution in which the retailer argues it annually publishes a corporate social responsibility report that includes information about identifying and responding to opioid-related risks. The chain also maintained a board committee that reviews risks and press releases are periodically issued.

In arguing its case, however, an attorney for Walgreens wrote to the SEC that the proposal was unwarranted for several reasons: The proposal refers to “ordinary business” matters, which is “not appropriate” for a shareholder vote, seeks to “micromanage” the company, and suggested the coalition sought to restrict Walgreen from selling opioids, which the shareholder resolution does not request (look here and scroll down).

Ultimately, the SEC disagreed. In a Nov. 20, letter, the agency wrote “we are unable to conclude that this particular proposal is not sufficiently significant to the company’s business operations such that exclusion would be appropriate. … We are also unable to conclude that the proposal micromanages the company to such a degree that exclusion of the proposal would be appropriate.”

Meanwhile, two influential shareholder advisory services are supporting the shareholder resolution.

In explaining it decision, GlassLewis noted that in June 2013, Walgreens paid $80 million to settle civil claims for an “unprecedented number of record-keeping and dispensing violations” of the Controlled Substances Act. A Florida distribution center and six pharmacies allegedly allowed controlled substances, such as oxycodone and other prescription painkillers, to be diverted for abuse and illegal black market sales.

“Given the nature of its operations, we believe the company has been and may be further exposed to certain direct, legal, and reputational risks as a result of its involvement in the distribution of opioids and its political activity,” the firm report in a report to clients.

“We recognize that the company has taken certain actions in recent years in direct response to the opioid epidemic and that it briefly describes its risk management oversight as it pertains to opioids in its response to this proposal. However, we believe that the company could reasonably enhance its disclosure to provide shareholders with the information requested by this proposal.”

Similarly, Institutional Shareholder Services argued that “despite a continuing proliferation of lawsuits, subpoenas, and investigations related to the opioid epidemic, Walgreens does not seem to have taken steps at the board level related specifically to managing risks stemming from the opioid epidemic.

“… The potential regulatory, legal, and reputational risks associated with the ongoing controversy and scrutiny facing U.S. drugstores, including Walgreens, continues to mount. Accordingly, shareholders would benefit from more specific information about proactive steps the board is taking to ensure the company is complying with the law, effectively managing risks, and that incentives are aligned with the health of the communities it serves. As such, shareholder support for this proposal is warranted.”

The outcome of the vote, however, is highly uncertain, since Walgreens chief executive officer Stefano Pessina holds 15 percent of the stock. In any event, such proposals have been well received elsewhere. Last October,  more than half of Rite Aid (RAD) shareholders voted to require the board of the pharmacy chain to report on opioids are monitored, and how the company is managing related financial and reputational risks.

It would appear that these large investor groups are pressuring various chain pharmacies that profits, share prices and reducing fines from the DEA are more important than the pts that have a valid need for controlled substances.

Money in these stockholder pockets is apparently more important than a large part of our population’s quality of life because they can’t get their necessary medication(s).

About a THIRD of all community pharmacies are independently owned… that includes franchisees of Medicine Shoppe, HealthMart, Medcap and others. Generally, patronizing an independent pharmacy you are dealing with the Pharmacist/owner, whose primary focus is to provide good service and typically long waits to get a prescription is the exception rather than the rule.

They typically have more staff because they don’t have to pay for a large costly supervisory infrastructure and HQ to support.

If these stock investors are interested only in the money in their pockets and if these chains start loosing business from the chronic pain community and their families.. Maybe that will get their attention when the company’s profit starts eroding.

How to find a local independent pharmacy/Pharmacist

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Psychiatric Medications Kill More Americans than Heroin

www.rehabs.com/pro-talk-articles/psychiatric-medications-kill-more-americans-than-heroin/#disqus_thread

We often hear the shocking fact that deaths from heroin increased nearly 5 fold (374%) between 1999 and 2014, but rarely – if ever – do we hear that deaths from psychiatric drug overdoses have increased nearly 4 fold (278%) over the same time period. The data are summarized in Figure 1.

The biggest killers are sedatives (benzodiazepines such as Xanax and Z-drugs such as Ambien), antidepressants, psychostimulants (Ritalin, amphetamine, and methamphetamine), and antipsychotics, in that order, as shown in Figure 2.

What accounts for this high overdose death rate for users of psychiatric medications and for the steep climb in death rates over the past 15 years? A number of factors appear to contribute to this, including increased prescribing, increased polypharmacy (prescribing multiple drugs to the same person at once), increased off-label prescribing, and increased prescribing of psychiatric drugs by non specialists, including general practitioners, nurse practitioners, and others untrained in the field of psychiatry. We will proceed to look at each of these factors below.

According to data from the MEPS (Medical Expenditure Panel Survey) database, the number of prescriptions for psychiatric medications (i. e. sedatives, antidepressants, psychostimulants, and antipsychotics) increased 117% between 1999 and 2013, from 197,247,557 prescriptions in 1999 to 427,837,506 prescriptions in 2013. Meanwhile, death rates from psychiatric medication overdose climbed a whopping 240% over the same time period, from 1.31 deaths per 100,000 in 1999 to 4.46 deaths per 100,000 in 2013 (we are excluding the CDC death rate data from 2014 since the MEPS 2014 data has not yet been published).

Details of prescribing by drug class are given in Figure 3 and percentage of increase in prescribing is in Figure 4. Although the increase in number of prescriptions partially accounts for the increase in death rates, it is clear that it does not account for all of them, and that there must be other factors involved. Those primary factors are most likely polypharmacy, off-label prescribing, and non-specialist prescribing.

Polypharmacy

Although medical scholars use the word polypharmacy in several different ways, the simplest definition is “the prescription of two or more drugs at the same time.” In other words, drug mixing. In some cases, such as HIV treatment, polypharmacy is an evidence-based best practice. In other cases, such as psychiatric treatment, there is little research to back up most instances of polypharmacy; moreover, inappropriate polypharmacy can be harmful or even deadly.

Kingsbury and Lotito (2007) state that:

“A great deal of data exists about the dangers of polypharmacy. Persons with psychiatric disorders experience increased risk for adverse drug interactions because of the great frequency with which multiple medications are used. Using multiple antipsychotics concomitantly has been associated with increased mortality in patients with schizophrenia. Reports of adverse psychiatric polypharmacy effects are abundant, including increased duration of hospital stay.“

Kukreja et al. (2013) tell us that:

“While evidence for the added benefit of psychiatric polypharmacy is limited, there is growing evidence regarding the increased adverse effects associated with such combinations. Concerns with polypharmacy include not only possibilities of cumulative toxicity and increased vulnerability to adverse events but also adherence issues which emerge with increasing regimen complexity.“

Mojtabai and Olfson (2010) report major increases in psychiatric polypharmacy: in office-based psychiatry practices in the United States the median number of medications prescribed per visit doubled from 1 in 1996-1997 to 2 in 2005-2006 and the mean number increased by 40.1% from 1.42 in 1996-1997 to 1.99 in 2005-2006.

In Figure 5 we show the percentage of deaths due to drug mixing in each psychiatric medication class in 2014. Figure 6 lists the drug combinations with psychiatric medications which had the highest death rates in 2014.

Off-label and general practitioner prescribing of psychiatric medications: Off-label prescribing refers to prescribing a drug for a reason other than one which has been approved by the FDA. Although there are instances where off-label prescribing is based on sound published scientific evidence, this is not so in the vast majority of cases. Radley et al. (2006) found that only 4% of off-label psychiatric prescriptions had strong scientific support. Ali and Ajmal (2012) report that off-label prescribing carries clinical risks, such as adverse effects and unproven efficacy. Additionally, Mojtabai and Olfson (2011) report that 72.7% of antidepressant prescriptions in 2007 were written in the absence of any psychiatric diagnosis. Moreover, according to Mark et al. (2009) less than one fourth of prescriptions for psychiatric medications are written by psychiatrist, over three fourths are written by general practitioners, nurse practitioners, and others untrained in the field of psychiatry.

In my personal experience running an alcohol support group, I have had countless women tell me that, despite admitting they were drinking too much, their GPs still prescribed an SSRI antidepressant and, shortly after starting the antidepressant, their alcohol consumption went through the roof. This is not surprising, in light of the fact that research by Naranjo et al. (1995) showed that women treated with SSRIs drank significantly more than women given a placebo; a survey by Graham and Massak (2007) also found antidepressants were useless for reducing drinking in women. Unfortunately, doctors who have been encouraged to write off-label prescriptions frequently jump to the conclusion that women who drink too much must be depressed, so they wind up prescribing an antidepressant that actually makes them drink more. There is a great deal of potential harm which can result from off-label prescribing.

Alternatives to Drug Therapy

Wouldn’t it be great if there were some way we could permanently change the wiring of the brain to ameliorate or eliminate things like depression, anxiety, and schizophrenia without a lifetime reliance on potentially deadly drugs? Actually there is: it is called psychotherapy.

Everything you do which changes the way you think also changes your brain. Recent neuroimaging studies of people who have undergone Cognitive Behavioral Therapy (CBT) by Porto et al. and by Quide et al. show different patterns of brain function than those who have not had such therapy. There is another type of psychotherapy known as Dialectical Behavioral Therapy (DBT) which incorporates mindfulness and meditation practices into CBT. A large body of neuroimaging studies by Newberg demonstrate that mindfulness and meditation practices also permanently change the functioning of the brain.

But what about schizophrenia? Isn’t the only hope for schizophrenics to keep them doped up in a zombified stupor until the day they day? A recent New York Times article titled “New Approach Advised to Treat Schizophrenia” says no; the best treatment for schizophrenics is minimal use of antipsychotic drugs and lots of psychosocial therapy. The article then goes on to tell us that there is actually nothing “new” in this treatment approach, as it has been used in Scandinavia and Australia with great success for decades. It is only new to American psychiatrists who are too ignorant and arrogant to learn anything from the rest of the world and will only accept a study that has been carried out in America. But the reality is that it is not new – even in America. It is the model pioneered by Loren Mosher back in the 1970’s before Big Pharma got him fired from his post as chief of NIMH’s Center for the Study of Schizophrenia…because he was interfering with the profits from their latest huge money maker: antipsychotic drugs.

The reality is that drugging patients into a stupor with huge doses of antipsychotics prevents recovery from schizophrenia. This is why third world countries like India and Nigeria have much higher recovery rates for schizophrenia than the US; they cannot afford antipsychotic drugs which have good short term effects and very bad long term effects. Harding’s Vermont study found that half to two thirds of unmedicated schizophrenics recovered and Harrow found similar results. This is in stark contrast to medicated schizophrenics whose recovery rate is around 10 to 20%.

Conclusion

When prescribed appropriately, psychiatric medications are lifesaving, life changing wonder drugs. However, when over-prescribed or inappropriately prescribed they can lead to great harm and even death. What is needed is a major curtailment of polypharmacy, off-label prescribing, and non-specialist prescribing. The use of psychiatric drugs needs to be reduced to a mere fraction of current use rates and needs to be replaced or supplemented with appropriate psychosocial interventions which include not only therapy but such basics as housing, food security, and education. Money needs to be invested in social change rather than pill popping if we wish to create a healthy nation.

Would we say that just because insulin is good for diabetics that everyone should take it? No, that is nonsense because it would totally destroy a normal metabolism. Yet this is exactly the approach we are taking with psychiatric medications thanks to the misinformation that Big Pharma feeds to doctors and the general public in order to increase their sales and line their pockets.

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A new wrinkle in the cannabis/rights issue:

17-year-old Native American man was issued a cannabis card through Alternative Wellness, a consortium of physicians I work with. He had sustained a back fracture as a passenger in a car crash at age 16. He was offered opiate therapy and declined. He has found cannabis to help his severe back pain. He obtained Two physician signatures as required by law for pediatric cases.

He was given a urine drug screen prior to the start of his wrestling season, he displayed his cannabis card to the athletic director, his urine drug screen came up positive for cannabis only, and they mistakenly suspended him from participation in sports for 10 days. Their next mistake was to recheck his urine two weeks later and it was still positive for cannabis( not surprisingly, given cannabis takes 30 days to clear). Then they suspended him for 30 days, effectively ending his wrestling season.

William’s grandfather William has been a patient of mine and contacted me about this.

I spoke with Williams father Jake and he delineated the whole story to me.

At some point the athletic director recommended William obtain a prescription for Marinol, hoping that that would settle the issue.  Marinol is a schedule II Rx often given for nausea. It is derived from cannabis, highly expensive, yet often used in patients who want to use cannabis while having a “legitimate“ prescription.

Because time is of the essence I wrote that Prescription and sent it to William’s father Jake.

Apparently, William is still suspended, endangering his entire wrestling season.

William is now 18. He and his father are still working hard to save his wrestling season.

Jake, the father, presented the Rx to the coach, AD, and principal.

They each told Jake,”Well, this is above my pay grade”, and William remains suspended.

Weirdly, because of the positive urine screen for cannabis William is being forced to go through alcohol and drug treatment counseling. Another weird factor is the person doing the urine drug screening is the person doing the drug and alcohol counseling. My concern Is that we are taking a young man with goals, thwarting those goals, then teaching him about drugs and alcohol while he has nothing to do as his wrestling teammates keep working out.

In the same way as taking a infant away from their breast-feeding mother is a violation of civil rights, prohibiting a young man with a legitimate cannabis card from wrestling also seems to be a violation of his civil rights.

I have not used last names In this letter, though Jake has given me permission to talk to anyone about his son’s case.

I was a wrestler in high school. I remember how important my sport was to me. I have also worked in Wolf Point and Poplar in the past, so I care.

If this kind of case sparks your interest please contact me at 406-439-0752.

I will happily share with you the family’s contact information.

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The Medical Board of California has launched investigations into doctors who prescribed opioids to patients who, perhaps months or years later, fatally overdosed.

The effort, dubbed “the Death Certificate Project,” has sparked a conflict with physicians in California and beyond, in part because the doctors being investigated did not necessarily write the prescriptions leading to a death. The project is one of a kind nationally, although a much more limited program is operated by North Carolina’s board.

So far, the board has launched investigations into the practices of about 450 physicians and referred the names of 72 nurse practitioners, physician assistants and osteopathic physicians to their respective licensing boards.

To date, the regulators have formally accused at least 23 doctors of negligent prescribing, and more accusations are expected. Some of the accusations, like one 63-page document filed against Dr. Frank Gilman, a San Diego internist, detail hundreds of prescriptions for one patient over four years, most of them by him. Gilman did not respond to a request for comment.

Using terms such as “witch hunt” and “inquisition,” many doctors said the project is leading them or their peers to refuse patients’ requests for painkiller prescriptions — no matter how well documented the need — out of fear their practices will come under disciplinary review.

The project, first reported by MedPage Today, has struck a nerve among medical associations. Dr. Barbara McAneny, the American Medical Association president and an Albuquerque, N.M., oncologist whose cancer patients sometimes need treatment for acute pain, called the project “terrifying.” She said “it will only discourage doctors from taking care of patients with pain.”

The influential California Health Care Foundation also has pushed back against the project, saying it could harm patients. (California Healthline is an editorially independent publication of the California Health Care Foundation.)

Unusually aggressive for the board, the program is a reaction to the by now well-known phenomenon of physicians over prescribing opioids. Nationally, a host of policy changes and educational efforts have driven down the rate of opioid prescriptions in recent years.

The goal of California’s program, quietly launched four years ago, is not necessarily to link a doctor’s specific prescription to a specific patient’s death — although many of the cases do — but to find doctors whose patterns of prescribing are so dangerous they may lead to patients’ ultimately fatal addictions.

.

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Steve,

It’s a weird situation, Employer got on the phone with Caremark yesterday and verified I can fill that prescription and they would cover it. They even called the pharmacy and were told all they were waiting for was my Dr to verify the prescriptions. They claimed their phones were down for 24 hours.

Now today the Drs office let me know that CVS would not under any circumstances accept me as a customer because of my high dose.

So the insurance carrier Caremark will cover the dose but CVS will not fill it.

Now I have to pharmacy shop to find one that will fill my prescriptions. In the mean time I can’t go to work because of the pain and getting sick from withdrawals.

   I have been exchanging emails with this pts for months and has been put thru the ringer by various healthcare providers. This pt needs a high dose of opiates due to a accident 2-3 decades ago and taking this high dose enabled this pt to engage in a highly technical job on a full time basis and generating a income way above the average.

This pt has seems be entangled in the new CDC guidelines and pain specialists who are exempt from such guidelines but are still functioning under the premise that they are not and targeting this pt to being weaned down to the 90 MME’s limits.

It will be interesting if this pt is forced to go on disability, if an attorney will be able to see the “substantial financial damage” that is being caused and willing to take on a case on a contingency basis ?

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