Category Archives: evidence based medicine

Decriminalizing CBD Oil: Let’s Do a Good Deed Together


Complaining about current conditions or worse ones in the pipeline gets tiresome sometimes—nobody really wants to be Debbie Downer. So I’m glad to let you know of a bill in the works for Alabama this year with bipartisan support that could not only actually pass but also truly be a good deed. 

HB 207/ SB 174 would decriminalize the possession of CBD oil from marijuana plants for persons needing it to treat their own medical conditions or their children.

CBD oil, cannabidiol oil, is a natural derivative of marijuana with minimal amounts of THC (the part that makes people high). Although there is not enough THC in the oil to be psychoactive, just the tiny amount present makes the product illegal in our state. Google CBD oil and you’ll pull up rave reviews for treatment of just about everything under the sun. I’m generally suspicious of panaceas—cure-alls, good for what ails you miracle drugs, generally turn out to be fads that get dropped when, surprise, they don’t actually cure it all. I wrote that last line before I found this article with a good description of the endocannabinoid system using almost the same words—by a physician in favor of medical marijuana.

Not all the purported benefits of CBD oil have been seriously studied, but some have. It turns out the research is compelling in animal models of epilepsy. CBD oil has shown strong anti-seizure effects for generalized, partial and temporal lobe epilepsy. We don’t have that level of data for human use, just a few small studies in adults. For children, we do have multiple anecdotal reports of patients with intractable seizures, who didn’t respond to any other treatment, using CBD oil with good results. Some of the stories are enough to make me catch my breath— children with Dravet Syndrome, suffering years of daily prolonged seizures and associated developmental regression, becoming not only completely seizure free or close to it but also showing reversal of their brain damage.

There is one published survey, from Stanford, of 19 parents who tried CBD oil for their children with epilepsy, including Dravet Syndrome. Sixteen of them, 84%, reported fewer seizures, most with 80% reduction or more. The three who didn’t respond did not get worse. The only side effects reported were drowsiness (37%) or fatigue (16%). The authors point out that common side effects of prescription seizure medication—rash (sometimes life-threatening), vomiting, irritability, dizziness, confusion and aggressive behavior did not happen with any of the children.

Animal studies have also not uncovered serious adverse reactions. One paper noted a shift in cytokine production by human cell cultures exposed to CBD, which could be helpful for autoimmune and inflammatory illnesses but might be harmful in chronic infections like HIV. We don’t have good quality clinical data on this question—Cochrane Reviews could not come to a conclusion about long term effects of marijuana or derivatives in HIV outcomes, for good or ill.

The way to find out if CBD will live up to these early reports? More well designed trials, and larger ones.  We need to know if there are side effects that didn’t show up in the smaller groups, the best dosing regimens, and who is most likely to benefit. We need access to oil that will have a reliable concentration of CBD. The FDA has approved sites to study a specific, reliable concentration CBD oil in children, and 7 additional sites will be given IND (Investigational New Drug) approval for compassionate use.

Now I’m at the exciting part. Alabama may be getting one of those compassionate use approvals. I spoke to a respected pediatric neurologist who would be heading the program if done here. She has high hopes that the CBD oil may prove its worth.  She told me it was very important for children to be able to get CBD oil with a known percentage of active ingredient and low THC, because parents had reported inconsistent results from one batch of oil to another with non-standardized products. The problem is that it is illegal in Alabama, standard or not. So parents in the FDA approved program would risk arrest – unless we pass a law to protect them.

The bill doesn’t recommend CBD oil use—both versions are going through their respective Judiciary Committees, not Health. Sure, they leave other ground untouched, like medical marijuana in general or even recreational marijuana. I think it would be inhumane for legal marijuana advocates to ask these children to wait until more comprehensive legislation has a chance. An exhaustive evidence base is not necessary. All we need to do is say CBD oil has no reason to be illegal. I could walk down any drugstore aisle in Alabama, close my eyes, spin around and point my finger, and I’d put money in advance that whatever I’m pointing at would have more known side effects.

When I first spoke to Mike Ball, the House sponsor, he was concerned he might meet opposition from those who are just going to say no to anything remotely related to marijuana. He said it was probably risky to sponsor the bill during an election year, but that after meeting the parents who are begging for help, he had to take the chance. He told me this hill was worth dying on.

I’m a skeptic about politicians, just like panaceas, and I tend to distrust their motives more often than not. Even though Mike and I don’t see certain critical issues the same way, I believe he is an honest man, and I believe he sincerely had his heart touched by these children and their parents. I’m impressed that he was willing to take a political risk for a good deed.

Since we talked, I’m seeing reports that the bill may not meet the opposition he anticipated—that’s good news, and all the more reason for us to pile on. First, we want to be darn sure it passes. Second, we don’t always have to pick only the iffy bills to champion. Sometimes, it might just be good to show an overwhelming support, across partisan lines, for a worthwhile goal. Sometimes, we can all get to be the home team. If you agree with me, please take this opportunity to contact your legislators. No matter what happens in the 2014 midterms or in 2016, we are going to need to find a way to get things done together in Alabama, and maybe it starts with something this simple and sweet.

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Filed under Children's Issues, evidence based medicine

Serious Brain Illness: We Can Tear Down This Wall


Today, on the birthday of Dr. King, what will you do to honor his memory?  I took some time to think about the particular essence of the work he took up, the work that never gets completed and is always necessary.  I’d like to suggest there are two basic elements of that work.  First, we must always bear witness to our shared wrongdoing, by naming and calling out the human-made class, habit and stereotype driven barriers to human potential; and second, we must just as vigorously speak of our capacity for something better, offering each other enlivening glimpses of the possible future, through the yet-to-be torn down walls.

The barrier I want to call out to you today is the one we’ve created for those with serious brain illnesses like schizophrenia and other psychotic disorders.  We didn’t cause these brain illnesses, as best we can tell— they present their own barrier, for sure, but that’s not the one I’m naming. 

The barrier I mean is our special singling out of humans with life-threatening brain illnesses to be left largely without treatment, ignored and even criminalized.   If you watch this video of a man with schizophrenia, homeless due to his illness, being beaten to death by police instead of given desperately needed treatment, and you then learn his killing was not found criminal by a jury, you can see what our created barrier has done.

I had a hard time watching that.  I had to do it in pieces.  I said I wasn’t going to watch, because my imagination was painful enough, and because nothing about this event is actually new or unusual, and because I am a caregiver for a young adult with this same illness, and because I didn’t need another reason to cry about what is happening to sick people.  Lots of excuses, but bearing witness means we have to watch the hard parts.

Now you can take a breath, and I’d like to offer the second half, a glimpse of a future where we tear down the barriers to treatment we have built.  We made them:  we can take them down. 

We haven’t seen substantial national legislative effort to do anything until recently, with the Helping Families in Mental Health Crisis Act.  Representative Tim Murphy, a psychologist, has put forth a game-changing bill that would go a long way towards allowing people with serious brain illnesses to live safely and with dignity in their communities, instead of being consigned to homelessness, jail, and early death.  I have read and thought about the bill in entirety (there are links in the site above).  I endorse it strongly. I am contacting my legislators to request their support.  I believe it will do some work that seriously needs doing.  That’s my short version.  If you’d like to know a few more specifics, please read on and also see discussion of the bill here.  If there are questions not addressed, please let me know and I’ll try to get an answer for you.

Quick Summary of HR3717: Helping Families in Mental Health Crisis Act

This bill would restructure administration of planning and funding at the federal level in a shift towards known to be effective policy and an evidence-based approach to evaluating programs.  Focus would be put on services allowing persons with serious brain illness to stay in their communities while being effectively treated.  Specific parts of HIPAA (health information privacy law) would be modified to allow caregivers to know information necessary to health and safety. 

I have seen criticism of the bill from advocates with milder brain illnesses who fear mandatory treatment would be forced upon them or that choice would be removed from those who have done, as is typically said “nothing wrong besides being mentally ill and homeless.”  I can certainly understand why someone with a mild illness would extrapolate the same ability to think and reason clearly to someone more severely affected and be concerned about the ill person’s freedom.  Indeed, we all might do well to have the level of concern necessary to monitor treatment programs and legal action from misuse.  There will always be a gray zone where assessment of competency to make decisions is uncertain.  On the other hand, we don’t quit giving antibiotics to patients with meningitis just because they are used wrongly for viral illnesses. We don’t shut down hospitals that are needed but are not functioning well, because we still need somewhere to go when we have heart attacks—we fix them. Wait, we DID do that…but only for brain illnesses.

Reading this bill, I would say that if an error has been made, it appears more likely in the direction of slightly undertreating, due to long-standing fears of overcalling brain illness.  The gray zone has been largely excluded. Only those with the most severe psychotic illnesses are addressed by the bill, and some will still be left out in the effort to preserve rights.  Breaking down a barrier takes time and sometimes has to be done stepwise.

As I’ve discussed in prior blogs, those with severe brain illness often present with anosognosia—inability to recognize their illness.  Rational thought is lost due to the illness itself, which renders the choice of treatment or not meaningless to the person.  Paradoxically, mandatory treatment can sometimes restore thinking ability to the point of competency.  Even when that doesn’t happen, treatment increases the chance substantially that the person will be able to live in the community and enjoy the normal rights and potentials the rest of us enjoy.  A person having a stroke will be treated, even though he can’t ask for help.  A person with severe brain illness, whose illness steals his ability to understand why help is needed, is not treated because he doesn’t ask.  Both must be treated in order to access their ordinary civil rights.

Funds Currently Misdirected

SAMHSA, the Substance Abuse and Mental Health Services Administration, would come under direction of a new office, the Assistant Secretary for Mental Health and Substance Use Disorders, as part of the Department of Health and Human Services.  This person would have to be an actual psychiatrist or psychologist with research and clinical experience.  A National Mental Health Policy Laboratory would consult with the National Institute of Mental Health to identify evidence-based policy, implement it, and monitor outcomes.  An interagency coordinating committee would work to integrate all federal work on mental illness and would include representatives affected by brain illness under treatment, family members, and advocates.  Professional peer review would be required for all grants and proposals.

At present, SAMHSA is not administering available funds in a targeted, evidence-based manner.  Priority is not being given to those with the most severe though treatable illnesses and is being distributed to various fluff grants instead.  Sometimes redesigning administrative functions is just window dressing.  And sometimes, that is the only way to shake things up enough to change them.

A few years ago, I was offered a chance to attend a SAMHSA funded training session for healthcare providers on substance abuse screening.  Because I was in the process of helping a group of pediatricians in my state select a screening tool for teens, I registered, hoping I would learn more about how to use the tool.  I had a paid trip to Miami, where I stayed in a fancier hotel than I would ever manage on my own, for a 2 day session targeted primarily at screening and motivational interviewing for basically well people.  Instead of focusing on how we could work with patients ill with serious addiction, the thrust was on how anything more than 1 drink a night for women or 2 for men could be a health risk and how we could help people quit doing that.  Addiction was normalized and thus forgotten.  How many people could have undergone actual treatment for the funds taken to do that conference?  If the restructuring frees up funds to be used well, we can afford to do so much more.  Throwing money at a problem definitely doesn’t solve it when so much goes in the storm drain or gets blown away—aiming and directing money at a solution works much better.

Redirecting Funds: What is AOT?

There would be 50 grants available to establish new Assisted Outpatient Treatment programs (AOT).  AOT is an evidence based therapy to provide monitored treatment of brain illness in an outpatient, community setting.  The requirements are stringent—only those who are not able to provide for their own basic needs due to brain illness, who are likely to substantially deteriorate without treatment, who lack the capacity to make decisions, who have a history of violence, incarceration due to illness or repeated hospitalizations due to non-adherence with treatment, or who present a danger to self or others would be included.  AOT has been determined constitutional in court.  Typically outpatient commitment is ordered for a one year period and can be renewed, but only if the same conditions are still met.  At the court hearings for commitment to AOT, the patient would have legal representation and could give testimony.  No permanent or longstanding sentence is imposed.   If a year seems long, remember illnesses this severe and chronic are not likely to be going away.  And prison sentences for untreated persons are often far longer.

This does not mean the eccentric guy who puts out funky lawn ornaments is going to be held down and given a shot.  It does not mean every person who hears voices, or mumbles to herself in the grocery store, or is disheveled, or preaches on the street corner is going to be picked up by police.  Forget what you’ve heard about mental illness being so common and ordinary—it is not, not the kind covered by this bill.  We don’t have the money to do that kind of thing anyway.

The bill would increase funding for the most serious forms of brain illness and specifically devote a portion to illnesses associated with violent acts, in effort to find more effective treatments.  It would provide for education in schools on signs of brain illness and how to respond.  It would extend meaningful use funding for electronic health records to psychiatric facilities.  Liability protection would be extended to qualified volunteer physicians at outpatient psychiatric clinics.  Funding would be put into suicide prevention programs.

The bill would give grants to establish telepsychiatry programs and train primary care doctors to work in collaboration with psychiatrists.  It would give planning grants to 10 states to establish Federally Qualified Behavioral Health Clinics, which would be required to include child and adolescent trained psychiatrists and staff, training in dual diagnosis (addiction plus another brain illness), rehabilitation services, peer support, and supported education/ employment.   It would fund training for first responders to recognize brain illness and act appropriately to avoid killing the person they need to help or being killed themselves.  It would strengthen funding for mental health courts and veterans’ treatment courts.  It would protect medications from exclusion from state Medicaid formularies.  It would fund inpatient and residential treatment for those on public insurance between age 21 and 65.

Eliminating Obstacles to Sharing Vital Information with Caregivers

For patients being supported by a caregiver, usually a family member, at present HIPAA creates a dangerous barrier to good care.  In order to provide home care that is actually a form of residential, medical care, the parent or other family member must be able to know what medications are to be given, what side effects to look for, what symptoms of relapse are, and how to respond appropriately.  The caregiver must also be able to locate a hospitalized family member and be able to give crucial information to the treatment team.  We ran into a problem with this a few years ago, when we were not contacted upon hospitalization of our family member until he gave consent the next day.  He had been started on a medication that had given him dangerous side effects in the past, and we could have prevented that had we been notified.

The bill would allow only such pertinent information to be shared with caregivers, the same as it would be shared with nursing home staff.  If a person is not ill enough to need a caregiver, this section is irrelevant.  So it does not mean that your therapist is going to tell your mother about your session and what you said about her.

Flaws in the Bill

So, what are the flaws in this bill?  Every bill has them, of course.  These are the ones I see:  non-brain-based language is used throughout—“behavioral” is a particular annoyance.  People with heart attacks are having a “behavior” when they grab their chests, I guess.  The same-old same-old “quality” monitoring measures and incentives are proposed, which are not really measurements of quality care but of less sick patients.  Effective quality improvement can be done, and not like that.  The HIPAA improvements do not, for some reason, include 14 to 18 year olds.  A friend suggested to me this was because state laws regarding minors are so different.  However, at least it would be wise to include caretakers for emancipated minors in the safety-motivated release of information.  There is no provision to require medical information to be given to primary care doctors by psychiatrists, which turns out to be harder to get done than you’d think.  Many states have restrictions on sharing such information, despite it being crucial to safe patient care.  I see a lot of grants and funding which appear temporary, so I do have concerns that states may establish services that will then lose funding.   This is not a reason to avoid beginning, just a caveat that we will need effort to maintain what we start.  I do not see any of these flaws as critical to change before passing the bill.

Today, I have made my very small act in honor and appreciation of Dr. King and his life’s work.   I have called out a harmful, human-made barrier to the lives and dignity of those affected by serious brain illness.  And I have shown you a view of the possible, a better path forward.  Small acts can add up, when we all do them.  What do you see, in place of the barrier?  What will you do to help take it down?

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Filed under addiction, evidence based medicine, Healthcare reform, mental health

The Dismantling of Justice and Rise of the Medical-Police State


As Alabama continues its slide into financial ruin, many of you may be unaware how severely curtailed some of our necessary state functions already are.  We continue to pile on the tax incentives to corporations without demanding proof of economic effectiveness, and at the same time we add new crimes at a fast clip.  Increased demands on law enforcement and prisons are oddly excused from state requirements to locate funding for the effects of legislation.

 

Drug possession is arrested heavily in Alabama, without regard to whether the possession results from addiction and/or other illnesses, like chronic pain with inadequate treatment or mental illness.  The great majority of arrests have nothing to do with sales—less than 10% in our state.  It is illegal to have the active illness of addiction, and extra illegal to be addicted and black.  If you are a woman and happen to become pregnant while addicted, you can be additionally prosecuted for the “chemical endangerment” of a child.  This is a gender-specific crime—there’s no penalty to the man who contributed to initiating pregnancy within the body of an addicted woman. The only sure-fire way for a woman to avoid those additional charges is to abort.

 

Who will pay the cost of our medical police state?  Just as with sales tax, the burden of funding will fall increasingly on the shoulders of those least able to pay.  We already have multiple “pre-trial diversion” programs in Alabama that allow arrested persons to enter various treatment programs, at their cost, instead of going through the court system, at our cost.  I’ve talked with attorneys who are glad to have these options for their clients, but they admit the programs are mismanaged in many cases and that addicts are placed in them often without regard to likelihood of ability to complete such a program.  Upon failure, they enter prison according to their pre-signed guilty admission and still owe the costs of the diversion program.

 

One lawyer told me he has clients do a dry run of treatment, not supervised by the court, in the time leading up to a decision on diversion.  Because our system has such a backlog, he may have as long as a year to see if his client can succeed.  He will only advise his client to enter formal diversion if the person has done well on the practice effort.  But with low pay for court appointed attorneys, there are unfortunately those with far too heavy a caseload who don’t even meet their clients ahead of time.

 

The quality of the programs is borderline in many areas of the state.  I have a friend whose significant other, a man with bipolar illness and addiction, was sent to one of the “faith-based” programs locally.  When he told the supervisors about his mental illness diagnosis, did they do the correct thing and request psychiatric treatment?  No.  They called in a couple of preachers to pray away the demon of bipolar.

 

Arrest and exorcism as a treatment tool in the war against drugs makes about as much sense as arresting tobacco addicts in the war against cancer.

 

Twelve step groups can be critical for recovery of the whole person, more than just treatment of the addiction itself, and I’ve spoken to many addicts in recovery who say the groups saved their lives.  They tell me there is a tremendous difference between being sober as a “dry drunk” and being in meaningful recovery as part of a community.  But “intention to treat” success rates in twelve step recovery are not substantially better than other methods, meaning that when you take a random group of addicts and send them to walk the twelve steps, it “works if you work it.”  Many addicts will benefit from such groups as an adjunct to additional medical and professional psychological treatment but will fail without ongoing professional help.  There are evidence-based treatments available, including for dual diagnosis of addiction and mental illness, but they cost money—Alabama has none left after the corporate vig.

 

SB 285 is up (again) this year.  This bill would expand the use of pre-trial diversion at the unregulated discretion of the local DA, without need for local legislation or approval.  It specifically allows the use of “certified” faith-based programs.  The administrative fees paid by arrestees would go into the DA’s funds, instead of being used to fund good treatment programs or legitimate fair trial in drug courts.  Although there are provisions to waive the fees for indigent clients, there is no provision against causing a minimally self-supporting person in recovery to become indigent as a consequence of the fees.  I am told by treatment providers this creates a significantly higher risk of relapse during early recovery.  Advocates for those with addiction and mental illness need to vigorously oppose “pay to play” programs that financially burden sick people without giving them a fair trial.

 

We need to reform our entire approach to drugs and addiction.  I’d like to suggest Alabama enter a state-wide Twelve Step program, which can be done in a non-religious way.  Our first step as co-dependents is to admit that all our efforts against drugs that treat addiction as criminal have failed, and the second is to look elsewhere for help.  Testing potential Medicaid and foodstamp recipients for drug use and then cutting off benefits or throwing sick people into prison makes as much sense as emptying an addict’s stash into the toilet or tying a drunk man to the bedposts and hitting him with a skillet.

 

We need to move to the making amends part pretty quickly.  A good start would be to accept the Medicaid Expansion post-haste as well as fully funding addiction and mental health treatment services—good ones, not those involving exorcism. Then we need to seriously consider the benefits of Medicare for All, with full parity for addiction and mental health medical treatment.  Treatment should ideally be provided through evidence-based public programs instead of through faith-based or private programs that rely heavily on funds from high relapse rates.

 

Please contact your legislators and tell them why you are opposed to these bills.  Speaking as an individual citizen and not in representation of any advocacy group, I am dismayed at the public silence of the Alabama Department of Mental Health.  On behalf of their clients, they ought to be all over the news, calling for a moratorium on criminal prosecution of illness.  Their vision statement reads “lifting life’s possibilities through a system of care and support that is consumer driven, evidence-based, recovery focused, outcome oriented and easily accessible, with a life in the community for everyone.” DMH, where are you? Will you not speak up?

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Filed under addiction, Alabama Legislative Session 2013, evidence based medicine

Circumcisions R US? Try again, AAP


Early Monday morning, the American Academy of Pediatrics put out an updated policy statement on circumcisions to replace the 1999 version. The new statement comes out mainly in favor of circumcision and says insurances should have to cover it.  I’m very disappointed, not only in the conclusion but in the way the authors reached it.

Previously, the 1999 statement said basically “we aren’t sure, there are reasons to circumcise and reasons not to—think about it and decide for yourself.”  Since then, the rate of newborn circumcisions in our country has declined gradually, to a little over half of newborn boys.  Some say this is a direct result of the AAP statement, leading to decreased coverage by insurers.  I suspect it is also because pediatricians and parents became more aware the evidence for cutting wasn’t powerful.

In other developed countries, circumcision is even less common.  I don’t think this is all based on finances but likely involves a more reasoned approach to the evidence plus a different ethic regarding the rights of children.  Even though the US did sign the UN Convention on the Rights of the Child, we never did ratify it.  We, of the developed countries, have one of the strongest tendencies to treat children as the chattel of their parents, rather than offering full protection of human rights from the state.

Without going into every detail of the policy statement, I’ll point out a few elements to give you the general flavor.  First, the authors say that based on new evidence, they can state “the health benefits of newborn male circumcision outweigh the risks.”  Further on, after a discussion of selected risks like surgical infection, bleeding, disfigurement and sexual function (but ignoring certain conflicting data on sexual satisfaction and pain), they acknowledge it proved impossible to quantify the risks!  They say “based on the data reviewed, it is difficult, if not impossible, to adequately assess the total impact of complications, because the data are scant and inconsistent regarding the severity of complications. ” And “financial costs of care, emotional tolls, or the need for future corrective surgery (with the attendant anesthetic risks, family stress, and expense) are unknown.”  And “the majority of severe or even catastrophic injuries are so infrequent as to be reported as case reports (and were therefore excluded from this literature review). These rare complications include glans or penile amputation, transmission of herpes simplex after mouth-to-penis contact by a mohel (Jewish ritual  circumcisers) after circumcision, methicillin resistant Staphylococcus aureus infection,  urethral cutaneous fistula, glans ischemia, and death.”

Now tell me, even without a statistical or medical background, how anyone can say benefits outweigh risks when said risks can’t be well described?  The authors probably know that, because in their shorter paper meant for lay persons to review, they admit “health benefits are not great enough to recommend routine circumcision for all male newborns.”

The authors divided up over 1000 medical papers between themselves to study, and they set some rules for which papers to consider.  One of their rules was to exclude any studies that failed to meet a certain level of evidence.  They used a common scale to describe level of evidence that goes from 1 to 8, with 1 being the best level of evidence and 8 being the poorest.  For this paper, they said they would not use any level of evidence worse than 4.

Unfortunately, their cornerstone of evidence favoring circumcision was a recent paper done by the CDC describing potential cost savings of newborn circumcision in the US, based on HIV data from studies in Africa.  There was no data on HIV prevention in the US by circumcision included in this study.  What’s the problem with that?  HIV transmission in the African studies was mostly heterosexual, and the disease happened in men who also had high rates of other STD’s that had caused skin breakdown and/or ulcers.  These other STD’s are not as common here.  Circumcision does not appear to reduce same-sex HIV transmission.  So while it might be true that the same protection from HIV in heterosexual males might happen in the US, we really still don’t know.  Medical history is littered with the bad results of reasoning that seemed good at the time.

Because we know reason in place of evidence often fails to hold up under scrutiny, studies that use extrapolated data or data collected for other purposes are labeled category 7 in quality of evidence. The only level poorer is “common sense.”  The crux of this new AAP statement is a paper with a level of evidence far lower than what the authors agreed to even look at, and they make no effort to point this out.  It should have never gotten past peer review.

How do we weigh risks and benefits in medicine, in general?  It can be harder than you’d think!  When the outcome involves death or permanent disability, it’s easier.  Otherwise, often we wind up looking at things so different they are like comparing vision to taste—which sense organ is your favorite?  Would you rather take this medicine that might make you live 3 more months or would you rather have 3 more weeks that will probably be less painful?  Would you rather wear a condom or do you place less value on your foreskin?   In those cases, it is most reasonable to explain the various outcomes to patients and let them make the call.

Sometimes policy recommendations are made on a cost-benefit basis, when the medical risks aren’t clear.  If there is an extreme cost difference, I won’t say that isn’t reasonable—but it should be made excruciatingly clear to individual patients when a given practice is based on cost, not risks and benefits.

When the science is in debate, I think it is ethical for parents to make the call as proxies for their children.  I don’t believe it is ethical, if the science says something is too risky, for parental religion or preference to overrule science. What is the situation with circumcisions?  I don’t know.  Personally, I think there should be an overwhelming evidence of benefit if you are going to permanently remove a body part.  I say I don’t know for certain, though, because for specific, individual children the risks could be overwhelming.  HIV can be overwhelming, even if it is now more treatable, and it might turn out that circumcision does reduce HIV even in our country.  Urinary tract infection, more common in uncircumcised male infants (as common as in girls), can be overwhelming or even deadly.  I have seen, with my own eyes, a newborn boy die of overwhelming kidney infection despite desperate and skilled resuscitation efforts (he was circumcised)—but only one, in 16 years of practice.  I don’t see evidence that the rates of these tragic events outweigh the occurrence of circumcision-related risks in the population as a whole, but for a specific child, I don’t have a crystal ball to know.  So I do think it may be acceptable for that child’s proxy, the parents, to decide.

A couple of years ago, I was explaining this to a group of residents and students while in process of teaching them to do a circumcision on a baby whose parents requested it.  I said my gut feeling was that the evidence was going to weigh more against circumcision than for it, and that we would eventually regard it with as much horror as most of the world does female genital mutilation.  But I said we were probably not yet in the position to know enough to outlaw it or refuse to do it at parental request.  I am very comfortable with refusing to do something to a patient for medical reasons, but not at all comfortable with refusing for personal reasons.

Right afterwards, we got in the elevator, and a little girl of about 4 looked up at me with solemn eyes as she asked, “Why did you cut that baby’s pee-pee?”  I was struck dumb—it was as if I’d dropped into a movie like the Sixth Sense.  The procedure room is closed, so I knew she couldn’t have seen us.  Her mother laughed and told us the girl’s brother had his circumcision that morning.  The memory of that question still unnerves me, and I am quite relieved that I personally no longer have to do the procedure, now that a “circumcision team” has formed at my hospital and I’m not on it.  I guess that is a cop-out.  I still am not sure how to answer the little girl’s question.

Whatever you think about the science and ethics of circumcision and medical decision making, I would think most of us could agree that the AAP policy statement, by dismissing risks it can’t quantify and using a level of evidence it claims not to, has serious flaws.  I am embarrassed for a paper like that to be issued from my professional society.  It should be revised and made honest. 

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Filed under Children's Issues, evidence based medicine, healthcare

Unguarding the Henhouse: HR 676, Part 9, Prescriptions


If you’ve been following along with me on HR 676, the Medicare for All bill, we are now at Section 205, Payment for Prescription Medications, Medical Supplies, and Medically Necessary Assistive Equipment.  Even more than payment of physician and hospital costs, the problem of medication and device coverage is incredibly complicated.  I could spend a year blogging just about that one topic and still not get to everything.  The more I think about it, the more amazed I am that this bill manages to cover the whole thing in four concise paragraphs.

 

Here’s the meat of it:  prices to be paid by our national insurance will be negotiated annually; there will be a prescription drug formulary to “encourage best-practices in prescribing and discourage the use of ineffective, dangerous, or excessively costly medications when better alternatives are available”; generics will be promoted but use of brand-name and off-formulary medications will be allowed; and both clinicians and patients can petition their regions or the Director to add or remove drugs.

 

I hope you all know what an error it was to prevent Medicare from negotiating drug prices.  A person unfamiliar with the deep grasp of corporate money on our political system could probably infer it from just this one flagrant dereliction of duty to citizens.  The result?  Needless waste of our Medicare money on overpriced products.  We know this, and even so, it is unlikely to change any time soon

 

That provision seems obvious.  The formulary, though, strikes me as fascinating and different from other plans I’ve seen.  Any of you who have insurance, public or private, have a formulary—a list of medications covered by your plan.  There are a variety of approaches to limiting the use of expensive treatments.  Many policies have “tiers” – a preferred list of drugs we can buy for cheaper co-pays, and one or two additional lists of drugs available at higher cost-sharing.  Sometimes the first tier drugs are actually better and cheaper generics, but often they are just the ones your particular insurer got a better deal on.  These negotiated deals are bundles—drug companies will offer packages to insurers where they give deep discounts on certain medications in order to get preferred treatment on the big ticket drugs.

 

Because the packages are all different between insurers, it means that patients switching from one employer to another often have to change their long-standing medications.  I’ve told you about one such case I had recently, when an insurer insisted it would only cover one asthma controller medication for my patient—to which my patient happened to have a life-threatening allergy. I was finally able to convince them otherwise but it took a lot of back and forth.  Usually there is a process to appeal these decisions, often with inordinate amounts of fax and telephone time, and there is nothing to say they have to give a final decision that makes sense.

 

There are also always medications the insurer just will not cover under any circumstances, and these vary from plan to plan.  This seems to have nothing to do with medical effectiveness and everything to do with what they can get away with—the target patients are often those less likely to stand up for themselves, such as addicted people or the mentally ill.

 

It has been the general consensus that without such restrictions, docs will just willy-nilly bust the bank—that we are so much in the hands of drug reps that we are no longer capable of wise prescribing.  Did you notice there is no restriction in HR 676?  There is just encouragement and discouragement.  Unless the Program chooses to add to that in the regulatory process, there would be no teeth here of the type we are accustomed to.  Because there is no cost-sharing, patients would not pay more for inappropriate or excessively costly drugs.  I suppose it is possible there would wind up being some of those ghastly “incentive” programs for physicians, but I hope not. 

 

Possibly the ability to negotiate prices would be all that is needed – we could just simply refuse to pay more than a drug is worth, so that drug companies would quit wasting our time and money.  Can we trust doctors enough to use good sense in prescribing—pick the more effective generic and leave the “me-too” brand-names alone?  Is there any additional provision that would help strengthen the “encouragement”?

 

I think there are a few.  Accurate public and physician information tools, feedback on prescribing habits, and inclusion of certain OTC medications in the formulary.

 

Carrots and sticks are not effective tools for higher-order decision making.  In my experience, many patients (and even some doctors) translate the higher prices for second tier medicine and the extra hoops into a belief that these hard to get products are better.  Anything that takes so much time and effort must be worth it, right?  So even though constructing some sort of barrier to overspending is quite tempting, I believe it ultimately costs us more.  What does help people make better decisions?  Honest feedback and trustworthy, unbiased information. 

 

Along with reforms of the FDA (a topic for another post), we need more effective patient and physician education resources untainted by sneaky drug company advertising.  It would be very possible to design such tools so that we could all know the best available information on what works and what doesn’t.   Doctors who have a pattern of prescribing outside the fold could be closely observed—and not just in a heckling sort of way, but with a curious, open approach.  Because maybe their patients are doing better—maybe they know something we need to know.   Or maybe they need to update their education. 

 

Instead of basing payments on various grading systems as some insurers now do, we could try simply providing feedback to physicians on their prescribing habits and cost-effectiveness compared to national benchmarks.  I get charts like that from a couple of insurers, and even though the data doesn’t change my salary I do pay attention.  Once I saw that Medicaid had to pay more for one brand name asthma medicine than for another with the exact same active ingredient (remember this varies per plan), and because I don’t like to waste our money, I quit using the higher priced product for that insurer.  Most of us don’t like to be extreme outliers and will adjust our practices accordingly.  But the information needs to be presented in a truly useful way—right now, I have one patient with a genetic disease whose single expensive prescription from the specialist skews my data so much that I have no idea where my numbers really are anymore.

 

Including certain OTC medications in the formulary, just as Alabama does for Medicaid, would be essential.  I’d like to see that provision specifically stated in the bill.  Many patients in my practice ask me to switch to a prescription drug when their previously effective treatment goes over the counter, because the co-pay is cheaper than the OTC price.  There is also a certain placebo boost that goes with that prescription signature.  Including OTC coverage for selected items would remove a fair amount of prescribing pressure.

 

I can imagine a scenario like this:  you have arthritis, and you visit your doctor to find out what to do about it.  Once you have the diagnosis, you check the patient information portal with our national health plan and learn that OTC drugs like ibuprofen are just as effective as some of the expensive newer prescriptions.  You learn that in your particular case, with no increased risk for stomach bleeding, there is no reason whatsoever to start with a brand name drug.  Your doctor knows that too and what’s more—she knows you know better than to go by the deceptive advertising.  She also knows that even if you are on a very limited income, you are able to get the ibuprofen covered. So she recommends a trial of ibuprofen along with diet changes and exercise, educates you on possible side effects, and lets you know there are other options if needed.

 

For my friends who worry that a single formulary would restrict their options excessively, I hope you are impressed by the wording in this bill.  It is more open-ended than any private insurance formulary you will ever see.  It is a leap of faith worth making.

 

What do you think?  I’d be interested in hearing your prescription stories and thoughts.

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Less is More? Junk Science and You


I’m traveling to DC this weekend for the annual meeting of Physicians for a National Health Program, so next week I’m sure I’ll have some interesting new material for you about Medicare for All.  This week I’m going to address (as in criticize) a study you probably heard about, supposedly showing women shouldn’t take various vitamins and supplements.  It was all over the news.  Sometimes the press is to blame for over-interpreting data, but in this case the authors also deserve a slap on the wrist.  The study is titled “Less is More:  Dietary Supplements and Mortality Rate in Older Women” from the Iowa Women’s Health Study.  I have read the full article because my employer has a subscription but can only give you the abstract link

Less is More?  I used to be shocked that journal editors would let their authors get away with that sort of thing, but I’ve seen it too often now to be surprised.  Inside the study, the authors admit that they can’t really draw any definite conclusions from their data. Their uncertainty didn’t make it into the title or many of the press reports.

Basically, what the researchers did was to get self-reports of supplement use from almost 39 thousand older women (mean age 61.6 years in 1986).  Women reported 3 times, in 1986, 1997 and 2004, and deaths were captured through public records.  It turns out that for some supplements, including multivitamins, B6, folic acid, iron, magnesium, zinc and copper, the risk of death was increased.  Yes, I know we all have a 100% risk of death, but we are talking about absolute risk increases ranging from 2.4% for multivitamins to 18% for copper during that study period.

Sounds dangerous right?  Less is More—we ought to be getting those things from food.  But there are multiple problems with that conclusion.  First of all, the researchers completely neglected to ask the women any questions about why they were taking these supplements.  In the introduction, they say that in “well-nourished populations” supplements are taken to prevent chronic disease.  They did not look at these data to see if the women had a diet that was nourishing or whether they already had a chronic disease.

The only health conditions these women reported on were smoking, hormone replacement, high blood pressure, diabetes mellitus, BMI and physical activity level.  It is true that physical activity can sometimes be a marker for overall health, but it really doesn’t provide enough information this time.  Some may have been participating in exercise programs prescribed by their doctors for specific illnesses.  People do sometimes take multivitamins for general prevention—others take them because they are aware they don’t eat enough fruits and vegetables or feel “run-down”.   

Some of the other supplements are not commonly used by healthy people.  B6 is touted by health sites for depression—we also recommend B vitamins for people who take certain chronic medications, such as for migraines or seizures.  Migraines are related to a higher risk of stroke.  Folic acid is interesting—that is a synthetic form of folate, found naturally in leafy greens.  Other studies have raised concerns about folic acid.  But again, except as part of a prenatal vitamin, most people don’t add folate unless they have another condition.  Some of the arthritis medications deplete folate.  I personally have to take L methyl-folate with my arthritis medication, or I get anemic.  This same form of folate can be used to treat depression.   Arthritis and depression, in turn, are each linked to a higher risk of cardiovascular disease.

Do you take magnesium, zinc or copper as a separate supplement?  If so, you are probably treating some sort of symptom, even if you don’t have a formal medical diagnosis.  All of these are commonly recommended by alternative health sites for fatigue and various sorts of inflammation.  Obviously, such symptoms could indicate underlying illnesses increasing one’s risk of earlier death.  Fatigue, in particular, even if related to simple sleep deprivation, clearly increases the risk of motor vehicle collision from falling asleep at the wheel.  Shift work, a common cause of fatigue, is associated with increased risk of cardiac disease and cancer.

Do you see the problem?  Less (planning and information) is not more (useful data).  How could we possibly know, without asking more questions, whether the supplements increased or decreased the risk of death for these women?  Perhaps, for a specific illness or symptom, those who took the supplements in question actually had a decreased risk of dying.  Or perhaps the risk was even worse than it appears.

I always look to see if there is any financial conflict of interest with the researchers.  In this case, the only thing reported was one person being an unpaid member of the Scientific Advisory board of the California Walnut Commission.  I don’t know if that is important or not, although certainly it is in the best interest of the Walnut people for us to eat more nuts instead of taking vitamins.  Finding out if the researchers have a bias against supplements in general would be a little more tricky, but we have evidence that personal beliefs do affect the quality of research and even outcomes.

I believe this was a poorly designed study from the beginning—the flaws I mention should have been obvious and could have been easily prevented.  It is impossible to draw any conclusion at all about safety of supplements from it.  However, even with a better design, all a study like this can do is find “associations”.  It could never have determined a cause and effect relationship.  To do that, we would need to do a randomized, double-blinded placebo controlled prospective trial (I’ve written a little more about what this means at the end of this post). 

Should you toss your supplements?  I have no idea! I’m not going to.  Should you demand higher quality research from your NIH tax dollars, unfettered by drug company or other corporate self-interest?  Should you be able to have free access to the full reports generated from that money? Should you demand a press free of corporate influence, who could give a more honest and thorough evaluation of such reports?   Yes.

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