Drug Research Needs The Placebo — that’s science

placebo_pillNew drugs need to be compared to something.  And, at a very minimum that something is the placebo, a sugar pill.  When you see an advertisement claiming some product is 80% better, a reasonable person would ask, “better than what?”

A comparison group is hugely important in all of science.  One of the biggest flaws in all research is not picking an appropriate control or comparison which makes the research worthless.

Erik Vance of the Washington Post reported on 12/2/16: “People susceptible to the placebo effect may be keeping us from getting new drugs.”  The idea is many drugs can’t be proven to be better than a placebo.  The FDA prevents those poor drug companies from marketing those drugs and making tons of money.

So here is the anti-scientific conclusion Mr. Vance reported: only use people that are unaffected by placebos in the control group.  Sadly, that would exclude most conscious human beings.  The control group would be strange people that could feel the tiny effects of the drug and ignore any psychological impact of taking a pill.  And, voilà drug approved.  A drug that most people would find no better than eating a sugar cube could be marketed at $800 per pill.  And, advertisements could fool most practicing physicians into prescribing it.

This idea is totally nuts.  The FDA would be within its authority to only allow the drug to be prescribed to that small group of strange people, not the whole world.  Assuming the FDA was reasonably competent the idea and the huge profits should go down the drain.

Do you want to take a medicine that fails to work as well as a sugar pill?  Probably not.  Expect good science. Demand honest comparison with placebos.

 

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US Healthcare Diagram — results are what count

us-healthcareThe U.S. healthcare system is going to change or at least be updated in the coming years.  So, when congress tinkers with the system what might be good changes and what might be bad changes?  That is the $3 trillion dollar question!  It would be fair to say most people and most congressmen do not understand U.S. healthcare — the prevailing notion is overwhelming complexity and way too much cost.  However, this blog is going to make the case the key to understanding and the key to making changes is to keep your eyes on the results.

What results?  It’s not complicated, it has to do with measurements.  Consumer Reports and J.D.Power know we want to buy value.  And, value in this case is the reasonable cost for wellness, longevity and successful treatment of disease.  That’s it, three things.  Whatever changes or tinkering are contemplated we just need to know those three things will be getting better and simultaneously costing less.  Politicians have a really bad habit of saying the changes they propose will do the job.  Nobody can predict what will work — there are always unintended consequences — so, any proposal must include a dedication to measuring the outcomes we want — if the change does not work it needs to be discarded as soon as possible.  And, discarding what does not work can’t wait for the next election and should not wait until tomorrow.  Simply, we want results, and we want the data as proof.  On a hopeful note, if something works, keep doing it.

The above diagram describes U.S. healthcare.  It is more simple than the systems in other countries.  The system is linear — people, illness and unlimited money on the left side pass to the results on the right side.  This is a flow diagram of the system.  The complexity can be hidden by thinking in terms of the five boxes.  Later, some of the complexity will be discussed.  First, consider the boxes:

  1. Money to pay for the system.   The money people earn is paid to the health care system.  Money is money — it does not matter if the money comes by way of taxes, insurance or cash.  Funds that do not come from insurance come from the other sources.  This is the cost of U.S. healthcare which is about $3 trillion.  Don’t pay the money, you don’t get healthcare.
  2. The healthcare providers.  Traditionally we only think of doctors, hospitals and drugs.  We often overlook the other things in the box.  Things we don’t like, things healthcare providers would like to see in another box.  These other things are hugely expensive and fully under the control of the healthcare providers.  Unnecessary treatment is perhaps one of the worst — treatment or tests that are not needed.  For example, an EKG done as part of a yearly exam on a healthy person.  Profit is in this category.  Clearly, no profit, no healthcare system.  But, profit beyond what is needed is just waste for the system — it is money that leaves the system and does not come back.   Inefficiency comes in many forms.  Failing to prevent diseases early, only to spend more money later is supremely inefficient.  Corruption is a problem in every human endeavor.  Errors turn huge amounts of money into waste.  The money spent on medical liability suits is just the tip of the iceberg.  Money spent to prevent errors is minuscule compared to the money spent on drug marketing.
  3. Who gets healthcare?  Everybody.  The aggregate need for healthcare is fairly stable for the system.  But, for an individual the need is hugely variable — an auto accident is not predictable.  And, when disease strikes most of us can not afford the cost without insurance.  Statistics show 50% of Americans do not have access to $4oo for an emergency.  The very people who don’t have emergency funds are the very people who do not want to purchase health insurance.  Sadly, those people end up in bankruptcy while the system grudgingly provides the care.  Now that more people have insurance those without may find less compassion from the providers.  Many feel there are freeloaders in the system — people who do not contribute.  Does a birth defect, mental illness or low IQ make people freeloaders — that’s an ethical question which is beyond the scope of this discussion.
  4. Waste.  In monetary terms this about $1.5 trillion dollars per year with a huge death toll in the US.  A hospital acquired infection is very expensive and kills many of those affected.  The high profile infections from spinal injections are just the tip of the iceberg, again.  Re-hospitalization for an unresolved health problem is another example.  Paying $800 for a $10 epinephrine injector is another example.
  5. The results.  We want those good results.  Not just for cancer patients, not just for heart attack victims, not just for you, but for me too.   We don’t want promises, we want results.  In this age of smart phones and millions of apps there is no excuse for failing to have the data to prove the system is working in our hands every day.  We want the results today, not after several years of scrubbing the data in some moldy university.  We all must keep our eyes on the results and hold our elected officials accountable.

Complexity.   Medicine is a science and by its nature is very complex.  Open heart surgery is a good example — there are few people who understand the issues involved.  But, the system, from the patient’s view does not need to be complex.  In one country the cost of hospitalization is $400/day — the people there know exactly how much the illness will cost.  In another country, the prices of office visits are posted in the waiting room — it does not matter what insurance company you might have.   In another country all the providers use the same medical record system — not a big deal to move or see a consultant.  We seem to tolerate the complexity of our system and think it should be as difficult to understand as heart surgery.

The US pays about twice what other countries do for similar or better care.  There is enough money in our system now.   Our problem seems to be in the area of wasted money and effort.  It seems unlikely that just reducing payments to providers will reduce errors and wasted money — this supply-side economics does not get to the real problem.  More than likely, lower payment to providers will only result in lower income for them and perhaps more errors and unnecessary services.  But, if it works, do it.

Back to the initial warning.  Keep you eyes on the results of the system and the cost.  Whether any economic hypothesis proves correct is irrelevant.  What matters is the system must move in the right direction, always.

There is a lot to recommend the quality improvement method called “Plan – Do – Study -Act” or PDSA.  The idea is to plan a change to a system of care,  do the plan, make measurements to study the results then act to change the system to get better results.  This is an ongoing process.  Congress seems to be mired in a system of management which is one hundred years out of date — if anything, that’s what needs to change first.

 

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Leadership and Narcissistic Personality Disorder

ilovemeThe label narcissist or description as narcissistic has appeared in the current presidential campaign rhetoric.  Dictionary.com defines narcissism:

Inordinate fascination with oneself; excessive self-love; vanity.  Synonyms: self-centeredness, smugness, egocentrism. 

Personality is the way a person views themselves and the way they emotionally interact with the world.  We all have a personality.  The first writings about personality were in the Renaissance.  In modern times psychologists have applied scientific methods to this difficult concept.

Psychologists have discovered some very important things about personality.

  1. Personality is persistent through adult life and is likely coded in our DNA.  Even animals have personality.
  2. The survival of a tribe may be enhanced by having members with different personalities.  Like members with confidence in themselves, members who are passive followers, or members who like consistency.
  3. People can have bits and pieces of different personalities which are called personality traits.
  4. Personality alone does not define a person psychologically.  Other things like intelligence, environment and interactions with other people have a huge impact.
  5. A little personality is very good.  But, a lot of a personality which is rigid and unyielding to social pressures is actually a disease.  The disease is called a “personality disorder” rather than a “personality trait”.
  6. Personality disorders cause problems for the person who has them.  They ruin relationships, cause financial harm, and may cause unfavorable interactions with the law.
  7. Finally, a person is generally blind to their own personality and can not change it.  People can learn coping mechanisms by appreciating how other people react to them — sometimes called mirroring.  An overbearing person might “tone it down” in order to make friends.

So, back to the narcissistic personality disorder.  The scientific definition can be found in the Diagnostic and Statistical Manual (DSM).  The DSM is a publication of the American Psychiatric Association that seeks to define mental disorders for the mental health professions.  Click here for a link to the part about personality disorders.

Key elements include:

  1. A high degree of self-esteem.  “I am great and only I can do things well.”
  2. Validating self worth through others.  “Everybody likes me and knows I am great.”  They tend to be surrounded by people who do think they are great or perhaps are unwilling to challenge that assumption.  Extreme dislike of people who don’t appreciate their self-perceived greatness.
  3. Setting high standards to gain approval of others.  “I follow tax rules so well it makes me a success.”
  4. Lack of empathy.  Actions they take are viewed on how they affect them rather than the harm, embarrassment, or financial ruin that others may experience from the interaction.  Divorce and bankruptcy are sometimes the result.
  5. Difficulty with intimacy.  Relationships are superficial — glad handshakes or kisses that have no underlying meaning.
  6. Shows arrogant, haughty behaviors or attitudes.  Such as denigrating minorities or the opposite sex.  And, strongly seeks the attention of others.

OK, this could describe many politicians!

But, is this the personality most modern people want in a leader?  Probably not.  We don’t need a leader to take us on a hunt for a woolly mammoth.  In primitive times people needed a grandiose leader to spur them on, but it’s likely when the mammoth stepped the leader the feeling was “better him than me.”  Now we want “servant leaders”.  People who have personality traits adapted to successfully improve our lives, not just theirs.

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UnitedHealth, Aetna & Humana — exit exchanges

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Insurance companies now have found a way to deny insurance because of pre-existing conditions, as a group.  This is nearly insane.  Any first year lawyer would realize the following:

  • It is not legal to kill a person so it is not legal to kill a group of people.
  • It is not legal to run a red light so it is not legal to run a group of red lights
  • It is not legal to deny insurance because of pre-existing conditions so it is not legal to deny insurance to a group with pre-existing conditions.

It took a few years since the ACA was enacted for insurance companies to realize the subsidized insurance exchanges have poor people, disabled people, and people who can’t work because of illness — they have, surprise, surprise, PRE-EXISTING CONDITIONS.

Now, after years of huge windfall profits, several large insurance companies have decided not to sell insurance to the group of people who purchase on the insurance exchanges.  Why do we need a Supreme Court decision when any cop knows it’s a crime.  Where do large companies like health insurance companies and Volkswagen get the idea they are entitled to do business as they please?

The insurance companies who have decided not to participate in the health insurance exchanges are listed below with the financials as reported on Yahoo.  They are not hurting, revenue last quarter is better than the same quarter last year.

Insurance company UnitedHealth Aetna Humana
Ticker UNH AET HUM
2015 Revenue (Billions) $176.10 $61.65 $54.53
Operating Margin 6.61% 8.18% 4.17%
52 wk price change $14.38 -$3.14 -$5.33
Quarterly revenue (yoy) 28.2% 5.4% 2.0%

A surprising twist to this story was reported by David Belk:  big insurance companies avoid risk by having the companies they serve “self-insure”.  Meaning, the companies (like a cable company or a hospital or an RV company) take the risk, put up the money, and let the “insurance company” just do the paperwork.  For the eight largest health insurance companies only about 30% of their business actually has financial risk — the rest is “self-insured”, otherwise called Administrative Service Contracts (ASC).

So now the picture is clear — insurance companies avoid risk.  They want someone else to take the risk and they are very skilled at shifting the risk to others.  The question is whether the U.S. really needs these paper shufflers skimming profits?

The simple answer is no.  Congress needs to level the playing field for insurance companies — if they sell insurance they must sell insurance on the exchanges.  Unless insurance companies can take the risk of health insurance exchanges they need to be replaced with a single payer system.  Colorado will decide this question on a ballot in 2016 — they have the right question, hopefully the people will choose the single payer system.

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EpiPen (R) (ephinepherine) — price problems

epinephrine_sMylan is the company that makes EpiPen(R).  It was one of those “inversion” companies that started in the US but is incorporated in the Netherlands to avoid taxes.  Yet, the administrative offices are in Pennsylvanian in the US.  It sells EpiPen(R) all over the world.  In Australia a subsidiary called AlphaPharm sells the product.  It’s a handy plastic syringe device that allows a person with a severe allergic reaction to grab the device and give an injection quickly.

It’s so handy that the company can sell the $1 device containing 3 cents of epinephrine for $697.  That’s the price quoted by Costco.  The same drug can be purchased online through Canadadrugs.com for $112.71 and through Kiwidrug.com for $122.51.  

It’s not clear why other companies that package injectable drugs don’t supply prefilled syringes for this purpose — probably a very aggressive legal department or the acquisition of competing suppliers.  The device is not something novel — it’s just a syringe — so it should never have received a patent.

Emergency Rooms and doctor’s offices don’t fool around with the EpiPen(R).  They just purchase cheap vials of epinephrine and cheap syringes to give the dose for a few dollars.  A patient could do this with a little training — it would save a lot of money.  The cost of an EpiPen(R) so high the people who need the medication don’t buy it — so the few seconds a patient might take to draw up the medication in a syringe is better than no medication at all.

The Mylan company is a good example of why drug companies should be more regulated and have profits limited.


Addendum 7-16-2016

Mylan purchased the decades old EpiPen(R) rights from Merck in 2007.  The consumer price in 2007 was about $60.  With a major marketing effort (basically convincing patients, schools and healthcare facilities to always have the product available) the price is now about $700 accounting for about 50% of company profits.  Teva Pharmaceuticals is working on a generic epinephrine injector but it probably will not be available until 2018.  A startup company Windgap Medical has invented a device using powdered epinephrine but it may be many years, if ever, before the device arrives on the market — but, the device promises to extend the shelf life from 18 months (for the EpiPen) to several years.

Here are some good references about EpiPen(R) and Mylan


Addendum 8/27/16

There is a perfectly acceptable (FDA approved) alternative to EpiPen in the form a competing product called Adrenaclick which costs only about $140 (according to GoodRx) for a two pack. This product does little advertising — certainly not as much as EpiPen. But, advertising does not equate to product superiority.  To get the less expensive product:

  1. If the prescriber wrote a prescription in a generic format (Epinephrine auto-injector 0.3 mg (or 0.15 mg) for injection in case of allergic emergency) then a patient should simply call the pharmacy to obtain the lower cost alternative.
  2. If the prescriber wrote the prescription for the easy-to-remember brand name a patient should simply call the prescriber’s office and ask that a replacement prescription be sent to the pharmacy for the Adrenoclick in the same dose as for the EpiPen.
  3. The two devices are not exactly the same but the technique is very similar. The patient should read the directions very carefully to understand the small differences — read this when the medication arrives, not when an emergency is present. The pharmacist is required to provide personal instructions and answer questions about products they sell.

Although the Adrenoclick is less expensive it is still much too expensive. The manufacturing price is probably less than $10 each.  Also, keep in mind the shelf life — liquid epinephrine only has a shelf life of 18 months — so even if the medication is not used there is a recurring cost for replacement.

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Telemedicine — the good, the bad and the ugly.

noseviewTHE GOOD:  If your brother is a doctor and you call him for medical advice that is probably good Telemedicine.   The doctor clearly has your interest at heart, you can call again, the doctor will likely look up information and will probably give you some Internet links to check out.  And, the doctor does not want to make you upset or interfere with the relationship you have with your actual doctor.  Good idea, except doctors will not usually prescribe for a relative, or should not.

THE BAD:  The same things wrong with actual provider interactions can still be wrong on video — not being given enough time to state the problem, not enough patient education, not enough of a partnership, and poor follow-up.  Also, prescribing antibiotics for viral infections (the common cold) can be even a greater temptation by video.

THE UGLY:  A low position of the video camera that seems to look up the doctor’s nose — yes, that’s ugly.

The most common reasons for visits to a health care provider are: cough, joint pains and skin conditions.

Evaluation of cough by telemedicine is difficult because it requires looking in the nose, ears and throat and listening to the lungs for wheezing or other sounds.  This is better in person.   Although, a telemedicine follow-up might be just fine.

Evaluation of joint pains is fairly easy with telemedicine.  For example, back pain is usually temporary and x-rays are not advised.  It’s easy to suggest ways to avoid straining the back and be encouraging.  Treatment usually involves over-the-counter medications.

Evaluation of a skin condition also is fairly easy with good quality video.  Diaper rash and acne are no-brainers.  But, trying to separate skin cancer from a benign seborrheic keratosis is a little harder — probably best left to an office visit.

Follow-up visits for lots of things can be done by telemedicine.  A follow-up visit for congestive heart failure can be done by video especially if the patient has a reliable scale at home.

Follow-up visits consume valuable office time that could and should be allotted to new or serious problems.  The phone will often work just as well.  Telemedicine visits can be done when office staff is not working — thus at a much lower overhead cost.

Provider-to-consultant video conferencing is a great idea.  This works particularly well if the two individuals work in the same organization.  If they are not in the same organization financial issues often get in the way.

A fine example of peer-to-peer video conferencing is in the UK where groups of NHS neurosurgeons at one hospital communicate with groups of NHS neurosurgeons at another hospital sharing x-ray images and and clinical details.  Very difficult decisions are often better with input from colleagues — and consistency of care is improved.

Telemedicine does not solve bad-care problems.  Switching bad-care in person to bad-care by video is not helpful.

Telemedicine can reduce the cost of care for simple issues that mainly need better health literacy and for follow-up of known health problems.  The capacity of health care is not adequate in many countries (including the US).   Telemedicine is a provider-extender and needs to be used a lot more.

 

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Medical Error as Cause of Death

deathAccording to a recent report in the BMJ medical errors are the third leading cause of death in the United States.  The chart below shows where the estimated number of deaths from medical error fit into known mortality data.  The article makes the remarkable observation  “medical error” is not allowed as the cause of death to be recorded on death certificates.  Indeed, when “medical error” is entered into the ICD 10 look up site for CMS here is the result:  There are no ICD-10 Codes that match that fragment.

To be fair, the rule for death certificates is the cause of death must be the final cause.  For instance, even though smoking causes heart disease which leads to a myocardial infarction (heart attack), the allowed cause of death is myocardial infarction rather than smoking, which is truly the root cause.  That’s just how the system has worked for decades.  So if a medical error causes a myocardial infarction the doctor must list myocardial infarction as the cause of death — in most states the qualifier “due to …” is allowed and smoking could be entered by the doctor.  Interestingly, if “medical error” is listed the death would become an “accidental death” requiring review by the medical examiner (not something most physicians or families want).

deathsperyear

251,000 deaths in the United States are caused by medical errors.  This fact has been hidden, like many other underlying causes of death.  The effect is that research into medical errors is lacking, the funding for research is lacking and the problem is ignored.  Why should heart disease research be funded when some “cardiac” deaths are actually due to a nurse giving the wrong medication to the patient.  The research really needed is to find how to prevent the medication error.

Although the graph above is bad enough, consider that the size of the bars for heart disease, cancer and COPD should all be smaller — because the real cause, in many cases, is medical error.

The number of medical errors is staggering.  The errors that cause death are just the tip of the iceberg.  Lots and lots of medical errors only have minor consequences.  Every physician makes several errors each day.  Every review of a medical chart reveals numerous errors.  Care providers are astounded by this news.  However, simple things like not seeing a lab report with a low blood count until the following day is an error even if nothing bad happened as a result.  Of course, it would be malpractice if something bad did happen as a result.

The prevailing notion in quality improvement circles is, “don’t waste your time unless there was a bad outcome.”  This notion comes from a lack of staff, and intense criticism when a provider is involved.  “What do you mean there was an error, my care was excellent, nothing bad happened, you should be fired.”

Although there is a real tendency to want to blame an individual provider, both small and large errors are the result of poor clinical processes.  Even errors due to provider fatigue and lack of sleep are truly process problems — a provider who worked during the night should not be working the following day.  A provider sick with a cold should not be working, but so often they are.

What needs to be done:

  1. Just like alcoholism, the first step is to admit there is a problem.
  2. See medical care as a process.  Strive to make sure the same problem gets the same treatment every time in every location.  OR change the process.
  3. Stop seeing medical care as art.  What work of art ever killed a person?
  4. Separate the compensation for medical errors from improving medical processes.  Injured patients need quick compensation and medical care needs quick changes to improve.  Lawsuits seem to have little impact on process of care — if lawsuits prevent errors why are we in this mess?
  5. Establish a non-profit foundation to advocate for reducing medical errors — something the public might be very willing to support.  Sorry, Heart Association, Lung Association, Cancer Association — some money needs to go toward reducing errors.  After all, if a wonderful heart medication is given to the wrong patient what good is that?

 

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