Posts Tagged Washington Post

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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Emergency General Surgery — dangerous and expensive

viewinsideabdomenEmergency general surgery (EGS) is common in the United States.  11% of surgical admissions require emergency surgery.  The statistics on EGS seem to create more questions than they answer:

  • The 11% of surgerys classified as EGS are associated with 50% of all surgical deaths.
  • Poor people who have EGS have a greater risk of death than average
  • Rich people who have EGS have a lower risk of death than average
  • Seven surgeries (removing part of the colon, removing part of the small-bowel, removing the gallbladder, operations related to peptic ulcer disease, removing abdominal adhesions, appendectomy and other operations to open the abdomen) accounted for 80% of the deaths and hospital costs related to EGS.
  • The cost of ECS in the U.S. is about 7 billion dollars per year.
  • EGS patients admitted by a surgeon have lower hospital costs than those admitted by a hospitalist.
  • Specific quality guidelines for ECS do not exist.

One might be tempted to say the diagnosis is so complicated nothing could improve the situation for patients.  However, this would be like the situation for pilots and passengers 30 years ago when major airliner accidents happened at least once a year.  The quality movement swept over the airline industry which is now is rated as one of the safest of complex human endeavors.  Those same measures need to be applied to EGS.

When an airplane has an emergency the crew pulls together and acts as a team.  They follow a procedure practiced many times.  They have simulators and tests.  If an engine fails, if there is a fire, if a landing gear fails there’s a procedure to follow.  Each pilot does not invent a procedure just because they are the pilot that day. Likewise, every surgeon should not invent a procedure just because they are the surgeon that day.

It would be easy to blame surgeons or the patients themselves for such dismal outcomes.  But, as people in the quality improvement department say:

IT’S NOT THE PEOPLE, IT’S THE PROCESS.

The first step is to acknowledge EGS is a process.  When a patient arrives in the emergency room with abdominal pain, low blood pressure, free air in the abdomen and a high white blood count there should be no barriers to evaluation an treatment.

  1. The goal is to have the patient in the operating room within 90 minutes from  crossing the ER threshold (T).
  2. Blood tests and CT scan of the abdomen are done by T+ 20 minutes.
  3. Surgeon is in the ER to evaluate the patient by T + 30 minutes
  4. A decision for operation is made by T + 45 minutes.
  5. Pre-op antibiotics, fluids, and pressors are started as needed.
  6. Anesthesiologist begins care of the patient in the ER by T + 60 minutes.
  7. Central line is inserted, operating room is notified, ICU is notified, critical care team is notified by T+75 minutes.
  8. Patient is transported to the operating room.  The opening incision is made by T + 90 minutes.

Such a process is obviously difficult.  First, the ambulance crew can not transport a patient with an abdominal emergency to a facility unable to deal with the problem, like a small rural hospital or an urban community ER.  This will require training of the ambulance crews and communication with a high level ER.

General surgeons and back-up general surgeons must be available within 30 minutes.  It’s a difficult life to be immediately available — the hospital is responsible to either pay surgeons to be on-call or to hire surgeons to stay in the facility.  Hospitalists are not an appropriate substitute to deal with an acute abdomen or even severe abdominal pain of uncertain cause.  A helicopter ride to a higher level facility is the best solution for patients with severe abdominal pain entering a facility not capable of following the above protocol.  The crazy practice of having a night-time hospitalist admit a critical surgical patient for a surgeon to see “in the morning” must come to an end.

Since the mortality rate of EGS patients is quite high the intensive care unit is the place they should go after surgery even if they seem stable in the operating room.  Complications are very common so early recognition and treatment is essential.  Returning to the operating room later may be needed and should not delayed.  Critical care consultation should be strongly considered.  Multidisciplinary rounding with critical care specialists, nurses, pharmacists, dietitians, and social workers is strongly advised.  Rushing to get the patient out of the hospital to a secondary level of care is a mistake since re-admission is fairly common.  The patient needs to be as stable as possible before discharge.  Hospitalization for 1 – 2 weeks is not uncommon.

The difference in outcome of EGS between rich and poor is not uncommon for many things in medicine and surgery.  Several factors are at play but probably the biggest is fear of big medical bills — if you can’t pay one would wait till the last moment.  Second, medical literacy — always a bigger problem for lower socioeconomic groups — if you think Tums or Rolaids will fix anything you might wait too long to go for help.  Finally, a negative bias toward Medicaid or “cash” patients — sometimes the finances determine whether a hospital will keep or transfer patients.  At midnight many cases seem to be too “hard” and must be sent to a referral hospital which wastes valuable time.

Since prospective research is difficult and time consuming (taking years or decades) a local and national registry should be utilized.  The diagnosis, the surgical approach and the outcome must be tracked to find the best combinations for the best outcome.  As best practices are identified surgeons and hospitals must quickly change protocols and surgical techniques.  U.S. healthcare can not stand the usual 15 years needed to implement new practices.

References:

If any nurse out there has a standard order-set for EGS please share it.

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