Sunday, March 26, 2017

Beware of Joining a Clinical Trial - Medical Research Must Come Clean

From time to time, friends, patients and relatives ask my advice on participating in a medical experiment.  My response has been no.  More accurately, once I explain to them the realities of research, they don’t need to be persuaded.  They back away.

Here’s the key point.   When an individual volunteers to join a research project, the medical study is not designed to benefit the individual patient.  This point is sorely misunderstood by patients and their families who understandably will pursue any opportunity to achieve some measure of healing for an ailing individual.  I get this.  In addition, I believe that these research proposals are often slanted in a way to suggest that there may direct benefit that the patient will receive.  I am not accusing the medical establishment of uttering outright falsehoods to prospective study patients, but there are two powerful forces that may incentivize investigators to recruit patients with undue influence.
  • The Medical Research Industrial Complex is a voracious beast that needs a steady diet of new recruits.  In other words, the beast must be fed.
  • Investigators have bias favoring their research and truly believe that the new drug has a real chance of helping study patients.
The truth is this.  In general, research projects are designed to generate new knowledge that will be used to help patients down the road, not those in the study.  Of course, I cannot state with absolute certainty that a study patient won’t realize a favorable result, but this serendipitous outcome is not the study’s planned yield. It should be viewed as a happy accident.  This is why the study is properly called a research experiement.

Napoleon Has Stomach Pain.
Should He Join a Study?

Beware of the packaging.  If your mom or dad has Alzheimer’s disease, of course, you would be susceptible to the following hypothetical pitch.

Is someone you love struggling against Alzheimer’s disease?  Our Neurological Institute is fighting hard against this disease and is now testing a new drug to help conserve memory.  Call for confidential information. 

Recently, in France, 90 volunteers took a study medicine testing the safety of a psychiatric medication.  One volunteer is now dead and others have suffered irreversible brain damage.  We don’t know the underlying facts yet.  While a horrible outcome is not tantamount to guilt, this is a terribly troubling event that must be sorted out. We will find out soon enough if the French study subjects were given all the information they were entitled to, and if the investigators and others behaved properly.  The investigation that must be full and fair.  A conclusion of c’est la vie won’t be enough.

If you want to join a medical study to serve humanity – and not yourself – then you are free to make an informed choice.  Be mindful of the risks including those that are not known. 

Helping others is a praiseworthy act.  So is telling the truth.

Sunday, March 19, 2017

Medical Marijuana Use - Ready, Fire, Aim!

Promoting medical marijuana use is hot – smokin’ hot.  States are racing to legalize this product, both for recreational and medical use.  In my view, there’s a stronger case to be made for the former than the latter. 

Presently, marijuana is a Schedule I drug, along with heroin, LSD and Ecstasy.  The Food and Drug Administration (FDA) defines this category as drugs with no acceptable medical use and a high potential risk of addiction.  Schedule I contains drugs that the FDA deems to be the least useful and most dangerous.  Schedule V includes cough medicine containing codeine.

On its face, it is absurd that marijuana and heroin are Schedule I soulmates.  I expect that the FDA will demote marijuana to a more benign category where it belongs.  It will certainly have to if marijuana is going to be approved as a medicine. 

There is no question that some advocates favoring medicalization of marijuana were using this as a more palatable route to legitimize recreational use.  The strategy was to move incrementally with the hope that over time the ball would cross the goal line.  We have seen this same approach with so many other reforms, legal decisions and societal acceptances, many of which we take for granted.  Consider gay marriage and women’s role in the military as two examples of goals that required a long journey to reach.

Marijuana has had no personal or professional role in my life.  I do not object to responsible recreational use and would support such a measure.  To criminalize marijuana use while cigarettes, chewing tobacco and alcohol are entirely legal seems inconsistent and hypocritical.  Is smoking marijuana more dangerous than riding a motorcycle?

Paradoxically, I have hesitancy at this point to endorse medical marijuana use based on the fragmentary data that supports its efficacy.  If you ‘Google’ this subject, and you believe what you read, you will conclude that marijuana is the panacea we’ve been waiting for.   It helps nausea, neuropathic (nerve) pain, glaucoma, muscle spasms, Crohn’s disease, multiple sclerosis, epilepsy, Hepatitis C, migraines, arthritis, Alzheimer’s disease, cancer and numerous other ailments.  Do we accept so readily that one agent can effectively attack such a broad range of unrelated illnesses?  It sounds more like snake oil than science. 

Cure is Just a Puff Away!

Shouldn’t high quality medical studies demonstrate benefit before we sanction medical marijuana use?

The medical profession and our patients should demand that all our medicines be rigorously tested for safety and efficacy.   I realize that there is huge public acceptance that marijuana is real medicine.  Not so fast.  Let the FDA evaluate marijuana as it does for all medications and treatments.  I do not think we should relax our professional standards just because the public is willing to inhale without evidence and entrepreneurs want to cash in.

If you had a chronic disease, would you expect your doctor to offer you a medicine with definite risks but no proven benefit?  Why would you accept it and why would he prescribe it?  

Sunday, March 12, 2017

Why Are Drug Prices So High?

Why are the costs of prescription drugs so high?  While I have prescribed thousands of them, I can’t offer an intelligent answer to this inquiry.  Of course, all the players in this game – the pharmaceutical companies, Pharmacy Benefit Managers, insurance companies, consumer activists and the government- offer their respective bromides, where does the truth lie? 

While I don’t fully understand it, and I don’t know how to fix it, we all know that the system is broken.  More than ever before in my career, I am seeing patients who cannot afford the medicines I prescribe for them.  In the last few weeks of this writing, 3 patients with colitis, a condition where the large bowel is inflamed, called me to complain about the cost of their new medicine.  The annual cost was in the $2,500 - $3,000 range, which is way out of range for normal folks.  While I was only focused on the colitis drug, many of these patients face prohibitive costs over multiple medicines.  All of these patients had medical insurance, thought it didn’t feel like it to them. 

Medicine or Retirement?

Should sick patients be given the added burden of price gouging?

I'm not an attack dog against PhRMA.  I've expressed sympathy on this blog and elsewhere that it costs pharmaceutical companies a fortune to design, test and market new medicine.  R & D is not cheap.  If we want this industry to take risks developing tomorrow's drugs, then they deserve a profit high enough to justify the investment.  Nevertheless, from the prescribers and the consumers points of view, the system is out of balance and needs to be recalibrated.  

I reviewed my colitis patients' formularies, which is the list of medicines that patients' insurance companies cover.  If a drug is labeled as a ‘Tier 1’ drug, then the cost to the patient is the lowest.  The higher the Tier #, the more the patient will pay.  This is how the insurance company ‘guides’ physicians to prescribe cheap drugs.  Of course, the insurance company will never say that the patient can’t receive an expensive drug.  That’s a decision, they claim with a straight face, that’s between a patient and the doctor.  Give me a break.  Ordinary folks, especially retired people on fixed incomes, are confined to lower Tier medicines.

I have no issue with the Tier system as long as there is at least one Tier 1 drug that can do the job.  If there are half a dozen heartburn medicines that are equally effective, I understand if an insurance company makes one of them Tier 1, their preferred choice.  This happens when the insurance company gets a special discount on this particular medicine.  

With regard to my 3 colitis patients, the only Tier 1 drug was one that came on the scene decades before I was born.  The standard colitis medicines that every gastroenterologist would have prescribed were all upper Tier. My patients had no choice but to accept an inferior drug. 

If any reader can explain why our drug prices are the highest in the world, can you also explain why insurance companies are not practicing medicine?

Sunday, March 5, 2017

Should Attorney General Jeff Sessions Resign?

For me, the test of fairness, which many of us fail, is if we would have the same view of events if the situation were reversed. 

An employee approaches his boss requesting a raise, pointing out that he has not had a raise in 2 years, while other colleagues have received pay increases.  The boss responds that while his performance was highly satisfactory, the colleagues who did receive pay raises demonstrated sterling reviews.  The employee believes this decision is unfair, and suggests there may have been some favoritism at play.   The fairness test here is what would the employee do if he were the manager.

A nursing supervisor is told that two nurses on a hospital ward are unable to report to their shift.  Each nurse has to carry a heavier patient load for that shift.  These nurses believe that they are entitled to additional compensation as their already heavy work load has been increased.  This request is denied by the hospital’s administration.  I wonder if the hospital administrators would agree with their edict if they were the overworked nurses on that shift.  Would they still agree that no additional pay for additional work is downright fair?  Can't you just hear them saying that if they were these nurses that they would welcome the opportunity to be saddled with extra work and would refuse any offer for additional comp.  (Readers are invited to laugh at this point.)

Events always look a little different when we swap places. 

The Attorney General of the United States, Jeff Sessions, is the newest star performer on CNN and other networks this week.  He gave misleading responses during his confirmation hearings when asked if he had any contact with Russian officials during the campaign.  In addition, he did not correct his misstatements afterwards until his 2 meetings with the Russian ambassador were disclosed.  He has been accused of lying and deceiving congress, an allegation that he denies.  He claims that he misunderstood the question and had no intent to mislead anyone.

Public Enemy #1?

Personally, I am not satisfied with his inaccurate testimony and subsequent silence    Did he lie?  I’m not sure.  If so, it would seem to be a poor choice since telling the truth of the two meetings could have been justified and explained.  

Many Democrats are screaming for his resignation and for a special counsel to be brought in to assess the situation independently.   I suggest that the reasons behind these two Democrat requests have nothing to do with Sessions’ behavior, but deserve a larger context, which I’m sure my readers will acknowledge.

We all know that when there is an independent counsel that the investigation always morphs into a mega-mission creep that extends far beyond the initial target.  That’s why political partisans always zealously request this measure when the other party is under attack, but push back hard when they are in the crosshairs.  

Now for the fairness test.   Remember when the Democrats were screaming and whining when independent counsel Ken Starr was on the attack?  His mission started with Whitewater but was incrementally expanded and extended to the Monica Lewinsky affair.  I think the Democrats had a valid point that his investigation became untethered.  However, is an independent counsel only fair when your opponents are being targeted?

As for Jeff Sessions resigning, I think this is transparent partisanship.  How would the Dems react if the situation were reversed?  The experiment has already been done.  Remember when Loretta Lynch, the Attorney General had a near hour long meeting with Bill Clinton on the tarmac while Mrs. Clinton was the target of an FBI investigation?  Quite a long time to be discussing golf and grandchildren.  

How many Democrats called upon her to resign or face a special prosecutor?   Have they passed the fairness test?

Of course, many partisan Democrats will point out the the Lynch affair is 'completely different' from the Sessions matter.  How stupid do they think we are?

I'm taking aim at the Democrats here, but I fully acknowledge that the GOP also fails the fairness test regularly.  

Sunday, February 26, 2017

Do Doctors have a Right to Free Speech? Hippocrates Weighs In.

Free speech is one of our bedrock constitutional rights.  The debate and battle of what constitutes lawful free speech is ongoing.  The issue is more complex than I can grasp with legal distinctions separating political speech, commercial speech and non-commercial speech.  And, of course the right of speech does not permit the free expression of obscenity or ‘fighting words’, along with some other exclusions.  And, there is no right to free speech in a private work place, where an employee can be fired for speaking his or her mind.  While worker in a private shop may claim that he had a right to call his boss a flippin’ jerk, he would likely find that he suddenly has an abundance of free time to contemplate his prior utterance.

Leaving aside the First Amendment, physicians have always enjoyed free speech in our offices.  We ask our patients questions of the most private and intimate nature.  And, they answer us.  We ask such questions because, under appropriate circumstances, we need the information in order to provide our best medical advice.   We ask about specific sexual practices.  We ask about prior or current substance abuse.  We ask if patients are alcoholics.  We ask if patients are suffering from abuse or neglect. 

While we may not invariably receive truthful responses from these inquires, often we do.  Patients trust us to respect their confidentiality, which has been embedded into medical culture and practice since the time of Hippocrates.

And whatsoever I shall see or hear in the course of my profession, as well as outside my profession in my intercourse with men, if it be what should not be published abroad, I will never divulge, holding such things to be holy secrets.

Hippocrates -2500 years before HIPAA!

His admonition holds true nearly 2500 years later.  How’s that for meeting the test of time?

In 2011, the Florida Republican legislature, with the approval of the governor, passed a law that restricted physicians from inquiring of their patients about gun ownership and safety.  Physicians found to be in violation risked loss of their professional licenses or fines.  Nearly two weeks ago, an appeals court struck this silly law down.  Not only was such a law an obvious encroachment on physicians’ First Amendment rights, but also posed a barrier preventing doctors from doing their jobs.  Should a pediatrician, for example, be prevented from asking a parent if firearms in the home are properly secured?  This is not a political or partisan issue – it’s a medical and safety issue.

Of course, the appeals court got it right in a case that I regard as a judicial lay-up.  But, how did such a ridiculous law get passed in the first place?

Sunday, February 19, 2017

Do Judges Legislate from the Bench? What's Your Ruling?

Judge Neil Gorsuch, President Trump’s nominee to fill a vacant seat on the Supreme Court of the United States, will face a contentious vetting process in the U.S. Senate.  I expect the sausage-making process to be an opportunity for political grandstanding where bombastic bloviators will spew forth partisan pabulum.  Look for a senator, for example, to point out that the judge did not clean up after his dog when he was in the 7th grade.  “If we can’t trust you to clean up after Sparky, then how can we trust you to mind the Constitution?”

We read and hear about the scourge of judicial activism (JA), where judges invent laws rather than interpret existing law, as they are charged to do.  The antidote to judicial activism is judicial restraint (JR), when judges exercise modesty and base their rulings on the intent of the framers or on the words in the statute.  If, for example, the statute does not specify that “the puppies shall be saved”, then it is not for the judge, who may be a dog lover, to take on canine rescue as a ‘pet project’.

Let me define JA and JR more clearly for readers who do not wallow in the judicial universe.

Judicial Activism: A ruling that is disliked by various individuals and interests.
Judicial Restraint: A ruling that is celebrated by various individuals and interests.

If a judge rules for your cause, then he or she is a titan on the bench.  If however, you did not receive your desired judicial outcome, then the judge is an activist hack who is legislating from the bench.  I am generalizing, of course, but you get the point. 

A Den of Activism?

How has the judicial branch been performing?  A lot better than the other two branches, in my view.  Here’s some rough polling data.

      Approval Rating
Trump                            38%  (2017)
Congress                        28% ((2017 –  Surging -up 9 points in 1 month!)
Supreme Court             42% (2016)

Let’s not read more into this than the numbers merit.   Negative poll numbers do not mean that an individual or an institution is not performing well.  It simply means that the public is dissatisfied.  If Congress, for example, passes a law eliminating the deductibility of home mortgages, which may be a sound public policy measure, don’t look for an upward spike in poll numbers.

Hopefully, this blog, at least from time to time, polls well with readers.  What’s your ruling?  Of course, if I don’t like it, I will merely label you as an Activist Reader!