MD Whistleblower

Yes, with an explanation.  Of course, if your doctor is prescribing a medicine, it must be approved by the Food and Drug Administration (FDA). But, it may not be approved for your specific condition.  Let me explain. The FDA is charged with determining when a drug is considered safe and effective and can be brought to the marketplace.  Bringing a drug from the research bench to the pharmacy is a complex and arduous process that takes many years, even when it’s running smoothly and on schedule.  As you might expect, there are often unforeseen obstacles that will extend the timeline to approval when the FDA requires more studies to address their concerns.  Often, the drug must be abandoned at some point in the process, after millions of dollars of R & D investment.  We should consider this reality before we demonize PhRMA reflexively, which has become sport today.  Guardians of Safety When a drug is ultimately approved, this approval...

Have you ever heard of a drug called Ozempic?   Just kidding.  As we all know, this medicine and numerous related drugs are the rage.  It is classified as a GLP-1 drug.  The percentage of my patients who are taking these drugs is steadily rising.  Of course, initially Ozempic’s purpose was in diabetic management.  Once it was discovered that weight loss was a ‘side-effect’, a new therapeutic mission was discovered.  Indeed, public demand to use this medicine off-label for weight loss has risen sharply.  Currently, there are two GLP-1 agonist medicines that the FDA (Food and Drug Administration) has approved for obesity treatment.  I can promise you that pharmaceutical R & D on similar and next-generation weight loss pharmaceuticals is supercharged.  Why the interest? There is an obesity epidemic in America. The medical, financial and societal consequences of obesity are staggering. Diet and exercise options are insufficiently ...

In two prior posts , I have offered my steep skepticism that probiotics deliver on the claims their manufacturers make.  By not being classified as actual drugs, these products leapfrog over traditional Food and Drug Administration scrutiny and are marketed directly to the public who seeks relief from various chronic diseases – conditions that conventional medicine doesn’t handle well. While I have lambasted the lack of medical evidence underlying probiotic treatment claims, in fairness, I will now offer an opinion that also has no supportive medical evidence.   So, probiotic enthusiasts may wish to call me out as well. I worry about unproven but plausible risks of long term probiotic use to the individual users and to society at large.   These products  are tampering with our own bacterial ecosystem that we don’t yet truly understand, always a dicey prospect.   And keep in mind that if you scan the labels of probiotics that fill several shelves in reta...

Recently, I stated that probiotics are marketed and sold free from the strict scrutiny of Food and Drug Administration  (FDA) oversight that our prescription drugs routinely undergo.  And this is just how these companies want it.  Trust me, if probiotics had to endure the same vetting process that actual drugs go through, most of them would be snuffed out along the way. Here’s a simplified glimpse of how the system works. Yo ho, hey hey, keep away from the FDA! Many probiotics are classified by the FDA as dietary supplements, rather than drugs.   Indeed, it is this classification that allows the industry to thrive.   The FDA regulates supplements much more leniently than they do conventional prescription drugs that must endure years of intensive vetting and successive clinical trials.  The drug approval process is so rigorous that most drug candidates will not reach the finish line.  The FDA maintains high standards for safety and efficacy....

Usually, we doctors give you advice.   In this case, I’d like readers to offer an opinion on an issue that patients and I face regularly. First, let’s acknowledge the huge reservoir of frustration and anger directed against insurance companies concerning their coverage decisions.   I have willingly entered this arena to wage battles for patients.   Despite my vigorous prosecutions of these contests, the outcomes have been variable.   Indeed, these competitions are not for the causal physician combatant.   The doctor must have the mettle, determination, skill and endurance of a Navy SEAL if there is to be any prospect of success. Some of my prior duels against Big Pharma and Big Insurance are chronicled in the Pharmaceutical Quality category on this blog.   Considering many insurance company coverage actions and decisions, it is understandable that patients do not believe that these companies prioritize the health of their members.   Althou...

Many of my patients are using medical or recreational marijuana to ease symptoms that do not respond well to conventional medical treatments. I understand this.  I have already opined on this blog that I believe that the medical evidence supporting the safety and efficacy of medical marijuana is rather thin, very different from the strict standards that the Food and Drug Administration (FDA) relies upon in assessing prescription drugs and medical devices.  Moreover, here in Ohio and elsewhere, our legislature is deeply involved in determining which medical conditions are eligible for medical marijuana treatment, a role that I believe should be handled exclusively by medical professionals and appropriate federal government agencies, such as the FDA.  Politicians should leave this to the professionals. How can you argue otherwise? I am employed by Cleveland’s largest health care organization which has national and international reach.   The organization will not per...

When I was training to become a gastroenterologist decades ago, the heartburn drug Prilosec (omeprazole) was released in the United States.  I prescribed it then to patients who had been suffering from heartburn for most of their lives.  After just days of treatment, their heartburn disappeared.  These folks couldn’t even remember what it felt like to live without heartburn.  And suddenly, they were cured with one small pill daily.  Now I know that heartburn is not exactly cancer, but this experience very early in my career showed me the potential for a pharmaceutical agent to improve lives.   I still relay this vignette to patients. Pharma is not the enemy. Think of all of the institutions and professions that we and our politicians demonize -   lawyers, oil companies, congress, corporate America, Big Tech and the pharmaceutical industry.   Recently, Ivy League universities have been promoted to a top ten ranking on this coveted list.   ...

Several times each month patients solicit my view on probiotics.   The tens of billions of dollars spent annually by Americans on these agents provides us with overwhelming evidence of an economic truth – marketing works.   Conversely, the evidence that probiotics actually deliver on their health claims ranges between thin and absent.   Why, then, are they so popular? While modern medicine has delivered much for the public, there are so many mysterious and chronic afflictions that remain out of reach.   Patients and physicians struggle over addressing bowel disorders, chronic arthritis, depression, fatigue, memory lapses, allergies, autoimmune diseases, skin rashes, sleep disorders, obesity and many other stubborn conditions.    When conventional medicine fails to deliver, many other treatments of questionable quality emerge.   This is undeniable.   Claiming benefit, however,  should not be sufficient.   Any new treatment should be sub...

One of the conundrums in medical practice is to determine if a medication is causing a side effect.  Sometimes, this issue is very straightforward.  A new medicine is prescribed.  Three days later, the patient develops a new symptom of constipation.  The medicine is stopped and the bowel pattern normalizes.  Most of us would agree that the evidence that the medicine was responsible for the bowel change is beyond a reasonable doubt. The above is a textbook example of a side effect, but alas, patients often have not read the textbook.   Consider a patient having diarrhea from colitis.   The gastroenterologist prescribes an appropriate medication.   Two weeks later, the patient contacts the doctor to report that his diarrhea has worsened.   Although diarrhea is among the long list of potential side effects of the medicine, might the increased diarrhea simply be from his underlying colitis? It's 'alimentary', my dear Watson! I have seen many ...

Over the past several years, there has been an important change in how diverticulitis is treated.  This topic sentence may seem out of place on this blog which is largely a site for commentary.  This is not a site that discusses medical breakthroughs on the treatment of constipation or heartburn.  But diverticulitis does offer a commentary angle, if you will read further. Decades of teaching and dogma have informed the medical profession that diverticulitis is a localized infection of the colon.   Diverticula, or pouches, are weak points in the large bowel.   If a tiny puncture develops at one of these sites, some stool can leak out contaminating the sterile abdominal cavity.   A n infection develops which, of course, needs to be treated with antibiotics. Indeed, for most of my medical career, every case of diverticulitis I encountered was treated with antibiotics.   In most cases, these patients recovered fully.   This observation may be Trut...

For those who can’t stand the sight of blood, I would advise against pursuing a career in gastroenterology.   We confront blood more often and more directly than nearly every other medical practitioner.   One of the most common reasons we are called to see hospitalized patients is to evaluate internal bleeding that originates somewhere within the alimentary canal.   It is then our task to identify the exact site of leakage and to caulk the leak, if possible.   As even a casual TV watcher knows that blood thinning medications are ubiquitous.    In the olden days, there was Coumadin (aka warfarin), which is still in use today.   It is a rather clumsy drug that requires frequent monitoring and dosage adjustments.   At times, and for no apparent reason, a Coumadin user’s blood will become thinner than desired and internal bleeding may result.   More recently, new generations of blood thinners have emerged giving physicians many new ways to th...

Physicians have great responsibility to protect the health of their patients.   But the practice of medicine is a shared responsibility.   Patients – the major stakeholders – obviously have responsibility for their own health.   In my view, they are charged with questioning and understanding the rationale of proposed medical advice.   I do my best to explain my advice clearly.   If there are reasonable alternatives, then I present them.   But if the patient before me remains unclear on the situation, then he needs to ask me to repeat and clarify.    Patients must exercise personal responsibility. If a surgeon enters an exam room and tells you that surgery is scheduled for the following morning, I would hope that you would be fully informed on what operation is planned and why it is necessary.   It sounds absurd that a patient would consent to an unspecified surgery.   "Ready for pot luck surgery tomorrow?" And yet, I reg...

A federal judge in Texas recently issued a ruling that would ban mifepristone by nullifying the Food and Drug Administration’s original approval of this medicine, which occurred 23 years ago. Mifepristone is one of two drugs that are used for medical abortions.  If this decision is ultimately upheld, it would ban this FDA approved drug throughout the country. Ironically, on the very same day, another federal judge in Washington state issued a contradictory ruling that would protect mifepristone’s status as an approved medicine.  An appellate court ruled a few days later that mifepristone's approved status remained valid, although prior restrictions on its use would be resumed.  This past Friday, the Supreme Court gave mifepristone a 5 day reprieve giving time for both sides to submit briefs days from now.   Will the Supreme Court deliver peace in the valley?   Not at all.   We have all painfully learned since the Roe v Wade decision of 1973 that a ...

There are two ways to sedate patients for colonoscopy.  There is conscious sedation is when the gastroenterologist administers a ‘twilight sedation’, or moderate sedation when sedation is administered by an anesthesia professional, usually with propofol, a drug now known to most of us as  a contributor to the death of pop superstar Michael Jackson. Most Patients Prefer Propofol over the Twilight Zone Leaving issues of cost aside, most individuals involved in the colonoscopy experience prefers the propofol option.  Here’s why. The drug is extremely safe when administered by trained personnel, who in most cases are Certified Registered Nurse Anesthetists (CRNAs). Unlike with twilight anesthesia, the procedure is entirely painless.  Patients can expect to experience the same level of discomfort as they do with a haircut. Knowing that they face complete comfort during the procedure, patients are relieved of anxiety that often precedes the proce...

I’ve never subscribed to the caveat to scrub politics and religion from my discourse.   Indeed, you will find these two subjects riddled throughout this blog.   I think we need more dialogue, not less.   I do agree, however, that dialoguing is a skill.   But it’s not brain surgery.   Any of us can become adept practitioners of this seemingly lost art, if we so desire.   It requires listening with an open mind.   It implies that your view on an issue might be modified in the face of a persuasive argument.   And your responses should respond to what has just been said to you indicating that the other side has been heard. So, now let’s talk some politics.   First, assess your political acumen by answering the following quiz question. Which of the following issues should not be handled by elected officials? (a) Tax policy (b) Zoning ordinances (c) Which chemotherapy regimen should be permitted for breast cancer patients (d) Parks and ...

Life can be vexing.   Life is not a math problem that has one indisputable correct answer.   We are constantly weighing options as we make decisions.  How much risk would we tolerate in order to hope to capture a reward?  Does an NBA star go for the three pointer or drive to the rim?  Does a defense attorney put his client on the stand or leave him mute hoping that the prosecution hasn’t met the required burden of proof?   Does a surgeon recommend an operation today or should the patient wait another 24 hours to see if his condition improves without surgery? All of us struggle where to draw the line.   Look at the ongoing debates in the public square regarding national security.   While some government officials deny this, most of us acknowledge that there is a tension between guarding our civil liberties and protecting our security.  Civil libertarians claim that we can do both, but I believe that trimming civil ...

Pepto Bismol remains one of the most popular over-the-counter medicines that my patients swallow. They take it for all kinds of digestive distress.   Does it work?   Hard to say.   The elixir does have anti-bacterial and anti-diarrheal properties, but I suspect that there is a potent placebo effect at play also.   I personally think that these sales are largely the result of decades of brilliant marketing by the company.   We can all remember their television commercials in the days of yore when we would watch the pink liquid oozing down the esophagus and then gently coating the stomach creating a blanket of healing and protection.   What a graphic!   Many patients have internalized this marketing believing that this medicine is the fire extinguisher that can quiet their internal flames.    Right out of the doctor's 'black bag'. Patients are generally unaware of two important properties of this product. First, Pepto Bismol can turn the st...

Over recent weeks, several times I have prescribed medications for patient that they could not afford. Insurance plans do not cover every benefit.  With respect to drug coverage, each insurance plans has a formulary - a listing of drugs that are covered.     As patients have learned well, covered medicines are categorized into different tiers, which determines to what extent the medication will be covered   The lower the tier number, the more money that the patient will have to surrender.   Some drugs are simply not on the formulary and can have eye-popping costs which might approach a patient’s monthly mortgage payment. Distraught woman hoping for a win so she can afford her colitis medicine. The two medicines that I had prescribed which were then stiff-armed for coverage were for colitis.   I had the patients research the costs and they and I were shocked by their findings.   At first, I thought they may have misplaced the decimal point, but...

Do you know what medicines you are taking?  Do you know the doses?  Do you know the purpose of each of the medications?  These seem like rather basic inquiries and yet you would be surprised how many patients cannot respond accurately to these 3 simple questions.   The medical profession needs to emphasize the importance of patients achieving an adequate level of medical literacy.   Knowing their medications is an important element of this mission.   It is much easier for doctors to care for informed patients. When a patient is unsure, for example, why he is on Lipitor, we can easily explain this.   It is more challenging, however, for doctors and other medical professionals when patients do not know the specific dose of a drug or if a drug was omitted from the medication list.   This happens all the time. Now here's a guy who knows how to make a list! Electronic medical records (EMR) have the current medication list available for the medical ...

Stomach acid must be Public Enemy #1 for gastroenterologists and primary care physicians.  Why else would more than 10 million Americans swallow proton pump inhibitor (PPI) medicines each day? These medicines are potent stomach acid blockers.  Common examples of these medicines include Prilosec (omeprazole), Nexium (esomeprazole) and Protonix (pantoprazole).  PPI medicines have generated tens of billions of dollars for pharmaceutical companies.  And several of these medicines are available over-the-counter (OTC), which permits the public to self-prescribe for a variety of ailments. Are ordinary folks selecting these medicines appropriately when they purchase OTC?   I have my doubts particularly since medical professionals often prescribe these agents very liberally going beyond the boundaries of medical evidence.   I have also been culpable of the transgression of PPI mission creep.   Indeed, studies have shown that physicians prescribe these acid bl...