Scientific Reports, Media Reports and Ambiguity

Last week I read an article in a peer reviewed journal citing the benefits of a few eggs per week as part of a low carbohydrate dietary intervention for Type II Diabetes.  The information was so meaningful about a controversial food source of protein that I decided to write about it in my blog and pass it along to my patients.  Three days later the American Heart Association and American College of Cardiology discussed the increased risk of cardiovascular events and mortality in individuals consuming three or more eggs regularly. They talked about the detrimental cholesterol being concentrated in the yolk making egg white omelets look healthier than traditional omelets.

In the early 1970’s a VA study was published showing that veterans over 45 years of age who took an aspirin a day had fewer heart attacks and strokes and survived them better than those who don’t.  Fast forward almost 50 years and we have different recommendations for people who have never had an MI or CVA or evidence of cardiovascular disease compared to secondary prevention in individuals who have known coronary artery disease, cerebrovascular disease or diabetes. Throw in the controversial discussions of aspirin preventing colorectal adenomas from developing, aspirin preventing certain types of skin cancers and today’s report that suggests it may prevent liver cancer. Now three studies suggest that in older individuals (70 or greater) the risk of bleeding negates the benefits of cardio and cerebrovascular protection and aspirin may not actually prevent heart attacks and strokes in that age group.

We then turn to statins and prevention of heart attacks and numerous articles about not prescribing them to older Americans.  I saw articles on this topic covered by CNN, the Wall Street Journal, ARP Journal, AAA magazine and in several newsletters published by major national medical centers.  In each piece they caution you to talk to your doctor before stopping that medicine.

I am that seventy year old patient they all talk about.  I have never smoked. I exercise modestly on a regular basis, getting my 10,000 or more steps five or more days a week.  I battle to keep my weight down and find it difficult to give up sweets and bread when so many other of life’s pleasures are no longer available due to age and health related suggestions.

There are clearly no studies that look at patients who took a statin for 15 years and aspirins for over 20 years, stopped them and then were followed for the remainder of their lives.   How will they fare compared to patients who never took them?

I have this discussion every day with my patient’s pointing out the current guidelines and trying to individualize the suggestions to their unique lifestyle and issues. On a personal level, I still have no idea what the correct thing is to do even after discussing it with my doctors.  How can I expect my patients to feel any differently?

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Cipro, Levaquin and Tendon Rupture

For many years, fluoroquinolone antibiotics such as Cipro and Levaquin have been integral components of treating bacterial urine infections, travelers’ diarrhea, skin infections and certain pulmonary infections.  Like any chemical or medication, they do not come with a “free lunch.”  There have always been potential side effects and adverse effects possible, in addition to drug to drug interactions with other medications, the prescribing physician needs to take into account before suggesting these products to patients.  In recent months, the use of these antibiotics has come under further critique from individuals developing unexpected tears of tendons and having an increased risk of rupturing a major blood vessel such as the aorta.

The subject of fluoroquinolone antibiotics and tendon rupture was addressed in a recent study of the United Kingdom Clinical Practice Research Datalink and discussed in the on line journal MPR.  They looked at 740,926 users of fluoroquinolone (FQ) antibiotics and tendon ruptures. Of that group, only 3,957 cases of tendon rupture were reported.  This correlated to a risk of 3.73 events per 10,000 person years with an even lower risk for Achilles tendon rupture of 2.91.

When they then looked at which patients with rupture were additionally taking corticosteroids such as prednisone they found the risk increased to 21.2 per 10,000 PY.  The study showed that females were more likely than males to develop a tendon rupture and those over 60 years old as well.

Cipro and Levaquin can certainly remain part of a treatment plan as long as we realize that patients taking steroids, especially women and patients over 60 years of age, are at higher risk than others. That risk, however is extremely small.

Statin Related Muscle Pain and Coenzyme Q 10

Statins are used to lower cholesterol levels in an effort to reduce the risk of developing cardiovascular disease. They are used after a patient has exhausted lifestyle changes such as changing their diet to a low cholesterol diet, exercising regularly and losing weight without their cholesterol dropping to levels that are considered acceptable to reduce your risk of vascular events.

Patients starting on statins often complain of muscles aches, pains and slow recovery of muscle pain after exercising. In a few individuals the muscle pain, inflammation and damage becomes severe. One of the known, but little understood, negative side effects of statin medications are the lowering of your Coenzyme Q 10 level. CoQ10 works at the subcellular level in energy producing factories called mitochondria. Statin drugs, which inhibit the enzyme HMG-CoA Reductase lower cholesterol while also lowering CoQ10 levels by 16-54 % based on the study reporting these changes.

The November 16, 2018 edition of the Journal of the American Medical Association published a review article by David Rakel, MD and associates that suggested that supplementing your diet with CoQ 10 would reduce muscle aches and pains while on statin therapy. Twelve studies were reviewed and the use of CoQ10 was associated with less muscle pain, weakness, tiredness and cramps compared to placebo. The studies used daily doses of 100 to 600 mg with 200 mg being the most effective dosage. Finding the correct dosage is important because the product is expensive with forty 200 mg tablets selling for about $25.

Since CoQ10 is fat soluble, you are best purchasing formulations that are combined with fat in a gel to promote absorption. As with all supplements, which are considered foods not drugs , it is best if they are UPS Labs certified to insure the dosage in the product is the same as listed on the label and that it contains no unexpected impurities.

Controlled Substances and Schedule Drugs

The right to prescribe narcotics and controlled substances is regulated by the Federal Government. Physicians, dentists and health care providers apply for licensing with the Drug Enforcement Agency and request the right to prescribe medication from the different “schedules.” State legislatures and state medical boards regulate this further. Most people are unaware which medications and drugs are in which schedules or categories.

Schedule I – For the most part, these are substances which have no current accepted medical usage and are easily abused.

Examples are: Heroin, LSD, Ecstasy (methylenedioxymethamphetamine), Quaaludes          (methaqualone) and peyote.

Schedule II – These are substances with high potential for abuse with a risk of physical and psychological dependence.

Examples are: Vicodin, cocaine, methamphetamine, methadone, hydromorphone (dilaudid), meperidine (Demerol), oxycodone (OxyContin), fentanyl, Dexedrine, Adderall, Ritalin

Schedule III – these are drugs with moderate to low potential for physical and psychological dependence.

Examples are: Products with < 90 milligrams of codeine per dosage unit such as Tylenol with codeine, ketamine, anabolic steroids and testosterone.

Schedule IV – These are drugs with a lesser risk for abuse and dependence.

Examples are: – Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, and AmbienTramadol.

Schedule V drugs have lower potential for abuse than Schedule IV drugs and contain limited amounts of narcotics. This would include antidiarrheal medications, antitussives, and mild analgesics. Cough medications with less than 200 milligrams of codeine per 100 milliliters such as Robitussin AC, Lomotil, Lyrica and Parapectolin.

All the medications on these schedules must be reported to E-Forcse, the Prescription Drug Monitoring Program, within 24 hours of dispensing by pharmacies. They all require the prescribing doctor to check E-FORSCE before prescribing.

A Clinician’s View of the Opioid Crisis

“Do Not Get Caught.” seems to be the real rule of the law in S. Florida, where I live.

I was trained to limit the use of controlled substances, narcotics, hypnotics and sedatives. Their use can affect consciousness, ability to drive a car and work.  More severe consequences include respiratory depression and overdose from too high of a dosage or mixing too many medications and over the counter items.

The Joint Commission on Accreditation, medicine’s good housekeeping seal of approval authority, along with major medical organizations have accused clinicians of under treating pain. “Pain” is the fifth vital sign, they said.

This was accompanied by professional society leadership and academic researchers receiving grants from pharmaceutical companies touting the newer longer acting pain medications which “have very little addictive potential”. We were then informed we would be receiving evaluations and scores of our treatments of pain which would influence our reimbursement if we under treated pain.

In my current concierge medical practice I see 10 or fewer patients per day. In my previous general practice I saw 2- – 30 patients per day. I could go days without prescribing a narcotic pain medication. In most cases when I wrote out a script for a narcotic pain medication it was for a patient with a severe chronic pain problem, seeing a specialist for that problem, and requiring a pain pill because there were few effective alternatives. The patient visits to doctors and physical therapists and massage specialists and other alternative pain therapies were well documented in the medical record and mostly unsuccessful in attempts to relieve the pain.

This contrasts markedly with the opening of pain clinics in nearby counties with their own in-house prescribing pharmacies. One or two physicians wrote thousands of pain pill prescriptions per day. Patients lined up around the block to see these employed physicians of the pain clinic with many arriving in cars from other states. The cash flow generated was so vast that the clinics needed private security to protect the profits. Many of the security hired were off duty city and county police officers trying to supplement their income.

It’s hard to imagine that law enforcement and the DEA, were unable to recognize the difference between pill distributing centers and legitimate practices prescribing medications on a limited basis to individuals with documented needs. City, County and State governments gladly accepted the tax benefits, occupational license fees and pharmaceutical license fees from these sham clinics while drug dealers drove in and out of our state to obtain prescription pain medications for sale in their home towns. Of course the blame for this was placed on the doctors and dentists.

The State of Florida tightened up its laws and somehow law enforcement was given the tools to see and eradicate what was occurring right under their very noses. As prescription drugs dried up, the Mexican drug cartels got smart and flooded the market with cheap strong heroin. It was obviously the fault of the physicians and legitimate pharmacies that white working class people were buying plastic bags full of dope and inserting needles into their veins to avoid the pain of life.

As drug addiction soared, City and County Governments found it in their hearts to sit as zoning boards allowed drug rehabilitation centers to open up in the heart of their communities. There was little or no effective investigation of who was running these clinics and or their previous experience, methods and or success rates. If you want to read about where the soaring number of narcotic overdoses occur in our community – follow the zoning board’s placement of rehab centers and sobriety houses. What better way to increase your drug overdoses than to encourage unsuccessful addicts to come to your community and leave their money and their family’s money to improve the tax base and create new headaches for EMS and police officers?

Somewhere there should have been a higher level of thought by our elected and appointed officials about the consequences of bringing hundreds of drug dependent individuals into our area before they permitted these facilities to open.

Last week my advanced pancreatic cancer patient with severe back pain tried to purchase a controlled substance prescribed by his oncologist to relieve his suffering. Six pharmacies no longer stocked the product due to their fear of liability. It took hours to find a pharmacy that would order the medication for the patient. Physicians, pharmacists and law enforcement accessing our state narcotic registration website clearly can see that this patient only uses his medications as prescribed by one physician. This patient, and others like him, are victims of the government legitimizing of pain pill mills and drug rehabilitation centers in their communities.

As a physician we all have our failures in this area as well. I painfully recall the doctor’s wife I sent to a disciplined pain doctor to wean her off narcotics prescribed by a rheumatologist, urologist and gastroenterologist for legitimate reasons documented by tests and biopsies. I refilled the prescriptions for her convenience and ease never dreaming I was contributing to her problems.

I feel for my colleagues in the Emergency Department and in orthopedic offices having to daily differentiate acute pain requiring intervention with controlled substances as opposed to individuals with drug seeking personalities. This being said, the opioid crisis was caused by the most trusted members of the academic medical community in cooperation with the medical inspection and certifying agencies in concert with public officials and law enforcement looking the other way. They all made a great deal of money at the expense of the public. Now as they struggle to clean it up they give us medical and recreational marijuana.

Generics and Therapeutic Substitution – Safety and Efficacy?

Excuse me for being a “doubting Thomas,” but when I saw articles in JAMA Internal Medicine and commentaries supporting use of generics instead of brand name drugs I asked myself “Where is the proof of equivalent results and safety?”.  Generic substitution implies that the original product is no longer patented and exclusive and another firm is now producing an identical chemical version which produces the same beneficial effects on the patient.  Therapeutic substitution means your pharmaceutical insurance company or pharmacy changes the drug you are prescribed to one in the same drug class. Think of drinking Coca Cola and having the supermarket substitute a comparable brand instead.

The reason for this is simply to spend less money. Many pharmaceutical insurance companies realize if they put an obstacle in your path of obtaining your medication you likely will pay for it independently saving them money.  The authors of the JAMA articles estimate between 2010 and 2012 therapeutic substitution would have saved $73 billion. The out-of-pocket savings to the patient would have amounted to $25 billion.

I’m for saving money and spending less with certain guidelines. However; I want to know that a generic medicine is produced in a factory inspected by the Food and Drug Administration (FDA) at least as frequently as the drugs produced in North American factories. I like to know where the drug was made including country of origin, city, location and the plant’s track record for health and safety. I also want to know the generic medication produces the same drug levels and positive effects as the brand name medication and is made with no more contaminants than the original branded product.

I need reassurance that my patient isn’t receiving a counterfeit product with stolen original labeling, which has been a scam fooling pharmacists and Customs agents for years.   I would additionally like to know that the generic product, or therapeutically substituted product, works as well as the original. We know for example that Levothyroxine generics and substitutions are problematic.  We additionally know that the beta blocker carvidilol (Coreg) has certain unique properties that other beta blockers do not provide making therapeutic substitution for less expensive medications in the beta blocker class problematic.

Once this information is available it should be distributed in package inserts, online and taught in pharmaceutical, nursing and medical school courses as well as CME courses for health care professionals.

There is an abnormally perverse concern that if a pharmaceutical representative takes a health care provider out for a meal and a drink while explaining their product, we will prescribe it even if it is more expensive or doesn’t work as well.  I doubt sincerely that most physicians would do that but do believe if the cost is comparable, or less, and the efficacy is as good, they might choose the product as a viable alternative.

Antibiotic Associated Colitis Increases Risk

At least a half dozen times per week patient’s call with symptoms of a viral upper respiratory tract infection or present to the office for a visit with symptoms and signs of a cold.  These illnesses are caused by small viral particles which do not respond to antibiotic treatment.   Your body’s defense system attacks these viral particles and over a period of hours to days defeats them.   Despite years of ongoing public health announcements and handouts by doctors and nurses and attempts at patient education you find yourself negotiating with strong willed patients who want a “Z Pack” or some other antibiotic which they do not need.  “I know my body,” they argue.  “My northern or previous physician knew to always give me an antibiotic, why won’t you?”

The answer is quite simple. They do not work to shorten the course, intensity or duration of your illness. They do in fact put you at risk of developing complications of antibiotic use. When your infection requires the use of antibiotics to restore health, it is worth taking these risks. When you do not need the medication it definitely is not. This was confirmed by an article and research presented by E Erik Dubberke, MD of Washington University School of Medicine in Saint Louis, Missouri commenting on Medicare Data about the death rate associated with antibiotic related colitis infections due to Clostridia Difficile.  Bacteria normally reside in our large intestine and promote health and digestion.  When we prescribe an antibiotic it kills off the healthy and beneficial bacteria as well as the infection related bacteria. This destruction of healthy bacteria creates an environment conducive to “opportunistic “bacteria normally suppressed by the normal flora to invade and take over your gut. The resulting fever, cramping, diarrhea with blood occurs as the intestine become inflamed with colitis. One of the common opportunistic pathogens is Clostridia Difficile.

Dr. Dubberke looked at Medicare data and compared 175,000 patients older than 65 years of age and diagnosed with Clostridia difficile infection and compared them to 1.45 million control patients. He found that those with clostridia difficile infection had a 44% increased risk of death. When comparing admissions to nursing homes for treatment there was an 89% increased risk due to antibiotic related colitis care.

Antibiotics are wonderful when appropriate. They will always carry a risk of a side effect, adverse reaction or complication which is a risk worth taking in the correct setting.  It is clearly not worth the risk when your doctor tells you that it will not work.