Who Is Addressing the Availability, Safety & Efficacy of our Medications?

I watched all three presidential debates this summer with health care being a time-consuming topic for all. Universal health care and Medicare-for-All, with or without an option for private insurance, were debated and discussed at length.

At the same time NBC Nightly News presented a story documenting that all our antibiotics come from production in China. With globalization policies, which promote moving production to lower cost overseas factories, there is no longer any production of antibiotics in the USA. A former member of the Joint Chief of Staffs, citing the current trade conflicts and China’s aggressive military stance in the Pacific, considers this a security issue. I have heard not one question or comment on this topic in the debates?

This week, once again, the blood pressure medicines losartan and valsartan were recalled because they contained potential carcinogens. These generics were produced in India, Asia and Israel. These same drugs have been recalled multiple times in the last few years for similar problems.

Due to reduction in funding for FDA inspections, many of these foreign plants have not been inspected for years. We can add recalls of generics to drug shortages. We suffered a shortage of intravenous fluids for hydration because the primary production site in Puerto Rico was destroyed in a hurricane. We had shortages of morphine and its derivatives for treatment of orthopedic trauma and post-surgical pain. They substituted foreign-produced short acting fentanyl. I saw pediatric ER physicians unable to administer the most effective treatments for sickle cell crisis in children because it required the use of a narcotic drip to offset the dramatic pain the treatments induce as they stop the crisis.

Then there are the psychiatric patients on antidepressant generics who are paying hundreds of dollars per month for products that wear off in 16 hours rather than 24 as the brand product did. Their symptoms creep back in allowing them to tell time based on the reduced efficacy of these products. By law, generics are required to provide 80% of the “bioavailability” of the brand product but what does that mean and who is testing?

This all began when the Reagan Administration closed the FDA research lab. Prior to that, all new products were sent to that lab for approval prior to being released in America. On their watch, a pharmaceutical product never had to be recalled. Big Pharma complained they took too long as did some consumer groups. This resulted in the defunding and closing of the lab. Products are now outsourced to private reference labs and their reports are sent to the FDA for review. The frequent drug recalls contrast to the success of promoting safety when the FDA did it themselves.

Isn’t it time for the health care debate, especially the presidential debates, to discuss the safety, efficacy, supply and cost of pharmaceutical products? I am all for bringing production home to the USA, restoring the FDA funding for the reopening of their lab as an impartial test site and putting the cost of repeatedly testing the generics for efficacy even after approval and release on the backs of Big Pharma. Let’s see these topics introduced to the health care debate too.

Antibiotic Use – Independent of Physician Prescribing

A recent article in the Annals of Internal Medicine looked at individuals who took antibiotics without them being prescribed by physicians at a visit.  The authors looked at 31 published studies between January 2000 and March 2019.  The medications came from family and friends, online distribution sites, drugs prescribed for their animals by their veterinary doctors and those stored after a previous indicated use.   When asked about it, and the reasons why these patients took these medications, the main factors cited were lack of health insurance or lack of healthcare access, cost of physician visits or medications, long waiting times in clinics, embarrassment for needing antibiotics, lack of transportation and/or easy availability of antibiotics  from other sources.

We are currently going through an antibiotic resistance crisis in the world.  Most of the fault lays with agricultural industry feeding livestock tons of antibiotics to fatten them up. Patterns of resistance develop on the farms and are passed species to species.

To remedy this, the US agriculture industry, especially in chicken production, has cut back drastically on this process.  At the same time, we are requesting physicians to work with infectious disease doctors in stewardship programs to reduce their use of ineffective antibiotics and to prescribe with precision when these medications are needed.  It works. Studies are beginning to show the benefits of these programs.

Despite this, the pressure from patients to be given something when they pay for, and invest in, a medical evaluation for an infection is overwhelming. In the setting of telemedicine, as well as walk-in and urgent care centers, reviews and patient satisfaction survey results are tied to whether the patient was given an antibiotic whether it was indicated or not.

As bacteria become resistant to common and inexpensive antibiotics, pharmaceutical manufacturers are not being incentivized to produce newer more efficacious medications.  At the same time, older useful antibiotics which do not generate much of a profit are not even being ordered and stored by chain pharmacies that lose money each time the older generics are prescribed.

To begin solving this problem, an improvement of our health literacy is required. Education in schools and in public health announcements, both in print and social media, need to realistically address the issue. This education will not replace the need for access to health care and health, but it is a beginning to make individuals understand how, when and why these “miraculous” medications can and should be used.

Is that Z Pack for the Cough Safe? Do Antibiotics Trigger Arrhythmias?

“Hello Dr Reznick, this is JP, I have a runny nose, a cough productive of yellowish green phlegm, a scratchy throat and I ache all over. My northern doctor always gives me a Z Pack or levaquin or Cipro when I get this. I know my body well and I need an antibiotic. Saul and I are scheduled to go see the children and grandchildren next week and I want to knock this out of my system. Can you just call in a Z-Pack? I don’t have time to come in for a visit.”

This is a common phone call at my internal medicine practice. Despite the Center for Disease Control and the American Academy of Infectious Disease Physicians running an education al campaign on the correct use of antibiotics, patients still want what they want , when they want it. The Annals of Family Medicine , March/April issue contained a study by G. Rao, M.D., PhD of the University of South Carolina in Columbia which examined whether a Z Pack (azithromycin) or a fluroquinolone (levaquin) can cause arrhythmias and an increased risk of death. Their study was a result of a 2012 study in the New England Journal of Medicine that proved that macrolide antibiotics were associated with a higher cardiovascular death risk and rate than penicillin type antibiotics such as amoxicillin. To examine this issue closely, Rao and associates examined data from U.S. veterans who received outpatient treatment with amoxicillin (979,380 patients), azithromycin (Z Pack 594,792 patients) and levofloxacin (levaquin 201,798 patients). These were patients in the VA health system between 1999 and April 2012. Their average age was 56.5 years.

The patients were prescribed the antibiotics for upper respiratory illnesses (11 %), chronic obstructive pulmonary disease (14 %) and ear- nose and throat infections (29.3 %). The azithromycin was administered as a Z Pack and the risk of an arrhythmia or cardiovascular death was increased for the 5 days the patient took the medication. For every million doses of azithromycin administered there were 228 deaths at five days and 422 at 10 days. For levaquin there were 384 deaths at five days and 714 deaths at 10 days per million prescriptions administered. Ampicillin showed far lower numbers with 154 deaths at 5 days and 324 deaths at 10 days per million prescriptions.

The overall risk of arrhythmia and cardiovascular death was quite low with all the medications but clearly levaquin carried a higher risk than azithromycin or amoxicillin. The risk of arrhythmia with levaquin was about the same with azithromycin.

This study points out another danger of taking antibiotics inappropriately or indiscriminately. We usually point out the dangers of antibiotic resistance and antibiotic related colitis when explaining to a patient why we do not want to prescribe an antibiotic when none is warranted. We can now add arrhythmias and sudden cardiac death to the list. This doesn’t mean we shouldn’t take an antibiotic when appropriate. It does mean we may want to avoid certain antibiotics in patients who have cardiovascular risk factors.

It’s Only a Cold …

As a concierge medical practice we pride ourselves on being available to help our patients with access to the doctor by phone and same day appointments. At this time of year we are faced with daily phone calls regarding cold or flu like symptoms.  Thus, I thought it appropriate to share some topical information which should be useful in helping anyone decide whether they should “ride out the storm” or give their doctor a call.

There are at least 1,500 different known viruses that lead to a viral upper respiratory tract infection sometimes known as “the common cold”.   With these, a high sustained fever of 101 degrees Fahrenheit is rare.  Aches and pains, nasal discharge with runny nose and post nasal drip are common. Dry cough advancing to a barking cough productive of clear, yellow and often greenish phlegm is common as well.  You’ll most likely feel miserable. Your sinus and head congestion make you feel like you are in a tunnel, a sound chamber, or wearing a deep sea diving helmet. Your appetite waxes and wanes. You are exhausted with the activities of daily living.  Getting out of bed to wash your face and groom yourself may seem as challenging as a 26.5 mile race up a hill.

Currently, there is no cure for the common cold. Antibiotics do not work.  A “Z Pack “does not speed up the process. An injection of antibiotic does not make it go away faster. The infection could care less if you have a high school reunion to go to in Philadelphia, a grandchild’s bar mitzvah or baptism, or a flight to Paris for a combined work/pleasure excursion. Frankly, once you have this type of viral infection you will most likely have to ride out the storm.

Furthermore, going to the ER and sitting and waiting to be seen doesn’t make the infection go away quicker. Paying for a visit at a walk in center or urgent care center where you are more likely to negotiate successfully for an unwarranted or needed antibiotic will not help either.

In most instances, your recovery from the virus will take 7-14 days providing you drink plenty of warm fluids, rest when you are tired and use common sense. Cough medicine may ease the cough. Saline nasal solution may clear the nasal congestion. Judicious use of a nasal decongestant under your physician’s supervision may help as well.  It will take time. You are contagious. No you should not go to the gym if you are feeling poorly. Chicken soup, tincture of time, hot tea with honey, plenty of rest and common sense are recommended remedies.

If at any point you still feel you have the plague, dengue fever, the bird flu or the Ebola virus come on in. We will take a look, evaluate your symptoms and likely tell you, “It’s a cold.”

Should We Treat Sore Throats With Antibiotics?

How many of us have called our doctor with a scratchy throat, mildly swollen glands, congestion and overall malaise and requested an antibiotic?   “I know my body best and if I take an antibiotic I knock it out quickly.” is a common refrain.

In most cases, sore throats are due to viruses. Fewer than 10% of sore throats are caused by bacterial Group A streptococcus.  Antibiotics such as a Z-Pack (Zithromax), Penicillin or Ampicillin do not kill viruses.  If by chance a patient has a sore throat and an upper respiratory tract infection, the length of illness before recovery averages 4-7 days with or without antibiotics -whether strep is present or not.

How then did the throat culture and use of antibiotics begin and what is its rational? In the 1940’s and 1950’s when antibiotics were being introduced to the public it was determined that streptococcus pyogenes was the cause of Rheumatic Fever.  Researchers found that by administering antibiotics to patients with a strep throat they could reduce the rate of acute Rheumatic Fever from 2% to 1% (notice that even with appropriate antibiotic use we cannot prevent all the cases of Rheumatic Fever).

Applying this data in 2011 we find that there is about 1 case of Rheumatic Fever in the United States per 1 million cultured strep throats. In other words, we must prescribe one million prescriptions for antibiotics for sore throat to prevent one case of Rheumatic Fever. In turn, these antibiotics may cause 2,400 cases of allergic reactions, 50,000 cases of diarrhea and an estimated 100, 000 skin rashes.  It doesn’t make sense.

In a recent editorial article in MedPage, an online periodical supported by the University Of Pennsylvania School Of Medicine, George Lundberg M.D. presented a cogent case against throat culture use and antibiotics in sore throats and bronchitis. He suggested that “physicians should not prescribe antibiotics for sore throats….  They don’t help. They often hurt. First, do no harm!”

As an internist dealing with adult patients I am not seeing the groups most likely to catch a strep throat which is young children 2-7 years of age and their caregivers.  If patients present with fever, exudative tonsillitis and pharyngitis with large swollen cervical lymph nodes I will still culture them.  I will treat based on their immune status, general health and risk of having a significant bacterial infection. If I choose to prescribe an antibiotic I will make an adjustment based on the culture results.