How to Deal With Pharmaceutical Product Recalls

In the last six months there have been numerous products voluntarily recalled because in the manufacturing process a possible human carcinogen was inadvertently produced as part of a new modernization of their production product. The important things to remember is that the product MAY have been produced and that the element produced MAY be a human carcinogen.

Mass media has used this information to inaccurately heighten the fear of consumers and sell more newspapers, magazines and air time. The risk, if there is a risk at all, is quite small.

The recalls all involve generic blood pressure medications manufactured outside the United States of America. Many of the factories have not been inspected in years because the US public’s thirst for “small government” has led to a decimation of funding for the federal agencies assigned to train inspectors and send them out to monitor manufacturing plants.

If you believe your medication has been recalled I suggest these steps:

  1. DO NOT ABRUBPTLY STOP TAKING YOUR MEDICATION.
  2. CALL YOUR PHARMACY THAT SOLD YOU THE PRODUCT AND ASK THEM IF THE PARTICULAR PRODUCT YOU HAVE HAS BEEN RECALLED. Most of these products come from multiple manufacturers and they may have a supply of non-recalled medication.
  3. If your supply has been recalled ask the pharmacy to replace it with non-tainted product. If they have a replacement product then call your prescribing doctor to seek a similar or alternative product.
  4. DO NOT STOP THE MEDICATION UNTIL YOU SPEAK TO YOUR PRESCRIBING PHYSICIAN. The risk of contracting cancer from taking these pills is minimal. The risk of getting ill from inappropriate worry and or concern is higher than the risk of cancer from these products.
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Tdap Booster Vaccinations

Several years ago an epidemic of whooping cough (pertussis) was ongoing in affluent areas of California and Arizona. Epidemiologists from the Center for Disease Control (CDC) and National Institute of Health (NIH) descended on those areas to determine the cause of the life threatening illness to very young children.

Much to their surprise, grandparents were inadvertently transmitting it to their new and not completely vaccinated grandchildren. As youngsters, these grandparents took the suggested DPT series of shots believing they were resistant to diphtheria, pertussis and tetanus for life.

Like most things, as we get older, the immune system just doesn’t work as well. The immunity to pertussis waned and adults were catching the adult version of whooping cough in the form of an upper respiratory tract infection with bronchitis. The adult version resembled a run of the mill viral upper respiratory tract infection with a prolonged barking cough. This was just the type of infection which infectious disease experts were suggesting we do not treat with antibiotics and instead let our immune systems fight off independently. Unknown to us was the fact that even after we stopped coughing, if this was in fact adult whooping cough, we could transmit the pertussis bacteria for well over a year after we stopped coughing.

The solution to the problem was to give these adults a booster shot against pertussis when they received their tetanus shot booster. It is recommended that we get a tetanus booster every seven to ten years.

Tdap, produced by Sanofli Pasteur, was the solution and an international campaign of vaccination was begun. The campaign was successful but what do you do seven to ten years later when the next tetanus shot is due? In a study sponsored by the manufacturer, adults 18- 64, were given a second dosage 8-10 years after the first Tdap shot and tolerated it very well. Blood levels for immunogenicity taken 28 days later showed the benefit of the second shot.

The data has been submitted to the CDC and its vaccination Prevention Advisory Panel for consideration for a change in the recommendations on vaccinating adults.

Marijuana, Pain Relief and the Facts

On a daily basis patients of mine come in for office visits complaining of wear and tear injuries, as well as aches and pains, and their methods of dealing with chronic pain. As we all know, aging is a part of the normal life process.

For instance, as we approach 70 years old we typically lose three quarters of our functioning kidney cells (nephrons) but do well with our limited reserve as long as we do not constantly call on that reserve. When we take nonsteroidal anti-inflammatory drugs like ibuprofen and naproxen to relieve pain we are challenging that reserve leading seniors to look for alternatives. Opioids, even when appropriate, have become taboo so alternatives are being searched for.

Medical marijuana has become a very hot topic recently.  It is being heavily marketed as a pain relief alternative in several forms.  However, what little legitimate research has been conducted indicates it is not very good at relieving non cancer related chronic pain.

Not a day goes by when several patients reveal they are using cannabis products obtained out of state for pain relief with no consideration of how it interacts with the medications they are already taking. Recently, strong public relations campaigns for legalizing medical marijuana have led to its legalization in different forms, in various states, even if it doesn’t work. A select group of investors have positioned themselves to make vast sums of money from a product with little documented upside and potentially unknown downsides.

At the same time that medical marijuana enters mainstream medicine there is a similar legislative and marketing push to legalize marijuana for recreational use. Once again, a well-financed lobby of investors is trying to sell the concept of marijuana being less troublesome than legalized tobacco or alcohol. In the last few weeks there have been several articles appearing in reputable medical journals and periodicals such as the Wall Street Journal, New York Times and New Yorker magazine all examining the known results of liberalizing marijuana use in three states.

First of all, today’s marijuana is far stronger and potent than the “love generation’s” weed of the 1960’s with a higher percentage of the hallucinogen THC. To that point, states that have legalized marijuana have seen a tripling of visits to the emergency department for psychotic behavior. Also, violent crime and murders have tripled in many jurisdictions. A growing body of evidence indicates auto accidents have increased as a direct result of marijuana’s use.

Medically speaking, there is little research evaluating marijuana as a drug. Many questions remain.  What is the minimal dosage to create an effect? What is the dosage that can cause medical illness? How does the mechanism of delivery affect the final effects such as smoking versus vaping versus eating the product? Beyond the stoners’ credo of “start low and go slow” there is little data to evaluate the product as a pharmaceutical drug and or how it can interact with other drugs prescribed for you.

I am far from an anti-marijuana critic. I’d just like to know what I’d be getting in to before I consider hallucinating. It seems to me that before we liberalize marijuana use, the product needs to be put through the type of research and scrutiny the old Food and Drug Administration (FDA) put a product through before it was approved for public use.

Chocolate as a Cough Suppressant

Well before Valentine’s Day, and conspicuously in the middle of cold and flu season, Alyn Morice of the University of Hull in Yorkshire, England published a study showing that dark chocolate derivatives may be more effective than codeine in suppressing a cough. In a small study of 163 individuals, each with a cough due to an infection, her group randomly assigned them to a group receiving a codeine based cough syrup or a chocolate cocoa based syrup called Rococo. Their results showed that within two days the chocolate based recipients felt significant improvement in their cough compared to the codeine based group. A similar study had previously been performed at the imperial College in London showing that theobromine, a product in cocoa, is superior to suppressing coughs over codeine.

Professor Morice believes the properties in cocoa are demulcent and help relieve irritation and inflammation. “This simply means it is stickier and more viscous than standard cough medicines, so it forms a coating which protects nerve endings in the throat which trigger the urge to cough. This demulcent effect explains why honey and lemon and other sugary syrups help.” They believe chocolate has additional helpful ingredients so much so that they advise sucking on a piece of dark chocolate as a mechanism of relieving a cough. We now have some science to back mom’s hot chocolate and hot cocoa for a cold and a cough.

Winter is the Season for Upper Respiratory Tract Infections and Influenza

It’s the season for winter viral upper respiratory tract system infections. It is also influenza and influenza- like illness season.

Winter brings crowds of people indoors together and holiday travel places crowds together in indoor areas as well. These viral illnesses are transmissible by hand to mouth transmission and airborne particle transmission with coughing. The viral particles can live with minimal water on surfaces for long enough periods of time to infect patients who unknowingly touch a foreign surface and bring their hands up to their mouths. Hand washing frequently is an essential part of preventing the transmission of these diseases. Common courtesy such as covering your mouth when you sneeze or cough and not coming in close contact with others when ill is essential.

Research has shown that consuming an extra 500 mg a day of Vitamin C can prevent colds and reduce the intensity of a cold if you catch one. You must take the Vitamin C all the time and in advance of exposure. Waiting until you have symptoms has no positive effect. Viral upper respiratory tract infections usually include fatigue, runny nose (coryza), sore throat (less than 90 % of adult sore throats are not a strep throat).

If you have been around a sick child age 2-7 who has a fever, swollen neck glands and an exudative sore throat your chances of having a strep throat are increased. Fever is usually low grade, less than 101, and short lived. Very often patients develop viral inflammation of the conjunctiva or conjunctivitis. While this is very contagious to others, it is self-limited and rarely requires intervention or treatment.

Caring for a cold involves listening to your body and practicing common sense solutions. Rest if tired. Don’t go to the gym and workout if you feel ill. If you insist on going, warm up slowly and thoroughly and, if you do not feel well, stop the workout.

Sore throat can be treated with lozenges. Warm fluids including tea and honey (honey is antimicrobial and anti-viral), chicken soup, saline nasal spray for congestion and acetaminophen for aches and pains or fever are mainstays of treatment. Over the counter cough medications like guaifenisin help.

Some of the viruses affect your gastrointestinal tract causing cramps and diarrhea. Nausea and vomiting are sometimes present as well. The key is to put your bowel to rest, stay hydrated and avoid contaminating or infecting others. Clear liquids, ice chips, shaved ices, Italian ices or juice pops will keep you hydrated. A whiff of an alcohol swab will relieve the nausea as well. If you are having trouble keeping food or fluids down call your doctor. If you are taking prescription medications, call your doctor and see which ones, if any, you can take a drug holiday from until you are better.

Influenza is more severe. It is almost always accompanied by fever and aches and pains. Prevention involves taking a seasonal flu shot. Flu shots are effective in keeping individuals out of the hospital from complications of influenza. They are not perfect but far better than no prevention. If you run a fever of 100.8 or higher, and ache all over, call your physician. An influenza nasal swab can confirm influenza A and B 70 % of the time.

The new molecular test which can provide results in under an hour is far more accurate but not available at most urgent care or walk in centers or physician offices. Immediate treatment with Osetamivir (Tamiflu) and the newer Peramivir are effective at reducing the duration and intensity of the infection if started early. Hydration with clear fluids, rest, acetaminophen or anti-inflammatories for fever in adults 101 or greater and rest is the mainstay of treatment. Prolonged fever or respiratory distress requires immediate medical attention. Call your doctor immediately.

I get asked frequently for a way to speed up the healing. “My children are coming down to visit. We have a cruise planned. I am flying in 48 hours on business.”  I am certainly sympathetic but these illnesses need to run their course. They are not interested in our personal or professional schedule and everyone you come in contact with is a potential new victim. If you are congested in the nose or throat, and or sinuses, then travelling by plane is putting you at risk of severe pain and damage to your ear drum. See your doctor first. Patients and pilots with nasal congestion are advised not to fly for seven to ten days for just this reason.

If you have multiple chronic illnesses including heart disease, lung disease, kidney disease and you run a fever or feel miserable then call your doctor and make arrangements to be seen. It will not necessarily speed up the healing but it will identify who actually requires antibiotics and additional follow up and tests and who can let nature take its course.

Artificial Sweeteners and Your Health

An article published in the online version of Primary Care brings up the issue of whether artificial sweeteners are a positive, helping people lose weight, or is there more to the story. Editor David Rakel MD, FAAFP discusses a recent article in the neurologic journal STROKE showing an association between the number of artificially sweetened beverages consumed per day and the onset of a stroke. This relationship was seen only with artificially sweetened beverages not with sugar sweetened beverages.

Dr Rakel goes on to discuss the ongoing public health concern of consuming nonnutritive sweeteners and its effects on weight gain and insulin resistance. Recent studies known as observational studies have linked high consumption of beverages with nonnutritive sweeteners with weight gain, increased visceral adiposity and a 22 % higher incidence of diabetes despite consuming less energy.

The reasons for consuming fewer calories but gaining weight are considered to be many. Sweet tasting compounds including NNS activate sweet “taste receptors” that were once thought to be only located in the mouth but are now known to be throughout the body. This activation results in release of insulin. The continued release of insulin by the pancreas, without energy producing calories present to be metabolized, may lead to insulin resistance. Insulin resistance involves insulin being released in response to food being consumed but is becoming ineffective in moving sugar into the cell where it can be metabolized into energy.

There is additional belief that supplying sweetness without calories may result in disturbances to appetite regulation and communication within the body about when we are full. Products such as aspartame, saccharin and sucralose have been found to have negative effect on the intestinal bacteria or microbiome potentially having an effect on glucose tolerance and metabolism.

We see artificial sweeteners on tables in every setting. Aspartame produces a sweetening effect 200x sugar. Saccharin produces a sweetening effect 500x sugar. Sucralose is 600x sugar sweetening and Advantame 20,000x sweeter.

A teaspoon of sugar only contains 16 calories. Portion control of products made with real sugar may be the safest and healthiest way to eat sweets as the holiday season approaches. A level teaspoon of sugar in your coffee or tea may be far healthier for you than that packet of artificial sweetener.

Continuity of Care with a Primary Care Doctor Lowers Costs and Hospitalizations

The Annals of Family Medicine published an article that compared the health costs and hospitalization rates of patients who had a primary care doctor, and saw that physician regularly, as compared to individuals who did not. The study used Medicare data from 1,448,952 patients obtaining care from 6,551 primary care physicians.

Upon analyzing the data, the researchers discovered that those individuals who saw a primary care physician regularly and had a primary care physician who “assumed ongoing responsibility for the patient, with continuity framing the personal nature of medical care” the patient’s cost of care per year was 14.1% lower and hospitalization rate 16.1% lower than individuals who did not have primary care continuity.

In an editorial piece accompanying the study, David Rakel, MD FAAFP, noted that in 2016 America spent $3.3 trillion on healthcare. If you extrapolate out the benefits of a continuous therapeutic relationship with a primary care medical doctor the result would be a cost savings of $462 billion.

The message is clear. Find yourself a primary care physician and establish a professional relationship. If you find the care is attentive and compassionate stick with that physician. It will save you money and may save your life.