Tuesday, November 5, 2019

Vaping - what we know and what we don't

Some 70 years after Doll and Hill published their landmark paper in the British Medical Journal linking smoking to lung cancer, we know a lot more about both the dangers of cigarettes and the predatory practices of the tobacco industry. A major public health campaign that included both education and regulation has led to decreased smoking and a corresponding drop in coronary disease. We still need on-going efforts, as the effects can be overcome by tobacco advertising. Banning flavored cigarettes or restricting their sale was shown to work in a study comparing youth smoking in Lowell, which had such a restriction beginning in 2016 and Malden, which did not. The consequences of smoking are still a huge problem in China and in many developing countries where tobacco ads dwarf public health measures, so we must stay vigilant.

The new epidemic which requires action is the use of e-cigarettes, or “vaping.” Vaping is the act of inhaling the aerosol produced by a battery-powered device. E-cigarettes contain pre-filled pods of liquids that the user adds to the device, and now are most commonly small devices that resemble a USB stick, and so are easy to carry and use. The liquids generally consist of glycerin, water, propylene glycol, nicotine and flavorings. Juul, by far the leading seller of e-cigarettes, has claimed that they are selling their product as a smoking cessation aid, and prominently feature adult smokers extolling the value of the product for this purpose. However, they clearly market to youth on social media, and by far the biggest selling products are those that are flavored. Flavor was the reason that about a third of users first tried e-cigs and most (63%) current users used flavors other than tobacco. Fruit flavors were most likely to motivate young adults to try vaping. In 2018, two thirds of U.S. middle and high school students had tried e-cigarettes or been exposed to second-hand aerosol in the previous 30 days. E-cigarette use is also a strong gateway to use of tobacco cigarettes among youth, with over 4-fold greater smoking among e-cig users.

Are e-cigarettes safer than combustibles? Clearly smoking causes cancer. Mint- and menthol-flavored e-cigarettes have very high levels of pulegone, a known carcinogen. E-cigarette smoke has also been shown to induce cancerous changes in the lung and bladder of mice. Smoking is a major contributor to coronary disease. What about e-cigarettes? They are associated with an increased risk of myocardial infarction that is similar to that of smoking conventional cigarettes, and dual use is riskier than using either product alone. Many women use e-cigarettes while they are pregnant, perhaps believing that they are safer than combustibles, but e-cig use has been shown to delay implantation and cause reduced weight gain of the fetus. While some short-term studies have shown minor improvements in measures of lung function among COPD patients who switched from combustible to e-cigarettes, vaping has been clearly shown to cause airway inflammation and lung disease. Finally, our dental colleagues have reported that e-cigarette aerosols increase the risk of cavities similarly to gelatinous candies.

Last, but far from least, is the mysterious and frightening epidemic of vaping-related lung disease. This was first reported from the upper Midwest in the spring of this year but has rapidly spread. Vaping-related lung disease has now been reported in 49 states (all but Alaska), DC and the US Virgin Islands. The number of cases is a moving target, but as of Oct 29, 2019, there were 1888 confirmed and probable cases and 37 deaths. The illness consists of early symptoms of nausea, vomiting and abdominal pain, followed by progressive shortness of breath, often leading to respiratory failure and the need for being placed on a ventilator. The chest X-ray shows diffuse infiltrates. The exact cause is still controversial. Among patients with full data, 86% reported use of THC-containing products, 64% nicotine-containing products and 52% both. No single compound has been shown to be the cause. The majority of those affected have been teens and young adults, though the death rate has been higher in middle-aged and older victims. Because the cause remains unknown, the CDC recommends against the use of any vaping products.

The bottom line: vaping is NOT safe, and best avoided.

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Monday, October 28, 2019

What is "pre-illness" and what can you do about it?

OK, so you have been told you have “pre-diabetes” or “pre-hypertension.” What does that really mean? What should you do about it?
“Pre-disease” is a relatively new concept, unheard of when I started practice, but being applied more and more. It simply means that you have some measurement that is abnormal but does not meet the established criteria for a diagnosis. A friend of mine once observed that “there are no healthy people, simply those who have not had enough tests,” and this concept of our fragility seems to be applied more and more. Commonly used labels I have come across, in addition to pre-diabetes and pre-hypertension (now more commonly described as “Stage 1 hypertension”), include dyslipidemia, osteopenia and pre-cancer. The rationale for applying these labels is that catching a disease early, in its “pre-“ stage, and treating it, will somehow help avoid serious problems down the road. The evidence that this is true is very limited.
The CDC recently claimed that 84 million Americans had pre-diabetes – an enormous number, and an enormous potential group of customers for the pharmaceutical industry. An article in the journal Diabetes Care in 2016, however, found that only about 2% of pre-diabetics went on annually to have overt diabetes. At least a third in whom no intervention was carried out reverted to completely normal blood sugars, and the rest remained with mildly elevated sugar values. A more recent study in the same journal looked at 3313 black adults and defined pre-diabetes as a fasting sugar between 100 and 125 (below 100 being normal). They found no increased risk of cardiovascular disease in those with mildly elevated sugars.
Hypertension was previously defined as a BP persistently over 140/90, but values of 130-139/80-89 are now called “Stage 1 hypertension,” and it is estimated that one third of American adults have this “condition.” There are many problems with this labelling. One is that there is increasing evidence that office or clinic BP measurements are not truly representative of our usual BP and are frequently not even measured accurately. Another is that there is to date no evidence that treating this with medication does more good than harm.
Another common “pre-condition” is osteopenia, a bone density below normal but not severe enough to be osteoporosis. Some estimates claim osteopenia affects about 43 million U.S. adults, mostly women. How important is this? A study of 5000 older women with osteopenia found that after 10 years, only 5% had gone on to develop osteoporosis. If you want to estimate your risk of fracture, and you know your actual bone density numbers, you can go to https://www.sheffield.ac.uk/FRAX/ and run the numbers. (If you are a U.S. Caucasian, go to https://www.sheffield.ac.uk/FRAX/tool.aspx?country=9)
What should you do if you have been told you have one of these “pre-diseases.” What I would NOT do is begin medication. You may want to take this as a kick in the rear to motivate you to make some healthy lifestyle changes. Losing a few pounds or beginning a regular exercise program will usually reduce your sugar. Exercise, a more vegetarian diet and cutting down on alcohol will drop your blood pressure. Weight-bearing exercise and a diet rich in Vitamin D and calcium (but not supplements) and stopping smoking will strengthen your bones. Note the common thread in all of these?
Equivocal cancers are a whole other subject, which I will get to in another post.
Happy exercising!

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Thursday, October 17, 2019

Should you get a flu shot?

Let’s get one thing out there up front: flu shots are not guaranteed to prevent you getting influenza. Neither are seat belts a guarantee you won’t die in a car crash or bicycle helmets that you will survive getting thrown off your bike, but we still strongly recommend that you wear your seat belt when in a car and a helmet when on your bike. Why? Because they both greatly increase your odds of surviving an accident. It is the same with a flu shot: getting the shot cuts your odds of being hospitalized or dying of influenza by about a half.
A few facts: during the 2018-19 flu season, about 50,000 Americans and 3500 Canadians died of influenza. When the CDC looked patients hospitalized with influenza, those who had received the vaccine had a 36% lower risk of dying and 34% less risk of needing to be on a ventilator than those who had not.
Even if you do catch influenza despite getting the shot, you are going to be less sick and have a much lower risk of passing the disease on to others, which is one reason health care facilities make such a push to get all of their staff immunized.
Let’s clear up some common myths. First, influenza is not just a bad cold. If someone says they missed a couple of days of work because of the flu, they did not have influenza. With influenza you are sick for a good week or more with high fever, terrible cough and ache all over.
Second, you cannot catch anything from the shot. I used to hear “I had a flu shot once and got sick, so now I don’t get one.” The influenza vaccine is a “killed vaccine.” There is no live virus in the shot, just ground up particles from killed viruses. What may happen is that after getting a flu shot you get the same cold you were going to get anyway, and blame it on the shot. While you may get minor soreness at the site of the injection, serious side effects are very rare.
“I’m not around people that much, so I don’t need it.” True if you are a hermit, but not if you are a normal person, even an at-home worker. It is clearly true that school teachers, bus drivers and others who are around lots of people are at higher risk, but in an epidemic year we are all at risk.
Finally, “they never get it right.” We are all aware that some years the vaccine seems more protective than others, because the public health authorities who tell the manufacturers what strains of influenza to include in each year’s vaccine are making “educated guesses,” based on which strains were common in the southern hemisphere during their season. Some years they get it spot on and others they do not, but even a less-than-perfect vaccine is better than none.
So… role up your sleeve and do it before the flu season is in full swing.

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Monday, October 7, 2019

Getting the most from a doctor visit

For most of us, going to the doctor is not at the top of our favorite things to do list, but it may be one of the most important. Whether the visit is for a scheduled check-up or to deal with a new problem, there are ways you can make the visit less stressful and more useful.
You must remember that things have changed. In the “good old days,” when I started in practice, the visit involved just the patient and the doctor. Nowadays, there are many other players, who may not be physically present but are influencing the visit, including insurers, lawyers and the ubiquitous electronic medical record (EMR). I recently saw an article headlined “Don’t let patient care interfere with documentation,” not-so-subtly making the point that doctors are overwhelmed with demands for data to satisfy the demands of multiple third parties; it has been estimated that for every hour directly interacting with patients, doctors spend two hours on administrative tasks. Despite this, most doctors really do want to do what is best for their patients, and you can help them achieve this.
Arrive on time for your visit, but be prepared to wait. Doctors run late for many reasons. It may be the fault of the office, scheduling patients to maximize the doctor’s time at the expense of patient convenience, and if you ALWAYS wait a long time, you may want to change doctors. More common reasons are that earlier patients arrived late but were seen anyway or that patients had more complicated problems than anticipated, turning a 15-minute visit into 30 minutes or more.
Silence or turn off your cell phone! It is hard enough to have a good conversation about an illness without the distraction of a phone going off. If you actually answer the phone, my reaction would be that since you are clearly not very worried about your health problem, I will not be either.
Do your homework and arrive prepared. While the doctor may be the expert on medicine, you are the expert on your own body, and you are the one to note that while a symptom may not be dramatic, it is new. Before the visit, put things down in chronologic order – what happened first, what happened next, and over roughly what time frame. It is OK to check your symptoms “on-line,” but please use a legitimate web site such as NLM.gov, CDC.gov, webmd.com or mayoclinic.org and do not “google” your symptoms. Whatever you do, do not say “I read on Facebook…” or your doctor will mentally tune out everything else you say.
Bring notes and take notes. It is easy to get side-tracked and forget things you thought were important. Have a summary of prior surgery, current medications, medication allergies and major medical problems printed and on your phone. Since it has been shown that 80%+ of what a doctor says is forgotten by the time you leave the building, either bring a friend or family member to act as a scribe and second pair of ears or make some written notes. Ask the doctor if it is OK to record the visit so you can listen to the conversation and advice given when you are less stressed.
It is OK to question the doctor. While doctors know a lot more about medicine than you do, we are not infallible. If the doctor dismisses a complaint when you “know” something is wrong, it is reasonable to ask for a second opinion. Misdiagnosis is increasingly recognized as a serious problem. You should be prepared to ask the doctor why they have made a diagnosis and what else it could be. You should also have a timetable for when you should feel better and what the plan is if you do not respond to the suggested treatment.
Remember: it is not your job to please the doctor; it is the doctor’s job to help you feel better. If you have a doctor with whom you cannot communicate, look for another.

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Thursday, October 3, 2019

Where's the beef?

A study published by the Annals of Internal Medicine on October 1 titled “Unprocessed Red Meat and Processed Meat Consumption: Dietary Guideline Recommendations from the NutriRECS Consortium” has unleashed a firestorm of controversy. This publication and the reaction to it reveal so much about medical studies and recommendations that I was tempted to write a book about it, but will try to be briefer.

The conclusion of the paper was that adults continue their current consumption of both red meat and processed meat, noting that the recommendation was a weak one based on low-quality evidence. The reaction from such groups as the Harvard School of Public Health, the American Cancer Society and the American College of Cardiology was vehement opposition to this statement, implying that the authors were irresponsible and would contribute to more heart attacks and cancer.

Why the controversy? First, we must note that the ideal way medical recommendations are reached is through randomized controlled clinical trials: a group of people are given treatment A or Treatment B, selected randomly, and neither the subjects nor the researchers know which they get. The groups are followed for an appropriate time and at the end, the researchers look for a difference in the outcome between those given A and those given B. If there is a substantial difference between the groups, and if the people given A and those given B are shown to be pretty much the same except for the treatment, it is assumed that the difference in outcome was due to the treatment. I must note that small differences in outcome may be “statistically significant” if the groups are large enough even though the magnitude of the effect may be so small that it is not “clinically significant.”

While randomized trials work well when comparing two medicines, they are impossible to do when studying diet. Most of us can tell the difference between a steak and a roasted cauliflower. Dietary studies are thus mostly done by looking at what people do, generally based on self-reporting, and comparing the outcomes between those who claim to eat one way or another. These observational studies are fraught with difficulty. We learned long ago that when you compare people who do one thing differently, it is highly likely they do other things differently. Studies comparing vegetarians with omnivores cannot assume that their diets are the only thing different between them. Vegetarians may smoke less, may drink less (or more), may exercise more, may be leaner – all factors that impact health.

The NutriRECS group took this into account when they looked at all the published studies on diet and health. They concluded that the evidence base for recommending people cut down on their consumption of red and processed meat was weak. They also noted that the absolute benefit, in terms of number of heart attacks or cancers prevented, was relatively small. One example was an estimated 7 fewer cancers per 1000 people over their lifetime, a risk that omnivores might be willing to take when weighed against quality of life.

So, who is right? Both sides! If you are a vegetarian, you can be satisfied that you are slightly reducing your risk of cancer and heart attack (though slightly increasing your risk of stroke per another recent study in the British Medical Journal!) If you like to eat meat, you can be content that the absolute risk of your preference is relatively small and you do not need to make yourself miserable – and you can always balance your love of steak by walking more and dropping a few pounds.

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Thursday, September 26, 2019

The computer will see you now

I recently saw a cartoonist’s view of where the clinical encounter is going. A new doctor was being shown an exam room with a doctor and a nurse standing by a computer and was told “The computer will diagnose the patient and prescribe treatment.” But, the new doctor asked, what does the doctor do? “Oh, the doctor reads what the computer said to the patient.” And the nurse? “The nurse slaps the doctor’s hand if they deviate from what the computer says.” With all the recent hype about Artificial Intelligence (AI) and Big Data, is this truly the future of medicine?

In the traditional medical encounter the patient describes their story and the doctor asks questions to expand and clarify the symptoms, followed by a physical exam: the classic H&P (History and Physical) that have been little changed for millennia. A paper in the British Medical Journal back in the 70’s found that about 75% of diagnoses were made on the basis of the history, with the physical exam taking this up over 80%. Less than 20% of diagnoses needed lab tests or X-rays, though these helped confirm the H&P.

The future, we are often told, involves computers crunching the numbers on millions of patients and finding previously unknown connections and making better diagnoses and better prognostication that doctors have been able to do. Most of the big tech companies, Apple, Google, Amazon, IBM, as well as numerous start-ups, are betting billions of dollars on the future role of AI in medicine. Successes to date have been limited but well-touted. The areas which seem most promising involve very specific well-defined tasks where there is good data for the computers to crunch and where the answer is clear-cut. Examples include evaluation of skin lesions to pick out melanomas, diagnosis of retinal lesions from retinal photographs and specific questions in radiology. When such AI systems look at less well-defined problems, the successes to date are not evident.

When looking at people with ill-defined complaints, the medical record contains a lot of “noise:” data that may be relevant or utterly irrelevant to their problem. To date, physicians seem much better at separating the wheat from the chaff than do algorithms. There is another factor at play: association is not the same as cause and effect. The classic example is the old finding that when an American League team won the world series, the stock market went up. While this is interesting, I would not want to bet my retirement on this investment advice. Similarly, if computers look at large data samples, there will invariably be associations found purely by chance if enough data is crunched. Humans are needed to ask if this is plausible, if there is some possible biologic basis for the association. Another monkey wrench has been thrown into the mix: a study compared what emergency medicine residents documented in the electronic record and what they were observed to do by researchers who shadowed them. A claim of AI evangelists is that now that so much data is available via the EMR that was previously locked away in doctors’ scribbled handwritten notes, new insights are ready for the analysis. The study found that when the observers’ records were compared to the data in the EMR, there was a match for only 38% of medical history items and 53% for the physical exam. It is so easy with EMRs to click and document something you never did that notes are invariably bloated – after all, a longer note justifies a higher bill. Crunching invalid data is unlikely to result in valid conclusions!

There is also the fact that physicians are to a degree confidants and counselors as well as technicians. Your genome may suggest what diseases you are prone to get, but a human who knows you can put that in context and suggest what things you as a unique individual should do.

With all our high-tech tools, the old-fashioned H&P was recently shown to still have value. A study in Circulation found that despite the availability of echocardiograms and bio-markers, physical exam findings in patients with congestive heart failure offered significant independent prognostic information.

Bottom line? A physician using current and developing AI tools will often do a better job, but AI is not yet ready to replace the human.

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Friday, September 13, 2019

New but necessarily improved

One of the major arguments that Big Pharma and its apologists make against any attempt to lower the sky-high prices Americans pay for medication is that doing so would stifle innovation. While it is true that many new drugs introduced in recent years have helped extend life, it is also true that many have been of marginal benefit at best. One example is the recent flurry of “check-point inhibitors” that have been tested against a variety of cancers. There are now six checkpoint inhibitors on the market and more on the way. The Cancer Research Institute estimated recently that some 2,250 clinical trials are underway testing this class of drugs. Unfortunately, many of these trials duplicate each other, and three recent studies looked at the use of these drugs against multiple myeloma. All three showed no benefit. Did we really need to put so many patients through these trials? Could not the investigators have waited for preliminary results from one before starting another trial?
Many cancer drugs are approved by the FDA based on “statistically significant” improvement in life span even if the extension is measured in weeks and comes at the price of nasty side effects. Still others are approved based on so-called “surrogate end-points:” tumor shrinkage or lab test improvement, even if they have not shown any improvement in lifespan. We really need pharmaceutical companies to be looking for drugs that give meaningful extension of life without horrid side effects rather than developing yet another “me-too” drug that will probably be able to obtain FDA approval and then be marketed at high price.
Another way drugs can get FDA approval without offering much benefit is by showing “non-inferiority” compared to a treatment already approved. Do patients really want to be offered a drug that “is probably not much worse” than another? A recent study published in JAMA Network Open at the end of August 2019 looked at 74 such trials of cancer drugs. While 61% could justify their use by offering convenience (such as oral rather than IV use) along with similar survival, 39% offered no obvious reason to choose the new drug over an old one - but did come at higher cost. The majority of trials showing non-inferiority without any justification for caring if the new drug was probably as good were industry-sponsored.
To regain our trust, the pharmaceutical companies need to show they are concentrating on developing truly innovative drugs that make a difference in patients’ lives and not just pushing out high-priced drugs that do little to improve quality or quantity of life but do add to our already staggering financial burden.

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