It’s been 50 years since the 1964 Surgeon General’s report that stated that smoking was harmful to our health. The Smoking and Health Report (what it was formally called) was based on a review of an estimated 7000 documents. It concluded that “cigarette smoking is causally related to lung cancer in men; the magnitude of the effect of cigarette smoking outweighs all the factors; and the risk of developing lung cancer increases with the duration of smoking and number of cigarettes smoked per day, and diminishes by discontinuing smoking.” Just so we women don’t feel left out, subsequent studies and reports stated that it was just as harmful and perhaps even more addictive for women, but I digress…

The January 8 issue of JAMA was dedicated to the last 50 years of tobacco control. In an editorial, some fascinating statistics were presented that I would like to share:

Half a century after the release of the 1964 report, tobacco dependency continues to devastate US society. Nearly 42 million smokers still struggle with this addiction. Unfortunately, even though 70% want to quit only 3 to 5% annually can do so on their own. New estimates of annual tobacco related deaths now approaches half a million in the United States and more than 5 million worldwide. Children and adolescents are especially affected by tobacco dependency through secondary smoke an onset of smoking. Other vulnerable populations include the poor, those with mental illness or substance-abuse disorders, lesbian, gay, bisexual and transgender population as well as the homeless and those who are incarcerated. The tobacco industry spends more than $8 billion a year in the United States to advertise and market cigarettes and smokeless tobacco, while also promoting cigars, pipe-tobacco and newer products which include dissolvable tablets and electronic cigarettes.

But before you grasp your head and begin to shake it and moan oy! there are some encouraging statistics. Although there have been 17.6 million smoking attributable deaths in the last 50 years, it’s estimated that 8 million premature deaths have been prevented because of tobacco control measures. It’s estimated that one-third of the gains in life expectancy for men (30%) and 29% of the gains for women during these past 50 years were due to declines in smoking. Moreover six nations, including the United States, have had reductions in smoking prevalence of greater than 50% during the past 25 years.

Another article in JAMA points out the factors that have helped smoking cessation in the U.S. Firstly, documentation of the danger of environmental tobacco smoke which has led to a flurry of clean indoor air legislation. Currently, 26 states and the District of Columbia ban smoking in enclosed public spaces. Secondly, the 1988 Surgeon General’s report documenting tobacco use as an addiction changed public perception of tobacco use from habit to “of free choice” to true drug dependency similar to that of heroin and cocaine.Thirdly, cigarette tax increases, clean indoor air laws and efforts to prevent adolescents from purchasing tobacco or starting to smoke have proved effective. Fourthly, there has been some very public litigation by private individuals, the States and the US Department of Justice against the tobacco industry. Indeed, there was a settlement in 1998 mandating that the tobacco industry pay the States $246 billion over 25 years. (The tobacco companies are bad… to add to their list if immoral and death producing offenses, in 2006 they were found guilty of racketeering.) But let’s get back to “the making a difference” factors… There are current evidence-based smoking cessation treatments – both counseling and FDA approved medications – that can markedly increase cessation rates among smokers trying to quit. And these will now be paid for by the Affordable Care Act

We all know that Bacchus was a man. Based on gender stereotypes, most of us assume that women are less likely to excessively imbibe alcohol then men. (For the sake of transparency, the Superbowl was playing while I wrote this and all that celebrated testosterone caused me to make that last statement). But not necessarily so… According to a recent CDC report in “Vital Signs,” more than 14 million US women binge drink about three times a month and consume an average of six drinks per binge. This number includes one in eight women and one in five high school girls! The report states that binge drinking is most common in young women, women who are white or Hispanic, and among women with household incomes of $75,000 or more. Oh…and half of all high school girls who drink alcohol report binge drinking.

A woman’s ability to metabolize alcohol differs significantly from that of a man. When we drink alcohol it is absorbed more quickly, deactivated by enzymes less efficiently, and gets to the brain faster. (Well, we always knew that our brains have rapid and superior circulation. ) We generally weigh less than men so we are also less likely to dilute the stuff. As a result, one drink for a women has the impact of two for a man.

The definition of binge drinking for a woman is consumption of four or more alcohol drinks on an occasion. And an occasion is considered to be 2 to 3 hours. Although binge drinking in high school or college can lead to a higher incidence of alcoholism in later life, most binge drinkers are non-alcoholics and not alcohol dependent. The CDC reports that drinking too much (which of course includes binge drinking) results in about 23,000 deaths in women and girls each year and increases the chances of breast cancer, heart disease, sexually-transmitted diseases, unintended pregnancy as well as other health problems. If a woman binge drinks while pregnant, she risks exposing her baby to high levels of alcohol during its development which can lead to miscarriage, low birth weight, sudden infant death syndrome (SIDS), attention deficit/hyperactivity disorder (ADHD), and fetal alcohol syndrome (facial disfigurement and mental deficiencies). This is where I’m supposed to say it’s not safe to drink alcohol any time during pregnancy.

Aside from giving warnings, the CDC and its Guide to Community Preventive Services recommend certain strategies for preventing excessive alcohol consumption.. These include:  

*Increasing alcohol taxes.

*Reducing the number and concentration of stores that sell alcohol in a given area.

*Continuing government controls over alcohol sales.

*Maintaining or reducing the days and hours of alcohol sales.

*Enhanced enforcement of laws prohibiting sales to minors.

*Electronic screening and counseling for excessive alcohol use.

I know some of this sounds excessive and may go against our sense of what the government should and should not do. (There are no blue laws in California, and according to that wonderful series Boardwalk Empire, prohibition doesn’t work!) To help avoid teenage binging, the best plan might be to make sure that our teens can’t get into our liquor closet and of course, maintain zero tolerance for alcohol use before, during and after school parties. And then we should listen to the anti-binge advice ourselves. Remember abstaining from that second and certainly the third drink may lessen our risk for breast cancer, heart disease, stupid behavior, and worse yet, the wrong sexual and reproductive decisions. We just don’t need that extra glass of wine, cocktail or beer to enjoy the game, the dinner or the party. The salute ” Le Chaim” (translated, for those of you who need it) to “To Life” need not be accompanied by 4 drinks…one is healthier and should suffice.

A quick personal note: I am traveling to Mozambique next week with several women to see the school we built through the LA Associates of Save the Children. I will be happy to share pictures and stories upon my return.

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The CDC, most medical journals, and mainstream media have been covering the disastrous infections caused by the contamination of the steroid that was distributed by a compounding pharmacy in New England. Three potentially contaminated lots of this steroid were used by physicians in epidurals, and joint injections in over 14,000 persons. They have, so far, caused stroke, meningitis, bone infections and in some instances death, in over 137 patients.

The initial detection of this serious contamination reads like a detective story. On September 18, 2012 the Tennessee Department of Health was alerted by an observant physician that a patient had a confirmed fungal infection (to be exact, Aspergillus fumigatus) diagnosed 46 days after epidural steroid injection. By September 27, an investigation carried out by the Tennessee Department, in collaboration with the CDC and the North Carolina Department of Health, had identified 8 more cases. All nine patients had received epidural steroid injections with preservative free methyl prednisone acetate solution (MPA) compounded at the New England Compounding in Framingham, Massachusetts. And as of October 10 (when last reported in JAMA) a multistage investigation by the CDC together with local health departments and the FDA have identified 137 cases and 12 deaths associated with this outbreak in 10 states. The invoices from the pharmacy showed that approximately 17,500 vials of MPA were distributed to 75 facilities in 23 states!  By October 6, the vials not already used were recalled. And as of October 10, health departments reported that 90% of patients exposed to the medication from one of the suspected infected lots of MPA had been contacted at least once.

The patients and their doctors have been advised that they should get tested if they develop neurological symptoms such as headache, neck rigidity, fever, nausea, unsteady gait or sensitivity to light…and if so a lumbar puncture should be done to check for the fungal infection. Those patients that had joint injections should notify their physician if they develop increasing pain, redness or swelling, in which case fluid should be aspirated from the affected joint for culture. This all sounds ominous and in fact it is! Right now it’s postulated that the incubation periods for infection range from 4 to 42 days, but the maximum incubation for this infection is not known. Treatment with high dose anti-fungal therapy for months may be necessary.

If anyone doubts the importance of the epidemiological sleuthing carried out by our health departments and the CDC…this should dissuade them. And additionally, there is the issue as to whether products from compounding pharmacies are indeed safe. In an article published on December 6 in The New England Journal of Medicine, the authors summarized the evidence for compounding safety…. First, they explain what these pharmacies do: “Pharmaceutical compounding refers to the combining, mixing, or altering of ingredients of a drug by a licensed pharmacist to produce a drug that is tailored to an individual patient’s medical needs on the basis of a valid prescription from a licensed medical practitioner.” They go on to state that ” there are few reliable data on the prevalence of compounding, but it has been estimated that 0.25% to more than 2% of dispensed  prescriptions in the United States are compounded drugs. Under certain conditions, compounding may serve an important public health benefit by providing access to the needs of individual patients when a commercially available product is unavailable; however, compounded drugs are not approved by the FDA and should not be confused with generic drugs all of which must be approved by the FDA before marketing. Compounded drugs are not reviewed and approved by the FDA; therefore, their safety, efficacy, quality and conformance with federal manufacturing standards have not been established…. The regulatory authority of the FDA over compounding pharmacies is different and more limited than is its authority over pharmaceutical manufacturers.”

 

Bottom line: Thank you to the FDA and CDC. Even though regulations can be burdensome and costly they are worth it; they protect the purity and sterility of our medications. And if I do prescribe a compounded medication, I tell the patient and request that she fill the prescription in a closely monitored pharmacy.

I’m sure anyone who has read a newspaper in the past few months is aware of the fears that are engulfing (of should I say filling) the French women who have received silicone implants. A company in France produced a popular (and apparently not too expensive) implant termed the Poly Implant Prothese (otherwise known as PIP). It was sold in 65 countries throughout the world over the last decade and used for breast augmentation or reconstruction in more than 300,000 women. The company that made the implants was shut down by the French government for fraud in 2010. It turns out that they had been using industrial grade silicone that was (obviously) not approved for medical use. The concern was (aside from the fact that no woman wants her breasts augmented with the same stuff they use in building or road construction) that these implants were far more likely to rupture…. apparently of the 30,000 French women who have had these implants, 1,000 experienced a rupture or leak. The French are advising those women who still have PIP implants to have them removed. Other countries are deciding what to suggest and many are simply suggesting that the women discuss “what to do” with their physician.

Why has this not been a problem here in the USA? This timely question was addressed in an article in the January 14th issue of Lancet titled “Silicone breast implants: lessons from the USA.”

The silicon-gel implants that are used in our country have been FDA approved after a long and arduous history. Currently the FDA assures us that they are safe. Their approval has allowed 150,000 American women to get silicone-gel implants for breast augmentation and 46,000 women to get them for breast reconstruction in the last year alone. In 2010 after 2 days of public testimony from silicon implant manufacturers, surgeons and scientists, the FDA concluded that American women can “consent with confidence to procedures involving silicon implants, which are considered safe but with acceptable risk of local complications (rupture, tissue hardening, pain, inflammation, and infection).” (Note the same complications occur with non-silicone, i.e. saline implants.) And just to be more precise the FDA published a 63 page report assuring the safety of silicon-gel implants.

There is quite a chronicle that preceded this. Silicon-gel implants were available in the US since the early 1960’s, but not until 1976 were they regulated by the FDA. In 1988, the FDA classified them as devices (duh) that needed their safety and efficacy to be proven in order to stay on the market. They gave the manufacturers 30 months to provide the necessary data. Apparently they could not. In 1991, it was deemed that the data did not fully assess the risks and in 1992 (this s a history lesson!) the FDA imposed a moratorium on silicon-gel implants. They were only to be used for reconstruction (after mastectomy for breast cancer or redoes of bad previous implants) and not electively for augmentation until their safety was proven. Then all hell broke loose (at least litigiously) and in 1995 the biggest US class action lawsuit took place, for $4.3 billion. Subsequently, publications in peer-reviewed journals and a 400-page report of the Institute of Medicine failed to link systemic disease with silicon breast implants. The ban was lifted in 2006 and since then 2 manufacturers; Mentor and Allergan have supplied the US market. They have promised to conduct ongoing post-approval studies and are following 40,00 women for 10 years,

So right now we feel (sorry about the use of this word) that our silicon-gel implants are safe. The authors conclude with the statement that “some critics argue that the FDA’s approval process is too slow and bureaucratic” But they add “but at what cost to safety?”

I agree with them. We should expect no less.

Here’s a great study for those of us who grew up in the 60’s, 760’s or, for that matte, up till present time. Smoking marijuana may not be as bad for our lungs as our parents, doctors (or we, to our kids) have said. A study published in the January 11, 2011 issue of JAMA titled “Association between Marijuana Exposure and Pulmonary Function over 20 Years” has come to the conclusion that…well before I give away the punch line let me set up the story (I mean the study).

There has been an ongoing survey in which, among other health issues, the pulmonary function of young adults has been followed for 20 years. It’s called The Coronary Artery Risk Development in Young Adults (CARDIA). The study was designed to measure risk factors for coronary disease (hence the title) in a total of 5115 men and women aged 18 through 30 over a period of 20 years in four U.S.A. communities (Oakland, Chicago, Minneapolis and Birmingham). The participants were felt to comprise a broad cross-section of typical tobacco and marijuana use patterns. They underwent a baseline examination with 6 follow-up exams over a total of 20 years. Pulmonary function testing was performed in years 0, 2, 5, 10 and 20. At each visit the use of tobacco (cigarettes smoked a day) and intensity of marijuana use (episodes in the last 30 days) was assessed. For the latter there was a questionnaire that asked about number of joints or pipe bowls smoked per episode. (No, they did not ask about brownies). This was then put in scientific terms or “joint years”. One joint a day or 365 joints a year was equal to 365 filled and smoked pipe bowls and this was termed a one-joint year. (Some would simply say it was a good year…I’m having a blast this!)

Here are the results: More than half of the participants (actually 54%) reported current marijuana smoking, tobacco smoking, or both on one or more exams. The tobacco smokers tended to have a lower education and income and to be slightly shorter and less active, whereas marijuana smokers tended to be taller and more active. (I’m not sure what to do with this fact.). To no one’s surprise, tobacco smoking (both current and lifetime) was associated with a decrease in pulmonary function. BUT, exposure to marijuana was NOT, and was actually associated with improved function! (This was measured with volume of forced expiration and something called forced vital capacity, which basically measures the ability of the lungs to expand, take in and let out air). But there was a caveat…. too much smoking of marijuana leveled this benefit or even reversed it.

The authors calculated that with 7 joint-years of lifetime exposure (which equals 1 joint a day for 7 days or 1 joint a week for 49 years) there was no evidence that marijuana adversely affected pulmonary function. Higher levels were not deemed equally safe, but the authors admitted that they had insufficient numbers of heavy users to confirm this.

Now why, one would ask, does smoking marijuana increase pulmonary function? (At least that was one of my questions.) Well, l some investigators have proposed that the deep breaths that are taken to get the marijuana smoke into the lungs (those reading this will probably know what I mean) can stretch the lungs and allow them to take in a larger volume of air. Also the musculature of the chest may improve…..a sort of “aspiratory training”.

The authors state at the end of the article: “Marijuana may have beneficial effects on pain control, appetite, mood and management of other chronic symptoms. Our findings suggest that occasional use of marijuana for these or other purposes (and I am assuming they mean recreation) may not be associated with adverse consequences on pulmonary function. It is more difficult to estimate the potential effects of regular heavy use….; however our findings do suggest an accelerated decline in pulmonary function with heavy use and a resulting need for caution and moderation when marijuana use is considered”

I wonder how many rewrites and consultations with lawyers were needed to come up with that last published sentence. In any case, occasional use doesn’t seem to hurt the lungs. I know a lot of people who will be reassured by this. I can actually tell them to “put this in their pipe and smoke it” (Purely a common expression and not meant to actually encourage marijuana use.) Amazing that smoking tobacco remains perfectly legal…

Over the years many of my patients have come in with the happy announcement that their home pregnancy test was positive, but then voice their concern: ” I drank (wine, beer, the hard stuff) before I knew I was pregnant. Does this mean that I damaged the pregnancy? Should I worry?” (This is LA, some were already planning the preschool, grade school, high school and ivy league school that the 7 week old fetus would eventually be attending and worry that her or his chances were ruined!)

Fetal alcohol syndrome has been recognized for over a century. (It obviously has been around for as long as fermented beverages have been consumed; although when I watch all those television series about 16th century nobility, the males seem to be imbibing while the erstwhile maids, women and even princesses and queens are rarely portrayed sipping wine or mead. Considering the absence of birth control, some must have been pregnant.) Full blown fetal alcohol syndrome is pretty hard to miss: it manifests as low set ears, facial changes small chin and jaw, small head circumference, joint contractures, cardiac defect, varying degrees of mental retardation, behavioral abnormalities, hyperactivity and developmental delays. This array of fetal malformations can vary but, in general, has been associated with alcohol abuse (5 or more drinks a day) that continues throughout the pregnancy. So, could a mere drink or two a week in the first trimester do harm?

This question was addressed in a study published in a 2010 British Journal of Obstetrics and Gynecology and recently reviewed in the journal titled Obstetrical and Gynecologic Survey. (The latter allows me to catch up on the myriad articles published in my field.) The article detailed a prospective study of 2900 pregnancies in Australia (where I guess alcohol is readily available) between 1989 and 1999. A 14-year follow up of the children born to the women allowed the researchers to ascertain if alcohol had been harmful to the children’s behavior and development.

During various times in their pregnancy, the women were asked if they were or had been abstaining from all alcohol or occasionally drank (up to one standard drink per week), drank lightly (2-6 standard drinks per week), moderately (7-10 standard drinks per week) or heavily (11 or more standard drinks per week). The children from their pregnancies were then studied at birth and at 2, 5, 8, 10 and 14 years. The researchers also tried to correct for variables that could influence a child’s behavior, such as maternal age and education, the occurrence of stressful events during the pregnancy, maternal smoking and the presence of the father in the home as well as family income.

The results were somewhat surprising: In this analysis, the offspring of women who drank 2 to 6 or 7 to 10 drinks per week during the first 3 months of pregnancy did not have behavior problems up to the age of 14, and in fact had better behavioral scores than the offspring of mothers who did not drink at all!
The author of the review article points out that fetal susceptibility to alcohol is now known to be partially dependent on how rapidly alcohol is metabolized by the mother. Those who metabolize it more slowly have a higher peak blood alcohol level for a longer time than “fast metabolizes”. Alcohol breakdown (not that of the drinker, but that of the intoxicant) is dependent on possessing certain alleles (or genes), called ADH1B2 and ADH1B3. (Of note ADH1B3 has a high frequency among African Americans; unfortunately, the Australian study did not report the race of their participants.) But then how many women know their alcohol allele status? So although the allele data is interesting, it probably won’t help most women’s concerns regarding their alcohol consumption, especially in early pregnancy.

Bottom line: There are many factors that influence fetal susceptibility to alcohol, and it’s certainly best to “play it safe” and just not drink during pregnancy. But the current study allows physicians to continue reassuring their patients that have drunk less than 11 drinks per week in their first trimester that this was unlikely to have caused adverse fetal affects. And I have to add…. no one can guarantee the “right” school admission

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