Drug Prices in the United States - Drain the Swamp

The pharmaceutical lobby in this country is very powerful. They have convinced our politicians to restrict drug price negotiations, have prevented generic competition through, what in most industries, would be restraint of trade, and convinced our government not to regulate companies who raise prices at will.

The National Academy of Science has published a recent guideline on how we can realistically control prices while still allowing big Pharma to make a profit.

Will President Trump drain the drug swamp? Does the fact that a reputable scientific organization recommend it result in him ignoring it? Or will Pharma money win out again?

NAS Article

Birth Control Pills and Breast Cancer

In a study recently released, Danish researchers followed 1.8 million women aged 18-49. In Denmark there is universal health care and a common data base, which allows scientists to very accurately monitor health and disease causing activities. They found that the use of hormonal contraceptives resulted in 13 more cases of breast cancer per 100,000 women. N Engl J Med 2017; 377:2228-2239.

However, in reviewing the results, the journal mentioned that there are several limitations to the study; including not allowing for confounding factors such as family history, smoking, etc. As well, the risk of complications should a women have an unwanted pregnancy exceeds this excess risk.

Finally, in an editorial, the Journal pointed out that the copper IUD, and proper use of male condoms were as effective as the birth control pill and involved no hormones. Of course insurance coverage and education is important.

Do Men Really Get Sicker than Women?

There has been a lot of publicity lately about "man-flu", where men get sicker than women.

This was based on a study (BMJ 2017;359:j5560) where the author reviewed studies suggesting that males have weaker immune systems than females, perhaps owing to hormone differences between the sexes. They surmised that this may be an evolutionary adaption so sick men would be less likely to expose themselves to risk of hunting when sick.

There was actually no evidence for the existence of a man-flu to be anything more than the Oxford definition "a cold or similar minor ailment as experienced by a man who is regarded as exaggerating the severity of the symptoms." Sorry guys.

Exercise Helps Academics

When I was in school, physical education was mandatory. For some years after that students did less activity while emphasizing academics.

Fortunately there has been more physical activity in school in recent years. And in a recent study of over 10,000 children aged 4-13 physical exercise was significantly associated with improved academic skills in reading and math!

So get your kids to exercise! Its important to health and academics!

Álvarez-Bueno C et al. Pediatrics 2017 Dec

How the Republicans Encourage Abortion

With many of our politicians refusing to believe in science, it is not surprising that their actions can result in unexpected (at least to them) consequences.

In a recent study, Biggs MA et al. Obstet Gynecol 2017 Dec, researchers followed 19,700 women from a clinic in California. They found that those who had insurance which covered contraception were three more likely to use appropriate contraception and not use abortion as birth control.

In California, low-income women are mandated to have coverage for contraception. With repeal of the mandatory coverage of birth control, and further repeal of other mandates we can expect abortion rates to increase.

This may cause these same politicians to make abortion more difficult, or illegal. Other studies have shown that making abortions illegal or difficult do not change rates of abortions; just rates of legal abortions. And illegal ones have much higher risks.

The only effective way to decrease abortions is to encourage the use of proper contraception. And of course, in these circumstances it is the low-income women who suffer the most.

Generic Drug Pollution in India

Most of our generic drugs are produced in India. Although there is good quality control, and the medications are evaluated by the FDA, the environmental laws in India are much less strict than here.

To evaluate the effects of antibiotic production, researchers collected 28 water samples from the direct and greater environment of bulk drug manufacturing facilities in South India.

The found over 15 different antibiotics, some in concentrations over 950,000 allowed in the US; and many over 20 times the amount one would find in therapeutic blood levels.

Although tap water from the villages did not contain the antibiotics, some actually contained bacteria. There was a high incidence of antibiotic resistance genes in bacteria in that region.

My daughter Carolyn shops at Whole Foods because she says they ensure their suppliers not only produce real organic food; but also follow proper farming techniques. Drug companies should do the same to help prevent emergence of highly resistant bacteria!

Lübbert C et al., Infection 2017 Apr 26

But that might decrease their bottom line - and what really is more important. Just ask our chief executive, "coal burning man".

Alcohol and Marijuana - Not Innocuous

Marijuana is becoming legal in many states. But it is not without some potentially dangerous effects; just as alcohol has. Using these mind-altering drugs must be done in moderation and care.

In a recent study (https://doi.org/10.1177/2047487317723212) in European Journal of Preventive Cardiology researchers found that among 1200 participants there was a 2-3 times increased risk of death related to high blood pressure among users.

In another study, researchers looked at marijuana's effects on anxiety and stress (Drug Alcohol Depend 2017 May 30). It is approved for PTSD and chronic anxiety. In this report they found that, in normal volunteers, a higher dose (12.5mg) increased depression, anxiety, and confusion; while the lower dose 7.5 mg actually decreased anxiety. It is important to be aware of this possibility if you take marijuana for medical reasons, and of the side effects tht can occur with recreational use.

Finally, British researchers did a 30 year study on the effects of alcohol on the brain. They found that levels equivalent to 1 glass of wine a day had no effects; but increasing levels, up to 2 glasses a day, was associated with a 3-6 times amount of decrease in brain mass (in the memory centers) when compared to non-drinkers.

BMJ 2017 Jun 6. Welch KA

As usual moderation is the key, and knowing the possible effects of our recreational drugs is important!

Vitamin D - Are we over-prescribing?

Vitamin D is known to be needed for bone metabolism; in abnormally low levels we get a softening of the bones called rickets.

However, there seems to be an association of low (what is low - see below) vitamin D levels with a variety of diseases, including ,migraines, depression, insomnia, etc.

Being an association, this means we do not know if the vitamin D increases risk of these illnesses; or somehow when we get these our levels drop as a result or in combination. So "correcting" this may not help and can even have adverse effects.

In a recent study, Australian researchers found that patients with levels below 12 developed bone disease. The "normal" levels in the US range fro 20; or even 50. This seems too high.

J Clin Endocrinol Metab 2017 Mar 30; 102:2321

In a second study reviewing Vitamin D supplements, it was found that, looking at over 39,000 patients,over 18% of patients take more than 1000 units and 3% more than 4,000 units daily. High intake was most common in women (25.9%), non-Hispanic whites (21.8%), and older participants (age, ≥70; 38.5%).

The recommended maximum dose is 600-800 units. High dose Vitamin can cause increased fractures and kidney disease and is associated with premature death.

JAMA 2017 Jun 20; 317:2448

Take 600-800 units daily if you desire. Don't take excess doses - more is not better. And if your level is 20 or above (or even close to that) I would not take supplements.

Unproven Treatment - Stem Cells - Exploitation for Money

Stem cell therapy may one day lead to treatment of many diseases. In theory, stem cells, which are embryonic (undifferentiated) cells can grow into any tissue in the body - in the proper environment and stimuli. And extracting stem cells is, currently, very complex.

However this has not stopped money hungry doctors trying to take advantage of patients. For example, despite the theoretical promise of stem cell therapy for heart failure (HF), the treatment has not worked in clinical trials and has not been approved by the FDA. These facts have not discouraged direct-to-consumer promotion by “stem cell centers” of the therapy for cardiac regeneration. To learn more, investigators used scripted telephone surveys with staff at these centers.

They found 39 centers offering treatment from $6,000 to $8,000 for one treatment (not covered by insurance) with cash discounts. Of 79 physicians associated, 13 had no board certification (extremely rare today), and only one was a cardiologist.

Center representatives characteristically promoted the efficacy of the therapy for HF (and other conditions) and undermined the patient's relationship with their regular doctor.

The promotion of this unproven and expensive therapy shamefully exploits patients with HF, who may be desperate for a “cure.” Although 7 of the 61 centers had been closed by the FDA or no longer had an active website, much stronger oversight and enforcement by FDA would be welcome.

JAMA Intern Med 2017 Jul 24

Lung Cancer in Non-Smokers

Is there something in our environment causing lung cancer. It seems that the incidence has been increasing among non-smokers.

• The percentage of lung cancer patients who never smoked increased from 8.0% to 14.9% from the years 1990–1995 to 2011–2013

• The percentage of women with lung cancer who never smoked increased from 10.2% to 22.1% from 1990 through 2013, and the percentage of men with lung cancer who never smoked increased from 6.6% to 8.9% during the same period.

These results were consistent in three hospitals in different socio-economic areas in Dallas and Nashville.

Researchers wondered if there is something in our environment that is causing this increase.

J Natl Cancer Inst 2017 Jul 109:djw295

New Drug for Heart Disease and Cancer? - Not Yet

There have been headlines about a "New Drug Lowers Heart Disease and Cancer"

http://time.com/4916…/drug-inflammation-heart-attack-cancer/

However, once again the media is exaggerating and misquoting. The drug, Canto, has immune regulating and anti-inflammatory properties. Its use was associated with a 15% decrease in heart attacks in a large group of patients who had previous heart attacks and signs of increased inflammation (C-Reactive Protein elevation).

Compared with placebo, Canto was associated with a higher incidence of fatal infection, a lower incidence of cancer death, and no significant difference in all-cause mortality.

This study is dramatic in that it confirms that inflammation is a significant cause of heart disease, probably independent of cholesterol. Unfortunately the increased risk of fatal infections makes use of this medication not really feasible. In addition to the $200,000 per year cost.

How is causes the very slight lowering of cancer deaths needs further study as well.
N Engl J Med 2017 Aug 27. Harrington RA. N Engl J Med 2017 Aug 27.

So the press has exaggerated once again a preliminary interesting report. Some may even call this fake news?

The End of The Low Fat Diet?

Many of you may have heard of a recent study in Lancet (Published: 29 August 2017

DOI: http://dx.doi.org/10.1016/S0140-6736(17)32252-3

on-line) where researchers reviewed the diet history of thousands of people in 18 countries and looked at death rates. Though there may some issues with the study, the results were that low fat diets resulted in higher risk of premature death as compared with low carbohydrates.

The dietary fat dogma started more than a century ago with some meat-eating rabbits.

Back in 1908, scientists noticed that rabbits who were fed high cholesterol diets (meat, eggs, milk) developed plaque in their arteries. It was the beginning of a diet-heart hypothesis that reached full flower in the 1950s when researcher Ancel Keys convinced the world that diets high in saturated fat increased the risk of heart disease.

Lately there have been several studies that suggest moderation is the key. In fact there were even two studies never published in the 70's that also argued against the low fat diet hypothesis; the data was recently re-analyzed - BMJ 2013;346:e8707 from 1973 study data: In this cohort, substituting dietary linoleic acid in place of saturated fats increased the rates of death from all causes, coronary heart disease, and cardiovascular disease.

Bottom line - healthy diet, moderation, and (in my opinion) avoid highly processed foods!

Does Advil Cause Heart Attacks?

Maybe. But Maybe not. In a highly publicized study from the British Medical Journal (BMJ 2017;357:j1909) researchers from McGill University (my medical school) did a retrospective statistical analysis of several studies. Using data from other publications where heart attacks were reported, they looked to see if NSAIDs (like advil, aleve, etc) were more likely to have been taken in the month prior to the heart attack in those patients versus the control population.

They found that there was a 20-50% increased probability of the use of these drugs in the week or month before the heart attack.

So what does this mean? I interpreted the results to mean that many patients mistook their chest pain for muscular and took readily available advil or aleve. Or does it mean that those people who had major blockages made it worse by taking these? Surely taking Advil for a week in a normal person would not cause a heart attack!

So no, I don't trust this entirely - even though it was done at McGill. But as usual moderation is the key. And if you don't know what is causing that chest discomfort don't assume its muscular!

Interesting Articles on Vitamin D

An Interesting Article on Vitamin D

https://www.nytimes.com/…/vitamin-d-deficiency-supplements.…

Those Baby Blues - Can Diet be Effective?

Postpartum blues occur in about 75% of women, typically peaking on postpartum day 5 and usually disappearing by day 10. Women who experience severe postpartum blues are more likely to develop postpartum depression, which develops in about 13% of all women. Immediately following childbirth, a woman's hormones levels change dramatically and this is thought to be the cause.

Researchers created a dietary supplement (consisting of tryptophan, tyrosine, and blueberry juice) to counter the effects of certain postpartum hormonal changes. (Proc Natl Acad Sci U S A 2017 Mar 28; 114:3509)

In this very small study (42 women) they found this supplement significantly decreased depression indexes.

A larger study should be underway, and hopefully we will find a simple treatment to those baby blues!

Keeping our Children Healthier - Juice and Cold Medications to be avoided

Both should be avoided at certain ages.

The American Academy of Pediatrics has expanded its recommendation against offering juice to all infants 12 months and under because it offers no nutritional benefit. Previously, the group advised against juice consumption in infants 6 months and younger.

Among the group's other recommendations, published in Pediatrics:

• When a pediatrician deems juice to be medically necessary in infants older than 6 months, it should be given in a cup, not a bottle.

• For toddlers, 100% juice (4 oz. or less) may be offered as part of a snack or meal.

• For children aged 4 through 6 years, consumption should be limited to 6 ounces a day; for those 7 to 18 years, the recommended daily limit is 8 ounces.

• For children with chronic diarrhea, abdominal pain, excessive flatulence, and bloating, clinicians should inquire about juice consumption.

• For children with poor or excessive weight gain, clinicians should recommend cutting all juice from the diet

Over the counter cough and cold medications have never been shown to have any efficacy in children. The common cold in children is generally a self-limited illness that requires nothing more than hydration, rest, and sometimes fever treatment.

On the other hand they can be dangerous. To assess the rate of pediatric adverse events associated with over-the-counter (OTC) cough and cold medications in the U.S., investigators analyzed data from the Pediatric Cough and Cold Safety Surveillance System for patients <12 years of age reported to have at least one adverse event associated with any of the following pharmaceuticals: brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, pseudoephedrine, and phenylephrine.

They found over 3,000 adverse events from 2009-2014, often from accidental ingestion and overdose. These included rapid heart rate, agitation, hallucinations, and two deaths. (Green JL et al. Pediatrics 2017 Jun).

With no known benefit and such severe possible risk, these should be avoided in all children especially those under 4.

Cancer Checkpoint Therapy - Move Towards a Cure (slowly)

When cancer forms, the cells have many mutations which would make them appear foreign to our body's immune system and should trigger an immune response which destroys them.

One of the reasons this does not happen in many cancers is that they also produce a a "checkpoint" molecule that tells the body's defense cells to desist.

Researchers have produced a drug that can block this checkpoint molecule therefore leaving the cancer cell vulnerable to the body's defense system. After checkpoint-inhibitor treatment with pembrolizumab (Keytruda), some responses were seen in 53% of patients, and complete responses were seen in 21% in 12 different types of cancer including metastatic cancers previously thought incurable. Treatment generally was tolerated well, although there is some concern about the possibility of attacks on normal tissues.

Currently about 60,000 patients a year could fall into the response group. We will have to see if relapse or resistance becomes a problem.

Measles - why are we talking about it?

Largest measles outbreak in Minnesota in decades sickens children, leads to hospitalizations. And another outbreak in Portugal led to the death of a 17-year-old girl. Wouldn’t it be great if we had a simple, effective way of preventing measles? Oh, wait.

https://www.nytimes.com/…/…/measles-minnesota-vaccines.html…

http://www.euronews.com/…/death-of-portuguese-girl-proves-m…

Scamming The Medical System and Increasing Costs - Drug and Insurance Companies

The recent unsuccessful attempt to repeal Obamacare (probably due to having no viable alternative) has once again put some focus on medical costs.

Two recent reports show how easy it has been to squeeze more money out of an already bloated system.

In the first, the New York Times reported how UnitedHealth Group and other insurance companies stand accused of "systematically bilking" Medicare Advantage of billions of dollars annually. The accusation comes from a whistle-blower, a former finance director at UnitedHealth. He told the Times that the company uses data-mining to find ways to increase the apparent seriousness of patients' illnesses — and thus Medicare's payments to the insurer. UnitedHealth denies the allegation.

Medicare pays these insurance companies a fixed amount every month to take care of patients; but the amount varies depending on how sick the patient is.

https://www.nytimes.com/2017/05/15/business/dealbook/a-whistle-blower-tells-of-health-insurers-bilking-medicare.html?_r=0

I can tell you that when I worked with the HMOs in Florida, they did not hide the fact that they wanted me to use certain codes; and indeed would send a representative periodically to try and get me to up-code my patients. My only reward was that I was less likely to be dropped from their panel - which, under current laws they can do for no reason.

Drug Prices

As the use of generic drugs has grown substantially to >85% of dispensed U.S. prescriptions, prices of some commonly prescribed generic drugs have also risen dramatically, such as the Epi-Pen! Researchers found increases in generic drug prices were inversely proportional to competition level: 64% for low-competition drugs, 44% for medium-competition drugs, and 10% for high-competition drugs. Some low-competition drugs rose in price by >1000% in <6 years!! (Ann Intern Med 2017 Jul 4)

Regulatory policies that encourage competition or limit monopoly manufacturers of generic drugs may be necessary — and vital — to achieve reasonable drug costs.

The insurance companies and drug manufacturers have had a free ride under to current system. This needs to be addressed!