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!