Vol. 131 September 1, 2015 Current, Recurrent Controversies

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“Anachron’s Law:
There is no myth which is so irrational that no one will believe it.
Anachron’s Corollary:
There is no truth which is so obvious that everyone will accept it.”
George Hammond

“How Much Is That Pill In The Window?”:
It costs either $2.6 BILLION or $1.4 BILLION to develop a new drug depending on which report you believe… the Tufts Center for the Study of Drug Development (supported in large part by drug companies) or Jeffery Avorn, MD of the Division of Pharmacoepidemiology and Pharmoeconomics of Harvard Medical School. The discrepancy is important since the high price of drugs is becoming a hot topic in this pre-election year. Read this NEJM article to get a glimpse of the smoke and mirrors used in such calculations (how to calculate capital costs?, what is a “self-originated” drug?, how much of R&D costs are covered by public tax money (NIH grants)?, what are R&D and what are marketing costs?, etc.). (1)

  • 80% of new compounds fail to meet expectations and are abandoned during development. This, of course, raises the calculated cost of developing the successful ones.
  • Both reports agree that the time required for new drug approval by the FDA has decreased to the point where it as fast as, or faster than other countries.

“Gadar” is faulty :
Ten years of research has not appreciably advanced our understanding of what makes people gay according to a “state-of-the-art” review of research into sexual orientation held every five years in a remote location. This year’s conference was held at the University of Lethbridge in Western Canada. The sharp dichotomy between nature (genetics) versus nurture (cultural) causes, the focus of numerous “twin studies” in many countries over many years, has been significantly blurred. The search for the “gay gene” has been tempered by the realization that at least 150 genes are involved in determining “something as simple as your height.” (2)

A new concept, the “environment of the womb”, has recently received greater research interest, but data remains inconclusive. The “environment of the womb” swirls with all sorts of different, and changing, levels of hormones and proteins for 9 months, and researchers  continue to look for its effects on the fetus – “epigenetics”. “Genes are the ingredients of grandma’s apple pie. Epigenetics is the recipe of how she actually makes it.” (2)

The scarce support of sexual orientation research is due in large part to societal controversies  (hence the remote locations for conferences to reduce easy access for “Spotlight Investigative Teams” roaming for hot topics). I wonder if such research is even worth it at all. Any research conclusion will likely be ignored by those people with the strongest negative opinions about sexual orientation because many have clearly shown no acceptance of scientific evidence about anything.

“Low-T” is another manufactured diagnosis:
Despite the lack of scientific evidence showing any benefits, 2.2 million men were prescribed testosterone in 2013 for “age-related hypogonadism”, a brand new diagnosis limited to aging men and apparently coined in response to a demand for testosterone prescriptions. Most of the men are 40 to 64 years old, and one-third of them had never had their actual testosterone blood level checked prior to the prescription. The authors of this report suggest that direct-to-consumer marketing for the improvement of “low-T symptoms” is a major reason for this wide-spread, increasing usage. The FDA has identified a “weak signal” that testosterone usage has adverse cardiac effects, and is concerned … so they have… “recommended some drug label revisions”. (3)

“Lingering Lyme”:
The CDC notes that one in five patients treated for Lyme disease may develop a persistent syndrome of fatigue and other symptoms known as “post-treatment Lyme syndrome”, and no one knows what causes it. It is NOT cured by continuous long-term antibiotics. There is new laboratory animal evidence that some of the organisms causing Lyme go into a “dormant state” when under antibiotic attack. They are NOT resistant to the antibiotic. The cell metabolism function that is attacked by the antibiotic just shuts down temporarily when the antibiotic is present, and so the organism survives. The researchers found that reintroducing the same antibiotic in the lab animal after a time off antibiotics subsequently killed these “persister” organisms. This is a new direction of inquiry in Lyme disease, but not everyone believes in “persisters” and “pulsed antibiotics”. They won’t believe, and shouldn’t, until all four of Koch’s postulates  for establishing a link between a disease and an organism are met. (4)

“Water, Water Everywhere…but not needed”:
The persistent myth that 8 glasses of water will keep you healthy was apparently initiated by readers of a 1945 Food and Nutrition Board recommendation that people need 2.5 liters of water a day. BUT, the readers ignored the next sentence that read “most of that quantity is contained in prepared food” … like fruits, vegetables, juice, coffee, tea, and even beer. Prospective studies have failed to find any benefit on skin elasticity, kidney function, “healthy appearance”, disease-free state, or mortality in those healthy people who increase their water intake. A recent study using a urine osmolality of 800 mOsm/kg (a measure of concentration) as the “normal” value in children concluded that more than half of 4,000 symptom-free, healthy children were “dehydrated”! It would seem that we should throw that particular “normal” standard out the window … or at least into the crapper. (5) Water is good for you, but, let’s face it, you really don’t need take a water bottle with you in the car when you go to pick up the mail.

References:
1. “The $2.6 Billion Pill – Methodologic and Policy Considerations”, Jeffery Avorn, MD, NEJM 372;20, May 14, 2015 .
2. “What Makes People Gay?- Revisited” , Neil Swidey, Boston Globe Magazine, August 23, 2015,
3. “Testosterone and ‘Age-Related Hypogonadism’ – FDA Concerns”, NEJM 378;8, Aug 20, 2015
4. “Lingering Lyme”, Scientific American, Sept. 2015, pg.17
5. “The Persistent Health Myth of 8 Glasses of Water A Day”, Aaron J. Carroll, MD, NY Times, Aug. 25, 2015, pg. A3

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