April 13th, 2011 by Linda Burke-Galloway, M.D. in News, Opinion
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This post is written as a follow-up to The Hijacking of Pregnant Women.
It is said that sometimes you have to rock the boat in order to shift the course of progress. Well today pregnant women have reason to celebrate. The winds of change are apparent.
Bowing under pressure, K-V Pharmaceutical Company reduced the price of Makena from $1500 to $690. Makena is the trade name for hydroxyprogesterone caproate or 17OHP. It is a drug recently approved by the Federal Drug Administration (FDA) to reduce premature deliveries before 37 weeks if it is given before 21 weeks gestation. It has been used for years as an off-label drug and costs approximately $10 to $20 to make by compound pharmacists. When the FDA gave K-V an exclusive right to manufacture the drug, their integrity flew out the window. The pricing strategy of K-V is a case study of corporate greed. Most drug companies will use the “research and development” logic to explain their rationale for marking up the cost of a drug. In the case of Makena, that excuse is valid. The research and development of Makena had already been done by Squibb Pharmaceuticals who had sold the drug for years. Is it any wonder why U.S. citizens will cross geographic borders and purchase drugs from their Canadian and Mexican neighbors?
Kudos are in order to the American College of Obstetricians and Gynecologists (ACOG) who took the lead in questioning K‑V’s pricing strategies. Read more »
*This blog post was originally published at Dr. Linda Burke-Galloway*
February 8th, 2011 by Harriet Hall, M.D. in Better Health Network, Research
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Ear infections used to be a devastating problem. In 1932, acute otitis media (AOM) and its suppurative complications accounted for 27 percent of all pediatric admissions to Bellevue Hospital. Since the introduction of antibiotics, it has become a much less serious problem. For decades it was taken for granted that all children with AOM should be given antibiotics, not only to treat the disease itself but to prevent complications like mastoiditis and meningitis.
In the 1980s, that consensus began to change. We realized that as many as 80 percent of uncomplicated ear infections resolve without treatment in three days. Many infections are caused by viruses that don’t respond to antibiotics. Overuse of antibiotics leads to the emergence of resistant strains of bacteria. Antibiotics cause side effects. A new strategy of watchful waiting was developed.
Current Medical Guidelines
In 2004, the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) collaborated to issue evidence-based guidelines based on a review of the published evidence. Something was lost in the transmission: The guidelines have been over-simplified and misrepresented, so it’s useful to look at what they actually said. There were six parts:
1. Criteria were specified for accurate diagnosis.
- History of acute onset of signs and symptoms
- Presence of middle ear effusion (ear drum bulging, lack of mobility, air-fluid level)
- Signs and symptoms of middle ear inflammation: Either red ear drum or ear pain interfering with normal activity or sleep
They stressed that AOM must be distinguished from otitis media with effusion (OME). OME is more common, occurs with the common cold, can be a precursor or a consequence of AOM, and is not an indication for antibiotic treatment. Read more »
*This blog post was originally published at Science-Based Medicine*
December 30th, 2010 by admin in Better Health Network, News, Research, True Stories
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Gene Goldwasser died last week. He was 88, and he was my friend.
I wrote previously about a series of conversations I conducted with Gene and Rabbi A.J. Wolf a few years ago. I met Gene one spring day after calling to invite him to sit in on a class I was teaching to a small group of medical students about social issues in healthcare.
I’d read about him in a book called “The $800 Million Pill,” by Merrill Goozner. In the book, Goozner writes the story of Gene’s two-decade hunt to isolate the hormone erythropoietin (EPO).
Part of the story relates how Gene tried to interest traditional big pharma companies in his discovery, only to be brushed aside. Instead, Gene wound up sharing his discovery with what became Amgen. The company went on to make a windfall from recombinant production of the hormone and licensing it as a drug for patients with anemia and kidney failure. Read more »
*This blog post was originally published at ACP Internist*
October 28th, 2010 by Steve Novella, M.D. in Better Health Network, Health Policy, Opinion, Quackery Exposed, Research
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In my group practice, the Yale Medical Group, drug company-sponsored lunches and similar events have been banned. This is part of a trend, at least within academic medicine, to create some distance between physicians and pharmaceutical companies, or at least their marketing divisions. The justifications for this are several, and are all reasonable. One reason is the appearance of being too cozy, which compromises the role of academic physicians as independent experts.
But the primary reason is the belief that “detailing” by pharmaceutical sales representatives has a negative effect on the prescribing habits of physicians. There is reason to believe this may be the case because of cases of bad behavior on the part of pharmaceutical marketing divisions — ghost writing white papers, for example.
The concern, backed by evidence, is that pharmaceutical companies introduce spin and bias into the information they provide to physicians, whether though CME, detailing, literature, or sponsored lectures. Even when the information itself is not massaged, it is cherry picked, so in the end physicians are not getting a thorough and unbiased assessment of the facts. Read more »
*This blog post was originally published at Science-Based Medicine*
August 20th, 2010 by Steven Roy Daviss, M.D. in Better Health Network, Health Policy, Humor, News, Opinion, Research, True Stories
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By ClinkShrink
There’s always something new, even in the world of substance abuse. Lately I’ve been reading a lot in the media about K2, a synthetic cannabinoid that’s being sold (and outlawed) in many states. It’s commonly mixed with herbal incense and smoked. Nicknamed “spice,” it was originally created by scientists and called JWH-018.
Apparently some states’ poison control centers have been getting calls about it due to the physical symptoms it can cause, specifically palpitations and GI problems. The part of the story that I thought was interesting was the fact that originally only 250 milligrams of the stuff was created, in an “official” research lab, but that home chemists quickly took up the experiment and it’s now a part of our national drug culture. Read more »
*This blog post was originally published at Shrink Rap*
This post is written as a follow-up to The Hijacking of Pregnant Women. 
