There were lots of interesting events in health care last week – some that you probably read about like the resignation of HHS Secretary Sebelius and the nomination of Sylvia Mathews Burwell as her replacement. There was also the announcement that enrollment in Obamacare is expected to top 7.5 million – no doubt disappointing the folks who worked so hard and spent so much money trying to scare people away from signing up.
But here are four health care stories that I stumbled across this last week that have important implications for health and health care that you may not have read about.
1. New Drugs May Cure Hepatitis C
An editorial in the April 4, 2014, issue of the New England Journal of Medicine discusses the implications of three studies published in that issue that show dramatic impact of new antiviral regimens, made up of the drugs ledipasvir and sofosbuvir, in the treatment of chronic hepatitis C. All three studies showed dramatic and sustained virologic responses varying between 93% to 99%. What’s more, the single-tablet regimen was easy to administer and had few side effects. Sound like a dream drug? Yes, but there is a catch. Right now a 12-week regimen of sofosbuvir alone will cost $84,000 (or $1,000 per pill).
Of every 100 persons infected with HCV, approximately
- 75–85 will go on to develop chronic infection
- 60–70 will go on to develop chronic liver disease
- 5–20 will go on to develop cirrhosis over a period of 20–30 years
- 1–5 will die from the consequences of chronic infection (liver cancer or cirrhosis).
The ongoing debate related to this story is likely to be related to the very high cost of the drug. Look for further stories that make an attempt to do an analysis of costs with and without the drug. Also, it will be important to determine exactly who should be treated and when. Finally, look for the payers to weigh in on this one – they are, after all, the ones who will pay for this expensive treatment.
BTW, the politicians have already started reacting to the cost issue. According to an article in FiercePharma, “Rep. Henry Waxman and several Democratic colleagues in Congress wrote Gilead CEO John Martin an excoriating letter on Friday, demanding to know why the drug costs so much–and whether Gilead is doing anything to make sure that poor patients get access to it.”
2. Growing Vaginas in the Lab
On April 11, 2014, Scientific American reported that researchers have grown customized and functional vaginas in a lab and implanted them into four teenage girls who were born with a rare genetic condition, Mayer-Rokitansky-Kuster-Hauser syndrome [ever noticed how many names are attached to these rare conditions?] in which the vagina and sometimes the uterus are underdeveloped or absent. The replacement vaginas were grown by harvesting a small section the girls’ vulvar tissue, separating the cells into muscle and vaginal epithelial cells. The researchers shaped a scaffold out of a biodegradable fabric-like material specifically for each girl. The different cells were placed on either side of the scaffold and incubated in a bioreactor. Once fully formed, the vaginas were surgically implanted. At follow-up, five to eight years later all four of the girls reported normal sexual function.
Why is this story important? According to Dr. Anthony Atala, director of the Institute for Regenerative Medicine at Wake Forest, as reported on the BBC News website:
“Really for the first time we’ve created a whole organ that was never there to start with, it was a challenge.”
This procedure, which took about 6 weeks from harvest to implant, offers a better, safer, alternative to existing treatments – that’s big. Also, this work paves the way for more regenerative medicine efforts to grow and replace other absent or damaged organs.
3. Millions Spent Stockpiling Flu Medication That May Not Work
Nature News reports on the controversy surrounding a recent report on the limited efficacy of Tamiflu, an antiviral drug used to treat seasonal and pandemic flu. According to a Cochrane analysis, the drug only shortened flu symptoms by a half a day in adults and just over a day for children. The report also said there is no evidence that Tamiflu prevents hospitalizations or complications of flu-like pneumonia.
Why is this story important? There are several reasons why this story is important. Governments around the world have stockpiled Tamiflu to treat flu due to pandemics (including the eventuality that a pandemic could be terrorist-related). The US has spent $1.5 billion and the UK $710 million on the stockpiles, which have to be replenished as the drug expires. Other reasons to pay attention to this story is because of charges that the people behind the report have an ax to grind related to lack of access to unpublished studies performed by the manufacturer, Roche.
In addition, this story raises interesting questions about what type of study should be considered when doing comprehensive reviews of the efficacy of a treatment. One researcher not involved in the Cochrane review, Jonathan Nguyen-Van-Tam, was quoted in Nature News as saying “they have chosen not to consider the many other observational studies.” The authors of the Cochrane report counter that only randomized, controlled trials should be used to measure a drug’s efficacy.
This story is likely to continue boiling as a separate group in the UK, the Multiparty Group for Advice on Science (MUGAS) is due to report the results of their review later this year. Per Nature News, MUGAS is partly funded by Roche. If you are interested in evidence-based medicine, then this is definitely a story to follow.
4. ACP Releases a Position Paper on Reducing Firearm-Related Injuries and Deaths in the US
The specialty society for Internists, the American College of Physicians issued a comprehensive position paper on firearms. It includes calling for physicians to speak out on the issue and it specifically states that “states and federal authorities should avoid enactment of mandates that interfere with physician free speech and the patient-physician relationship” [such the recently overturned law in Florida]. It declares that the ACP supports “appropriate regulation of the purchase of legal firearms…consistent with Second Amendment. It has a number of provisions related to mental health, including reporting to NCIS and supports modifying firearms to make them as safe as possible. The paper also notes that the College favors enactment of legislation to ban the sale and manufacture for civilian use of assault weapons. Finally, the paper calls for more funding for research on ways to reduce injuries caused by firearms – again a specific counter to the NRA supported law that prohibits such funding.
Why is this story important? Because it bucks the national trend to shy away from bold positions on firearm regulation for fear of the wrath of the NRA. Medical societies tend to be conservative organizations because they largely rely on dues-paying members for revenue. Leadership is often leery of taking on controversial issues much less coming out with College-endorsed positions as explicit as this one. I have no doubt that the NRA already has the ACP in its sights and will be gunning for them soon. Their usual tactic is to activate their membership to send a barrage of communications to the offending organization. Batten down the hatches ACP. You are now in the NRA line of fire.