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This sort of Op-Ed piece in this coming week's JAMA sort of sums up the present and near future therapeutic landscape as well as attempting to address the pricing issues. I plucked out what I thought were the most important bits, but the full text is free at the JAMA Network site.

http://jama.jamanetwork.com/onlineFirst.aspx

(If, instead, you are looking for July 23/30 JAMA paper on the cure rates in co-infected folks that kind of made the news overnight, that link (also full free text) is here.)

Treatment of infection with hepatitis C virus (HCV) has changed substantially in the last 3 years, with new therapies now reaching cure rates (defined by sustained virologic response) higher than 95%. As little as 3 years ago, treatment involved an arduous course of pegylated interferon and ribavirin, which caused serious adverse effects in more than 80% of patients; less than 50% of patients could finish the treatment course.

In 2011, introduction of the first generation of protease inhibitors, particularly telaprevir and boceprevir, heralded change. ... However, these agents were much more expensive than standard therapy, at a cost of more than $80‚ÄČ000 per course of therapy, and were associated with high levels of viral resistance ... if patients did not strictly adhere to therapy.

In 2014, the introduction of polymerase inhibitors set a new standard. The first in this class, sofosbuvir ... in patients with genotype 1 HCV. Sofosbuvir also can be combined with another new protease inhibitor, simeprevir, to treat patients in whom interferon-based therapy has failed. These regimens provide interferon-free treatment protocols that are shorter and well tolerated and have 80% to 95% cure rates. This fall, an oral combination of sofosbuvir and ledipasvir will be introduced ... and has been shown to reduce treatment to an 8-week course with cure rates of more than 95%. Now, a chronic disease that affects millions of Americans can be cured by well-tolerated oral medications.

The price of sofosbuvir is essentially $1,000 per pill, or $84,000 for a standard 12-week course. The fact that pricing in the United Kingdom for a similar regimen is $54,000, and perhaps as low as $900 in Egypt and other developing countries, indicates that the pricing in the United States is a purely financial decision by Gilead and has outraged many. Indeed, some pharmacy benefit managers are calling on their clients to boycott these products until alternatives are available late in 2014.

While a daily oral medication that costs $1000 per pill gains attention, the more important issue is the number of people eligible for treatment. With broader screening, the pool of eligible patients may be as high as 3 million in the United States alone. The simple math is that treatment of patients with HCV could add $200 to $300 per year to every insured American's health insurance premium for each of the next 5 years. Thus sofosbuvir is not really a per-unit cost outlier but is a "total cost" outlier ...

These costs will be especially burdensome over the next year. Presently, Gilead has a monopoly, and its investors expect it to make a profit during this period. However, it is anticipated that by December, another highly effective oral regimen will become available.

Given this context, how should costs be managed? In some state Medicaid programs, the new medications have not been added to the formulary, despite the new practice guidelines. Physicians for whom the drug is denied by the state are going to Gilead, and, by report, the company is quietly subsidizing the costs--there is an official assistance program offered by Gilead. 

... 

Some private insurers have added sofosbuvir to the formulary and are absorbing the costs but also are taking steps to ensure appropriate utilization by developing prior authorization programs based on practice guidelines. Some insurers are asking physicians to treat only patients who absolutely need therapy now.

The ultimate approach to cost will be lower prices, which will occur as more products create competition. However, it will likely entail narrower formularies, in which the physician choice of a particular medication is limited by the deals negotiated by insurers and pharmacy benefit managers.

#####

For more on the business side of HCV drug development, as well as a bit of a look into the future of hep C rx, have a look at Matthew Herper's piece in Forbes magazine last month: Why Merck Just Spent $4B On New Drugs for Hepatitis C

Read about AbbVie's all oral, 3-in-1 combo regimen, expected in October at (and one state's efforts to play the two off one another for a 50% price reduction), among other places, Pharmalot.

Drs. Feeney and Chung (Mass General, Boston) in a July 7th clinical review for the BMJ report that over the next 1-2 years, "several new agents and classes of direct-acting antiviral are likely to be licensed," expanding the options for interferon-free regimens. "These interferon-free regimens," they write, "could enable many patients with HCV (even those with cirrhosis and those who have not responded to previous PI-based treatment) to be cured with an oral course of antiviral without the use of interferon and its associated side effects."

A year or so ago, I came across a journal article reporting the use of weekly ear (aka auricular) acupuncture for help managing the side-effects of interferon therapy. While the number of people treated was small (14) and effectiveness was assessed by self-report, the results are intriguing nonetheless.

Severity of fatigue, muscle aches (myalgia), irritability and nausea were all reported to decrease.

If  you're curious, the ear points these clinicians used were Shen Men, Thalamus, Lung, Liver "and/or" Sympathetic. Interestingly, they used 32-gauge (0.18 x 25 mm) needles. Retention time: 30-45 minutes. All results were statistically significant, although the nausea change just barely so. Reductions in irritability showed the most impressive decrease, followed by muscle aches (myalgia).

One wonders if the results might have been even better if the treatments could have been performed more frequently (it appears that folks had only 4 treatments over a period of 6 months), maybe using ear seeds, tacks or magnets for home or office stimulation between visits, and if some body points could have been added. (BaiHui and HeGu were employed in an undisclosed number of cases, presumably in accordance with individual pattern presentations.)

There does not appear to be much published research on the use of acupuncture--ear or otherwise--to manage the side effects of interferon therapy. And except for a few lucky souls (mostly those with genotypes 2 and 3) who can expect to clear the virus with a non-interferon based hep-C combo, it seems we are stuck with at least 12 weeks of weekly sub-Q interferon injections.

I contacted the author of the paper, an acupuncturist MD at the VA in Portland, OR, to try to find out additional information on her study and any plans for follow-up investigation. She explained their plans for a larger and "cleaner" study in order to tease out the exact contribution of the acupuncture intervention, as well as to better understand the optimal timing of the acupuncture treatment in relation to self-administration of interferon injection.

(Readers might also want to check out the medhelp.org (or other) online community forum for other peoples' experiences. The one I happened onto this morning yielded several helpful first-hand experiences: One person writes that s/he heads to acupuncturist the morning after the previous night's interferon jab, and that it really helps. Of course, not everyone can afford or has the required insurance plan to cover weekly (or, perhaps better: biweekly) visits to an acupuncturist in private practice. But as someone from the Bay Area wrote in, communal or group acupuncture places (officially called "community" acupuncture) offer scaled-down but completely adequate services for a fraction of the cost of a private session. This person was going to a community acupuncture place in Berekley, CA for all of $15 a visit! And don't forget massage. Many folks report that a monthly massage also really helps.

I haven't seen any $15 price points in NYC (more like $40, $45, $55), but there are a handful of group/community acupuncture places in metro NYC: Manhattan Community Acupuncture (UWS), New York Community Acupuncture (West 36th Street),  Harlem Village, Olo, City Acupuncture, Bae (Williamsburg) and Third Root (Ditmas Park). (I have first-hand experience with only Olo Acupuncture (West 23rd Street, between Sixth and Seventh), City Acupuncture (Fulton Street) and Third Root (on the Q and M trains! And I once studied with the woman who started NYCA); the others I found through a search engine.) I am told that City Acupuncture is  soon to open a second location across the Hudson in Hoboken or Jersey City. Anyway, there seem to be more community acu places in the Garden than Empire state at the moment. Stay tuned...)

Housing Works, with Positive Health Project centers in East New York, downtown Brooklyn, West 13th Street and East 9th Street in Manhattan, offers an acupuncture option to its HIV+ clients ("every Tuesday and Thursday from 1pm-5pm") but to my knowledge is not currently offering acupuncture services to their HCV+ folks. (Please correct me if I am wrong!)

Of course, for hep-C infected folks who are not ready (or willing) to take the peg-interferon/ribavirin-PI plunge or waiting for easier-to-take, better tolerated drug combos and are concerned about their liver health, there are quite a few good herbal formulas out there reported to support healthy hepatocyte regeneration, prevent further liver damage and reduce the risk of fibrosis. (This would apply equally to HBV-infected folks who are not on suppressive antiviral therapy.) More on that in a future post though! In the meantime, I would love to see some of the HCV service centers in the city begin to offer this ear acu option to their clients.

Mike Barr is a board certified acupuncturist and herbalist and can be reached at Turning Point Acupuncture (just off Columbus Circle across from the new Mandarin Oriental hotel) and at Suite 904 in the Flatiron District. His interests and experience include sports acupuncture, pain syndromes, liver health, immunological support, herbal and acupuncture approaches to getting off/putting off prescription medications of unsatisfactory or unclear benefit, and in helping to manage the side-effects of other necessary and life-saving biomedical interventions. He has also been busy exploring the application of Chinese herbal therapies, and specific acupuncture protocols, for all aspects of sexual health and anti-senescence.

CL found that because coconut water contains lots of potassium (and very little sodium), sports drinks might actually be a better choice. Large quantities of potassium could impart a laxative effect (desirable or undesirable, you decide) while coconut water drinks without added sodium are probably not as good as sports drinks after "intense, prolonged exercise."

And they add, "plain water may be sufficient for simple rehydration." In a 2012 study all 3--sport drink, coconut water (both pure as well as reconstituted from concentrate), water--were shown to be of equal utility.

Or you could give the Mother Earth a break and just make your own electrolyte post-workout beverage.

Basically these drinks are just a quarter cup or so of fruit or fruit juice (containing variable proportions of glucose, fructose, sucrose) with a little salt (sodium chloride +/- potassium iodide and possibly some other trace minerals if it's fancy) mixed into water. For help choosing from among isotonic, hypertonic and hypotonic options, this BBC page might be useful.


Mike Barr is a board certified acupuncturist and herbalist and can be reached at Turning Point Acupuncture (just off Columbus Circle across from the new Mandarin Oriental hotel) and at Suite 904 in the Flatiron District. His interests and experience include sports acupuncture, pain syndromes, liver health, immunological support, herbal and acupuncture approaches to getting off/putting off prescription medications of unsatisfactory or unclear benefit, and in helping to manage the side-effects of other necessary and life-saving biomedical interventions. He has also been busy exploring the application of Chinese herbal therapies, and specific acupuncture protocols, for all aspects of sexual health and anti-senescence.

Saturdays @ Turning Point Acupuncture

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I am happy to report that I am now the Saturday guy at Turning Point Acupuncture at Broadway and 60th, just off Columbus Circle and across from Equinox and the new Mandarin Oriental hotel. Founded by Naomi Rabinowitz in the 1980s, Turning Point was one of only two Oriental medicine practices (the other being Eleven Eleven Wellness) in NYC who welcomed HIV+ persons at that time.

Dr. Rabinowitz has since (and enviably) relocated to the great Colorado outdoors, leaving TPA in the more than capable hands of a new clinical director, since 2007 I believe, E. Shane Hoffman. I am thrilled and honored to be included in their company.

(If even the near Upper West Side gives you nosebleeds, I'm still on 21st & Fifth other days.)

As readers of my writings for Poz over the past 18 years likely already know, I am especially interested in liver health, immunological support and herbal (and sometimes acupuncture) approaches to getting off/putting off prescription medications of unsatisfactory or unclear benefit. And in helping to manage the side-effects of other necessary and life-saving biomedical interventions.

I have also been busy exploring the application of Chinese herbal therapies, and specific acupuncture protocols, for all aspects of sexual health and well-being--a topic that gets precious little attention in TCM schools in this country.

I realize it's not the first time something like this has happened, but really??

The Reproductive Health Drugs Advisory Committee of FDA voted 10-4 AGAINST approval of the antidepressant paroxetine (basically low-dose Paxil) for menopausal hot flashes in women. But their superiors decided to approve it anyway.

Surely GSK and its shareholders welcome a new indication for a novel reformulation of a blockbuster drug that lost patent protection some 10 years ago.

The evidence of benefit? Median of 5.0 vs. 5.6 "moderate to severe" hot flashes per day (at Week 12), paroxetine vs. placebo.

Admittedly it will be an apples to oranges comparison, but I will look up the effect size from acupuncture and, if available, herbal medicine trials and post later today. (I finally got around to looking up the Norwegian (AcuFlash) study stats: number of hot flashes decreased by average (mean) of 5.8 per 24 period in the acupuncture group--vs. mean reduction of 3.7 in the control ("advice on self-care") group. Hot flash intensity also decreased by roughly twice as much in the acupuncture group compared to control group: 3.2 vs. 1.8. All results were statistically significant: p<0.001.)

And the Black Box warning on the medication?: Although the risk of suicidality associated with Brisdelle is uncertain, it is noteworthy that the concerns about suicidality associated with higher doses of paroxetine pertain to children and young adults, a population for whom Brisdelle clearly is not indicated. Nonetheless, the Brisdelle label recommends monitoring patients for suicidal thoughts and behaviors and discontinuing treatment if there is worsening depression or suicidality.

Plus... as a potent inhibitor of cytochrome P450-CYP2D6 paroxetine, even at this relatively low dose, also has the potential for a wide array of drug-drug interactions: most notably, with tamoxifen, where it reduces plasma levels of the drug by 64%.

This decision is particularly surprising because the current FDA Commissioner, Peggy (aka Margaret, former NYC health chief) Hamburg has historically been very women's health and "community" friendly--or at least she used to be before, maybe, she obtained so much power or responsibility? Maybe she doesn't know about the AcuFlash studies or the bevvy of Chinese herbal formulas for managing menopausal symptoms: Er Xian Tang, Geng Nian An Pian, Da Bu Yin Tang and (Zhi Bai) Di Huang Tang aka "Rehmannia 6." (Personally, I prefer Health Concerns' tweaking of the classic formula, which they playfully call Three Immortals. They add Er Zhi to Er Xian--plus magnolia tree and lycium root bark (Mu Dan Pi, Di Gu Pi, respectively).) Should we write Dr. Hamburg--or the committee members--a letter?

A "Perspective" of the FDA's decision to override its own advisory committee appears in this week's New England Journal of Medicine. Read the full (free) text here. The NEJM editors conclude that: "Recognizing that no hormone-free drug product has been approved to treat vasomotor symptoms, and after careful review of the efficacy results, the FDA concluded that Brisdelle offers a clinically meaningful benefit for some menopausal women."

Clearly we have alot of work still to do.


Mike Barr is a board certified acupuncturist and herbalist and can be reached at Turning Point Acupuncture (just off Columbus Circle across from the new Mandarin Oriental hotel) and at Suite 904 in the Flatiron District. His interests and experience include sports acupuncture, pain syndromes, liver health, immunological support, herbal and acupuncture approaches to getting off/putting off prescription medications of unsatisfactory or unclear benefit, and in helping to manage the side-effects of other necessary and life-saving biomedical interventions. He has also been busy exploring the application of Chinese herbal therapies, and specific acupuncture protocols, for all aspects of sexual health and anti-senescence.
I honestly can't keep up with Dr. Oz's daily trend-making recommendations. I think it was a year or two ago that he implored us all to jump on the krill oil bandwagon. Most people I know are getting their (yes, super trendy) Omega Threes from flaxseed or, less commonly, evening primrose oil (EPO) and/or borage oil.

But there seems to be an increasing amount of evidence (should I write "evidence"?) that fish or at least "marine" (which I guess includes algae and other sea critters that are not technically fish) sources might be superior to the seed sources.

I am interested in this only because there seems to be a potential use (or at least potential benefit with sufficient probability to explore) in cardiovascular health, cognitive function (especially in the elderly), depression and/or other mood disorders and possibly even dermatology! So I wanted to know more.

Behold, appears in my Inbox last week Consumer Labs' up-to-the minute review and thoughtful discussion of all of the aforementioned. Super helpful, super thorough, super credible--and with even a twist of bitchiness is one looks closely enough! I particularly enjoyed that.

This post threatens to grow unmanageable, so let me try to give away the ending here:

Bottom Line
Marine (includes fish, algae, krill) sources of EPA and DHA oils "offer a wide range of potential benefits" for

  • mental health
  • treating inflammatory diseases (which would include some skin problems)
  • "and even cancer prevention"
Importantly, they conclude that where cardiovascular health is concerned, eating fish twice (or more) weekly is more effective than taking fish oil supplements.

Here are the recommended dietary sources of oily fish (per AHA):

  • anchovy
  • bluefish
  • carp
  • catfish
  • halibut
  • herring
  • lake trout
  • mackerel
  • pompano
  • salmon (farmed probably has higher levels of PCBs)
  • striped sea bass (isn't this on verge of extinction?)
  • albacore tuna (see above and also mercury concern)
  • whitefish
Dose (and relative proportion, EPA to DHA) appears to Important. And MORE IS NOT NECESSARILY BETTER. (Large doses (>2-3g per day) have been shown to suppress immunity. Source cited for this is an animal study: Fenton, Prostag Leukotri EFAs, 2013,

That said, I recall reading (but cannot find source/citation just now, I am thinking it was Dr Dickson Thom, a naturopathic physician from this weekend seminar I attended recently) that if one is using fish oil for dermatologic indications (for example, eczema or other stubborn rash), twice the 1,000 mg daily dose (i.e., 2g daily) is recommended. I will look for the source.

Mehmet's fancy krill oil is, not surprisingly, the costliest of all the options. And there doesn't seem to be much evidence that it is superior to the others. The only difference is the inclusion of the antioxidant carotenoid phytochemical called astaxanthin. But the CL watchdogs have discovered that only really 1-2 companies actually have krill oil with this rhapsodized constituent naturally occurring. That's right, the others ADD IT IN after the fact!

I will have to summarize the rest (and there is so much to tell!) tomorrow. If you are feeling flush with cash, you can become a CL member supporter and read it all first-hand today. I think a year's access only sets you back sixty bucks. And now I see they have NPR type options where they bill you $2.46-3.00 a month, depending on whether you opt for 12-month or 24-month commitment.


I see they also just did a review of 41 different "probiotic" products. (I can explain the quotation marks later.) Will have to get to that later this month.

Mike Barr is a board certified acupuncturist and herbalist and can be reached at Turning Point Acupuncture (just off Columbus Circle across from the new Mandarin Oriental hotel) and at Suite 904 in the Flatiron District. His interests and experience include sports acupuncture, pain syndromes, liver health, immunological support, herbal and acupuncture approaches to getting off/putting off prescription medications of unsatisfactory or unclear benefit, and in helping to manage the side-effects of other necessary and life-saving biomedical interventions. He has also been busy exploring the application of Chinese herbal therapies, and specific acupuncture protocols, for all aspects of sexual health and anti-senescence.



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