Thursday, December 31, 2015
Wednesday, December 30, 2015
Tuesday, December 29, 2015
Monday, December 28, 2015
Sunday, December 27, 2015
Saturday, December 26, 2015
Friday, December 25, 2015
Thursday, December 24, 2015
Wednesday, December 23, 2015
Tuesday, December 22, 2015
ICH endorses a faster, less expensive approach to cardiac safety testing
iCardiac CEO Alex Zapesochny
Drug developers must demonstrate that new medications are safe and effective in order to win regulatory approval. The gold standard in cardiac safety testing has been the Thorough QT study, a separate, expensive trial that is typically conducted late in the clinical development process.
The international body that informs drug development standards has just revised its stance to support definitive QT testing based on ECGs collected during existing early-stage trials. iCardiac Technologies, where I’m a board member, pioneered this approach in conjunction with the FDA. I asked iCardiac’s CEO Alex Zapesochny to explain what is happening.
- What is the ICH and why does it matter for clinical trials?
The International Council for Harmonisation is an international forum for regulators to harmonize drug approval practices. The group includes pharmaceutical industry representatives and regulators from the United States, Canada, the European Union, Japan and Switzerland.
As for the clinical trials process, the ICH aims to make recommendations toward achieving greater harmonization in the interpretation and application of technical guidelines and requirements related to research and development of new drugs. These guidelines can assist with pharmaceutical product registration and help reduce or avoid duplication of testing carried out during R&D.
- ICH has issued a regulatory revision for cardiac safety testing. What specifically has it done?
Currently, the FDA and other regulators expect nearly all new drugs to be tested using a costly, stand-alone Thorough QT (TQT) study to assess a drug’s effect on the QT interval before market approval. This is an important step, since a prolonged QT interval is associated with a heightened risk for arrhythmias and possible sudden cardiac death. The latest revision adopted by the ICH states that data from ECGs collected during routine Phase I or other early clinical trials may be used to conclusively demonstrate a drug’s QT effect. This approach relies on intensive, high quality ECG analysis and the use of exposure response modeling.
- What led to the change?
Regulators around the world want to make the drug development process as safe, precise and efficient as possible. The ICH revision emerged a year after the U.S. Food and Drug Administration helped to organize a meeting of thought leaders to discuss the results of a successful prospective validation study demonstrating the ability to determine cardiac safety much earlier in the development process. This revision is likely the most significant regulatory shift in cardiac safety since the original E14 guidance was adopted by the ICH in 2005.
- What role did iCardiac play? The FDA?
iCardiac has been championing this alternative approach for several years, including collaborating with thought leaders from the FDA and from industry to help organize a prospective validation study to definitively test this new approach. Ultimately iCardiac sponsored that definitive validation study, and it was overseen by iCardiac personnel and used our proprietary High Precision QT methodology to perform the critical data analysis. Leaders from the FDA have been involved in multiple key ways, including decisions around the validation study design and co-authoring publications about the validation study and its implications. Of course, the FDA is also a participant in the ICH and played a direct role in the new regulatory revision.
- What will be the practical implications?
This development provides an alternative path for sponsors with regard to demonstrating the effect of their drug on QT, which is a critical part of gaining market approval for a new drug. By analyzing ECG data from a Phase I or other early clinical study, sponsors can choose to seek a waiver from regulators from having to do a TQT study. The FDA granted the first TQT waiver based on this alternative approach earlier in 2015. So apart from saving time and money, this approach gives drug developers insight into their compound’s QT liability much earlier in the clinical trials process.
- What are you doing to let people know more about the implications?
iCardiac will conduct two free public webinars to explain the new ICH guidance and the standards it establishes for receiving a waiver from the Through QT study. Dr. Borje Darpo, a cardiologist and chief scientific officer at iCardiac, will discuss the impact of this regulatory revision on the clinical development process. The webinars will be held on January 12th and January 20th, 2016. You can follow the links below to register for one of iCardiac’s webinars:
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By healthcare business consultant David E. Williams, president of Health Business Group.
from Health Business Blog http://healthbusinessblog.com/2015/12/22/ich-endorses-a-faster-less-expensive-approach-to-cardiac-safety-testing/
via A Health Business Blog
Monday, December 21, 2015
Sunday, December 20, 2015
Saturday, December 19, 2015
Partners and Hallmark drop deal talk: I’m quoted
Partners HealthCare and Hallmark Health System have called off merger talks. See (In face of opposition, Partners unlikely to expand further in Mass.) in the Boston Globe. This is not too surprising, considering the pushback Partners has received from the Health Policy Commission, Attorney General’s Office among others.
Health Policy Commission chairman Stuart Altman told the Globe:
“We’re not opposed to thoughtful consolidation or restructuring.” But plans “really need to be based on improving quality and access, and not just a thinly veiled attempt to raise prices.”
Ouch.
I’m quoted as well:
“Partners is in a new era,” said David E. Williams, president of the Boston consulting firm, Health Business Group. “What the regulators and the Health Policy Commission are signaling is that they don’t want Partners to grow by acquisition.”
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By healthcare business consultant David E. Williams, president of Health Business Group.
from Health Business Blog http://healthbusinessblog.com/2015/12/19/partners-and-hallmark-drop-deal-talk-im-quoted/
via A Health Business Blog
Friday, December 18, 2015
Health Wonk Review is up at Workers’ Comp Insider
Workers’ Comp Insider hosts the last 2015 edition of the Health Wonk Review. It’s a lively edition, replete with exciting stories on the Affordable Care Act, physician economics, compliance, ethics and more. And the Santa graphics are a must-watch!
from Health Business Blog http://healthbusinessblog.com/2015/12/18/health-wonk-review-is-up-at-workers-comp-insider-12/
via A Health Business Blog
Thursday, December 17, 2015
How Martin Shkreli is driving down drug prices
Thanks Mr. Evil for helping build consensus
Turing Pharmaceuticals CEO Martin Shkreli made waves this year by boosting the price of generic drug daraprim from $13.50 to $750 per tablet. Now he’s angling for an FDA voucher worth hundreds of millions of dollars by abusing an incentive program intended to encourage development of new drugs for neglected diseases. He’ll be ratcheting up the price of another drug to boot. And finally his interview with HipHopDx reveals him to be a very nasty and unsavory character. (Jump straight to the last question if you don’t believe me.)
Yet ironically his well publicized price-jacking of a few specific products seems reasonably likely to lead to a slowdown in price increases for the pharma industry as a whole, if not outright price controls. You see, what Shkreli has done differs only in degree from standard industry practices.
The industry spends a lot of money and energy to explain that its pricing is directly related to the high cost of drug development. We know that’s not true, but even if it were true it would not explain why prices for medications rise so quickly, even for products that have been on the market a long time.
The Shkreli affair, along with shenanigans from Valeant, have awakened serious journalists, who have started to look into drug pricing more broadly. This Wall Street Journal article (How Pfizer set the cost of its new drug at $9,850 a month) is a good example. Pfizer doesn’t set its price based on R&D costs, but it doesn’t charge the maximum it can get away with either. Pfizer is in this game for the long term and likes the status quo. It doesn’t want to generate a backlash. But Shkreli is generating a backlash, not just against him but against the whole industry. Politicians are seizing on him as an example, and rightly so.
Free markets unfettered by government interference are great, but as I have written (Why drug price regulation should not be ruled out) we have to remember that the government plays a very big role in enabling high and rising product prices: it grants monopolies and market exclusivity that keep out competitors. And, through Medicare, Medicaid and other programs the government is the biggest payer for many products. Shkreli’s actions present legislators and the president with an opportunity to re-examine drug pricing policies and consider changes that are in the country’s interest. The longer he keeps up his act, the higher the chance for significant reform.
Image courtesy of Sira Anamwong at FreeDigitalPhotos.net
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By healthcare business consultant David E. Williams, president of Health Business Group.
from Health Business Blog http://healthbusinessblog.com/2015/12/17/how-martin-shkreli-is-driving-down-drug-prices/
via A Health Business Blog
Wednesday, December 16, 2015
Tuesday, December 15, 2015
Monday, December 14, 2015
Nice
http://40.media.tumblr.com/e238c58d81e4739462cd1ebee269aad9/tumblr_nfd5cdpYNA1qdblieo1_500.jpg
from Discount Store Returns Blogger blog http://discountstorereturns.blogspot.com/2015/12/nice.html
via Discount Store Returns Blogger Blog
Nice
from Discount Store Returns Blogger blog http://discountstorereturns.blogspot.com/2015/12/nice.html
via Discount Store Returns Blogger Blog
6 reasons to ignore listicles, even this awesome one
Captain Listicle
Are you bothered by articles with headlines like, 21 Euphoric Experiences for People Who Just Love Food, 11 Christmas Cards Only Cubans Would Send or 7 Surprisingly Easy Ways to Get Organized for the Holidays? (These are just a few of the articles on BuzzFeed’s home page as I write this.)
I don’t like them either, and I don’t read them. (Neither should you.) So I thought I would do something therapeutic by explaining what’s wrong with them.
- The name for this format is “listicle.” It suggests a popsicle. Sweet, cheap, and with no nutritional value. That should be enough to keep you away.
- Most listicles are unoriginal. The writers aren’t experts; they’re just organizing a bunch of other junk they found on the web.
- Listicles are a tired format. Maybe you enjoyed the first few. Even the first few dozen. But aren’t you sick of them by now? Or are listicles more like crystal meth where you just can’t stop even if you’re brain literally rots out of your head?
- A good writer only needs three reasons to explain something.
- You’re a mature person. You’ve learned to avoid jailbait and are probably not even tempted by it. Can you say the same about clickbait? The publishers don’t care if you learn anything from the listicle. They just want you to see the advertising surrounding the piece.
- Listicle sounds way too much like a synonym for gonad.
Image courtesy of iosphere at FreeDigitalPhotos.net
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By healthcare business consultant David E. Williams, president of Health Business Group.
from Health Business Blog http://healthbusinessblog.com/2015/12/14/6-reasons-to-ignore-listicles-even-this-awesome-one/
via A Health Business Blog
Sunday, December 13, 2015
Saturday, December 12, 2015
Friday, December 11, 2015
Thursday, December 10, 2015
Should patients choose doctors who are friends?
Can I help you?
In the social media era, it’s common to read articles discussing the blurring boundaries in the doctors/patient relationship. Usually it’s some version of, “Should a doctor accept friend requests from patients on Facebook?” or “Is it ok for doctors to Google their patients?”
The Wall Street Journal (The New Boundaries Between Doctors and Patients) explores these issues and goes on to explore what happens when patients and doctors become friendly during the course of treatment. In the midst of this there’s a throwaway paragraph:
“Some boundaries are clear. Professional medical organizations have strict rules against sex and romance with patients. Doctors are also advised not to treat family or close friends, situations that could compromise objectivity and judgment.”
I have no problem with the part about sex and romance. I also kind of understand the family issue. But the friend one is more interesting to me.
I read a few pieces that discuss this topic. (Here, here and here.) The typical scenario is a friend asking for medical advice in a casual setting, often on a topic that’s not related to the doctor’s specialty. I get why that’s a bad idea.
In my own case I know many practicing physicians socially, and most are in the prime of their careers: mid 40s to early 50s. A couple years ago when I was having trouble finding a new primary care doctor after mine retired, I asked physician friends who they went to. That was a little too clever on my part, since I forgot to account for the fact that physicians get treated differently than regular people when they go to the doctor’s office. No NPs for them!
But after some so-so experiences with a particular medical specialty, I decided to ask a specialist friend if he would be comfortable being my doctor. He said yes and I started seeing him. He’s a longtime friend but not an extremely close friend. I’ve been extremely satisfied with the experience. Partly because he’s an excellent doctor but also because I feel he understands me better and may even provide a little extra attention. He trusts me enough to exchange detailed emails. I’m not embarrassed to share personal medical details that I wouldn’t be comfortable with sharing someone who’s just a friend. Honestly, for me I don’t see the downside.
I did the same thing when I a needed a new dentist and that’s worked out well, too.
I hope I stay reasonably healthy and then die peacefully in my sleep when I turn 100, so I don’t have to spend a lot of time as a patient. But realistically it’s likely that I’ll be seeing more specialists as time moves along. I’m definitely planning to keep friends in mind when it comes time to find people to treat me.
Image courtesy of stockimages at FreeDigitalPhotos.net
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By healthcare business consultant David E. Williams, president of Health Business Group.
from Health Business Blog http://healthbusinessblog.com/2015/12/10/should-patients-choose-doctors-who-are-friends/
via A Health Business Blog
Wednesday, December 9, 2015
Tuesday, December 8, 2015
Monday, December 7, 2015
Sunday, December 6, 2015
Saturday, December 5, 2015
Friday, December 4, 2015
Health Wonk Review is up at Health System Ed
Health System Ed extends the Thanksgiving theme with the Healthcare on Parade Edition of the Health Wonk Review. The subtitle (“It’s beginning to look a lot like… chaos”) is, sadly a good summary of the healthcare scene.
In any case you’ll want to read the posts to get yourself at least partially straightened out.
Enjoy!
from Health Business Blog http://healthbusinessblog.com/2015/12/04/health-wonk-review-is-up-at-health-system-ed-3/
via A Health Business Blog
Thursday, December 3, 2015
Twitter share counts – what happened?
Tweety bird on the way out?
Oh where oh where have my Twitter shares gone? Oh where oh where can they be?
Like most bloggers I have an option for readers to share posts they like (or hate) on social media, including Twitter, Facebook and LinkedIn. The share buttons at the bottom of the posts also indicate how many people have shared a post on each platform. Usually Twitter is the most popular share for my blog, followed by LinkedIn and then Facebook.
WordPress.com is pretty easy to use but it’s also glitchy. When I scroll down the page on my blog I notice it often stops showing share counts after the first several posts, although if you click on a specific post the share counts will reappear.
So at first when the Twitter counts disappeared a couple weeks ago I figured it was just a WordPress problem and probably a transient one. But after a few days I started to get suspicious and so probed a bit further. Turns out Twitter announced a couple months back that it was removing the share counts. For the life of me I can’t figure out why they would do it. All the other social media sites have kept theirs.
Search Engine Watch has a good take on this:
“So, all this move does is:
- Irritate publishers, bloggers and authors like me who use share counts as a lightweight performance metric
- Stick another two fingers up to developers, who are used to it by now
- Remove Twitter from being relevant, when it comes to social proof“
I’ve put quite a lot of effort into Twitter over the past five years or so and have a solid following there of over 9500 people. Twitter is easy to use and informative, but this move is a real pain in the neck.
My favorite social network is LinkedIn. I’m proudest of the posts that generate the most shares there and am surprised at how many people read the blog on LinkedIn.
Anyway, you’re still invited to share my blog posts on Twitter. You just won’t know if you’re the first or 101st to do so, and neither will anyone else.
Image courtesy of olovedog at FreeDigitalPhotos.net
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By healthcare business consultant David E. Williams, president of Health Business Group.
from Health Business Blog http://healthbusinessblog.com/2015/12/03/twitter-share-counts-what-happened/
via A Health Business Blog
Wednesday, December 2, 2015
Tuesday, December 1, 2015
Joslin Diabetes CEO faces ‘big challenges’ –I’m quoted
It’s tough to win in the diabetes business
Diabetes is a huge health problem, and Joslin Diabetes Center is a renowned, world-class institution. You’d think it would be a good moneymaker, or at least able to break even. But, as the Boston Globe explains in Big challenges ahead for new Joslin CEO, that’s not the case.
Here’s the part of the article where I’m quoted:
Diabetes typically doesn’t require the kinds of expensive treatments or surgeries used to fight illnesses such as eye diseases and cancers. That means Joslin doesn’t have the same opportunities to generate revenues as other specialty clinics in Boston, such as Dana-Farber Cancer Institute and Massachusetts Eye and Ear Infirmary.
“Diabetes is not as profitable a market as more procedure-oriented specialties,” said David E. Williams, a Boston health care consultant
Several years into health reform, it seems odd that we’re still rewarding expensive interventions rather than the type of coordinated, prevention-oriented care that Joslin provides. In some fields, prevention has an uncertain payoff, yet for diabetics proper care helps head off terrible and expensive downstream complications such as amputation, blindness, heart disease and kidney failure.
Joslin has a couple other things going against it:
- Big healthcare systems have focused on keeping all care within their own systems, preventing “leakage” to other providers even when those providers are excellent
- Joslin derives a fair amount of its revenue from research. Unfortunately for Joslin NIH rules such as salary caps and COLA freezes make research a loser from a purely financial standpoint. There’s also a lot of competition for grant dollars
Joslin has actually done a good job of recognizing these problems, and has built a substantial commercial business to license its knowhow and brand. But that hasn’t been enough to make up for all of the headwinds.
I am wishing new CEO Dr. Peter Amenta the best of success as he tries to turn this ship around.
Image courtesy of smarnad at FreeDigitalPhotos.net
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By healthcare business consultant David E. Williams, president of Health Business Group.
from Health Business Blog http://healthbusinessblog.com/2015/12/01/joslin-diabetes-ceo-faces-big-challenges-im-quoted/
via A Health Business Blog
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