While scientists can already screen for SMA, allowing parents to seek an abortion or decide against having children, doctors are split on whether or not to recommend routine screening due to cost concerns.

The new study analysis comes to $5 million for each case of SMA avoided by prenatal screening- and decides its too expensive.

“We found it to be too expensive,” said Dr. Sarah Little of Massachusetts General Hospital, who worked on the study. She added that the value for money was a tiny fraction of what is generally considered acceptable by health economists.

While a genetic test for SMA costs just under $500, more than 12,500 women would have to be screened to prevent one case of SMA, which affects only about 1 in 10,000 newborns.The results bolster guidelines from the American College of Obstetricians and Gynecologists, which recommends that only parents with a family history of SMA get screened.

However, another professional association, the American College of Medical Genetics, was not impressed with the study, which was published in the American Journal of Obstetrics and Gynecology.

“They came to the wrong conclusion because they used the wrong tool to do the evaluation,” said Michael Watson, executive director of the American College of Medical Genetics, which recommends universal screening for SMA.The team used the standard method of calculating cost-effectiveness, which naturally favors screening for diseases such as cystic fibrosis in which patients live long lives and require expensive treatment.

When patients die young, in contrast, they don’t incur a lot of expenses, and so the dollar value of preventing such diseases is smaller.  “It’s just not a practical approach,” said Watson, adding that “we could save a ton of money in the US if everybody died.”  I have often pointed this out to those who criticize fertility care as being too expensive for the health care system.  Cancer care and  intensive care units are very expensive.  If we only use cost effectiveness analysis then we would only offer preventive health, nutrition, smoking cessation, and vaccinations.  Much more cost effective then treating elderly sick people!

As a fertility specialist I deal with the SMA genetic screening test on a daily basis.  I advise all infertile couples of the existence of the test and the risks of being a carrier and having an affected child.  As is the case with cystic fibrosis and fragile X most couples do want to be screened once they know the test exists.  For those who test positive in both male and female some have chosen to have PGD where I test the embryo during IVF to see if it is affected and only replace those that are not.  I have had couples use this test to successfully have a healthy child unaffected by SMA.  Just recently I saw couples who came specifically for PGD having lost more than one child who died from SMA– and they were unaware that testing existed before.

This reminds of when a west coast state (think it was washington) used a cost effectiveness analysis to decide which medical treatments their public health insurance would cover.  Treatments were ranked and they went down the list until the budget ran out.  This system was very poorly received.

I hate to rock the boat but as advances in genetic diagnosis are exploding this problem is going to go through the roof.  I can now test for far more genetic diseases than tests existed for 10 years ago.  Using DNA chip technology I can now screen for over 200 diseases.  Is this cost effective?  Would you want to have it done?  When I thought about having children I wanted to be tested for everything possible!  Just last week I had a Yale student on a research elective with me.  He could not believe we don’t universally screen everyone for everything possible–yet many patients don’t want any test not 100% needed.  Others striving so hard to have a baby want to be tested for everything possible.  As the number of diseases we can test for heads north of 1000 in the next years our ability to test has outpaced policy decisions and protocols of what should be done for the couple who never had a child.   The bigger issue as we enter the future of Obama health care is where does genetic screening for low risk couples for diabling or fatal diseases (the ultimate preventative care) fit into the economic analysis.  How much is too much?  I guess it depends on who you ask and who’se paying…

As the letter reads:

The purpose of this letter is to inform you of important safety information for VIBATIV™
(telavancin) for injection, a once-daily intravenous antibiotic indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following organisms.
An informational program for healthcare providers has been established to help minimize the risks associated with the use of VIBATIV; the most important relates to the use of the product during pregnancy. Animal data indicate that use of VIBATIV during pregnancy is associated with reduced fetal weights and increased rates of digit and limb malformations in offspring, although these malformations were infrequent.
Women of child bearing potential should have a serum pregnancy test prior to administration
of VIBATIV. Patients should be counseled on the risks and benefits of VIBATIV. Consideration
should be given to using an alternative course of therapy, if a positive test result is obtained.
The use of VIBATIV should be avoided during pregnancy unless the potential benefit to the
patient outweighs the risk to the fetus. Women of childbearing potential (those who have not
had: complete absence of menses for at least 24 months or medically confirmed menopause,
medically confirmed primary ovarian failure, a history of hysterectomy, bilateral oophorectomy, or tubal ligation) should use effective contraception during VIBATIV therapy. Patients should be
instructed to notify their prescribing physician/healthcare provider if they become pregnant while taking VIBATIV. A pregnancy registry has been established to collect information about the effects of VIBATIV use during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the pregnancy registry by calling 1-888-658-4228.

Olive Medicalhas developed a single use HD endoscopic camera system for surgical applications.  Traditional endoscopic camera systems consist of a camera head with a coupler to attach it to the scope and a camera control unit.  Camera head and control systems typically cost in the $30, 000 range.  olive’s approach is to make the camera had single use and delivered in a sterile peel pack ready for the operating room.  They intend to deliver such a system at under $300 per case — less than 1% of a current cost to purchase a system.  What’s more the system is native HD at up to 1080 resolution.   I had a chance to speak with them about the system and they claim they are using a native HD imaging sensor chip.  if so, they would be the first surgical camera system to do so.  All other HD systems available today do not natively sense in 1080 but rather employ post imaging processing to upscale and modify the image.  Their camera unit also includes integrated still image capture software eliminating the need for yet another $10,000-$30,000 box - although with obviously less features (no video, printer, etc).  Their fulls specs include :

• Full 1080p Video Output
• 2 DVI and 2 HDMI Outputs
• Touch Screen LCD Interface
• Integrated Storage of 40 Images

Following the disposable razor model, they would provide the camera control box to the facility for minimal (or no cost) and camera heads would be purchased per use.  Following the green bandwagon they intend to accept the cameras back after use for reprocessing.  Of course the obvious thought would be for a facility to just buy a few $300 cameras and use them over and over again.  They have addressed this issue with some novel patented software that recognizes if the unit is shut off and watches and limits use until its factory reset.  The team at Olive includes several ex-stryker hardware and software engineers so they know the traditional market well.

The idea of disposable systems is not new.  Over the years I have seen many disposable laparoscopes and hysteroscopes and even limited use imaging systems.   Many years ago I presented at the AAGL conference the first ever fully digital scope with a cmos image sensor and LED illumination.  At that time I predicted that such a set up by eliminated camera control and illumination box requirements would enable the entire thing to become wireless and disposable.  More recently more recently an Italian group wrote about such a disposable system viewed through a PC that achieved only VGA resolution.  Olive has upped the ante by designing something at a fraction of the cost at true HD definition!  They have some video on their website but its not labeled which one is recorded with which camera so I can’t link here yet.

This is a totally logical progression as Moore’s law gets applied to medical imaging in the OR. Chip fabrication follows Moore’s Law with dropping cost and doubling performance every 2 years.  The expensive parts of these systems are now basically computer chips and related hardware.  Therefore as technology accelerates we’ll see exponential advances in performance and miniaturization for lower costs.  Given Imaging and others have produced disposable self-contained pill-cams that have a low cost cmos chip and LED illumination in a swallowable capsule.  Chip CMOS sensors with integrated processing leverages consumer-based electronic technology advances (and economies of scale) as well as trickle-down military imaging technology.  HD (and beyond) sensors are going to get very cheap in the future for these markets- not to mention the demand for real time HD video imaging on cell-phone cameras as wireless bandwidth goes beyonf 3G.  The sensors really are basically the same. 

The unit is not yet FDA approved.  While I have seen videos I have not yet had he unit in a live lab evaluation so the final grading will ultimately rest of real world image quality, resolution, color fIdelity, and light sensitivity.  I know several of the major traditional manufacturers have seen the unit.  I can only imagine them buying to squash it.  Such a low cost device certainly does not fit in with the traditional low volume high cost + service contract scope camera model used today.

What’s the Sensor?–They obviously would not verify to me the sensor inside the unit– no company ever does.  I usually find out once the camera is released and a competitor cuts one open and sends me detailed photos and spec sheets.  I did do some hunting around and was able to verify there are now American company produced CMOS imaging chips natively 1080p60.  They make a standard 2/3 inch chip imaging max at 2112 x 1188.  The ones I saw are 2.1-2.5 megapixel.  The same fabricators also produce a 1/3 inch version.  Researching this i got quite excited about he prospects for using these chips for consumer electronics in ultra-low cost HD camcorder/still devices.  Flipvideo has some competition coming!  

Such a device if the quality and reliability is there could be very attractive to many facilities battling down time service and sterilization issues.  This could enable higher throughput in the OR with less capital outlay and lower manpower.  The other (even larger in my opinion) potential market is office-based facilities which now primarily bag or high level disinfect such systems.  This would be a very attractive alternative for them.  Until now capital equipment requirements have been a barrier to entry for many doctor’s (and vet) offices.   Ob Gyn , urology, orthopedics, ENT, general surgery, ICU’s and the ER  among others are specialties are those where there is currently a significant application for imaging in the non-OR setting.  This low cost idea is not alone- several companies have introduced low cost integrated camera-view- display units based on cmos- such as the tower-free hysteroscopy system with LED LCD screen and CMOS.  The difference with Olive’s approach is single use eliminates the sterilization costs and they are offereing it for less than 10% of the cost of even the ultra-low cost systems coming out.  Just look at the price of computer LCD panels and HD camcorders (10% where they were recently) and you can appreciate the technology price advances pushing this model. 

Don’t underestimate the difficulty of sterilization.  While many current ystems are labelled as autoclavable most facilities have found that significantly reduces the lifespan.  In january the FDA shut down the use of one of the most common OR scope-camera disinfection systems from Steris used in 23,000 sites.  This whole issue is a subject of an upcoming post but basically the FDA said Steris made too many changes since approval of the device– so it not the same device anymore and shut the thing down!  While the issue is being resolved it has been a nightmare for case preparation and opens up the reexamination of sterilization.  Up until now disposable of resposable systems have not been attractive because they were priced at >10% of system costs.  Now Olive is getting to the <1% price point - and that’s a different story. 

I look forward to some hands on testing…

I’m so excited to share with you my latest docinthemachine podcast with Jeff Cohen — serial entrepreneur and current CEO of Halt Medical (a gyn fibroid treatment statup), Voyage Air Guitar (the world’s best foldable guitar),  and Nashville publishers Savannah Music Group just recorded live at the 38th Global Congress of Minimally Invasive Gynecolog in Orlando Florida.

You might recognize Jeff who was recently featured on ABC’s Shark Tank where he turned down the shark’s offer of $500,000 for his guitar idea.  In the podcast we discussed the unique opportunities and challenges of medical device development- and innovation in general.

I was immediately struck by Jeff’s unique perspective and vision when I met him.  He has innovated in so many different areas and has successfully partnered with physician inventors for blockbuster devices.

Topics We Cover in the Podcast:

• What’s unique about medical device development and how the potential returns differ from other industries
• Advice for the physician/inventor where to go with your idea–pitfalls, how to protect your intellectual property and how to partner and start a company
• Is your idea good enough to form a company?
• The dangers of big companies and the opportunities of start-ups
• All you need is a fantastic idea and where to go from there
• What to look for in a business partner
• What’s similar between innovation in any industry-medical,  music publishing, and internet?
• What is the unique opportunity in today economic climate?

Hope you enjoy and get inspired…  All you need is a great idea– and as Jeff says- I believe everyone has one.

You can listen to the podcast below or download it in 3 versions — a single file or split into part 1 and 2.

MEETING ANNOUNCEMENT  —The Adequacy of Assisted Reproductive Technology Oversight

Monday, December 14, 2009

Thea article describes an all too common problem I see in fertility treatments (and medicine in general) -  doctors who jump to conclusions and make diagnoses based on assumptions rather than facts- and then lead the patient down treatment paths that may not be optimal - or even correct!

The article goes on to say some doctors mistakenly decide in 18 seconds!  I usually spend more than an hour with a new infertility patient asking and listening to determine exactly what the potential issues are.  Unfortunately the article says some decide in just 18 seconds.

My Threshold First Step - Make sure you can tell your whole story- insist on an accurate diagnosis before treatments begin.  As it states in the article:

If your doctor appears to be in a rush and interrupts frequently, you’re at greater risk of being misdiagnosed. “Don’t assume that just because someone has given you a diagnosis that it’s necessarily accurate and complete,” says Dr. Steven Palter, medical and scientific director of Gold Coast IVF of Syosset, a reproductive medicine and surgery center. “The patient should communicate to the physician all of their concerns and symptoms. . . . There’s rarely only one treatment option, so the patient should ask what are the risks and benefits, and what options does the doctor have experience with and what they don’t.”

The Six Steps:

1. Make sure you can tell your whole story
2. Ask your doctor three questions after he or she comes up with a possible diagnosis
3. Verify any shocking results
4. Don’t discount doctor-patient chemistry
5. Acknowledge your quirks
6. Allow for the possibility of uncertainty

For an explnation of each step and thte specific questions to ask your doctor go here to Newsday for the full text of the article and the full 6 steps:

The AAGL Global Society for Gynecologic Minimally Invasive Surgery Launches Center of Excellence in Minimally Invasive Gynecologic Surgery Program at Annual Meeting November 16-20, 2009 in Orlando, Florida —dedicated to establish and verify standards at surgical facilities and hospitals.

(click green play arrow to hear presentation audio and automatically advance slides)

The primary objective of the AAGL and its professional interest partner the Council of Gynecologic Endoscopy (CGE) is to promote the adoption of minimally invasive gynecologic surgery with its reduced morbidity, shorter post-operative recovery time, less invasiveness, and reduced costs.

Our Analysis of patient and provider needs worldwide showed that there are widely divergent qualities of practice and that patients and providers have difficulty in identifying excellence.  There is a lack of national standards to improve outcomes.  While payors seek to control costs/outcomes patients lack access to the educational resources to direct them to the appropriate center to meet their needs in many cases.  As I stated in my address:

We recognize in the modern era of health care we have a unique opportunity as well as an obligation to use our educational resources and multidisciplinary expertise to help promote those systems and procedure which can improve patient outcomes in women’s health while reducing costs to both patient, payor, and society as a whole.

The CGE has therefore launched two new programs to address these needs.

First is an individual registry of physicians based upon peer review of operative experience and complications. The CGE, founded in 1996 has over 1100 individual gyn surgeons who have meet its standards.  The new program integrates an evaluation based on today’s complexity of procedures in minimally invasive surgery.  It is a tiered system with 3 levels of practice (based on procedure complexity) and 4 areas of proactive experience and specialization (General Gynecology Procedures, Fertility Enhancement Surgery Procedures, Repair of Pelvic Floor Defects & Urogynecology Procedures, Gynecologic Oncology Procedures)

Second is a Center of Excellence Program In Minimally Invasive Gyn Surgery.  This is in recognition  of the modern notion that to achieve best-in classs surgical outcomes requires not only an expert surgeon, but an integrated multidisciplinary surgical facility with systems and procedures in place to maximize quality cost effective safe outcomes for patients.

9 Requirements: Areas of Review To Qualify as a COEMIG:

1. Institutional Commitment to MIGS
2. Director of Division
3. Medical Staff Physician Qualifications
   -Dedicated Educational Program
   -Formalized Credentialing Guidelines & Systems to Introduce New Procedures
   -Procedures for Minimizing Complications
4. Sufficient Experience with Procedures
5. A Full Complement of required Non-Surgeon Consultative Staff
6. Ancillary Staff
   -Dedicated Team-Based Concept
   -Dedicated non-physician Educational Program
7. Equipment Guidelines
   -Availability & maintenance
8. Treatment pathways
   -Linked to Peer reviewed Practice Guidelines
9. HIPAA Compliant prospective Outcomes Data Tracking

In my presentation launching this program at the AAGL annual meeting I shared

The AAGL is extremely excited and totally committed to the concept of Gynecologic Minimally Invasive Surgery Centers of Excellence.  It represents a unified vision for women’s health that integrates our entire educational mission and expertise over the past 38 years.

First Ever Global Opportunity for Standards of Excellence:I was equally excited to present the concept to the Affiliated Societies of the AAGL which is made of representatives of National Minimally Invasive Gyn Societies from around the World.  Our dedication to this concept and recognition of its value was shared by representatives of Partner Societies from South America, Europe, and Asia.  We agreed to work together collaboratively to establish a shared Global Standard and to establish a shared program to advance Women’s health under the AAGL CGE COEMIGS program in cooperation with each Nation’s Society.

I will share further details of the program with you here as they are released!

Details of the society are are on the website of the AAGL

Information on the CGE

Information and Applications for the COEMIG Program

The EFI or endometriosis fertility index was just presented by Dr David Adamson, a fertility specialist at the 38th annual Global Congress on Gynecologic Minimally Invasive Surgery– the annual meeting of the AAGL in Florida.  As a fertility specialist and surgeon myself it was starred on my agenda not to miss as a highlight of the entire congress.  Here’s all the details of his presentation and the scoring system.

Here’s my podcast interview with the lead author Dr Adamson just after he gave his talk at the 38th AAGL Global congress in Orlando

In a docinthemachine exclusive first I am excited to share with you a new endometriosis scoring staging system that is the first ever to predict a patients chance of getting pregnant without IVF.

The EFI or endometriosis fertility index was just presented by Dr David Adamson, a fertility specialist at the 38th annual Global Congress on Gynecologic Minimally Invasive Surgery– the annual meeting of the AAGL in Florida.  As a fertility specialist and surgeon myself it was starred on my agenda not to miss as a highlight of the entire congress.

Why Its Important: Every staging system up to now were made by committee trying to guess what would be an important factor– but none have ever directly predicted a patient’s chance of pregnancy– they main thing they need to know. This study was mathematically devised and DOES the allow a patient to know her direct chance of having a baby after surgery!!!

In this post I’ll review his findings and share the scoring forms and data.  My next post will be an exclusive  podcast interview I just did with the author of the importance of this major breakthrough. The paper is being released today as “in press” in the journal “Fertility and Sterility” of the ASRM (here’s the link) — but you’ll need a membership to access it.  I’ll post the final pubmed links when it comes out in print.

Background- What’s endometriosis? Endometriosis is a devastating disease where the cells that normally line the uterus and grow each month in preparation for a baby grow abnormally outside the uterus on it surface or on the tubes ovaries or other internal organs.  These cells bleed cyclically each month internally an cause inflammation resulting in pain, infertility , and damage to other organs.  It affects 5% of the population who have no symptoms but up to 25-33% of women with infertility or pelvic pain.  A valuable resource is the endometriosis association who I work with frequently.

Lead Author–is my friend collegue and mentor from a distance Dr David Adamson.  He’s and ob gyn fertilit specialist who is on the faculty of both UCSF and Stanford and who specializes in both fertility and reproductive surgery — he’s served as president of both our fertility society ASRM and our surgical society AAGL.

The Results– Predicting Fertility:  Chances of pregnancy by Stage

The risk of listeriosis in pregnant women and their fetuses is greater than previously thought, researchers said.

Listeria monocytogenes — one of the most dangerous foodborne pathogens in the U.S. — can cause miscarriages and stillbirths, according to Mary Alice Smith, PhD, and colleagues at the University of Georgia in Athens.