How Much is Your Baby’s Life Worth? Experts Use Economics to Decide on Genetic Screening

Posted on March 15, 2010 by Steven F. Palter, MD

Screening all pregnant women for a rare but fatal genetic disease is too expensive, researchers say in a new report that adds to a recent controversy about whether genetic tests are worth the cost. The research is reported in the new issue of AMJOG and reported in summary here.

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…

Breaking News: Vitabiv Antibiotic Associated With Birth Defects

Posted on March 15, 2010 by Steven F. Palter, MD

I have just received a breaking news update from Astellas regarding risks of using their antibiotic Vitabiv in pregnant women. This is one of the most strongly worded warnings on use of an antibiotic in pregnancy I have seen recently. I received a generic warning update last week from the American College of Ob Gyn that “some warning regarding a drug in pregnancy” was coming today.

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.

First Disposable Single Use HD Endocopic System-DITM Exclusive

Posted on March 8, 2010 by Steven F. Palter, MD

Docinthemachine first exclusive report!

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…