FluChip shows promise in diagnosing A(H5N1) avian flu, and others including pandemic flu

The New York Times reports on a new test for A(H5N1) avian influenza (commonly called bird flu) which is undergoing further research. The FluChip was designed by Robert D. Kuchta and Kathy L. Rowlen, a University of Colorado chemistry professor who led the team that developed the test. Current tests for A(H5N1) require culturing the virus in eggs to get enough genetic material to test and identify the virus, taking up to 5 days not including transport to these specialty labs. The FluChip cuts that time down to less than 12 hours.

The technology used by the FluChip is called a microarray, or gene chip, which uses genetic principles to identify what kind of flu it is. The chip has genetic material, RNA, from 5,000 samples of different animal and human flu virus which help differentiate the flu in question, since the DNA of that flu will stick to the RNA on the chip.

To get enough DNA of the flu you're trying to identify, scientists use polymerase chain reaction amplification (PCR) to duplicate the virus DNA so that it can be used with the chip. This is great for flu viruses that we already have the DNA of, such as avian influenza A(H5N1), but points out a significant problem when thinking of pandemic flu.

Pandemic flu is anticipated to be an entirely new virus that the world has not been exposed to before, which would assist it's spread since we will not have had any possible way to develop antibodies against it yet. It will take time for scientists to identify and isolate the DNA of this new virus to be able to use to make tests like the FluChip useful, so don't expect the CDC to whip this out at the start of a pandemic.

This is promising, but won't be helpful at the outset of pandemic flu. It's helpful for A(H5N1) but with the success in controlling the spread in Vietnam & Thailand, and improvement in control in Indonesia, avian influenza A(H5N1) isn't expected to become a pandemic, in part because it has not been able to spread between humans, only from birds to humans.

It's still a big step ahead of my currently available test for influenza. It's a dipstick test I can run in my own office that identifies influenza A within minutes. My problem is that I can't tell what strain of influenza A it is, so the presumptive diagnosis of A(H5N1) is still by details of the patient's history and physical exam.

43 Commenting at Google News

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Electronic Medical Records Under Senate Scrutiny

Steve Lohr's article for the New York Times this week, "Smart Care via a Mouse, but What Will It Cost?" highlights the support expected from politicians as a bill meanders through senate committee. It touches on a number of interesting points concerning electronic medical record (EMR) cost, quality and research.

One concern highlighted is the potential for increased costs for providing care as improved record keeping uncovers inadvertent lapses in regular health care maintenance and management of chronic diseases. I'd argue that these up-front increased costs are acceptable to take since the U.S. Preventive Services Task Force (USPSTF) who creates these guidelines takes into account the cost-benefit ratio. That is to say, USPSTF issues guidelines with the expectation that the costs of implementing preventive care will decrease the cost of future complications, as well as be an acceptable cost in our society's culture for the value we place in the health received.

Another concern is increased costs by "providing more care for more people" since unserved populations could be alerted to the fact that a drug or therapy is available for them. I'd argue that if those treatments truly give those people better health, then that's great! Again, our society places a high value on health, which is why many people have broad options within their health insurance plans to pursue various treatments.

One potential cost savings highlighted is the potential for research from EMRs to support the use of cheaper drugs. Kaiser uses lovastatin, a generic drug that is appropriate for many people with high cholesterol. The leading drug in this class is Lipitor (disclosure: I take it), which costs a lot more since it's a branded medication, and the most potent in it's class. Research gleaned from de-identified data from EMRs could support the use of the lower cost medication if it showed similarly good outcomes when used at higher doses, as compared to the more potent Lipitor. Kaiser claims that it does have that evidence. I'm curious how, since they've just recently started to implement Epic's EMR (disclosure: I use it daily). I suspect they collected the data painstakingly by hand from paper records. I'm glad that going forward they'll have an easier time at supporting these worthy research goals.

A final example is a bit more fanciful. Marshfield Clinic researchers claim that by personalizing drug dosing according to genetic profiles, quality and safety will increase. The drug in question is warfarin, a blood thinner, which is notoriously tricky to keep therapeutic, but not thin the blood too much. Too little warfarin and your blood is too thick. Too much warfarin and you will bleed dangerously easily. I'd argue that it's more important to get your care from a good clinic that monitors the thinness of your blood very regularly, rather than figure out your genetic profile to be able to get the dose right initially. I'm not saying it wouldn't be helpful, it's just that keeping you at the right blood thickness has less to do with the initial dosing, than the ongoing monitoring and adjustment of dosing.

I'm a supporter of EMRs, heck, I use them everyday. I just would like to see more acceptance of the fact that better care costs more money. Money that our society deems an acceptable burden, one that is smart money that decreases costs of chronic care in the long run.



24 folks currently digg it

42 folks' comments are tracked by technorati:
Sydney Smith of Medpundit has this to say: "So, has it come to this? We need to invest in expensive computer software to counteract sophisticated drug industry marketing? Jeesh." With 5 commenters on her post.
Al Hawkins laps at the kool aid: "Glossed over are the potential for increased patient safety (by having charts readily accessible and legible), convenience (making your records available to whatever care provider you are currently seeing), and awareness (helping you track the course of your illness along with your health care provider)... No, it's not a panacea. There are a lot of problems with 21st century health care, and those problems exist in every single industrialized country in the world. EMRs can help root out inefficiencies and catch small mistakes before they become big ones."
David Ermer supports EMRs
Healthcare IT bets on EMR saving money.
George Chinnery worries about privacy.

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Will Getting Chipped Keep You Healthier?

I recently wrote about how RFID chips could possibly help surgeons find sponges they might have otherwise left inside their patients. Now, RFID chips by VeriChip Corporation are being paid for by Horizon Blue Cross Blue Shield of New Jersey (BCBS NJ) to see if patients at Hackensack University Medical Center will be healthier by using them.

You might wonder how anyone could get healthier by having a chip implanted under their skin. Well, these RFID chips uniquely identify you in VeriChip's central database. BCBS NJ is betting that over a two-year trial, the insurance company will save more than the $200 per chip implanted, plus the $80 a month for each patient's subscription fee to the central database. That may seem like a lot of money, but by slowing the progression of a chronic disease like diabetes, you decrease the costs of providing care for the complications such as hospitalizations for heart attacks, strokes, kidney problems, infections, and eye damage. But how does a chip help? By having a unique identifier to summarize the care a patient gets across all of the physicians they get care from, the insurer gets a more accurate summary of how well they're keeping up with their health care maintenance. A friendly suggestion to a delinquent patient's primary care doctor goes a long way to have that doctor follow up with the patient.

Having a unique identifier is only one part of getting healthier. Incentives for the physician to follow chronically ill patients more carefully is another important aspect. Large physician groups have incentives to show that they're providing better care, hence the pay for performance programs that reimburse these groups for achieving those goals. Large groups can afford the electronic medical record technology to provide insurance companies these reports to show they're achieving the measures set.

One concern is that RFID is not a completely secure technology. I've read reports of how easy it is to clone the RFID signature, not specifically of the VeriChip device, but others. If someone were to clone your unique signature, they could identify themselves as you, and potentially either receive services on your behalf, or even have data entered into your record that's based on their body not yours. I'd want to be sure it's secure before I'd get one injected.

Another concern is that readers for these chips have to be widely distributed before they're of any use to identify you. Your medical information also has to be accessible in an EMR, or the physician won't have anything to look up after they've successfully identified you.

This is exciting technology, but there are still a lot of developments needed before it's really useful.

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Diabetes Management Via Cell Phone

Seeing CrunchGear get excited about HealthPia's upcoming offering of their Diabetes Phone seemed premature. It's a great idea, consisting of an integrated glucometer that checks a diabetic's blood sugar, uploads it to an online data center, and offers suggestions on how to manage a particular reading. It eliminates the common problem of patients losing their record of their blood sugars or forgetting to bring them to their office visits.

I just wonder who will monitor this record of blood sugars on an ongoing basis. I don't see physicians devoting their precious medical assistant's time to tracking these online records down, and wanting to be responsible for managing these trends outside of a clinic visit. The unfortunate truth about fee-for-service medical care is that any care provided outside of a clinic visit isn't reimbursed, such as telephone calls.

I can see that the diabetes disease management programs that health maintenance organizations (HMO) run could be interested. These programs hire nurses to monitor the health of many patients with chronic illness, and by improving their health, decrease their hospitalizations, decreasing the cost of care. HMOs are interested in decreasing the cost of care since they receive a set amount of money per patient, and have to take care of the patient with that set amount. The healthier the patient, the more profitable the HMO.

This conundrum brought me back 6 years ago to my time at Medicalogic, an internet based electronic health record (EHR) company. At the time, we partnered with Nokia and their subsidiary LifeChart who had a spirometer that uploaded peak flow readings to a central server to monitor the health of asthmatics. LifeChart needed a way to get these readings into the record that the physician recorded chart notes, and that was the business Medicalogic pioneered - an internet based EHR. That is to say, the readings could be uploaded electronically to Medicalogic's data server where both physicians and patients could view the readings and the status of their asthma.

The difficulty lies in who will pay for these devices, and for the physicians to participate in the increased technology and work it takes to care for these patients. Patients are unwilling to pay for the devices, as you see that devices only are widely adopted when covered by insurance. Physicians are reluctant to do more uncompensated work. Physicians don't want to pay for EHR, neither the software nor the hardware costs.

Until disease management programs see these devices, and the interfaces with EHRs, as critical to the success of keeping their patients healthy - I don't see them reimbursing for the costs involved. I posted recently about Viterion's success in keeping Congestive Heart Failure patients out of the hospital. When these new devices can show similar successes in cost reduction, then you'll see insurance companies stepping up to pay for them and the physician's fees in monitoring them.

As for the expense of the EHRs, hospitals and health groups have recently been granted an exception from Stark laws, and now can pay for EHRs for physicians. In the past, government policy prohibited this in order to decrease physician dependence on a particular institution, and increase competition among hospitals. Recent changes were due to the realization that EHRs are so important in improving the quality of healthcare, that this is more important than the anti-competetive provisioning of EHRs. EHRs completely change the workflow of a physician's office, and for the better. It does lock physicians to the group paying for the EHR, which the institutions love since they often make significant profits off of their ancillary care such as laboratory tests and x-rays. I'd argue that the quality improvements are worth this anti-competetive risk.

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Air Travel With Medical Devices

Today, the Homeland Security alert was hightened to it's highest levels in response to the arrest of suspected terrorists in London who reputedly planned to blow up flights from London to the USA using liquid explosives. All carry-on baggage are prohibited, excluding prescription medication. Even iPods and portable electronic equipment are prohibited since they are among the devices suspected of potentially harboring components for bomb-making.

This came to mind today when Michael Rack, a sleep specialist blogger, referenced a how-to article from Sleep Review Magazine for patients suffering from sleep apnea who require CPAP (continuous pressure airway pressure) devices while in-flight. I remember many people snoring loudly on my 20 hour flight back from Singapore a month ago who would have benefited from one, but the buzzing from the CPAP would probably have been more annoying to me.

These reccomendations are generalizable to medical devices, and I'd add to the list, a recently signed letter from your physician documenting your diagnosis and need for the device to be used while in-flight. Briefly, adapting quotes from a frequent traveller with CPAP: Holly Larkin, RPSGT, of AEIOMed, Minneapolis:

Inform the airline about using the device while onboard.
It is important to get approval to use the device onboard before arriving at the airport. Many airlines have strict policies regarding using devices while in flight, but by calling beforehand, users can minimize the hassle that is sometimes involved with using a device while flying.

Use a battery-powered device.
Battery-powered devices are recommended because these devices offer access to therapy when power is not readily available.

Bring an extension cord.
If users don't have access to a battery-powered device, they may want to bring an extension cord in case the nearest outlet to the bed is out of reach of the cord for the unit.
Enoch: An adapter for use of the airline seat outlets can help provide power if you run out of juice mid flight.

Travel with refill/replacement equipment.
Filters can get dirty, especially in places with poor air quality.
Enoch: Refills are important since you may be delayed longer than you expect, such as in times like today with the incredibly long security check lines. Also you should be prepared for delays in landing if you need to be redirected, such as the flights that couldn't land in London today, and were redirected to others in Europe.

Simplify equipment cleaning.
Larkin said that it is a good idea for patients to come prepared to clean equipment. She recommends that users bring a hanger with a clip on it to help in drying the equipment. "I take a hanger with a clip on it," Larkin said. "I take one of those with me because when you rinse out your hose or your mask, you can clip it to that and put it over the shower bar and let it dry."

Pack distilled water for humidifiers.
Keeping a small bottle of distilled water in a container is an easy way for users to carry along the water needed for humidifiers, Larkin said.
Enoch: This may not be allowed since all liquid containers are being prohibited from being brought on board. The point of bringing extra of whatever you need to maintain your device is still a good one. You may not be able to get it on board, such as getting bottled water from the stewards.

Update: Bill Quick, the Diabetes Doc, reposted some helpful Discussion Forum entries regarding medications requiring refrigeration:

- Traveling forum, entry 767: I emphatically do not suggest putting Byetta in checked luggage, not even in the thermos. There is no way to be sure that you'll get your luggage at the same time you arrive. I have had my luggage lost so many times.

- Byetta forum, entry 3752: It appears that you can bring your Byetta to the airport check-in line in any disposable carrier you want, then hand off the carrier to a friend who's not flying, and that you can plan to have someone meet you at the arrival area and have another one ready to go. Or you can do a last-minute switch, moving your carrier into your checked luggage.But also keep close track of how long your Byetta is out of refrigeration, and carry extra prescriptions so that you can buy more whereever you land (remembering of course that Byetta is available in only a few countries, so that's probably not possible if you're flying internationally).

- Byetta forum, entry 3753: Suggestion from a frequent flyer: ice baggie pen on way to airport, pitch bag at door. Drinks are available after check-in while you're waiting for flight, get ice from vender to keep pen cool, pitch before boarding plane. Get ice from attendant during flight.

Update:
As of August 16th, Medical Prosthetics have been approved:

Small amounts of Baby formula and breast milk if a baby or small child is traveling
Liquid prescription medicine with a name that matches the passenger’s ticket
Up to 8 oz. of liquid or gel low blood sugar treatment
Up to 4 oz. of essential non-prescription liquid medications
Gel-filled bras and similar prostethics worn for medical reasons

Tags: Healthline, health, medical, medical device, air travel, refrigeration, insulin, red810

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CPSC Fails To Act as Shopping Carts Pose Hazards To Kids

The American Academy of Pediatrics (AAP) just announced the release of a policy statement, "Shopping Cart-Related Injuries to Children" which makes a lot of sense. It shares evidence that has been known for 30 years, but the CPSC has dragged their feet doing much about. The CPSC (U.S. Consumer Product Safety Commission) is our government's arm which monitors products and issues orders to recall ones that are not safe.

By the CPSC's own admission, "an annual average of about 17,300 children ages five and under are treated in U.S. hospital emergency rooms for falls from shopping carts. Injuries range from minor abrasions to concussions" which ER physicians report can be life threatening. In response, in July 2004 the CPSC issued a voluntary standard for this 70 year old design of shopping carts, addressing performance requirements for restraint systems and labeling requirements. Does this go far enough?

I'd argue no, and agree with the AAP, who believes that up to 3,400 more per year are injured. Kids who fall from, or are trapped in tipped-over carts are subject to the possiblity of serious injury to their head and neck. Shopping carts need to be redesigned. Why should 1 child suffer when we have the ability to design safer carts? Until they are, I agree that you need to strap kids in securely and never leave their side. That sounds draconian, but if you've ever seen the effect of a serious head injury on a child, and the potential lifelong effects, it's heart wrenching.

Some suggestions from the AAP make sense, such as carrying babies in baby bjorn. Some suggestions aren't very practical, asking parents to leave their kids at home with others, where most parents don't have someone to rely on in that fashion. A suggestion I'd add would be avoiding the use of the cute and comfortable pads that fit into the cart seats, but prevent the use of seat belts. A possibly dangerous suggestion is to leave younger kids with older ones while in the cart, since I remember all too well my adolescent years trying to "pop a wheelie" by standing on the back of carts to lift up the front wheels and try to balance - a perfect way to tip it over.

I hope the CPSC goes further than they have. I agree with the AAP:

"Parents are strongly encouraged to seek alternatives to transporting their child in a shopping cart until an effective revised performance standard for shopping cart safety is implemented in the United States."

Update: Vincent Iannelli, the pediatrician of about.com, agrees in his post "Shopping Cart Safety."

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CDC Starts Blogging

The United States Government's Centers for Disease Control and Prevention (CDC) is the world's preeminent organization devoted to public health research and disease outbreak control and prevention. It's very exciting to see that their director of the National Center for Health Marketing (NCHM) has begun blogging, and here is Jay M. Bernhardt's rationale:

Every 2 weeks or so I’ll write about different issues related to research, science, and practice in health marketing, health communication, social marketing, information technology, public health partnerships, and other related issues... being part of the government, comments will be moderated to protect privacy and decorum (but not to reduce debate or limit differences of opinion).

I'm looking forward to his writing on health marketing, also called social marketing in some circles. Marketing is considered an evil activity by some, but in the context of social marketing, the purpose is entirely different from Madison Avenue's. NCHM's social marketing seeks to use the best strategies available to provide the greatest good to the greatest number from the best of the research and knowledge the CDC and NCHM has to offer. This kind of social marketing takes the ad agencies' strategies and uses them to promote health, rather than shill a product. I applaud them!

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Metered Dose Inhalers Don't Reveal When They're Empty and Patients Suffer

Could you imagine driving a car without a fuel gauge? In the July 2006 Annals of Allergy, Asthma and Immunology, results from a 500 person telephone survey suggest that patients don't know if there's any medicine left in their metered dose inhalers. Pressurized metered dose inhalers are used by many patients with asthma and COPD (chronic obstructive pulmonary disease). In patients with asthma, one medicine delivered by an inhaler is albuterol (Ventolin) which provides rapid relief of breathlessness by relaxing the smooth muscle in the airways. Having their inhaler available at all times is important in order to prevent worsening breathlessness.

The most common way patients are instructed to monitor remaining medication in their inhaler is by counting down the number of puffs left, which was ineffective for many patients that use inhalers infrequently. Most patients don't count, and insteade consider their inhaler empty when no more puffs come out. Unfortunately, they don't realize that the inhaler only delivers medicine for a certain number of puffs, then afterwards, continues to appear to puff but only is releasing the propellant and pressurized air without any medication. Either situation is dangerous, since the patient doesn't have access to the medication that can save them from more serious immediate breathing problems. In the Annals article, 25% of respondents thought their inhaler was empty when it stopped puffing, and 7 had to call 911 because they couldn't manage their breathlessness with an empty inhaler.

As an allergist's son, I also remember years back when he instructed patients to discard their inhalers when they don't float in water, but now that's been found to be unreliable to see if medication remains due to the remaining pressurized propellant.

The article and accompanying editorial support a counter that would instruct patients how many doses of medication remain. The way it could work is by a mechanism similar to that of a medication i had to use after a chronic cough last year - advair. Although advair (salmeterol/fluticasone) is a delivered as an inhaled powder, it has a counter to let me know how many doses remain. That way I can call for a refill if I needed it, especially with the delay in delivery from my insurance company's mail-order pharmacy which is a lot cheaper, and is willing to provide 3 month refills rather than 1.

References

1. Sander; Chipps
Dose counting and the use of pressurized metered-dose inhalers: running on empty
Annals of Allergy, Asthma and Immunology, Vol. 97, No. 1, pp.34-38

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Magnetic Stimulation of Brain Shows Promise in Stroke Survivors

Leave it to inquisitive Harvard researchers to stimulate brains with magnets to help stroke survivors. In the August issue of Stroke, researchers repeated earlier successes with stroke surviors by magnetic stimulation of the brain on the opposite side of the patient's stroke in 15 patients. [1] Over the 2 week period, patient's abililty to use their affected hand improved. Side effects including confusion and seizures were not found to occur, using EEG (electroencephalogram) and psychological testing.

I've always discounted my in-laws' love of magnets, but now I'll have to think twice. Just how these magnets work, who knows? I'm looking forward to larger studies to see if the benefits are prolonged past 2 weeks and no side effects occur. Even if the treatment needs to be ongoing, I don't see a lot of potential ongoing side effects. I just wonder if the benefit will continue with continued treatment.

References

1. Fregni, Pascual-Leone
A Sham-Controlled Trial of a 5-Day Course of Repetitive Transcranial Magnetic Stimulation of the Unaffected Hemisphere in Stroke Patients
Stroke 37: 2115-2122; published online before print as doi:10.1161/01.STR.0000231390.58967.6b

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Radiotherapy Sets Off Airport Security Screening

This was news to me, which came out in the British Medical Journal editorial today. [1] The BMJ publised a case report of a man who received radiation therapy (radioiodine) to treat his overactive thyroid gland, thyrotoxicosis. [2] Unfortunately, he wasn't told that 6 weeks later, the radiation wouldn't have degraded enough to slip under the radar of Orlando airport security. If he had been carrying documentation of his radiation treatment, he could have saved himself "much embarrassment." Hoorray for Homeland Security's increased sensitivity after 9-11. This serves as a reminder for those travelling, to keep a copy of your medical record if there are these kinds of significant treatments in your history.

How else could one have streamlined the "long period of investigation" that was necessary to clear up these kinds of misunderstandings? One way would be to grant Electronic Health Record (EHR) access to the investigators. An EHR is a combination of the physician authored Electronic Medical Record (EMR) as well as patient access through a Personal Health Record (PHR). PHRs provide patients with read-only access to the physician's documentation of their care, and could have been proof to the investigators that this patient did indeed receive radiation therapy when he claimed to have. PHRs are often designed to allow emergency access to patient's records to ER physicians, so they could be engineered to give access to investigators as well, with consent from the patient. PHRs can provide interaction with physicians as well, but I'll save that for another article.

This is of personal interest to me since both my dad and father-in-law have received radiation therapy for cancer. I remember that shortly afterwards, they needed to wear lead aprons before playing with my infant & toddler. But before many weeks passed, they both went on international flights without incident. I suspect the dose of radiation has a lot to do with tripping the alarms, and I'll be sure to remind my patients who travel a lot to be aware of this fact.

1. Radiotherapy patients can trigger airport radiation alarms
BMJ 2006 333: doi:10.1136/bmj.333.7562.0-a

2. Triggering radiation alarms after radioiodine treatment
Kalyan Kumar Gangopadhyay, Francis Sundram, and Parijat De
BMJ 2006 333: 293-294

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RFID Chips Prevent Sponges From Being Left Behind During Surgery

Radiofrequency Identification (RFID) chips are not just in your Mach3 razor packages, they're showing promise in surgery as well. In the July Archives of Surgery, Stanford researchers found that they could detect sponges left behind with an RFID wand reader with 100% accuracy. [1] Sponges and other foreign bodies are sometimes inadvertantly left behind and the surgical site closed. This can happen even though there's a nurse counting so that each sponge used during surgery is accounted for at the end, before they wrap up. Some time later, these left-behind foreign bodies are perfect places for infections to start since bacteria can grow on them, and the body can't adequately attack these infections.

The researchers had surgeons play hide-and-seek, with an initial surgeon hiding the RFID tagged sponge, and a second surgeon who had not been watching, find the hidden sponges. Every sponge was able to be found, and at no time did the wand reader indicate that a sponge was there when it wasn't.

This is a promising use of technology that originally was designed to track manufactured products through the supply chain. I'm looking forward to having this reassurance in surgery.

One pause of concern is this note from JAMA (Journal of American Medical Association):

"Editor's Note: Dean and Sharon Morris own several patents and have patents pending related to RFID-tagged sponges. Dean Morris is a director and Sharon Morris is a nursing consultant for ClearCount Medical Solutions Inc. This study was supported in part by a grant from the Small Business Innovation Research Program and the National Institutes of Health."

References

1. Macari; Morris
Initial Clinical Evaluation of a Handheld Device for Detecting Retained Surgical Gauze Sponges Using Radiofrequency Identification Technology
Arch Surg. 2006;141:659-662.

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