GAO Report Discredits Home Genetic Test Kits

Yesterday, Dr. Hsien-Hsien Lei of geneticsandhealth.com reviewed a Government Accountability Office (GAO) report to the Senate that over the counter home genetics tests are fraudulent and misleading, specifically discrediting the products of Suracell, Genelex, and Sciona.

“This industry represents a fraudulent mutation of that promise,” says Gordon Smith, R-Ore., chairman of the Senate Special Committee on Aging. Smith, who called for the study, said consumers should visit their doctors for tests if they are concerned about particular diseases.

In an age where we hope to ensure our own privacy by doing our pregnancy and HIV tests at home, the technology behind these genetic test kits are obviously not quite ready yet. I hope that public backlash against these frauds doesn't taint future tests that could be more promising.

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Malaysian Muslims Must Manage Misfigured Mugs

Did my alliteration catch your attention? Well, this BBC article alerted me to the recent National Fatwa Council's decision to ban Botox. Malaysia's top Muslim cleric council decided that Botox contained prohibited substances, including those derived from pigs. In any case, I think wrinkles give character to one's face...

This is unfortunate, with all of the benefits botulinum toxin (Botox) is providing other than for cosmetic improvement. Some medical conditions causing ongoing spasm of muscles and chronic pain have recent case reports of patients experiencing improvement. These are "off-label" uses of Botox, meaning that the FDA has not approved using this medication yet for these purposes.

I think the most important thing to check before receiving any therapy, is to ask your physician what's the evidence for benefit from that treatment. Your doctor will appreciate it since many patients don't take the effort to understand the risks and benefits, and are sometimes disappointed at the outcome.

I'm usually happy when a patient comes in with a pile of internet printouts - it lets me know their interest and background knowledge. I even send my patients home with web links from Healthline to do additional reading. Some of my patients can read these using their Personal Health Record account our our visit, but more on that another time.

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Gastric Bypass Is Superior to Adjustable Gastric Band in Super Morbidly Obese Patients

According to a report in the July issue of Archives of Surgery, gastric bypass is better than adjustable gastric banding in super morbidly obese patients. Why does this matter? Bariatric surgery by laparoscopy, or keyhole surgery, to assist obese patients in weight loss has been proven to work, and is even offered by HMOs such as Kaiser. When an insurance company that is run by doctors, like Kaiser, decides it profits them to provide a surgery -- you can bet it provides some benefit.

What is a super morbidly obese patient? It's a patient with a body mass index greater than 50 [calculated as weight in kilograms divided by the square of height in meters]. That may sound complicated, but it's easy: take your weight in pounds, multiply by 703, divide that answer by your height in inches, then divide that answer by your height in inches again. Check this chart to see if you are under- over- or just the right weight.

The article reviewed the outcomes of 106 super morbidly obese adults, and shows that these patients liked gastric bypass more, lose more weight by it, and suffer less complications from it. This is a small study but is prompting more investigation into just how well gastric banding performs, since it was until now seen as a possibly as effective and less invasive alternative to the traditional gastric bypass surgery.

For more opinions, most of the recent Google News on gastric banding covers this article.

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Ethical Imbroglio Faces Cyberonics Regarding Neuropsychopharmacology Article

In medical school, I thought it was fascinating that electroconvulsive therapy (ECT) was useful in severe depression which was resistant to other treatments. Those memories resurfaced as I was prompted by a recent Wall Street Journal article to read an article in the journal Neuropsychopharmacology which described research showing a vagus nerve stimulator (VNS) having similar promise in treatment-resistant depression.

Who would know what would be disclosed, that every author had an undisclosed financial relationship with the device manufacturer, Cyberonics:

Ronnie Wilkins, the executive director of the medical society that publishes Neuropsychopharmacology, says that the consulting arrangements should have been disclosed and that a correction will be published as soon as possible. He says the authors did report their financial relationships with the company in forms they are required to fill out as part of the publication process. However, he says the consulting information was not included in the manuscript of the review piece as required.

It will be interesting to see what the fallout is regarding the editor of that journal having also been an author of the article in dispute. Cyberonics tries to show it had no influence by granting an unrestricted grant to undertake the research. But the article should have clearly stated the financial arrangements -- curious how that escaped publication.

Electroconvulsive therapy has long been practiced as effective treatment for severe depression and psychotic depression. According to the Nature paper, in 2001 the FDA approved VNS as an alternative to electroconvulsive therapy which lacked evidence of long-term benefit and side effects. Since then, a limited number of patients have been studied, not many more than those reviewed by the Technology Evaluation Center of the Blue Cross Blue Shield Association in August 2005 (TEC).

At that time, the TEC stated that the "available evidence is not sufficient to permit conclusions of the effect of VNS therapy on health outcomes." Specific concerns included the study's definition of treatment-resistant depression and the lack of statistical significance of the results. Some providers define treatment-resistant depression as patients having failed to improve after 6 weeks of therapy on 2 medications, but others allow for a total of 10 to 12 weeks [1]. By defining it with this shorter duration, possibly less severely affected patients were included in the trial. What a lack of statistical significance means is that by the study's numbers you can't be sure that this treatment helped.

Sounds like ECT will continue to be used in severe depression for some time, until these ethical quandries are cleared up and more studies are done.

References:
1. Nemeroff CB. Augmentation strategies in patients with refractory depression. Depress Anxiety 1996-97;4:169-81

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Children's Health First Aid Kits

A friend of mine recently asked what I'd put in my children's first aid kit. Here's what I have (or want to have in it).

• 2 weeks of any prescription medication, including an epipen junior if allergic to the the point of being anaphylactic (a severe reaction threatening one's breathing).

• An oral syringe or calibrated cup or spoon. I find a syringe most easy to draw up the right number of milliliters and to squirt it in my kid's mouths.

• Oral rehydration fluids, such as Pedialyte, to help with the dehydration that infant diarrhea can bring.

• Infant & child thermometers (both digital and ear). The ear thermometers are most convenient and speedy, but sometimes don't work with a lot of earwax.

• Children's and infants' over the counter non-aspirin liquid pain reliever (acetaminophen), to avoid the risk of Reye's Syndrome with asprin.

• Topical aveeno lotion or hydrocortisone cream for insect bites and rashes. Over the counter zanfel or tecnu can help wash out the toxins from poison ivy or oak and relieve the itch in minutes.

• Alcohol swabs to clean skin, thermometers, tweezers, and scissors

• Hydrogen peroxide to get blood out of clothes, I don't use it to clean cuts and scrapes because it damages skin. Soap & water will do.

• Antibacterial cream, also for cuts and for scrapes

• Tweezers for splinters and ticks

• A pair of sharp scissors

• Child-safe sunscreen lotion: SPF 15 is the highest needed, just make sure to apply a thick layer and re-apply after dunking in the water or being worn off after sports and sweat.

• Child-safe insect repellent. Nothing bugs me more than seeing my kids itch incessantly. Pun intended.

• Physician-approved children's-strength liquid decongestant and cough syrup.

• Nasal aspirator bulb which helps suck out nasal thick mucous.

• Bandages with your child's favorite cartoon characters imprinted on them.

• Gauze rolls (1 inch wide) to wrap around arms and legs with cuts and scrapes.

• Gauze pads (2x2 inches) to apply over cuts and scrapes.

• Adhesive tape, preferrably paper tape which doesn't stick so firmly to skin.

• Coban, which is shaped like ACE wrap but functions more like tape, stretchy and only sticking to itself, not to you or anything else like bandages.

• Mild liquid soap, or even better, alcohol based handwash which has been shown to kill bacteria more effectively than handwashing with soap and water.

• A reusable heat/ice pack which can be placed in the microwave or the freezer.

• A pen-sized flashlight to see throats, cuts, and splinters more clearly.

• A First-Aid guide suggested by your physician.

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Mobile Medical Devices During Disaster: Treating Snakebites

The following is my sixth and final comment in a series of articles reviewing FDA guidelines on using Medical Devices in a disaster, with my comments in italics from my reflections about volunteering in medical clinics following Katrina. Concerning Treating Snakebites:

Treating Snakebites

If medical care is rapidly available, then initial treatment should include immobilizing the affected limb and minimizing physical activity as much as possible (ideally entirely immobilizing the patient) during transport to a medical facility.
If care is delayed, a loose-fitting pressure bandage that does not restrict arterial and venous flow (but does limit lymphatic flow) is recommended as a first-aid measure while the victim is moved as quickly as possible to a medical facility. Tourniquets that impair blood flow to the affected limb are generally contraindicated.

Specific therapy for snakebites varies with the type of snake. Procedures such as making cuts over the bite marks and attempting to suck out the venom should not be done. Ice should not be placed on the bite. Immediate transport to a medical facility and treatment with snake antivenin is the treatment of choice.

This is not a condition I encountered in Katrina, although I heard that the floodwaters brought out more snakes. From my experience as an Urgent Care physician, I've encountered plenty of patients who have followed folk wisdom and cut themselves -- even sucking after the cut -- to try and remove venom. These methods aren't effective and tourniquets do more harm by allowing for tissue to be deprived of the blood needed to keep them alive.

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Mobile Medical Devices During Disaster: Heat and Humidity

The follwing is fifth in a series of articles reviewing FDA guidelines on using Medical Devices in a disaster, with my comments in italics from my reflections about volunteering in medical clinics following Katrina. Concerning Heat and Humidity:

Dealing with Heat and Humidity

Heat and humidity can have an effect on home diagnostic test kits (including blood glucose tests used by people with diabetes). Test results may not be accurate. Read your owner’s manual to make sure your test kit is performing properly.

Special Information about Using Blood Glucose Meters

Heat and humidity can damage blood glucose meters and test strips.

If you use a blood glucose meter, check the meter and test strip package insert for information on use during unusual heat and humidity. Store and handle the meter and test strips according to the instructions. Perform quality-control checks to make sure that your home glucose testing is accurate and reliable.

To protect your device from heat and humidity, follow the steps below:
Use a dry cloth to wipe off your device regularly (e.g., mechanical infusion pumps).
Keep your device out of direct sunlight.
Enclose your medical products in plastic containers to keep them dry (e.g., wound care supplies).
Do not use ice if there is a danger of water contamination; use dry ice or instant cold packs to keep your device cool (e.g., prefilled syringes).
Do not use disposable devices that are wet (e.g., wound dressings, disposable thermometers, tubing)

In my experience in Katrina, noone excaped with more than the clothing on their backs, so all of their equipment were waterlogged and heat damaged. In such a extreme disaster, you'll have to depend on the shelters to provide you replacement medication and devices. Hopefully, you'll be faced with a less intense disaster, and if you are prepared with zip lock bags, instant cold packs, and a portable drink thermos, you will be prepared to keep your medication cool & dry for a few hours at least. Hopefully help will reach you in that time. It's important to keep devices in ziplock bags if you keep them in the cooler since water condensation can otherwise damage them.

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Mobile Medical Devices During Disaster: Sterility

The follwing is fourth in a series of articles reviewing FDA guidelines on using Medical Devices in a disaster, with my comments in italics from my reflections about volunteering in medical clinics following Katrina. Concerning sterility:

Sterility
When performing medical procedures, maintain a clean environment by using bleach, alcohol, or a disinfectant in the area you are working (e.g., catheter changes, dressing changes, suctioning).
This was particularly difficult after the flooding following Hurricaine Katrina. Whether it was in the shelters, or where we were in St. Bernard parish, each had sterility challenges. We certainly kept our environment as clean as possible with alcohol wipes and beach to surfaces, but some things couldn't be controlled. A strong wind would regularly whip up the dust left behind in the sediment from the dried up flood waters, settling into every nook and crack. It was challenging to keep ahead of the wind.

Check sterile packaging to make sure it is dry and intact (e.g., sterile gauze).
When you purchase supplies, always check the packaging to make sure it hasn't been damaged.
In addition to checking if the packaging is torn, also make sure it's not expired by checking the expiration date.

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Mobile Medical Devices During Disaster: Water Contamination

The follwing is third in a series of articles reviewing FDA guidelines on using Medical Devices in a disaster, with my comments in italics from my reflections about volunteering in medical clinics following Katrina. Water Contamination:

Some medical devices and equipment, such as dialyzers or IV pumps, require safe water in their use, cleaning, and maintenance.


Hurricanes, especially if accompanied by a tidal surge or flooding, can contaminate the public water supply. In the area hit by a hurricane, water treatment plants may not be operating; even if they are, storm damage and flooding can contaminate water lines.
This was the case after Katrina. Flooding not only brought industrial waste but also oil from tanks displaced from their foundations.

Listen for public announcements about the safety of the municipal water supply.


In an emergency situation, follow these steps to ensure that your water is safe for use with your medical device:

Use only bottled, boiled, or treated water until your supply is tested and found safe.


If you use bottled water, be sure it came from a safe source. If you do not know that the water came from a safe source, you should boil or treat it before you use it.


Boiling water, when practical, is the preferred way to kill harmful bacteria and parasites. Bringing water to a rolling boil for 1 minute will kill most organisms.


When boiling water is not practical, you can treat water with chlorine tablets, iodine tablets, or unscented household chlorine bleach (5.25% sodium hypochlorite).
This was a common way of treating water after Katrina.

If you use household chlorine bleach, add 1/8 teaspoon (~0.75 mL) of bleach per gallon of water if the water is clear. For cloudy water, add 1/4 teaspoon (~1.50 mL) of bleach per gallon. Mix the solution thoroughly and let it stand for about 30 minutes before using it.


Note: Treating water with chlorine tablets, iodine tablets, or liquid bleach will not kill parasitic organisms.

Use a bleach solution to rinse water containers before reusing them. Use water storage tanks and other types of containers with caution. For example, fire truck storage tanks and previously used cans or bottles may be contaminated with microbes or chemicals.
The summer heat allowed for microbes to grow even faster, following Katrina.

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Mobile Medical Devices During Disaster: Power Outage

The follwing is second in a series of articles reviewing FDA guidelines on using Medical Devices in a disaster, with my comments in italics from my reflections about volunteering in medical clinics following Katrina. Power Outage:

Notify your electric company and fire department to let them know you have a medical device that needs power (e.g., ventilator, apnea monitor).
Local fire departments have paramedics who could assist in a more locally contained disaster, but patients depending on devices for life support, such as ventilators need their own disaster planning. Many already do, since they live in an assisted living or higher level of care. Even for those with less dependence on their devices should have a local plan to support their devices for a few days.

Read your user instructions or call your distributor or device manufacturer to find out if your device can be used with batteries or a generator.
Very essential. We were in St. Bernard parish 1 month after the flooding, and no services were available yet.

Locate a generator if possible.
Find a shelter.

Make sure you check for water before plugging in your device. Do not plug in a power cord if the cord or the device is wet.
Devices are not typically intended for immersion. Don't use your device if it's been submerged.

When the power is restored, check to make sure the settings on your medical device have not changed (often medical devices reset to a default mode when power is interrupted).
This is really important, that you have access to whomever needs to make those settings, if they are not able to be set by you.

Warning about Potential Carbon Monoxide Problems when Using Generators

Since many medical devices used in the home require a source of electrical power, generators are often used to supply electricity during a general power outage. The following points should be followed to prevent carbon monoxide poisoning.

Never run a generator, pressure washer, or any gasoline-powered engine inside a basement, garage, or other enclosed structure, even if the doors or windows are open, unless the equipment is professionally installed and vented.
Never run a motor vehicle, generator, pressure washer, or any gasoline-powered engine outside an open window or door where exhaust can vent into an enclosed area.

This was an unfortunate problem and we saw some folks dizzy from carbon monoxide poisoning. I heard of cases of death as well.

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Mobile Medical Devices During Disaster: General Safety

After my experience treating patients in New Orleans following the Katrina Hurricane flooding, i became more interested in using medical devices during disaster. The FDA came out with guidelines regarding this, and I wanted to let you know how well they applied from my on the ground experience. I wanted to give context to these guidelines, pointing out some situations where they may come into play.

This article is the first in a series reviewing the FDA's recommendations, six in total. The General safety guidelines follow, with my comments following in italics:

General Safety
Keep your device and supplies clean and dry.
This was nearly impossible for those escaping from their homes with barely their clothes, much less, their medication. This applies more to medications received in shelters after being rescued.

If you depend on your device to keep you alive, seek emergency services immediately. If possible, notify your local Public Health Authority to request evacuation prior to adverse weather events.
This is tricky since there are many in New Orleans who have "bunkered down" and "rode out" many hurricaines. Hopefully, this recent tragedy will impression in patient's minds the need to evacuate when asked to, and have plans on how to do so.

Always use battery powered flashlights or lanterns rather than gas lights or torches when oxygen is in use (to minimize the risk of fire).
This important to remember for patients who depend on oxygen, since gas generators are often used to power shelters and emergency clinics that are set up.

If your device appears to be damaged, or if you need a back-up device, contact your distributor or device manufacturer.
This isn't very practical in the immediate short-term, but soon after Katrina evacuees settled into shelters, device manufacturers poured donations into the volunteer clinics set up there.

Check all power cords and batteries to make sure they are not wet or damaged by water. If electrical circuits and electrical equipment have gotten wet, turn off the power at the main breaker.
Going one step further, it's not prudent to try and operate a medical device after it's become wet. Most are not designed to endure submersion.

Maintain your device only in a well lit area so you can assess your device's performance (e.g., refilling your insulin pump, checking your glucose meter).

Keep your device in as clean and secure location as possible: off the ground, away from animals or crowded areas.
This is very difficult in the crowded environment of a shelter. Fortunately, I did not hear of one theft among evacuees. More concerning is trying to keep equipment out of the hands of children, since there is no practical way to secure it easily.

Always check your device for pests before you use it (e.g., syringes, mechanical devices).

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Home Health Technology

This eWeek article by M.L. Baker of Ziff Davis Internet, "Report: Digital Health Coming to Grandma's House," covers a Parks Associate report claiming that Home Health providers will increase their use of monitoring technology to decrease their cost and improve the quality of care.

Home health providers are nurses and aides that come to your house to monitor your health and sometimes perform tasks that are too complicated for you to do yourself, such as administer intravenous medication or change wound dressings.

The article points out an important issue facing Home Health, namely, who pays? Thin margins allow for little ability to invest in these technologies. Increasing costs of labor and nursing shortages further pressure the bottom line. Although many devices could improve the quality of care provided to seniors who are homebound, I believe that insurance companies will only cover products that have an established record of improving health enough to decrease hospitalization costs and the costs of caring for complications.

Although the article doesn't name any of these technologies, I know of one. I spoke on a IFTF panel last fall with Pramod Gaur, CEO of Viterion, whose vital sign monitoring device has been approved for over 50,000 Veterans Administration patients due to it's ability to decrease hospitalizations for congestive heart failure patients. It transmits patient's weights to their provider to monitor for an increase, which would trigger a nurse disease manager to provide instructions to use more diuretics (water pills) to drain fluid from their lungs. This is one example of a simple monitoring device, easy enough to use for patients, and simple enough for a provider to work into the workflow of their clinic.

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Recall on Welch Allyn PIC 50 Automated External Defibrillators

This is the kind of news that strikes fear into people who want to be proactive about the safety of their environment, whether it be an airport, convention center, business or their own home. You expect that these Automated External Defibrillators to work without maintenance -- when you stick the pads on someone who's heart has stopped, you expect it to provide a shock, if the person's in ventricular tachycardia, not to display "various error messages on the display panel, including the "Defib Comm" error message." The breadth of time period is pretty suprising as well, 2 1/2 years of manufactured AEDs, "manufactured from March 2002 through October 2004."

I wonder if this will give consumers pause as to the reliability of all AEDs or if they'll treat this as an isolated event. Probably not even the latter, as few folks hear about these MedWatch recalls. Another concern I have is that I received this email a month after the initial report of concerns of a related product on 6/12/06, which I didn't notice: "a voluntary worldwide Class I recall of 580 AED20 automatic external defibrillators. An intermittent electrical connection within the device may result in failure or unacceptable delay in analyzing the patient’s ECG, failure to deliver appropriate therapy and failure to resuscitate the patient. FDA defines a Class I recall as one in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death."

Here's the current recall notice:

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Welch Allyn PIC 50 Automated External Defibrillators
Audience: Emergency services personnel and risk managers

MRL, Inc., and FDA notified healthcare professionals of a Class I recall
of Welch Allyn PIC 50 Automated External Defibrillators, catalog #97108X
manufactured from March 2002 through October 2004. An electrical
contact problem may result in the device's failure to provide a
defibrillation shock, that could result in delay or failure to
resuscitate the patient. This failure may be accompanied by various
error messages on the display panel, including the "Defib Comm" error
message.

Read the complete MedWatch Safety summary, including links to the FDA
Recall Notice and previous MedWatch alert

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