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As I’ve commented many times before, Airborne is just an unsafe product and furthermore, their claims are highly inaccurate. Airborne was sued with a class action suit in California courts for having deceptive advertising and among which it claimed to have a clinical trial on the efficacy of its product. The clinical trial turned out to be fraudulent. The courts claim that theirs was “a fraud scheme alleged to have cost consumers hundreds of millions of dollars.”
They settled out of court Wednesday for $23.3 million dollars. Attorneys on the state side are still going forward with charges, stating that the settlement does not include statues that Airborne must stop their fraudulent advertising. Airborne faces similar litigations in New Jersey federal court.
File for a refund here (you don’t need to have a receipt)
It looks like Merck find themselves in court once again. On January 17, Merck and Schering-Plough are listed as defendants in a class action suit which charges them with fraud and misrepresentation for withholding a study that could be damaging to their drug - Vytorin.
Vytorin (Simvastatin and Ezetimibe), a cholesterol lowering agent, is a joint venture between the two companies, with Merck contributing the drug simvastatin and Schering-Plough contributing Ezetimibe.
The clinical trial in question is called the ENHANCE study. The trial began in June of 2002 and looked at 720 patient who has a genetic disorder which gave them high blood cholesterols. This population is different from the majority of people who are high blood cholesterol who may have a genetic disposition to have high cholesterol, but are more of a result of age and diet.
It was recently discovered that the ENHANCE trial showed that Vytorin did not decrease blood cholesterol more effectively than simvastatin alone and additionally, Vytorin may cause MORE atherosclerotic plaque build-up in the blood vessel than through using simvastatin alone. The rub about this information is that the first part is shown to be statistically significant and the latter point has not shown to be statistically significant (p=0.28).
The ENHANCE trial was first expected to be release in November of 2006 but the companies delay the release until March of 2007 and then again until March of 2008 and at which point the company tried to change the original endpoint of the study and when the FDA took up the investigation.
The companies had foretold that if this research gets out, it would undermine the sale of Vytorin. I personally, don’t think the plaintiffs in this case will be victorious unless they fall into this small population of patients whose high blood cholesterol is caused by their genetics. But through the poor handling of this situation and the public reading poor interpretations of the ENHANCE trial, their reputation and the reputation of Vytorin will be significantly smeared.
I do not recommend that anybody stop taking their prescribed therapy until speaking with their primary care physician.
Stocks of both companies fell today after the news.
Read more coverage on Health
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On Jan. 2, the U.S. Food and Drug Administration (FDA) expanded the indication for a liquid fibrin sealant to help control bleeding during general surgery. Fibrin is a protein that helps blood clot.
The sealant, called Evicel, is sprayed or dripped on small, oozing blood vessels. Once applied, it forms a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery. This approval expands Evicel’s indication to include general surgery applications.
“This approval provides a new option to help control bleeding during general surgery, when other approaches and techniques are ineffective or impractical,” said Jesse L. Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.
Evicel contains fibrinogen and thrombin, two proteins involved in the production of fibrin. Fibrinogen and thrombin are found in human plasma, the liquid portion of blood. The plasma used to manufacture the product is collected from donors who have been screened and tested for blood-transmitted infections. The fibrinogen and thrombin also undergo a two-step process to further reduce the risk for the transmission of potentially contaminating bloodborne viruses. While the potential risk for infectious disease transmission is remote, it cannot be eliminated.
A study of 135 patients undergoing abdominal surgery showed Evicel to be safe and effective in controlling bleeding. Adverse events reported during the clinical trial included anemia, abdominal abscess, blockage of the small intestine, and loss of urinary bladder tone, when the urinary bladder does not empty effectively, which can cause discomfort and infection.
FDA approved Evicel’s predecessor (Crosseal) in 2003 for use during liver surgery. It became Evicel in May 2007 when FDA expanded the indication to include use during vascular surgery.
Evicel is manufactured by OMRIX biopharmaceuticals LTD (located in Kiryat Ono, Israel) and marketed by .
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In a study published January 16th, in the British Medial Journal (BMJ) [equivalent to our New England Journal of Medicine (ENJM)] found that postmenopausal women receiving extra-dietary supplements may be at increased risk of myocardial infarction, stroke and sudden death.
The study was down out of the University of Auckland, New Zealand. They looked at data from a research done on 1,471 postmenopausal women over the age of 55 (average age 74) randomized into a placebo and calcium supplement arm to look at calcium supplement’s effect on bone fracture. The study followed the medical history of these women over five years.
The results showed that:
- Reports of myocardial infarction (heart attack) were significantly higher in the calcium group than in the placebo group (45 events in 31 women versus 19 events in 14 women).
- The occurrence of any three vascular events, myocardial infarction, stroke, or sudden death was also significantly more common in the calcium group (101 events in 69 women versus 54 events in 42 women).
- Because the results were so important, the researchers went back and checked hospital records and death certificates to look for any unreported events.
- After adjusting the figures for the newly found and previously unreported events, they discovered that myocardial infarction (heart attack) was still more common in the calcium group (36 events in 31 women versus 22 events in 21 women on placebo).
- The figures for heart attack, stroke or sudden death also went up in the calcium group (76 events in 60 women versus 54 events in 50 women on placebo) but were shown to have borderline significance.
The researchers concluded that:
“Calcium supplementation in healthy postmenopausal women is associated with upward trends in cardiovascular event rates.”
However they cautioned against rash treatment decisions by saying that:
“This potentially detrimental effect should be balanced against the likely benefits of calcium on bone.” This was particularly important in the case of elderly women they said.
You can read the whole article at BMJ.
So what does all this information mean? There are experts out there who have came out publicly saying that this data is a fluke and should be disregarded. I don’t think this view point is wise to judge the data so harshly, one way or the other. Clearly this data is unnerving, especially when it goes against the commonly recognized practices in medicine, but this data is significant and should be treated with care. In my opinion, something like this should call for is more researchers to look into the problem. A retrospective analysis could quickly be done on previous data done on this patient population.
The women in the study specifically took Citracal (Mission Pharm., San Antonio, TX) perhaps it is this specific formulation that is causing the adverse results, we just don’t know.
If you’re a patient currently on calcium supplement therapy, I would recommend printing out the article and making an appointment with your doctor to discuss your particular situation before making any therapy changes.
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Benefits Check-Up
Free, useful service that lists federal and state assistance programs for older Americans. It was the answer to address the problem of older adults being eligible for benefits and yet not utilizing them. Millions of older Americans may benefit from public programs that offer such things as health coverage, supplemental income and utility bill assistance.
PhRMA
Provides updated lists of patient assistance program directory
Needy Meds
Similar format to RXAssist in that the site provides a catalog of available programs listed according to drug name and manufacturer
Shoot-up to stay drug-free - the promise by Drs. Tom and Therese Kosten, the husband and wife team, researchers at the Baylor College of Medicine, who’ve developed a cocaine vaccine.
According to the Houston Chronicle, the Kostens have been working on the cocaine vaccine for the last decade. The idea behind the concept is to inject a modified cocaine molecule into the body to stimulate the immune system. After the immune system recognizes the cocaine molecule, subsequent exposure to the cocaine molecule will stimulate the immune system to destroy the molecule before it is able to mount its activity on the brain. The reason that the cocaine molecule evades the immune system is because it is too small to be recognized. The Kostens have created a molecule large enough to stimulate the immune system.
It’s a brilliant idea and it is working. From Phase 2 clinical trials, the Kostens found that addicts who receive their vaccine on average use 50% less than they did previously. They are currently waiting approval by the FDA to start Phase 3 clinical trials where they will enroll 300 addicts in their cocaine withdrawal program that will include vaccine therapy and psychological counseling.
There are many ethical issues being put on the table in regards to the vaccine’s use. Although it may be a great tool to stop cocaine addiction, the concern is whether or not it is ethical to give the vaccine to children in an attempt to steer-head their use of the drugs before it even occurs?
[the structure on the left :: Hyoscyamine; right :: Cocaine]
My concern is the medical safety of this vaccine. Cocaine is a small molecule that has chemical properties as well as structures similar to those molecules that naturally occur in the body. In the above figure, one can visually see that cocaine is a very similar in structure to the drug hyoscyamine. Hyoscyamine is used to calm intestinal spasms. What will happen when we create an immune system that looks after similar molecules? Yes, it does destroy the cocaine molecule when it sees it, but does it also destroy drugs with similar structure or naturally occurring molecules in the body with a similar structure?
That being said, it is wise to note that there are over 22 million cocaine users in the United States, costing the US population nearly half a trillion dollars annually. In the end, I’d to take a quote from Dr. Peter Cohen, a Georgetown law professor and chairman of the District of Columbia Medical Society’s physician health committee: “Overall, the benefits to society of such vaccines would outweigh the risks. There are certainly important issues there, but I don’t think any are insurmountable.”
American Diabetes Association (ADA)
This is as “must” source for newly diagnosed diabetics or those wishing to learn more about their condition. The site has sections for those who were recently diagnosed, those with Type 1, or Type 2 Diabetes along with an “Ask the Pharmacist” area. The ADA also supplies a newsletter that diabetics may subscribe to in order to receive news and events occurring in the world of diabetes.
For a much more interactive presentation on Diabetes provided by the ADA, users may watch Link for Life. Also available is a Diabetes Risk Test.
Not all glucometers work the same way and the importance of measuring ones blood glucose cannot be stressed enough. For those who need more help in learning to use your meter, please check this link. According to the FDA, it lists the Diabetes Education programs recognized by the American Diabetes Association. These Recognized programs meet the National Standards for excellence in diabetes education.
Diabetes Research and Wellness
This is a non-profit organization that offers free diabetic resources including free a pocket diary, diabetes identification card and diabetes necklace. The necklace will alert healthcare providers about your condition before they treat you.
Drug Companies Diabetes Resource Sites
Drug companies offer online diabetic tools for diabetics and especially for those patients who are using their meters.
Novo-Nordisk: Diabetic management features such as a diabetes care plan, menu planning tools, and stories written by patients on ways to live with diabetes
BD Diabetes: Provides flash-based patient education animations on how to draw, mix, and inject insulin. It even has a section for diabetes and pets.
Health 2.0 Sites
MySugarLevel
Tracking sugar site that charges users for access. Allows users to track and monitor sugar levels.
SugarStats
Site that allows you to monitor your suguar levels along with your foods. It provides users with graphs and trends.
TuDiabetes
Community for those affected by Diabetes. The site contains social networking features such as blogging, adding friends, and groups.
dLife
Diabetes resource that contains Q&A with experts, recipes, the “Wall”, and blood sugar management, among others.
Other related:
Johnson and Johnson’s Tour de Cure
The FDA recently (Dec 12, 2007) approved ProDisc-C for cervical vertebra use. They first approved ProDisc-L for lumbar-vertebra use in Aug 2006.
ProDisc was designed in the late 1980’s by a French Spinal Orthopedic Surgeon name Thierry Marnay. Marnay implanted this artificial disc into 64 patients in the early 90s and almost a decade later these patients were studied to determine the long-term results of implantation. Three patients had died from unrelated causes, but the remaining 58 were studied extensively at 7-11 year follow-ups. All implants were intact and functioning. There had been no implant removals, revisions, or failures.
There was no evidence of subsidence (sinking or settling in bone) on follow-up radiographs compared to the peri-operative films, as reported by the operating surgeon as well as by an independent US Orthopaedic spine surgeon.
A significant (99.99% confidence) reduction in patient-reported back pain and leg pain was identified. 92.7% of these patients were “satisfied” or “extremely satisfied” with the procedure.
Two-thirds of these patients had single vertebra implants while one-third had two vertebra replaced. There was no outcome difference between the 1 and 2 level ProDisc implantations.
During follow up, there were no device-related safety issues, no untoward effects, no complications and no adverse events.
ProDisc is made of metal endplates made of a cobalt chromium molybdenum alloy (CoCrMo). The convex bearing surface, snap-fit into the inferior end plate, is made of ultra-high molecular weight polyethylene (UHMWPE). The artificial disc is attached through a large central keel and two spikes on each endplate. Physiologically, the ProDisc matches the range of motion in flexion, extension, axial rotation, and lateral bending as a normal spine.
From these positive results, the ProDisc has been implanted in over 8000 patients in Europe since December 1999. A multicenter FDA study was started in the United States in October 2001. The first ProDisc in the United States was implanted at the Texas Back Institute on October 3, 2001. Nineteen study centers participated in the prospective randomized study, comparing the ProDisc to the current standard treatment of a 360° (front and back) fusion using allograft in the intervertebral space and pedicle screws with autograft posteriorly.
ProDisc is the only one of the artificial discs undergoing FDA trials that is being investigated for multiple level lumbar disc disease. Other disc replacement devices include: Maverick, Flexicore, Kineflex.
The two level study arm completed enrollment in November 2003. Continued Access in this arm began in January 2004, where a limited number of patients may be treated at study sites with two-level ProDisc surgery as long as they meet the original study criteria, and continue follow-up for collection of safety data.
Thanks for the input and collaborations with Dr. Sue Snyder.
As covered in a story from Venture Beat and from their own press release, Cogentus Pharmaceuticals of Menlo Park, CA just received $62.5 million in third round funding for their combination drug of clopidogrel (an anti-platelet) and omeprazole (a proton pump inhibitor). The idea behind this combination is omeprazole will help with the gastro-intestinal side effects of clopidogrel, a “blood thinner.” Both of these drugs have recently gone off patent and can be reproduced cheaply.
Convention would suggest that a doctor would not prescribe a combo-drug when two generics are cheaper for the patient. However, the market proves otherwise. On the list of top 200 drugs prescribed, we find many combo-drugs such as Advair Diskus, Vytorin, Symbyax, etc. Combo drugs are convenient for patients, and if a company could get the doctor to be aware of their drug, they’ll probably prescribe it because taking one drug vastly improves a patient’s compliance to drug therapy as compared to taking two drugs. Unfortunately, there’s a large hurdle for Cogentus, and that is the third party payers.
The successful combination drugs on the market all contain one common characteristic - at least one of the drugs in the combo is still under patent and buying them in a combination form would save money for a patient/third party payer compared to buying the two drugs separately. If the third party payer does not put Cogentus’ drug onto their formulary, it may be written, but it’s not going to be dispensed. Making a drug attractive to a patient and prescriber is not good enough, Cogentus needs to make a drug attractive to the third party payer. If I was Congentus, I’d try to obtain really good pharmaco-economic models on how the drug would be saving money.
There is yet one last hurdle for Cogentus’ combination drug and that is other generic companies. The generic manufacturer is on a crowded list of companies who function on slim margins. If Cogentus is successful with their venture, what is to prevent a company like Teva from coming along and copying it?
MyOpenCare, a health site that we previously mentioned has announced a compelling competition.
The site has announced the “Create an H-Book and Win Company Shares” contest. In an effort to encourage greater member involvement in the site, the company will offer the winner of the best H-Book 0.5% shares in the company and those finishing second through sixth place will each receive 0.1% of MyOpenCare shares. The H-Book, otherwise known as the Health Book, is is a feature that every User has access too. It allows users to display information about particular disease states and conditions. However, unlike Wikipedia, MyOpenCare gives credit to the author.
The contest is a smart marketing move by MyOpenCare - increase user participation while promoting quality information.
This is from the pile of cool products you may not know existed. The GlucoWatch is made by Cygnus, Inc of Redwood City, CA and was approved by the FDA on March 22, 2001. In March of this year, Animas Corp of West Chester, PA bought out Cygnus for $10 million. As of July 31, 2007, Animas will no longer be marketing the GlucoWatch.
What is it?
The GlucoWatch Biographer is a glucose monitoring device that a patient wears like a wrist watch. Glucose measurements are taken non-invasively through the skin every 20 minutes for up to 12 hours at a time. The GlucoWatch measurements are not intended to replace finger-stick glucose measurements, but instead should be used to detect trends and patterns in glucose levels. It is only approved for use in adults age 18 and over.
How does it work?
After a 3-hour warm-up period, the patient calibrates (sets) the GlucoWatch Biographer using a finger-stick measurement. After calibration, the Biographer will begin monitoring glucose values. A low level electric current pulls fluid through the skin into gel discs in the Biographer. Electrodes in the Biographer measure glucose in the collected fluid for up to 12 hours at a time. The GlucoWatch Biographer also contains a built-in alarm that can be programmed to alert the user when results fall below pre-set low levels and above pre-set high levels.
Why is it used?
The GlucoWatch Biographer is not intended to replace fingerstick measurements but used to see the rise and falls of glucose throughout the day that intermittent fingerstick measurements cannot tell. This additional glucose information may help people with diabetes and their healthcare practitioners better manage their disease by providing more information on glucose trends.
So why was this product so successful?
There were many reason why the GlucoWatch didn’t succeed, but in my personal opinion as a healthcare practitioner, the primary reason is because it wasn’t accurate. The reason that the GlucoWatch wasn’t accurate is because the glucose that they measure was plasma glucose that had traveled through all the tissue of the skin, whereas fingerstick measurements take the glucose out of whole blood (a droplet of blood). A practioneer and a patient needs to count on the accuracy of any test measurements, the GlucoWatch just did not provide that stability. It’s a great idea, and one that is critically needed, but the execution needed some work.
Hologic, Inc. announced that the FDA Obstetrics and Gynecology Devices Advisory Panel recommended the pre-market application for Adiana Permanent Contraception for female sterilization as approvable in a panel vote of 10 to 3.
The FDA is not required to accept the panel’s decision, but traditionally follows their recommendations. The panel recommended approval of the device contingent upon several conditions, including long-term follow up of current pivotal trial patients, a new post approval study of new patients and physicians, and more specific labeling recommendations.
Bilateral tubal ligation — commonly referred to as “getting your tubes tied” — is the most common form of contraception used throughout the world. The surgery is typically performed in a hospital operating room under general anesthesia and requires the physician to make one or two incisions in the abdomen. This usually requires approximately four to five days of recuperation.
In contrast, Adiana is a minimally-invasive, non-incisional alternative. This procedure uses hysteroscopy, generally requires only local anesthesia, and can be performed in a physician’s office. Patients are typically able to return to work or resume their everyday activities within a day.
Adiana is a novel, two-step approach to permanent contraception. First, a catheter is positioned immediately inside the opening of the patient’s fallopian tube using a hysteroscope, eliminating the need for any incisions. The catheter applies a very low-level of bi-polar radiofrequency (RF) energy to remove a thin layer of cells that line a 1cm section of the inside of the fallopian tube. The catheter then delivers an implantable, soft polymer, called a “matrix,” which remains within the prepared section of the tube. The matrix is smaller than a grain of rice. The procedure is then repeated on the other fallopian tube. Healthy tissue will grow into the matrix, creating a complete blockage of each tube.
As mentioned earlier in an article on Disaboom, a site should be accessible to a wide range of users. A lot of sites incorporate flash which is not user-friendly for blind individuals who utilizes screen readers. In the realm of healthcare, sites that are developed for patients should take note to build a site that is user-friendly and accessible to different types of the patient population. With that said, an interesting article on Businessweek discusses and asks the question of: “Is your web site handicap-accessible?”
Highlights of the article:
- Class action law suit against Target filed in 2006 Alameda County by National Federation of the Blind : Law suit alleges that Target’s refusal to make its website accessible to the Blind violates the Americans Disabilities Act
- Having a site revamped for disability access may cost $5,000 to $15,000 but return on investment from increased search engine optimization
- Find a web designer who is familiar with Section 508 Compliance
SEX ID
A set of visual challenges developed by psychologists to [Source: BBC World]:
- Get a brain sex profile and find out if you think like a man or a woman.
- See if you can gaze into someone’s eyes and know what they’re thinking.
- Find out why scientists are interested in the length of your fingers.
- See how your results relate to theories about brain sex
How Pregnancy Happens
When does pregnancy occur? It’s a simple question but a lot of people are confused about the process. This is a flash clip developed to illustrate the process. The character design is…explicit but the explanation is entertaining.
SearchMedica is a search engine developed primarily for physicians. Unlike other engines that search the entire world-wide web for information, SearchMedica only delivers results from websites dedicated to health professionals. These websites may include credible journals, evidence-based articles, and national associations.
Results are neatly categorized into areas that are meaningful to a clinician. The categories include:
- Research Reviews and Editorials
- Practice Guidelines
- Patient Education Materials
- Clinical Trials for Patients
- Continuing Medical Education
The engine was developed by CMP Healthcare Media.
This is a useful engine for those practicing in family medicine. It cuts out the clutter and delivers relevant and useful information.
Doctors and Med 2.0
Business Journal’s interesting article on doctors trying med 2.0. Article highlights are:
- Fliqz launches customized website for HealthGrades, allowing visitors to virtually tour various medical facilities as well as view a physician’s bedside manner.
- In May, Johnson & Johnson sponsored blogger’s events in Las Vegas
- Medem and Youtube strike a deal to bring internet videos to physicians, allowing them to create and broadcast welcome videos for new patients
Microsoft’s Digital Health View
Microsoft painting a rosy picture of the future of digital health. In the article, Bill Crounse, Microsoft’s worldwide health director, sketches the future of healthcare dominated by tablet PCs and real-time patient monitoring.
Comment: Like most pharma companies who design difficult-to-use glucometers, these technology companies do not realize how user-unfriendly some of their products are. What’s the use of overloading a product with neat tools if patients are unable to figure out how to use it?
Telemedicine becomes more valuable as number of seniors increase
Physicians and healthcare experts are predicting that telemedicine is the answer to caring for chronically ill elderly patients. The core of the software is the ability to track data such as blood pressure and medication adherence. The other major area of telemedicine is the ability of alerting-on call medical professionals if vital signs are not within desired limits.
[Source: Inside BayArea, Worcester Telegram]
Comment: The best form of a telemedical device has to be touch screen. You eliminate the cumbersome use of the mouse and decreases the learning curve of using the system.
ABC’s World News reports that the health IT at the Veterans Health System is considered by most experts as “one of the best health care systems in the country.”
Most private hospitals repeat 20% of their lab tests because physicians are unable to find the patient’s results. However, unlike the VA system, the lab results are kept in an EHR, saving millions of dollars from repeated lab tests. Along with the superb EHR is the use of an electronic band.
Patients are provided with a band that looks like a typical hospital ID. This band is an electronic monitoring device that when scanned, provides a photo of the patient along with his current treatments.
Video available here.
[Source: ABC World News]
Comments
The VA Medical System’s EHR is superb. It takes less than 5 minutes for a new VA healthcare professional to figure out where to find lab results. However, it is not just the VA’s user friendly EHR that reduces costs, it’s also their operation and approach to patient care.
Unlike a lot of private hospitals, the VA is heavy on utilizing a multi-disciplinary approach. Each medical team consists of a a clinical pharmacist who rounds with the medical residents. So you have your doctors who are the diagnosing experts along with the pharmacist who is the drug specialist. During each patient case review, nurses are also involved in the discussion of the patient’s everyday progression. This allows for a detailed approach towards caring for the patient.
In addition to their multi-disciplinary approach is their drug-check system. Every order inputted by a medical resident or attending is sent to the inpatient pharmacists who double-check the drug dose, allergies, use, proper dosage according to lab results and so forth. This reduces errors as well as provides improved patient care.
WiiFit was launched in Japan and will not be available in the United States until next year. However, if you are really gung-ho about getting your hands on this game package, you can try snagging one at Success-HK, Play-Asia, or Amazon Japan.
The WiiFit bundle comes with a copy of the WiiFit and the Wii Balance Board. The game begins by calculating your BMI which it then uses to set your individual fitness goals. After the game obtains the necessary information, your body receives a “real age” based upon your BMI rating along with the appearance of your avatar. So you may be older or younger, based upon your “real age” and how healthy you’ve been keeping yourself. After the 20 seconds the system takes to determine your BMI, you have a variety of games to choose from, including yoga, skiing, and soccer.
Just how popular is WiiFit? It is currently the top selling game on Amazon Japan [Source: PunchJump] with product reviews averaging 4.5/5. The WiiFit is going to make a huge splash in the United States with plans of launching next year.
This is probably the ultimate combination of Health and Games 2.0 combined. Who knew that being healthy could be so much fun?
[Picture Sources: iDorkas , GoNintendo]
[Source: Famitsu]
Picture 1: The line for WiiFit [Famitsu]
Picture 2: The Wii Fit System [GoNintendo]
Picture 3: WiiFit Yoga [IDorkas]
Picture 4: WiiFit Games [IDorkas]
Picture 5: WiiFit Checking out [Famitsu]
The Journal of the American Medical Association review of autopsy studies found that doctors misdiagnose 8 - 24% of the time. According to Jerome Groopman, author of How Doctors Think and chairman of experimental medicine at Harvard University, errors are due to what experts term “anchoring” Anchoring is when a healthcare professional is stubbornly stuck on a diagnosis and fails to consider other possibilities.
Doctors are increasingly using the internet to assist in finding answers to a patient’s ailments, according to “Googling for a Diagnosis” a British Medical Journey conducted last year. While some are “Googling for a Diagnosis”, others turn to Isabel, a decision support system already implemented in 18 hospitals across the United States.
Isabel is simple to use. Healthcare providers enter typical patient data such as age, gender, pregnancy status, location, and symptoms. The system then releases possible diagnoses neatly categorized into different types of diseases and other possible causes such as medication. The software also takes into consideration the diseases native to a particular part of the world.
While technology advances medicine, it is important to know that it will never surpass the individual judgment of a healthcare provider. Although the lofty sum of $50,000 a year to use Isabel is pricey, the potential cost-savings associated with preventing a diagnosis error as well as ensuring the well-being of the patient is worth every penny.
The cost: around $50,000 a year for a 300 bed hospital
Demo: USA News, Official Isabel
[Source: USA News]
Other related:
The Medication Errors Panel, Persuant to California Senate Concurrent Resolution 49:
“The most recent estimate of costs associated with drug-related morbidity and mortality in the U.S. exceeds $177 billion per year. Amazingly, this amount is significantly greater than the amount actually spent on prescription drugs during the same year. In terms of patient harm, the Institute of Medicine projects that at least 1.5 million Americans are sickened, injured or killed each year by medication errors. “
We have covered Health 2.0 in regards to websites and games but there’s a small uprising in another area of medicine, call it Doctor Visit 2.0, a word HippocraTech KF reader termed.
Jay Parkinson, MD/MPH can probably be called the ultimate Dr. Geek, or rather, Dr. “House” (as in house calls). This 31-year-old physician began his New York medical practice in September, shorty after finishing his residencies in pediatrics from St. Vincent Hospital and Preventive Medicine from Johns Hopkins. Because of his unconventional approach to medicine, he already has a TV series planned for next season, a book deal and he was recently interviewed on the Colbert Report.
Dr. Parkinson’s approach has been termed by the media as “Medicine 2.0.” He incorporates the use of video chat, e-mail, and IM into his medical practice. Patients can see “open-slots” on his website where he uses Google Calendar then text him for an appointment.
After receiving the text, Dr. Parkinson would then personally go see the patient even if it is within the next hour. Patients spend 10-15 minutes filling out their health information on the website before the visit so that Dr. Parkinson has a snapshot of the situation, saving both him and the patient time.
During the housecall, he performs physical exams, explains his services, and assesses the patient’s medical status. Visits usually last about half an hour. His electronic medical record is ran on his iPhone and he uses a Mac computer.
The cost of his medical startup: less than $1500 (HisTalk)
Other coverage: NY Post, Gothamist, GeekSugar, Wired, WSJ
A phenomenon that most diabetics often encounter is hypoglycemia or an abnormally low level of blood sugar. Because the brain runs primarily on glucose, hypoglycemia may severely harm the patient, putting them into a coma or worst. The most common causes of hypoglycemia are certain classes of anti-diabetic medications or insulinomas. Whatever the cause, it is recommended that diabetics carry glucose tablets in case of a hypoglycemic event.
Novo-Nordisk has just released a kit called the GlucaGen HypoKit (see picture below) that allows a patient to inject glucagon directly into their system.
Taking a look at this needle and syringe system, it looks intimidating to use. The directions released from Novo Nordisk are as follows:
Just in Case - Simple Steps for Use
- Insert the needle through the stopper and inject all the liquid into the vial
Insert the needle through the rubber stopper on the glucagon vial. Inject all the liquid in the syringe into the vial. The rubber stopper can be stiff, but the needle is strong enough to puncture it.
- Gently shake the vial
Leave the syringe in place and gently shake the vial until the powder is completely dissolved.
- Withdraw all of the liquid into the syringe
While the needle is still inside the vial, turn the vial upside down and while keeping the needle in the liquid, slowly withdraw all the liquid into the syringe.
- Inject the solution into loose tissue
Insert the needle into loose tissue under the injection site and inject the glucagon solution.
- After GlucaGen HypoKit Treatment, Give Extra Carbohydrates
As soon as the person awakens and is able to swallow, he or she should be given extra carbohydrates. This is especially important in children and adolescents. These carbohydrates can include a fast-acting source of sugar — such as a regular soda pop or fruit juice — and a long-acting sugar — such as crackers and cheese or a meat sandwich.* It is recommended that the person with severe hypoglycemia be examined by a doctor.
My question is, why didn’t Novo Nordisk make it easy to use like the Epi-Pen?
The directions for the EpiPen is as follows: 1) pop the safety cap 2) jab the pen into your thigh 3) call 911.
In an emergency situation, an individual does not have time to fidget with a needle and syringe (the effects of hypoglycemia is light-headedness, shakiness, confusion).
Novo Nordisk, turn the GlucaGen into the GlucaPen, and then perhaps you’ll save some lives.
The following are sites that connect patients to clinical trials. Clinical trials are controlled drug/device testing environments conducted on disease states that have no current treatment or try to improve upon a current treatment.
This is not an endorsement for any of these sites or any particular clinical trial but rather serves as another resource for physicians to explore options for their patients. Please remember that these trials have both benefits as well as risks.
ClinicalTrials.gov
This site is developed and maintained by the National Library of Medicine at NIH. It contains updated information on a variety of clinical trials that are sponsored by NIH, federal agencies and academic medical institutions. Users may enter geographic or descriptive search terms and a list of open clinical trials along with eligibility criteria and contact information shall be provided.
CenterWatch
CenterWatch allows physicians and patients to locate on-going clinical trials that may be appropriate to their specific condition. The site provides an alphabetical geographic listing of available clinical trials complete with protocol descriptions, eligibility criteria, as well as contact information. Interested patients may sign up with the Notification Service which will provide e-mail updates in regards to the status of a new or ongoing clinical trial.
The Washington Post reports that Revolution Health, created by AOL founder Steve Case, has acquired two new websites to join the revolution offering. HealthTalk, a site focused on patients with chronic diseases and SparkPeople, a site that is dedicated to the fitness of its users.
According to Steve Case: “We are building a platform that reaches the largest possible audience, and in the process want to build the largest health brand from a consumer standpoint.”
October data gathered by comScore, an Internet market research firm reports the following:
- Revolution Health - 105 million page views
- Spark People - 84 million
- Health Talk - 8 milllion
Thus far, Revolution Health has (source:Washington Post 12/5, Heath) :
- Revolutionhealth : health information site
- Drugstore : site that allows users to purchase health related items
- CarePages : social-networking site for people with chronic illness to connect and discuss issues
Comments
It seems like Revolution Health, in an effort to outdo WebMD, is on a buying spree. A better strategy is to not buy more information of what consumers already have, but give consumers what they need but isn’t yet available. In addition, the site should focus more upon perfecting the user-interface to make it friendlier for everyone to use. Most importantly, the site needs to work on its branding among health professionals and patients.
Currently, Revolution Health is known as the “site that the AOL founder guy created,”not “the site I go to find health information.” Steve needs to look into building the brand name by seeking opportunities to sponsor national marathons such as the Avon Walk for Breast Cancer or the MS Walk. “Revolutionizing” health isn’t about acquiring multiple sites, it’s about “doing” something that people need. Show users that you’re “revolutionizing” health. A start would be to have Revolution Health employees participate in health marathons or hold fundraisers. Revolution Health is doing a lot virtually but what are they doing in real life to build their brand?
More Pharma companies are embracing the Internet as a means of advertising medication and marketing their brand. According to the Baltimore Sun, the latest players to enter the shift to online advertising are AstraZeneca and Merck Co. Because doctors have little time and patience for unannounced pharmaceutical representatives to provide drug presentations, these Pharma companies have implemented the Web into their marketing strategy. Among other things, pharmaceutical representatives from these companies are booking appointments with doctors via websites for drug presentations.
According to Merck Co., the average online appointment with a physician is 10 minutes compared to 4 minutes in person. A survey reports that “nearly half of all physicians prefer to learn about new medications through the Internet, instead of through a salesperson.”
Also covered by: USA Today, Star Tribune,
Related
Fora.tv: Mashup’s article on Pfizer partnering with Fora.tv to launch a Health and Wellness channel.
Johnson & Johnson Launches Medical Assistance Program Drug Tool
Pharmaceutical Marketing: Stuck in Web 1.5: Interesting analysis on percent of patients looking for information online as well as information on the online marketing services or programs that US Pharmaceutical Marketers provide to consumers. Studies show that the pharmaceutical companies are stepping into the Health 2.0 movement are causing them to miss opportunities to build relationships with patients.
Pharmaceutical Marketing: Stuck in Web 1.5: Interesting analysis on % of patients looking for information online as well as information on the online marketing services or programs that US Pharmaceutical Marketers provide to consumers. Studies show that pharmaceutical companies’ baby-steps into the Health 2.0 movement are causing them to miss opportunities to build relationships with patients.
BurstMedia: Survey done on 3,700 users that found women ages 25-34 as the power searchers of online health information.
Digital Communities: 2007 Consumer Medical and Health Information poll, commissioned by Ask.com and conducted by Harris Interactive found that Americans turn to the Internet for health information nearly as often as they turn to doctors.
Chicago Tribune: More people are turning to the web for health information. “Boomers are the key drivers of that shift. Fifty-three percent of all visitors to health sites are age 45-to-64, according to comScore Media Metrix.”
Fora.tv: Mashup’s article on Pfizer partnering with Fora.tv to launch a Health and Wellness channel.
JNJBTW: Johnson & Johnson enters the blogsphere.
Hearst Magazine’s acquires the website RealAge. RealAge is a site that that provides users with an online test where they answer questions and in turn, the site spits out the user’s “biological body age.” The site has about 8 million users, mostly women aged 30-59 years old. The Herald Tribune believes that the acquisition price was near $100 million.
Man has three loves in his life: his work, his family and his best friend….whether you call this best friend a dog, cat, fish or even a pig. The current boom of combining healthcare with the internet has been obsessively and narrowly focused upon the healthcare of humans, leaving a “Dolittle” hole.
While there are social-networking for animals such as Dogster and Catster, that offer some medical information, there is a lack of a resource totally dedicated to the health of our furry friends. Animals are prescribed the same types of medications as do humans. The difference is in the dosage as well as how they respond to the medication’s side effects. Different animals take different doses and respond differently to medication.
Where do I go to look if my Great Dane or German Shephard was responding strangely? I can’t ask my dogs if they’re feeling nauseous or dizzy. Where do I go to look up medication administration to my dogs who always manage to eat the entire hotdog yet spit out the hidden pill?
Health information delivered to veterinary pets are different from that of humans. With that being said, this is an untapped, unpenetrated area of “Health 2.0″ that should be addressed. Our furry friends deserve the same amount of care as we do. Perhaps…the Pet 2.0 revolution?
Feline Health Videos
A video site developed by Cornell University College of Veterinary Medicine. The site provides videos on:
- caring for your diabetic cat
- giving your cat a pill or capsule
- giving your cat liquid medications
- trimming your cat’s claw
- taking your cat’s temperature
- brushing your cat’s teeth
Cornell also provides Consultant, a “database designed to link over 500 clinical signs and symptoms to nearly 7,000 possible diagnoses or disease conditions. Thus, it can help you find summary information about animal diseases. In addition, it can assist in compiling lists of diseases with certain clinical signs, such as all of the dog diseases that have “diarrhea” as one of the clinical signs. Consultant also contains a selected list of up-to-date journal articles on each diagnosis. “
Merck Veterinary Manual
“The Merck Veterinary Manual is the single most comprehensive electronic reference for animal care information. It is brought to you as a service of Merck & Co., Inc., providing quality medical information on a not-for-profit basis for more than 100 years, and Merial Limited, dedicated to producing a wide range of pharmaceuticals and vaccines to keep livestock and pets healthy and productive.”
Traineo + Dogster
Dogster and Traineo have teamed up to develop the “Dogster.com Fitness with Dogs Group.” The site’s purpose is to not only get pets into shape, but pet owners as well. Users will be assigned a “Training buddy” when they register as well as have the option of sharing ideas on how to get both their pet and themselves in shape.
On September 27, 2007, President Bush signed the Food and Drug Administration Amendment Act of 2007 or FDAAA. Along with continuing FDA user fees, the act contained numerous other issues and is considered the most significant revision to the Federal Food, Drug and Cosmetic Act (FDCA) in decades. We’ll cover the overview of it here.
- Drug User Fees
- Pediatric Research
- Clinical Trial Databank
- Post-marketing Safety
Drug User Fees
Currently the FDA charges companies to submit their application for New Drug Application (NDA), this was to expire September 30 of this year. This expiration prompted the quick passage of FDAAA – Title I, the Prescription Drug User Fee Amendment (PDUFA). This amendment authorizes the FDA to continue to collect these fees until 2012, increasing total fees by $90 million a year to $393 million annually. Additionally, it allows the FDA to collect an additional $225 million to enhance drug safety. One of these fees will come from direct-to-consumer television advertisements. The fee is for reviewing such ads.
Pediatric Research
Title IV – Pediatric Research Equity Act (PREA). This act requires manufacturers of new ingredients, indications, dosage forms, regimens and route of administrations to submit a pediatric assessment. Manufacturers may request a waiver if pediatric formulations are not possible. PREA is active through 2012.
Clinical Trial Databank
Title V – Requires that all drug/device/biologics clinical trials (except Phase I) be registered in an FDA controlled database. This is significant to what was previously required of “serious or life-threatening” diseases. The information from the database will include demographics, primary and secondary outcomes. The intent of this section is to enhance patient access to and understanding of clinical trial results. A penalty of $10,000 per day will be accessed for those companies who do not follow these guidelines.
Post-marketing Safety
Title IX – strengthens the FDA’s powers of asking companies for post-marketing studies on their drugs. One of the biggest problems that I have with the previous FDA system is the lack of post-marketing data from drugs. In the current structure, the FDA uses primarily Phase 3 clinical trials (large pre-marketing clinical trials conducted on thousands of participants) to decide passage of a New Drug Application (NDA) and rarely asked for Phase 4 clinical trials (post-marketing) data.
While at the FDA, I brought up the issue of Phase 4 trials on numerous occasions but quickly became aware that changes could only be done from the top (Congress). Title IX still does not go far enough in regards to post-marketing data. In my perspective all manufacturers need to conduct Phase 4 trials. While Phase 3 trials are large (thousands), Phase 4 trials can contain millions of participants and a much broader patient demographic.
With the recent string of debacles at the FDA, the public does not understand that the FDA is drastically under-funded to look after the prescription drug/device/biologic market. I am really glad that FDAAA allows the bureau to obtain more money and consequently more man power to regulate this system.
December makes me think of JC, a 20-year-old patient who was rushed into the Emergency Room after he was found collapsed on the lawn. We couldn’t save him. It wasn’t a heart attack or a drug overdose, he died because he was on Lipitor (atorvastatin) 40mg every day and drank a large amount of grapefruit juice. His mother, with all the best intent, bought him grapefruit juice because she read in a magazine that it helped in lowering cholesterol. The grapefruit juice inhibited the breakdown of Lipitor (and all statins like it) to a toxic level in his blood.
One of the biggest issues that have always bothered me is the amount of counseling given to patients in regards to drugs. While there is an emphasis on drug-drug interactions, I have noticed that there is a lack of emphasis on drug-food and drug-herbal interactions.
Are people aware that grapefruit interacts with statins, anti-arrhythmics (i.e. amioradone), some anti-depressants and many other drugs?
Does someone who is on a monamine oxidase inhibitors(MAOI - i.e. Selegiline, Isocarboxazid) know that he should avoid tyramine containing foods such as cheese, sauerkrauts, snow pea pods?
We cannot assume that patients will read the package inserts.
With that being said, here are some sites that send users the latest information about their medication or alert users of FDA recalls due to an adverse reaction such as the Vioxx situation. Unfortunately, I am unaware of any alerts that reminds users of drug-food or drug-herbal interactions.
iGuard
iGuard is a drug alert system that sends users notification of important safety information. It alerts you when there is information pertaining to your drug sent by the FDA, drug manufacturers, or the scientific community. It also provides you with a personalized risk rating that assesses your risk for a potential side effect along with its potential severity. The site was developed by Dr. Hugo Stephenson, who was President of the strategic research and drug safety division of Quintiles Transnational, a firm providing clinical research services to the drug industry.
FDA e-Mail Alerts
The FDA sends e-Mail alerts in the area that you are interested in. Of particular interest are the subscriptions under “Consumer Health Information”:
- FDA & You
FDA newsletter on medical products and health topics for teens, parents and educators- FDA Consumer Education about Medicine
Consumer education on making the best medicine choices, buying safely, and using medicine safely and effectively- FDA Consumer Health Information
Timely and easy-to-read articles on product approvals, safety warnings, and other health information. Articles cover all FDA-regulated products, including drugs, medical devices, vaccines, blood, food, dietary supplements and cosmetics- Maturity Health Matters
FDA newsletter on regulated products for older adults, their families and caregivers.- Medicines in My Home
An interactive and educational program about the safe and effective use of over-the-counter medicines
Navigating the FDA Maze:
A few weeks ago, there was a post in regards to providing free or low cost medication to uninsured or unemployed patients. However, Johnson & Johnson has launched a far superior tool called Access2Wellness to help patients find assistance programs for drug discounts or access to free drugs. The site is very user-friendly. Users select the drug that they are interested in and then answer six short questions on the “Eligibility Tool”:
- State of Residence
- Age
- Whether or not you are eligible for Medicare Part B and/or Part D
- Prescription drug coverage?
- Family members who are legally dependant on your household income
- Family’s gross annual income
The tool immediately delivers a list of programs that the user is eligible for as well as a link to the program assistance page. The site has information for patients, physicians, caregivers, and hospital administrators who are interested in assisting friends or family to obtain discounted medication.
The hardest thing for anyone to admit is that they’re not being compliant with their medication because of a cost issue. So I urge all healthcare providers as well as family and friends of loved ones to share this important tool with everyone.
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