Who says there’s no more creativity in American business?

Alzheimer’s disease is a brain disorder named for German physician Alois Alzheimer, who first described it in 1906. (He forgot about it shortly thereafter.  Kidding!)  Alzheimer’s is a progressive and fatal brain disease. As many as 5.3 million Americans have Alzheimer’s disease. Alzheimer’s destroys brain cells, causing memory [...]]]> Source:  AARP Bulletin, July 2010

Who says there’s no more creativity in American business?

Alzheimer’s disease is a brain disorder named for German physician Alois Alzheimer, who first described it in 1906. (He forgot about it shortly thereafter.  Kidding!)  Alzheimer’s is a progressive and fatal brain disease. As many as 5.3 million Americans have Alzheimer’s disease. Alzheimer’s destroys brain cells, causing memory loss and problems with thinking and behavior severe enough to affect work, lifelong hobbies or social life.  It is the seventh-leading cause of death in the United States.

The most common form of the disease is dementia (general memory loss) which interferes with daily life.  The disease is currently without a cure.

A small company in Philadelphia (of all places), Avid Radiopharmaceuticals, has offered information on a radioactive dye which may be used in connection with currently existing PET scan technology.  The dye “sticks” to the plaques (a protein known as beta-amyloid) on the brain which are associated with Alzheimer’s and appear whiter on the scan.  Reportedly, the dye finds and highlights plaques in 97% of the PET scans.

The test, if approved for marketing by the US Food & Drug Administration, could help diagnose the disease in its early stages to allow for medical intervention.  For those suffering along with a family member who has Alzheimer’s the value of added time can not be denied.

~Posted by D.M. Schwadron, Esquire

The U.S. Food and Drug Administration today announced approval of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older.

 The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or [...]]]> FDA NEWS RELEASE

The U.S. Food and Drug Administration today announced approval of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older.

 The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or symptoms of hepatitis. HCV is transmitted through exposure to infected blood, which, for example, can occur during intravenous drug use. The virus can also be transferred from an infected mother to her child. Hepatitis C can lead to liver inflammation and dysfunction and, over time, to liver disease and liver cancer.

 OraQuick is a test strip and does not require an instrument for diagnosis. It takes about 20 minutes to obtain results from the test.

 “Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Getting faster treatment is an important public health step to control this dangerous disease.”

OraQuick is not approved for HCV screening of the general population.

 According to the U.S. Centers for Disease Control and Prevention, there are approximately 3.2 million people in the United States chronically infected with HCV and each year, about 17,000 people are newly infected. Chronic HCV infection is a leading reason for a liver transplants in the United States and HCV is associated with an estimated 12,000 deaths annually. Approximately 75 to 85 percent of people who become infected with the hepatitis C virus develop chronic infection.

 OraQuick is manufactured by Bethlehem, Penn.-based OraSure Technologies Inc.

 Gayle R. Lewis, Esquire

Still think screening for breast cancer doesn’t matter?  In this country there is a lot of debate about that very topic.  Opponents of screening suggest that it results in over-treatment for “lumps” that may be benign cysts or nothing at all.  What is over-treatment?  Sometimes simple referral for ultrasound [...]]]> Source:  BBC Health; Journal of Medical Screening

Still think screening for breast cancer doesn’t matter?  In this country there is a lot of debate about that very topic.  Opponents of screening suggest that it results in over-treatment for “lumps” that may be benign cysts or nothing at all.  What is over-treatment?  Sometimes simple referral for ultrasound or MRI and sometimes referral to a breast surgeon for aspiration (withdrawing cells through a needle), biopsy (cutting out a portion of the lump) or excision (removal of the lump).

Well the latest study, out of England, focused upon 80,000 women aged 50 and over.  (Women in England between 50 and 70 receiving screening every 3 years under the National Health System).  The results?  Over a period of 20 years,  5.7 (yeah, I don’t know what a .7 person is either) breast cancer deaths were prevented for every 1,000 women screened.  2.3 of those 1,000 women were told they had a lump of unclear significance.  Okay, that’s raw numbers, what does it mean?  Well, for every 28 cases diagnosed, 2.5 women had their lives saved and 1 woman was over-diagnosed.

According to the authors of the study, “The benefits in terms of numbers of deaths prevented are around double the harm in terms of over-diagnosis.”  Projecting forward leads them to believe that, “A significant reduction in breast cancer deaths in association with mammographic screening.”

Because of research such as this the NHS plans to extend mammography to women 47 to 73 by 2012.  Meanwhile, here in the United States and with the possible implementation of a National Health Care Service we appear to be going in the opposite direction.  Here we debate the costs of screening women under 50.  Whether or not it’s prudent.  Economically effective.  And whether or not too much screening, rather than resulting in more diagnosis and lives saved, results in over-treatment (read more money).

And back across the pond, a spokesperson for Cancer Research UK, Sara Hiom, was quoted saying, “What we need to remember is that detecting cancers earlier generally means improved survival.  And we know through trials and through research that breast cancer screening can save lives.”

Deputy Directer of the NHS cancer screening programmes (thats Brit for programs) adds, “There is a risk of over-diagnosis and possible subsequent over-treatment associated with any screening programme” and that, “The latest independent study shows that the risk of over-diagnosis is very much lower than some other recent estimates have claimed and that the benefits [of mammography screening] far outweigh the risks.”  Well put.

~Posted by D.M. Schwadron, Esquire

A Duke University study published in the American Journal of Roentgenology (that’s x-rays) found that plain x-rays miss a surprising amount of fractures compared with MRI.  How many?  Out of 92 patients undergoing x-ray and then checked with MRI, 35 fractures were missed.  That’s more than 1/3 of fractures [...]]]> Source:  American Journal of Roentgenology; BBC Health

A Duke University study published in the American Journal of Roentgenology (that’s x-rays) found that plain x-rays miss a surprising amount of fractures compared with MRI.  How many?  Out of 92 patients undergoing x-ray and then checked with MRI, 35 fractures were missed.  That’s more than 1/3 of fractures for the slow at math.  Oh and 11 patients had a fracture suggested by x-ray that wasn’t on the MRI (a false positive).

The problem? Well outside of the obvious, is that a negative finding read on an x-ray will not result in any additional study.  In a Hospital Emergency Room Setting, the goal is to rule out traumatic fractures and move on to other diagnoses.  Which means that patients are getting sent home with fractures that could potentially result in greater injury (ie. risk of fall, accident, extension of fracture, etc).

The suggestion of the authors was to use MRI in addition to x-rays, where doctors have doubts -particularly in the frail or elderly patient population.  (Like you, I was looking to see if the study was funded by the MRI Manufacturers Association, but I could neither confirm nor deny that.) Hip and pelvic fractures are common among this group.  (Who else thinks putting the call back upon the doctor is an inherently good idea?)  Maybe I’m missing something (no pun intended) but if ER doctors are using x-ray to rule out fracture, why would they go any further once they get a negative result.  Further, won’t the hospital administration and the Insurance Companies question the diagnostic rationale of obtaining an additional study when the first study was negative?

Okay, here is the point where I go off on an associated tangent, but a tangent, nonetheless.  The point of this study was to use MRI as a back up where there were questions about an x-ray finding.  Maybe the better practice would be to simply use MRI as the first study and do away with conventional and, apparently out-dated, x-ray technology?

What do I mean by “outdated?”  A quick history lesson.  It was 11/08/1895 when Wilhelm Conrad Röntgen accidentally discovered an image cast from his cathode ray generator.  A week after his discovery, Rontgen took an X-ray photograph of his wife’s hand which clearly revealed her wedding ring and her bones. The photograph electrified the general public and aroused great scientific interest in the new form of radiation. Röntgen named the new form of radiation X-radiation (X standing for “Unknown”).  Wilhelm’s wife, who served as chief tester would later die of radiation over-exposure.  In 1913, William Coolidge invented the X-ray tube which then revolutionized the generation of X-rays and is the model upon which all X-ray tubes for medical applications are based.  I’d consider that outdated.  Hey, what do I know, I’m a lawyer, not a doctor.

~Posted by D.M. Schwadron, Esquire

No, it is not anticipated that home testing for breast cancer, ovarian cancer or prostate  cancer will be available any time in the near future.  However cervical cancer is unique due to it’s associated risk with the human papillomavirus (HPV or genital warts), 13 of it’s 100 variants apparently cause cancer.

The issue [...]]]> Source:  BBC Health News

No, it is not anticipated that home testing for breast cancer, ovarian cancer or prostate  cancer will be available any time in the near future.  However cervical cancer is unique due to it’s associated risk with the human papillomavirus (HPV or genital warts), 13 of it’s 100 variants apparently cause cancer.

The issue is so serious that a vaccine for HPV was introduced in the past few years and made available to school-aged girls.  So then what role does testing play?  First, not all women are receiving vaccinations for HPV.  Second, not all women are undergoing routine screening for HPV at their gynecologist’s or primary care provider’s office.  For these women, the availability of a reliable home test could be an option.

HPV causes cellular damage even after the initial infection clears.  A simple swab may collect damage cells and tell doctors a great deal about a woman’s risk for the development of cervical cancer.  Were it only that all medical solutions were simple solutions.

~Posted by D.M. Schwadron, Esquire

A stroke is the interruption of blood to the brain.  It is most commonly caused by vascular interruption from a blood clot or cholesterol blockage or cholesterol embolus.  Rarely, it may also be caused by fungal endocarditis and fungal emboli following mitral valve replacement surgery.

Strokes have been classified as “brain attacks.”  [...]]]> Source:  BBC Health; The Lancet

A stroke is the interruption of blood to the brain.  It is most commonly caused by vascular interruption from a blood clot or cholesterol blockage or cholesterol embolus.  Rarely, it may also be caused by fungal endocarditis and fungal emboli following mitral valve replacement surgery.

Strokes have been classified as “brain attacks.”  Like heart attacks, strokes can damage and kill tissue and result in temporary or permanent brain, injury, nerve injury (palsy), paralysis, loss of coordination and balance,neurological impairment, loss of speech and death.  Predicting them and treating them before they occur can be critically important.

Researchers are calling for new guidelines for GP’s (General Practitioners or Primary Care Providers here in the US) to ensure that blood pressure remains at a steady level.  While lower is preferential, it appears to be the fluctuation (change up or down) of blood pressure that determines the risk of stroke.   Current guidelines call for a re-check of a high blood pressure only.  If that second pressure is normal there is rarely treatment in the form of medication.  And medication alone might not be the answer.  Studies published in The Lancet have suggested that beta blockers (a common class of heart medication) may increase variation in blood pressure.

Like the fable the tortoise and the hare, it appears that slow and steady really does win the race when it comes to blood pressure and decreasing the risk of stroke or at the very least predicting those patients at risk for stroke.

~Posted by D.M. Schwadron, Esquire

192,000 men are diagnosed with prostate cancer annually.  27,000 cases are terminal.  Currently under investigation is a new chemotherapy drug -Cabazitaxel which is being administered in conjunction with Mitoxantrone (a commonly used drug f0r prostate cancer).   Men receiving this chemo cocktail (no pun intended) had a 30% increase in survival.  [...]]]> Source:  Annual Genitourinary Cancers Symposium; Medline

192,000 men are diagnosed with prostate cancer annually.  27,000 cases are terminal.  Currently under investigation is a new chemotherapy drug -Cabazitaxel which is being administered in conjunction with Mitoxantrone (a commonly used drug f0r prostate cancer).   Men receiving this chemo cocktail (no pun intended) had a 30% increase in survival.  To you or I 15.1 months to live vs. 12.7 may not seem like a lot but if you were dying and those were your options, wouldn’t you want more time?  It is thought that giving the combination of drugs early in the diagnostic stage might translate to even greater survival times.

To that end researchers are developing better diagnostic tools for Prostate Cancer.  Showing promise is the PCA3 urine test.  Apparently overly expressed in men with prostate cancer, gene 3 is a fair predictor for advanced prostate disease.   The current complaints against the standard PSA testing is the high rate of false positives resulting in biposy.

Finally, the tried and true cystoscopy procedure (Yes, the one where they insert a catheter with a small camera into the bladder. Over the river and through the woods…Well not quite.  Cystoscopy has been found to be remarkable cost-effective.  Accordingly, look for it to be featured more in insurance schemes and offered more by urologists.  Cynical? Perhaps.  But you’ll see.

~Posted by D.M. Schwadron, Esquire

Men should discuss the benefits and risks of prostate cancer screening with their doctors, according to revised prostate cancer screening guidelines from the American Cancer Society (ACS).  Yes. That’s what they said.  Not much of a guideline is it?

Okay they say a little more.  But really, only a little.  The American Cancer [...]]]> Source: American Cancer Society

Men should discuss the benefits and risks of prostate cancer screening with their doctors, according to revised prostate cancer screening guidelines from the American Cancer Society (ACS).  Yes. That’s what they said.  Not much of a guideline is it?

Okay they say a little more.  But really, only a little.  The American Cancer Society recommends that doctors more heavily involve patients in the decision of whether to get screened for prostate cancer.

ACS recommends that men with no symptoms of prostate cancer who are in relatively good health and can expect to live at least 10 more years have the opportunity to make an informed decision with their doctor about screening after learning about the uncertainties, risks, and potential benefits associated with prostate cancer screening. These talks should start at age 50. Men with no symptoms who are not expected to live more than 10 years (because of age or poor health) should not be offered prostate cancer screening. For them, the risks likely outweigh the benefits, researchers have concluded.

ACS recommends men at high risk – African-American men and men who have a father, brother, or son diagnosed with prostate cancer before age 65 – begin those conversations earlier, at age 45. Men at higher risk – those with multiple family members affected by the disease before age 65 – should start even earlier, at age 40.

For men who choose to be screened after discussing the pros and cons with their doctor, the new guidelines make the digital rectal exam (DRE) optional and offer the option of extending the time between screening for men with low PSA levels.

There it is. No specific PSA recommendations, or even whether PSA testing should be considered mandatory.  So start “talking to your doctor” about screening.  Does this sound an awful lot like the burden of screening for Prostate Cancer is being placed back upon the patient? Yeah. It sounds that way to me too.

~Posted by D.M. Schwadron, Esquire

It is a fact of chemotherapy (chemical treatment for cancer) that some patients simply don’t respond to medications. Or that they stop responding over time.  With more than 45,400 women diagnosed with breast cancer every year, scientists have been furiously trying to decode our genetic patterns for reasons such as [...]]]> Source: BBC Health; The Lancet Oncology

It is a fact of chemotherapy (chemical treatment for cancer) that some patients simply don’t respond to medications. Or that they stop responding over time.  With more than 45,400 women diagnosed with breast cancer every year, scientists have been furiously trying to decode our genetic patterns for reasons such as this.

Starting with 829 genes present in breast cancer cells, the focus has been drawn to just 6 genes which appear to impact the efficacy (medical effectiveness) of chemotherapy.  If they are correct then it may be possible to develop a simple test to determine whether or not certain drugs, in this case paclitaxel, will be beneficial to patients.  Another one to watch.

~Posted by D.M. Schwadron, Esquire

Pediatric respiratory emergencies result from a variety of causes, including chronic medical conditions, infections, allergic reactions, and obstruction from foreign bodies. At the American Academy of Emergency Medicine, held February 15 to 17 in Las Vegas, Nevada, management of the pediatric patient with a respiratory emergency and [...]]]> Source:  Medscape Medical News

Pediatric respiratory emergencies result from a variety of causes, including chronic medical conditions, infections, allergic reactions, and obstruction from foreign bodies. At the American Academy of Emergency Medicine, held February 15 to 17 in Las Vegas, Nevada, management of the pediatric patient with a respiratory emergency and some of the hidden and potentially life-threatening causes of respiratory distress was one of the educational tracks.

In this interview, MedscapeEmergency Medicine discussed the topic with Karen Santucci, MD. Dr. Santucci is medical director and section chief of pediatric emergency medicine at Yale-New Haven Children’s Hospital and is associate professor of pediatrics at the Yale University School of Medicine in New Haven, Connecticut.

Medscape: What do you look for first when a pediatric patient presents to you in respiratory distress?

Dr. Santucci: The first thing I do is a very careful physical exam. Oddly enough, sometimes you can do your best physical starting outside the exam room. Pediatric emergency medicine is a little bit different from adult emergency medicine, in that there’s a huge anxiety component, particularly in older infants and younger toddlers. Sometimes I pause outside the exam room for 5 or 6 seconds just to get a look at the status of the child in terms of increased work of breathing, because once you walk into the room, you introduce a new variable in terms of frightening the kid to death.

You can get a good sense of their baseline respiratory rate and what their affect looks like. Are they frightened because they have a partial airway obstruction or because they are really having a lot of difficulty breathing, or are they frightened because you just walked in the room and they associate any of us in healthcare with an immunization, a needle? There’s a huge fear factor.

So standing outside the room, getting a sense of how they’re interacting in their comfort zone with their family member and whether or not they’re manifesting any head bobbing, which would be movement of their head with every respiration, which would be an indication of increased work of breathing and accessory muscle use, and if they might even have nasal flaring, which is also evidence of severe respiratory distress. The physical exam is certainly critical, but I think it starts outside the exam room.

And then doing a good lung exam and observing how they’re moving air, using all your senses in terms of whether you hear stridor. Is there evidence of congestion? Is there audible wheezing? Feeling them in terms of their capillary refill, tapping on their nail bed, seeing how long it takes to refill, feeling their distal extremities, whether or not they’re warm and well perfused or cool, because children are at increased risk of becoming dehydrated with respiratory distress because of insensible losses. Certainly, if they’re manifesting with a fever, they’ll also have increased insensible losses, and they’re more at increased risk of dehydration.

Medscape: Once you’ve gone through the physical exam findings, are there any questions or particular areas you focus on when taking the history of a pediatric patient?

Dr. Santucci: One of the major things that tends to be missed in pediatrics is asking about potential risk for a foreign-body exposure, and I probably spend half of the talk on that because it is so pediatric-specific in terms of occult exposure to a foreign body that could have been missed.

Medscape: Is there a risk of clinicians becoming complacent and missing the less common causes of obstruction?

Dr. Santucci: A lot of what we see in terms of respiratory distress is associated with more common things; for example, at this time of year — January, February — we’re seeing a lot of [respiratory syncytial virus]–related bronchiolitis, particularly in children less than 2 years of age. What I would caution the clinician about is tending to think, it’s bronchiolitis season, so if an infant or toddler is presenting with respiratory distress, it’s probably bronchiolitis. I think maintaining the possibility of it being something else is so critically important.

Increased work of breathing and some congestion, and a little bit of a wheeze . . . could also be something like an inborn error of metabolism, and the child is actually presenting with what appears to be increased work of breathing because they’re developing increased respiratory drive to compensate for a metabolic acidosis.

In one case we had, what was felt to be bronchiolitis in a 10-month old was actually a salicylate overdose secondary to a mother giving increased amounts of Maalox Extra Strength for gastroesophageal reflux. We discovered that this baby had an increased anion gap . . . and, had we not erred on the side of sending a tox screen and had not this been recognized in real time, this child would have died. . . . Ask about over-the-counter meds and ointments and preparations because they can kill an individual — so [that is] very significant information.

One of the hugest points that I’ve learned over the years is maintaining a differential diagnosis when the points don’t seem to fit, delving and asking some questions, maybe sending a few extra labs to err on the side of being overly cautious and not just accepting things at face value. Even if you can’t figure things out in the emergency department, sharing that you’re really perplexed by a patient with the accepting team upstairs when you’re admitting a patient and making sure that they follow up on the lab tests as quickly as possible and initiate a pretty comprehensive work-up can absolutely be life saving.

Medscape: What are some of the tools that physicians can use to work through and manage respiratory distress in children?

Dr. Santucci: One specific case was a case of a 4-year-old girl presenting in the winter with some stridor, and she had some tripodding, which means she was leaning forward because she was trying to maximize airflow through the upper airway, and she was febrile to 104 degrees. This was a little girl who presented with all the classic signs and symptoms of epiglottitis. Even at a major tertiary-care center, there were specialists who just didn’t believe in epiglottitis any more. Ever since we’ve introduced Haemophilus influenzae type B vaccination, and this has become routine, we have reduced the incidence of epiglottitis so immensely that many people in healthcare don’t believe that it exists anymore.

The [attending ENT] was able to successfully intubate her in the operating room, but she clearly had epiglottitis and a near-complete airway obstruction, because the epiglottis was so inflamed and swollen, so edematous. The only way they were able to secure her airway on direct laryngoscopy was to squeeze her thorax and create a small air bubble. This could be a life-saving technique if you can’t get the child to the operating room, to squeeze the chest. While you’re doing direct laryngoscopy, there can be an air bubble, which will delineate where to pass the endotracheal tube.

Medscape: Besides H influenzae type B, are there other organisms that can cause epiglottitis?

Dr. Santucci: We almost always attribute it to H influenzae type B, but there are other types of bacteria — Staphylococcus, Streptococcus, and other serotypes of H influenzae — that can cause epiglottitis. Quite amazingly, there are other etiologies for epiglottitis — inhalational if someone is inhaling different types of illicit drugs. We’ve had a couple of cases associated with cold weather where people will take a gulp of some hot chocolate while they’re outside, and this thermal injury to the epiglottis will cause inflammation of the epiglottis.

So epiglottitis is still out there. We still need to maintain an index of suspicion for this, just like with foreign bodies. If you don’t think about it, you’re going to miss it, and someone’s going to die.

Have an index of suspicion for things like foreign bodies, and what kids are doing. They like to put stuff in their mouths, and so that’s a huge risk factor for morbidity and mortality if it’s not recognized early.

Medscape: Can a child’s activities before coming to the emergency department raise your suspicion of a foreign body?

Dr. Santucci: When you have a really sick kid, a lot of people mobilize, and they want to be at the bedside, but one thing that I’ve learned over the last couple of decades is that having a person break off from the bedside to talk to the family . . . it can be life-saving just to take a moment to go back and do a really thorough history.

Medscape: To wrap things up, can you give me a couple of bullet points that a physician should keep in mind when seeing a child in respiratory distress?

Dr. Santucci: An increased respiratory rate is not always a respiratory problem, so remember that tachypnea is not always a respiratory etiology and that sometimes that increase in respiratory rate is because of a compensatory mechanism for a metabolic problem. Propionic acidemia [propionyl-CoA carboxylase deficiency] is one example, and another would be diabetic ketoacidosis. Another thing is to remember the developmental status of children, particularly older infants and toddlers, and that whole foreign-body spectrum.

With regard to increased respiratory rate and increased work of breathing, when someone is presenting with acute anaphylaxis and severe allergic reaction, all the studies support getting epinephrine in within the first 30 minutes — it can absolutely save a life. If you delay that intramuscular injection of epinephrine, the cascade has already taken place in terms of what’s going on chemically, and you may have irreversible anaphylaxis. If you’re thinking about epinephrine, it would be better to give the epinephrine than to delay it.

We do not give the epinephrine intravenously. We give it intramuscularly. It’s going to be absorbed very nicely from an [intramuscular] route, and it’s extremely safe to give it intramuscularly.

Even in adults, giving intramuscular epinephrine is really quite safe. Anaphylaxis absolutely affects the heart as well, and if you don’t treat the anaphylaxis, someone might actually develop an acute myocardial infarct because of the anaphylaxis and the strain on the myocardium. So when you weigh all the pros and cons, you’re better off erring on the side of giving the epinephrine intramuscularly. That’s a huge critical life-saving point.