Dr. Gustin's Blog

A new test for Stevens Johnson Syndrome

All emergency physicians have made the dreaded consult call to the dermatologist: "Patient with drug eruption, rule out Stevens-Johnson syndrome." Although adverse cutaneous drug eruptions are common, Stevens-Johnson syndrome (SJS) and its more severe variant, toxic epidermal necrolysis (TEN), are fortunately rare. These extensive mucocutaneous blistering drug eruptions are associated with significant morbidity, even death. In the case of TEN, mortality rates may exceed 20%.

In the past, the condition was easy to miss, and the consequences were often catastrophic.  Many a medical malpractice lawsuit has been filed on account of this missed diagnosis.  Medical expert witnesses from the fields of emergency medicine and dermatology have testified for and against plaintiffs whose families survived them, or who were left with dire and permanent health effects.  The diagnosis is not always apparent, but unfortunately the condition is often fulminant.   Less than a day can pass between discharge home and a full blown desquamating rash.

Now for the first time, there is a new test that will diagnose the condition before it has advanced to a critical stage.

Intervention for full-blown SJS and TEN consists primarily of supportive measures such as management in a burn unit (for TEN), prophylaxis against infections, correction of fluid and electrolyte imbalances, and prevention of stricture formation and ocular complications. Recently, intravenous immunoglobulin therapy has shown promise as an early intervention, potentially arresting progression of SJS and TEN if administered early enough. In this context, early detection of SJS/TEN might greatly improve clinical outcomes.

Granulysin, a cytotoxic lipid-binding protein that induces cell apoptosis, is found in high concentrations in blister fluid from patients with SJS/TEN.  Recently, Abe and colleagues found significantly elevated serum granulysin levels in patients with SJS/TEN.  Intriguingly, these elevated levels occurred before the development of skin and mucosal detachment and dropped rapidly within 5 days of disease onset, suggesting that serum granulysin may be a useful marker for the early phase of SJS/TEN.

Inspired by these preliminary data, Fujita and colleagues developed a simple rapid immunochromatographic test for elevated serum granulysin. This test is completed in only 15 minutes and yields a clinically visible result line at a threshold of 10 ng/mL of serum granulysin.

In order to gauge the sensitivity and specificity of this novel screening test, Fujita and colleagues tested serum samples from 5 patients with clinically confirmed SJS/TEN. The samples were taken early in the disease progression (ie, 2-4 days before development of mucocutaneous erosions). For comparison, serum samples were taken from 24 patients with non-SJS/TEN drug eruptions, defined in this study as "ordinary drug-induced skin reactions" (ODSRs), and 31 healthy controls. Interestingly, 4 of the 5 serum samples from SJS/TEN patients showed positive bands, whereas only 1 of the 24 samples from patients with ODSRs and none of the controls showed positive bands. Test sensitivity was 80% and specificity was 95.8% for SJS/TEN vs other drug eruptions.

Viewpoint

If future larger studies confirm that this screening test is both sensitive and specific for SJS/TEN, then it should see immediate clinical use.

Of note, because serum granulysin levels peak before the onset of mucocutaneous erosions and decline as the disease progresses, the absence of a positive test will not be enough to rule out SJS/TEN. Hence, the serum granulysin rapid screening test should be most useful in identifying the subset of drug eruptions that are most likely to progress to SJS/TEN. Once this subgroup is identified, closer clinical monitoring and a lower threshold for initiating intravenous immunoglobulin therapy may be warranted.

Do Cell Phones Cause Brain Cancer?

In recent news, a World Health Organization scientific panel has raised the issue of cell phone safety by stating that they may cause brain cancer.  A panel of 31 scientists reviewed the available data and have concluded that cell phones are a possible carcinogenic hazard.  For years people have wondered whether cell phones and the radio frequency magnetic fields they produce are safe.  

The statement was issued by the International Agency for Research on Cancer" (IARC) after a "weeklong meeting" during which experts reviewed "possible links between cancer and the type of electromagnetic radiation found in cellphones, microwaves and radar." The IARC classified cellphones in "category 2B, meaning they are possibly carcinogenic" to humans. The assessment now "goes to WHO and national health agencies for possible guidance on cellphone use."

Read more ...

THE PUSH TO FAST EMERGENCY ROOM TREATMENT

Emergency rooms around the country have gotten into the mode of marketing their services.  One aspect that each is focusing on is the speed by which a patient is seen once he or she presents to the hospital.  Historically, visits to an emergency room can take many hours even for minor problems such as colds or bruises.

 

Hospitals are dealing with this delay in treatment by streamlining services with the use of fast track concepts.  Triage nurses will sequester patients into acuity groups and will move minor problems to an area in the ER where a physician's assistant or nurse practitioner can see the patient immediately, treat, and discharge the patient in a timely manner.

 

Also, hospitals are now purchasing billboards to advertise about shorter wait times in their emergency rooms.  Patients can actually find out in advance, thanks to a new program that publicizes each hospital’s average wait times via text messaging, electronic banner ads and the Internet.

 

The challenge of course is that speed does not compromise quality and standards.  There are numerous incidents of patients hastily treated in the minor side area, who had serious conditions overlooked.  Whether or not this results in an increase in medical malpractice lawsuits remains to be seen.

 

Litigators, Emergency Department Directors, Hospital Administrators, Risk Managers, and Hospital Joint Commission officials are watching these developments closely.

 

ZOCOR SAFETY ALERT

The Food and Drug Administration on Wednesday announced new safety restrictions on high-dose simvastatin, also known as Zocor, a cholesterol-lowering drug taken by an estimated 2.1 million Americans.

The agency said the 80-milligram dose caused a potentially severe muscle disease, called myopathy, especially in the first year of taking the medication.

No new patients should be put on the high dosage, the F.D.A. said, recommending that existing patients should continue only if they have used the drug for more than a year without experiencing muscle pains. Alternative statins may be safer, the agency said.

This surely will lead to a spate of product/medical liability lawsuits against the manufacturers of this drug.

See the entire article in the NY Times by: Clicking Here

Arsenic in Chicken

The latest report from the FDA says that for decades chickens have consumed feed contaminated with Arsenic, a known poison and carcinogen.  The FDA backpedals on this finding by saying that chicken is still safe to eat because the amount of Arsenic that has found its way into edible portions of chicken are too low to be significant.  But they do not comment on the cumulative effect of regular Arsenic ingestion.

In response to this discovery, the companies that produce substances contaminated with Arsenic have stopped their production of these substances because of the possible adverse effect on the health of Americans.  To read the full NY Times article, CLICK HERE.

New Treatment Protocols For Sepsis

Sepsis kills.  Delayed diagnosis and management of sepsis results in mortality rates that are sometimes higher than 50%.  Mismanagement of Sepsis is a major cause of medical malpractice lawsuits.

Recently the American College of Critical Care Medicine has made recommendations that will soon find its way into treatment protocols including Advanced Pediatric Life Support.  The recommendations and the particular study from which those recommendations are derived can be seen in the June issue of Pediatrics.

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Methamphetamine and New Legislation

Several states are considering new legislation that will make decongestants prescription medication requiring a doctor's signature.  The main ingredient of these medications is pseudoephedrine, an essential ingredient in the production of Methamphetamine.  In one state alone, Tennessee, police shut down over 2000 Methamphetamine labs last year, about a 50% increase from the year before.

Methamphetamine is an extremely dangerous street drug.  Once an individual becomes habituated, studies show that their life expectancy is less than 10 years.  Once hooked, because of its effects on dopaminergic receptors of the brain, it is extremely difficult to stop use, and relapse is the rule rather than the exception.

Methamphetamine damages the brain, central nervous system, heart and other organs.  It not only destroys the life of the user, but often seriously impacts those closest to the person including friends and family.  Methamphetamine has become a serious public health problem in the U.S., and state legislation will be a big step in helping to curb access to this substance.

The Emerging New Superbugs

An article appeared in a recent Forbes Magazine about the dangers of superbugs.  The WHO (World Health Organization) has said that these bugs, which have appeared in Britain, India, and Pakistan, are immune to our current battery of antibiotics.  In the U.S. alone, infections kill about 100,000 patients a year.  

So what is the FDA doing?  Nothing.  In fact, quite the opposite.  They have said, as an official statement, that the approval policy will be lengthened, not shortened, and that there will be more hoops to jump through in order to conduct R&D.  In fact, new FDA rules are now retroactive to existing clinical trials.  The FDA has no plan to revamp its slow and deadly approval process.  Drug companies like Pfizer, has dumped its antibiotic research pipeline because of this.  Other pharmaceutical companies are sure to follow.

This should be an issue of the greatest urgency; yet it's received hardly any attention from our leaders in Washington, and even less attention by the usually sensation-seeking media.  The dearth of new antibiotics in the pharmaceutical R&D pipeline is a omnipresent scandal that should justify focused and persistent media attention.  Sadly, it may take the entrance of a few of these superbugs into our communities for the FDA to alter their policies.  But by then, it might be too late.

Medical Malpractice Statistics

In its 2002 comprehensive report titled: "Medical Malpractice: Verdicts, Settlements and Statistical Analysis, Jury Verdict Research (JVR) details nationwide statistics regarding medical malpractice cases.

 

JVR reports that between 1994 and 2000, the most frequently claimed injury in a medical malpractice case was death (23%), followed by brain damage (9%), genital injuries (7%), leg injuries (5%), Cancer, spinal nerve and eye injuries (each at 4%), paralysis, amputations, intestinal tract and foot injuries (each at 3%). All other injuries accounted for 3%.

 

JVR also reported on the probability of a plaintiff verdict for medical malpractice with regard to specific type of theories alleged. For instance, the probability of a successful plaintiff case involving an alleged diagnosis error was 37% in 2000, down from a high of 39% in 1994. Similarly, the probability of a plaintiff verdict in a negligent surgery case was reported as 48% in 2000, up from the 1999 figure of 32%. In childbirth cases, the probability of a plaintiff verdict was 38%, down from a high of 46% in 1995 and 44% and 43% respectively for the years 1998 and 1999.

 

The lowest probability of success were claims involving an allegation of lack of informed consent. In these cases, JVR reported that plaintiffs prevailed only 26% of the time.

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