Time is Brain – Benefits of Early Treatment of Stroke

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Why do only 5% of stroke patients receive clot busting drugs?  The National Stroke Association reports that stroke is the fourth leading cause of death in the United States, and a huge cause of disability as well.  And 80% of strokes are preventable!  What’s going on here?

All professions tend to resist change.  But this resistance poses a problem for professions like medicine, since research can indicate that what doctors thought was best at one time is no longer effective, and doctors (like all of us) need to be flexible and humble enough to change when change is needed.  One example of this resistance to change that I’ve seen firsthand is the tendency of doctors, especially ER doctors, to avoid giving clot-busting drugs to patients who come to the ER after the onset of stroke symptoms.  The fear seems to be that these drugs may not be effective, or they may cause bleeding and the risk of bleeding exceeds the benefit of giving the drugs to break up clots causing a stroke.  But these beliefs must change.

A quick review:  strokes are the result of interrupted blood flow to the brain, like a heart attack is the result of a decreased blood flow to the heart.  Stroke come in 2 forms – ischemic stroke and hemorrhagic stroke.  Ischemic strokes are strokes that result from decreased blood flow caused by a blockage of some sort in one of the arteries supplying blood to the brain, whereas hemorrhagic strokes are caused by a rupture of a blood vessel supplying blood to the brain.  By a huge margin, most strokes are ischemic strokes.  The American Stroke Association says that 87% of all strokes are ischemic strokes.

Many studies have shown that giving a clot busting drug, like tPA, to ischemic stroke patients can be very effective in reducing the severity of the stroke and returning function.  The sooner the drug is given, the better.  As you’ve probably heard, “time is brain” in these circumstances.  A recent study has shown that early treatment with tPA is extremely effective in reducing the severity of  ischemic strokes and returning function to those patients.

Let me just give you their conclusion:  “IV thrombolysis within 90 minutes is, compared to later thrombolysis, strongly and independently associated with excellent outcome in patients with moderate and mild stroke severity.”  This is an important study, and gives great hope to the millions of stroke victims that early treatment can help them enormously.  Here’s a link to a summary of this study.

An important point to remember is that this study deals with very early treatment – within 90 minutes of the stroke symptoms.  That is not to say that later treatment is not effective in many patients.  In fact, studies show benefits in many patients from treatment later than 90 minutes and perhaps up to 6 hours, according to this summary by emedicine of the benefits of thrombolytic therapy.  The FDA recommends tPA be given within 3 hours of symptoms.

So, what should patients do to put themselves in the best position to benefit from drugs like tPA?  This article on ischemic stroke says that one of the main things we need to do is be aware of stroke symptoms and act FAST.

  • F – Face – Ask the person to smile.  See if  one side of the face droops
  • A – Arms  – Ask the person to raise both arms.  See if one arm drifts downward
  • S – Speech – Ask the person to repeat some simple phrase.  See if they can’t repeat it or speak in gibberish
  • T – Time – if any of these symptoms are present, call 911 immediately.

 

New Case Clarifies Emergency Room Standard in Georgia: What Level of Care are Patients Entitled To?

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If you or a family member go to an Emergency Room in Georgia, what level of care do you expect to receive?  Some lawyers for doctors and hospitals say that you are only entitled to receive something called “slight care” which is lower than the historical standard of “ordinary care” or reasonable care” that we’ve operated under for many years in Georgia medical malpractice cases.

This lowering of the standard of care was done without a lot of public participation, and my guess is that most folks who go to the E.R.- or take their children or family members there – expect to receive a reasonable level of care.  Nonetheless, in 2005 a new law was passed in Georgia that attempted to lower the standard of care to the level of “slight care” in ERs, at least in some circumstances.  The truth of the matter is that this is a terrible law, and puts our families at greater risk when we go to ERs.  Seems to me that we deserve better care than that.

The law in question generally says that the “slight care” standard – also known as “gross negligence” ( a doctor is grossly negligent when he does not use slight care, these are two sides of the same coin) – only applies to patients who are not stable.  The idea seems to be that if a patient is stable, then that patient is entitled to the same care they would get if they went to a regular doctor’s office or received other types of medical care in a non-emergency situation.  In other words, emergency room doctors should only get the benefit of this low standard of care when there is a real emergency and little time for reflection or for getting a complete history of the patient.

But few cases had addressed this issue of stability.  A new case has done that and made it clear that a jury will often have to decide if a patient is stable, thus triggering application of the ordinary negligence standard.  In Bonds v. Nesbitt, 13 FCDR 1342, Case Number A13A0348, the Court made this rather clear:

The statute provides that a doctor’s conduct becomes subject to the more rigorous ordinary negligence standard of care rather than the gross negligence standard when the patient’s condition improves, or at least stabilizes. In other words, the statute provides that the condition of the patient controls, not the opinion of the physician. If a physician or health care provider mistakenly concludes that a patient has become “stabilized” and “capable of receiving medical treatment as a nonemergency patient” and therefore stops providing emergency care to that patient—notwithstanding that the patient still needs emergency care—and if the patient is injured or killed as a result of the withdrawal of emergency care, the physician or health care provider is entitled to claim the protection of the gross negligence standard.

The Court went on to say that in the context of the  factual circumstances of the Bonds’s case “that claim must be made to the jury.”  This case is very important because it pays close attention to the actual words of the statute, and clarifies that the issue of stability is an issue to be determined by the jury, at least in cases where there are facts in dispute about it.

Supreme Court Closes Courthouse Doors to Patients Harmed by Generic Drugs

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Karen Bartlett took a generic drug called sulindac that her doctor prescribed to her for shoulder pain.  About three weeks later,  her skin began to peel off due to a reaction to the drug.  She is now left with burn-like lesions over two-thirds of her body and she is nearly blind.   She spent months in a burn unit in a medically induced coma.  Her burn doctor described her condition as “hell on earth.”   She cannot read or drive or work, and she will likely lose all vision.  She sued the drug maker – Mutual Pharmaceuticals – and her case proceeded to trial and resulted in a New Hampshire jury returning a verdict of $21 million.  Many of us would applaud the good sense of a jury in returning this verdict to help this lady in such great need.  But the highest court in the land wasn’t so happy about Karen’s victory.

A majority of the United States Supreme Court reversed the jury’s verdict, leaving Karen with nothing.  Justice Sotomayor wrote a dissent that called the majority decision “frankly astonishing.”  Along with several other decisions from our highest Court, this decision prompted Andrew Cohen at the Atlantic to derisively refer to it as a “great day for corporations.”  The majority does seem to go out of its way – and well beyond the professed originalism of Scalia and others – to lend a helping hand to corporations.   Here’s a link to Andrew Cohen’s Atlantic article and a blog entry on the Pop Tort about the case.

But the majority’s loving embrace of corporations didn’t really surprise me – that is what the majority seems to do so often. It’s something else that frightens me:  this drug was allowed to be sold to patients despite evidence  – as reported in the Pop Tort’s blog post – that Mutual Pharmaceuticals knew that sulindac’s rate of life-threatening conditions was comparable to the rate for a drug that the FDA had recommended for removal from the market.  Why are drugs with these sorts of risks being sold to patients?  And why isn’t full information given to patients, at the very least?

One answer is provided in books like Overdosed America by Dr. John Abramson.  He shows that the research and approval process for drugs is often flawed, in large part because of the fact that much of the drug research is done by institutions or individuals with financial ties to the pharmaceutical industry.   Even many doctors unwittingly rely on studies that are flawed, as shown in his well-researched book.  With this sort of “fox guarding the hen house” situation, it is predictable that dangerous drugs will get FDA approval despite a lack of good research supporting their safety.  As corporate money continues to infiltrate universities and research groups, this situation get worse.  And it is magnified further when a majority of the Supreme Court moves in lockstep with corporate power.

 

Medical Misdiagnoses More Common Than Drug Errors and Wrong-Site Surgery: A Little Humility Goes a Long Way

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We are often led to believe that medical misdiagnoses are rare, and that drug errors and wrong-site surgery are more common.  A recent article in the Washington Post  debunks this belief.  The article discusses the case of a physician, Itzhak Brook, whose throat cancer was misdiagnosed – by very good specialists – as acid reflux.  Who made the correct diagnosis?  A resident, not the specialists.   So much for ceding our health completely to specialists.   The doctor lived, but now speaks in a whisper.

Another sobering example from the article:  Karen Holliman was put through an odyssey of more than 50 medical visits with a variety of doctors, who told her that her fatigue and back pain were caused by fibromyalgia or psychiatric problems, when she actually had developed metastatic breast cancer.  Of course, the lawyers for the involved hospital denied any liability.  Karen is terminally ill.  She is 52 years old.

Some of the more general findings mentioned in the article include these:

  • 10-20% of medical cases involve medical misdiagnoses
  • 28% of medical errors reported anonymously by doctors were life-threatening, according to a 2009 study
  • 40,500 deaths each year are related to ICU misdiagnoses
  • the vast majority of misdiagnoses do not result in any legal action
  • overconfidence by physicians contributes to misdiagnoses

There is likely no one easy answer for these troubling findings, but a couple of things may help.  First, doctors should not be afraid of sending patients for second opinions.  Also, maybe more doctors can practice a little humility and take the time to do correct differential diagnoses, spend a little time with their patients talking with them and carefully observing them.  Maybe a little old-fashioned attention to the people who trust them with their health will go a long way toward preventing these types of outcomes.  Medical technology is great, but spending time with patients may be the best medicine of all.

Myths of Medical Malpractice

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I wanted to share a very good article that reveals some truths about medical malpractice in our country.   It might be hoped that articles debunking the common myths about medical malpractice and “tort-reform” legislation would not still be necessary, but false beliefs have a tenacity that is sometimes hard to explain.  Maybe it’s just that people tend to believe untrue things when the belief in those false things serves some other conscious or unconscious purpose.  Nonetheless, belief in fairy tales is no basis for making laws that affect all of us when we visit a hospital or doctor’s office.

This article is important not just because it shows the falsity of these myths, but because of who wrote it and who published it.   A physician and a professor collaborated to write an article entitled Five Myths of Medical Malpractice.  In the article, the authors examine certain false beliefs – including the belief that the civil jury trial system delivers unusually high verdicts, and the belief that physicians move to states with damage caps (caps on the amount of money a person can receive in a malpractice case).  These and a few other common falsehoods are exposed in detail and with plenty of supporting evidence.

It is also revealing that the journal Chest published this article.  This is a peer-reviewed journal of the American College of Chest Physicians.   My hope is that the physician-readers will study this article with an open mind and begin to at least wonder whether the whole “tort-reform” movement is simply a manufactured “crisis” that may serve insurance companies needs, but does nothing to help physicians and, more importantly, does nothing to make patients safer.