tPA ... "it's a cookbook, like making pork roast"
In October of 2002, a patient arrived in the ED at York Hospital with symptoms of a stroke, as well as a headache. She was seen and admitted. She was not given tissue plasminogen activator (TPA) because she had told the treating physicians that her symptoms began long enough ago that, by the time her labs and CT results were available, she was outside the three hour time window used to define eligibility for this therapy.
The treating physician and the hospital were sued for failing to give TPA.
Please note: The treating physician and the hospital were successfully defended in this malpractice lawsuit.
At trial, Dr. Ira Mehlman testified for the plaintiff that TPA should have been given and that it was the standard of care. In the course of his testimony, Dr. Mehlman made numerous statements that seem inaccurate. The following is a list of the statements made by Dr. Mehlman, with commentary as needed. Page numbers refer to the page in the accompanying transcript. Readers are encouraged to refer to the actual transcript to ensure that no statements are taken out of context.
In many cases, the attorney's question is given, then the witness's answer, followed by commentary. Throughout the testimony, the name of the plaintiff and the treatment date(s) have been removed to maintain patient confidentiality.
Witness states that patients who get TPA, even if they have a bleed, will have a better outcome than those patients who are untreated: "But despite that, the statistics on TPA say that patients who get TPA who are candidates and get it, even if they have a bleed, even if they have the worst complication of bleed in their head, their survival is still better than the untreated group. That's important. Even if they get this thing that people worry about…but even if they get that bleed, they have a greater survival than untreated patients who were candidates for TPA."
Continuing the argument begun on page 41 (above), the witness claims that TPA is the only thing that will prevent a stroke patient from becoming paralyzed. It is important to note that this statement was not in response to a question about alternate treatments or the outcome of a stroke. Rather, the testimony was in response to a question about where in the body bleeding occurs after a patient receives TPA: "…but it's [TPA] the only chance of somebody not being paralyzed for the rest of their life, trapped in their body and a burden on their family in their mind, whether they are or not, but in their mind certainly, and it's the only chance that somebody, a family member would have of being whole or markedly improved."
Question: "And with an ischemic stroke, is that a stroke where a patient could be a candidate for TPA?"
Answer: "Absolutely. It's the standard of care"
Comment: At the time of this writing, and at the time of the testimony, the issue of the use of TPA in strokes is highly controversial, with well know experts coming down on both sides. As such, it simply cannot be claimed that TPA is the standard of care. In making this claim, the witness also ignores numerous articles questioning the wisdom of this therapy as well as statements by numerous professional medical societies, including AAEM, which do not describe this therapy as standard of care. Indeed, the AAEM statement on this issue directly states that TPA is not the standard of care.
The witness is asked "…is there any other medication available in 2002 to treat stroke patients to lessen the effects of the stroke?"
The witness answers "No.'
Comment: This ignores a large body of literature that describes the beneficial effects of aspirin, specialized stroke units and physical and occupational therapy in stroke patients. These treatments have attracted far less controversy than has TPA.
Question: "Doctor, back in October of 2002, if a patient was not a candidate for TPA was there any other medication available to be used in its place?"
Answer: "No. They would be committed to a life of paralysis and dependence."
Comment: The truth is that many stroke patients recover all or part of their function prior to hospital discharge, even without treatment. Claiming that all patients become paralyzed and dependent without TPA is incorrect and misleading. Later, on the same page, the witness again claims that TPA is the only therapy available for treatment of stroke.
Dr. Mehlman states that if the patient had gotten TPA " you wouldn't expect her outcome to be anything other than better than what it was."
Comment: At the time of this writing, there is no basis for this statement. It is a wild exaggeration to claim that all patients receiving TPA improve. Even the NINDS study, which is the most closely analyzed study of the benefits of TPA, shows that many patients either have no demonstrable improvement or get worse.
Questioning has now turned to headaches. Dr. Mehlman discusses intracranial bleeding: "It can make you think of a bleed sometimes. But the headaches that are associated with bleeds are the kind of really severe, knock your socks off kind of headache…They're severe headaches, and typically a bleed again is more likely to be associated with a tremendous level of mental status changes and not focal findings"
Comment: Headaches associated with intracranial bleeding is not necessarily always severe, and in fact smaller subarachnoid bleeds may cause mild or moderately severe headaches. We are unaware of data that supports the contention that intracranial bleeding is usually associated with severe alterations in mental status but not focal neurologic deficits.
Dr Mehlman is asked to describe a subarachnoid hemorrhage. He responds: "Well, a subarachnoid hemorrhage is that space, the subarachnoid space where a bleed occurs, and it's a terrible event. It causes patients to go into a coma readily, and there's a high mortality associated with it.
Comment: Pain, mortality, presence of altered mental status and severity of that alteration are all related to the Hunt and Hess clinical grading system of subarachanoid bleeding. According to Rosen's, only 50% of patients have any sort of altered mental status. Stating that such patients readily go into a coma seems an exaggeration.
One line of defense was that the treating physicians were concerned about a possible subarachnoid hemorrhage. By exaggerating the presentation of this condition, Dr. Mehlman unfairly creates the appearance that there is no way the patient could have had this condition and thus attempts to eliminate this defense.
Comment by Dr. Mehlman "And yeah, TPA is dangerous. So is too much water."
Comment: Hardly an appropriate comparison. By comparing TPA to water, Dr. Mehlman seems to be minimizing the danger of giving TPA, which can be listed as being among the most dangerous drugs available when judged by the frequency and severity of complications.
Dr. Mehlman is questioned about the American Academy of Emergency Medicine's statement about use of TPA in ischemic stroke, as well as the Society for Academic Emergency Medicine's position. He responds by citing the American College of Emergency Physicians: "The American College of Emergency Physicians is the official organ that represents emergency physicians. That's the national official group. There is also societies [sic], and it turns out that the societies that were mentioned are, have taken a position that's contrary to what the joint commission of a hospital accreditation is, the American Heart Association…"
Comment: Of course, ACEP is not "the official organ" of emergency physicians in the United States. The joint commission has no statement about TPA being the standard of care for stroke patients. And, finally, ACEP's statement about TPA also does not define it as the standard of care, but rather states that it may be helpful and that further study is needed, points that Dr. Mehlman concedes on pages 119-121.
On the risks involved in getting TPA: "6 percent increased chance of bleeding, but the mortality is still smaller in the group that's treated, regardless even if they get a complication they still do better."
The claim that a patient with bleeding inside of the brain caused by TPA will do better than a patient without bleeding defies logic. We are not aware of any scientific data supporting this claim.
Question: Are you aware that Genentech, the company that makes the drug, is the one that sponsored the study?"
Answer: "I'm not aware of that. I'm sure they've probably provided the TPA, but I'm not, I'd be surprised if they paid for the entire study."
Comment: Genentech did. Surprise!
Dr. Mehlman denies knowledge of any literature that suggests TPA may not be beneficial. This in spite of original research, editorials and reanalysis all published well before the time of his testimony questioning the wisdom of TPA.