Stroke Treatment TPA - Most Deadly Drug given with No Consent for Moderate Stroke
TPA givers don't see the Fatal Bleeds they cause; Death Certificate doesn't state TPA given
Fatal TPA Malpractice Case Blocked in Many States
Stroke TPA History and Controversy(Questionable Benefit with Significant Death Risk)
Stroke TPA Controversy Links
Stroke TPA Debate Video Links
Deadly Stroke TPA Now Delievered to Your Home
AHA Guidelines State Stroke TPA Consent Not Needed
Fed/County/State Health Department's TPA Promotion without Stating Risk/Controversy
Promising and Safer Stroke Recovery Drugs and Therapies
Some Other Dangerous Drugs, Vaccines and FDA failures
Conclusion: A Right to a PreStroke TPA Informed Consent Record is Needed

Stroke Treatment TPA - Most Deadly Drug given with No Consent for Moderate Stroke

The controversial clot-buster drug is by far the most deadly treatment drug in US hospitals and is being given without informed consent in emergency rooms to patients with stroke symptoms. The clot-buster stroke drug is Tissue Plasminogen Activator(TPA) and by a legal theory is being given as a kind of CPR for stroke without either written or verbal consent for a patient's non-life threatening moderate ischemic clot stroke.

Stroke TPA does not save a person's life and only has a controversial claimed possibility of a modest recovery benefit after 3 months but carries a signficant risk of causing a fatal brain bleeding hemorrhage and that risk reaches Russian roulette levels(16%) in the elderly. And TPA protocol errors are common which increases stroke TPA's death risk into the 20-30% range. In Europe stroke TPA is not approved for patients over 80 but here in the US there is no such restriction.

In a moderate or severe ischemic clot stroke an area of brain cells is deprived of blood causing brain cells to die within minutes but TPA is not given until hours later at the hospital. Stroke TPA is recommended only for a moderate ischemic stroke which is not normally a life threatening emergency as stroke rehap and other safer treatments are effective. Stroke TPA is FDA approved for only 3 hours after stroke onset and blood pressure must be and kept under safe levels.


TPA givers don't see the Fatal Bleeds they cause; Death Certificate doesn't state TPA given

When a person discovers a family member with stroke symptoms they will usually call 911. However, the 911 operator and arriving paramedics are usually not aware of the deadly TPA stroke drug which they will be delivering the patient to and so do not inform a family member to go to the hospital with the patient to provide consent and confirm the critical stroke onset time.

When a stroke patient enters the Emergency Department a CT scan is given and if a brain bleed is on the scan(a likely hemorrhagic stroke) then TPA is not given otherwise after some blood tests the neurologist will order the ER MD and nurse to give TPA over a 1 hour infusion. The patient is then moved from the Emergency Department and admitted into the hospital. If a patient should then develope a TPA induced brain bleeding hemorrhage in the hours later(a real emergency) then essentially nothing is done to stop the bleed until death occurrs. The ER TPA nurse, ER MD and neurologist usually never see the brain bleeding patient aftermath. The hospital nurses who treat the patient's internal bleeding symptoms(vomitting) are typically unaware that TPA was even given to the patient in the Emergency Department.

And the Death Certificate will typically not state that TPA induced the fatal bleed leading to death. It will typically only mention that stroke was the cause of death.


Fatal TPA Malpractice Cases Blocked in Many States

Obtaining an attorney for an eldely wrongful death case is rarely possible as many states have low non-economic damage caps that limit malpractice awards(like California's MICRA). This is typically the only award type available for a wrongful-death malpractice case when the victim has no job income and punitive damage awards are rarely given. However, if a stroke patient does not receive stroke TPA then attorneys are willing to take a "Fail to Treat" case because there is a large award possible. This creates a legal environment in many states where hospitals have little chance of being sued if they give deadly stroke TPA and a significant chance of being sued if they don't.

Medical malpractice cases in all states require expensive medical expert testimony. Emergency Medicine and Neurological professionals are reluctant to testify against each other in fatal stroke TPA cases as protection for each other as it is the AHA GuideLines, the Legal environment and Hospital management policies that essentially forces MDs to give stroke TPA. MDs are now more and more foreign born and educated and being brought into the US by J1 and H-1B work visa programs and these MDs are even more reluctant to question stroke TPA usage. Foreign MDs who decide to work for a non-profit or public hospitals, including VA hospitals, are not subject the H-1B cap.


Stroke TPA History and Controversy(Questionable Benefit with Significant Death Risk)

The clot buster drug(thrombolytic) was first used in the 1980s for a blood clot in a heart artery which causes a heart attack(MI: myocardial infarction). In repeated clinical test trials of TPA for MI the results showed a consisted benefit with only a minimal hemorrhage risk and that benefit extended to actual community hospital use. TPA was then later tested and used for a lung blood clot(PE: Pulmonary Embolism). TPA for MI, PE and Acute Stroke are of similar dosage based on body weight however for MI and PE the dosage is given over 1.5 to 3 hours but for Stroke the dosage is given over a more intense duration of only 1 hour. See PDF: Genentech TPA Prescription Guide

In the 1990s, the clot buster drug was then tested in European clinical trials for ischemic clot stroke and the early test trials resulted in no significant benefit and with a significant rate of causing brain bleeding hemorrhage deaths. Brain cells die within minutes of being deprived of blood once a clot in a blood vessel in or to the brain occurs and the hospital is giving stroke TPA hours later. But TPA supporters claim there may be a salvageable brain cell area(penumbra) around the dead brain cell area which may be saved leading to improved patient long term recovery after 3 months. However, if there is a salvagable penumbra that is slowly being lost during the first few hours after stroke and TPA is supposed to salvage it then TPA should show a short term recovery benefit but it does not as all the clinal trails have shown.

In 1995 the National Institute of Neurological Disorders and Stroke(NINDS) clinical trial tested TPA for ischemic stroke and found no significant benefit after 24 hours(Part 1). However, a secondary study(Part 2) on the trial data found a controversial benefit of an 11% increase in chance of a "favorable improvement" in recovery 3 months after being given TPA. A FDA panel with ties to TPA's manufacturer Genentech then approved TPA in 1996 within 3 hours of stroke onset.

Genentech's prescription guide section for Activase(TPA) application on "Acute Ischemic Stroke Patients" states the NINDS-Part 1 result after 24 hours was not significantly different between the TPA group and Placebo group and had an increased internal bleed risk for patients over the age of 75 or patients with blood pressure >= 175. See PDF: Genentech TPA Prescription Guide. For each decade after a person turns 60 the chance of a stroke doubles so most stroke patients are typically our elderly.

If patients receive TPA for minor partial clot strokes(which clear on their own) or for stroke mimics and recover within a few hours the patients may conclude that TPA was the reason for the improvement but that conclusion is not supported by the 1995 NINDS trial's Part 1 result. Stroke mimics have been shown to be misdiagnosed by physicians in the hospital setting up to 31% of the time, see: Stroke Mimics are Frequent. Stroke TPA does not save a person's life but has a significant chance of ending it.

The 1995 NIND trial was controversial since the TPA test group had signficantly less severe strokes than the placebo group and most of the improvement at 3 months came in the group that received TPA within 90 minutes of stroke onset which few real world patients will be in when the typical stroke occurs outside of the hospital. The FDA approval panel mostly heard from NINDS trial clinical investigators who were employees of TPA's manufacturer Genentech, See PDF: Why were the benefits of tPA exaggerated? The role of interpretation bias

The average age of NINDS trial patients was 67.5 and TPA's manufacturer Genentech warns of a further increase in bleed risk for those over 75. The trial's 6.4% hemorrhage rate was significantly underrated for people over 80. The raw NINDS trial data which was withheld from independent researchers for several years revealed that patients over 80 have a 16% chance of hemorrhage from TPA with no significant improvement; see: NCBI article on Stroke TPA Risk over Age 80. Europe does not approve stroke TPA for patients over 80.

Maintaining a safe blood pressure level is a critical step during and after stroke TPA. The NINDS and Europe's ECASS-3 trial excluded patients who had high blood pressure or required aggressive treatment to control. Hospitals make the additional risky choice of attempting TPA for a patient with high blood pressure by given a BP reduction drug like Labetalol which in many cases fails to keep BP at safe levels. And many Hospitals will not take post-TPA treatment steps for a TPA induced brain bleeding hemorrhage such as giving cryoprecipitate, protamine and a blood platelet pack: Ventura County Health Care Agency Stroke Treatment(section III. MANAGEMENT OF INTRACEREBRAL HEMORRHAGE). Tranexamic acid, which can stopped a TPA induced brain hemorrhage bleeding, is also typically not give either: Tranexamic Acid after TPA.

Frequent TPA protocol violations occur(ex. not maintaining safe blood pressure, not confirming stroke onset time) when stroke TPA has been studied in actual rushed hospital ER settings increasing the TPA hemorrhage risk further. The TPA hemorrhage rate for persons over 80 with these extra risks can climb from 16% to the 30% range.

In 2000 an American Heart Association panel upgraded TPA to a Class I category(definitely recommend). The AHA panel had 8 of it's 9 members with financial ties to Genentech. The panel member with no Genentech ties, Dr. Jerome Hoffman, wrote a dissenting opinion that wasn't even acknowledged by the panel. See article: Conflicts of Interest in Clinical Trials (Case 2: Biased Clinical Guidelines)

In the following years Genentech gave millions of dollars to the AHA who influenced the Brain Attack Coalition, Joint Commission, Get With The Guidelines and other organizations to create "certified stroke centers" with stroke teams at hospital ERs in the US to deliver TPA as the "Standard of Care" for ischemic stroke; see article: Why We Can't Trust Clinical Guidelines(at End in Green: "Exuberant Claims for alteplase(TPA) in Stroke", "Best Guidelines Influence Can Buy: How It Happens").

The stroke TPA medical controversy divides the neurologists who mostly support TPA as the "Standard of Care" for ischemic stroke and the ER physicians and nurses who in surverys mostly do not. However, neurologists do not inject the TPA or have to deal with any TPA induced brain bleeding symptoms that begin before the 1 hour TPA infusion ends.

On entry to the Emergency Department a stroke patient will be given a CT scan in an attempt to confirm a ischemic stroke but this is error prone. There are superior methods to confirm an ischemic stroke but many Hospitals do not provide them such as a type of MRI known as Diffusion-Weighted Imaging(DWI). Another is a CT perfusion which is a study of brain blood flow and volume which helps identify ischemic infarct and any possible salvageable brain cell area(penumbra). Although time consuming, cerebral angiography and carotid ultrasound can confirm a clot.

Stroke severity is usually measured by a not always accurate question and observation test known as the National Institutes of Health Stroke Scale(NIHSS) score: 1-4 is minor, 5-22 is moderate/moderate-severe, 22-42 is severe. TPA is recommended for a moderate to moderate-severe ischemic stroke score of 5-22 which is not normally a life-threatening stroke.

There are other stroke treatments alternatives other than deadly TPA. The body has the ability to make about a 20% natural recovery from a moderate ischemic stroke on its own. Long term treatment with physical, speech and occupational therapy also usually leads to a significant recovery after several weeks to months. Promising and less risky drugs for stroke recovery include Enbrel, Ampyra, Minocycline, Gingko Biloba tree leave supplement and a curcumin-derived compound. Promising therapies are magnet, DC current, laser light, neural stem cells, optogenetics and brain cooling. See: Promising Stroke Recovery Treatments

"Call 911 for stroke symptoms" is promoted by corporate media, hospitals, county health departments and professional organizations like the American Heart Association and affiliated American Stroke Association. The AHA has received tens of millions of dollars from Genentech and promotes the off-labeled use of TPA to 4.5 hours after stroke for patients under 80. These organizantions might mention that there is a time-sensitive treatment at the ER. However, they always fail to disclose that the treatment(TPA) is controversial and has a significant risk of death especially for older patients. In addition, Medicare's DRG 559 billing code now reimburses hospitals several thousand dollars for use of stroke TPA. How and why TPA has now become essentially a mandatory "Standard of Care" for ischemic stroke in most US hospitals is nothing short of a scandal.


Stroke TPA Controversy Links

Knowledge is essential in making an informed consent decision for stroke TPA but critical information is not currently available from hospitals, the mainstream media, major health web sites, stroke associations or county/state/national health departments. One has to find medical publications/journels/blogs to discover most information on the stroke TPA controversy.

The American Academy of Emergency Medicine(AAEM) consists of several thousand ER doctors and nurses. The AAEM doesn't accept donations from pharmaceutical companies. The AAEM's position document on stroke TPA states "...the EP(Emergency Physician) at the bedside has not been convinced by those promoting this therapy... This document will certainly not be welcomed by the makers of TPA. Fortunately, the Academy has carefully developed itself in a manner that has precluded its dependence on funding from outside sources. We therefore are able to speak to what we feel best serves the majority of the membership." see: AAEM Stroke TPA Position

"The NNT" is a medical drug research group that states "No Benefit Found" for stroke TPA. They only use sound double-blinded randomized clinical trial(RCT) evidence for their recommendations. The NNT web site states that there were 12 stroke drug trials completed and 10 of them failed and the 2 that show an improvement, US's NINDS-2 and Europe's ECASS-3(which studied TPA being given in the 3-4.5 hour window but excluded patients over 80 or with high blood pressure), were not without controversy as both industry funded trials gave TPA to a test group that had less severe strokes than the placebo group, see: The NNT Stroke TPA Summary of Test Trials

From a Discover Magazine article on the TPA controversy: "...Despite following each step of the established protocol for this new treatment, (the MD) experienced the unthinkable - his patient's death. (Patient) suffered a massive brain hemorrhage and died, not from his stroke but from effects of tPA,...", see: Discover Magazine article: Wonder Drugs That Can Kill

2008 American Family Physician article: "...In a review of 63 patients in which t-PA was given at 16 Connecticut hospitals, the protocol was violated in two thirds of the patients. What was the outcome? One of every four patients(25 percent) who received t-PA died...When I(an MD) am asked what I would do if it was my own family member, I answer honestly: I would not give this therapy." see: American Family Physician article: Treatment of Acute Ischemic Stroke with t-PA

2009 article: TPA NINDS trial data shows patients over 80 have 3 times TPA hemorrhage risk than younger patients: 4 of 25 TPA patients over 80 bleed for a 16% bleed rate. And a small hospital study of stroke TPA giving to patients over 80 showed a 28.5% hemorrhage rate. see: National Center for Biotechnology Information article

In an actual community hospital setting stroke TPA protocol errors are common and lead to significantly higher hemorrhage rates. Another stroke TPA study at Cleveland hospitals found a hemorrhage rate 3 times higher than the NINDS trial. And another study at Indianapolis hospitals resulted in a hemorrhage rate nearly twice as high as reported in the NINDS trial. Even minor TPA protocol errors increase TPA's hemorrhage risk significantly, see: 2002 Jama Network article

From a 2010 article from MD David D. Vega of the American Academy of Emergency Medicine at: Google "Medscape Vega The Other Corporate Practice of Medicine" which states "..there remains question about how corporate support may have influenced the recommendations to use tPA in acute stroke. Genentech is the U.S. producer of tPA. Internationally, the drug is distributed by Boehringer Ingelheim. The disclosures of the AHA Stroke Guideline writing group show that these companies (and a lot of other pharmaceutical manufacturers) have very good representation...there remains a great divide between supporters and opponents of this drug. It appears that individuals who have any sort of association with the manufacturer usually interpret the evidence to say that tPA's benefits far outweigh its risks. Many others who are not associated with the company interpret the very same evidence much differently, stating that at the very best, the benefits of tPA are minimal compared to the risks...With an issue as important as stroke and a treatment option that has a fairly high risk of death, we must make every effort to know what the studies really show and not what the pharmaceutical industry would want us to know..."

In the 1995 NINDS TPA stroke trial the following stroke severity imbalance shows why the TPA treated group had better outcomes at 3 months than the Placebo group. For patients in the TPA treated 91-180 minute group(most patients will be in this group for the typical stroke that occurs outside of the hospital) the results were: 27.5% of the placebo patients had NIH stroke scores of over 20 or more but only 18.3% of the TPA-treated patients did and 19% of the TPA-treated patients had NIH strokes of 5 or less while only 4.2% of the placebo patients did: EM Ireland Researcher Site(Part 1)

In a 2013 British Medical Journal article "Do risks outweigh benefits in thrombolysis for stroke?" which states "... With regard to the only other positive rtPA trial (NINDS) Hoffman and Schriger make a compelling case that the "treatment effect" observed in NINDS is due largely to allocation bias with a greater number of more severe strokes in the placebo group... We wholeheartedly agree that patients with stroke and their families need to be partners when deciding on treatment options. This should be informed by a realistic appraisal of the risks and potential benefits of thrombolysis, which at present should be considered an unproven therapy with a substantial associated risk of harm." see: British Medical Journal article

In February of 2013, the American College of Emergency Physicians(ACEP) published a Clinical Policy statement regarding the use of stroke TPA Level A recommendation and the response from it's membersip was unprecedented as the ACEP Scientific Assembly and the ACEP Council voted to “reconsider” this Clinical Policy, see: EP Monthly Article and see: Another EP Monthly Article and see: Med Page Article .

And from a Medscape article entitled "Why Choosing Wisely Won't Protect You in a Lawsuit", as of January 2015 ACEP has not changed their controversial Level A recommedation for stroke TPA: "... A public outcry by emergency physicians after the publication of the thrombolytic guidelines caused the ACEP Board to open the guidelines for comment on ACEP's website, but the results of the comments were never made public and the policy was never rescinded. A poll of readers in Emergency Physicians Monthly showed that 88% of respondents believed that ACEP's thrombolytic guidelines needed to either be rescinded or revised to reflect the current standards of care... In addition, after the guidelines were published, an article in the British Medical Journal noted that several of the guideline authors failed to disclose their associations with the manufacturer of the thrombolytic being used in the guidelines. Despite a strong "Level A" recommendation from several professional organizations, these stroke guidelines showed potential harm to patients and continue to be questioned by most practicing physicians."

A Christian ER Training site it mentions TPA controversy and no risk rehap instead of TPA: "...early aggressive rehab is extremely important in stroke care, and can help many patients achieve significant improvement (in ATLANTIS, with baseline NIHSS score of 11(moderate stroke score), 32% of placebo patients with excellent neuro recovery, and in ECASS III, 45%)", see: Christian ER Teaching site

A 2014 article by Dr. Anand Swaninathan states: "A recent EP Monthly poll showed that emergency medicine community do not consider tPA for CVA a level A recommendation. There were 88% of physicians who thought the new ACEP guidelines(upgrading this recommendation of TPA) should be revised or rescinded.", see: NINDS Trial Review. In another 2013 article he recaps the TPA controversy by examining the 1995 NINDS TPA clinical trial data and mentions the patients over 80 had nearly 3 times greater TPA hemorrhage rate than those under 80 and with no significant improvement when given TPA, see: TPA Risk over age 80.

2013 Emergency Physicians Monthly article mentions a recent survey that resulted in only 39% of ER Physicians stating that they gave TPA because they felt it led to an improvement in outcome which is shocking for a "standard of care" essentailly mandatory drug with a signficant risk of death which does not require consent; see: ER Physicians Survey; Not Supportive of Stroke TPA . This article also fails to disclose the NINDS trial controversy resulting in inflated benefit and minimization of risk.

In 2000 the AHA upgraded it's Guidelines for use of tPA for ischemic stroke to a Class I intervention (always acceptable, proven safe and definitely useful). The majority of the 2000 AHA panel had ties to the manufacturer of tPA or associated firms; from an emergency physician on TPA Trial Controversy and Panel Conflict of Interest: 2000 TPA Approval Panel Conflict of Interest

2014 article by Chris Nickson, ER MD, on stroke TPA and it's controversy, see: Life in the Fastlane Medical Blog which concludes evidence for stroke TPA is weak and flawed test trials had bias.

Dec 2012 by ER MD Michelle Johnston, on stroke TPA and it's controversy, with many comments, see: Life in the Fastlane Medical Blog

2013 article by MD David Newman; reviews stroke TPA test trials and concludes: "Thrombolytics benefit acute stroke patients is rather conspicuously not supported.", see: Smart ER Medical article

2012 MD Jerome Hoffman, Cooper article on recent 3rd international stroke trial(IST-3)(Not a RCT), see: Online Library Medical article

2001 Genentech's monetary influence on the AHA support and false claims of live-saving TPA, see: Mother Jones article

2010 Stroke TPA article: "Biased Policies on Stroke: It's Only Partly Pharma's Fault", see: Brody Hooked Medical Blog

2008 Article: "A User's Guide to the NINDS rt-PA Stroke Trial Database"(public access to DB was denied for several years), see: Plos Medicine article

2009 MDs Jerome Hoffman, David Schriger, Review NINDS Trial data - no significant benefit for TPA, see: Hoffman and Schriger Review

2013 Rogue Medic on TPA Controversy with Links to other MD papers, see: Rogue Medic Blog on TPA

2009 Article: ER MD on the difficulty of informed consent for TPA in ER, also comment section: 2009 Kevin MD

2010 Article: Neurologist on the difficulty of informed consent for TPA in ER - All the more reason for a pre-Stroke TPA consent decision: 2010 Kevin MD


Stroke TPA Debate Video Links

Most Medical professionals are unaware of the stroke TPA controversy however within Emergency Medicine and Neurology it's well known. Dr. Jerome Hoffman was the lone dissenting member of the AHA panel that approved stroke TPA. Dr Greg Albers is director of the Stanford Stroke Center and a past consultant for Genentech, TPA's manufacturer. In this debate sponsored by the Oregon Stroke Network both MDs have vastly different opinions on the use of stroke TPA. see: Stroke TPA Video Debate.

Also, from p. 25 of Hoffman TPA Debate PDF which quotes Genentech scientist Elliot Grosbard: "We do not know how another trial would turn out, and if we do not come out ahead, we would have a terribly self-inflicted wound....[Another study] may be a good thing for America, but it wouldn't be a good thing for us."

In another stroke TPA debate, Dr. Anand Swaminathan debates Dr. Andy Jagoda. Dr. Jagoda is also a consulant for drug companies including Boehringer Ingelheim which has the international license for stroke TPA. At minute 43 of the video even Dr Jagoda admits how dangerous stroke TPA is for older patients as he states the hemorrhage risk is 17% for a patient at age 82(which is even higher when TPA protocol errors occur which are common), see: Another Stroke TPA Video Debate.


Deadly Stroke TPA Now Delievered to Your Home

Deadly stroke TPA is now starting to be delievered to US homes by ambulance following the 911 call. Google: stroke treatment TPA ambulance or see US News Health article: Stroke TPA To Your Home: US News Health and see Neurology Today article: Stroke TPA To Your Home: Neurology Today


AHA Guidelines State Stroke TPA Consent Not Needed

The American Heart Association releases guidelines that hospitals follow for stroke care. In addition to the earlier mentioned 2000 AHA panel which upgraded tPA for ischemic stroke to a Class I intervention, the AHA in 2007 and 2013 AHA panel released "Guidelines for the Early Management of Adults With Ischemic Stroke" document which continued the Class I recommendation for stroke TPA and also stated that TPA consent was not required.

From the 2013 AHA "Guidelines for the Early Management of Adults With Ischemic Stroke" at: AHA 2013 Stroke Guidelines which states on p. 28(Consent Issues) that no consent for "fibrinolysis"(TPA) is needed.

The 2013 AHA Stroke Guidelines p. 51-54 also lists the AHA panel member disclosures of financial ties with pharmaceutical companies including Genentech and Boehringer Ingelheim(has rights to stroke TPA in Europe). Also, from AHA TPA Sponsorship Bias article which states: "...the AHA has again come under scrutiny for extensive conflicts of interest in their Clinical Practice Guidelines, raising disturbing questions about the independence and reliability of the guidelines. The influence of financial ties is well documented in the medical literature, with meta-analyses and systematic reviews showing strong associations between pharmaceutical funding and favorable published outcomes."

Since there is so much credible controversy for stroke TPA within the medical community the AHA Stroke Guidelines "no consent required" position for stroke TPA should be challengeable in court of law especially if those deciding are a jury of 12 of your peers; stroke TPA is not CPR. A person has the right to know and approve what is being put in their body. An informed consent decision for stroke TPA should be made pre-Stroke and that decision record made available at the ER. Whose benefit is it serving to deny a pre-stroke TPA decision record? - certainly not the public.


Fed/County/State Health Department's TPA Promotion without Stating Risk/Controversy

Goverment(Federal, County and State Health Departments) typically advise the public to call 911 for stroke symptoms and may mention that a "TPA or a time-sensitive" stroke treatment drug is available but they have never disclosed the controversy surrounding the deadly stroke TPA drug.

In California, the Contra Costa County Health Department web site has public stroke response information and even mentions TPA but fails to mention it's controversy, deadly risk or safer alternatives: Contra Costa County Health Department Info for Stroke (click the 5 tabs for stroke information).


Promising and Safer Stroke Recovery Drugs and Therapies

The body has ability to make about a 20% natural recovery from a moderate ischemic stroke on its own. Long term treatment with physical, speech and occupational therapy also usually leads to a significant stroke recovery. Promising and less risky drugs for stroke recovery include Enbrel, Ampyra, Minocycline, Gingko Biloba tree leave supplement and a Curcumin-derived compound. Promising therapies are neural stem cell treatment, bone marrow stem cell treatment, magnet, DC current, laser light, optogenetics and brain cooling. These drugs and therapies do not have the sudden and significant death risk that stroke TPA does.

The approved arthritis drug Enbrel(aka etanercept) has shown promising results in stroke recovery(2012), from: Sun Sentinel Article on use of Enbrel for Stroke Recovery, states: "A single injection, then a five-minute wait. That's all it took for hundreds of stroke and traumatic brain injury patients from South Florida and nationwide to reverse years of debilitation. Now they're walking more steadily, reading more easily, concentrating better, speaking more clearly and regaining use of once-rigid limbs, long after giving up hope that their bodies would ever respond...Enbrel's makers warn of side effects from continued use, including headaches, upper respiratory infection and, in severe cases, immune system impairment, risk of cancer, heart failure and blood and nervous system problems. But stroke and TBI patients undergoing Tobinick's therapy are receiving only one, maybe two, doses of etanercept, the doctor said, so it is rare for his patients to see side effects... In a peer-reviewed study published Dec. 1 in the Adis medical journal, "CNS Drugs," Tobinick's Institute of Neurological Recovery gave etanercept injections from November 2010 to July 2012 to 617 stroke patients and 12 patients who had suffered a traumatic brain injury (TBI), 161 of them Floridians, largely from Palm Beach, Broward and Miami-Dade counties. Of the total studied, more than 80 percent saw improvements in their ability to walk; more than 80 percent had less spasticity; and more than 85 percent exhibited improved motor function. Improvements also were recorded in many patients' range of motion, pain and cognition, as well as their ability to speak, see, swallow, concentrate and maintain bowel control...(p. 2:) Because the therapy's "off-label" use of etanercept is not FDA-approved, this treatment is not covered by Medicare or most insurance plans. Monday's visit cost the Alfaros $4,800, including the injection and follow-up visits.... Who's a candidate? The vast majority of stroke and traumatic brain injury survivors living at home or in a rehab center are candidates for the etanercept therapy...".

A 2014 National Center for Biotechnology Information article on the promising result of a study on use of Enbrel(aka Etanercept) in stroke recovery: NCBI article on use of Enbrel(Etanercept) for Stroke which states: "...In December 2012, an observational study of 629 patients treated off-label with perispinal etanercept was published. The study included 617 consecutive patients treated a mean of 42 months following stroke... Statistically significant improvements in neurological and cognitive function and reduction in pain were noted in the stroke cohort. Perispinal etanercept produced rapid improvement in a variety of chronic post-stroke neurological dysfunctions....".

YouTube contains videos on the use of Enbrel for Stroke. Australian version of 60 Minutes news program covers stories of stroke victims recovering signficantly after receiving Enbrel at Florida clinic, see: YouTube Vid on use of Enbrel for Stroke. And Another Stroke Patient account of Recovery after being given Enbrel

Also Google: "stroke treatment enbrel kurg 91 year" for the Recorder article on new stroke treatment etanercept, sold under brand name Enbrel, which resulted in significant recovery improvement for a 91 year old stroke victim: “Now he can walk with a cane...His good leg is worse than the one that wasn’t working before!...he was like a whole new man...The physical benefits are great, but the treatment has had a tremendous impact on Krug’s morale as well...This medicine does away with inflammation in the brain”.

Ampyra, approved in 2010 for use in MS, showed a significant improvement in walking among stroke patients(2013), see: Ampyra for Stroke

Minocycline is an approved antibiotic drug with an established safety record has shown stroke recovery benefits when giving up to 24 hours of stroke onset(2007), see: Minocycline for Stroke

Gingko Biloba tree leave supplements can protect against stroke-related neurologic deficits. A double-blind, placebo-controlled, randomized controlled trial resulted in an observed significant NIH Stroke Score decline in the Gingko biloba group compared to the placebo group. See: Gingko Biloba for Stroke

A new curcumin-derived compound(CNB-001) from spice turmeric has shown evidence of protecting and regenerate brain cells after a stroke, see: Curcumin(Spice Turmeric) for Stroke Recovery and Stroke Prevention Strategies.

Low Electric DC(Direct Current) to the Brain Area has shown promise in Stroke Recovery(2012): see: DC Current for Stroke Recovery which states: "Transcranial Direct Current Stimulation(tDCS) is a form of neurostimulation which uses constant, low current delivered directly to the brain area of interest via small electrodes. The technique works by sending constant, low direct current through electrodes. When these electrodes are placed close to the region of the brain of concern, the current induces electrical flow. The flow can then either increase or decrease the the way that brain neurones react which leads to alteration of brain function. What the research team behind some recent studies put forwards was the (tDCS) can have various positive effects on the brain lasting for up to 12 months, Science News reported. In particular, non-invasive brain stimulation had a positive effect in aiding recovery among stroke sufferers... "

Neural Stem Cells therapy has shown promise in Stroke Recovery. Search on "stem cell stroke treatment, John Brodie, Bart Starr or Gordie Howe" who all received the treatment and made significant stroke improvement or see: Neural Stem Cells Therapy for Stroke helps Sport Legends .

Bone Marrow Stem Cells therapy From: Non-embryonic Stem Cells(bone marrow) Therapy for Stroke Recovery which states: "...Five people who had suffered severe strokes regained the power of speech, use of their arms and legs and improved cognition... The three men and two women, aged between 45 and 75, were treated with stem cells extracted from their own bone marrow in the first experiment of its kind."

Magnet therapy has shown promise in Stroke Recovery. From a study(2012): Magnetic Therapy for Stroke which tested 60 stroke sufferers who had mild to moderate muscle weakness down one side of the body and used magnets to stimulate the neurons in the brains of stroke patients to help them recover from their post-stroke paralysis, the study stated: "... One group received magnetic stimulation to the half of the brain affected by the stroke. The second group received magnetic stimulation to the half of the brain not affected by the stroke...The results were quite exciting. Both treatment groups saw significant improvements. They gained more control over fine motor movements like the ones used for writing or cutting up food, and they also saw a measurable improvement in bigger-muscle activities like walking as well..."

In another Magnet therapy study(2013), from: Magnetic Therapy for Stroke which states: "Magnetic stimulation of the brain appears to help speed recovery of speech and language in stroke survivors, a small new study finds. Transcranial Magnetic Stimulation (TMS) uses a handheld magnetic coil that delivers low-intensity stimulation and causes muscle contractions when placed over the brain's motor cortex... On average, patients in the TMS group showed three times greater improvement".

Infrared Laser Light therapy has shown promise in Stroke Recovery, from: Infrared Laser Light Therapy for Stroke Recovery which on p. 14 states: "..Researchers have also tested light energy against acute ischemic stroke. In the placebo-controlled NeuroThera Effectiveness and Safety Trial (NEST-1), people...received infrared laser light applied over the scalp. Although its mechanism is unclear, the treatment improved functional outcome when given within 24 hours of stroke onset."

Optogenetics therapy which targets light-driven stimulation of nerve cells in the brain has shown promise in Stroke Recovery, from: Optogenetics Therapy for Stroke Recovery which states: "...we found that direct stimulation of a particular set of nerve cells in the brain(nerve cells in the motor cortex) was able to substantially enhance recovery..."

Brain Cooling therapy also may perserve brain nuerons to buy time until until the blood clot is safely dissolved: from: Brain Cooling Therapy for Stroke Recovery which states: " put the brain in a state of hibernation to reduce its need for nutrients and oxygen, allowing neurons to survive longer during the blood deprivation..." And see: Brain Cooling Therapy for Stroke Recovery which states: "...brain tissue not only dies when blood flow is interrupted, it's also injured immediately after the brain artery is re-opened - what is called reperfusion injury..."


Some Other Dangerous Drugs, Vaccines and FDA Failures

The prescription drug painkiller Vioxx caused tens of thousands of deaths by stroke and heart attack before it was recalled by the manufacturer in 2004, see: Pain-Killer Vioxx Recall. A more recent deadly prescription drug story is the blood thinner Pradaxa, see: Blood Thinner Pradaxa. The deadly use of both of these drugs resulted in class action lawsuits against the manufacturer but the total compensation award to all the victim families was only a fraction of the drug sales.

More and more toxic vaccines are being given causing harm and even death and a harmed family can not sue the vaccine company(Vaccine Injury Act of 1986). And there is a drive back by vaccine companies to make them mandarory in states. see: Vaccine Controversy and Vaccine Impact Info.

For more information on dangerous drugs see: Drug Recalls and Defective Drugs Resulting in Class Action Lawsuits. And a movie on pharmaceutical companies risking patient safety to maximize profit, see: Money Talks Movie.

The FDA has numerous conflicts of interest with the pharmaceutical industry they oversee which puts patient safety at risk of drugs that are not properly tested. There are however FDA changes that can be made to increase public safety, see: FDA Conflict of Interest and Possible Solutions


Conclusion: A Right to a PreStroke TPA Informed Consent Record is Needed

Stroke is a brain injury where the patient does not have full mental alertness and the patient is being offered or are just given deadly stroke TPA by a ER doctor who is a stranger to the patient in a rushed ER setting. The public assumes a hospital's ER function is to stabilize a patient not to administer a drug with a significant death risk and a controversial benefit for a non-life threatening condition.

The ER is no place for a brain damaged patient or even an alert family member to make an informed consent decision on deadly stroke TPA as they have only minutes to decide with no way of confirming what is begin presented to them or discovering safer alternative stroke treatments as this 2009 article details on the difficulty of obtaining informed consent for stroke TPA in the ER, see: Stroke TPA Drama in the ER

Hospitals and primary care physicians should be disclosing the complete truth on stroke TPA for the patient's age and health before a stroke occurs when a patient has a fully alert mind and the opportunity to verify the claims and discover safer alternatives before making a decision with their Family whether to be given TPA for any future stroke.

A patient's decision for TPA should then be on computer record such as in the Advance Health Care Directive, so that an ER may later access it if/when a stroke occurs. This is a basic human rights issue - a person has the right to know and agree to what is being put into their body especially if the drug or procedure has a significant risk of causing death or serious harm.

There should also be a national data base opened to the public on stroke TPA results that requires mandatory(not voluntary) updates with a record on every person who receives stroke TPA. Medicare's DRG 559 billing code now reimburses hospitals several thousand dollars for use of stroke TPA. Before our Medicare tax dollars reimburse a hospital for stroke TPA it should require the data base to update with a stroke TPA results record.

The record should include any brain bleed hemorrhage outcome within 36 hours(as the 1995 NINDS clinical trial did), patient age, condition, stroke onset time, if any blood pressure reduction drugs were used and the BP check intervals, and what if any consent information was given and obtained. The record should be updated after 3 months to show the patient's current condition along with the amount and type of stroke rehabilitation received.

There also should be a requirement that when a person is given stroke TPA and a fatal brain hemorrhage occurs within 36 hours(NINDS tracked for this period) then the death certificate should require stating that stroke TPA was given.