Medical Forum / General / Cardiology / February 2005
Doctors can reduce Adverse Effects by listening to their patients
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Sharon Hope - 21 Feb 2005 19:20 GMT "Patient-reported medication symptoms in primary care." This was published by the Archives of Internal Medicine, Volume 165, No. 2, January 24, 2005, and mentioned in the People's Pharmacy column today.
At first glance, it should be a big DUHHHH (perhaps meriting its own Doctoring for Dummies book), but unfortunately it is not only an important consideration in medicine, but too infrequent for quality care.
I attended a seminar on Medical Ethics (illustrated by the case of statins) last week at UCSD, and I was struck by one doctor (a ranking member of the medical college, both a physician and a lawyer) who absolutely categorically stated several times that he DID NOT BELIEVE that physicians would tell patients that it was "impossible" that statins could be responsible for the adverse effects they were experiencing. Unable to contain myself, I spoke up from the audience and, holding up printouts from 5 different emails that I had personally received just in the past week by people who had heard just such pronouncement from their own physicians - each of whom refused to even consider statins as causitive in the symptoms the email author or his/her loved ones were experiencing, even though all of the symptoms were well documented in the medical literature as known statin adverse effects. To this the dubious doctor said that, while he didn't doubt the PATIENTS claimed the doctors said it was impossible, he did not believe that the doctors ever said "impossible." To this the presenter of the ethics seminar said that, while she would have been inclined to agree with his opinion several years ago, having consulted with several of these dubious physicians (at the patients' insistence), she no longer doubted the patient reports that their doctors said it was "impossible." Disturbingly, the opinionated doctor (who instructs other doctors and doctors to be in medical school) then said, I do not believe you. Effectively, branding not only the presenter, but all the patients referenced, liars.
Naturally, this was disproportionately disturbing to me, as there had been ***AMPLE OPPORTUNITIES*** for intervention during the 4 year decline on 10mg Lipitor when my husband's growing constellation of symptoms, increasing in severity, had been repeatedly discussed with his Primary Care Physician and his Cardiologist. Never once did either of them relate these symptoms to the statin (exception: Muscle pain, he was told it was the statin, but to "tough it out"), nor did they explore other causes (exception, near the end of the 4th year, there was a carotid artery scan done at my insistence to eliminate a blockage of blood flow to the brain as a cause - it was clear and nothing else was done).
It was from this perspective that this morning's People's Pharmacy reference struck me as important. Here, without further introduction, is the abstract:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstra ct&list_uids=15668373
Arch Intern Med. 2005 Jan 24;165(2):234-40.
Patient-reported medication symptoms in primary care.
Weingart SN, Gandhi TK, Seger AC, Seger DL, Borus J, Burdick E, Leape LL, Bates DW.
Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, MA, USA. saul_weingart@dfci.harvard.edu
BACKGROUND: Little is known about the prevalence and character of medication-related symptoms in primary care and their relationship to adverse drug events (ADEs) or about factors that affect patient-physician communication regarding medication symptoms. METHODS: The study included 661 patients who received prescriptions from physicians at 4 adult primary care practices. We interviewed patients 2 weeks and 3 months after the index visit, reviewed patients' medical records, and surveyed physicians whose patients identified medication-related symptoms. Physician reviewers determined whether medication symptoms constituted true ADEs. We used multivariable regression to examine factors associated with patients' decision to discuss symptoms with a physician and with physicians' decision to alter therapy. RESULTS: A total of 179 patients identified 286 medication-related symptoms but discussed only 196 (69%) with their physicians. Physicians changed therapy in response to 76% of reported symptoms. Patients' failure to discuss 90 medication symptoms resulted in 19 (21%) ameliorable and 2 (2%) preventable ADEs. Physicians' failure to change therapy in 48 cases resulted in 31 (65%) ameliorable ADEs. In multivariable analyses, patients who took more medications (odds ratio [OR] = 1.06; 95% confidence interval [CI] = 1.04-1.08; P<.001) and had multiple medication allergies (OR = 1.07; 95% CI = 1.03-1.11; P = .001) were more likely to discuss symptoms. Male physicians (OR = 1.20, 95% CI = 1.09-1.26; P = .002) and physicians at 2 practices were more likely to change therapy (OR = 1.24; 95% CI = 1.17-1.28; P<.001; and OR = 1.17; 95% CI = 1.08-1.24; P = .002). CONCLUSION: Primary care physicians may be able to reduce the duration and/or the severity of many ADEs by eliciting and addressing patients' medication symptoms.
Publication Types: Multicenter Study
PMID: 15668373 [PubMed - indexed for MEDLINE]
So, as many of you have seen in most of my posts, if only the adverse effects were more widely known, and if only doctors would screen for them, others need not become disabled due to statin adverse effects. A simple message, now worked up as a study.
Unfortunately, the situation persists.
And unfortunately for patients, doctors-to-be are being instructed by doctors like the one in the audience of the ethics seminar, who is so deeply in denial as to ignore evidence all around him (and at least he attended). It is little surprise that that particular physician felt the need to attain a law degree to go with his medical credentials - one wonders if it would have been a perceived need had he spent the hours listening to his patients that he instead expended at law school?
Andrew B. Chung, MD/PhD - 21 Feb 2005 21:03 GMT In truth, once a doctor hears about an adverse effect, it has already happened and even listening (i.e. acting on the information which most already doctors do) will not reduce (the rate) of adverse effects.
You will remain in my prayers, dear Sharon, whom I love, in Lord Christ's holy name.
May you reject your pride and accept Him as your personal Lord and Savior, someday, so that you too will have eternal life and the amazing peace of His everlasting kingdom.
Here's how:
http://makeashorterlink.com/?I22222129
Please note that God truly made this special link describing that He is the great "I am" and that His message is as simple as the number 2 which is a number between 1 to 9 and reminds us of His 2 commandments, the 2 arms of the cross, the 2nd part of the Trinity, the 2 finger sign of the Prince of Peace [who remains *V*ictorious over death and satan], and the 2PD Approach. Let it not ever be written that Christ did not make His presence known here on Usenet :-)
Also, note that Exodus 16:16 continues to remind us that 16 oz plus 16 oz makes 2 pounds, which is "a certain measure of weight," which is what "omer" literally means in Hebrew.
Enter the 2PD-OMER Approach:
http://www.heartmdphd.com/wtloss.asp
At His service,
Andrew
 Signature Andrew B. Chung, MD/PhD Board-Certified Cardiologist
** Suggested Reading: (1) http://makeashorterlink.com/?L26062048 (2) http://makeashorterlink.com/?O2F325D1A (3) http://makeashorterlink.com/?X1C62661A (4) http://makeashorterlink.com/?U1E13130A (5) http://makeashorterlink.com/?K6F72510A (6) http://makeashorterlink.com/?I24E5151A (7) http://makeashorterlink.com/?I22222129
> "Patient-reported medication symptoms in primary care." This was published > by the Archives of Internal Medicine, Volume 165, No. 2, January 24, 2005, [quoted text clipped - 108 lines] > have been a perceived need had he spent the hours listening to his patients > that he instead expended at law school? Sharon Hope - 21 Feb 2005 22:47 GMT > In truth, once a doctor hears about an adverse effect, it has already > happened and even listening (i.e. acting on the information which most > already doctors do) will not reduce (the rate) of adverse effects. Yes, but the severity of damage can be mitigated by early intervention.
If the muscle pain, for example, which started nearly immediately, had been taken as a signal to discontinue the drug (yes, this was well before Baycol was pulled, and long before the two AHA/ACC/NHLBI joint advisories), the damage might have been minimal, and recovery might have happened in a matter of months.
Instead, by NOT listening, the damage continued for 4 years until PATIENT intervention, and the disabilities remain 3 years later.
Even here, the RATE of adverse effects would have been lower, because the chronic fatigue, peripheral neuropathy, cognitive damage, memory loss, transient global amnesia, and aphasia took longer to become evident.
Thus 1 AE, had it been addressed, became 7+ AEs.
> You will remain in my prayers, dear Sharon, whom I love, in Lord > Christ's holy name. Thank you.
> May you reject your pride and accept Him as your personal Lord and > Savior, someday, so that you too will have eternal life and the amazing [quoted text clipped - 172 lines] >> patients >> that he instead expended at law school? Andrew B. Chung, MD/PhD - 22 Feb 2005 05:47 GMT > > In truth, once a doctor hears about an adverse effect, it has already > > happened and even listening (i.e. acting on the information which most [quoted text clipped - 16 lines] > > Thus 1 AE, had it been addressed, became 7+ AEs. That's not how the reporting is done. If one person out of a thousand is having adverse reaction(s), the rate stays at 0.1% even if the one person has 100 different symptoms (though the list of AEs gets longer).
At His service,
Andrew
-- Andrew B. Chung, MD/PhD Board-Certified Cardiologist
** Suggested Reading: (1) http://makeashorterlink.com/?L26062048 (2) http://makeashorterlink.com/?O2F325D1A (3) http://makeashorterlink.com/?X1C62661A (4) http://makeashorterlink.com/?U1E13130A (5) http://makeashorterlink.com/?K6F72510A (6) http://makeashorterlink.com/?I24E5151A (7) http://makeashorterlink.com/?I22222129
Hawki63@sbcglobal.net - 21 Feb 2005 22:52 GMT however true this is...
if ANY doctor used the word "IMPOSSIBLE" to me....that would likely be my last visit!!!
> In truth, once a doctor hears about an adverse effect, it has already > happened and even listening (i.e. acting on the information which most [quoted text clipped - 179 lines] >> patients >> that he instead expended at law school? listener - 21 Feb 2005 23:38 GMT > however true this is... > > if ANY doctor used the word "IMPOSSIBLE" to me....that would likely be > my last visit!!! I agree. But perhaps part of the reason many doctors feel strongly about statins (in particular) is in part due to statements like these (besides what they see firsthand in theiw own practice):
"Statin therapy has saved thousands of lives by preventing heart attacks and strokes. In major studies of thousands of patients on statin therapy, as many patients had muscle complaints on placebo or nothing as on statin therapy! This means that when patients are not sure whether they are receiving sugar pills (placebo) or statin therapy, they are as likely to have muscle complaints on the sugar pills as they are on the statin therapy. Therefore many patients with muscle complaints on statins are not having a reaction to the drugs and they should continue this important therapy.
The vast majority of patients receiving statin therapy tolerate it without any side effect. Statins have been shown to be safer than aspirin in studies of over 80,000 patients. There is some evidence that patients with heart and vascular conditions who stop their statin therapy abruptly may be at increased risk of having medical problems. "
http://www.impostertrial.com/patient.htm
...."the substantial protective effect of statins, particularly on coronary artery disease, is well documented and by far outweighs the potential risk of statin-induced polyneuropathy."
Statins and Risk of Polyneuropathy: A Case-control Study, by D. Gaist, MD, PhD; U. Jeppesen, MD, PhD; M. Andersen, MD, PhD; L. A. Garcia Rodriguez, MD, MSc; J. Hallas, MD, PhD; and S. H. Sindrup MD, PhD; Neurology, May 2002.
"...high blood levels of cholesterol do bear a relation to heart disease risk; and statin drugs that lower cholesterol reduce the risk of heart disease and stroke, which are primary causes of death and disability, respectively, in the US:
Beatrice A. Golomb, MD, PhD on Statin Drugs March 7, 2002 interview
"Considering that Dr. Golomb is the premier research authority on statins in the world, and also is independent of pharm co funding and has absolutely no reason to 'spin' anything, I take her at her word."
Sharon Hope sci.med.cardiology
So we have a class of drugs that is helping millions. Hopefully, ongoing research will aid in weeding out those few who might be predisposed to more severe side effects. Just as *we* have to grapple with the risk/benefit issue of these drugs so too do the doctors who prescribe them and many of them feel the benefit outweigh the risks.
L.
Hawki63@sbcglobal.net - 22 Feb 2005 02:29 GMT I agree ...and am a perfect example....I entered a Lipitor drug trial...being assured that I would at least receive Lipitor...but maybe not a vitamin that was being tested with it...ie ...could be in the placebo group...but was guaranteed that I would receive Lipitor
within 2 weeks I "ached all over"...having watched my spouse have Lipitor troubles...I reported to the NP that I was dropping out of study...
she politely broke my code..and said "you have been on placebo.....total placebo..as this trial for the first month EVERY patient took no active drug...
good illustration of the workings of the mind!!
since that time I tried statins again...first Pravachol...no side effects...but 18 months later..my lipids hardly budged..so started Lipitor..voila...after 3 months my lipids dropped like a rock...NO side effects...
unfortunately I have recently stopped the Lipitor..mainly due to "heartburn"....may or may not be related....in fact...4 months no Lipitor..and heartburn is still there...
>> however true this is... >> [quoted text clipped - 54 lines] > > L. Sharon Hope - 22 Feb 2005 03:48 GMT >> however true this is... >> [quoted text clipped - 22 lines] > > http://www.impostertrial.com/patient.htm Yes, Dr. Phillips does not seek to unduly alarm the patient.
You fail to mention that on that same page, however, he includes: a.. What are the Symptoms of Muscle Toxicity?
a.. What is Myopathy?
a.. What to do if You Think You are Having a Reaction to Your Statin Therapy
On the physician side of that same site, professional due diligence in attention to adverse effects is assumed: http://www.impostertrial.com/physician.htm Physician Information a.. Statin Associated Rhabdomyolysis
a.. What is Known about Statin Associated Myopathy with Normal CK?
a.. How to Evaluate Patients with Muscle Symptoms on Statins?
a.. How to Treat Patients with Hypercholesterolemia Who Can't Take Statin Therapy
a.. Percutaneous Muscle Biopsy
a.. Post-Rhabdomyolysis Syndromes
> ...."the substantial protective effect of statins, particularly on > coronary artery disease, is well documented and by far outweighs the [quoted text clipped - 4 lines] > Rodriguez, MD, MSc; J. Hallas, MD, PhD; and S. H. Sindrup MD, PhD; > Neurology, May 2002. Again, correct. But you left out the findings of the study:
"We found that users of statins were at a 4- to 14-fold increased risk of developing idiopathic
polyneuropathy compared with the background population,
and that this adverse effect may primarily
occur after long-term treatment with statins."
and
"For patients treated with statins for 2 or more years the odds ratio of definite idiopathic polyneuropathy was 26.4"
and
"Conclusions: Long-term exposure to statins may substantially increase the risk of polyneuropathy."
> "...high blood levels of cholesterol do bear a relation to heart disease > risk; and statin drugs that lower cholesterol reduce the risk of heart [quoted text clipped - 3 lines] > Beatrice A. Golomb, MD, PhD on Statin Drugs > March 7, 2002 interview more from that interview:
"On March 7, 2002, Colorado HealthSite interviewed Beatrice A. Golomb, MD, PhD, principal investigator of a study on Statin Drugs by the National Institutes of Health: "Question: What are the common complaints of patients who take statins? Dr. Golomb: The most common problems we hear reported pertain to muscle pain or weakness, fatigue, memory and cognitive problems, sleep problems, and neuropathy. Erectile dysfunction, problems with temperature regulation (feeling hot or cold, or having sweats), are among the other problems reported. " http://www.coloradohealthsite.org/topics/interviews/golomb.html
> "Considering that Dr. Golomb is the premier research authority on statins > in the world, and also is independent of pharm co funding and has > absolutely no reason to 'spin' anything, I take her at her word." > > Sharon Hope > sci.med.cardiology Dr. Golomb is often interviewed about adverse effects of statins. An example is the following: Statin Adverse Effects: Implications
for the Elderly
by Beatrice A. Golomb, M.D., Ph.D.
" Nonetheless, all drugs have
potential adverse reactions despite their potential
benefits. Understanding these risks is vitally important,
particularly in elderly patients in whom both risks and
benefits differ relative to younger patients."
and
"Muscle problems are the most common reported
adverse effects of statins, according to an observational
database maintained by the University of California at
San Diego Statin Study group. Perhaps the most feared
adverse effect of statins is rhabdomyolysis--a condition
in which there is severe breakdown of muscle tissue
that may be toxic to the kidneys and result in kidney
failure or death."
and
"
Adverse muscle problems from statins, in addition to
rhabdomyolysis, take a variety of forms (Table).
Shortness of breath sometimes accompanies statinassociated
muscle problems. The "respiratory exchange
ratio"--the ratio of carbon dioxide exhaled per oxygen
inhaled--is altered in people with statin myotoxicity
(Phillips et al., 2004). Occasionally, shortness of breath
is the predominant symptom. Patients may experience
marked shortness of breath that occurs following
initiation of statin therapy and is sustained while statins
are continued for which no etiology is identified on
extensive cardiopulmonary workup. These symptoms
resolve completely with statin discontinuation.
Muscle problems associated with statins may be more
common among the elderly."
and
"Cognitive problems also occur with statins and may
also have more impact in elderly patients. Two
randomized trials that were designed to assess cognitive
effects of statins have shown worsening in cognitive
function (Muldoon et al., 2002, 2000). In addition,
several case reports (King et al., 2003, 2001; Orsi et al.,
2001) and one large case series (involving 60 patients)
(Wagstaff et al., 2003) have reported deleterious
cognitive effects of statins on memory and cognitive
function."
and
"Analogous to the case for muscle adverse effects, the
impact of cognitive adverse effects from statins, when
they occur, may be more profound in the elderly."
and
" A large variety of other adverse effects have been
reported with statins, including (but not limited to)
gastrointestinal and neurological effects, psychiatric
problems, immune effects (e.g., lupus-like syndrome),
erectile dysfunction and gynecomastia (breast
enlargement in men), rash and skin problems, and sleep
problems.
Of particular note for the elderly population, the
PROSPER trial found a significant 25% increase in
incident cancer in participants over age 70 randomized
to statin therapy versus placebo (Shepherd et al., 2002)."
> So we have a class of drugs that is helping millions. Hopefully, ongoing > research will aid in weeding out those few who might be predisposed to [quoted text clipped - 3 lines] > > L. listener - 22 Feb 2005 05:12 GMT > "listener" <listener@nospam.net> wrote in message >> [quoted text clipped - 22 lines] > > Yes, Dr. Phillips does not seek to unduly alarm the patient. Nice way of putting your "spin" on it. So is he just making it all up? Thousands of lives saved..? safer than aspirin...? It clearly speaks for itself.
> You fail to mention that on that same page, however, he includes: No I didn't. Do ya see the link I posted?
>> ...."the substantial protective effect of statins, particularly on >> coronary artery disease, is well documented and by far outweighs the [quoted text clipped - 6 lines] > > Again, correct. But you left out the findings of the study: I think the words I quoted speak for themselves.
>> "...high blood levels of cholesterol do bear a relation to heart >> disease risk; and statin drugs that lower cholesterol reduce the risk [quoted text clipped - 17 lines] > among the other problems reported. " > http://www.coloradohealthsite.org/topics/interviews/golomb.html Boy, ya got me there. Right. People sure do complain! Even with that, Dr. Golomb sees the value in statins. I thought you took her at her word? I guess your a discriminating word taker - the ones you don't like you discard.
>> "Considering that Dr. Golomb is the premier research authority on >> statins in the world, and also is independent of pharm co funding and >> has absolutely no reason to 'spin' anything, I take her at her word." >> >> Sharon Hope >> sci.med.cardiology Strong words. Unfortunately, your misleading, over-emphasis, skewing of studies and overreaching make it difficult to take *you* at your word. It gets really screwy when you imply that, when I quote from the very studies you cite, the authors themselves are misleading!(or something like that - it's hard to know exactly what your point is).
>> So we have a class of drugs that is helping millions. Hopefully, >> ongoing research will aid in weeding out those few who might be [quoted text clipped - 3 lines] >> >> L. L.
Sharon Hope - 23 Feb 2005 04:09 GMT >> "listener" <listener@nospam.net> wrote in message >>> [quoted text clipped - 51 lines] > > >a.. Post-Rhabdomyolysis Syndromes
> No I didn't. Do ya see the link I posted? Not everyone trusts links and exercises them.
The snippet you provided was significantly out of context. The context was statin adverse effects.
>>> ...."the substantial protective effect of statins, particularly on >>> coronary artery disease, is well documented and by far outweighs the [quoted text clipped - 50 lines] >> among the other problems reported. " >> http://www.coloradohealthsite.org/topics/interviews/golomb.html Your choice of quotes were so far out of context per the content and intent of the citations to be laughable.
They simply didn't pass the "laugh test."
Is this approach something that you needed to go to class at Pfizer to learn to do?
I ask because it is exactly reminiscent of the approach that Pfizer took last week at the FDA hearing.
Per http://tampatrib.com/nationworldnews/MGB3UOEJA5E.html Witnesses Challenge FDA Over Painkillers By RICARDO ALONSO-ZALDIVAR Los Angeles Times Published: Feb 17, 2005
"Although a Pfizer scientist asserted that there is no clear evidence that Celebrex poses a risk, members of the committees rejected his position. ``That just doesn't pass the laugh test,'' Alastair Wood of Vanderbilt University, chairman of the hearing, said after Pfizer omitted the key study that documented problems with Celebrex.
Wood was referring to a study sponsored by the National Cancer Institute involving 2,000 patients over almost three years. Patients receiving higher doses of Celebrex had higher rates of heart attacks and strokes.
All three cox-2 drugs were approved by the FDA as stomach-friendly alternatives to traditional drugs for the relief of arthritis pain, beginning with Vioxx in 1999."
The news article didn't mention if ad hominem attacks were also part of the Pfizer corporate approach in the hearings...
>>> L. > > L. listener - 23 Feb 2005 14:29 GMT >>> "listener" <listener@nospam.net> wrote in message >>>> [quoted text clipped - 20 lines] >>>> >>>> http://www.impostertrial.com/patient.htm
>> No I didn't. Do ya see the link I posted?
> Not everyone trusts links and exercises them. ! Excuse me for saying this, but that is a really stupid thing to say.
> Your choice of quotes were so far out of context per the content and > intent of the citations to be laughable. Sorry that you find such a serious issue laughable. (With thanks to A. Chung!)
> They simply didn't pass the "laugh test." > [quoted text clipped - 3 lines] > The news article didn't mention if ad hominem attacks were also part > of the Pfizer corporate approach in the hearings... I don't know but it seems to me that you've been consistently attacking *me* lately. You really seem hung up on the "ad hominem' thing that you accuse me of....Although with your view, I can understand how you might take criticism and correction as attacks.
As I said, I think the quotes speak clearly for themselves. Everyone can read the full context and make up their own mind.
L.
Andrew B. Chung, MD/PhD - 23 Feb 2005 18:37 GMT > >>> "listener" <listener@nospam.net> wrote in message > >>>> [quoted text clipped - 32 lines] > Sorry that you find such a serious issue laughable. (With thanks to A. > Chung!) (You are welcome although God should get the credit for any real change in you, Frank)
At His service,
Andrew
-- Andrew B. Chung, MD/PhD Board-Certified Cardiologist
** Suggested Reading: (1) http://makeashorterlink.com/?L26062048 (2) http://makeashorterlink.com/?O2F325D1A (3) http://makeashorterlink.com/?X1C62661A (4) http://makeashorterlink.com/?U1E13130A (5) http://makeashorterlink.com/?K6F72510A (6) http://makeashorterlink.com/?I24E5151A (7) http://makeashorterlink.com/?I22222129
Sharon Hope - 28 Feb 2005 03:56 GMT >>>> "listener" <listener@nospam.net> wrote in message
>>> No I didn't. Do ya see the link I posted? > >> Not everyone trusts links and exercises them. > > ! Excuse me for saying this, but that is a really stupid thing to say. http://www.us-cert.gov/current/current_activity.html
http://www.google.com/search?hl=en&lr=&q=security+malicious+code+link+spoofed
listener - 28 Feb 2005 04:53 GMT >>>>> "listener" <listener@nospam.net> wrote in message > [quoted text clipped - 9 lines] > http://www.google.com/search?hl=en&lr=&q=security+malicious+code+link+s > poofed Not that this deserves an answer....
Still really stupid.
L.
Sharon Hope - 22 Feb 2005 03:14 GMT Yes, I hear from people all the time who have taken such action. Unfortunately, depending upon their insurance coverage, they can then wait months to see another doctor.
Also, for others, particularly those harmed by statin adverse effects when there was little or nothing published, the questions asked about the symptoms include a list of things, including all meds, as well as family background, possibility of stroke, possibility of stress, etc. When the doctor is ruling out a list of causes, and the patient really has no idea of the cause but is simply concerned that the symptoms go away, it is less likely they would stomp out and discontinue with the doctor.
Either way, while it should be buyer beware, the study is a worthwhile reminder to doctors to listen to their patients.
> however true this is... > [quoted text clipped - 195 lines] >>> patients >>> that he instead expended at law school?
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