With which exhibits is Dr. Simon familiar?
1-5, 8-9.
How many times has Dr. Simon prescribed Sanguixa?
Zero. (72-73)
How does chronic kidney disease affect blood thinners?
It affects the metabolism of blood thinners. (78)
How many files did Dr. Simon review, what drugs were ALL of the patients taking, and when were the drugs prescribed in relation to the date of Mr. Vinson's prescription?
22, RENIBIX + Amtamid + Sanguixa, prior to the issuing of Mr. Vinson's prescription.
Which drug(s) does Dr. Simon think were unnecessary for Mr. Vinson?
What is Dr. Simon board certified as?
An internist. (4)
What is Dr. Simon's opinion on the regulations that govern compounded drugs?
They're lax. (19)
What are two consequences of blood thinners for patients with kidney disease?
Serious bleeding complications and further decreased renal function. (75-76)
What condition did all 22 of Dr. Davis' other patients have?
Reduced kidney function. (129)
To what portion of Mr. Vinson's medical file did Dr. Simon have access?
The entirety. (167-168)
How much has Dr. Simon been paid for this case?
$850 and hour, plus travel expenses. (13-14)
What three things should be tried before resorting to compounded drugs?
Non-drug treatments, over-the-counter medication, FDA-approved medications.
What two effects of kidney disease may increase bleeding risk?
Uremic platelet disfunction, anemia. (76-77)
In how many cases did Dr. Simon believe a blood thinner may have been appropriate?
What risk increases in patients with a history of falls?
Over 50. (109)
Why would Dr. Simon be surprised if a doctor prescribed the same compounded medication to many patients?
In the rare cases that it is appropriate to prescribe a compounded medication, the formulation should be tailored to each patient. (43-45, 61)
What co-morbidities does Dr. Simon list for those with kidney problems?
Hypertension, diabetes, atherosclerosis, and lipid disorders. (68)
Why does Dr. Simon claim that prescribing compounded drugs to patients is akin to treating them like guinea pigs.
The doctor does not know how a formulation is going to work. The idea is that the doctor keeps trying new combinations until a patient reports that a certain mixture is working. (31-34)
How many different factors increased Mr. Vinson's bleeding risk, according to Dr. Simon's review of Exhibit 9, and what are they?
Four: kidney problems, aspirin, sanguixa, fall risk.
Why does Dr. Simon caution his students against relying on one study?
Patients included in Phase 1 are not representative of actual patient populations. (95-96)
According to Dr. Simon, how does one know if a compounded drug is working?
One cannot. One can never know if the drug is working or if it is only a placebo effect. (33-34)
How should Wafarin be prescribed to patients with kidney disease?
In lower doses. (80)
In the cases in which Dr. Simon thought a blood thinner may have been appropriate, what was his reasoning?
The patient was at risk for a heart attack or stroke. (135)
What three factors does Dr. Simon cite to support his determination that Mr. Vinson presented as a fall risk?
Broken bones as reported in intake form, weakness in legs, construction job.