Questioning Medicine

Weekly Medical Update 177


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Circulation

Bariatric Surgery and Cardiovascular Outcomes in Patients With Obesity and Cardiovascular Disease: A Population-Based Retrospective Cohort Study

Circulation 2021 Apr 13;143(15)1468-1480, AG Doumouras, JA Wong, JM Paterson, Y Lee, B Sivapathasundaram, JE Tarride, L Thabane, D Hong, S Yusuf, M Anvari





Patients with CVD who underwent bariatric surgery were matched 1:1 with similar CVD patients who did not undergo bariatric surgery.

primary outcome was major adverse cardiovascular events (MACE) (first occurrence of all-cause mortality, myocardial infarction, coronary revascularization, cerebrovascular events, and heart failure hospitalization)

n follow-up of 4.6 years, the primary outcome was lower in the surgery group compared with the control group occurred in 11.5% (151/1319) of the surgery group and 19.6% (259/1319) of the controls that is roughly a NNT of 12.





But enough with the observational trials- do what we want to see or don’t do it.











And while observation studies annoy me, sometimes they are necessary evil lead to practice or board changing answers,



Girometti N et al. Clinical and serological outcomes in patients treated with oral doxycycline for early neurosyphilis. J Antimicrob Chemother 2021 Mar 30; [e-pub]. (https://doi.org/10.1093/jac/dkab100)



The board question is someone comes in with neurosyphilis but is allergic to penicillin- the answer on every test is always who cares give it to them anyways. You go with penicillin desensitation, with is painfully slow and annoying.



But in this study



retrospectively evaluated 87 patients with early neurosyphilis who either received intramuscular (IM) penicillin with oral probenecid for 14 days (71%), 200 mg oral doxycycline twice daily for 28 days (18%), 2 g IM or intravenous ceftriaxone daily for 14 days (3%),



a majority did get the penicillin but . All patients attained seroreversion to a negative rapid plasma regain [RPR] or a fourfold decline in RPR titer.

And

At 30 days after completion of therapy, 91% of patients receiving parenteral penicillin therapy and 100% of doxycycline recipients achieved symptomatic resolution.



But enough of the observation data lets move onto a viewpoint in JAMA



Industry-Sponsored Speaker Programs—End of the Line? | Law and Medicine | JAMA | JAMA Network



November 16, 2020 for only the 6 times in 20 years the the Office of Inspector General (OIG) for the US Department of Health and Human Services (HHS) issued a Special Fraud Alert on “abuse risks associated with the offer, payment, solicitation, or receipt of remuneration” relating to industry-sponsored speaker programs



Now when I was a resident I took a free dinner but I was never invited back because I would ask a bunch of hard questions about the methods of the study that the speaker wasn’t prepared to answer. It was entertainment, education, and a free meal. SINCE becoming an attending I have not been to one and I said that with pride.



industry-sponsored speaker programs dates back to the 1950s and they have always been ‘dirty’ with physician kick backs and bias. And off these CME or speaker sponsored programs are “offered under circumstances that are not conducive to learning. ALSO lets be very clear often these drugs are not better than current standard of practice and they are more expensive which is a losing situation for our patients.



But why this fraud alert issued?? Well



July 1, 2020, During covid peak, Novartis quietly agreed to pay 678$ million dollar settlement for fraud charges of payment to physician and speak programs.



And I quote- Novartis “violated the federal False Claims Act and Anti-Kickback Statute by providing doctors with cash payments, recreational outings, lavish meals, and expensive alcohol to induce them to prescribe Novartis cardiovascular and diabetes drugs reimbursed by federal healthcare programs.”



From 2017 to 2019, drug and device companies reported paying health care professionals nearly $2 billion in compensation for services other than consulting but I suspect this will be going down significantly in the near future as it is hard to continue to issue kickbacks when you have the attention of the office of the inspector general. SOO if you are a big pharma industry sponsored event attendee that like a free industry sponsored meal, enjoy it while you can because this for the betterment of medicine and the well being of our patients is likely going away.



And while we are talking about government lets talk politicians and something they did positive which is usually few and far between but



on December 27, 2020, congress passed the Surprises Act — which banned “surprise billing”



and in order to talk about how this is a good thing lets quickly make sure we are all on the same page.



Lets say a patient gets sick and goes to the ER and then gets admitted to the hospital. Once in the hospital that patient has no control over what doctors they see. IF they see a doctor or two that are out of their network. Since insurance plans aren’t required to pay out-of-network providers their full charges, clinicians may bill the patient for the difference between the insurance payment and their charges.



This ends of up being a surprise bill and usually a surprise that is a lot of money. This is terrible. You get sick, you just want to get better, you are at a hospital and you have no control if the pulmonologist or cardiologist is in your insurance plan but yet SURPRISE you get stuck with the bill. BUT BUT BUT





Effective January 1, 2022, patients receiving out-of-network emergency services, air-ambulance transportation, or out-of-network nonemergency services at in-network facilities may be billed only the amount they would owe for an in-network provider.



Finally lets end with a little game from JAMA internal med.



Adverse Events Associated With the Addition of Aspirin to Direct Oral Anticoagulant Therapy Without a Clear Indication | Atrial Fibrillation | JAMA Internal Medicine | JAMA Network



ASA and anticoagulation is done wrong all the time so lets play a game



The combination of ASA with oral anticoagulation can be indicated for patients with??



The answer is

certain devices (eg, left ventricular assist devices) , patients with nonvalvular atrial fibrillation and have acute coronary syndrome (ACS) and undergo percutaneous coronary intervention (PCI). And finally those with venous thromboembolism (VTE) and have acute coronary syndrome (ACS) and undergo percutaneous coronary intervention (PCI).





Boom that is it! If you use combination therapy outside this setting then likely more harm than good and in this registry-based cohort study



researchers looked at the medical records of almost 3300 patients and matched up Roughly 1000 patients who received a DOAC plus aspirin were matched to 1000 who received a DOAC alone. During a 12month follow-up, patients on combination therapy were more likely to experience a bleeding event and Hospitalization for bleeding. BUT Thrombotic events, did not differ between the groups.

So you bleed more but you have the same risk of thrombotic events which sounds like a major losing strategy and something we should all keep in our minds for times when we can do a drugectomy and remove either the ASA or the anticoagulant, which ever is not needed.

So I ask you again

The combination of ASA with oral anticoagulation can be indicated for patients with??



The answer is

certain devices (eg, left ventricular assist devices)
patients with nonvalvular atrial fibrillation and have acute coronary syndrome (ACS) and undergo percutaneous coronary intervention (PCI).
And finally those with venous thromboembolism (VTE) and have acute coronary syndrome (ACS) and undergo percutaneous coronary intervention (PCI).


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