Are we really receiving the best evidence and advice from high-impact journals?

[Skeptical_Pharmacist]

Hello,

First time posting though I've browsed this website many times as a student, resident, and pharmacist. I'm interested to hear your opinions on recently published clinical trial data that we have available to support the use of new medications. It appears that the COVID pandemic brought with it a whole new level of industry-supported trials and I'm concerned that future studies will fail to address re-purposing of old, useful medications due to the large amount of profit associated with the release of new, branded medications.

My intention and the purpose of this post is to not start a conversation about COVID, most of us are sick of it at this point (pun intended). I'm interested in learning if my recent skepticism towards medicine in general is warranted.

Thanks,

Skeptical_Pharmacist

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[sadface]

I think the lack of studying old medications/unable to be patented meds was already a thing, not just after covid.

 

[JustFillIt]

emergency use authorization. It’s changed the playing field permanently

 

[Skeptical_Pharmacist]

Agreed, definitely occurred prior to the covid pandemic. Perhaps I should specify that there have been multiple articles pulled from (insert large medical journal here) for containing knowingly false information during the pandemic. This was not quite as public as it should have been given the impact of the studies on policy and the journals, but that is life in the US in the 2020's. Does this raise red flags for you?

 

[Old Timer]

The skepitcal pharmacist is not skeptical all. He is lazy. I suggest you go to clinicaltrials.gov. Look at all of the studies. I believe Hydroxycloroquine was the single most studied drug during the pandemic. They studied and are still studying Ivermectin, why I have no idea. They studied colchcine. In case you are interested, A new indication gets you a new patent. See Colchcine as an example. When I was a we lad pharmacist 40 years ago colchicine was dirt cheap. Now, not so much. Let's say they find Hydralazine works for Covid. They will come with 43.5 mg tablets and charge $12.00 a pill. Drug companies can sell ice to the Eskimo's and space heaters to the devil.

 

[Skeptical_Pharmacist]

Did you find it interesting that colchicine was expensive prior to the pandemic? It's been a quite few years since I've practiced in a retail setting but from what I recall, there wasn't and hasn't been a generic colchicine available for at least 4-5 years at this point, correct me if I'm wrong?
I am familiar with some of the hydroxycholorquine and ivermectin studies but I don't want to get into that (see original post) given how highly politicized the topic is and how anyone who knows the drug name is now an 'expert' on the evidence.

Let me clarify my original question with an example.
We're starting to see empagliflozin used in reduced EF and preserved EF heart failure WITHOUT type 2 DM. The studies (EMPEROR-Reduced, EMPEROR-Preserved, both industry sponsored) that support the use of empagliflozin in HFrEF and HFpEF show reductions in cardiovascular mortality (HFrEF) and/or hospitalization (HFrEF and HFpEF). The physiologic mechianism for these benefits is not well described in either study. Empagliflozin tends to have a diuretic effect in conjunction with lowering blood sugars. My question is: what are the chances that thiazide/loop diuretic use (generic) in HF plus excellent BP +/- tight glucose control in diabetics would result in the same outcomes thereby decreasing the need for a new, branded medication like Jardiance?

 

[WorthlessOxygen]

from what I recall, there wasn't and hasn't been a generic colchicine available for at least 4-5 years at this point, correct me if I'm wrong?

Generic colchicine has been back on the market for several years at this point

 

[Old Timer]

Really don't thunk HCTZ is going to cut it here.
Unraveling the Molecular Mechanism of Action of Empagliflozin in Heart Failure With Reduced Ejection Fraction With or Without Diabetes

 

[Rockinacoustic]

There are plenty of treatments to be contrarian about, but SGLT2s in HF is a pretty poor example to start questioning

 

[DH1987]

Did you find it interesting that colchicine was expensive prior to the pandemic? It's been a quite few years since I've practiced in a retail setting but from what I recall, there wasn't and hasn't been a generic colchicine available for at least 4-5 years at this point, correct me if I'm wrong?
I am familiar with some of the hydroxycholorquine and ivermectin studies but I don't want to get into that (see original post) given how highly politicized the topic is and how anyone who knows the drug name is now an 'expert' on the evidence.

Let me clarify my original question with an example.
We're starting to see empagliflozin used in reduced EF and preserved EF heart failure WITHOUT type 2 DM. The studies (EMPEROR-Reduced, EMPEROR-Preserved, both industry sponsored) that support the use of empagliflozin in HFrEF and HFpEF show reductions in cardiovascular mortality (HFrEF) and/or hospitalization (HFrEF and HFpEF). The physiologic mechianism for these benefits is not well described in either study. Empagliflozin tends to have a diuretic effect in conjunction with lowering blood sugars. My question is: what are the chances that thiazide/loop diuretic use (generic) in HF plus excellent BP +/- tight glucose control in diabetics would result in the same outcomes thereby decreasing the need for a new, branded medication like Jardiance?

The answer is pretty simple: the Jardiance has RCTs to back it up, thiazides/loop diuretics do not. Doesn't mean it can't work, but the best practice is to make decisions that have clinical evidence to back them up.

 

[Skeptical_Pharmacist]

Is it though? Who sponsored the studies? What were the conflicts of interest disclosed by the researchers? How many billions of dollars went into the “unbiased” study?

Question everything my friends. I challenge you to start thinking outside of the proverbial box and beyond what the mainstream healthcare channels are telling you. Just because something was published in NEJM, JAMA, etc.. doesn’t mean that it’s true or unbiased.

This is what I get for trying to start a meaningful intelligent conversation on a message board lol

 

[sadface]

I think everyone knows to question those things, doesn’t every school have a class on evaluating drug literature? But at some point you’re only going to have so much information to make clinical decisions with. And I’m not gonna weigh Facebook posts as the same level of evidence as RCTs that may have validity threatened by the funding source — as long as there are no apparent reasons why it wouldn’t be generalizable to my patient population or major problems with the study design. I am quick to point out when the design seems extremely engineered to find a benefit or doesn’t reflect current practice if those would seem to skew the outcome in the drug companies favor.

Anyway, what are you suggesting we do about this? What articles were pulled?

 

[Rockinacoustic]

Is it though? Who sponsored the studies? What were the conflicts of interest disclosed by the researchers? How many billions of dollars went into the “unbiased” study?

Question everything my friends. I challenge you to start thinking outside of the proverbial box and beyond what the mainstream healthcare channels are telling you. Just because something was published in NEJM, JAMA, etc.. doesn’t mean that it’s true or unbiased.

This is what I get for trying to start a meaningful intelligent conversation on a message board lol

Who do you think funded the RCTs that got our now cheap generics iniitially approved as branded medicines? And what journals do you think they were published in back in the day? You take for granted how heart failure is a manageable disease with relatively affordable therapies.

Reminds me of an old post by @Old Timer talking about when the first ACEi was approved (Capoten?)

 

[Old Timer]

Who do you think funded the RCTs that got our now cheap generics iniitially approved as branded medicines? And what journals do you think they were published in back in the day? You take for granted how heart failure is a manageable disease with relatively affordable therapies.

Reminds me of an old postr by @Old Timer talking about when the first ACEi was approved (Capoten?)

Yep, no biggie. All of the cardiologists are brainwashed by the drug companies. We will just use dig and Lasix.

 

[lane one]

Drug companies are making billions by developing drugs and funding quality studies that support their use. I don't see it as a conflict of interest as long as the investigators are blinded. Unless they're egregiously falsifying data, I don't see why they shouldn't be allowed to sell their products.