Are med students allowed to this?

[W19]

allowed to do*


Can we accept anything from big pharma? i.e going to their conferences and accept dinner from them. It's very weird and uncomfortable that you have to give these people your name for such trivial stuff...

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[olivarynucleus]

?

Give them your name, just not your real email address . Eat their food.

 

[sloop]

I got free lunch every day for an entire block. If there was a rule against it, I was unaware of it. Evidently about half of my classmates were as well, since they had similar experiences.

Most academic hospitals, as far as I know, have hospital policies against taking gifts from pharma but I don't think there are usually rules against taking them if you're working in a non-affiliated clinic.

I used to sign their sheets or whatever, too, and I took their literature. I usually found their presentations interesting. I'm pretty pro-information. As long as you're cognizant of where the information comes from, it beats no information at all. I'm also strongly pro-free-food.

 

[notbobtrustme]

i took all the free food. to the point where i was labeled the lunch destroyer.

 

[Psai]

bro you're a poor med student. the people who want to make you feel bad are the ones who have already been suckling at the teat of big business for decades in exchange for their undying loyalty. we just want some free food and a bit of education on the medications. I mean they won't even allow for free pens. That's absurd

Eat your heart out

 

[TBV]

Correct me if I'm wrong but I believe that the information is only stored/shown in databases if you have a medical license. I think they only want you to sign so they can justify the amount of food they purchased. So med studs should be fine

 

[Doctor Bob]

Can we accept anything from big pharma? i.e going to their conferences and accept dinner from them. It's very weird and uncomfortable that you have to give these people your name for such trivial stuff...

Yes you can. If they offer you a free dinner at some fancy joint in exchange for listening to a boring talk, take it.
And as someone mentioned, the have signins at these things because the reps have to justify the expense. "I expensed $3000 on dinner because there were 30 people at the talk. And here's the signin list to prove it"

 

[charmiedermie]

allowed to do*

Can we accept anything from big pharma? i.e going to their conferences and accept dinner from them. It's very weird and uncomfortable that you have to give these people your name for such trivial stuff...

No. Your unprofessionalism citation will be coming in the mail shortly, turned in by Astra-Zeneca.

 

[DocVapor]

I had one rotation where I was provided lunch nearly every day, breakfast most mornings, and even mid-morning coffees. I ate. It. All. Gained >10 pounds before I started eating the salad that would always come and skipping the coffees.

Never felt the least bit guilty about it. It's the least they can do for you if they are going to regurgitate mechanisms and statistics that they don't understand.

The best ones though were the ones that already had a solid relationship, and just dropped off food and chatted about everyone's children.

 

[sloop]

I'd also like to add to my above comment that I think the reps can actually be quite educational for students. The reps will spin some things but they're legally pretty constrained about what they can tell you. Most of what I got was FDA approved indications, MOA and some pathophysiology information on clinical expectations one can have for the drug.

The block where I talked with the drug reps almost every day was before my second year and I can tell you that I barely had to study at all in the diabetes section of my pharm course because of all the Januvia, Invokana, etc. reps I talked to. If you're inquisitive and have decent clinical intuitions, you will learn quite a lot about the adverse effects, too, though they're not always as forthright with these as with other things. I remember being informed about Invokana being an SGLT2 inhibitor and asking whether that would predispose to UTIs. That rep was great and I wound up learning a ton in that encounter.

People who are strongly anti-drug rep are mostly that way out of some identity-driven social justicey outrage. In reality, if you're not a ***** and you have some sense of what drug reps can and cannot tell you, you can learn a ton from them. I would highly encourage students to sit and listen to drug reps if they can—even putting aside the issue of free food. The free food thing really makes it a no-brainer to me.

 

[Cytarabine]

Best ever was dinner at a steakhouse with an open bar.

Hnnnnnnnnnnnnnnnnnnnnng

 

[kenjixshadow]

 

[cbrons]

I'd also like to add to my above comment that I think the reps can actually be quite educational for students. The reps will spin some things but they're legally pretty constrained about what they can tell you. Most of what I got was FDA approved indications, MOA and some pathophysiology information on clinical expectations one can have for the drug.

The block where I talked with the drug reps almost every day was before my second year and I can tell you that I barely had to study at all in the diabetes section of my pharm course because of all the Januvia, Invokana, etc. reps I talked to. If you're inquisitive and have decent clinical intuitions, you will learn quite a lot about the adverse effects, too, though they're not always as forthright with these as with other things. I remember being informed about Invokana being an SGLT2 inhibitor and asking whether that would predispose to UTIs. That rep was great and I wound up learning a ton in that encounter.

People who are strongly anti-drug rep are mostly that way out of some identity-driven social justicey outrage. In reality, if you're not a ***** and you have some sense of what drug reps can and cannot tell you, you can learn a ton from them. I would highly encourage students to sit and listen to drug reps if they can—even putting aside the issue of free food. The free food thing really makes it a no-brainer to me.

**BEEEP*** ***BEEEEP***
Undercover drug rep detected in sector 5
***BEEP*** *BEEEEP****

 

[sloop]

**BEEEP*** ***BEEEEP***
Undercover drug rep detected in sector 5
***BEEP*** *BEEEEP****

Nice try. Don't you think it would have been weird for someone to register almost a month ago and spend most of his time on the site in the Step 1 forum talking and asking about his study experiences only to, a month later, happen upon an ongoing thread about pharma and post comments in support of pharma reps to an audience of mostly medical students? Seems plausible.

Seriously though, I just had great experiences with drug reps. I got fed and learned a lot. Is it really so evil to have that experience and recommend it to others?

 

[cbrons]

Nice try. Don't you think it would have been weird for someone to register almost a month ago and spend most of his time on the site talking to people in the Step 1 forum talking and asking about his study experiences only to, a month later, happen upon an ongoing thread about pharma and post comments in support of pharma reps to an audience of mostly medical students? Seems plausible.

Seriously though, I just had great experiences with drug reps. I got fed and learned a lot. Is it really so evil to have that experience and recommend it to others?

I don't know how you learned anything from an uneducated person hired on the basis of their looks. But I don't think it is evil to take their food or listen to them read a script they don't understand.

 

[sloop]

I don't know how you learned anything from an uneducated person hired on the basis of their looks. But I don't think it is evil to take their food or listen to them read a script they don't understand.

Maybe you have seen some really ****ty drug reps. All of the ones I met were at least college educated and knew their drugs pretty well. I wound up talking about college with a few of them and all of them either majored in a hard science or took significant coursework in it (I can't say for sure this is universal, but that was my experience). They answered my questions and explained mechanisms of action pretty well. Drug reps only rep a limited range of drugs so they can learn them well. I'm not sure why you think learning the ins and outs of a limited range of pharmaceuticals is beyond the ken of most college educated people . . .

Although I will maintain that all the drug reps I encountered were competent, I will not deny that they were also almost universally attractive. So what? All the more reason to talk to the reps.

 

[W19]

bro you're a poor med student. the people who want to make you feel bad are the ones who have already been suckling at the teat of big business for decades in exchange for their undying loyalty. we just want some free food and a bit of education on the medications. I mean they won't even allow for free pens. That's absurd

Eat your heart out

It's another med student who is saying he thinks it's something unethical. He is anti big pharma... We are working on the same research project and our PI is usually the paid speaker for that company. That med students never went to these presentations even if that pharm rep goes out his way to invite us. I asked him why he never went and that was when he unloaded on me about big pharma. He even was also very critical of our PI for being a paid speaker for big pharma...

 

[sloop]

It's another med student who is saying he thinks it's something unethical. He is anti big pharma... We are working on the same research project and our PI is usually the paid speaker for that company. That med students never went to these presentations even if that pharm rep goes out his way to invite us. I asked him why he never went and that was when he unloaded on me about big pharma. He even was also very critical of our PI for being a paid speaker for big pharma...

Pharma does some wonderful things and creates drugs that save many people every day. Part of the business model that supports that activity is having paid speakers and presentations that often involve free food. I wonder what alternative he proposes—that pharma should not try to profit off of its time, innovation and expenses in developing drugs?

Some medical students and doctors are full of themselves. Medicine is very rewarding and is unique in many ways but it is not special with regards to how it operates at its core. Medicine is a business. If he doesn't like that he should probably just leave medicine now. Surgeons don't do surgery for free. Internists don't treat diabetes for free. Pharma doesn't develop drugs for free. This is how the world works.

 

[pd1112]

I don't know how you learned anything from an uneducated person hired on the basis of their looks. But I don't think it is evil to take their food or listen to them read a script they don't understand.

I don't think you understand what being a drug rep entails. I have a good friend who works for Pfizer. He has to pass an initial certification test anytime he changes drugs & annual recertification tests thereafter. They are difficult tests & require extensive knowledge of the primary literature & clinical trials in order to pass. N=1, but I don't think this is rare.

 

[Psai]

Yep drug reps aren't just pretty faces that show up to feed you. They have to know the literature. Whether or not the data they show is cherry picked or biased is up for debate but they are very limited on what they can say. The diabetes drug reps tended to know their stuff.

The alternative to advertising to docs is advertising to mid levels who have prescription pads and much less of an education to evaluate claims carefully. Or they can market the drugs directly to the consumer so not only do you get nothing, you have to repeatedly explain to patients why the incredibly expensive drug they saw on tv is not indicated for them

 

[alpinism]

I'd also like to add to my above comment that I think the reps can actually be quite educational for students. The reps will spin some things but they're legally pretty constrained about what they can tell you. Most of what I got was FDA approved indications, MOA and some pathophysiology information on clinical expectations one can have for the drug.

The block where I talked with the drug reps almost every day was before my second year and I can tell you that I barely had to study at all in the diabetes section of my pharm course because of all the Januvia, Invokana, etc. reps I talked to. If you're inquisitive and have decent clinical intuitions, you will learn quite a lot about the adverse effects, too, though they're not always as forthright with these as with other things. I remember being informed about Invokana being an SGLT2 inhibitor and asking whether that would predispose to UTIs. That rep was great and I wound up learning a ton in that encounter.

People who are strongly anti-drug rep are mostly that way out of some identity-driven social justicey outrage. In reality, if you're not a ***** and you have some sense of what drug reps can and cannot tell you, you can learn a ton from them. I would highly encourage students to sit and listen to drug reps if they can—even putting aside the issue of free food. The free food thing really makes it a no-brainer to me.

I'll just leave this here.



In addition the bolded is completely untrue:

http://www.ncbi.nlm.nih.gov/pubmed/7715044?dopt=Citation

More reasons not to take free food:

http://www.ncbi.nlm.nih.gov/pubmed/10647801?dopt=Abstract
http://med.stanford.edu/coi/journal articles/Wazana_A-Is_A_Gift_Ever_Just_A_Gift.pdf

 

[deleted480308]

I don't know how you learned anything from an uneducated person hired on the basis of their looks. But I don't think it is evil to take their food or listen to them read a script they don't understand.

I hate it when pretty people buy me expensive things....suuuuuuper frustrating

 

[deleted480308]

I'll just leave this here.



In addition the bolded is completely untrue:

http://www.ncbi.nlm.nih.gov/pubmed/7715044?dopt=Citation

More reasons not to take free food:

http://www.ncbi.nlm.nih.gov/pubmed/10647801?dopt=Abstract
http://med.stanford.edu/coi/journal articles/Wazana_A-Is_A_Gift_Ever_Just_A_Gift.pdf

I call bull.....be an adult and don't sell out your clinical decision making, but there is no reason to not take a meal and an informational session. Remember the big evil pharma you are railing against is the same big evil pharma that makes all the drugs you use to help patients

 

[DocVapor]

I call bull.....be an adult and don't sell out your clinical decision making, but there is no reason to not take a meal and an informational session. Remember the big evil pharma you are railing against is the same big evil pharma that makes all the drugs you use to help patients

Also, I have yet to see that "alteration of prescribing" is necessarily a bad thing. I get why people who don't know any better have these gut feels about it being bad. In my experience though, any alteration of prescribing was done because the pharm companies offered financial assistance to patients, allowing them to obtain the drugs they needed (often after failing on multiple other therapies).

Admittedly I haven't done a tremendous amount of research into this sort of thing.

 

[W19]

How come they don't put PA/ARNP on the 'open payments' cms database? There were as many PA/ARNP as physicians to the couple of big pharma conferences that I attended. Physicians seem to always take the blame for everything that is wrong with our healthcare system. PA/ARNP are ripping off some of the same 'benefits' while staying above the fray. It's freaking unfair!

 

[Psai]

I'll just leave this here.



In addition the bolded is completely untrue:

http://www.ncbi.nlm.nih.gov/pubmed/7715044?dopt=Citation

More reasons not to take free food:

http://www.ncbi.nlm.nih.gov/pubmed/10647801?dopt=Abstract
http://med.stanford.edu/coi/journal articles/Wazana_A-Is_A_Gift_Ever_Just_A_Gift.pdf

bro it's not untrue
have you even had any experience with drug reps? i learned a ton from them and what they said meshed with what i learned about the drugs during my medicine rotation
your citation is a 1995 paper that says that 90% of what reps told physicians were true. when's the last time you had a 90% batting average with the statements you make?
other papers are just metaanalyses of papers from over 15 years ago that say that they looked at a select bunch of papers that said that drug reps affect prescribing patterns
well no ****, if you come out with a new drug and you tell me about the drug, i'm probably going to use it more than if no one tells me about the drug
do some critical thinking and not just going on pubmed, searching "doctors pharmaceutical companies prescribing bias"

you don't sit there and eat a nice lunch and then start prescribing their drugs haphazardly. they give you free samples and you try it on some patients with their permission and evaluate whether or not it's better for them than what you've been using previously. if it works out then great, if not then don't bother.

i mean hell i've seen a bunch of people on atypicals for bipolar disorder prescribed by nurse practitioners. who do you think are courting them? but no one talks about that when their prescription pads can do the same thing ours do.

you're using a video made by a comedian to bolster your claims for christ's sake

 

[jdh71]

allowed to do*


Can we accept anything from big pharma? i.e going to their conferences and accept dinner from them. It's very weird and uncomfortable that you have to give these people your name for such trivial stuff...

Who is going to stop you? The police?

I still don't think these food get together are good ideas, and ethically problematic. The intuitive argument is "I can east burritos without be influenced by the drug manufacturers!" I used to be in the camp. Sadly, the data that has been collected on this drug company influence has shown that it's real and these feeds and greets work for the drug companies. If they didn't, they wouldn't do them. No reason to spend the money.

I avoid these folks like the plague in my new clinic. Some of my partners like bringing them in because of the free food for the staff, which is good for morale in any clinic. I'd prefer to set aside some of our own money and just buy lunch for the staff once per week instead. I'm working on it. I don't eat their food. People think I'm weird. Cultures change slowly.

 

[charmiedermie]

I'll just leave this here.



In addition the bolded is completely untrue:

http://www.ncbi.nlm.nih.gov/pubmed/7715044?dopt=Citation

More reasons not to take free food:

http://www.ncbi.nlm.nih.gov/pubmed/10647801?dopt=Abstract
http://med.stanford.edu/coi/journal articles/Wazana_A-Is_A_Gift_Ever_Just_A_Gift.pdf

You probably should have kept it with you, since the issue is a lot more complicated than some dopey comedy show to explain it. Also, great job citing an article from 1995 to back up your point.

 

[charmiedermie]

It's another med student who is saying he thinks it's something unethical. He is anti big pharma... We are working on the same research project and our PI is usually the paid speaker for that company. That med students never went to these presentations even if that pharm rep goes out his way to invite us. I asked him why he never went and that was when he unloaded on me about big pharma. He even was also very critical of our PI for being a paid speaker for big pharma...

No offense, but why do you care what another medical student thinks? He has no idea what his PI's dealings are with pharma, and for someone standing on his moral soapbox about how bad he is, that student is still doing research with him.

How come they don't put PA/ARNP on the 'open payments' cms database? There were as many PA/ARNP as physicians to the couple of big pharma conferences that I attended. Physicians seem to always take the blame for everything that is wrong with our healthcare system. PA/ARNP are ripping off some of the same 'benefits' while staying above the fray. It's freaking unfair!

Because PA/NP students aren't like your friend. No, but seriously, it's because of the Sunshine Act in the ACA. It covers doctors, but not midlevels.

 

[Elixir6]

Wow, you guys are really ****ting on @alpinism. So he used a pretty funny comedy piece and an outdated paper to make a point - relax.

Now I definitely don't agree that any company is "evil" and pharmaceutical companies do lots of good. I think the problem here has to do with anytime you have giant organization that have lots of money/power/influence combined with interests that can be at clearly at odds with society = recepie for wrong-doing. Pharmaceutical companies are one of those special players in society because the person who decides on use of the product (the doctor) is a different person than the person who buys and who consumes the drug (combo of person and their insurance). People rely on physicians to act in their best judgement and accepting gifts and going to industry sponsored talks certainly no one can argue has the potential to influence physicians in ways that are not in the best interests of the patients. I hope people can see that this is a little different from a landscaper recommending you use Scotts grass seeds because she went to a paid industry talk.

Obviously if these gifts/talks etc... didn't work, the pharmaceutical companies wouldn't continue spending so much money doing it. You could argue that their communication with physicians is just helping physicians get necessary/helpful drugs to patients, but you could also easily argue that it causes inappropriate prescribing.

Personally, I am not against information dissemination from pharma to physicians. I am not per se against lunches etc.. either. But I think there has to be some oversight. Preferably if physicians organizations committed themselves to high ethical standards. If we are not careful as a professional these types of things will result in erosion of the public trust.

At my academic institution drug company representatives are not even allowed on the premises (device reps are a whole other thing that I ran into in the operating room constantly). As a med student though, I would take whatever free **** they give ;-)

 

[bc65]

My medical group has banned all gifts from drug companies and manufacturers. They do allow attendance at company-sponsored lectures, and they permit the acceptance of meals that are provided at such open meetings, but not meals provided one-on-one.

Drug companies and medical device manufacturers spend many millions of dollars each year in marketing to physicians, much of it in the form of meals and gifts to physicians. They don't spend this money out of the goodness of their hearts. The information that you get from drug reps is advertising. Like all advertising, some of it is true, some isn't, much is slanted and misleading. If you want objective information about drugs, read the Medical Letter, read medical journals, and ask your local pharmacist or formulary committee.

For medical devices, the reps provide essential information on how the product is used that may not be available elsewhere, but they may not be objective in explaining the benefits of the competitor's products.

You will also be inundated with free meals from "investment advisers" who want to teach you about finance. Oddly enough, they always just happen to sell a financial product that will be great for you, but later you'll realize is a terrible investment that provides a great commission to them ( e.g. whole life insurance, annuities ). In that case, the meals end up costing you a lot.

Caveat emptor.

A doctor I know once got free trips to the superbowl with airfare, tickets, and hotel rooms for being the leading prescriber in the world of a particular drug. How likely do you think he was to switch to a cheaper brand? There are good financial reasons for drug companies to buy you stuff, and good reasons for you to say no. You have to decide for yourself.

 

[cbrons]

Who is going to stop you? The police?

I still don't think these food get together are good ideas, and ethically problematic. The intuitive argument is "I can east burritos without be influenced by the drug manufacturers!" I used to be in the camp. Sadly, the data that has been collected on this drug company influence has shown that it's real and these feeds and greets work for the drug companies. If they didn't, they wouldn't do them. No reason to spend the money.

I avoid these folks like the plague in my new clinic. Some of my partners like bringing them in because of the free food for the staff, which is good for morale in any clinic. I'd prefer to set aside some of our own money and just buy lunch for the staff once per week instead. I'm working on it. I don't eat their food. People think I'm weird. Cultures change slowly.

Wont that make you broked? 🤔 Or maybe I am just used to having an income of $0 that I forget you do eventually get paid at some point.

 

[jdh71]

Wont that make you broked? 🤔 Or maybe I am just used to having an income of $0 that I forget you do eventually get paid at some point.

We could probably afford it. At least twice over month of someone was trying to be really cheap. But it's the free food that is great for the rest of the staff in the clinic.

 

[Winged Scapula]

I avoid these folks like the plague in my new clinic. Some of my partners like bringing them in because of the free food for the staff, which is good for morale in any clinic. I'd prefer to set aside some of our own money and just buy lunch for the staff once per week instead. I'm working on it. I don't eat their food. People think I'm weird. Cultures change slowly.

We have this issue in our office as well.

The free food, Starbucks, etc. is good for the morale of hourly wage earning staff; they really do enjoy it. The staff now understands what the rules are (about accepting reps offers) and how the partners differ; I objected to what I saw as our staff asking reps for free things/enticing them to provide food and little gifts. I feel bad depriving them of it and tend toward just buying then lunch myself a couple of times a month.

However, I refuse to see reps that are uninvited by me (i.e., I've seen a product or device I'd like to learn more about) and frankly, since we don't close for lunch I simply don't have time (or the interest) to stop between patients and talk with others who represent a product I don't already use or want to learn more about. Just last Tuesday I got surprised by the arrival of a pathology group rep (didn't see it on the calendar and no one ran it by me); I felt like I had to see "yes" to talking with her because her boss is the brother-in-law of a friend. I felt trapped because I have no intention of switching groups, they always take more than the "just 10 minutes" they claim and of course, she brought a large lunch spread for the staff. Someone got in trouble that day (although I suspect the rep played up the "WS's friend's family member" connection to get in the door and my staff didn't know how to say no). Bleh.

 

[madchemist89]

I have partaken in a few drug lunches, but I got sick and tired of having to listen to them about their new insulin analog that lasts 5 minutes longer than detemir. I don't care what food is offered. It isn't worth my sanity.

 

[W19]

The food these people give are really good and somewhat expensive; I can see why some physicians are reluctant to say no...

 

[deleted480308]

The food these people give are really good and somewhat expensive; I can see why some physicians are reluctant to say no...

More so med students....I'd let the socialist party buy me a steak and that says a lot for me

 

[sloop]

I'll just leave this here.



In addition the bolded is completely untrue:

http://www.ncbi.nlm.nih.gov/pubmed/7715044?dopt=Citation

More reasons not to take free food:

http://www.ncbi.nlm.nih.gov/pubmed/10647801?dopt=Abstract
http://med.stanford.edu/coi/journal articles/Wazana_A-Is_A_Gift_Ever_Just_A_Gift.pdf

Old article, but even so:

Dude, 89% accuracy of information is pretty good. Just because an article writer frames a result one way doesn't mean you have to look at it that way. If you talked extensively about medicine with your med student colleagues, do you think you'd get much higher than 89% accuracy? I've been in PBL groups most days for the last 2 years and I consider 89% accuracy to be quite good in the vast majority of cases. There are tons of med students who would be ecstatic to consistently get 89% on exams.

Do you suggest that we also shouldn't learn from what we're told by our colleagues? I think this is a crappy reason to not take the gifts.

As far as changing prescribers' actions: of course it will change their actions. I said before that I think the pharma reps give pretty good education about their drugs. If you learn more about some new drugs, obviously that might change prescribing practices. Unless you're operating on the assumption that anything good for pharma is bad for other people, explain to me how exactly this is necessarily a bad thing.

 

[jdh71]

Old article, but even so:

Dude, 89% accuracy of information is pretty good. Just because an article writer frames a result one way doesn't mean you have to look at it that way. If you talked extensively about medicine with your med student colleagues, do you think you'd get much higher than 89% accuracy? I've been in PBL groups most days for the last 2 years and I consider 89% accuracy to be quite good in the vast majority of cases. There are tons of med students who would be ecstatic to consistently get 89% on exams.

Do you suggest that we also shouldn't learn from what we're told by our colleagues? I think this is a crappy reason to not take the gifts.

As far as changing prescribers' actions: of course it will change their actions. I said before that I think the pharma reps give pretty good education about their drugs. If you learn more about some new drugs, obviously that might change prescribing practices. Unless you're operating on the assumption that anything good for pharma is bad for other people, explain to me how exactly this is necessarily a bad thing.

If the new fancy drug hasn't been shown to be BETTER by clinical trials than what the reps would have me trade their new drug for, then they can go **** themselves. 1) cheaper, 2) fewer sided effects, or 3) works better than what I'm using based on commonly agreed upon disease end points - any one of or combination of those and I'll listen. Otherwise GTFO of my office and take your expensive catered lunch with you, my patients deserve better.

 

[sloop]

If the new fancy drug hasn't been shown to be BETTER by clinical trials than what the reps would have me trade their new drug for, then they can go **** themselves. 1) cheaper, 2) fewer sided effects, or 3) works better than what I'm using based on commonly agreed upon disease end points - any one of or combination of those and I'll listen. Otherwise GTFO of my office and take your expensive catered lunch with you, my patients deserve better.

What exactly do you think Phase III clinical trials are for? If you're interested in this, ask the reps about their phase III research. If it didn't perform substantially better than treatment-as-usual, they will tell you. They may try to spin it with another advantage the med has, but they legally can't straight-up lie to you about this.

There are a few drugs that are marketed under an NDA prior/concurrently to Phase III, but this is not standard practice. Additionally, they will probably tell you about this up front. If they don't, they will definitely tell you if you ask about their Phase III results.

This outrage is silly. The FDA doesn't just throw drugs onto the market that are more dangerous, less effective and overall less advantageous than treatment-as-usual. The advantages may not justify the cost, but just inquire about this and try your best to take everything into consideration when deciding on a drug for a particular patient.

 

[jdh71]

What exactly do you think Phase III clinical trials are for? If you're interested in this, ask the reps about their phase III research. If it didn't perform substantially better than treatment-as-usual, they will tell you. They may try to spin it with another advantage the med has, but they legally can't straight-up lie to you about this.

There are a few drugs that are marketed under an NDA prior/concurrently to Phase III, but this is not standard practice. Additionally, they will probably tell you about this up front. If they don't, they will definitely tell you if you ask about their Phase III results.

This outrage is silly. The FDA doesn't just throw drugs onto the market that are more dangerous, less effective and overall less advantageous than treatment-as-usual. The advantages may not justify the cost, but just inquire about this and try your best to take everything into consideration when deciding on a drug for a particular patient.

Phase III trials are not about proving a medication performs better. They are about making sure a drug does what it says it does without serious side effects.

While I appreciate the "lecture" the FDA does approve drugs all the time that aren't shown to them directly to be better or have less side effects.

Thr only way to demonstrate the superiority of a drug is a double blind RCT.

 

[sloop]

Phase III trials are not about proving a medication performs better. They are about making sure a drug does what it says it does without serious side effects.

No. This is what happens in phases I and II. Phase III compares the drug against a "gold standard" or "treatment as usual." It looks for efficacy compared to a standard. Phase III is most typically pre-marketing.

While I appreciate the "lecture" the FDA does approve drugs all the time that aren't shown to them directly to be better or have less side effects.

Thr only way to demonstrate the superiority of a drug is a double blind RCT.

Phase III trials are randomized clinical trials . . .

 

[jdh71]

No. This is what happens in phase II. Phase III compares the drug against a "gold standard" or "treatment as usual." It looks for efficacy compared to a standard. Phase III is most typically pre-marketing.

Phase III trials are randomized clinical trials . . .

http://www.nlm.nih.gov/services/ctphases.html

Phase III trials cannot tell you if it is "better" than what is commonly used, all it can tell you is if the drug appears to do what it's supposed to or what the other drugs in the class do in a general sense.

These are not double-blinded RCTs comparing one drug to another. Phase III is impotent to tell me if a drug is better for my patient.

 

[sloop]

http://www.nlm.nih.gov/services/ctphases.html

Phase III trials cannot tell you if it is "better" than what is commonly used, all it can tell you is if the drug appears to do what it's supposed to or what the other drugs in the class do in a general sense.

These are not double-blinded RCTs comparing one drug to another. Phase III is impotent to tell me if a drug is better for my patient.

Please explain how Phase III is "impotent" with regard to telling you whether a drug is better for your patient when, according to the link you just provided:

Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

 

[jdh71]

Please explain how Phase III is "impotent" with regard to telling you whether a drug is better for your patient when, according to the link you just provided:

You really want me to spell this out?? I can't believe I need to do this.

Phase three will tell us if a new inhaler improves COPD patient symptoms and doesn't kill them, in a generally similar manner to current inhalers.

What phase III can't tell me if if the new inhaler is actually BETTER than the current inhaler being used until one is compared to the other. You know by doing science and a trial.

Did you come from a science background? Or were you one of those liberal art folks med schools like to pick up to try and have some kind of "diversity"?

 

[sloop]

You really want me to spell this out?? I can't believe I need to do this.

Phase three will tell us if a new inhaler improves COPD patient symptoms and doesn't kill them, in a generally similar manner to current inhalers.

What phase III can't tell me if if the new inhaler is actually BETTER than the current inhaler being used until one is compared to the other. You know by doing science and a trial.

Did you come from a science background? Or were you one of those liberal art folks med schools like to pick up to try and have some kind of "diversity"?

Are you serious? If you do a trial comparing a new drug to the standard you will wind up with results that can tell you whether the drug did better, worse, or the same as the standard with regards to the endpoints studied. If you study tachycardia in new drug X compared to albuterol, if the RR for the new drug is 0.5 with a 95% CI from 0.4 to 0.6, you can conclude it's most likely better with respect to that endpoint. Likewise, if you do a t-test and the results suggest a statistically significant difference between the two groups with regard to relevant patient and disease-related endpoints, you can figure out which intervention is likely better.

These are things that are done in Phase III . . .

 

[Psai]

You really want me to spell this out?? I can't believe I need to do this.

Phase three will tell us if a new inhaler improves COPD patient symptoms and doesn't kill them, in a generally similar manner to current inhalers.

What phase III can't tell me if if the new inhaler is actually BETTER than the current inhaler being used until one is compared to the other. You know by doing science and a trial.

Did you come from a science background? Or were you one of those liberal art folks med schools like to pick up to try and have some kind of "diversity"?

i know you're an attending and all but i'm under the impression that phase iii does compare the new treatment vs the standard and tells you if it's better or at least non-inferior

 

[jdh71]

Are you serious? If you do a trial comparing a new drug to the standard you will wind up with results that can tell you whether the drug did better, worse, or the same as the standard with regards to the endpoints studied. If you study tachycardia in new drug X compared to albuterol, if the RR for the new drug is 0.5 with a 95% CI from 0.4 to 0.6, you can conclude it's most likely better with respect to that endpoint. Likewise, if you do a t-test and the results suggest a statistically significant difference between the two groups with regard to relevant patient and disease-related endpoints, you can figure out which intervention is likely better.

These are things that are done in Phase III . . .

Of course I'm serious. The only way to show one drug is superior to another for the same disease is to compare them directly and phase III does not do this. If it did there would never be a head to head drug trial or even non-inferiority trials because we'd already have the data. The comparing that goes on in phase three is does the drug do what it says it does in a similar manner to other drugs - ie does this new inhaler improve patient symptoms subjectively or does this new blood pressure medicine actually lower blood pressure. There is no one getting other meds to compare in any kind of head to head fashion.

 

[jdh71]

i know you're an attending and all but i'm under the impression that phase iii does compare the new treatment vs the standard and tells you if it's better or at least non-inferior

Phase III is not designed to show superiority. and it can't even tell you if it's noninferior. All that can be said is that this drug does work in this condition and didn't kill anyone or cause very severe side effects.

 

[sloop]

Of course I'm serious. The only way to show one drug is superior to another for the same disease is to compare them directly and phase III does not do this. If it did there would never be a head to head drug trial or even non-inferiority trials because we'd already have the data. The comparing that goes on in phase three is does the drug do what it says it does in a similar manner to other drugs - ie does this new inhaler improve patient symptoms subjectively or does this new blood pressure medicine actually lower blood pressure. There is no one getting other meds to compare in any kind of head to head fashion.

You do not understand how statistics work. You also seem to not understand how comparison works.

Phase III compares the efficacy of a new drug to a standard. We agree on this at least, right?

When you compare the performance of things, there are three results you can come up with: They perform equally well, thing 1 performs better and thing 1 performs worse. These are the only logical possibilities that exist here.

The statistics we use for comparison are specifically designed to discern which of these possibilities is most likely. What statistical comparison modality do you know of that will tell you if two things are equal in performance but will not tell you if they are unequal? This makes no sense statistically but it also makes no sense logically. If something can usefully tell you that two things are equal in performance, it must also be able to tell you when that is not the case.

t-tests, ANOVAs, etc. all tell you whether two things are different with respective endpoints.

You say "there is no one getting other meds to compare in any kind of head to head fashion." Sorry, but you're wrong. I know you're embarrassed that you're wrong on this so you're sticking to your guns, but you're wrong. The very quote you gave from the FDA said that Phase III compares new drugs to standards. If I'm wrong about this, how exactly do you compare two drugs in a trial without ever giving anyone one of the drugs? Surely you must see how this is nonsense.

Maybe this site will clear some of this up for you: http://www.cancer.org/treatment/tre.../clinical-trials-what-you-need-to-know-phase3

Just to quote a selection of what it says in this website of the American Cancer Society:

Phase III clinical trials: Is it better than what’s already available?
Treatments that have been shown to work in phase II studies usually must succeed in one more stage of testing before they are approved for general use. Phase III clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment.

So look: You're wrong. Man up and admit it so we can move on with this discussion. Your hang-up about this is clearly about pride and not about actually knowing you're right.