"Sickening - How Big Pharma Broke American Health Care"

[5MilesBack]

Me

Exactly.

 

[bdan68]

The whole "everything in moderation " advice is what's caused lots of people to become obese and unhealthy.

 

[Rob5589]

More than "initially believed". Yuhp, still "practicing medicine". IMO, docs are, by and large, quacks--paying for second and third houses and spouses, constant new cars and toys for them and the trove of kids and newest model spouse. They don't spend any time with patients. No use for them.

Blood type diet had some good info for me. Never said I was militant on it. YMMV.

But, always glad to know we have experts like you aboard.

You can't be that broad with your assertions. The docs the average person encounter generally aren't the ones doing the research and recommending changes. They're following guidelines/protocols/best practices at that time. Even in my little medical space in EMS, we are constantly having changes made to our protocols based on the latest research. What once was bad is now OK, and vice versa. Medicine is an ever evolving "practice."

 

[Shraggs]

What was your role at Merck?

I don’t personally know anyone who is alleged to have died from Vioxx, or anything about the dosing.

Are the reports of internal Merck communications about the Vioxx dangers false?

EDITED - to try to be less argumentative

I was in sales, diabetes and cardiovascular. for one year i had to step in for a retired vioxx rep.

So, share the data you have. Or, perhaps share why that data was not released if you are prohibited from sharing the actual data.

Give your facts? What data says it is safe? Applying the precautionary principal to everything is BS. However, once there is a signal of harm in the data, the risk benefit balance changes. Vioxx treats pain, but does not alter disease, so the benefit is already low, making the acceptable level of risk low as well.

Trying to compare one person to a large sample is misleading at best. Similarly, asking someone to prove the deaths is to ask for an impossibility. Proof would be considered a high quality RCT (but of course science never proves anything, it only fails to disprove). Carrying out an RCT to see how many people are harmed by the intervention is unethical. Keep in mind, to be proof, it must be a primary outcome of the RCT, secondary outcomes are not strong enough. Asking for what will not be obtained is unfair. However, if you can provide proof that Vioxx never hurt anyone, then I will consider your point valid.

A better question, is it reasonable to expect the risk to have been detected before bringing the drug to market? I.e. is there evidence of negligence or malice? Without evidence of one of those, criticism of a pharmaceutical company in such cases is asking for cristal ball predictions, which is impossible and thus utter BS.

what is in the public domain, highly summarized.

the impetus stems back from a national news cast, stating vioxx causes MIs, based on a retrospective analysis by an academic project. as such, the recruitment from the law adds started, as you im sure you recall. 650 ish lawsuits were filled. Merck voluntarily pulled all samples from offices, pharmacies and distributors - and ceased all promotion.

roughly 2/3 of the cases went to trail by jury, all were found in favor of the defendant, merck. none of them found by jury that vioxx cause a MI.

the remaining third settled in a class payout to the law firm and their plaintiffs. to my knowledge there was no penalty financially enforced by the FDA to merck, but they did want a label change and an action plan for promotion highlighting more prominently the reason why one dose should be restricted more clearly.

Marble, wasn't sure your tone, ok. i think you know this;

Vioxx is a COX2, basically for those outside of medicine - its an nsaid, ie like advil. advil and similar are great for pain and inflammation, but acutely not chronically as these will or likely lead to severe bleeding in stomach, and chronically can cause MI as was noted in a naproxen trail. the niche, a merck hallmark, is improving therapy with improved tolerance. It is indicated for the chronic relief of pain due to RA without likely bleeding. basically you can take it daily. it was a remarkable drug for those with arthritis. two doses, 10mg and 25mg.

The 50 mg carried an additional indication for acute pain, ie severe injury, post surgery pain mgt and severe menstrual cycles to not exceed 5 days of use.

The label clearly states that, with the appropriate trail data to support the indications and limits of use. especially in the 50mg.

The courts never found what has been written here in the thread, which is what has been written by all kinds of media, academic and news institutions that gets parroted as fact.

so we don't dwell on this, let me further note. while i had that product, every sunday night i would get a list of doctors who were inappropriately perscribing the 50 chronically. i was required to visit each and every one of them and inform, and instruct to cease outside the label and document the discussion - this is long before the lawsuits, because the risk of the 50 may do cardiovascular harm consistent with nsaids. generally the resistance was based on the "if the 25 worked so well the 50 is better" despite clear fda labeling. i have had more the one doctor tell me to **** off.

there were plaintiffs in my area, although i would not know them personally.

it is my personal guess, speculation assumption. im guessing, and want to be clear on this next passage as i was not part of the legal or leadership team... ive wondered if the remaining cases were in fact plantiffs prescribed 50mg chronically who did have an MI. the nature of the each of those trails changes dramatically if doctors are called to the stand. may have been a better plan to just settle, and protect and maintain good relations for the trove of other products. complete guess on my part. wild ass guess, no one should parrot that as fact in any way.

Merck was found to have not be clear enough in the label, in our national meetings we were told that merck is volunteering not to resume promotion of vioxx, despite a formal request by the FDA to please do so.

 

[Shraggs]

I in know way am saying all pharma have been good or not a problem. i can give examples of such that are clear and factual. but to say that pharma is the downfall of medicine is just not the case, there is plenty of blame. couple of thoughts i can back up personally

in my above, pharmacists are required to square away contraindications or persriptions written inconsistent with the label. and call the doctor to advise... even tho i was not to required to, in one case i found out one of pharmacist from the doctors who tells me to **** off and and challenged them on vioxx. the person told me "hey we make our money per prescription dispensed and we're filling them"....

Merck invented a new diabetes class of medicine, another remarkable product. at that time, the going rate for 30 days of branded tablets prices was around $245. of course patients pay their copays, but that was behind the scenes pricing. we priced the drug and $125 im sure because a new class like this was likely to be a very important development and well used if the affordability was also reflective of the need. interesting that not a single patient saw a price difference from any other branded price and or copay...

in 2007 or 8, a joint "study" with academic and cleveland clinic with funding from one insulin company did a trail to show insulin is a better for type 2s that oral meds. hey type 1 are 5% of market, type 2 is 95 - lets get them all on insulin. without going into a ton of detail, formularies changed making insulin a preferred agent cause of greater efficacy. now insurance companies don't get graded on hetitis metrics like providers, they get graded on compliance by 5 star basically are patients taking their meds. a massive insurance company called me after a couple of years, as their 5 star rating was at risk for the medicare patients who are diabetic, most were on insulin - the most expensive diabetes therapy and they are not taking anything because of the now new donut hole... they asked if could help with a massive substitution to get patients therapy with our new med. i checked with senior leaders, yes and we'll not ask for liberties with regard to our product preference. admirable. we had one condition we stated - - - our product was for type 2, before we substitute insulin we must to a cpeptide test to be sure they are a type 2 just on insulin. the insurance company said no........

this is not even the tip of the iceberg

 

[fwafwow]

the impetus stems back from a national news cast, stating vioxx causes MIs, based on a retrospective analysis by an academic project. as such, the recruitment from the law adds started, as you im sure you recall. 650 ish lawsuits were filled. Merck voluntarily pulled all samples from offices, pharmacies and distributors - and ceased all promotion.

roughly 2/3 of the cases went to trail by jury, all were found in favor of the defendant, merck. none of them found by jury that vioxx cause a MI.

the remaining third settled in a class payout to the law firm and their plaintiffs. to my knowledge there was no penalty financially enforced by the FDA to merck, but they did want a label change and an action plan for promotion highlighting more prominently the reason why one dose should be restricted more clearly.

[snip]

The courts never found what has been written here in the thread, which is what has been written by all kinds of media, academic and news institutions that gets parroted as fact.



Merck was found to have not be clear enough in the label, in our national meetings we were told that merck is volunteering not to resume promotion of vioxx, despite a formal request by the FDA to please do so.

You never answered my question about alleged internal communications that are said to have shown the drug was known to have risks. Are those reports false?

Serious question - so this article (https://www.drugwatch.com/vioxx/lawsuits/) is completely off base, including the one civil verdict in favor of a plaintiff (which I admit is fewer than I expected), the $950 million paid to the DOJ to settle criminal charges and civil claims, and stated fine of $321 million for a criminal violation of the FDCA? There are said to have been more payouts to Medicaid states and the US and a shareholder lawsuit, and based on my quick math counting the class action settlement - all totaling well over $7 billion. But it was a media caused problem, exacerbated by attorneys and just a labeling issue?

Your last paragraph - are you saying the FDA wanted Vioxx to continue to be sold and promoted? That sounds like a scene of one of the internal sales training classes from Dopesick. I guess I can see that someone said that, but it sounds like something told to the troops but not consistent with reality.

 

[Shraggs]

I can not discuss internal documentation

 

[fwafwow]

I can not discuss internal documentation

That’s fair

 

[Shraggs]

I think what I quickly summarized from memory mirrors that article. I’m unaware and was completely compartmentalized. Only when I was involved. I cannot personally confirm those writings in later years.

Suing Pharma and other medical companies, providers and hospital systems is big business. It is ongoing especially if blood is in the water.

Beyond that, suggest you seek disclosure to contents of those rulings and read the details.

 

[Squincher]

You never answered my question about alleged internal communications that are said to have shown the drug was known to have risks. Are those reports false?

Serious question - so this article (https://www.drugwatch.com/vioxx/lawsuits/) is completely off base, including the one civil verdict in favor of a plaintiff (which I admit is fewer than I expected), the $950 million paid to the DOJ to settle criminal charges and civil claims, and stated fine of $321 million for a criminal violation of the FDCA? There are said to have been more payouts to Medicaid states and the US and a shareholder lawsuit, and based on my quick math counting the class action settlement - all totaling well over $7 billion. But it was a media caused problem, exacerbated by attorneys and just a labeling issue?

Your last paragraph - are you saying the FDA wanted Vioxx to continue to be sold and promoted? That sounds like a scene of one of the internal sales training classes from Dopesick. I guess I can see that someone said that, but it sounds like something told to the troops but not consistent with reality.

I can not discuss internal documentation

Surely, there is no prohibition against discussing communications or documentation that never existed.

 

[Marbles]

I was in sales, diabetes and cardiovascular. for one year i had to step in for a retired vioxx rep.

what is in the public domain, highly summarized.

the impetus stems back from a national news cast, stating vioxx causes MIs, based on a retrospective analysis by an academic project. as such, the recruitment from the law adds started, as you im sure you recall. 650 ish lawsuits were filled. Merck voluntarily pulled all samples from offices, pharmacies and distributors - and ceased all promotion.

roughly 2/3 of the cases went to trail by jury, all were found in favor of the defendant, merck. none of them found by jury that vioxx cause a MI.

the remaining third settled in a class payout to the law firm and their plaintiffs. to my knowledge there was no penalty financially enforced by the FDA to merck, but they did want a label change and an action plan for promotion highlighting more prominently the reason why one dose should be restricted more clearly.

Marble, wasn't sure your tone, ok. i think you know this;

Vioxx is a COX2, basically for those outside of medicine - its an nsaid, ie like advil. advil and similar are great for pain and inflammation, but acutely not chronically as these will or likely lead to severe bleeding in stomach, and chronically can cause MI as was noted in a naproxen trail. the niche, a merck hallmark, is improving therapy with improved tolerance. It is indicated for the chronic relief of pain due to RA without likely bleeding. basically you can take it daily. it was a remarkable drug for those with arthritis. two doses, 10mg and 25mg.

The 50 mg carried an additional indication for acute pain, ie severe injury, post surgery pain mgt and severe menstrual cycles to not exceed 5 days of use.

The label clearly states that, with the appropriate trail data to support the indications and limits of use. especially in the 50mg.

The courts never found what has been written here in the thread, which is what has been written by all kinds of media, academic and news institutions that gets parroted as fact.

so we don't dwell on this, let me further note. while i had that product, every sunday night i would get a list of doctors who were inappropriately perscribing the 50 chronically. i was required to visit each and every one of them and inform, and instruct to cease outside the label and document the discussion - this is long before the lawsuits, because the risk of the 50 may do cardiovascular harm consistent with nsaids. generally the resistance was based on the "if the 25 worked so well the 50 is better" despite clear fda labeling. i have had more the one doctor tell me to **** off.

there were plaintiffs in my area, although i would not know them personally.

it is my personal guess, speculation assumption. im guessing, and want to be clear on this next passage as i was not part of the legal or leadership team... ive wondered if the remaining cases were in fact plantiffs prescribed 50mg chronically who did have an MI. the nature of the each of those trails changes dramatically if doctors are called to the stand. may have been a better plan to just settle, and protect and maintain good relations for the trove of other products. complete guess on my part. wild ass guess, no one should parrot that as fact in any way.

Merck was found to have not be clear enough in the label, in our national meetings we were told that merck is volunteering not to resume promotion of vioxx, despite a formal request by the FDA to please do so.

Thanks for the detailed reply. It is significantly more informative. In truth, I know little about Vioxx beyond it being a Cox-2 inhibitor (all of which increase cardiovascular risk, or so I have been taught).

 

[Marbles]

FWIW, I think his take is more complicated. He walks through the history of insulin - from insulin derived from pig and cow pancreases, to recombinant human insulin (Humulin R and N), to insulin analogs. I don't think he argues that the changes are needless, but that the stated benefits of insulin analogs are exaggerated - including a 2003 Cochrane Collaboration study that compared recombinant human insulin to the predecessor, and three more Cochrane Reviews between '06 and '08 comparing analogs to recombinant human insulins - but 90% of insulin prescriptions were for analogs by 2010.

I believe his primary point, however, is the cost comparison. Humalog is said to have cost $21 per vial in 1996 and was $330 per vial by 2017 (compared to $38 in Canada).

As for any changes for compliance and safety, if the source of any basis for the same is a drug company study, that ends up (almost invariably) touting the newer and more expensive treatment, then that's an axe to grind.

I looked quickly at that chapter and I don't think that's what he is saying. The discussion focuses on how studies usually compare the new drug to doing nothing, as opposed to other existing therapies - like Humira/adalimumab as compared to methotrexate - for efficacy (and the studies show they are comparable - he does not mention side effects). Then he argues that the studies should have compared Humira to the most effective conventional therapy - methotrexate, HCL* and sulfasalazine. To try to be more succinct - I think in the adalimumab discussion, he's arguing for more info for doctors, not that one particular drug is better in all ways, for all patients.

I haven't read any positive reviews - I don't personally trust anyone else to review something, even a movie, for me. As for the positive comments on this thread, I am not sure how many have read the book.

All are argued for in the book.

Agree on all points.

Agreed.

I was hoping you would chime in on this post. PM me your address and I will send you a copy of the book. I'm not suggesting that your reading it will mean you agree with him, or my points above - I actually want someone with medical knowledge to read it and tell me where he is missing the mark.

* - I hesitated to include this here due to a tangential issue that may arise...

Well, after reading the chapter and doing some limited verification, overall, the meat of his argument on insulin analogs appears to be sound. So, I have to retract that objection and reconsider my evaluation of the book.

 

[5MilesBack]

The whole "everything in moderation " advice is what's caused lots of people to become obese and unhealthy.

That's not the advice that's causing that........that's their misinterpretation of the "advice", or misinterpretation of "common sense", or completely ignoring both altogether. And THAT was my point. People are going to do what they're going to do regardless what the advice is, and then blame someone else for their problems.

 

[bdan68]

That's not the advice that's causing that........that's their misinterpretation of the "advice", or misinterpretation of "common sense", or completely ignoring both altogether. And THAT was my point. People are going to do what they're going to do regardless what the advice is, and then blame someone else for their problems.

It is, but you're not going to get it. I wouldn't have either until I educated myself.

 

[SouthPaw]

I disagree. The "Food Pyramid" isn't being used, "Myplate" was rolled out in 2012 and is a much better set of recommendations. There are also private food pyramids that do a great job explaining basic diet.

The reason people are fat and diabetic is because we live in an incredibly prosperous place with unlimited calorie potential and food is a drug. People get addicted to sugar, fat, and salt to their detriment. Until I became a nurse and witnessed it firsthand I wouldn't have believed it. People completely ignore diet advice at every turn. Many, many attempts at intervening are made with individuals and they are in large part ignored. Not 100% obviously, but enough that kidney failure and foot amputations are very common.

I really don't think we disagree. I'm not saying the food pyramid is the single root cause, but its general structure is a contributing factor given it was pushed on generations of Americans for decades and the habits it produced are now firmly in place. The issues of sugar addiction, cheap/available processed foods and grains once being promoted as a healthy staple of diet, in addition to lack of exercise and discipline all compound to the result we find in most American adults today. We live in a world that provides total comfort and people have no self-responsibility to take care of themselves, and modern medicine and the associated profit machine enables it (while many, like yourself, may not encourage the behavior and are ignored).

 

[doc holiday13]

That's not the advice that's causing that........that's their misinterpretation of the "advice", or misinterpretation of "common sense", or completely ignoring both altogether. And THAT was my point. People are going to do what they're going to do regardless what the advice is, and then blame someone else for their problems.

Exactly this. Despite the evilness of the villian in basically every movie, the villians are correct in that the majority of people want to be told what to do. Without being told exactly what to do or not do, people will plead ignorance and blame shift instead of accepting responsibility for themselves.

 

[MattB]

Typed fast. There are many participants in the failure and success of medicine. Tried to detail a few.

The boggie man is not pharma. I’d look to those claiming they are is more responsible or in part. Masking their responsibility. You know Solinski

I agree. The thesis of this thread is akin to saying that law enforcement caused the 2020 BLM riots. They played a role in the factors that led up to it for sure, but when ascribing blame the parties are far broader and law enforcement was not the biggest culprit by any stretch. Not to mention that perspective lumps all cops together, good or bad.

One can point to situations like the Purdue/OxyContin debacle, but that is not representative of the general conduct of big pharma. Pharma, health insurance companies, lawyers that specialize in class action suits, healthcare systems, etc. all play a role.

 

[Shraggs]

It’s also akin to say that gun manufacturers have ruined hunting and shooting…. Its exactly the same argument imitated by the very same liberal Marxist instigators.

Poorly designed product is one thing, but useage is a very different problem. Can’t blame that, but people do and the same is true in medicine.

Folks aren’t looking at the mis-usage side. As I carefully detailed above.

 

[fwafwow]

I agree. The thesis of this thread is akin to saying that law enforcement caused the 2020 BLM riots. They played a role in the factors that led up to it for sure, but when ascribing blame the parties are far broader and law enforcement was not the biggest culprit by any stretch. Not to mention that perspective lumps all cops together, good or bad.

One can point to situations like the Purdue/OxyContin debacle, but that is not representative of the general conduct of big pharma. Pharma, health insurance companies, lawyers that specialize in class action suits, healthcare systems, etc. all play a role.

IMHO I believe you have misread the thesis of the thread, at least with regards to my OP - note the third sentence: “Note - not all blame is placed on pharmaceutical companies - it is shared with medical journals, government agencies and politicians.” And I’m fine adding insurance companies and others to the list.

If you haven’t read the book, I will be glad to send you a copy and then welcome your feedback.

 

[5MilesBack]

It is, but you're not going to get it. I wouldn't have either until I educated myself.

Educated yourself on what........what moderation actually means? You see......"proper" moderation is different for everyone. Only the individual can figure out what that is.....and obviously in America, most never figure out what that is.

Now I will give you.......I'm the last person that should be dictating what someone else's "moderation" should mean.........as I go way beyond what my own moderation should be on a daily basis. But then again, I'm not overweight or have any health issues at 57.......other than neck, back, and joints. I avoid veggies like the plague, and I still eat bacon several times a week, 20oz+ fatty ribeyes and prime rib routinely, BBQ ribs, carnitas cooked in lard (or anything else deep-fried), lots of pasta and potatoes, and have never met a non-cake dessert I am willing to pass up. As for moderation, I'll eat $10 worth of apple fritters in one sitting. And still go through three gallons of 2% milk a week, plus coffee every day at least a couple times a day. I also drink about a gallon of water every day. But apparently, I am an anomaly. If I was overweight or my blood work was way off, my moderation would completely change, regardless what the experts recommended.