Post by WanderingWinoZ on Sept 21, 2015 9:13:56 GMT -5
Looks like they are doing some long form piece....I can't follow it, but maybe somebody else is interested?
America's most admired Lawbreaker
Over the course of 20 years, Johnson & Johnson created a powerful drug, promoted it illegally to children and the elderly, covered up the side effects and made billions of dollars. This is the inside story.
but they basically pushed a dangerous drug, made $30B and paid a $2B in federal penalties?
Yup, and not only pushed it, but pushed it on children and the elderly, which the FDA specifically excluded as target patients due to side-effects. J&J tried for approval for a wider market, FDA said newp market it for its intended use only, J&J said Fukkit we need results for shareholders.
Longer version (Chapter 1): J&J patented Haldol for schizophrenia and BPD and made shittons of money until patent expired in mid-1980s. Generics flood the market, reducing J&J market share of Haldol/anti-psychotics. They develop Risperdal for S and BPD, try to get approval for wider-spread use, each application is denied by the FDA because of non-specifity ("we approve and you can market it for anything from anxiety and autism in children to dementia in elderly and a host of "what-if" uses and we're not going to allow that to happen.") and side-effects. J&J pushes to the intended markets anyway because Profits. They put a small portion of sales into an "expected liabilities" (or some such) fund to pay for lawsuits brought on by estates of dying elderly (marketed for dementia, an off-label/non-approved use) and children growing (46DD) breasts and other side-effects (not approved for children due to known and unknown side-effects.) So, in effect, a cost-benefit analysis says that the government won't fine them enough and lawsuits won't cost them enough to make them stop pushing the drug for off-label use before it goes off-patent and they're in the same situation they were with Haldol. Current CEO was instrumental in this marketing scheme and promoted as a result.
Post by WanderingWinoZ on Sept 21, 2015 11:57:23 GMT -5
Thanks for the re-cap.
So how is this getting prescribed & marketed? Are they lying to doctors? Wouldn't a doc check the FDA approval?? Didn't the FDA know it was being sold to these people it shouldn't be? Or are pharmacies allowed to do all sorts of off-label & non-approved scrip fills? So much I don't comprehend about the drug industry, other than BigPharma is buying doctors these days...
So how is this getting prescribed & marketed? Are they lying to doctors? Wouldn't a doc check the FDA approval?? Didn't the FDA know it was being sold to these people it shouldn't be? Or are pharmacies allowed to do all sorts of off-label & non-approved scrip fills? So much I don't comprehend about the drug industry, other than BigPharma is buying doctors these days...
Basically: (not from this specific article) puffery or outright lies, pressure, salesmanship, gifts and gimmickry, and lots and lots of free samples. Docs get reimbursed more for patented over generic drugs. Sales reps are probably doing the "new and improved, better than Haldol and the generics" song-and-dance even though the FDA expressly states they cannot compare the two as there haven't been side-by-sides, etc. Docs are busy and take the reps word on approvals or do minimal research and find that benefits outweigh risks, minimizations of side-effects, etc. And Money - always a factor.
So how is this getting prescribed & marketed? Are they lying to doctors? Wouldn't a doc check the FDA approval?? Didn't the FDA know it was being sold to these people it shouldn't be? Or are pharmacies allowed to do all sorts of off-label & non-approved scrip fills? So much I don't comprehend about the drug industry, other than BigPharma is buying doctors these days...
Doctors prescribe off label all the time. Sometimes that's good, sometimes it's not (for example, I've tried one drug off label that has multiple studies backing up the off label use, but they haven't tried to get approval).
And for Risperdal, you add in other factors. Many psychiatric drugs are not approved for use in children, so there can be no approved drugs to try. It's an atypical antipsychotic. Haldol was an earlier generation, and that generation had a hell of a lot more side effects. So if you have a hallucinating kid, especially at the time it made sense to try the new drug.
As for marketing... well, that's purely motivated by money and often an awful thing.
but they basically pushed a dangerous drug, made $30B and paid a $2B in federal penalties?
Yup, and not only pushed it, but pushed it on children and the elderly, which the FDA specifically excluded as target patients due to side-effects. J&J tried for approval for a wider market, FDA said newp market it for its intended use only, J&J said Fukkit we need results for shareholders.
Longer version (Chapter 1): J&J patented Haldol for schizophrenia and BPD and made shittons of money until patent expired in mid-1980s. Generics flood the market, reducing J&J market share of Haldol/anti-psychotics. They develop Risperdal for S and BPD, try to get approval for wider-spread use, each application is denied by the FDA because of non-specifity ("we approve and you can market it for anything from anxiety and autism in children to dementia in elderly and a host of "what-if" uses and we're not going to allow that to happen.") and side-effects. J&J pushes to the intended markets anyway because Profits. They put a small portion of sales into an "expected liabilities" (or some such) fund to pay for lawsuits brought on by estates of dying elderly (marketed for dementia, an off-label/non-approved use) and children growing (46DD) breasts and other side-effects (not approved for children due to known and unknown side-effects.) So, in effect, a cost-benefit analysis says that the government won't fine them enough and lawsuits won't cost them enough to make them stop pushing the drug for off-label use before it goes off-patent and they're in the same situation they were with Haldol. Current CEO was instrumental in this marketing scheme and promoted as a result.
But, yanno, the insane costs of prescription drugs is so drug companies can do R&D and not go out of business.
This is why people need to be going to prison, not hiding behind "the company." Start throwing some of these execs in prison and we'll start seeing attitudes changing.
So how is this getting prescribed & marketed? Are they lying to doctors? Wouldn't a doc check the FDA approval?? Didn't the FDA know it was being sold to these people it shouldn't be? Or are pharmacies allowed to do all sorts of off-label & non-approved scrip fills? So much I don't comprehend about the drug industry, other than BigPharma is buying doctors these days...
Basically: (not from this specific article) puffery or outright lies, pressure, salesmanship, gifts and gimmickry, and lots and lots of free samples. Docs get reimbursed more for patented over generic drugs. Sales reps are probably doing the "new and improved, better than Haldol and the generics" song-and-dance even though the FDA expressly states they cannot compare the two as there haven't been side-by-sides, etc. Docs are busy and take the reps word on approvals or do minimal research and find that benefits outweigh risks, minimizations of side-effects, etc. And Money - always a factor.
Um, no. Docs don't get reimbursed ANYTHING for any drug they prescribe (unless they are administering the drug, ie chemo, some other injectables in clinic and they actually own the clinic which is actually quite rare these days). It does not make any difference whatsoever in my pay whether I prescribe brand name or generic. I will always choose a generic if it is available and will even switch to a different drug class in order to prescribe generic as long as not inferior outcome for patient. I hate that so many people think doctors are behind this nonsense.
So how is this getting prescribed & marketed? Are they lying to doctors? Wouldn't a doc check the FDA approval?? Didn't the FDA know it was being sold to these people it shouldn't be? Or are pharmacies allowed to do all sorts of off-label & non-approved scrip fills? So much I don't comprehend about the drug industry, other than BigPharma is buying doctors these days...
Doctors can and do prescribe drugs off label for good reasons.
Legally, pharmas cannot even hint at non-approved uses in their marketing materials and conversations with physicians. Or they get fined. But evidently not enough.
So how is this getting prescribed & marketed? Are they lying to doctors? Wouldn't a doc check the FDA approval?? Didn't the FDA know it was being sold to these people it shouldn't be? Or are pharmacies allowed to do all sorts of off-label & non-approved scrip fills? So much I don't comprehend about the drug industry, other than BigPharma is buying doctors these days...
Doctors prescribe off label all the time. Sometimes that's good, sometimes it's not (for example, I've tried one drug off label that has multiple studies backing up the off label use, but they haven't tried to get approval).
And for Risperdal, you add in other factors. Many psychiatric drugs are not approved for use in children, so there can be no approved drugs to try. It's an atypical antipsychotic. Haldol was an earlier generation, and that generation had a hell of a lot more side effects. So if you have a hallucinating kid, especially at the time it made sense to try the new drug.
As for marketing... well, that's purely motivated by money and often an awful thing.
Sometimes you have to go off label. Haldol and Risperdal can be used to target psychosis and agitation in elderly patients. There is NO drug approved for this. So what should we use? Let people suffer? Give me a fucking break.
Haldol was was a miracle drug for many when it came out. It still is for some who don't respond to other antipsychotics. It is often given to women in pregnancy now because we have the most data on it. What should we use? What about for children? Risks and benefits people.
Risperdal was also a miracle drug. Older antipsychotics came with certain side effects like severe movement disorders. The next generation atypical antipsychotics came with much reduced risk of this side effect. There are other side effects to be sure, but ALL drugs come with side effects. Historical context people.
People want to shit on things they know nothing about.
As for making more money prescribing expensive drugs? Go fuck yourself. As if I have time in my day to spend on the phone getting an approval for the latest drug.
Now, recommending off label use by drug reps was previously wide spread and potentially dangerous. It is tightly regulated now. But, doctors still prescribe off label all the time. To help patients.
When someone has a grandmother/parent who is elderly and up screaming all night, going through the knife drawer and spreading shit on the walls, you will feel blessed there are medications that can help. Risk of early death? Maybe? But grandma will certainly live better for her last days if she is not floridly psychotic.
When your child is diagnosed with schizophrenia, and is hurting themself, what do you think an alternative to an antipsychotic would be?
These drugs have changed the lives of so many people who have suffered from horrible diseases. Thank God for them.
So how is this getting prescribed & marketed? Are they lying to doctors? Wouldn't a doc check the FDA approval?? Didn't the FDA know it was being sold to these people it shouldn't be? Or are pharmacies allowed to do all sorts of off-label & non-approved scrip fills? So much I don't comprehend about the drug industry, other than BigPharma is buying doctors these days...
FYI, Ripserdal and Haldol oral are generic. No one is promoting them through drug reps these days.
So how is this getting prescribed & marketed? Are they lying to doctors? Wouldn't a doc check the FDA approval?? Didn't the FDA know it was being sold to these people it shouldn't be? Or are pharmacies allowed to do all sorts of off-label & non-approved scrip fills? So much I don't comprehend about the drug industry, other than BigPharma is buying doctors these days...
Basically: (not from this specific article) puffery or outright lies, pressure, salesmanship, gifts and gimmickry, and lots and lots of free samples. Docs get reimbursed more for patented over generic drugs. Sales reps are probably doing the "new and improved, better than Haldol and the generics" song-and-dance even though the FDA expressly states they cannot compare the two as there haven't been side-by-sides, etc. Docs are busy and take the reps word on approvals or do minimal research and find that benefits outweigh risks, minimizations of side-effects, etc. And Money - always a factor.
Free samples allow my patients to get medication they otherwise would not be able to afford. That they need.
Do you think doctors do not know how to look at the mechanism of action for new drugs? Do you know which of the latest antipsychotics have been shown to be more effective than others?
Do you understand the difference between the side effects for Haldol vs. new meds? The way medications differ in terms of weight gain? Drug-drug reactions? How different drugs may be used effectively for different symptoms? I do and prescribe accordingly.
Benefits sometimes do outweigh risks. Pregnant women with a mental illness, for example, may absolutely need medication despite risks. An unmedicated pregnancy can have far worse consequences.
So what are you saying here other than a bunch of shit which is indicative of your ignorance about mental illness and available treatments?
Doctors prescribe off label all the time. Sometimes that's good, sometimes it's not (for example, I've tried one drug off label that has multiple studies backing up the off label use, but they haven't tried to get approval).
And for Risperdal, you add in other factors. Many psychiatric drugs are not approved for use in children, so there can be no approved drugs to try. It's an atypical antipsychotic. Haldol was an earlier generation, and that generation had a hell of a lot more side effects. So if you have a hallucinating kid, especially at the time it made sense to try the new drug.
As for marketing... well, that's purely motivated by money and often an awful thing.
Sometimes you have to go off label. Haldol and Risperdal can be used to target psychosis and agitation in elderly patients. There is NO drug approved for this. So what should we use? Let people suffer? Give me a fucking break.
Haldol was was a miracle drug for many when it came out. It still is for some who don't respond to other antipsychotics. It is often given to women in pregnancy now because we have the most data on it. What should we use? What about for children? Risks and benefits people.
Risperdal was also a miracle drug. Older antipsychotics came with certain side effects like severe movement disorders. The next generation atypical antipsychotics came with much reduced risk of this side effect. There are other side effects to be sure, but ALL drugs come with side effects. Historical context people.
People want to shit on things they know nothing about.
As for making more money prescribing expensive drugs? Go fuck yourself. As if I have time in my day to spend on the phone getting an approval for the latest drug.
Now, recommending off label use by drug reps was previously wide spread and potentially dangerous. It is tightly regulated now. But, doctors still prescribe off label all the time. To help patients.
When someone has a grandmother/parent who is elderly and up screaming all night, going through the knife drawer and spreading shit on the walls, you will feel blessed there are medications that can help. Risk of early death? Maybe? But grandma will certainly live better for her last days if she is not floridly psychotic.
When your child is diagnosed with schizophrenia, and is hurting themself, what do you think an alternative to an antipsychotic would be?
These drugs have changed the lives of so many people who have suffered from horrible diseases. Thank God for them.
This is a hell of an overreaction to my dislike of marketing. I have no issues with off label use of drugs, have used them, and gave two good reasons for why doctors might prescribe Risperdal off label.
I'm not saying and didn't say to let people suffer.
Sometimes you have to go off label. Haldol and Risperdal can be used to target psychosis and agitation in elderly patients. There is NO drug approved for this. So what should we use? Let people suffer? Give me a fucking break.
Haldol was was a miracle drug for many when it came out. It still is for some who don't respond to other antipsychotics. It is often given to women in pregnancy now because we have the most data on it. What should we use? What about for children? Risks and benefits people.
Risperdal was also a miracle drug. Older antipsychotics came with certain side effects like severe movement disorders. The next generation atypical antipsychotics came with much reduced risk of this side effect. There are other side effects to be sure, but ALL drugs come with side effects. Historical context people.
People want to shit on things they know nothing about.
As for making more money prescribing expensive drugs? Go fuck yourself. As if I have time in my day to spend on the phone getting an approval for the latest drug.
Now, recommending off label use by drug reps was previously wide spread and potentially dangerous. It is tightly regulated now. But, doctors still prescribe off label all the time. To help patients.
When someone has a grandmother/parent who is elderly and up screaming all night, going through the knife drawer and spreading shit on the walls, you will feel blessed there are medications that can help. Risk of early death? Maybe? But grandma will certainly live better for her last days if she is not floridly psychotic.
When your child is diagnosed with schizophrenia, and is hurting themself, what do you think an alternative to an antipsychotic would be?
These drugs have changed the lives of so many people who have suffered from horrible diseases. Thank God for them.
This is a hell of an overreaction to my dislike of marketing. I have no issues with off label use of drugs, have used them, and gave two good reasons for why doctors might prescribe Risperdal off label.
I'm not saying and didn't say to let people suffer.
Kirra, I was agreeing with your post and adding on to it. I dislike a lot of marketing too but if it gets me free meds for my patients, I will go with it. Sorry you got the wrong impression.
@adobeclay and fleurdelis My apologies. The comment was from other stuff I've read and heard (as one of you commented, I'm not the only one to have heard/read/seen such (mis)information). I actually initially posted a "would love to hear from doctors or pharma reps" but deleted the line in an edit. So I'm very glad you responded. I deserved the smack down.
I have no problem with the doctors giving samples to their patients. It's a very important mechanism for uninsured and underinsured patients. I do have other issues with Pharma and it came out in my post.
Post by WanderingWinoZ on Sept 22, 2015 6:39:35 GMT -5
Thanks for those chiming in with their own personal experience.
I know you aren't paid directly by Pharm, but aren't they tracking which doctors prescribe which meds? I thought I'd read/watched a show on some type of compensation (trips??)
Thanks for those chiming in with their own personal experience.
I know you aren't paid directly by Pharm, but aren't they tracking which doctors prescribe which meds? I thought I'd read/watched a show on some type of compensation (trips??)
Pharma rep chiming in here. I've been in the industry since 2001 and have worked for a small company and a big company. Neither of those companies have awarded doctors a trip for the amount of prescriptions they write since I've worked for them. From what I understand, the industry was extremely different in the 90's but that was before my time. Unfortunately, people still think pharma operates like they did in the 90's. I can assure you, we don't. We can't give anything to doctors other than the prescribing information, a reasonable amount of samples and an occasional modest lunch so we can have time to share our information with the providers. No gifts, no trips, no golf outings, no pens, no notepads, etc. I can't even give my providers a clinical reprint for them to read. As far as off label promotion goes, I have never promoted a product for off label use. If I did and was reported by someone, I would be fired. It's not worth my job. Do other reps do it? Yes, they do. There are people that make bad decisions in every industry. But that doesn't make the industry or all reps bad. The industry has changed a lot but most people choose to believe that what happened 15+ years ago is still happening. The media chooses to highlight things that happened in the 90's and act like it is still going on today. It is not. I don't even get compensated on how many scripts my providers write and that's the way it should be. They should prescribe products because they think it is the best product for their patients, not because a rep is bringing them lunch.
Thanks for those chiming in with their own personal experience.
I know you aren't paid directly by Pharm, but aren't they tracking which doctors prescribe which meds? I thought I'd read/watched a show on some type of compensation (trips??)
They track this data but they don't compensate doctors for it. All compensation from pharma to physicians is reportable under the Sunshine Act, a transparency that is not required by the politicians who made this law.
Thanks for those chiming in with their own personal experience.
I know you aren't paid directly by Pharm, but aren't they tracking which doctors prescribe which meds? I thought I'd read/watched a show on some type of compensation (trips??)
If they track this they have never told me. Trips and any gifts or compensation beyond lunch are illegal (and most docs don't even accept meals anymore). Insurance companies def track but not for purpose of benefiting doctors in any way I can assure you. We spend countless UNPAID hours each week arguing with insurance companies to justify meds, often even cheap ones.
Big pharma routinely pays doctors to promote its products, but soon patients will be able to get a clearer picture about a doctor's possible connections to the companies that make the drugs they may prescribe. The Affordable Care Act includes the Sunshine Act, which requires all pharmaceutical and medical device companies to publicly report all payments to doctors more than $10, according to Charlie Ornstein, a senior editor for the independent, non-profit newsroom ProPublica. The information will be made available in the fall of 2014. "This means patients, for the first time, will have a full window into how closely their doctors work with a pharmaceutical industry and be able to raise this with their doctors if they have questions," he said.
The practice of pharmaceutical companies working with doctors to develop new medications to treat conditions and help promote those medications has been in place for decades, but Ornstein, who is investigating this practice, said, "The promotion part has gotten a lot of attention in recent years because drug companies have paid hundreds of millions and sometimes billions of dollars to settle lawsuits that have accused them of improper marketing and giving kickbacks to doctors."
Ornstein continued, "It's illegal to give kickbacks to a doctor to prescribe drugs, but it is legal to give money to doctors to help promote your drug. Some doctors make tens of thousands or hundreds of thousands of dollars a year beyond their normal practice just for working with the industry."
The federal government unveiled data Tuesday detailing 4.4 million payments made to doctors and teaching hospitals by pharmaceutical and medical device companies.
The launch of the so-called Open Payments website, mandated under a provision of the Affordable Care Act, was far from glitch-free: Some users encountered long delays and sometimes error messages trying to access its seven data tables. Also, the site didn’t provide consumers with an easy-to-use lookup tool, a single place to search for a doctor’s name and see all results across data files.
It will take a while to dig deeply into this new trove of data, which covers the period of August to December 2013 and includes general and research payments, as well as payments to companies’ physician investors. All told, according to officials from the Centers for Medicare and Medicaid Services, companies spent a total of $3.5 billion during that period on 546,000 individual physicians and almost 1,360 teaching hospitals.