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Subject: Big Pharma
Posted by: Perm Dude
- [154552311] Thu, Sep 03, 2009, 13:04
It's time, I think, for a clear and critical look at Big Pharma.
Something I didn't know: They've spent over a billion dollars a year in fines over the last ten years.
Do we have a basic right to ineffective drug therapies?. This touches on the parts of HR3200 (themselves the children of earlier legislative efforts) on the effectiveness of various therapies. The wacky right call these a version of "death panels" and cry "rationing!" but trying to figure out which drugs actually work is ultimately a life saving process.
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| 1 | biliruben
ID: 461142511
Thu, Sep 03, 2009, 13:09
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Having worked with a few over the years, I have come to realize that we cannot let them police themselves and choose the questions they try to answer in their clinical trials. We need to beef up the FDA so as to not have to rely on big Pharma money to do all the studies.
What typically happens is they ask the questions they want answered, not the questions that the public needs to sort out:
1) Whether a drug is safe
2) Whether it's more effective than current, cheaper drugs already on the market.
They prefer not to do comparative effectiveness trials, and if they do, the spin the data so much that it's nearly impossible to figure out whether it's more effective, unless you get their data and re-analyze it yourself.
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| 3 | biliruben
ID: 461142511
Thu, Sep 03, 2009, 14:08
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To go into a bit more detail, safety-wise, what I've seen in the past is that they will focus on intermediate outcomes instead of what we are really concerned about.
For example, Calcium Channel Blockers may decrease your cholesterol, so they present that. At the same time, in increases your chance of death. They don't report that.
Effectiveness-wise, they like to compare the drug to someone not on the drug. It's an easier, shorter study to do. What we really need, however, are studies that compare the drug to the current standard of care. Those are harder to do, take longer, and often come up with equivocal results. Hard to justify paying 10 times as much for little benefit over the older regimen.
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| 4 | boikin
ID: 532592112
Thu, Sep 03, 2009, 15:40
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Those are harder to do, take longer, and often come up with equivocal results.
And then people get mad when they find out that potential new treatment is out there but because it is still in testing they could not have access too it.
We need to beef up the FDA so as to not have to rely on big Pharma money to do all the studies.
or just let the government run the big pharma.
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| 5 | Madman
ID: 20131721
Sat, Sep 05, 2009, 14:10
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Agreed with BR1, point 2.
I'd also propose the following. Any drug marketed direct to consumers cannot be sold through a tax-advantaged health insurance product.
If a drug has to be marketed direct to consumer, then by definition it's clinical effectiveness is being held secondary to its branding. There is no moral reason why those costs should be spread to the population at large via tax advantage or, in my opinion, through an insurance product.
I'd let Big Pharma choose. If you market direct to consumers, then the consumers have to buy "direct" from them. That's a pretty simple rule that would have some major implications, either in terms of reduced insurance costs or in terms of reduced advertising expenditures. This is a freedom-preserving cost reduction solution.
And, yes, it leaves unaddressed the issue of physician junkets.
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| 6 | biliruben
Leader
ID: 589301110
Sun, Sep 06, 2009, 01:22
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That's a great idea, but we still need clinical trials to answer the right questions. If we leave it up to the company, they won't. We need to fund the FDA adequately for the role they need to play. And we need to have the funding come from the taxpayer, not the company.
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| 7 | Khahan
ID: 486552412
Tue, Sep 08, 2009, 08:48
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Bili,
I'm not sure to what degree you've 'worked with a few' over the years. But I can assure you that a pharma's company testing process answers all the questions that the public wants to know.
The clinical trials may not answer those questions but the rest of the testing process answers those questions and a hundred questions the population at large never thought out. A drug can spend over 15 years in development before it gets to the point of being submitted to the FDA for approval for human testing. 15 years.
The FDA has their fingers so deep into what pharma can and cannot do that they are already 'running' most companies.
Did you know that if they run a human test of 1000 people and 1 single person, for example, throws up (and it turns out they threw up because they were ill and it had nothing to do with the drug) that the pharma has to report that as part of the side effects of the drug?
Did you know that every single email concerning a drug ever sent is viable evidence and needs to be saved/stored somewhere? If even a mention of a possible side effect is in an email and something comes out later, the company can be held responsible for millions of dollars?
I also want to address this from PD's post:
"Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines Wednesday and called the world's largest drugmaker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets."
This means that sales reps are no longer allowed to take lunches to doctors office for their staff and do presentations on the drugs. Some companies do not even allow their sales staff to give away pens anymore. That is how absolutely ridiculous this has gotten.
I'm not about to cry, "Poor Big Pharma." Because they do have their issues. But the stuff you are raising just isn't founded in reality.
The 2 questions you posed are exactly the first 2 questions they will ask. Why? Because it hits their bottom line. If a drug is not going to be safe they are not going to spend billions of dollars and over a decade of their time during further research.
And the second one, again, if its not cheaper and more effective than what is out there, why investigate and produce it? It won't make money.
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| 8 | Perm Dude
ID: 154552311
Tue, Sep 08, 2009, 10:23
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Pfizer's fine was for a lot more than for sales reps buying the staff of doctors' offices lunch (which, btw, they probably shouldn't be doing anyway). Pfizer's fine was for repeatedly going over the line.
Pharma's job is to make money. FDA's job is to make sure the drugs do what the drug companies say, and are safe. Sometimes these two things overlap, but not often enough to say that the FDA is running drug companies, despite their deep involvement in ensuring that the products are not harming people.
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| 9 | biliruben
Leader
ID: 589301110
Tue, Sep 08, 2009, 10:28
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My boss was an expert witness in several of the Vioxx cases, and at least in that case, Merck did every thing they could to present the data is such a way as to hide the excess deaths and infarcts.
I've done several papers with Glaxo, and it was like pulling teeth to get them to get them to compare their analytes to ones already out there. They only want to compare to nothing.
I could come up with dozens of examples.
Long-term side effects (like, say, death) can take decades to discover.
Also, if they've already spent a decade and millions bringing it to Phase III, then start to see side-effects, there are strong incentives to hide it if at all possible. Or better yet, design the study to not be powered to find it.
I'm not saying big pharma is evil. They just err by omission if they are allowed to.
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| 10 | Khahan
ID: 391582715
Tue, Sep 08, 2009, 12:30
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Just to clarify, there does seem to be a few different points and beefs being discussed here.
The one I'm focusing in on was bili's comments, though his quick summation: I'm not saying big pharma is evil. They just err by omission if they are allowed to. pretty much sums it up. Guess when it comes to the bottom line we aren't as off in our thinking as I believed.
I do not have the first hand experience on the side of the issues you have bili. What I know comes from my wife. She is in R&D for one of the major companies and has been for 15 years (early in the process). She has also done review work for the NHS to determine which projects receive government grant money.
This brings me to another point being discussed which was raised in the link pd issued. He said, the FDA is running drug companies, despite their deep involvement in ensuring that the products are not harming people.
While the FDA may not be sitting on any of the companies boards or hold a CEO type position, they are so deeply ingrained in these companies and so directly affect company policy that in a figurative way it can be said they run these companies. There are many times where FDA regulations seems to just handcuff something for no realistic reason. They can realy interfer in the scientific process. Thats not good.
And this is something I'm conflicted on. I abhor the very idea of government controlled ethics. But the FDA does need to exist to keep tabs and control HOW some of these pharma's make corporate policy. Regulating how they market drugs. Regulating advertisement. Confirming that models used for studies are sound etc. Those are all aspects of the FDA that are good.
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| 11 | biliruben
ID: 461142511
Tue, Sep 08, 2009, 14:30
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I'm certainly no expert on this stuff, but it is clear that when billions of dollars are at stake, and the difference between FDA-approval and no approval can sometimes be a nuanced interpretation, you have to have high-levels of regulation and oversight by highly trained professionals that have no possibility of having their judgment compromised by the stink of benjamins.
We don't have that right now.
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