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GSK Pays $3 Billion Fine

The following article is reposted from NeuroLogicaBlog. Happy Independence Day to all our American readers.

 

The pharmaceutical giant, GlaxoSmithKline, has agreed to pay three billion dollars in fines to settle three charges of fraud brought by the FDA. This is the largest health fraud settlement in US history. What are the implications of this settlement for how the pharmaceutical industry is regulated in the US and for the role that “Big Pharma” allegedly plays in US health care?

The three fraud charges admitted to by GSK include promoting the off-label use of two anti-depressant drugs – Paxil and Wellbutrin. In the US drugs are approved for specific indications, and they can only be marketed for those indications. So-called off-label use of drugs, however, is very common. Off-label does not necessarily equate to bad medicine, or to lack of scientific evidence or rationale. Often there is solid basic science and clinical evidence to support a specific use of a drug that is not approved by the FDA. That simply means the manufacturer did not apply to the FDA for that indication, which could simply be because they did not feel they would recoup the millions of dollars they would need to spend to get approval for the additional indication. In other words, FDA approval for secondary indications is as much about marketing and finance as it is about the science.

Regardless of whether or not a specific use is evidence-based, however, the rules regulating pharmaceutical companies are very clear – they cannot market a drug for a non-approved use. Doing so breaks the law. GSK broke the law.

The second charge was that GSK held back data and made unsupported claims regarding its diabetes drug Avandia. The third charge is that their sales force used inappropriate tactics to get doctors to prescribe their drugs, including various forms of “high-priced entertainment” and large speaking fees. This practice has come under heavy scrutiny in the last decade and rules regulating what pharmaceutical reps can give to physicians have been significantly tightened. According to the settlement GSK violated those rules, not to mention basic ethical behavior.

Mark Crislip summarizes the concerns well in an article for Science-Based Medicine. He concludes that pharmaceutical companies give misleading and biased information to physicians, who are influenced by their contact with pharmaceutical reps, and that the best policy is for practicing physicians to keep a healthy distance from reps (no free lunches, no sponsored lectures, no free gifts). This has become voluntary policy in many institutions, including Yale where I work. Access of pharmaceutical reps to physicians is strictly limited.

The debate continues, however, about whether or not there can be a healthy relationship between doctors and pharmaceutical companies, or whether we need an absolute wall of separation between the two. One recent article, for example, found that doctors who have no access to pharmaceutical reps were up to four times slower to adopt new medications than physicians with some access to reps. In addition, they were also four times slower to stop using a drug that has a new black box warning, meaning that negative information about safety has come to light. It seems, therefore, that pharmaceutical companies can be a useful conduit of information to physicians, but that also comes with a lot of baggage. It seems to me that we have two choices. Either we develop new ways of quickly spreading the word about new valuable drugs and new warnings about existing drugs (pushing critical information to physicians), and/or we need to carefully monitor and regulate the pharmaceutical company distribution of this information.

The GSK settlement, in my opinion, is just the most recent evidence that industry cannot be left to their own devices without proper monitoring and regulation. There is a certain efficiency and motivation for innovation in the private sector approach to drug development. That seems worth preserving. But companies are chiefly motivated by profit, and when billions of dollars are at stake there is a huge motivation to bend the rules. We take for granted that companies are going to distort information when marketing their products to the public. Experienced and savvy consumers view all commercial and marketing activity with a skeptical eye and we do need to take some personal responsibility for protecting ourselves (let the buyer beware).

At the same time the public largely expects that with health care issues the government will play some role in protecting the public from fraud, misinformation, unsafe and ineffective products and services. The stakes are just too high to make every consumer fend for themselves in a completely unregulated wild west of health care. In addition the science behind health care products and services is complex, and it is not reasonable to expect the average citizen to be able to sift through complex technical medical research. That is essentially the reason for the existence of the FDA.

I think that with careful, thoughtful, and evidence-based regulations we can have the best of both worlds. We can have a dynamic and innovative pharmaceutical industry that is also regulated to protect the public from misinformation and fraud and to ensure a minimum standard of scientific evidence for safety and effectiveness.

What this recent settlement indicates, in my opinion, is that companies will bend the rules to maximize their own profits, and that effective regulation can bring them into line and protect the public. I also think this settlement is a significant piece of evidence against the typical “Big Pharma” conspiracy theory that government is in the hands of industry. It’s hard to dismiss $3 billion dollars as a slap on the wrist. This was a clear statement.

I hasten to add that everything I said above is also true of other private segments of the health care industry, including the supplement industry (which has large and increasing overlap with the pharmaceutical industry), and the alternative medicine industry. They like to promote this false dichotomy between the business end of medicine they decry and the “holistic” practitioners who just want to help people. This is a fiction. The people most loudly playing that card are also the ones making the most money off of selling their products, services, and information. Supplements and CAM are big business. They routinely misrepresent scientific information, make unsupported claims for their treatments, ignore data about lack of safety or effectiveness, and personally attack anyone who will dare disagree with them. And they are doing this to sell treatments that are scientifically dubious or even disproved, yet they have been remarkably successful in eliminating regulations designed to protect the public from their own fraud.

It is hypocritical to simultaneously call for more pharmaceutical company regulation and less supplement and alternative medicine regulation, but that is what they do. Rather, I think we need fair and consistent science-based regulation across the board. No double standards, no false dichotomies. I agree that GSK should be heavily fined for making unsupported claims for its products. And so should every company selling herbs, supplements, fanciful treatment, and dubious products with unsupported claims. Instead they are shielded by industry friendly and anti-consumer laws crafted by the industry itself.

Posted in: Politics and Regulation

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40 thoughts on “GSK Pays $3 Billion Fine

  1. tgobbi says:

    My guess is that many proponents and exponents of pseudoscientific modalities are salivating and wringing their hands with glee at this news! For example, I can just picture the numerous chiropractors I’ve corresponded with over the years emailing me to say “I told you so! Big Pharma (and, by extension, mainstream doctors) are just as bad as you say we are!” It’ll be just like how they erroneously claimed that the Wilk case vindicated chiropractic.

  2. marilynmann says:

    I realize that only a lawyer would care about this distinction, but the case was brought by the Department of Justice, not by the FDA:

    “The criminal case is being prosecuted by the U.S. Attorney’s Office for the District of Massachusetts and the [DOJ] Civil Division’s Consumer Protection Branch. The civil settlement was reached by the U.S. Attorney’s Office for the District of Massachusetts, the U.S. Attorney’s Office for the District of Colorado and the [DOJ] Civil Division’s Commercial Litigation Branch. Assistance was provided by the HHS Office of Counsel to the Inspector General, Office of the General Counsel-CMS Division and FDA’s Office of Chief Counsel as well as the National Association of Medicaid Fraud Control Units.”

    Here is a link to the DOJ press release. The press release contains other pertinent links.

    http://www.justice.gov/opa/pr/2012/July/12-civ-842.html

  3. weing says:

    “It’s hard to dismiss $3 billion dollars as a slap on the wrist. This was a clear statement.”

    Yup. Wanna a see a slap on the wrist?

    http://www.iwatchnews.org/2012/07/03/9268/company-earned-millions-defense-contracts-while-making-illegal-sales-china

  4. anoopbal says:

    Combined sales from Avandia, welbutrin and Paxil totaled around 26 billion. So the $3 billion is got going to change much Mark.

  5. Jan Willem Nienhuys says:

    many proponents and exponents of pseudoscientific

    One such a proponent wrote to me that I am a coward because I attack homeopathy (‘amateur herbalists’) and remain silent about giants that poison helpless children.

  6. WilliamLawrenceUtridge says:

    anoopbal, check the after-tax profits on page 136 of their 2011 Annual Financial Statement, it’s £5.4B. Assuming the fine of $3B = £1.9B, that wipes out about a third of ther £5.4B profits. $3B is not an insubstantial amount, even for GSK. It’s like losing 1/3 the disposable income you have left after paying your mortgage, taxes, car, groceries, interest payments on debt . Still an immensely profitable company, and they still keep £3.5B, but they’re losing a lot of money. If someone’s an accountant here, they might have an idea of what it means for their US operations – which will probably have to borrow money from the rest of the company. Good for the DoJ.

  7. jmm says:

    @anoopbal: I totally agree. Fines need to be large enough to act as a deterrent. $3 billion probably barely erases profits stemming from the illegal activities in question, i.e. the ones they were caught doing, as opposed to other things they didn’t get caught at. While it’s a huge improvement on past settlements, which didn’t even manage that, when you factor in the << 100% probability of getting caught and fined, the economically rational thing for a pharmaceutical company to do in the face of such fines is to continue with such behaviors, modifying them only in ways that make them less likely to get caught. This needs to change. And a much more powerful disincentive would be criminal prosecutions of top executives. When criminal behavior is found out, somebody should serve some jail time.

  8. jmm says:

    @WilliamLawrenceUtridge, you are comparing a single year’s profits to activities that took place over a protracted period of time. Even with the fine concentrated in a single year, it’s not enough to push them into the red. Meantime the executives got their bonuses during all the good years.

  9. WilliamLawrenceUtridge says:

    jmm, do you think every time a company does something that gets them a fine, they should close shop? This should have fairly major ramifications in terms of profits, dividends, new investment, share price, R&D and really, most operations. If fines of this magnitude are applied recurrently, it could very well drive a company out of business in addition to undercutting the major reason why they fund drug reps – it drives up profits. If you get an extra $1B/year using drug reps, but you get a $3B fine, that’s 3 years of activity and resources utterly wasted. I’m pretty darned sure that a $3B fine is a substantial deterrent. Though I’ve long thought fines should be commensurate with the profits generated by the illegal or fraudulent activity, in some cases that would result in the company being liquidated. Great for Pfizer and Merck (one less competitor, lots of cheap equipment and a whole host of unemployed talent to hire) but overall perhaps worse for consumers. Ultimately someone has to manufacture pharmaceuticals.

    Prosecution of top executives (or whoever is responsible, there’s no guarantee it’s the CEO or board) would be a really, really nice cherry on top of the fine, in that regard I strongly agree. Might even work to alter the company’s culture. I wonder about how much work would be involved in proving it though (perhaps Jann Bellamy would have an idea).

  10. The statements about problems in the herbal supplement world are spot on. I’m an increasingly skeptical acupuncturst struggling to confront the blatant abuses of research and marketing claims in the Traditional Chinese Medicine (TCM) world. I have recently been censored, banned, and personally attacked on a professional forum when asking for critical review of my findings about misleading use of negative research to promote disproven herbal formulas for patients with HIV/AIDS. I’ve never experienced such a clear example of avoiding and dismissing an issue through ‘ad hominem’ tactics.

    I am still involved in the TCM world but gladly declare my Independence from the bulk of it. Many SBM readers may justly criticize some of my business and wonder why I’m involved in it at all. Researching and blogging about legal and ethical issues in the supplement world has led me to seek a career-path change towards a pro-science living. For now, I feel that I can push for useful change in the Chinese herbalism world from within by writing about fraudulent treatments for cancer, AIDS/STDs, autism, etc.

    For a living, breathing example of this controversy in action, see http://ancientway.com/blog/?p=2309. I welcome all comments, whether critical or supportive. I have been a regular reader of SBM for some time, and thank you all for your hard work. You have reached at least one person who used to identify as a CAM Artist but is reforming towards actual Health Science.

  11. WilliamLawrenceUtridge says:

    Many SBM readers may justly criticize some of my business and wonder why I’m involved in it at all.

    I don’t think most of us will wonder. Everyone needs to make a living, and after you invested time, effort and identity in establishing yourself as an acupuncturist and TCM practitioner you established a practice.

    Congratulations on questioning the underlying assumptions of your profession and attempting to do something about it. You may find this quackwatch article written by a former iridologist interesting.

  12. jmm says:

    @WilliamLawrenceUtridge, if the only reason a company stays in the black and hence in business is their illegal activities, and those illegal activities are found out and a fine is given that cancels out their illegal profits, then yes, I think they should close up shop. This equation would prove the economic logic that we are better off without them. Pharmaceutical companies spend far more on marketing, legal and illegal, than they do researching new drugs, and the value even of the legal marketing is dubious.

    If the big pharma companies all went under, we may in fact be better off. Big Pharma is not “too big to fail”. We could get existing drugs from generics at a small fraction of the cost.

    The vast majority of truly useful and innovative new drugs mostly come out of taxpayer and foundation funded work anyway, with rights bought up by the pharmaceutical industry, often at a surprisingly late stage of drug development. Big Pharma’s true “core competencies” are navigating the FDA approval process (so much for all their complaints about the FDA: if approval really was simpler, that would reduce barriers to entry for new competitors!), combined with high levels of innovation in the marketing and legal departments. We can do without the marketing and the protracted schemes for extending monopolies. We already have contract research organizations that can run clinical trials. Instead of Big Pharma, we need a new sort of contract organization that co-ordinates between the university (or startup spinoff) that invented a drug, the FDA and the clinical trial CROs. That doesn’t sound so hard a niche to fill. We also need an expansion of NIH funds to fund more phase III trials and FDA paperwork-filling via such companies: reduced drug costs via Medicare and Medicaid will make this more than pay off for taxpayers compared to paying Pharma rates for new drugs, and the NIH has often funded massive drug development already.

    And who knows, maybe one of those contract organizations will evolve into a new competitor to fill the pharma niche. If you want something in the private domain, it has to be possible for it to go broke because of its own mistakes. Especially when those mistakes are criminal.

  13. ConspicuousCarl says:

    anoopbal on 04 Jul 2012 at 11:15 am

    Combined sales from Avandia, welbutrin and Paxil totaled around 26 billion. So the $3 billion is got going to change much Mark.

    That is the total sales for several years, and these are not illegitimate drugs so not all sales are an offense. The fine is for specific marketing activities for shady applications. $3 billion is a big chunk. With the higher estimates of developing a single drug being around $1 billion, this fine could amount to doubling or more the cost of inventing these drugs.

  14. ConspicuousCarl says:

    Tangent I can’t help but extend…

    weing on 04 Jul 2012 at 9:23 am

    Yup. Wanna a see a slap on the wrist?

    http://www.iwatchnews.org/2012/07/03/9268/company-earned-millions-defense-contracts-while-making-illegal-sales-china

    If it’s not already bad enough that a US contractor is building advanced military helicopters for China… a brief skimming makes me suspect that UTC, which owns Sikorsky, may be taking advantage of technology developed by Sikorsky during the US-sponsored research for the RAH66 Comanche program, which we eventually canceled. So not only is our contractor selling to the enemy weapons which we don’t have, but we may have paid for some of the research! Take my wallet, buy an ax, chop off my arm, and beat me with it.

  15. weing says:

    “The vast majority of truly useful and innovative new drugs mostly come out of taxpayer and foundation funded work anyway, with rights bought up by the pharmaceutical industry, often at a surprisingly late stage of drug development. ”
    I’ve heard this claim before. Do you have any evidence to back it up?

  16. @weing, that sounds awfully like socialist speech to me.

  17. WilliamLawrenceUtridge says:

    if the only reason a company stays in the black and hence in business is their illegal activities, and those illegal activities are found out and a fine is given that cancels out their illegal profits, then yes, I think they should close up shop.

    Two points. First, your implying that GSK (or perhaps all pharma manufacturers) is primarily funded by illegal activities – which is dubious. Again referring to the financial statements, page 56 refers to selling, general and administration expenses (£8.8B) and there’s no further breakdown that I can see beyond the £157M for legal costs. GS&A covers a lot of ground, but includes salaries, which would be a pretty substantial amount.

    Second, the approach may result in a monopoly or complete abandonment of the country by that industry. Irrespective, such a large fine should have an effect on GSK and the industry in general.

    This equation would prove the economic logic that we are better off without them.

    You think society would be better off without vaccines and pharmaceuticals? That’s an…interesting thought.

    Pharmaceutical companies spend far more on marketing, legal and illegal, than they do researching new drugs, and the value even of the legal marketing is dubious.

    Again going back to page 56, R&D is a little less than half of SG&A expenses and wouldn’t include salaries. And as Dr. Novella says above, pharma reps do have a positive effect in promoting the adoption of new medications – and new medications can be good things. Big Pharma are not a perfect anymore than they are an absolute good.

    If the big pharma companies all went under, we may in fact be better off. Big Pharma is not “too big to fail”. We could get existing drugs from generics at a small fraction of the cost.

    Again, “interesting” is all I have to say here. While generics are good, they are only generic ’cause the companies that manufacture them doesn’t have to develop them – meaning we will keep needing new drugs for as long as we have diseases lacking effective treatments and cures. Last I checked, we haven’t found a cure for all disease (though numerous sCAMsters have apparently, bully for them).

    We can do without the marketing and the protracted schemes for extending monopolies. We already have contract research organizations that can run clinical trials. Instead of Big Pharma, we need a new sort of contract organization that co-ordinates between the university (or startup spinoff) that invented a drug, the FDA and the clinical trial CROs. That doesn’t sound so hard a niche to fill. We also need an expansion of NIH funds to fund more phase III trials and FDA paperwork-filling via such companies

    Do you live in the US? How do you feel about higher taxes? Not bad ideas, but much as private industry is profit-motivated, this provides them an incentive to drive down manufacturing costs. It’d be interesting to compare US costs for vaccine production with Danish (Denmark’s vaccines are produced by a public entity rather than a private company).

    And who knows, maybe one of those contract organizations will evolve into a new competitor to fill the pharma niche. If you want something in the private domain, it has to be possible for it to go broke because of its own mistakes. Especially when those mistakes are criminal.

    Two points:
    #Your first sentence would seem to “reset the clock” – you’d still end up with a big pharma, it’d just take a couple decades to develop into what we have now. Could be bad, could be good.
    #You’re still assuming that Big Pharma is evil through and through, and funded almost exclusively by illegitimate profits. That still seems a dubious claim.

  18. WilliamLawrenceUtridge says:

    With the higher estimates of developing a single drug being around $1 billion, this fine could amount to doubling or more the cost of inventing these drugs

    CC, I hadn’t thought of that. Man it would be nice if we could come up with a way of disincentivising bad marketing while not penalizing R&D. Private industry is still pretty good at innovation, and they hire lots of smart people. If not for Big Pharma and all teh evulz they do (for teh lulz), you’d have a ton of PhDs competing for a tiny number of academic positions. That, or you’d have to have a huge tax burden to support the public funding of all those universities and concomitant professorships.

  19. I always wondered about making our high school and middle school teachers have PhDs.

  20. jmm says:

    @weing, Marcia Angell’s “The Truth About the Drug Companies” does a good job of backing up the statement about where true innovations have been coming from. In particular, that they tend to come from academic research, funded extensively by the taxpayer, with marketing rights sold to drug companies at a late stage of development. When laying off research staff a couple of years ago, a Pfizer spokesman even openly stated (whoops) that research was not a core competency for them and they would rather buy that sort of thing in.

    @WilliamLawrenceUtridge, I made a statement of the form “if A then B”. For the record, I do not think it is clear whether A (GSK needs illegal marketing to stay in the black) is true, but IF it is, the rest (we are better off without them) follows from straightforward economic reasoning. As a result of this, we shouldn’t be afraid to disincentivize appropriately: IF GSK has ample legitimate income, appropriate fines that provide a disincentive will NOT drive them out of business. Conversely, if right-sized fines drive them out of business, then we are better off without them. We should not set the size of the fine based on keeping them in business, we should set the size of the fine so as to create a disincentive for illegal activiities.

    I don’t buy the accounts, BTW, they are far from transparent, and a likely high proportion of “R&D” is me-too drugs and marketing in disguise. The very high cost estimates per drug developed (again, see Angell’s book for a great analysis) owe a good deal to the extraordinarily low numerator of how many drugs the industry actually develops.

  21. jmm says:

    And my ideas would not lead to higher taxes: the savings via Medicare would more than compensate extra research costs. Plus the NIH-funded clinical trials would be more reliable than pharma-funded ones, given the scandals of withheld data.

    I do agree that we don’t want manufacturing costs driven down to the absolute lowest possible level. FDA regulation is certainly needed there to ensure manufacturing quality, no matter who is doing the manufacturing.

  22. weing says:

    @jmm,

    Thanks, I checked it out. The most recent data I could find is that about a third of the new pharmaceutical products wouldn’t have been possible without academic institutions and the implied government funding. As government funding dries up, there may be less new products coming out. http://www.fas.org/sgp/crs/misc/RL32324.pdf

  23. MarylandMD says:

    Dr Novella,

    I am concerned about the following statements in your article:

    “One recent article, for example, found that doctors who have no access to pharmaceutical reps were up to four times slower to adopt new medications than physicians with some access to reps. In addition, they were also four times slower to stop using a drug that has a new black box warning, meaning that negative information about safety has come to light. It seems, therefore, that pharmaceutical companies can be a useful conduit of information to physicians, but that also comes with a lot of baggage.”

    The article you link to is an industry-sponsored study that I find to be thin on useful information. Why do you refer to it without question as if it is a valuable study? Have you looked at it in detail? As a proponent of science-based medicine, why are you just quoting relative differences instead of absolute differences? Regarding one of the measures used in the study: is being more or less likely to prescribe Januvia when it was first put on the market a direct measure of quality care? Is NOT using Januvia a sign of an uninformed physician or just good sense? I have always been and I am still reluctant to use Januvia for my diabetic patients–it is expensive and does not do much to improve the A1c.

    I feel using the study to draw even the limited conclusion “that pharmaceutical companies can be a useful conduit of information to physicians” is a big stretch. I am concerned that this is a weak study being overblown by the pharmaceutical industry to counter some of the restrictions imposed by med schools and hospitals on the activities on drug reps. Is this really a good study, or did you fall for little more than drug company propaganda posing as science? I was hoping to see someone from Science-Based Medicine to take a long hard look at this very study, especially the statistical analysis, but instead you are treating it as accepted science. I am a bit disappointed.

  24. weing says:

    @MarylandMD,

    Januvia? Where is that on the Walmart $4 a month formulary?

  25. evilrobotxoxo says:

    @jmm and weing: most government-funded research is contracted out to private companies with names like Johns Hopkins, Harvard, etc., through NIH-funded grants. I’ve often thought that a more effective model for drug development would be to bring a larger portion of the drug development pipeline under this model by awarding large contracts to drug companies, sort of like defense department contracts to aviation companies, rather than giving them monopolies on drugs that are marketed direct to patients and physicians in ways that distort the quality of care patients receive. It will never happen, but it’s something to think about.

  26. 1) I wish there were criminal penalties. I still think every person from the CEO down to the some sales manager that approved some lame kickback should be doing time. I don’t have time to look, but a Stryker sales rep was sent to prison for off-label push of some implant.

    2) The Medicaid pricing fraud bothered me more than anything for some reason. With state budgets strapped to pay for medical care for our most at-risk citizens, the wealthiest crowd at GSK is doing its best to harm our weakest. There is just something offensive about that.

    3) Big Pharma needs to fix the paradigm of the sales rep/physician model. I just don’t see how it can work any more, like it did 30 years ago. There are some areas where the sales rep is a required asset, especially in high ticket items. Also, in certain areas like cardiovascular devices. But in pharmaceuticals in primary care or hospitals, what’s the use? They put the company at risk, because the rep is under pressure to make money by increasing prescriptions, so off-label use is highly lucrative. But physicians have so little time these days, I frankly don’t think that much valid information is going to be transferred. Big Pharma is just hiring hot young sales reps (yes, they are), and the doctor will given them 25 seconds of time just to see if they get a date (yes, they are), and maybe that increases the chances of getting a prescription on a new drug by 2.7% (yes, it does). That’s a dumb way to make this system work.

    @evilrobotxoxo NO. First Republican administration, it gets cut, and 10 years out, we have no drugs. You’re trying to destroy the pharmaceutical industry because of the stupidity and immorality of GSK.

  27. @MarylandMD

    I agree. I’ve been on the medical marketing side for many years, and I lost my faith in the return on investment in medical sales reps a long long long time ago. As I mentioned above, in a certain very specific set of cases, they are valuable. In pharmaceuticals, no. Physicians do not have enough time. Most reps aren’t hired on their expertise in pharmacology and medicine. As I mentioned above.

    I was involved in a marketing study (yes, an anecdote, but it’s the best I can provide) where physicians would speak into a recorder after meeting with any sales reps. They were just supposed to give 10-15 seconds of thoughts about what they heard. Mostly what they heard was apparently, “she looked cute” or “she didn’t know what she was talking about” or “why would I ever prescribe this drug” or other stuff. Not once, and I read hundreds of pages of transcripts, did I read, “that will help my patients.”

  28. evilrobotxoxo says:

    @Michael Simpson:

    I agree about the Republicans cutting it, and that’s one of the reasons it would never work. But my reasons for supporting a model like that have nothing to do with what GSK did here. The main issue is that drug companies try to maximize profit, and that means coming up with drugs that are the most profitable instead of drugs that have the largest impact on human health. Pharmaceutical companies are still coming out with new drugs where the first drug in the class was approved over 30 years ago, in cases where there is no reason to believe the new drugs will be more effective. Meanwhile, we desperately need new classes of antibiotics, for example, but that isn’t profitable enough to drive as much R&D as for drugs used in management of chronic conditions.

  29. @Michael, you sound like a failed sales rep. Perhaps you just were terrible at your job? Because characterizing physicians as horn dogs that just want to sleep with sales reps is ridiculous and insulting. I actually think the sales rep job should be eliminated, because they make too much money just pushing drugs. but I do like being catered to.

    I’ve always been ill-receptive to “big pharma.” Don’t try to sell me on your drug that combines two generics and charges ten times their combined price. Don’t try to convince me to refer them to hospice early “because it’s better” when you know damn well that you’re just going to charge them for longer. Don’t come lecture me about the benefits of your steroid pack when you don’t even know the difference between glucocorticoid and mineralcorticoid activity.

    I do realize its a double-edged sword. If “big pharma” doesn’t make money, then they don’t innovate new drugs.

    -

    Please leave politics out of these discussions. The first time we start a democrat vs republican thread is the death of this website! :)

  30. herbalgram11 says:

    To tgobbi:

    It’s not as if the GSK fraud case is an isolated case; the natural health care sector has long since known that drug based medicine is fraught with false claims and worse – some examples:

    A recent study in the Journal of the American Medical Association found over 40 percent of the best designed, peer-reviewed scientific papers published in the world’s top medical journals misrepresented the actual findings of the research.(i) The “spin doctors” writing the papers found a way to show treatments worked, when in fact, they didn’t.
    http://www.huffingtonpost.com/dr-mark-hyman/dangerous-spin-doctors-7-_b_747325.html

    Transparency International on Corruption in the Pharmaceutical Industry:
    http://www.transparency.org/global_priorities/other_thematic_issues/health/pharmaceutical_industry

    Dishonesty in Medicine Revisited by Herbert L Fred, MD, MACP
    Texas Heart Institute Journal, Vol 35, No 1, 2008
    http://www.texasheartinstitute.org/Education/THIJournal/upload/351_Fred.pdf

    COPE – The Committee on Publication Ethics, a UK-based charity, is concerned with the integrity of peer-reviewed publications.
    See list of cases of fraud committed which the organisation has investigated since its inception in 1997:
    http://publicationethics.org/case

    Michael P. Jones, Feinberg School of Medicine, Northwestern University Chicago, IL 60611:
    “Most practitioners probably have very little insight regarding the degree to which “science” has become a marketing tool.”
    http://www.bmj.com/content/327/7429/1442.full/reply#bmj_el_44960

    Jan L Brozek, physician:
    “EBM (evidence-based medicine) as we know it, or at least its part – critical appraisal of the published medical literature, has reached its limits and found itself in desperate need to develop new tools that would allow assessment of the validity of medical research. … I hate the idea that we all (and the whole EBM concept) may turn out just to be puppets in the “sponsored” theatre.”
    http://www.bmj.com/content/327/7429/1442.full/reply#bmj_el_52205

    Exploring the links at the Campaign Against Fraudulent Medical Research makes for some interesting reading: http://www.pnc.com.au/~cafmr/online/research/index.html

    An analysis of the British corporate science lobby, self-proclained “quackbusters” can be found in this free e-book by Martin J Walker: http://www.slingshotpublications.com/dwarfs01.pdf

    We Become Silent – a film by Kevin P Miller
    Narrated by Judy Dench
    http://topdocumentaryfilms.com/we-become-silent/

    Whistleblowing – The Price of Silence (BMJ 2009; 339:b3202)
    http://www.bmj.com/cgi/content/extract/339/oct27_3/b3202

  31. WilliamLawrenceUtridge says:

    the natural health care sector has long since known that drug based medicine is fraught with false claims and worse

    I was under the impression that the natural health care sector was a form of branding, not treatment. But please clarify one thing for me – were any of the publications above authored by the natural health care sector, or is it more accurate to say that conventional researchers were the primary authors (and peer reviewers, and audience) of the scientific publications cited above?

    If the answer is “no”, that suggests the natural health care sector are parasitic on the research of real doctors and scientists, and are mostly engaged in a public relations war to deflect attention from a few key facts:

    - most “natural” remedies are unproven (or have a more effective, safer and/or more convenient form produced in factories and labs with known potencies and extremely stringent quality control practices)
    - most proponents of “natural” remedies are hypocritical in that they hold doctors, drugs and hospitals to unrealistic standards of perfect safety and efficacy, standards they themselves can not meet
    - most proponents of “natural” remedies define themselves in opposition to medicine, which is to say they spend more time criticizing medicine than they do demonstrating their own nostrums are safe and effective
    - most proponents of “natural” remedies will over-cite limited, small-n and generally poorer quality studies while ignoring larger, better controlled (and generally negative) studies, thus showing the pseudoscientific tendency to try to co-opt the discipline and cultural authority of science while failing to adhere to any of the practices that make it the most effective way to learn about the world around us

    At least you didn’t cite John Ioannidis.

  32. weing says:

    @herbalgram11,

    Interesting. Your huffpo reference says not to trust JAMA and basis his recommendation on the results of a study published in JAMA. He also totally misinterprets the article as saying that the scientific method should no be trusted. Please read the original article. It is available free. It just takes a little effort. Then tell us what you think the article says.

  33. herbalgram11 says:

    Does it matter who conducted the research? Exposing the fraud in medical research is what matters for the purpose of the above argument.

    Medical journals receive funding from Big Pharma via ads, the physician’s main drug reference (MIMMS) has glorious drug advertising – i.e. receives funding from Big Pharma, the research teams and the medical faculties of universities receive funding from Big Pharma,…. get the picture? That’s why conflict of interest is rife in medical research.

    Unfortunately, research funding into nutrition and herbal medicine is meagre compared to drug based research and positive findings are mostly suppressed. In case you’re going to argue against this, here’s a reference of it being so:
    http://naturalsci.wordpress.com/2012/02/26/positive-clinical-trials-of-herbal-medicines-you-wouldnt-read-about-it/

    However, some credible research sources for therapeutic herbal and nutritional supplements can be found in Lesley Braun & Marc Cohen’s ‘Evidence based guides’ for Herbs & Natural Supplements published by Churchill Livingstone / Elsevier or online at: http://www.greenmedinfo.com/

  34. weing says:

    So you are saying you won’t read the article. You just give us some web sites that are invested in selling herbals. We are supposed to believe them because…..?

  35. WilliamLawrenceUtridge says:

    Medical journals receive funding from Big Pharma via ads, the physician’s main drug reference (MIMMS) has glorious drug advertising – i.e. receives funding from Big Pharma, the research teams and the medical faculties of universities receive funding from Big Pharma,…. get the picture? That’s why conflict of interest is rife in medical research.

    Wow, it’s good that we’ve got herbal medicine to keep us honest! I can’t wait to see the long list of publications in herbal medicine journals discussing undisclosed conflicts of interest, and the lengthy debate leading up to all medical articles requiring disclosure of conflicts of interest. Please provide those reference, I like to read.

    Of course, if the only place you can find those references are in mainstream medical journals, then that would imply it is medicine’s own practitioners who are aware of this issue and attempt to address it, and CAM practitioners are once again parasitic on those efforts in a fallacious attempt to distract attention from the failure of their own efforts to treat and cure disease.

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