Thursday, 22 September 2011

Pharma Corps put Money Before Swedish Women's Health, But Why Be Surprised?

Today, the Swedish branch of the international pharma corporation GlaxoSmithKlein (GSK) announced that it will appeal the decision of the united health care regions of Sweden to use the vaccine product of their competitor Sanofi Pasteur MFD (SP), Gardasil, over GSK's Cervarix. The decision is another stalling maneuver in a longwinded process following the decision of Swedish public health authorities to provide young girls and women with a publicly run vaccination programme against Human Papillomvirus (HPV) – causing both cervix cancer and STD's, such as condyloma. It is unknown how long the processing of the appeal will take, but the financial director of GSK in an interview alludes to an earlier court process (see below) that took about 18 months. Thus, due to GSK's decision today, during this time-period potentially all Swedish young females will be provided with no protection against HPV. Possibly, some of these will buy a vaccination with their own money, but that can hardly be credited  as an upside to GSK's decision, given that they could instead have received it for free.

However, this is not the first appeal in this story. In fact, the decision that GSK is now appealing is the result of a former appeal that SP made against an earlier decision to purchase Cervarix. Also in that case, the material effect of the appeal was endangerment of many, many young women's health. Both companies of course argue that their product is the best, but that's just smoke. What they do is to repeat their sales pitch, but now publicly rather than in the original business bid. In the case of GSK, they even have the poor judgement and tasteless arrogance of trying to present their bid as objective argumentation in a debate article. Come on! The assessment of these bids is the business of the buyer, and if the buyer makes a bad decision, that's where the responsibility is to be placed. However, the buyer of a large public health policy order has many things to balance. Of these the effectiveness of the product is, of course one. But effectiveness is a complex matter and in the case of HPV very much so, since different strands of HPV link to several different health problems. In addition to that, the expected effect has to balanced against the cost. This since, at the end of the day, every Swedish Crown spent unnecessarily is a crown that could instead have been spent on other important public health undertakings. Given this situation and given that all information from the bid-makers have their basis in the self-interest of a business organisation (which in the case of becoming a part of a large public health undertaking is huge), the argumentation like the one presented by GSK today is simply not credible. Of course, they have to say that they believe in their product, just as SP has to. But so what? Regardless of this, the buyer has to make an assessment and a decision. What the appeals create is only that this procedure has to be done all over again, the first time by the buyer (according to procedures prescribed in Swedish administrative law), and this last time by a court of law. In neither of these cases will the repetition of GSK and SP of the claim that their product is the best one mean anything. The whole process is so absurd, that the responsible politician for the process of buying the vaccine, Stig Nyman, today urges the government to change the regulation around purchase of health products by the public sector, so that the armies of lawyers of the pharma corps are barred from obstructing orderly processes of great benefit of the public to proceed. Similarly, in Sweden's foremost politically conservative news paper, Svenska Dagbladet, otherwise notorious for its overly charitable interpretations of the intentions and doings of private enterprises, the deadly outcome of GSK's decision is underscored and the analysis is made that the pharma area of business is in fact nothing but callous, inconsiderate and deceitful.

Now, GSK has realised that the decision to appeal yet another time does not put the company's image in a very good light and therefore tries to give an impression of having taken the decision greatly troubled and burdened by ethical considerations. All pharma corps nowadays do their utmost to project such an image of caring about the health of people and minding about ethics, and GSK is no exception. However, is this more than mere branding (a question that applies to SP  just as much, of course)? One of my department's most successful young researchers, Joakim Sandberg, wrote his PhD dissertation Ethical Investing: Making Money or making a Difference? (and numerous papers) on the issue of how much the projected interest of being "ethical" used as a marketing tool by companies in different branches (using the case of investment funds) is grounded in any substantial ethical commitment. The sign of such a commitment is double: (1) that the company has a clear, publicly accessible and plausible idea of the criteria for acting ethically defensible (most of the book is about what that implies) and (2) that this idea at least sometimes is actually motivating the company to make decisions that are less than optimal in business terms. Simply put, if you are not prepared to sacrifice anything for your ideals, you effectively have no ideals. Not surprisingly, perhaps, it appears that the examples of business operations projecting the image of being especially ethical and at the same time meeting condition (2) is a rare species indeed.

In the pharma area, there are numerous examples of this phenomenon. In fact, the list of cases is becoming so long and depressing that the mechanical repetition of the public relations departments of all of the pharma corps around the world that good ethics is a key endpoint of their enterprise is starting to sound like the gibberish of a mad clown who no one think is funny anymore. Just a few years back (before I started this blog, or you would have read about it here), Astra-Zeneca was exposed in a major research ethics scandal,  where they had deliberatly chosen to conduct a clinical trial of psychiatric drug in a country (Russia) that insisted on a placebo arm of the trial, although an existing efficacious treatment was in place. In effect, half of the participants were left with no rather than some treatment and a number of suicides had to occur before A-Z had the sense to abort. What is more, they did this not in order to have a license for the drug in Russia, but to have it in the EU. I and several bioethics colleagues in my country had no problem in harshly criticising A-Z (here, here) and the lame response from A-Z was that they indeed were an ethical company, since they had abided by Russian research ethical regulation - thus pretending that they carried no responsibility for having chosen (obviously for economical reasons) to house the trial in Russia in the first place. This is just one among many, many cases of what in bioethics circles has become known as clinical trial imperialism. Simply put, Western pharma corps systematically try to place their trials of new drugs in countries where the trial will be most cheaply run while still providing results that may get them a license somewhere in the West. As to upholding minimal standards of human subjects protection, reliable oversight and accountability – sod that!

So, to get back to GSK, SP and the HPV vaccination business. What we see happening in this case is just more of the same. Sweden just like all other Western countries are using tax payers money to provide pharma corps with very privileged positions: patent systems, drug subsidises, seed money to ease the establishment of offices and labs, access to the resources of medical schools, university hospitals and public health care systems, close cooperation to smooth the product development process, and support for a market for non-prescription drugs that in most cases actually is detrimental to the health of the population. They do all that because they see no alternative. The development of new pharmaceuticals for serious and widespread disease is a high risk endeavor and very expensive process, and most countries prefer to have it done with the funding accessible through business transactions. But this is no reason to be seduced by their marketing offices. Pharma corps don't care about anyone's health and even less about public health. In fact, the best business sitiuation for a pharma corp is a permanent health problem that never goes away, but where the company can supply a product that slightly mitigate the symptoms. That's far, far better business than anything that cures people or – to name the nightmare of a pharma – that permanently prevents the onset of the problem. Even less do they care about ethics or upholding minimally decent ethical standards. They demonstrate this convincingly by never ever being prepared to sacrifice a buck for adjusting to ethical considerations of any weight. They do, of course, abide by laws, but prefer to place production in countries where efficient industrial operation is combined with the most allowing rules – unless sale efficiency demands otherwise. They do, on homepages and in company prospects, repeat the words "ethics" and "ethical" (as well as "responsible") so often that the cursory reader might mistake them for something out of the Vatican, but, as the Swedish case of GSK and SP regarding HPV vaccination shows, all of this is smoke and bogus. All. That is not a very comforting thought, and in light of our view of pharma corps as necessary, that discomfort may trick us to believe otherwise. But this is, I claim, the sole truth.


  1. Thanks for the article Christian. Nice to see some well thought comments.

    My thought is that it all comes down to priorities. The companies probably want to be ethical but more than that they want to make money. Really end of discussion there...

    This simple fact about money takes away all the arguments GSK has. They are strongly biased and I'm even surprised that their article made it into DN. Maybe DN made themselves a bit of money for publishing...? But let's not be cynical ;)

    The fact that the system works as it does is... unfortunate sometimes I guess. It goes to show that there still is work to do to improve this society.

    End note of my comment:
    Money does not have history. Unethically earned money is worth exactly as much as ethically earned money. Money is the medium in use to control the world. Hence ethics, from a survival point of view (which I think is the view the employees of companies have when making these decisions), is less important than money. The faster people realize this the faster they can stop listening to biased opinions. Bias is a devilish thing and should be exposed the moment it becomes obvious.

  2. Lobbying is what took HPV vaccine to be implemented in the regular vaccine programme for children in Sweden. Johan Thor - former politician/nowadays employee at GSK=Glaxo/Smith & Kline - even got a prize as the Lobbyist of the year 2008 to use his political background to influence the Swedish board of Health and Welfare to quickly approve a vaccine against HPV.

    Human Papilloma Virus MIGHT cause cervical cancer if the infection isnt healed which happens in appr. 90 % of the cases. Usually its the partner reinfecting the female - making
    it impossible to get rid of the infection. Most people already have HPV in their system which makes these vaccines worthless and they might even increase the risk to get cervical cancer in the future if taken under such circumstances. Will each child be checked before given these shots? I dont think so.

    Theres a difference between GSK's and Sanofi Pasteurs/Merck's vaccines; the latter claims to prevent STD's - condyloma along with cervical cancer.

    Whats more important to know is; this kind of novelty vaccines with recombinant viral DNA-nano sized- is genetically engineered which if inserted into the human cell might stay there for ever causing a mutation. Foreign DNA might cause autoimmine reactions such as arthiritis, multiple sclerosis, diabetics etc. No studies have been done regarding future fertility if taking HPV vaccines. Gardasil contains polysorbate 80 which causes infertility when injected in rats according to studies.

    No other vaccines causes abortion/stillbirths as much as HPV vaccines.

    Theres been over 90 deaths occurring after taking HPV vaccines in USA alone- none of them admitted being linked to HPV vaccines- but healthy girls have died after taking HPV vaccines. I would never expose my child for anything jeopardizing her health its better to take the parental responsibility and the time to educate her how to protect and heal herself.

    With the information Ive gathered about these HPV vaccines I feel a relief that GSK continued their case. That way more parents hopefully might be aware of the risks with giving their daughters HPV vaccines.

  3. Ann-Britt: you confuse three separate issues.

    One is about what my post was about, where your examples of lobbying just add to my case. I might add that Sanofi Pasteur are no better: it is today revealed that they are sponsoring a bogus "patient initerest" organisation, thus covertly getting their marketting done under the smokescreen of patient concern.

    A second one is whether or not various vaccines meet medical standards of efficacy and safety. A third one is about whether the idea of a programme is a good one in the first place.

    You are, of course, right that pharma corps are lobbying heavily also in these two latter cases. However, there we also have to mind about another just as sinister lobby-group. Since I have been around for a while in the discussions on vaccines, I recognise the rhetoric of the anti-vaccination lobby in some of what you say (mentioning risks but not benefits is a classic). There are reasons to be cautious when alarms around vaccines are sounded - this we know from the MMR scare.

    The following case is educational:

    This one fairly well sums up my own position on that matter:

  4. Gustav: I used to think that pharma corps want to be ethical, but that priorities in terms of money gets the better of them. But I actually don't believe that any more. I don't think that they care about anything but the economic side, and I don't think they want to care about anything else. What they want is to project a (false) image of having such intentions. End of story.

  5. Note; I did mention that appr 90 % of all HPV infections heal naturally = the vaccine efficacy is appr 10 %.

    I thought it was obvious for all to do their own math what % these vaccines are meant to prevent after injecting the content of foreign nanosized DNA which passes the blood/brain barrier and stick to the fat in the human brain.

    Theres nothing classic in that at all - just pure facts.

  6. The last two comments vividly illustrates my point about the anti-vaccination lobby being just as deceitful and sinister as the pharma corps - albeit, possibly, for other reasons. Not unlikely the shade semi-religious and dogmatic ones of followers of the esoteric teachings of Rudolf Steiner. For these comments indeed demonstrate that this lobby is what is making its voice heard on this occasion.

    The numbers given above re. the benefits of vaccination, first, mean nothing unless the context is given. Percentages of what? We may also note that efficacy is confused with effectiveness - in addition an effectiveness that considers just one of several parameters of relevance from a public health perspective. Furthermore, none of the commentators claim that the proposed side-effects are actually side-effects at all. What they claim is that, supposedly, a number of bad effects occurred "after vaccination". Everyone who is familiar with the Andrew Wakefield case (see links above) recognises this rhetoric. After does not equal because of, that's the simple reminder to make here.

    Now, just to be clear about things: I do not claim that vaccines, especially live vaccines, lack risks. They do have risks, but does that mean that we shouldn't use them? These particular vaccines have been scrutinised and licensed under the same conditions as all other drugs. A very fresh scientifically serious assessment can be read here:

    But perhaps the commentators reason like this: we can't trust these assessment. Our guts are more reliable indicators than ambitious research and properly conducted meta-analysis, than government controlled assessment agencies? Well, so be it. But please, in that case, be honest. Tell the world that you oppose ALL drugs currently used in health care - not to speak of all of the other procedures that have not come close to being forced to undergo the sort of systematic scrutiny that chemical compounds to be used for health care purposes are forced to. Please tell the world that you would never, ever have a surgeon fix your child's broken leg, revive your father after a coronary seizure, or even taker a blood test to ensure that the levels of vitamin C and iron are OK. Because this is what you are effectively saying.

    From now on, comments from dishonest people like this will be deleted.

  7. I just want to announce that I have deleted one of the obvious anti-vaccination lobby comments above. The reason is that this comment is a blatant lie. I first thought I'd let it stand and have people draw their own conclusion when following the given link and find a NYT article from 2008 about a probe into suspected deaths after HPV vaccination. The comment made far stronger claims than that, however. I have now come to the conclusion that, in fact, the comment therefore constitutes a risk to the health of young women or their parents who may happen to read this thread.

    If you feel that you have been moved by this or the similar comments above from these people, here are some useful links:

    1. A recent and real scientific article on the state of HPV vaccination in all of those respects you may find important:

    2. An astute summary of what the anti-vaccination extremeists are all about from a world-renowned colleague of mine, Art Caplan: