Showing posts with label Astra-Zeneca. Show all posts
Showing posts with label Astra-Zeneca. Show all posts

Tuesday, 12 March 2013

Threats, Libel, Calls for FDA & Government Action – and a Petition to the Governor: Research Ethics Morass at the University of Minnesota Psychiatry Continues

The sad and disgraceful story about the appalling unwillingness of the University of Minnesota to in any way investigate closer what several pieces of evidence suggest may very well be a major research ethics scandal in its psychiatry department continues. The scandal involves drug trials connected to several major Pharma companies, such as Astra-Zeneca, but for once it is not them who appear to be doing the bad deed – it is the university itself.

Former reports on this by myself are here, and here. The reporting of University of Minnesota bioethicist Carl Elliott is assembled here – an overview of the basic background story about apparently mishandled psychiatric drug trials linked to at least one death by suicide is here. In the Scientific American, blogger and clinical trial specialist Dr. Judy Stone is also reporting and commenting on the case, here.

So, what's new?

Well, first of all, not only does the University of Minnesota clearly bend its own rules inside out to avoid what would otherwise be the obvious line of action: investigate, clarify and report with full disclosure and transparency. It has, it now appears, sunk so low as to use its own General Counsel – one Mark Rotenberg, who just happens to be identical to the lawyer who has been attempting to whitewash this story and motivate the avoidance of investigations – to in so many words try to threat Elliott with possibly disciplinary actions for pressing on for an inquiry. Yes, that's right, a university threatens one of its academic employees – a bioethics professor at that – for simply insisting on that the truth be sought out and revealed. In short: for doing his job well.

In fact, not only that – the University of Minnesota President, Eric Kaler has chosen this well-timed moment to hint that research ethics regulation at the University, not least with regard to academia-industry collaboration in psychiatry may be "excessively burdensome" and expressing a "low tolerance of risk" and that "we’re afraid a misdeed of two decades ago will reappear again" – the latter obviously referring to past very serious misconduct cases (described in the post linked to above) in, where do you think? – yes indeed, the department of psychiatry. Nice.

Second, the University has finally tried to respond to the claim of Elliott that several patient consent and other forms seem to exist in duplicate but not differing – for instance, not all are signed! – versions, apparently originating from different times. This is covered in Elliott's former postings linked to above, as well as Dr. Stone's astute analysis in the Scientific American. The formerly mentioned General Counsel, Mark Rotenberg, responds on behalf of the university in an article in the Star Tribune to this is, again in so many words: Hey, you probably faked those yourself – or the families of the victims did!! That is, he doesn't mention any particular party and uses the word "authenticity", but in context the content is clear. Being a European, even though I am a Scandinavian and thus possibly with some kinship to the mysterious Minnesota ways of academia, I may be misinformed of some legal peculiarities: but isn't it at least a little bit legally troublesome to accuse other people of illegal actions (forgery of official legal documentation is a criminal act in Minnesota and the USA, isn't it?) without any shred of evidence?

Elliott's own response is the obvious and only sensible one (besides suing the guy for libel, that is): if you say so, help me to find out! Substantiate your claim! Open the files! Disclose the evidence! That is, run the investigation that should have been run ages ago, but that you and those you serve have denied and forestalled!

Third, Elliott has now officially written to both the Office of Civil Rights of the U.S. Department of Health and Human Services and to the Office of Compliance of the FDA to call for investigations of related parts of this troubling story. The letters you can see and download below.

 


And Elliott is not the only one acting. A close friend and the mother of Dan Markingson, the young man whose death by suicide is clearly linked to one of the deeply suspicious psychiatry research trials involved in this potential scandal, is petitioning the Minnesota Governor to investigate the University of Minnesota for its refusal to act and investigate. You can read the statement and, if you want to, sign it yourself here.

There will be more, I'm sure......







Wednesday, 6 March 2013

New details on the University of Minnesota psychiatry morass: suspicion of vital documents falsified and hidden from court

More on what I posted on a few days ago with regard to a thickening enigma around the ethics of the so-called CAFÉ study – involving Astra-Zeneca and associated with at least one death – at the psychiatry department of the University of Minnesota, here.

To read the new developments, looki here! In short, as new evidence occurs the suspicions about a bona fide coverup, featuring falsified consent documents and other vital pieces of evidence hidden from court investigations – are strengthened.

I repeat myself when under stress: At the very least, the University of Minnesota should have a slight urge to look into to this, not least since it appears to be imperative according to its own regulative statutes.

More will follow, I'm sure.....

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.