and take names…

Posted on Tuesday 25 March 2014

The Sunday Times
by George Arbuthnott and Jonathan Leake
23 March 2014

No, I didn’t make the print disappear. It faded behind a right pricey Sunday Times paywall. If there’s anything to the story, the whole thing ought to show up on the Internet sooner or later. And I’m curious what those early Prozac approval studies would show [if they exist anymore]. It’s hard to imagine it now, but in those days I believed what I read, at least for starters.

The first time I ever prescribed Prozac was to the first HIV positive person I’d ever met.  He was a professor at a nearby university who had developed a lymphoma. As he was gay, his doctor suggested a brand new test [HIV], and it was positive. I’d never even heard of the test, and knew little about AIDS. At a later point, he wanted to try that new drug, Prozac. I read what there was to read, and we gave it a shot. His report was that it helped, but said he wasn’t sure it was an antidepressant. He called it an "anti-broodant." He didn’t "brood" about his plight so much. When the sexual side effects came, I went to the books again. "Rare" is what it said. He said, "’Well done’ is more like it!" and ultimately decided to stop, reporting that he felt bad coming off of it, but the bad feelings cleared after a time. So with this first patient, I learned about the anti-OCD effects of the drug, the sexual side effects, and about the withdrawal. He died from his primary illness before the modern treatments for AIDS came along.

Medicine is like that: a case with a new disease, or a first encounter with an old one, or some new treatment. The only way to do it is to know that you don’t know something, then hit the books, or go to the literature, or talk to colleagues, or get a consultation, or make a referral. I claim that’s why we call it practice, and why we call the people we see patients. Medicine just can’t be mastered. But I think the psychiatric drugs of the 80s and 90s were my first encounter with a situation where those usual sources weren’t helpful. Of course there had been adverse effects that showed up with usage, but I can’t think of situations before where they were known, but not acknowledged. And I certainly never imagined instances where the academic resources would become an active part of the denial.
… As I was writing, there was a ping and an email with this…
by Kevin Grogan
March 24, 2014

The movement for more data transparency has been given a shot in the arm following a Sunday Times report which shows that the UK medicines regulator routinely destroys information on the licensing application files for drugs it has approved after 15 years. The newspaper’s piece documents the bid by Peter Gotzsche, co-founder of the Cochrane Collaboration, to get access to the data used to support marketing approval for Eli Lilly’s now off-patent antidepressant blockbuster Prozac [fluoxetine]. He approached the European Medicines Agency which referred him to the Medicines and Healthcare Products Regulatory Agency [MHRA] as the UK acted as the reference member state for Prozac approval.

However, the agency has shredded the vast majority of the clinical evidence it held on the treatment and the Prozac case is not an isolated one. Prof Gotzsche was told that “under MHRA record management policy, all application files and data for licences are held for 15 years". After this period, "files are destroyed unless there is a legal, regulatory, or business need to keep them, or unless they are considered to be of lasting historic interest". The Sunday Times article noted that “the MHRA said it had shredded the detailed information and held only some documents that summarised the findings". Lilly retains the data and the MHRA "can order it to be submitted".

Ben Goldacre, co-founder of AllTrials, said: “The MHRA needs to recognise that the world has changed, it is no longer acceptable for decisions about medicines to be based on secret meetings, about secret information that is then shredded". He added that "doctors, researchers and patients need access to all the evidence, to make fully informed decisions about which treatment is best, and help spot problems with treatments as quickly as possible". Dr Goldacre concluded by saying that "science progresses, and medicine improves, when we have many eyes on the data".

In response, an MHRA spokesperson told PharmaTimes that “we closely monitor the safety and efficacy of all medicines throughout the product lifecycle and we retain all key information relating to the agency’s assessment and decision-making processes". He added that "we use modern adverse drug reaction reporting systems and current research studies that better reflect clinical use and build on the original licensing data". He also stressed that the MHRA "has the legal power to require manufacturers of medicines to share safety, efficacy and clinical trial information from any time period so we can thoroughly investigate any issues".

Regarding the Prozac case specifically, the MHRA notes that it was "the first regulator to conduct a comprehensive safety review selective serotonin reuptake inhibitors [SSRIs] of the risks of suicidal behaviour and withdrawal reactions". It adds that "our overriding responsibility is to ensure that medicines work, and are acceptably safe. Our role is not to protect industry interests". The agency concludes by saying that "we are committed to greater transparency in our activities [and] we have already shown this by publishing the minutes of our advisory committees and Public Assessment Reports, detailing the processes and decisions made when licensing a drug and disclosing the evidence underpinning our decisions in areas of public concern."
so sooner, rather than later …
I don’t totally fault the MHRA [though in this day and time, there’s no reason to throw away data ever with the availability of digital storage]. But I agree with Gotzsche and Goldacre, that this should never have been secret in the first place, and I hope Gotzsche goes after Lilly for that data.

What I was going to say above was that I want to know about all those early trials of the psychoactive drugs, and what they really showed. Every one of those studies is of "lasting historic interest." I’ve lived through a career without the traditional resources to learn from, including the academic department where I was a contributing member, a department chaired by Dr. Charles Nemeroff for twenty of the thirty years I’ve been a volunteer teacher – who sent me a letter every year thanking me for my service. During that time, almost everything I’ve learned about our medicines, I’ve learned from patients, particularly about the limited efficacy and the adverse effects. And it took a while to recognize that what I read in peer-reviewed journals was largely advertising pabulum.

It’s why I support the RIAT project [Restoring invisible and abandoned trials: a call for people to publish the findings]. That’s why I support AllTrials. I’d like to see critical analyses of all the drugs and trials that have come our way in the last twenty-seven years. Many of our critics point out that we [the physicians and psychiatrists] are the ones that wrote the prescriptions for every single pill taken, so I think we deserve to know definitively [whether we want to or not] what those clinical trials actually should have said – where those official guidelines and treatment algorithms actually came from. There is more than ample evidence that we were systematically deceived by the pharmaceutical industry and members of our own ranks who colluded with them and signed the articles that arose from those studies. That’s not to say that organized psychiatry and individual psychiatrists don’t also share in the blame.

People like to tease about Peter Gotzsche’s animated style, as he suffers fools lightly. But I have to agree with what David Healy said about that recently [Get Real: Peter Gøtzsche Responds]:
… History will recognize Peter as the man who, among other achievements, pried open the question of access to RCT data, forcing the European Medicines’ Agency to open up their files. His motivation to do this came in part from a discovery of how appallingly bad the state of affairs in psychiatry IS. How almost all trials on which the field depends are ghostwritten, all data withheld and all dissent suppressed. Whatever it is this is not science and there has to be a good chance it’s killing and disabling more people prematurely than it helps.

What you hear from Peter is a howl of horror. The rest of us have got so inured to the situation we can no longer see how bad it is. The Allied troops arriving at concentration camps must have reacted the same way, where many inmates had gotten used to the situation…
Sometimes we need somebody who is willing to kick ass and take names
    Steve Lucas
    March 25, 2014 | 3:55 PM

    Secrets seem to be the new way of doing business in academic America:

    If this is the way a major university selects its president, how can we expect the staff to operate. I do not believe much is unique and this is a trend I see in many areas, yes the clergy being one, where if we do not tell anyone it did not happen.

    Steve Lucas

    March 25, 2014 | 9:19 PM

    Just ran into a comment on a blog post about the designer who just committed suicide. It addresses “afluenza” and had this to say;

    … to The World Health Organization, suicide rates have increased 60 percent over the past 50 years, most prominently in the developing world. Since 1988, there has been an astonishing 400% rise in the use of anti-depression medication in America, and more shockingly, depression is still chronically under diagnosed and treated.

    I responded with this:

    Here’s what WHO has to say about suicide and antidepressants:

    In 2004 a group of Australian researchers and the WHO conducted a study across 100 countries which tested the theory that the implementation of national mental health policies, programs and legislation would be associated with lower national suicide rates. They found the opposite.

    The introduction of a mental health policy and mental health legislation was associated with an increase in male and total suicide rates, and the introduction of a therapeutic drugs policy was associated with an increase in total suicide rates.

    Crickets. Seems the psychiatric industrial complex has done an especially good job of convincing college-educate middle class persons that the bio-bio-bio model is sound science and that labeling people as broken and giving them medication for life reduces stigma and is kind.

    The world that is the bio-psychiatry is legion and all of it’s unscientific proposals can be asserted as truth with one statement. Challenging any of them is immediately attacked as either Scientology, a lack of compassion, or scientific ignorance. What cruel irony.

    March 25, 2014 | 10:17 PM

    Although the UK’s post-marketing adverse effect reporting system is far superior to the US’s FDA system, it is still inadequate for making drug safety decisions. The MHRA’s response is also disingenuous in that they must know future drug development efforts might find important information in old trial data. I wonder if someone higher up found a reason to shred the old Prozac records specifically.

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