How did Seroxat ever get a licence in the the first place?

I’ve often wondered, in idle moments, how a drug such as Seroxat was ever granted a licence in the first place.

From 1980-1991, approximately 5000 patients were tested on Paxil during SKB’s clinical trials. 83 different Paxil trials were conducted. Various time periods were involved in the individual trials. Many patients were tested for only a month or 6 weeks. Some were tested longer, including approximately 400 who were in trials longer than a year. SKB (Glaxo) pulled out all the stops to ensure the trials were successful. Only two positive trials are required for FDA market approval. By any reasonable person’s perspective, Paxil’s track record in the clinical trials was poor. After a decade of juggling data in the 83 different trials, SKB was finally able to cite 4 “positive” trials and three 3 “supportive” trials to justify Paxil’s approval. Dropouts in most trials were rampant. Most of the dropouts occurred because Paxil caused adverse experiences, and the victims wanted nothing more to do with the drug.

Paxil’s clinical trials were a statistical sham. Rather than deal with real numbers, SKB created a fraudulent measuring standard called “patient years” (or “patient exposure years”). The need for “patient years” became obvious in the 1980s. It was obvious in the late 1980s and into the 1990s that Paxil clinical patients were attempting suicide and suffering “adverse experiences” at an alarmingly high rate. Moreover, as indicated above, hundreds of Paxil volunteers dropped out because they could not tolerate the drug. The dropout rate was 20%. 58 patients alone attempted suicide after they were given Paxil. Hundreds of additional Paxil patients suffered adverse experiences caused by the drug. In 1991, SKB “ran the numbers” and discovered the absolutely horrible Paxil record. The 58 attempted suicides out of the patient base constituted a suicide rate of 0.77% in real numbers. Under clinical standards, a rate of 1% is considered a “frequent” occurrence.On those numbers, Paxil patients approached a “frequent” suicide rate. This was a far greater suicide rate than “placebo” or the other active drug being tested on the patient population. To avoid a company disaster on the Paxil project, SKB had to change the rules, and shift to the “patient years” sham.

It works like this. Assume 366 patients are selected at random to test Paxil. 365 patients take Paxil and suffer horribly the first day–immediately quitting the test. These patients are called, not surprisingly, “losers”. The 366th patient, however, tolerates Paxil quite well, and even improves on the drug, staying in one or more trials for a full year. This patient is a “winner” by SKB standards. Like a champion race horse, this “winner” is entered in all the sweepstake trials for Paxil–and these trials are intentionally programmed to be long. Knowing they have a champion race horse, SKB racks up “points.” By anyone’s common sense standards, 365 failures out of 366 attempts would render the drug a dismal failure. But not so under “patient years”. Under patient years, the one Paxil patient who tolerated the drug for one year counts the same as the 365 patients who couldn’t tolerate the drug and dropped out the first day. The “score” in this example is “one patient year” for each side. Not surprisingly, the mathematicians who go along with this voodoo math are subordinate to the physicians and clinicians in the corporate chain of command, and the physicians at the top of the FDA chain of command.

To read the rest of this fascinating story please follow this link which will take you to Truthman30’s site, GSK: Licence To (K)ill.

11 Responses to “How did Seroxat ever get a licence in the the first place?”

  1. truthman30 Says:

    Currently Im working on investigating the UK Seroxat licencing shambles, it was licenced in the UK first , in 1991, by the MCA(MHRA), two years later it was hoodwinked passed the American FDA…

    I think it is obvious how it was passed in the UK first …
    ….(Vested interests by certain individuals in positions of “power”)…

    http://truthman30.wordpress.com/

    Seroxat Link 4 : Seroxat Holocaust , !991, The First Wave

  2. Matthew Holford Says:

    I’ve just ‘mailed Robert Wardle, at the SFO, to try to ascertain if he was aware of Strange (but apparently true) Story of the 79 Negative Trials, which were ignored, in favour of the 4 positive ones.

    Matt

  3. truthman30 Says:

    Is there a way to get access to the failed trials pre 1991( before Seroxat was licenced)?..

  4. Matthew Holford Says:

    “Is there a way to get access to the failed trials pre 1991( before Seroxat was licenced)?..”

    Well, Peter Breggin wrote an analysis, which I think the quote at the top of the page is taken from. Maybe he’s got some of the data?

    Matt

  5. truthman30 Says:

    Yes , That quote is from Peter Breggin’s alalysis of the yugoslavia trials for paroxetine in regard to the FDA approval, which is posted on my blog, but I wonder what the process was in the UK , where it was licenced first?…
    How was it hookwinded passed the UK regulators?..
    Somehow..I think we know that already…

  6. Matthew Holford Says:

    Well, given the reported cost of the trials process, I would imagine that at least some of the same trials were presented to the MCA (the drug was licensed in the UK a couple of years before the US, if I remember aright?). That is, I doubt SKB did a whole bunch of different trials, just for the UK.

    I ‘mailed the MHRA, recently, to ask what it knew of the trials. I don’t doubt that its response will be a full and frank one, giving significantly more valuable and detailed information than was asked for, as is its modus operandi. When it fulfils its duty to the public in this efficient and competent manner, I’ll post the details here.

    Matt

  7. Matthew Holford Says:

    In the UK, the system has changed, as of 2005 – October, I think. The entity, which I imagine licensed Seroxat, used to be called the Committee on Safety of Medicines [sic]. It merged with the Medicines Commission to form the Commission on Human Medicines.

    The only information on the approval process, which I could find, was on Cancer UK’s pages, which also provides detail as to how drugs may be licensed through the European Agency for the Evaluation of Medicinal Products (“EMEA”). Apparently, EMEA is the body generally used by EU countries. However, there is a mutual recognition process in place, so when a company wishes to seek approval to market a drug in the EU, it goes to its domestic licensing body, which approves, or rejects. If it rejects the application, a company may appeal, and if it approves, other countries’ regulators may reject. If nobody objects, the drug may be marketed in any EU country, as I understand it.

    Anyway, the upshot is that even under EMEA, the Commission on Human Medicines is the first port of call for a company wishing to bring a drug to market. As I wrote, what the approval process involves now, and what the approval process involved in 1991, is unclear to me.

    Matt

  8. Matthew Holford Says:

    “the Commission on Human Medicines is the first port of call for a company wishing to bring a drug to market.”

    Just to clarify, for “company”, read “UK company”.

    I’ve since found this:

    http://www.gnn.gov.uk/environment/fullDetail.asp?ReleaseID=238144&NewsAreaID=2&NavigatedFromDepartment=False

    Blimey, talk about a captive audience. Let’s hope that patients are fully informed about the process, which does not appear to be the case with those kids’ parents, in Russia. I’ve also picked up on this:

    http://www.ahrp.org/infomail/05/06/14a.php, which includes the following quote: “The UK pharmaceutical industry association is lobbying Parliament to adopt rules “to force doctors to prescribe new treatments at the earliest opportunity.”” One would hope that the new trials process was led by a concern for patient health, rather than a product of ABPI lobbying.

    Matt

  9. Matthew Holford Says:

    OK, the MHRA has this to say:

    http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=99

    I haven’t read the detail on “Marketing Authorizations,” yet. But I do like the way that the process is purported to be complex, which presumably explains how numbskulls such as me just don’t understand how Seroxat is actually massively beneficial, when it looks like a crock.

    Matt

  10. Matthew Holford Says:

    http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=102

    There are four sentences on the assessment process, as far as I can see (see “Professional Assessment” and “Assessors”). None of which describe how assessment is carried out, only the criteria for assessment (safety, quality, efficacy), which we already knew.

    I guess the MHRA thinks the public would be too dumb to understand, so it doesn’t bother trying to explain. Time to flip its perception on that one, I think…

    Matt

  11. Matthew Holford Says:

    Oh, incidentally, that last link is out of date, because it still talks about the CSM as being the key advisory body. We know it doesn’t exist, anymore, which dates that page to at least two years old. Nothing like being kept informed of developments, is there?

    Matt


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