Big-Pharma   Drug   Corruption     
  Big-pharma drugs are not what they seem?  
    Introduction

In this article, we’ll examine the degree of corruption present in “independent” research into the efficacy of big-pharma drugs, why big-pharma drugs approved by regulatory authorities may be less effective and more dangerous than stated, and what you can do about it:

    Corruption in Big-Pharma Drug Research

Dubious practices by big-pharma are nothing new, as with the 139,000 heart attacks caused by Voixx, and the withholding by big-pharma company Merck of the treatment risks from doctors and patients [1].

Because research carried out by big-pharma has so frequently been discredited, regulatory bodies and clinicians – when assessing the efficacy and side effects of big-pharma drugs – often turn to research that has been carried out by independent researchers, those working for universities and other independent research institutions.

A very concerning study on the reliability of independent research into big-pharma drugs was published in January 2017 [2]. This study examined 195 randomized controlled trials on the efficacy of big-pharma drugs that had been published in core clinical journals. Now, for some years big-pharma has been making assiduous efforts to try to court favour with independent researchers, and, as a result, research journals now require researchers to disclose any financial interests they might have when they publish research papers. So, this study examined whether the presence or absence of financial ties between the principal investigators of these randomized controlled trials and the pharmaceutical industry had any influence on whether the research results where positive (the big-pharma drugs were found to be effective) or negative (the big-pharma drugs were found to be ineffective).

The first – quite alarming statistic – to emerge from this study was the number of researchers who had financial ties to big-pharma: financial ties between the principal investigators and the pharmaceutical industry were reported in 67.7% of randomized controlled trials. These financial ties included advisory and consultancy payments, speakers’ fees, honorariums, employer-employee relationships, travel fees, stock ownership, and patent ownership. Bear in mind that other undisclosed financial relationships might have been present in some cases, and so the true figure may have been even higher. So, clearly, big-pharma’s financial contributions to “independent” researchers are pervasive.

Of course, financial ties do not in and of themselves imply reporting bias. It’s possible, in principle, that the researchers were not influenced by these financial inducements into reporting positive results that would please the sponsoring big-pharma companies. So, let’s look at the study’s results.

Among those negative randomized controlled trials that did not find in favour of big-pharma, 49% of principal researchers had financial ties to big pharma. So, if financial ties do not incline researchers to bias their results in favour of big-pharma, then the percentage of financial ties to big-pharma should be similar in the case of those positive randomized controlled trials that came to the opposite conclusion. But the study found that the prevalence of financial ties in positive randomized controlled trials was 76%. So, this study implies that about 36% of randomized controlled trials on big-pharma drugs that report positive results are biased, and should, instead, have reported negative results.

As to whether the bias found in this study was due to unconscious inadvertence or to deliberate corruption on the part of the researchers is impossible to say. However, given the rigorous methodologies involved in the design and statistical analysis of randomized controlled trials, it is very difficult to envisage how this bias could have arisen unintentionally.

    Why Approved Big-Pharma Drugs Can’t Be Trusted

One serious implication of this study is that when a meta-analysis of the randomized controlled trials performed on a particular drug is undertaken, the high level of reporting bias is likely to skew the results, leading to the false conclusion that ineffective drugs are effective, and that drugs with dangerous side effects have acceptable side effects.

Who makes use of these research studies and meta-analyses? Well, regulatory bodies and expert groups. So, it seems quite likely that a significant proportion of the drugs approved for use by regulatory bodies, such as the FDA and NICE, or the drugs recommended in oncological guidelines, such as the NCCN, ESMO, and NICE guidelines, are drugs that would not have been approved or recommended in the absence of research bias. The end result is that some of the drugs recommended by your health-care practitioner may be doing you more harm than good?

    Implications for You as a Patient

What are the implications of this research bias for you as a patient? Well, you should start from the assumption that any big-pharma drugs you are being offered may well be less effective or have more serious side effects than has been suggested by your health-care practitioner.

One option is to review the research literature and look for solid evidence of the presence of efficacy and a lack of harmful side effects. In doing so, always examine the disclosure statement at the end of each research paper to see whether or not the authors believe that they have financial interests that should be disclosed. If the research paper is favourable to big-pharma and financial ties are disclosed, then there’s at least a 36% chance, and possibly a much higher one, that the results are biased, and that the conclusions should be negative instead of positive. So, unless the ratio of positive studies to negative studies is very high and the positive studies report very pronounced benefits, then be wary as to the merits of taking the drug in question.

Another option is to take those big-pharma drugs that are recommended but:

*Start at a dose that is lower than the standard dose to check for the presence of any severe side effects that might have been under-reported in the research literature;

*Take multiple treatments for the same conditionthe portfolio approach – just in case the big-pharma drug in question is less effective than has been reported in the research literature.

    References

[1] Wikipedia, “Rofecoxib”, Wikipedia.

[2] Ahn R., Woodbridge A., Abraham A., et al., “Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study”, BMJ, 2017, 356, i6770.