Whooda Thunk It? CNN: Study Raises Bias, Timely Disclosure Questions About Pharma Funded Drug Trials

Whooda Thunk It?

CNN reports that a recent study has disclosed evidence of bias in pharmaceutical company funded drug trials. The study found evidence of an inherent bias in favor of the drug being studies with such studies being 4 times more likely to report outcomes that favored the drug of the sponsoring pharmaceutical company. Industry funded drug trials were also less timely in providing public information about the trial results:

Researchers from the United States and Canada looked at 546 drug trials registered in ClinicalTrials.gov, a registry of both federal and private trials in the United States and abroad. 346 of them, or 63 percen, were funded by the drug industry. The remaining 200 were paid for by government or non-profit organizations. Study authors found that more than 85 percent of industry-funded trials in their sample posted favorable outcomes and were 4 times more likely to report findings that favored their drug.

"We did this study in order to determine whether there is an inherent bias because pharmaceutical companies fund trials on products in which they have a financial interest," said study co-author Dr. Kenneth Mandl of Children's Hospital, Boston. "The most reassuring result would have been that the rate of favorable outcomes would be the same regardless of funding sources. In a very dramatic way that was not the case and what we need to ascertain is if the cause of this shift toward favorable findings among trials funded by pharmaceutical companies is related to the details of the protocols and study design."

Dr. Florence Bourgeois, also of Children's Hospital, Boston and lead author of the study says typically trials sponsored by drug companies are more efficient and well funded. Still, she found the result stunning. "The implications of these findings are that we need more oversight in the way clinical trials are designed as well as in the analysis and reporting of the results. One option may be to make study protocols directly available on clinicatrials.gov as well as the comprehensive reviews complied by the FDA on trial results." She continued, "While we cannot specifically point to which factors contribute to the association between funding source and positive results reporting, our findings speak to the need for more disclosure of all elements of a study."

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According to Mandl, industry funded trials also were less timely in terms of providing public information including trial results. He says even though drug trials are overseen by the Food and Drug Administration, there are still some variables that could favor pharmaceutical companies, including placebo comparisons, dosing and duration. "The concern is the pharmaceutical industry is funding the studies of the drugs in which they have a vested financial interest."

The influence of pharmaceutical companies in last years widely criticized H1N1 pandemic was examined by the Parliamentary Assembly of the Council of Europe (PACE). In its March 23 2010 report The handling of the H1N1 pandemic: more transparency needed the PACE expressed concern over the connections between World Health Organization (WHO) science advisors and pharmaceutical company interests:

11. Independent experts from the medical community mainly criticised the agenda setting and governance process concerning the H1N1 flu in terms of the criteria used for declaring a pandemic, the lack of empirical evidence justifying such a step and the clearance to use certain medicines and vaccines. They also repeatedly raised the issue of the influence that private stakeholders from the pharmaceutical industry might have had on major decisions taken by international and national authorities. For the purpose of this memorandum the rapporteur has compiled the main issues raised in a critical perspective. All arguments presented seem to have one common reference point: the disparity between the relatively mild unfolding of the influenza and the actions taken at European and national level.2

None of this, of course, is to suggest that there is any  unhealthy pharmaceutical company influence on public health authorities involved with autism issues ... right Dr. Gerberding?   Maybe Dr. Julie Gerberding, President of Merck Vaccines  can put to rest fears of pharma conflicts of interest by pushing for a comparative study of autism rates in vaccinated and unvaccinated populations as once called for by  former CDC  Director Dr. Julie Gerberding who once said that "such studies could be done and should be done".

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Pandemic or Profit and Panic? WHO Scientist Claims Swine Flu Pandemic Was Completely Exaggerated

Inforwars (see also the Daily Mail) reports that a WHO scientist, Professor Ulrich Keil, director of the WHO’s Collaborating Centre for Epidemiology,     has testified  during hearings at Strasbourg France of the Parliamentary Assembly of the Council of Europe, a body comprised of democratically elected representatives of 47 nations, that the Swine flu pandemic was completely exaggerated:

“With SARS, with avian flu, always the predictions are wrong…Why don’t we learn from history? It [swine flu] produced a lot of turmoil in the pubic and was  completely exaggerated in contrast with all the really important matters we have to deal with in public health. We know the great killers are hypertension, smoking, high cholesterol, high body mass index, physical inactivity and low fruit and vegetable intake.  In spite of all these facts, governments instead wasted huge amounts of money by investing in pandemic scenarios whose evidence base is weak.”

PACE is holding hearings pursuant to a motion by the former chair of the PACE Health Committee, Dr. Wolfgang Wodarg, a former German lawmaker,  medical doctor and epidemiologist and will try to determine whether the Swine Ful, H1N1 pandemic was a false pandemic declared on the advice of medical advisors with close financial ties to the pharmaceutical companies that benefited from the production of the H1N1 vaccines.  The investigation will also look at why two shots were initially advised when one was later found to be sufficient, the haste at which the vaccines were developed and the use of adjuvants in the vaccines.

As reported by Infowars  Dr. Wodarg has been very critical of WHO actions in declaring the Swine Flu out break a pandemic noting that the definition of pandemic was changed and softened and that the pandemic was declared with very little evidence to support the declaration:

“It was stated in panic- stricken terms that this was a flu that could threaten humanity and a great number of humans could fall ill. This is why billions of dollars of medications were bought.” Wodarg said.

He added that the the change in definition “made it possible for the pharmaceutical industry to transform this opportunity into cash, under contracts which were mainly secret.”

“In my view, the WHO undertook an incomprehensible action, which cannot be justified by scientific evidence. The Council of Europe should investigate this to see how WHO can undertake this kind of dangerous nonsense,” said Dr Wodarg.

Infowars also reports that  WHO’s flu chief, Dr Fukuda, insists WHO's swine flu scientists were not improperly influenced by ties to  pharmaceutical companies. Dr. Fukuda  criticizes those who call the pandemic a fake:

“Let me state clearly for the record – the influenza pandemic policies and responses recommended and taken by WHO were not improperly influenced by the pharmaceutical industry.” Fukuda told the inquiry.

He said those calling the epidemic fake were wrong and irresponsible."

Personally,  I did wonder from the outset whether the pandemic label and the panic were justified.  But I am just an ordinary citizen and far from being  an expert on epidemic outbreaks.  There have been actual experts, even public health authorities, other than Dr. Wodarg, who have questioned all along whether the pandemic label and the panic generated by public health authorities pushing everyone to get the H1N1 vaccine was appropriate and necessary.

The PACE investigation is important for addressing issues fundamental to public health  around the globe.  Decisions made to invest in and promote vaccine ingredients will always have huge impacts on our health. The PACE investigation is examining whether resources that might have been spent elsewhere were diverted as a result of a false panic generated by profit motives and undue influence.  What they learn will be important for our future health decisions.  

The Swine Flu pandemic also raises issues fundamental to democracy.  The role of powerful, profit driven organizations in influencing public health decisions and allocating resources is critical.  The role of public health authorities in promoting panic based on weak evidence and demonizing citizens as irresponsible for questioning their decisions are important concerns to be examined by responsible bodies of deliberation. These are important issues for the health of citizens and for the health of democracies that purportedly value fee expression and government of the people, by the people, for the people. 

Videos and Transcripts of the statements by Professor Keil, Dr. Wodarg, Dr. Fukuda and Dr. Luc Hessel of the Europeoa Vaccine Manufacturers, along with their biographies are available on the PACE web site.

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