Tuesday, August 03, 2010

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."


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".


Claire said...

Lordy, Harold, does the expression "duh" cross one's mind at all in this?

Unknown said...

Yup it sure does. I am just amazed that CNN published this information about a pharma bias.

ian MacGregor said...

The article leaves a few things to be pondered. Are phase I and phase II trials more likely to result in failure then phase III or phase IV trials?

Also are the drug companies not reporting negative results on drugs which they are not marketing because of those failures or are they not reporting negative results on drugs they have gone on to market?

Anonymous said...

I am surprised that CNN actually covered this story, ...shocking news lost for words

Darsan Clinica said...

It's really very great. Even i am also shocked.CNN covered total pharmaceutical company drug trails etc. Thanks for sharing nice information.

Minority said...

Well, some negative news about drug companies does get published once in a while.

but you've got to understand that nothing negative ever applies to vaccines.

they are perfect, pig viruses and all.