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Industry-sponsored drug trials more likely to report positive results

The views expressed are those of the author and are not necessarily those of Scientific American.


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drugs being counted as trials backed by pharmaceutical companies are more likely to report positive resultsClinical trials to demonstrate the safety and efficacy of new drugs are expensive investments for pharmaceutical companies and other funding organizations—and failures can mean scrapping years of pricey work and going back to the drawing board. Perhaps it is little wonder then that this industry has backed a higher percentage of clinical trials with positive outcomes than either foundations or the government, according to a new study of more than 500 recent drug trials. The results of the analysis were published online August 2 in Archives of Internal Medicine.

The researchers assessed results and publication of 546 studies described on the open reporting site ClinicalTrials.gov that were testing antidepressants, cholesterol medication, antipsychotics, proton-pump inhibitors or blood pressure drugs, between 2000 and 2006. About two thirds of the trials had published their results by the end of the study period.
 
The majority (63 percent) of trials in the analysis period were primarily funded by the industry and of those that were, 85 percent of them reported positive outcomes—compared with 72 percent of the nonprofit or other nonfederal institution or 50 percent of those funded by the government.

"Publication bias is likely a contributing factor," Florence Bourgeois, of the Children’s Division of Emergency Medicine at Children’s Hospital Boston and lead author of the study, said in a prepared statement. "But there are likely many more, including biases in study design, patient selection, data analysis and results reporting." The researchers found that the industry-sponsored trials tended to be in later stages, such as phase 3 or phase 4, than trials backed by other sources, which might explain the increased likelihood of positive results ("because there is more certainty about the drug’s efficacy and safety at this advanced stage in the drug-development cycle," the study authors noted).

The Web site ClinicalTrials.gov went online in 1999 "in response to increasing concerns over the lack of transparency in the conduct of clinical trials," the researchers noted in their paper. But the process has not become transparent enough for everyone.

"While we cannot specifically point to which factors contribute to the association between funding source and positive result reporting, our findings speak to the need for more disclosure of all elements of a study," Bourgeois said.

Image courtesy of Wikimedia Commons/Linda Bartlett





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  1. 1. 3rd party 7:04 pm 08/2/2010

    It shouldn’t be a surprise since industry stakeholders have significantly more to lose, and hence spend more money in the analysis and design of registration and post-marketing studies than either foundations or government agencies. With the firewalls that have been instituted around access to patient data limiting industry interference.

    The phrase "Perhaps it is little wonder then that this industry has backed a higher percentage of clinical trials with positive outcomes than either foundations or the government" suggests shady-dealings, and yet some of the most compelling and expensive studies have been funded by industry with data control limited to experts and thought leaders (the REACH registry, anyone?).

    Well conducted industry studies ought to be lauded rather than reports that have little to report, other than "While we cannot specifically point to which factors contribute to the association between funding source and positive result reporting, our findings speak to the need for more disclosure of all elements of a study," Bourgeois said.

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  2. 2. quincykim 11:33 pm 08/2/2010

    3rd party – Yes, well conducted studies are to be lauded. The issue raised though is a lack of across the board transparency, so that rosy results may or may not be subject to close scrutiny. Maybe this blog entry sheds more heat than light, but the issue of transparency in clinical trials is an important one worthy of pursuit.

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  3. 3. Iahmad 2:27 am 08/3/2010

    That is very obvious. However, it will have strong scientific basis. Now let us look at US government reports on global affairs. It will be written by lobbyists who have immoral and dubious background. It will fully carry the taint of these lobbyists. Still worse; zionist controlled media reports are totally false and completely opposite of truth and reality. Whats being done to overcome these crimes? Nothing. Unfortunately most of the American people still believe these tabloid corporate reports from government and media as truth. They need to wake up and make these criminal government, media and lobbyists accountable for crimes committed in the name of American public.

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  4. 4. Sarah'sSmile 5:01 am 08/3/2010

    Yea, Iahmad; we’re not talking about US reports on global affairs. Stick to the topic at hand, please: "Industry-sponsored drug trials more likely to report positive results"…

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  5. 5. DianthusMed 5:06 am 08/3/2010

    Are you the study was published in Archives of Internal Medicine? I can’t find it on their website. Do you have a link?

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  6. 6. mercthemad 10:10 am 08/3/2010

    Drug companies are less likely to fund endeavors without some positive indication to begin with. Why would they throw money away on drugs they don’t expect to work? I would be very surprised if they didn’t have a high success rate since that would indicate someone running the company was clueless about how to generate profits.

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  7. 7. TheTobinTouch 10:21 am 08/3/2010

    Yes, this shouldn’t be a surprise at all – the studies are designed up front with ROI in mind.

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  8. 8. jtdwyer 1:32 pm 08/3/2010

    Antidepressants and antipsychotics seem to be particularly profitable for drug companies. Psychoactive ‘shotgun’ medications requiring long term use often seem to produce permanent disfiguring side-effects with prolonged use. As a result, medications much be changed frequently, eventually requiring production of new or variant medications. The newly developed medications are, of course, are not subject to competition from generic medications…

    Perhaps a range of more specifically targeted psychoactive medications would have fewer serious side-effects, but each would have high development costs, a smaller potential market and eventually be subject to generic competition.

    This is purely speculation, since I don’t have any evidence of conspiracy, but these economic factors certainly discourage any search for more effective, less dangerous psychoactive medications.

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