When drug makers fund their own clinical trials, they find their drugs more effective than trials funded by other sources, according to a new report published in the Journal of Political Economy.

The article's author named this blatant manipulation a “sponsorship effect” and proposes a method for reducing the drug manufacturer’s ability to misrepresent the safety and efficacy of their drugs.

Today, we'll examine this new report, what it uncovered, and its implications for osteoporosis drugs and treatment.

A New Report Finds Clear Evidence Of Bias

A new report published in the Journal of Political Economy reveals how financial incentives affect the results of drug trials.

Study author Tamar Oostrom, an assistant professor of economics at Ohio State University, analyzed the published results of 509 drug trials. She assessed how the financial sponsor of a trial impacted the results by comparing multiple studies of the same drug, some funded by the drug's maker and others not funded by the drug's maker.

The clinical drug trials she included were comparable in all other facets. Both studies compared the subject drug's effect on a participant group to a similar drug's effect on a different participant group. This comparison is used to measure a new drug's effectiveness and safety relative to drugs already on the market.

The results of clinical drug trials are used by the FDA to make decisions about approvals and safety warnings. The trial results are also used by medical professionals to prescribe drugs and help their patients find the most effective drug for them, with the least risks. However, this new report shows that results were biased in favor of the drug makers who paid for the trials.

Oostrom found that drugs were reported to be 49% more effective when the trial was sponsored by that drug’s manufacturing or marketing firm, compared with the same drug evaluated the same way, but without the financial backing of the drug's manufacturer or marketer.¹

Sponsored drugs were 43% more likely to report statistically significant improvements and 73% more likely to be the most effective drug in their trial, compared to the same drug tested against the same comparators, but without the drug manufacturer's sponsorship.¹

Oostrom called the impact of this bias a “sponsorship effect”.

Synopsis

A new report found that when drug manufacturers sponsored clinical trials of their drugs, the trial outcomes were more positive than comparable trials sponsored by other entities. These trials backed by pharmaceutical companies found their drugs to be 49% more effective than uncompromised trials. The report's author calls this bias a “sponsorship effect.”

Pharmaceutical Companies Seem To Alter Clinical Drug Trial Results

This evidence shows that pharmaceutical companies do more than pay for their own drug trials– they sometimes pay for their desired result, regardless of the facts. Oostrom did more than examine the difference between trials of a drug paid for by its maker and paid for by other sources. She also looked at how the trials were conducted to see whether the trial components were compromised by funding sources.

She did not find evidence of discrepancies in trial methodologies to suggest that funders were influencing the formal elements of the studies. However, she doesn't rule out this possibility as part of the cause. The studies seemed to have been carried out uniformly, regardless of funding. The impact of the funding bias turned up in publication.

No two drug studies will return precisely the same results. There are different participants in each group of each trial and different conditions across locations and time. Multiple studies are needed to draw sound conclusions and multiple trials are required of any drug seeking FDA approval.

When pharmaceutical companies pay for their own trials, they may conduct more trials than they publish. This gives them the ability to cherry pick the studies that have the most favorable results, publish those, and bury the rest.

Oostrom found that when she removed the sponsorship effect the difference in efficacy between sponsored drugs and comparison drugs in the trials fell by about 50%. This enormous effect on drug efficacy has significant impacts on drug approvals and prescriptions. The relative efficacy of a drug in preapproval trials largely predicts whether the FDA will approve the drug.

The study reports that if the sponsorship bias bump was removed from results, less of those drugs would have been approved by the FDA, and “removing the average sponsorship effect from each drug would result in an 18% decrease in prescriptions.”¹

By repeating trials until they achieve their desired result, and then only publishing the favorable outcomes, pharmaceutical companies seem to be deceiving the FDA and medical professionals.

Synopsis

The report suggests that pharmaceutical companies can fund multiple studies, then only publish the results that are favorable to their drugs. Without this “sponsorship effect” the difference in efficacy between sponsored drugs and comparison drugs in the trials would fall by about 50%, likely leading to fewer FDA approvals and prescriptions.

Impacts Of The Study

Oostrom presents a potential correction to the problem of sponsorship bias: preregistration as a condition for publication. If this were a universal rule, then for any study to be published, it would have to register before the study is conducted. That would prevent unfavorable studies from being excluded from publication.

Most of the trials that Oostrom analyzed were for psychiatric drugs, only because that was the area with the most studies that fit the criteria of this analysis. Her findings have dramatic implications for the accuracy of clinical trial data across pharmaceutical categories. Around 70% of clinical trials are funded by industry– suggesting that as much as 70% of clinical drug trial results could inaccurately represent the efficacy and safety of prescription drugs.¹

Osteoporosis drugs are included within those figures, and their makers have played an overt role in the development and trial of osteoporosis drugs, as well as heavily influencing the definition and diagnostic criteria of osteoporosis.

For example, pharmaceutical giant Merck sponsored their own clinical trials of alendronate (Fosamax) to obtain FDA approval for the drug based on the trial’s findings of the drug's efficacy in reducing the risk of spine and hip fractures.

Amgen, the manufacturer of the osteoporosis drug Prolia was ordered by the FDA to conduct additional trials after their initial studies showed a risk of potentially deadly side effects. The FDA approved Prolia anyway. Then, after the additional trials were completed, they added a black box warning label to the drug.

This new study underscores the flaws of the FDA approval process. If companies like Amgen were unable to bury study results, perhaps their drugs wouldn't have been approved in the first place.

Without the biased publication of sponsored drug trials swaying their decisions, it’s likely that more patients would choose healthier and safer drug-free interventions to strengthen their bones and address chronic health conditions.

Synopsis

The report recommends preregistration of studies as a condition for publication, so that pharmaceutical companies can't cherry-pick their results. The “sponsorship effect” is active in drug development for osteoporosis treatments and may have contributed to today's landscape of dangerous and ineffective osteoporosis drugs.

What This Means To You

Savers know that drug manufacturers aren’t always trustworthy providers of healthcare solutions, especially when it comes to osteoporosis drugs. This report highlights how biased research can lead to dangerous and ineffective drugs getting approved and prescribed.

But you don’t have to rely on risky medications to protect your bones. The Osteoporosis Reversal Program offers a natural, drug-free way to build stronger, healthier bones—without the harmful side effects of prescription drugs.

With simple changes to your diet, exercise routine, and daily habits, you can take control of your bone health and improve your overall well-being. You deserve a safe, effective approach that supports your health from the inside out.

References

¹ https://www.journals.uchicago.edu/doi/10.1086/730383