Wednesday, 22 May 2019

You are here

Ties to Pharma Influences Clinical Trial Results

A study published in The BMJ shows that financial ties between researchers and companies that make the drugs they are studying are independently associated with positive trial results; thereby questioning the bias in these objective trials. (Citation source: http://buff.ly/2jUnA3q)

Relationships with industry are common among investigators of randomised clinical trials (RCTs) - raising concerns about the effect that financial ties may have on the evidence base. But studies investigating these relationships have been conflicting.

US researchers studied this association by examining a random sample of 195 drug trials published in 2013.

They focused on trials that examined the effectiveness of drugs, because these studies have a high impact on both clinical practice and healthcare costs.

More than half (58%) of principal investigators had financial ties to the drug industry - of 397 principal investigators, 231 (58%) had financial ties, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers’ fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug.

 The results show that trials authored by principal investigators with financial ties to drug manufacturers were more likely than other trials to report favourable results. The prevalence of financial ties of principal investigators was 76% among positive studies and 49% among negative studies.

Thus the presence of a financial tie was associated with a greater than 3 fold odds of positive study outcome 

The authors point to possible mechanisms linking industry funding, financial ties, and trial results such as bias by selective outcome reporting, lack of publication, and inappropriate analyses.  They suggested that  trials with industry funding or authors with financial ties should be interpreted with caution until all relevant information is fully disclosed.

 

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Steroids, Not Biologics, Drive Arthroplasty Infections in RA

Medicare and Truven MarketScan administrative data study (2006 through 2015) of rheumatoid arthritis (RA) undergoing arthroplasty found that while that the risks of perioperative infection was similar across biologics, the infection risk with glucocorticoid use, especially at > 10 mg/d, was significantly greater.

Generic Price Fixing Alleged by State Prosecutors

The NY Times and 60 Minutes have reported that Connecticut, along with 43 other states, filed a mega-lawsuit accusing the generic drug makers of a massive, systematic conspiracy to bilk consumers out of billions of dollars. (Citation source: https://buff.ly/2vSmv03)

Drug Pricing Regulations in US and Canada

Reuters reports on regulatory efforts by Canada and the US to curb the rising cost of drugs, especially expensive new medicines. 

In Canada, a little-known government agency is increasing its oversight of expensive drugs sold in Canada. The federal Patented Medicine Prices Review Board (PMPRB) is targeting an increasing number of expensive drugs introduced in the last several years by drug makers.

Nonadherence is Costly for Patients in Pain

A comparative cohort study of patients with osteoarthritis (OA), gout, diabetic peripheral neuropathy (pDPN), post-herpetic neuralgia (PHN), and fibromyalgia (FM) shows that nonadherence to pain medications is high and leads to greater overall health care resource utilization and costs. 

Naproxen has no Effect on Alzheimer's

A randomized controlled trial shows that chronic low-dose naproxen does not reduce progression of presymptomatic Alzheimer disease (AD).

The INTREPAD trial was a 2-year double-masked prevention trial, that enrolled 195 AD who were randomized 1:1 to naproxen sodium 220 mg twice daily or placebo. The primary outcome was rate of change in a multimodal composite presymptomatic Alzheimer Progression Score (APS).