Pharmaceutical Company Funding Research Articles

Fraud and Deceit in Medical Research

Fraud and Deceit in Medical Research

A 'patient-industry complex'? Investigating the financial dependency of UK patient organisations on drug company funding.

We examined the minimum extent of dependency of UK patient organisations on pharmaceutical industry funding using drug company disclosure reports and patient organisation financial accounts from 2012 to 2016. We used linear regression to explain the overall share of industry funding ('general dependency') and top donor funding ('company-specific dependency') in organisations' income. Predictors included patient organisations' goal; having members and volunteers; geographical scope of activity; headquarter location; expenditure/income ratio; and disease area. The prevalent low levels of general dependency (IQR, 0.1%-6.0%) and company-specific dependency (IQR, 0.1%-4.3%) made a widespread capture of patient organisations unlikely, though only if one excludes the possibility of significant payment under-reporting. However, organisations with considerably higher dependency than others might be more prone to co-optation by industry. Of the 398 organisations, 18 (4.5%) and 8 (2.0%) had general and company-specific financial dependency over 50%, respectively. However, the shares of outliers exceeding the third quartile plus 1.5 times IQR were 51 (12.8%) and 56 (14.1%) for each dependency type. Certain characteristics including activity profile (advocacy) or indicating limited access to resources (remote location) made organisations vulnerable to developing financial dependency. Future research should examine both financial and non-financial links between the two sides and their impact on patient organisations' activity.

Different classes of antibiotics given to women routinely for preventing infection at caesarean section.

Different classes of antibiotics given to women routinely for preventing infection at caesarean section.

Retos y desafíos de la investigación clínica independiente

Pharmaceutical companies fund most clinical trials on drugs. However, there are clinical issues that might not be a priority from a commercial point of view, but that should certainly be addressed, given their importance for patients and society in general. Independent clinical research represents a fundamental pillar here and its basic element is investigator-initiated studies/trials. In these studies, it is the researcher who conceives the idea, develops the project and also acts as the sponsor. Most researchers are familiar with participating as collaborators in studies sponsored by pharmaceutical companies. In these studies, the company is in charge of all the scientific, legal and financial aspects, leaving the responsibility of the researcher mainly limited to the inclusion of patients and compliance with the protocol. On the contrary, the start-up and development of an independent research study requires considerable resources – of knowledge, money and time – and careful planning on the part of the researcher. In this manuscript, we will review the main characteristics of the studies initiated by the researcher and their fundamental differences with those sponsored by the pharmaceutical industry. We will also outline what its strengths and limitations are. Finally, we will propose some solutions to the main challenges they pose. Our ultimate goal is to stimulate potential researchers to undertake the challenge of conducting an independent clinical research project.

Response to “The Use of Non-Invasive Vagus Nerve Stimulation to Treat Respiratory Symptoms Associated with COVID-19: A Theoretical Hypothesis and Early Clinical Experience”

Response to “The Use of Non-Invasive Vagus Nerve Stimulation to Treat Respiratory Symptoms Associated with COVID-19: A Theoretical Hypothesis and Early Clinical Experience”

Demystifying pharmaceutical patient assistance programs

Prescription drug costs impose a significant financial burden on the United States healthcare system. Patients with chronic dermatologic diseases often require long-term and expensive prescription drugs. In an effort to expand drug availability, pharmaceutical companies fund patient assistance programs (PAPs) to assist disadvantaged patients in gaining access to high-priced brand name medications with no suitable therapeutic alternative. Patients and clinical staff often face difficulty navigating the various PAPs. Herein, we seek to explore the utility, criteria, and challenges in PAPs and provide a practical discourse for dermatologists caring for medically indigent patients.

Drug treatment for spinal muscular atrophy type I.

Background Spinal muscular atrophy (SMA) is caused by degeneration of anterior horn cells of the spinal cord, which leads to progressive muscle weakness. Children with SMA type I will never be able to sit without support and usually die by the age of two years. There are no known efficacious drug treatments that influence the course of the disease. This is an update of a review first published in 2009. Objectives To evaluate whether drug treatment is able to slow or arrest the disease progression of SMA type I, and to assess if such therapy can be given safely. Drug treatment for SMA types II and III is the topic of a separate updated Cochrane review. Search methods We searched the Cochrane Neuromuscular Disease Group Specialized Register (8 March 2011), CENTRAL (The Cochrane Library 2011, Issue 1), MEDLINE (January 1991 to February 2011), EMBASE (January 1991 to February 2011) and ISI Web of Knowledge (January 1991 to 8 March 2011). We searched the Clinical Trials Registry of the U.S. National Institute of Health (www.ClinicalTrials.gov) (8 March 2011) to identify additional trials that had not yet been published. Selection criteria We sought all randomised or quasi-randomised trials that examined the efficacy of drug treatment for SMA type I. Participants had to fulfil the clinical criteria and have a deletion or mutation of the SMN1 gene (5q11.2-13.2) confirmed by genetic analysis.The primary outcome measure was time from birth until death or full time ventilation. Secondary outcome measures were development of rolling, sitting or standing within one year after the onset of treatment, and adverse events attributable to treatment during the trial period. Data collection and analysis Two authors (RW and AV) independently reviewed and extracted data from all potentially relevant trials. For included studies, pooled relative risks and standardised mean differences were to be calculated to assess treatment efficacy. Main results One small randomised controlled study comparing riluzole treatment to placebo for 10 SMA type 1 children was identified and included in the original review. No further trials were identified for the update in 2011. Regarding the primary outcome measure, three of seven children treated with riluzole were still alive at the ages of 30, 48 and 64 months, whereas all three children in the placebo group died; but the difference was not statistically significant. Regarding the secondary outcome measures, none of the children in the riluzole or placebo group developed the ability to roll, sit or stand, and no adverse effects were observed. For several reasons the overall quality of the study was low, mainly because the study was too small to detect an effect and because of baseline differences. Follow-up of the 10 included children was complete. Authors' conclusions No drug treatment for SMA type I has been proven to have significant efficacy.

Survey of practices around pharmaceutical company funding for continuing professional development among medical oncologists and trainees in Australia.

The completion of continuing professional development (CPD) is mandatory for medical oncologists and trainees (MO&T). Pharmaceutical companies may fund some CPD activities, but there is increasing debate about the potential for conflicts of interest (COI). To assess current practices around funding to attend CPD activities. An electronic survey was distributed to Australian MO&T. The survey asked questions about current practices, institutional policies and perceptions about attending CPD funded by pharmaceutical companies. The design looked at comparing responses between MO&T as well as their understanding of and training around institutional and ethical process. A total of 157 of 653 (24%) responses was received, the majority from MO (76%). Most CPD activities attended by MO&T were self-funded (53%), followed by funding from institutions (19%), pharmaceutical companies (16%) and salary award (16%). Most institutions allowed MO&T to receive CPD funding from professional organisations (104/157, 66%) or pharmaceutical companies (90/157, 57%). A minority of respondents (13/157, 8%) reported that the process to use pharmaceutical funds had been considered by an ethics committee. Although 103/157 (66%) had received pharmaceutical funding for CPD, most (109/157, 69%) reported never receiving training about potential COI. The lack of education was more noticeable among trainees (odds ratio (OR) 8.61, P = 0.02). MO&T acknowledged the potential bias towards a pharmaceutical product (P = 0.05) but believed there was adequate separation between themselves and pharmaceutical companies (P < 0.01). Majority of CPD attended by MO&T is self-funded. There is lack of clarity in institutional policies regarding external funding support for CPD activities. Formal education about potential COI is lacking.

Pain leads the way: the development of evidence-based medicine for pain relief.

This paper describes the development of evidence based methods in pain medicine since the 1980s at the Pain Research Department of the Nuffield Department of Clinical Neurosciences, Oxford University. Pain medicine can be said to have led the way in terms of developing registers of randomized controlled trials (RCTs) and in developing appropriate methodology for assessing clinical trials and developing metanalytical techniques. This paper tells the story of that development which occurred in conjunction with the development of the Cochrane Collaboration. Pain has a larger body of evidence than many medical specialties with more than 30,000 RCTs and over 2,500 published systematic reviews. Our work continues to raise methodological challenges and a number of key ones are described: Size: We have added to the existing literature to show that small studies overestimate treatment effects. We consider studies with less than 50 participants per treatment group to be at high risk of bias. Mean pain scores: We have shown these to be unhelpful and misleading. We illustrate that response to analgesics is a U-shaped curve with a larger proportion of participants having either a poor response or a good response. Imputation: We discuss the problems of current methods. Tiers of evidence: We propose a way to assess evidence for pain studies. Duplicate publication of data can lead to inflated benefits in systematic reviews. In addition we touch on fraud, pharmaceutical company funding. The final sections cover developments in several areas of pain medicine, and suggest some developments going forward.

Abstract P1-09-21: Impact of the benfluorex scandal on French cancer patients’ attitude toward clinical trials

Abstract Background Enrolling cancer patients into clinical trials is an endearing process. Pharmaceutical companies fund nearly 40% of these cancer trials. A variety of considerations take part in a patient's decision to participate to a clinical trial, including their opinion regarding the pharmaceutical industry. Recently, benfluorex (Mediator®), a drug first marketed in 1976 for hyperlipidemia and diabetes by a French pharmaceutical company, has filled the French headlines repeatedly because of efficacy and safety issues. The impact of this scandal on French cancer patients’ attitude toward clinical trials is not known. The aims of this study were to determine i) cancer patients’ opinion toward the pharmaceutical industry, physicians, and research, and ii) their willingness to participate to clinical trials, in the context of the benfluorex scandal. Methods To investigate this issue, a self-administered anonymous survey was performed in 221 French cancer patients. The survey instrument collected information about age, gender, and whether the patient already participated to a clinical trial. A question with multiple answers queried whether the benfluorex situation casted suspicion on the pharmaceutical industry, physicians, clinical research funded by the pharmaceutical industry, or research as a whole. A yes or no question queried patients’ willingness to participate to clinical trials funded by the pharmaceutical industry. Logistic regression was used to examine the relationship between patients’ characteristics and the dependent variables. Results Median age was 64 years (range 19 to 86 years) and 57% of the patients were female. Thirty three percent of the patients had already participated to a clinical trial. Eighty five percent of the patients declared that clinical research was necessary, 11% that it was useful, less than 1% that it was not useful, and 4% of the patients did not know. The benfluorex scandal induced distrust toward the pharmaceutical companies in 75% of the patients, toward research funded by these companies in 43% of the patients, research as a whole in 20% of the patients, and toward physicians in 14% of the patients. These results were not influenced by age, gender, or previous participation to a clinical trial. Regarding their attitude toward clinical trials funded by the pharmaceutical industry, 60% of the patients declared that they were not willing to participate, 25% of them that they would participate, and 15% that they did not know. A negative answer was less likely when patients had previously participated to a clinical trial. Conclusions Although no connection exists between benfluorex and cancer, these results show that this scandal significantly impaired French cancer patients’ trust toward the pharmaceutical companies and research, and their willingness to participate to clinical trials funded by the pharmaceutical industry. These results highlight the need to better understand patients’ motivation to help implement strategies to maintain their participation to clinical trials. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P1-09-21.

Patient Advocacy Groups Concealing Drug Company Funding, University Study Says

Biotechnology Law ReportVol. 30, No. 3 Financial and Shareholder AffairsPatient Advocacy Groups Concealing Drug Company Funding, University Study SaysPublished Online:9 Jun 2011https://doi.org/10.1089/blr.2011.9861AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail FiguresReferencesRelatedDetails Volume 30Issue 3Jun 2011 InformationCopyright 2011, Mary Ann Liebert, Inc.To cite this article:Patient Advocacy Groups Concealing Drug Company Funding, University Study Says.Biotechnology Law Report.Jun 2011.364-364.http://doi.org/10.1089/blr.2011.9861Published in Volume: 30 Issue 3: June 9, 2011PDF download

Clinician Attitudes About Commercial Support of Continuing Medical Education

Pharmaceutical and medical device company funding supports up to 60% of accredited continuing medical education (CME) costs in the United States. Some have proposed measures to limit the size, scope, and potential influence of commercial support for CME activities. We sought to determine whether participants at CME activities perceive that commercial support introduces bias, whether this is affected by the amount or type of support, and whether they would be willing to accept higher fees or fewer amenities to decrease the need for such funding. We delivered a structured questionnaire to 1347 participants at a series of 5 live CME activities about the impact of commercial support on bias and their willingness to pay additional amounts to eliminate the need for commercial support. Of the 770 respondents (a 57% response rate), most (88%) believed that commercial support introduces bias, with greater amounts of support introducing greater risk of bias. Only 15%, however, supported elimination of commercial support from CME activities, and less than half (42%) were willing to pay increased registration fees to decrease or eliminate commercial support. Participants who perceived bias from commercial support more frequently agreed to increase registration fees to decrease such support (2- to 3-fold odds ratio). Participants greatly underestimated the costs of ancillary activities, such as food, as well as the degree of support actually provided by commercial funding. Although the medical professionals responding to this survey were concerned about bias introduced from commercial funding of CME, many were not willing to pay higher fees to offset or eliminate such funding sources.

Attention-deficit hyperactivity disorder, drug companies and the internet

This study investigated the influence of drug-company funding on websites about attention-deficit hyperactivity disorder (ADHD). Websites in the top 60 for either Google or Yahoo!Xtra with information about causation and treatment were analysed. Likert scales, based on those used in previous similar studies, were developed to rate aetiological explanations and recommended treatment approaches, on a dimension from psycho-social to biological. Overall, the quality of information on websites was poor with a strong bias towards bio-genetic aetiological explanations of ADHD. Twenty-one of the 57 websites (37%) were funded by drug companies. The drug-company funded (DCF) websites were significantly more likely than non-DCF websites to recommend medication rather than psycho-social treatments. The selective lack of consideration of psycho-social treatments by DCF websites is discussed in relation to the relevant research literature, including the evidence in favour of a multimodal approach. The findings, which are consistent with previous similar studies in relation to websites about adult mental health problems, confirm that the pharmaceutical industry is seeking to influence public opinion via the internet.

Those Who Have the Gold Make the Evidence: How the Pharmaceutical Industry Biases the Outcomes of Clinical Trials of Medications

Pharmaceutical companies fund the bulk of clinical research that is carried out on medications. Poor outcomes from these studies can have negative effects on sales of medicines. Previous research has shown that company funded research is much more likely to yield positive outcomes than research with any other sponsorship. The aim of this article is to investigate the possible ways in which bias can be introduced into research outcomes by drawing on concrete examples from the published literature. Poorer methodology in industry-funded research is not likely to account for the biases seen. Biases are introduced through a variety of measures including the choice of comparator agents, multiple publication of positive trials and non-publication of negative trials, reinterpreting data submitted to regulatory agencies, discordance between results and conclusions, conflict-of-interest leading to more positive conclusions, ghostwriting and the use of "seeding" trials. Thus far, efforts to contain bias have largely focused on more stringent rules regarding conflict-of-interest (COI) and clinical trial registries. There is no evidence that any measures that have been taken so far have stopped the biasing of clinical research and it's not clear that they have even slowed down the process. Economic theory predicts that firms will try to bias the evidence base wherever its benefits exceed its costs. The examples given here confirm what theory predicts. What will be needed to curb and ultimately stop the bias that we have seen is a paradigm change in the way that we treat the relationship between pharmaceutical companies and the conduct and reporting of clinical trials.

News Media Coverage of Medication Research: Reporting Pharmaceutical Company Funding and Use of Generic Medication Names

News Media Coverage of Medication Research: Reporting Pharmaceutical Company Funding and Use of Generic Medication Names

Ethics of pharmaceutical company relationships with the nursing profession: No free lunch….and no more pens?

In recent years, nurses have increasingly become recipients of pharmaceutical company gifts, funding and sponsorship. There has been little discussion in the nursing literature, however, of the ethical and professional implications of nurses’ acceptance of such sponsorship. This article examines ethical issues related to the issue of nurses’ accepting benefits from pharmaceutical companies (and other commercial enterprises). It aims to encourage nurses to look critically at the implications of accepting such gifts/sponsorship, or to enter any form of relationship with commercial companies within the health sector, and to stimulate further discussion of this issue within the profession.

Should Pharmaceutical Companies Fund Continuing Education for Nurse Practitioners?

Lois Rockcastle, RN, MS, FNP-BC, has been a family nurse practitioner for over 27 years. Her first 10 years of practice were in upstate New York. For the past 16 years, she has been working in Alaska. Her career has included urban, rural, and frontier settings. Currently, she works for the Yukon-Kuskokwim Health Corporation, North Star Behavioral Health, and is an adjunct faculty member at the University of Alaska. She serves on the board of the American College of Nurse Practitioners as one of two elected state affiliate representatives.

Posttraumatic Stress Disorder, Drug Companies, and the Internet

The public increasingly acquires information about the causes of, and treatments for, mental health problems from the Internet. This study investigated the top 54 websites about posttraumatic stress disorder (PTSD) in Google and Yahoo! to assess differences in the content of websites funded and not funded by drug companies. In all, 42% of the websites received drug company funding. There was no relationship found between the causes stated and whether the website was drug company funded. Drug company–funded websites, however, gave significantly more emphasis to medication in the treatment of PTSD. This study confirms an earlier study indicating that the pervasive influence of the pharmaceutical industry in the mental health field, designed to maximize product sales, now includes information available to the public via the Internet.

News Media Coverage of Medication Research

The news media are an important source of information about medical research for patients and even some physicians. Little is known about how frequently news articles report when medication research has received funding from pharmaceutical companies or how frequently news articles use generic vs brand medication names. To assess the reporting of pharmaceutical company funding and generic medication name use in news articles about medication studies and to determine the views of newspaper editors about these issues. We reviewed US news articles from newspaper and online sources about all pharmaceutical company-funded medication studies published in the 5 most prominent general medical journals between April 1, 2004, and April 30, 2008. We also surveyed editors at the 100 most widely circulated newspapers in the United States. The percentage of news articles indicating when studies have been pharmaceutical company-funded and the percentage that refer to medications by their generic vs brand names. Also the percentage of newspaper editors who indicate that their articles report pharmaceutical company funding; the percentage of editors who indicate that their articles refer to medications by generic names; and the percentage of newspapers with policies about these issues. Of the 306 news articles about medication research identified,130 (42%; 95% confidence interval [CI], 37%-48%) did not report that the research had received company funding. Of the 277 of these articles reporting on medications with both generic and brand names, 186 (67%; 95% CI, 61%-73%) referred to the study medications by their brand names in at least half of the medication references. Eighty-two of the 93 (88%) newspaper editors who responded to our survey reported that articles from their publications always or often indicated when studies had received company funding (95% CI, 80%-94%), and 71 of 92 (77%) responding editors also reported that articles from their publications always or often referred to medications by the generic names (95% CI, 67%-85%). However, only 3 of 92 newspapers (3%) had written policies stating that company funding sources of medical studies be reported (95% CI 1%-9%), and 2 of 93 (2%) newspapers had written policies stating that medications should be referred to by their generic names (95% CI 1%-8%). News articles reporting on medication studies often fail to report pharmaceutical company funding and frequently refer to medications by their brand names despite newspaper editors' contention that this is not the case.

Comment on: ‘Antidepressant medications and other treatments of depressive disorders: a CINP Task Force report based on a review of evidence’

The report of the CINP Task Force ‘Antidepressant medications and other treatments of depressive disorders’ (CINP Task Force, 2007) represents a scholarly and comprehensive review on the huge literature on antidepressants. As such, it is within the burgeoning modern tradition of evidence-based medicine. However, as a CINP report several points mentioned in the review could use additional emphasis. (1) The CINP is an organization promoting interaction between research psychopharmacologists, clinical psychopharmacologists and the pharmaceutical industry. A review done by a strict computer search, evidence-based approach can be biased by the fact that pharmaceutical company funding favours controlled trials of new patented compounds and that alternative and non-patented treatments often have small numbers and inferior methodology (Turner et al., 2008). The CINP is committed to attempting to correct this bias by searching out promising new treatments of depression anywhere in the world, including unpatented natural remedies that may have potential such as herbal remedies, Hypericum , inositol, omega-3, …