Health and Medical News and Resources

General interest items edited by Janice Flahiff

[Journal article] How Basic Scientists Help the Pharmaceutical Industry Market Drugs

Excerpt from the December 2013 PLoS article by Adriane Fugh-Berman 

In the 1970s, a Baltimore city senator who also owned a tavern backed legislation that helped his business. Accused of having a conflict of interest, Joseph J. Staszak, responded, “What conflict of interest? How does this conflict with my interest?” [1].

According to the Institute of Medicine, a conflict of interest is “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary influence” [2]. More simply, conflicts of interest may be seen as circumstances in which “individuals’ professional responsibilities diverge from their personal interests (or when different professional responsibilities clash)” [3].

In biomedicine, discourse on conflicts of interest (also called competing interests) has focused on relationships between industry and physicians or clinical researchers. However, basic scientists are not immune to industry influence on research and publications, and may be important to industry in the production and dissemination of marketing messages.

Depending on Industry

In 2007, industry was the largest funder of biomedical research, paying for nearly twice as much research (58%) as the federal government (33%) [4]. Most of this funding goes to clinical research; the share of spending by pharmaceutical and device industry on preclinical research has decreased from about half (55%) in 1998 to a quarter (25%) in 2010 [5]. A 2007 survey of 3,080 academic life science researchers found that half (53%) have some form of relationship with industry [6]. Among the 1,663 research faculty at academic medical centers, 42% of basic scientists had a relationship with industry. This number was similar to health services researchers/clinical epidemiologists (40%), but less than clinical researchers (67%) translational researchers (61%), or “multimodal” researchers (71%) [7]. At the 50 universities that received the most NIH research funding, 43% of 2,167 life science researchers reported receiving a research-related gift in the late 1990s [8]. Gifts included biomaterials (24% of respondents), discretionary funds (15%), equipment (11%), travel funds to professional meetings (11%), student support (9%), and other (3%).

Researchers were aware that something was expected in return for the gift. Sponsor expectations that the gift be used for its intended purpose and not be re-gifted, and that the sponsor be acknowledged in publications, are certainly reasonable. Disturbingly, however, about a third (32%) of gift recipients reported that the funder wanted prepublication review of any articles or reports stemming from the use of the gift. This expectation was higher for gifts of biomaterials: 40% of respondents reported that the firm wanted to receive prepublication review of articles or reports. Also, 44% of firms wanted assurances that the biomaterial was not to be used for applications that competed with company products [8].

Industry Funding Affects Results

In clinical research, investigators who receive industry funding are more likely to publish results that favor a sponsor’s marketing goals than are investigators who do not receive industry funding. The Cochrane Collaboration, renowned for creating and publishing high-quality systematic reviews, analyzed 48 clinical studies, systematic reviews, and meta-analyses that compared results from studies of drugs or medical devices based on sponsorship. This systematic review found that industry-sponsored studies, compared to non-industry-sponsored studies, were more likely to report favorable efficacy results for drugs or medical devices; less likely to find harms; and more likely to conclude that a therapy was beneficial [9].

Selective Publication

Selective presentations and publications are important tactics for industry. Industry relies on abstracts and posters to convey marketing messages at scientific meetings, because abstracts and posters are usually not peer-reviewed and can be easily altered up to the time of presentation. Posters and abstracts are often used for preclinical studies, case reports, or preliminary results of clinical trials. Promising preliminary results might be presented as a poster, and the results may be publicized, but if the final results of the study do not support commercial goals, the full study may never be published – or may be buried in an obscure, low-impact journal. In either case, scientists may have a positive impression of a therapy from a poster, and never learn that the therapy failed to show efficacy in the final study.

Perhaps because negative outcomes from industry-funded studies are less likely to be submitted for publication, industry-funded clinical trials overall are less likely to be published. An analysis of 546 drug trials listed in ClinicalTrials.gov found that within two years of study completion, about a third of studies that received full (32%) or partial (39%) industry support were published. In contrast, more than half (54%) of trials funded by government, and 56% of trials funded entirely through nonprofit/nonfederal funds, were published [19].

The majority of meeting abstracts and posters are never published. Posters and abstracts with positive results are far more likely to be published than negative studies [14],[15].

..

Once a drug is on the market, it can be prescribed “off-label” – that is, for any condition other than that for which the drug was approved. Although it is legal for physicians and other prescribers to prescribe a drug off-label, it is illegal for pharmaceutical companies to promote drugs off-label. Off-label use is common, accounting for about one in five prescriptions [23]. It is unknown how much off-label use is due to promotion.

Pharmaceutical companies use paid speakers, consultants, and researchers to promote off-label use [24].

,,,

Companies have paid billions of dollars in fines for off-label promotion, often using company-generated research, company-paid speakers, and ghostwritten articles to imply clinical benefits in the absence of clinical trials (or the presence of negative trials); fines have also been imposed for suppressing risks or misleading clinicians about risks [34].

Read the entire article here

 

December 8, 2013 Posted by | Biomedical Research Resources | , , , , , , , | Leave a comment

Introducing a three-part series on medical journal ghostwriting

Gary Schwitzer, at HealthNewsReview.org, presents a three part series on medical journal ghostwriting.

Good overview on how to spot ghostwriting and two examples of how ghostwriting may introduce conflicts of interest and skewed results.

 

January 29, 2013 Posted by | Biomedical Research Resources, Librarian Resources | , , , | Leave a comment

Your doctor has sold his practice: 6 tips for patients (tips are also good for doctors not selling their practice!)

Conversation between doctor and patient/consumer.

Conversation between doctor and patient/consumer. (Photo credit: Wikipedia)

I’m not sure I’d have the chutzpah to ask about performance requirements or conflicts of interest.
But maybe if I went to an office visit with these types of questions written down, I would be more likely to ask them!

(As an aside, I accompanied my mom to outpatient surgery yesterday. The only way I could assure myself I would
ask the surgeon a few questions while mom was in post-op…was to write them down and have them “on display” in what is now called the “interview room”. The surgeon did take note of the scrawled questions and was ever so patient and answered each one completely.
Granted, these were questions related to how to take care of my mom, not his performance requirements or conflicts of interest.
Still, I think I could build on writing down questions about how to take care of oneself or others to include questions relating the necessity of a medical test or procedure.)

I am not sure about two of the points.
Would anyone in the doctor’s office really be candid about performance requirements? Or even know about them?
The office staff has at least the potential about conflict of interest. They work for the doctor (and by extension any health organization the doctor belongs to which could be the source of a conflict of interest!) Maybe it would be best to ask the doctor directly.

Online databases and forums are most likely not objective. They only record input from folks. And the input is not evaluated for “truth”.
Crowdsourcing at times can point to the truth, but I believe at times crowds can be misinformed (and act on rumors). And I don’t think that online databases/forums can readily distinguish when reports are based on fact or falsehoods.

From the 3 January 2013 article by Cary Present, MD at KevinMD.com

When doctors sell their practices to hospitals or networks, the practices are typically restructured. When they restructure, the new arrangement can put the doctor under more pressure to treat you (the patient) more “economically,” so as to generate more income. This can mean ordering tests or prescribing medicines that you may or may not need – things that are more for “let’s just be safe” and would be avoided in a private practice.

What does this all mean for you as a patient? Other than potentially higher medical costs, possible deterioration in treatment, and a lack of personal attention as a person, it boils down simply to a conflict of interest. In other words, there is greater potential for disagreement regarding what is in your best interest according to convention and how the doctor or hospital treats you…

..

  • First, when your doctor is recommending tests or treatments or hospitalization for you, take the time to ask if you really the treatments – ask if the doctor would do the same for a family member
  • Second, ask for a second opinion to determine if you need the recommended care – this should be your standard reaction when tests are ordered…

Read the entire article here

January 4, 2013 Posted by | health care | , , , | Leave a comment

Guidelines Panellists’ Conflict Of Interest Raises Concern

From the 13 October 2011 Medical News Today article

An investigation published on bmj.com today showed that members of guideline panels in the U.S. and Canada have a high prevalence of conflicts and high numbers of under-reporting conflicts of interest (COI).

The problem of incomplete disclosure is exposed in the investigation, which also underlines the crucial relationship between presence of COI and sponsorship guidelines.

For over 20 years the incidence of COI among industry and clinicians has been a concern for the medical profession.

Because freedom from bias is important, the development of clinical practical guidelines is one area of particular concern for the presence of COI.

Even though the majority of companies that create guidelines have adopted conflict on interest disclosure policies, they are not usually clear, and might not be enough to stop members of guideline panels bias from influencing recommendations. …

Read the entire article

October 15, 2011 Posted by | Medical and Health Research News | , , , | Leave a comment

   

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