The real reason you aren’t getting your metformin..


As we’ve mentioned before on this site – metformin is an amazingly powerful yet safe diabetes drug that has also been shown to have additional cardiovascular benefits.. This doesn’t mean metformin has no side effects or contraindications (all medications have side effects and contraindications) but in comparison to all of the other available oral anti-diabetic medications, metformin continues to have the best safety profile.

The evidence is also overwhelming clear what are effective treatments for diabetes – and national guidelines reflect this.  (Nowhere in these guidelines are januvia, byetta and these other pricey medications listed.)  However, these guidelines are subject to change (along with anything else).. But who’s writing the guidelines?

But – it seems like that hasn’t stopped anyone from prescribing, and prescribing some of these very costly medications.. Now, on Medscape (and re-posted here for you) Reed Miller explains why as he reviews the recent paper by Jennifer Neuman, MD.

Conflicts of Interest Abound in  Diabetes Guidelines Committees

Reed Miller

Dr Jennifer Neuman (Mount Sinai School of Medicine, New York, NY) and colleagues reviewed the financial ties to industry of 288 panel members who served on 14 guidelines committees in the US and Canada between 2000 and 2010. Results of their study were published online October 11, 2011 in BMJ.

Five of the guidelines did not include a declaration of the panel members’ conflicts of interest, but 138 of the 288 panel members (48%) reported conflicts of interest at the time of the publication of the guideline. Eight reported more than one conflict. Of those who declared conflicts, 93% reported receiving honoraria, speaker’s fees, and/or other kinds of payments or stock ownership from drug manufacturers with an interest in diabetes or hyperlipidemia, and 7% reported receiving only research funding. Six panelists who declared conflicts were chairs of their committee.

Of the 73 panelists who had a chance to declare a conflict of interest but declared none, eight had undeclared COI that the researchers identified by searching other sources. Among the 77 panel members who did not have an opportunity to publicly declare COI in the guidelines documents, four were found to have COI.

The study also found that panelists on government-sponsored guidelines committees–such as those organized by the Veterans Administration or the US Preventive Services Task Force–were less likely to have conflicts of interest than panelists on nongovernment guidelines panels (15/92 [16%] vs135/196 [69%]; p<0.001). However, the researchers point out that the government-sponsored guidelines committees were less likely to have rigorous COI transparency policies.

A recent study of COI among members of American College of Cardiology/American Heart Association (AAC/AHA) – sponsored guidelines found that about half of guidelines committee members reported potential conflicts of interest. Neuman et al point out that their study includes a wider range of guideline-producing organizations and that it “exposes the problem of incomplete disclosure and highlights the important relation between sponsorship of guidelines and presence of COI.”

“In contrast to government-sponsored panels, we found that COI were very common among panel members for guidelines produced by specialty societies,” Neumann et al write.  Neumann cites a 2000 study [2] by Dr Roberto Grilli (Istituto di Ricerche Farmacologiche, Milan, Italy) as evidence that “guidelines produced by nongovernment-sponsored organizations have been shown to be of poor methodological quality; however, they contribute substantially to the guideline pool in the United States and Canada . . . [and] may have broad international influence. The high prevalence of COI among panel members of guidelines sponsored by specialty societies combined with the less rigorous development process may adversely affect the independence and the evidence base of the recommendations issued.”

One of the authors of the ACC/AHA study, Dr James Kirkpatrick (University of Pennsylvania, Philadelphia) told heartwire that he was pleased that the study by Neuman et al appears to confirm the main finding of his group’s study: “There are plenty of people who participated in the guidelines process who reported no disclosures. The implications are that it would not be too difficult to construct a guidelines panel without COI, or at least–as we suggested, and the authors also seem to suggest–with only COI related to research grant funding, exclusive of direct financial payments to members.” Kirkpatrick said he was surprised but reassured to see that Neumann et al found so few undeclared conflicts of interest.

“It is important to note that some governmental organizations don’t publish disclosures, which I believe they probably should,” Kirkpatrick said. “This problem is fairly widespread, not only among governmental organizations, but also other societies. It has the potential to erode public trust in the guidelines process as much as a relatively high rate of disclosed COI.”

How to Change the Culture of Conflicts

In an accompanying editorial [3], Dr Edwin Gale (Southmead Hospital, Bristol, UK) observes that the proportion of guideline committee members declaring a conflict of interest has increased recently, but the proportion of members with a potential conflict has not decreased.

The common suggestion that that guideline committees should include only experts with no conflicts of interest has “a charming sense of unreality,” Gale argues. “Money from drug companies is the oxygen on which the academic medical world depends. The income of the professional societies that publish guidelines largely derives from their annual conferences, which depend on the rents charged to exhibitors and the registration of company-sponsored delegates,” he observes. “Let us therefore forget the hand-wringing and confront the reality of the world in which we live.

Gale believes the conflicts on committees cannot be eliminated unless fewer experts take money from industry. “Legislation will not change the situation, for the smart money is always one step ahead. What is needed is a change of culture in which serving two masters becomes as socially unacceptable as smoking a cigarette. Until then, the drug industry will continue to model its behavior on that of its consumers, and we will continue to get the drug industry we deserve.”

Kirkpatrick agrees that the “culture” must change, but notes “there are other ways to make the process better.” For example, guideline-writing groups should follow the recommendations for COI laid out by the Institute of Medicine and Council on Medical Subspecialty Societies. “There needs to be a clear distinction between research and other payments,” because research grants are usually administered through third-party organizations that have “at least a semblance of improved oversight,” he said. However, Kirkpatrick believes that guideline committee members could be completely excluded from owning stock in affected companies or accepting fees for consulting or serving on corporate speaker’s bureaus for these firms. “I don’t see a problem with telling people they need to choose between this income and being on a guidelines committee.”

Neither Neumann nor Gale reported any conflicts of interest.

References
  1. Neuman J, Korenstein D, Ross J, and Keyhani S. Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and the United States: cross sectional study. BMJ 2011; DOI: 10.1136/bmj.d5621. Available at: http://www.bmj.com.
  2. Grilli R, Magrini N, Penna A, et al. Practice guidelines developed by specialty societies: The need for a critical appraisal. Lancet 2000; 355:103-106. Abstract
  3. Gale EAM. Conflicts of interest in guideline panel members. BMJ 2011; DOI: 10.1136/bmj.d5728. Available at: http://www.bmj.com.

Heartwire © 2011 Medscape, LLC

 ** metformin is usually safe from these considerations – it’s been out since 1977, has been generic years, and is currently featured on most $4 prescription plans – so it’s not pushed heavily by pharmaceutical reps.

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Update: February 2013 – A recent analysis on the safety recommendations and contraindications for use of metformin in patients with advanced kidney disease has been presented by a Pharmacy resident at the University of Texas – and he makes a compelling case that we should reconsider many of the current restrictions on using metformin in renal failure.

Unleash Metformin: Reconsideration of the Contraindication in Patients with Renal Impairment” by Wenya R. Lu, PharmD

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