Wednesday, July 15, 2009

Pharmaceutical Industry Influence on Guidelines and Performance Measures


The effect that industry influence has on individual doctors, hospitals and clinics through free lunches, CME dinners and trips and getting on the formulary has been well documented. However, one area that has not received enough attention is how industry encourages more care by financing and supporting more aggressive clinical guidelines and performance measures. More care is sometimes beneficial for patients and sometimes harmful; however more care is almost always beneficial for industry. I'll highlight 2 instances.

Amgen and KDOQI (Kidney and Dialysis Outcomes Quality Initiative)

Amgen "is the founding and principal sponsor" of KDOQI, getting their name and logo as a supporter of guideline development. KDOQI has established anemia guidelines on what is appropriate targets for hemoglobin in dialysis patients. These guidelines have led to a steady increase in average hemoglobin values in the US dialysis population from 10 in 1993 to 12 in 2004. The primary treatment for anemia are erythropoitin stimulating agents, such as Epogen and Aranesp, made by Amgen. Amgen's sales of Epogen and Aranesp in the US in 2005 were $4.56 billion. To be fair, some of this increase in hemoglobin may have helped some patients, but it is clear that it helped Amgen.

Sidebar: DaVita, a for-profit dialysis corporation, reported that 25% of 2005 dialysis revenues were from erythropoitin stimulating agents and that "our agreement w/Amgen also provides for specific rebates and incentives."

For more detailed information, see Coyne DW, "Influence of Industry on Renal Guideline Development" Clin J Am Soc Nephrol 2: 3-7, 2007.

Aventis and A1c < 7 In 2004, Aventis worked with a marketing firm to launch the "A1c<7 by 2007" campaign on World Diabetes Day. It was co-sponsored by the America Diabetes Association (which receives funding from Aventis), supported by the National Committee on Quality Assurance (the folks who brought you HEDIS) and the Congressional Diabetes Caucus. This is despite the fact that the Technical Expert Panel of the National Diabetes Quality Improvement Alliance unanimously rejected the A1c < 7 measure. In 2008, a series of trials (ACCORD, ADVANCE, VADT) came out which suggested that decreasing A1c levels to <7 may be harmful. Aventis makes Lantus, and the worldwide sales in 2007 was $2.785 billion, 33% increase from 2006. To be fair, some patients probably benefited from getting their A1c < 7; however, the best data now suggests that more were harmed. Clearly, Aventis benefited. Sidebar: This push to lowering A1c probably also led to overuse of Rosiglitazone (GlaxoSmithKline), which has now been shown to increase cardiovascular events. For more detailed information, see Aron D and Pogach L, "Transparency Standards for Diabetes Performance Measures" JAMA 301: 210-212; Jan 14, 2009.


In this era where the country is looking for maximum value for the healthcare dollar, we can no longer afford to continue to let the pharmaceutical industry unfettered influence in medicine.

5 comments:

Alex Smith said...

I've been thinking about other examples of how big pharma might be influencing our care of the elderly or persons with serious illness. The first thing that comes to mind is the off-label advertising of gabapentin. Seth Landefeld and Mike Steinman wrote a great report about this in NEJM:

The Neurontin Legacy

Since these marketing practices have come to light, I've not been sure to what degree the teaching I received about the use of gabapentin for neuropathic pain is correct, or evidence based. I was taught that gabapentin should be the first line therapy, that other medications such as opioids were less effective to ineffective, and that the dose of gabapentin needed to be aggressively titrated, upwards of 3600mg a day, to achieve effective results. I had many sleepy patients with marginally improved pain control. Andy Billings, chief of palliative care at MGH, always insisted that opioids should be first line therapy for neuropathic pain, and I've started to think perhaps he's correct. Has anyone done more critical thinking/research about this issue?

ken covinsky said...

Sei---I am attending on medicine this month and copied this post for the residents and students on my team as a compelling statement of how critical we need to be when we read guidelines. We really need to carefully ask who wrote them and what evidence supports them. These guidelines illustrate that guidelines supported by industry may support more aggressive care, and that this more aggressive care will generally be beneficial to industry, but may not be beneficial to patients. It may be even sometimes be harmful.

It is a shame that we have reached an era in which we may even need to be careful about guidelines supported by prestigious professional organizations. Shame on the National Kidney Foundation and the American Diabetes Association for accepting funding from "partners" who stand to profit from their guidelines and clinical recommendations.

Seth Landefeld said...

Sei,

You're absolutely right - the financing and production of practice guidelines by entities with commercial conflicts of interest produces biased guidelines that are bad for the public health as well as the public purse.

What can be done?

First, as your examples point out, everyone should be sceptical of "conflicted guidelines" - i.e., guidelines produced with commercial conflicts of interest.

Second, we should encourage regulation to prevent, or at least reduce, the production of "conflicted guidelines." Regulatory approaches may be limited, however, by free speech considerations.

Third, we can change our culture that accepts "conflicted guidelines" - they are not acceptable - and promote alternative means to produce unbiased guidelines. This builds on the recent IOM report's call to “create incentives for reducing conflicts in clinical practice guideline development” (Institute of Medicine. Conflict of interest in medical research, education, and practice. Washington, DC: National Academies Press,
2009. at http://www.iom.edu/CMS/3740/47464/65721.aspx.)

Seth Landefeld

Helen Chen said...

The HA1C target of 7 has become holy writ in some circles. Physicians with a contrarian view are accused of anti-evidence based blasphemy. However, many of us in the primary care trenches have seen the harms that have occurred (particularly to elders) through slavish adherence to this Big Pharma driven measure and have been heartened by recent papers arguing for a different approach to diabetes management (Montori VV, Fernandez-Balsells M. Glycemic control in type 2 diabetes. Time for evidence-based about-face. Ann Intern Med 2009; 150: 803). It is concerning that the current "quality" driven P4P measures in many practices rely on outcomes such as HA1C which may have numerous, harmful, unintended consequences.

Alex Smith said...

"DBs medical rants" is writing a talk about this, anyone who wants to give suggestions should go over to his site to give suggestions. DB Medical rants link.