Conflicts of interest

This week Fresenius Medical Care announced that it had formed a new renal pharmaceutical company, Vifor-Fresenius Medical Care Renal Pharma Ltd., as a joint venture with Galenica Ltd. The company is designed to develop and distribute products to treat iron deficiency anemia and bone mineral metabolism for pre-dialysis and dialysis patients.

This potentially creates an enormous number of conflicts of interest that should concern the dialysis patient community, dialysis care professionals, and policymakers for several reasons.

Do corporate goals influence the administration of medications in dialysis centers? One only needs to look at anemia drugs (ESAs). Under current policies, the more ESAs the patients receive, the higher the profits the dialysis provider enjoys. Examining the recent USRDS annual reports, of the three largest dialysis providers in the US (FMC, DaVita, and DCI), the one that administers the lowest doses of ESAs to its patients is the only one that is a non-profit corporation (DCI).

This is a case where one company will make the drugs and administer them to the patients as their caregivers. The drug company employees and doctors and nurses in the dialysis unit will all report to corporate entities with common financial goals. Will those who raise concerns or red flags — about a drug's effect, drug reactions, dosage amounts, or better medications to use — be seen as helpful or harmful to corporate goals? What usually happens to internal whistleblowers? As demonstrated by this September 15, 2010 FDA warning letter to Fresenius Medical Care, there are serious questions as to how thoroughly a corporation will investigate and address its own shortcomings.

Will Fresenius Medical Care fund studies that are designed to highlight the benefits of their medications and minimize their risks? Will adverse and disappointing results be hidden? Will they fund studies to show the inferiority of competitors' drugs? All these actions have been common in the pharmaceutical industry.

Will corporate treatment protocols be built around encouraging the use of the corporation's medications?

If nephrologists and nurses have stock options in the corporations, what and where are their best interests?

A final point: The need for these pharmaceuticals is also largely dependent upon the amount of dialysis therapy the patients receive. If patients receive the minimum amount of therapy that is normally provided with standard, in-center care, they will continue to need significant doses of these medications. There is a growing consensus that if patients receive longer and/or more frequent hemodialysis treatments, they require fewer medications and smaller dosages. If FMC is selling these drugs to all other dialysis providers, they have an interest in retaining short, 3x/week treatments as an industry standard.

Keep in mind that most dialysis patients are no longer sources of profit to the dialysis provider corporations if they survive on dialysis longer than three years.

While I believe there are many compassionate and caring people in these dialysis provider corporations, in today's world a large corporation must and will act in its own short-term interests… despite their intentions. This joint venture nullifies too many of the needed checks and balances for safe and effective patient care.

Comments

[Peter Laird, MD]

Thank you for the excellent commentary on corporate conflicts of interest. The issue of ESA usage is one of the darkest periods of medicine whereby doctors were given huge profits for giving more and more of the drug. Looking back at ESA, there were calls for caution at the onset of its use, but these warnings were put away until really 2007 or there about.

There are definite benefits to ESA use, but not for all patients and pushing the dosage limits on EPO non-responders surely led to many deaths and complications now well documented in several recent studies.

The issue really is a symptom of the broader problem of turning medicine into a business instead of a profession. I have long held the stance that medical corporations should be non-profit only. I worked at Kaiser for about 11 years and saw the direct benefit of being able to give that extra 15-25% taken to corporate profits in other companies directly to the patient and still have a healthy business status to continue to deliver care to those in need. Certainly, the experience over seas with some nations has led them to make all health corporations non-profit to the benefit of the entire population.

Lastly, for the individual doctor, we must return to the profession of medicine where we continue to hold the ideals of those that have gone before us. We have a new generation of practitioners many of whom consider this the best business to be in, yet they have forgotten the wisdom that made American medicine what it once was. It is time to turn the clocks back in time, but instead, we become more business oriented and less patient oriented all the time.

[Brian Riddle, NxStageUsers]

When I first saw this announcement about Fresenius going into the pharmaceutical business , I first thought the same thing..Is Fresenius now going to be putting a bandaid on patients by pushing the drugs instead of doing what is best for the patient?
It will be interesting to see how this will affect future profits of the company. How does something like this get approved?

[Zach]

In 2006, Fresenius bought the pharmaceutical company that made PhosLo. How has that affected their dialysis patients? Are calcium values higher in Fresenius patients?

[Valette Tillman (pct)]

I'm really not sure why anyone is worried about Fresenius owning a pharmaceutical company. Where were you when they started out as a dialysis machine making company that was able to buy most of the dialysis units here in the states;they are home based in Germany? Where were you when they bought a laboratory company that is able to do blood work,and colony counts for bacteria growth.Conflict of interest get real.

[Peter Laird, MD]

I will go one step further to call all for profit health companies into question on the issue of conflict of interest where profits are placed at a higher value in many cases than patient outcomes. It is worrisome to consider what potential effects the bundle system may produce. We bravely enter into that new experiment soon. For some reason, the dialysis industry has not had the strict regulations enforced under Pete Stark's legislation on self referral for instance to businesses owned by the referring physician. Simply because this industry has a long standing association with conflicting interests does not in any sense make it right.

[roberta mikles]

Peter, you statement "..dialysis industry has not had the strict regulations enforced...' is an understatement in many areas e.g. CMS' oversight of nursing homes, oversight of hospitals via state oversight e.g. increased focus in infection prevention. After reading through the 2010 surveys here in California, for dialysis centers, I am shocked at that which I read. Within a six month period, one facility was cited twice for giving the wrong patient the wrong dialyzer (reuse). Obvious that the facility did NOT follow their own Plan of Correction.j This is getting more and more frightening to see many of these deficiencies that are placing patients in harm's way. A surveyor finds, during survey, the wrong bath (K+). what if the surveyor was not there? The patient's level was high,,, .. just wondering how many patients, out of the sampled number, had same problems that were identified in the survey findings. I am sorry, but reality is reality and patients need to speak out and educate themselves (and, their loved ones). All facilities SHOULD allow who ever the patient wants to stay with them, just as hospitals do. If all are educated, we can work together to PREVENT errors that can be deadly

Roberta Mikles
www.qualitysafepatientcare.com