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05/18/2012

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Rich Berkowitz

This report is a very serious matter, and Gary Peterson should be commended for making it public. I'm certain in many respects it was a difficult decision, but only one which a person with great integrity would do.

This troubling report goes beyond the fact we have a dysfunctional dialysis system in the U.S. and beyond in most cases. We must be aware of what the "for-profit" dialysis system is capable of doing. It proves what the dialysis industrial-medical complex is capable of doing. Patients lives be damned! It comes down to quarterly reports nad what happens with shareholder earnings. This is not the way to run a health care system. How many times has something happened like this to which we are not aware.

We can point our fingers at other members of this industrial-medical complex whether it be providers, nephrologists, pharma, or others where we have heard of other issues. Immediate remedial action must take place in all cases. Unless patients stick up for ourselves nothing will change and we will die unnecessarily. Indeed, our government must step in. It's time for the entire dialysis system be re-examined by Congress. With thorough investigation I am certain this particular FMC "crime" is the tip of the iceberg.

Denise Eilers, BSN, RN

I consider myself largely a conservative with much of what that implies. So I have no problems with companies making a profit or with investors realizing a fair return on their money. It's part of the system called capitalism and I believe it works—most of the time. Where I part ways with the conservative philosophy is when it involves the health and lives of other human beings. People are not big-box-store products! People with chronic health conditions such as chronic kidney failure are arguably one of the most vulnerable segments of our society. They are dependent on not only the expertise but on the continual honesty and integrity of those professionals manufacturing their products and delivering their care. If corporate decisions and shareholder interests trump patient welfare, it is a sad commentary on the state of affairs.

Although not a perfect analogy, I think back to the Tylenol poisoning scandal of 1982. Rather than trying to cover up the situation, Johnson and Johnson stood by their philosophy of “protecting people first and property second.” They immediately issued public warnings and instituted a massive recall which cost the company approximately $100 million. In the end, it was also a good business decision. Following the debacle, J & J restored public faith in the product by taking measures to ensure that such an event would not be repeated. The Tylenol brand is still a giant in today's market and continues to maintain consumer confidence.

No health related company, even after jumping through all the hoops necessary to put a product on the market, can be 100% sure that after-market adverse effects, from whatever source, won't occur. If that does happen, as in the Tylenol case, the ethical thing to do is to recognize the problem, admit the problem exists, notify the appropriate agencies and take immediate steps to rectify it for EVERYONE affected.

As a nurse, a former dialysis care partner and someone who has many dear friends on dialysis, I am waiting for an honest explanation.

Fresenius?

Roberta Mikles BA RN

And, why does this NOT surprise me --- yet another coverup? Yet another situation where there is NO transparency!!! Yet another event where no one takes responsibility!!What next?
How many patients had negative outcomes due to this? How many negative outcomes are covered up by defensive documentation in the medical records.. How could we have come this far in this world of dialysis? Do the stockholders know of all these situations? Do they have no ethical backbones? Obviously those at the top of FMC can't be transparent, nor can they put themselves in the patient's shoes. SHAME SHAME SHAME on you FMC, once again. Even as I continue to read the FMC survey findings www.qualitysafepatientcare.com I continue to say "Why does FMC continue to not improve their day to day care for patients so that patient's lives have more quality and those who want to return to work can --- But then, for me, obvious, they just don't care --
In all my dealings with FMC I have never experienced any transparency when mistakes were made that my father experienced... NEVER - whatever happened to honesty?

opinions of Roberta Mikles BA RN
Dialysis Patient Safety Advocate
Daughter of father who encountered alot of problems at an FMC unit due to lack of education/training of staff and effective unit level supervision... Yes, Dad, FMC still does not care!

Gary Peterson

Additional information added May 21, 2:30 am EDT: In my effort to simplify the chemistry involved, I added an error to the article.


Sodium diacetate is made up of equal parts of acetic acid and sodium acetate. The acetic acid will become CO2 (carbon dioxide)and water, not bicarbonate in the body. The sodium acetate can become sodium bicarbonate in the body.

Gary Peterson

This is a story not about just one physician's conflict of interest, but about multiple persons' conflicts of interest in a vertically-integrated, for-profit healthcare corporation. All these conflicts of interest had a multiplying effect, resulting in risks and dangers for patients that are at a minimum, highly unacceptable, and at worst, criminal.

Statement from Fresenius Medical Care via NNI.

Rich Berkowitz

I too am now in possession of the internal and external memos referred to in the article. It's readily apparent that Fresenius treated its own physicians and facilities differently than non-FMC physicians and facilities. Why this double standard? I can think of a few reasons, but the bottomline is that Fresenius apparently hid the situation from competitors, although customers. How could any other provider trust Fresenius for supplies. I know I couldn't.

Gary Peterson

I hope the FDA realizes that Fresenius Medical Care (FMC) has knowingly created a system that allows FMC to withhold important information about the potential risks and hazards of FMC medical devices from its competitors, the non-FMC clinics.

The top FMC executives, who are not physicians but instead medical product sales and development experts, are able to greatly effect the medical care — and the risk of death — of dialysis patients in non-FMC clinics, while protecting their own corporation's patients.

How would FMC officials react if they discovered that another company was doing this to FMC patients?

FMC's corporate culture is so focused on its own needs that it is simply blind to basic medical ethics.

Chuck Weddle

After reading the Fresenius response in NNI, I'm left thinking that its just more smoke and mirrors.

How can one obtain a copy of the internal memo?

Denise Eilers, BSN, RN

@ Chuck: Obfuscation? Or maybe doublespeak?

Chuck Weddle

Denise, I don't know if I would call it obfuscation or not but it was definately smoke and mirrors. They said that the findings were not ready for peer review.

You can read the Fresenius response here...
www.nephrologynews.com/renal-business/article/fresenius-memos-bring-into-question-companys-handling-of-health-problems-linked-to-its-granuflo-dialysate-concentrate

Patricia Colongione

As a former CarePartner, I can certainly tell you, I would never allow my loved one to be treated in a Fresenius Center or a center that uses supplies from Fresenius ever again. I know I am being unrealistic. But They put people's lives at risk with no regard for the patient or their family. I am so angry right now and I am so afraid that they will get away with this. I hope they are truly punished harshly. For we do not know how many patients may have lost their lives at Fresenius's lack of RESPONSIBILITY TO THE PATIENT NOT THEIR BOTTOM LINE!!!!!

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