ARTS & FARCES internet

For more than 20 years, Amgen has enjoyed the benefits of a monopoly on treating anemia in end-stage renal disease patients on dialysis. Almost all dialysis patients are also severely anemic and receive regular intravenous injections of Amgen’s Epogen. Andrew Pollack, writing for the New York Times, reports Amgen sold about US$40 billion worth of Epogen over the past 23 years.

“Anemia drugs built Amgen into the world’s biggest biotechnology company,” writes Pollack. “In the early 1980s, as a small start-up, Amgen won a race to isolate the gene for erythropoietin, or Epo, a protein produced in the kidneys that causes the body to produce oxygen-carrying red blood cells. Amgen then spliced the human Epo gene into hamster ovary cells, which were grown in culture and could churn out large quantities of the protein to use as a drug.”

Amgen’s sole European patent on Epogen expired several years ago and the company and its drug has serious competition there. But in the US, Amgen was granted multiple patents on its single “invention,” resulting in a series of staggered patents, some of which don’t expire until 2015—much longer than the 20 years of exclusivity specified in US patent law.

The vast majority of US dialysis patients are on Medicare (I’ve been on dialysis since February 2000 and reamin privately insured). Before last year, the country’s two largest dialysis service providers—Fresenius and DaVita—could use Epogen as a profit center because Medicate would reimburse them for Epogen expenses at a rate higher than that which they paid Amgen for the drug. As a result, last year Medicare instituted a new reimbursement program—the “Dialysis Bundle”—whereby it pays a flat fee for dialysis services, including Epogen.

On 24 June 2011, the US Food and Drug Administration (FDA) announced that there is “no risk-free dosage level” of Epogen and similar erythroipoiesis stimulating agents (ESAs) and that these drugs should be used only to reduce the need for blood transfusions.

Yesterday, the FDA approved Affymax’s Omontys for treating anemia in dialysis patients. Omontys works the same way Epogen does in the body and will carry the same FDA “black box” warning. Some studies have indicated that some patients who take Omontys experienced a higher rate of cardiovascular problems.

John A. Orwin, Affymax chief executive, told Pollack that “... while the list price for Omontys might not be that different from that of Epogen, Affymax intended to make its product less expensive in its contract negotiations with dialysis providers….” And that’s precisely why most US patients will never see Omontys. As Pollock reports, DaVita has agreed to use Amgen’s drugs, including Epogen, “for at least 90 percent of its needs through the end of 2018.” Fresenius agreed to a three-year nonexclusive contract with Amgen.

Just trying to make sure I’ve got this straight….

Kimberly Saenz is on trial for capital murder in Angelina County, TX for allegedly injecting ten dialysis patients with bleach. Five of the patients died; five others became seriously ill.

DaVita is one of the two largest for-profit providers of dialysis services.

Kimberly Saenz was employed by DaVita as a registered nurse in its Lufkin, TX dialysis facility.

1. Defense attorney Ryan Deaton has repeatedly and aggressively alleged DaVita has tampered with evidence and hindered the investigation by police.
• DaVita representatives admitted opening an evidentiary sharps container before calling police.
• DaVita representatives delayed calling police for eight hours after the five dialysis patients died.
• DaVita conducted its own internal investigation; the judge in the case refused to allow this into evidence.
• DaVita allegedly prevented police from speaking with its employees for 18 days—after its internal investigation was concluded—after the patient deaths.
• DaVita employees allegedly changed carbon filter tanks without proper documentation.
• A DaVita supervisor is alleged to have stated that she would not go down alone.
• The judge disallowed testimony by DaVita dialysis facility janitors that they removed bags of shredded documents from the DaVita facility on the day the police were called.
• Peter Cartwright, a Minnesota-based water treatment consultant, testified that the DaVita dialysis facility at which the deaths occurred “is the most poorly run and operated system in hemodialysis I’ve seen.”
• Jonathan Neidigh, an assistant professor of basic sciences and biochemist at Loma Linda University, testified bleach traces found in some of the bloodlines had to be placed there after the dialysis machine was stopped.
• A forensic pathologist, Amy Gruszecki, testified none of the deceased patients—not one—had any sign of hemolysis (the breakdown of red blood cells). Gruszecki testified that bleach causes red blood cells to breakdown.

Regardless of the verdict the jury returns in this case, DaVita clearly has a lot of ‘splainin’ to do.

[Disclaimer: I’ve been a DaVita in-center hemodialysis patient since February 2000.]

Earlier this month, US District Judge Charles A. Pannell Jr., in Atlanta, refused to dismiss a whistleblower lawsuit alleging fraud against dialysis provider DaVita. Pannell found allegations made by two former employees appear to have merit. R. Robin McDonald, writing for the Daily Report, reports that Pannel writes in his decision, notes that the complaint—filed by a nephrologist and a nurse—“is replete with allegations that the defendants intentionally manipulated their corporate protocols and thereby created false records in order to induce the government to pay their claims based on those records.”

The complaint alleges that DaVita schemed to pad corporate profits by over-prescribing incredibly expensive drugs and discarding the unused remainders as waste while billing Medicare for both.

US government prosecutors have declined to prosecute DaVita based on the whistleblowers’ complaint. “After a four-year investigation, the US Attorney in Atlanta decided last year not to pursue the case. But US Attorney Sally Quillian Yates said in her letter declining the case that the federal government was retaining the right to intervene,” writes McDonald.

Health insurance premiums for myself and my wife may be almost three times as much as our mortgage payment, but never mind. Saint Paul is the best city for healthcare in the United States. So says the new Rising to the Challenge: Results from a Scorecard on Local Health System Performance, 2012 from The Commonwealth Fund.

The study used 43 metrics for its assessment including access, quality, costs, potentially avoidable hospital use, and health outcomes. Saint Paul scored in the top 25 percent of all 10 health outcomes sub-metrics which included infant mortality, obesity rate, rate of smoking, and deaths from breast cancer.

Not for nothing was I instructed by our attorney when I was diagnosed with end-stage renal disease in February 2000 to get a tattoo that said, “I don’t care where you found this body. Ship it back to Saint Paul, Minnesota.”

Kimberly Saenz is on trial for capital murder in Angelina County, TX for allegedly injecting ten dialysis patients with bleach. Five of the patients died; five others became seriously ill. Saenz was indicted on 30 March 2009 by an Angelina County, TX grand jury on one count of capital murder and five counts of aggravated assault. I’ll have a lot to say about this when all of the facts are in and the jury reaches a decision.

I’ve been reading the reports about this trial with great interest, for obvious reasons (Jessica Cooley’s nee Savage coverage for the Lufkin Daily News has been outstanding). I’ve held my tongue until now because I didn’t know all the facts. But something happened at the trial today—totally unrelated to Saenz’s guilt or innocence—and I can no longer remain quiet.

Nephrologist Imran Nazeer was the medical director of the DaVita dialysis center during the period of time that Saenz allegedly injected bleach into the bloodlines of ten dialysis patients. Nazeer “testified that center officials suspected bleach may have entered some patients’ bloodstreams but chose to keep the suspicions from the patients. He said he felt it was in the patients’ and clinic’s best interest not to say anything until all facts had been gathered,” reports Alexis Spears for KTRE, the ABC affiliate for the east Texas region.

That it’s in the dialysis center’s best interest to withhold suspicions that patients may have been injected with bleach is bizarrely logical, I guess. But how in any way possible is it in a dialysis patient’s “best interest” to withhold that information. Patients have an absolute right to be informed of any adverse event with regard to their treatment. Assuming Spears’s reporting of Nazeer’s testimony is accurate, Nazeer should lose his license to practice medicine.

[Disclaimer: I’ve been a DaVita in-center hemodialysis patient since February 2000.]