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Epogen

Erythropoietin (EPO) is a glycoprotein hormone that is a growth factor for erythrocyte (red blood cell) precursors in the bone marrow. It increases the number of red blood cells in the blood. Synthetic erythropoietin is available as a therapeutic agent produced by recombinant DNA technology. It is used in treating anemia resulting from chronic renal failure or from chemotherapy for the treatment of cancer. Its use is also believed to be common as a blood doping agent in endurance sports such as bicycle racing, triathlons and marathon running. more...

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Discovery and Biological Role

The existence of a humoral factor regulating red blood cell production was first postulated in 1906 based on transfusion experiments in rabbits. In 1950, the still unidentified erythropoietic factor was found to be stimulated in rats breathing a low-oxygen atmosphere, thus establishing the elements of its biological regulation. In the 1960s its source was identified as the kidneys. The human hormone was first purified in 1977 from human urine and a small amount was used experimentally to treat patients with anemia.

EPO has now been identified as a glycoprotein with a molecular mass of about 30,000 Daltons. It has a 165 amino acid chain with four oligosaccharide side chains and circulates in the blood plasma at a very low concentration (about 5 pmol/L).

In adult humans, EPO is produced primarily by peritubular cells in the kidneys, where its production is stimulated by low oxygen levels in the blood. Some EPO is also produced by the liver, which is the primary source in the fetus.

EPO acts by binding to a specific erythropoietin receptor (EpoR) on the surface of red cell precursors in the bone marrow, stimulating them to transform into mature red blood cells. As a result the oxygen level in blood reaching the kidney rises and the amount of EPO produced decreases.

Because the kidneys are the primary source of erythropoietin, chronic kidney disease often results in a systemic deficiency of EPO and consequent anemia. Anemia can also occur in cancer patients, sometimes as a direct result of the malignancy but usually as a side effect of chemotherapy.

Also, in patients who may require a blood transfusion or undergo surgery where blood loss is expected, EPO is given in advance as a precaution. The bone marrow produces more red blood cells, and if blood is lost during the operation, there is still enough to sustain the patient.

EPO as a Therapeutic Agent

A portion of the human EPO isolated from urine in 1977 was acquired by Amgen, Inc., an American biotechnology company. In 1983, the gene coding for it was identified at Amgen just weeks ahead of a corporate rival, allowing the company to establish a dominant patent position in the field after an epic legal battle. Recombinant DNA technology was used to express the protein in Chinese hamster ovary cells, which allowed a synthetic form of EPO (rEPO) to be produced in commercial quantities for the first time.

Recombinant EPO was launched as a pharmaceutical product by Amgen for treatment of anemia resulting from chronic kidney disease in 1989 under the brand name Epogen. In 1991 it was also approved for treating anemia resulting from cancer chemotherapy. Johnson & Johnson (J&J), an American pharmaceutical company, markets EPO under license from Amgen for cancer chemotherapy under the brand name Procrit. Amgen’s patents have so far prevented other companies from entering the US market. Even though the patents are all based on work done in the early 1980s, the last of them will not expire until 2015, thirty-two years after the date of the original application.

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Counterfeit drugs: check Combivir®, Serostim®, Epogen® - Brief Article
From AIDS Treatment News, 5/31/02 by John S. James

Since May 10, pharmaceutical manufacturers and the FDA have been warning medical professionals and patients about wrongly labeled or counterfeit drugs.

* Combivir: On May 10, GlaxoSmithKline announced that it had received four reports of bottles labeled as containing 60 tablets of Combivir (AZT plus 3TC) which actually contained another antiretroviral, Ziagen[R] (abacavir); the FDA also sent warnings. The main concern was that about 5% of patients receiving abacavir develop a hypersensitivity reaction, which could be life-threatening if not handled correctly. If patients and their physician did not know they were taking the drug, they would not be advised to be on guard for the reaction.

In this case, the Ziagen itself was the legitimate product.

From the Glaxo press release of May 10:

"Pharmacists, physicians and patients should immediately examine the contents of each Combivir[R] bottle to confirm they do not contain Ziagen[R] tablets. The two kinds of tablets are easily distinguishable. Combivir[R] is a white capsule-shaped tablet engraved with "GX FC3" on one side; the other side of the tablet is plain. Ziagen[R] is a yellow capsule-shaped tablet engraved with "GX 623" on one face; the other side is plain. The Combivir[R] label [meaning the prescribing information for physicians, not the label on the bottle - JSJ] shows a color photo of the tablet."

Pharmacist and patients who find the mislabeled medicine can call Glaxo at 888-825-5249.

* Serostim: On May 17 Serono, Inc. and the FDA announced that a counterfeit lot of Serostim, the company's human growth hormone, had been distributed. The drug had a fictitious lot number, MNH605A. "Any product labeled as Serostim[R] and carrying this lot number should be considered to be counterfeit." We have no information about what is in the counterfeit drug, except that it is definitely not the company's product. Patients or physicians who have questions can call Serono at 1-888-275-7376.

* Epogen: On May 21 we received a notice from the FDA that counterfeit Epogen (epoetin alpha) had been distributed. The counterfeit contains active ingredient, but in a concentration about 20 times too low. It is packed as EPOGEN 40,000 U/mL vials in ten-pack boxes, lot number P002970 expiration date: 7/03. More information is available at: http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#epogen

Comment

From the information we have seen (summarized above), the Ziagen falsely labeled as Combivir may be a result of somebody's incompetence or negligence; it makes less sense as a criminal design. Why use an expensive substitute that is easily distinguishable? In the other cases, fake drugs and labels were deliberately prepared and distributed.

It is not clear from the public information whether any of the mislabeled or counterfeit drugs got into the legitimate distribution chain (meaning that anyone's medicine could be at risk) -- or whether they were ordered from unknown Web sites that could have been set up by anybody. It should be possible to protect the legitimate drugs, since distributors and pharmacies are dealing with well known suppliers, and the source of each unit could be traced. There are indications that at least some of the bad products may have been bought on the Internet from unknown sites, although the public at least does not know for sure. (See "Clusters of Counterfeit Drugs" by Tim Kingston, San Francisco Frontiers, May 30, 2002; you can request a copy by email from the author at sfnews@frontiersweb.com.)

This is the latest of several incidents of counterfeiting of drugs often used in AIDS treatment. Activists should follow up on the investigations to find out what is learned about where the problems are coming from. We need to know whether or not there is any risk from the drugs on pharmacy shelves.

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