Two stories hit the wires this week that centered on Amgen and its blockbuster Aranesp and related drugs. It involves major fraud, conflicting polices between the FDA and Medicare, questions about how drugs are marketed and illustrates why health care reform has to be done right. These stories should be of particular interest to anyone who is a cancer, diabetes, kidney disease or transplant patient or is related to someone who is. It should also concern anyone who is on Medicare or Medicaid or who is paying premiums for health care. It concerns your health decisions (risks v. benefits) and your pocketbook.
The first story is the lawsuit filed against Amgen and an associated company by 15 AG's led by Andrew Cuomo for kickbacks paid to doctors and clinics who were encouraged by the company to commit fraudulent claims for payment for these blockbuster drugs to Medicaid as well as Medicare and health insurers. The case is United States of America et al v. Amgen Inc, U.S. District Court, District of Massachusetts, No. 06-10972.
Forbes has the details of the lawsuit here:
http://www.forbes.com/...
According to Cuomo's office, the lawsuit alleges that Amgen and two AmerisourceBergen units, International Nephrology Network and ASD Healthcare, conspired to encourage doctors to bill third party payers such as Medicaid for free Aranesp that was provided to them at no cost.
He also said the defendants conspired to offer kickbacks to medical providers, including sham consultancy agreements and weekend retreats, to induce them to buy and prescribe Aranesp.
"Drugs should be prescribed to patients on the basis of need, effectiveness, and safety, not on a corporate giant's promise of an all-expense paid vacation," Cuomo said in a statement. He said Amgen's bribing of doctors "left taxpayers footing the bill for free drug samples."
The second story is a study that questions the benefits of a drug that was approved and has been in wide use for 17 years but has been shown to have put many patients at higher risk of death or severe side effects such as strokes and other problems from blood clots. The drug is a biotech engineered hormone to get the bone marrow to produce more red blood cells. It is the same type of drug used in sports for 'blood doping' and is hard to detect since it is a natural occuring hormone produced by the body to carry oxygen. The more red blood cells, the more oxygen can be supplied to delay fatigue.
Wikipedia's article on 'blood doping' explains how EPO (epogen) replaced blood transfusions in bicycle racing and other sports and the risks involved to the health of the dopers looking for an edge.
http://en.wikipedia.org/... and more technical information in the article on Erythropoietin with a colorful picture:
http://en.wikipedia.org/...
In the late 1980s, an advance in medicine led to an entirely new form of blood doping involving the hormone erythropoietin (EPO). EPO is a naturally-occurring hormone growth factor that stimulates the formation of RBCs. Recombinant DNA technology made it possible to produce EPO economically on a large scale and it was approved in US and Europe as a pharmaceutical product for the treatment of anemia resulting from renal failure or cancer chemotherapy. Easily injected under the skin, pharmaceutical EPO can boost hematocrit for six to twenty four weeks, or longer. The use of EPO is now believed by many to be widespread in endurance sports.[citation needed]
EPO is not free of health hazards: Excessive use of the hormone can raise hematocrit above 70% which can cause polycythemia, a condition wherein the level of RBCs in the blood is abnormally high. This causes the blood to be more viscous than normal, a condition that strains the heart. Some elite athletes who died of heart failure — usually during sleep, when heart rate is naturally low—were found to have unnaturally high RBC concentrations in their blood[1].
It was also used and banned in race horses for the same reasons. They ran themselves to death or dropped dead from heart attacks or strokes.
The good thing about EPO was that it replaced the need for so many blood transfusions and their risks. The bad news is that it has so many risks of its own that are now being recognized and warned about.
Forbes has a detailed article giving the background of the Amgen scandal.
It's called : Amgen's Enemies
http://www.forbes.com/...
Here are some crucial points:
The third problem is that a dispute is brewing about whether certain Amgen patients are getting more of one costly drug than they really need. The drug in question is Epogen, which stimulates the body to produce red blood cells. Dosing levels have crept up by a factor of four over the past decade, though some doubt that this makes dialysis patients live longer. The higher doses have the side effect of fattening the bank accounts of both Amgen and the clinics that choose the prescriptions. The insurers who pay the bills have taken notice. That group includes Medicare, which spent $1.75 billion on Epogen last year, more than on any other drug.
Medicare spent more on Epogen than any other drug and it's not hard to understand why if you look at what is charged for a single injection and the number of patients who have cancer treatments and dialysis which qualifies them for Medicare no matter their age. For over two years after my last round of Chemo, I had to have an injection of Aranesp and Neulasta every two weeks for which the clinic charged over $10,000 a pop. People did not believe me when I told them about the costs. Blockbusters, indeed. That's for just what is called palliative care. That's not considering the blockbuster drug used for the treatment for the cancer itself. That's another story.
The article relates the conflicts between the FDA's panel's recommendations and the policies of Medicare which ignored them. I wish someone would come up with some figures on the waste and abuse from this overpaying and overuse. When Obama's people talk about savings from Medicare to pay for expanded coverage, they would have a good case to point to as a flagrant example.
When epogen is added to neupogen, which is a companion drug from Amgen to boost immunity, the costs skyrocket. Then add the marketing practices and you have a scandal that should be headlining the news as we talk about the need for reform. It's not just that the costs bleed the system, but that the overprescription and overuses cause a great deal of harm to the patients and their loved ones. After all, the drugs are supposed to make the anemic patients feel better and have more energy. You've seen the commercials for Procrit. One day moping around all pale and listless and a short time later running a bed and breakfast or on the streets shopping and helping out as crossing guards for school kids. I hated those adds for very personal reasons. When I would complain of cancer fatigue, people would chirp about getting Procrit to pep me up. They had no idea I was already on it and no ideal of the costs and they had no idea they it did not work as the ads portrayed. The FDA forced them to stop the ads when the test results started to show the dangers as well as the lack of significant improvement for many patients. It was false advertising of a very dark sort.
This website from the University of Florida has archives of the stories going back and showing the changes for anyone who wants to follow the story of the promotion of the drug and then the later findings.
http://www.ufscc.ufl.edu/...
Again, for patients and their loved ones, it's information they need to make informed decisions about their care and questions to raise with their doctors.
If you really want to keep up, it's not just the medical news you should check, but the business news. Investors get a lot more information than patients and in much more detail. The law requires companies to divulge much more than doctors do or have time to do.
Take a look at the prospects for Amgen in 2002:
http://www.marketwatch.com/...
Marketing of the drugs is big business,too and adds greatly to the cost. But the marketers know what's in the pipeline. It's good to check out their perspective. Here's an article that links the above mentioned stories with another very hot topic: biotech drugs that copy the blockbusters.
Merck recently announced it is forming a new division, Merck BioVentures MBV, to make copycat versions of biotech drugs. In its immediate target zone are products such as Amgen's Aranesp, a long-acting treatment for anemia that Merck expects to launch in 2012.
http://www.mmm-online.com/...
It brings up the issues of brands, generics and where's that's going with the biotech drugs.
So, where does this leave us with the Aranesp story. This article from the Boston Globe has combined the two stories and gives us some clues.
"The risks of the therapy were bigger than we thought, namely stroke, and the benefits were less than we thought, in quality of life,’’ said Dr. Marc Pfeffer, a cardiologist at Brigham and Women’s Hospital who led an international group studying Aranesp, which raises red blood cell levels.
Patients with type 2 diabetes and kidney disease often become anemic, and heart and kidney problems can be accelerated by anemia, so doctors have long prescribed Aranesp (darbepoetin alfa) and similar drugs believing that treating the anemia would improve patient’s prognosis. The study confirmed that patients taking Aranesp required fewer blood transfusions and suffered less fatigue, but other hoped-for outcomes were not seen.
A crucial message indeed as in the following quote from the article:
Dr. Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice said the findings reinforce a crucial message in medicine.
"This current study is an important reminder of how important it is not to assume the treatments work, but to prove them,’’ said Woloshin, who was not involved in the study. Aranesp, made by California-based Amgen, was approved by the Food and Drug Administration in 2001 for use in kidney patients, but a similar drug also made by Amgen has been prescribed for 20 years.
That's a quote worth remembering as we progess in the healthcare debate. We have to make sure that scientists are making the calls and they have the proof they need before businesses get to tell us "It's your money or your life." There are many lessons to be learned from this story and it affects us all as patients, providers, and taxpayers. As a country, we can do so much better if we use our healthcare budgets on proven drugs and find a way to limit the pressure on policy makers from lobbyists and limit the marketing practices that are bad for our health financially as well as medically.