Article by Dr. Michael A. S. Guth
Amgen (AMGN) Global Health Economics and Outcomes Research
Biotechnology company Amgen Inc. (AMGN) saw the price of its shares fall from a high of to around as of October 2, 2007. The decline in Amgen stock followed news of reduced sales forecasts for its best-selling drug, Aranesp. With declining revenues from drug sales, Amgen is being forced to trim expenditures. The company announced it was laying off between 12 – 14% of its workforce and planned to cut capital expenditures by .9 billion. See the related news story at URL http://biz.yahoo.com/ap/070815/amgen_restructuring.html?.v=9
Surprisingly, Amgen plans no reduction in staff in its Global Health Economics and Outcomes Research (HEOR) unit. This unit comprises a hodgepodge of professionals with Ph.D.s in economics, pharmacists, medical doctors, and assorted analysts with data manipulation backgrounds. Their mission is to analyze pre-clinical trial design and post-clinical trial data to extract some causal relationship between an Amgen drug and a positive benefit to clinical trial patients. Normally, the competent medical doctors supervising a clinical trial at field locations can observe whether a drug is having any positive benefit for patients. These doctors are perfectly capable of assessing the efficacy of a drug being evaluated in the clinical trial.
The HEOR unit is called to action to verify statistically what the doctors claim they observe in the field and to try to find additional, unintended benefits from the drug so that Amgen can apply for a patent on the unintended consequence. Due to the large number of clinical trials that do not reveal efficacy of proposed drugs, the primary work of Amgen’s HEOR unit seems to be salvaging any possible value or use for an Amgen drug rejected by the medical community.
There is a fine line between manipulating data to illustrate a deeply hidden benefit for patients versus trying to find a benefit where none exists. Relying on various statistical methods, Amgen’s HEOR staff proposes causal relationships and desperately seeks data to confirm them. Only people with a certain mentality can be stimulated by the daily prospect of sifting through garbage in hopes of finding a diamond.
On and on the data manipulation goes trying to prove the drugs rejected by the medical professionals in clinical trials do in fact show some obscure, often trivial, benefit to patients. The Health Economics and Outcomes Research staff would like to believe it is smarter than the doctors in the field, because the HEOR staff claim they can find medical benefits that doctors treating patients failed to observe. In reality, the Amgen HEOR staff research models and their statistical results are often tenuous, at best, and ludicrous, at worst. I teach Health Care Economics at both the undergraduate and graduate level. Having seen how my undergraduate students critique health care policy initiatives and the pharmaceutical industry, I have no doubt they would easily tear apart the assumptions, analyses, and conclusions of the Amgen HEOR studies and reports. Investors have to wonder why Amgen spends an estimated million in salaries for its HEOR professionals if their output is susceptible to rebuke by undergraduate students with no pharmaceutical training.
Another sign of the poor quality of Amgen’s Health Economics unit is its lack of publications. Amgen certainly takes pride when its staff can get research results published in peer-reviewed journals. Professional journal publications by Amgen staff aid the company’s marketing campaigns, add to the prestige of the company, and help enable them to recruit leading scientists. On October 2, 2007, I searched the Nexis “All Full-Text Medical Journals” database using the keyword “AMGEN” in the same sentence as “Health Economics” or “Outcomes Research.” A total of 0 articles were found. I then repeated this same search using the “All Medline Review Article References,” which contains journal publications pre-1975 to the present. A grand total of one article appeared entitled “Psychological outcomes associated with anemia-related fatigue in cancer patients,” which relates to Amgen’s now declining sales drug Aranesp. Desperate to find some evidence of tangible published research by Amgen’s HEOR unit, I then searched the database called “Healthcare Archive News,” which contains publicity announcements and press releases about even minor scientific and medical research findings. The database contained zero articles about any Amgen HEOR medical findings but did list a few press releases concerning the appointments of David Beier and Joshua Ofman to lead Amgen’s HEOR group.
In the fall of 2005, I was invited to visit Amgen’s headquarters in Thousand Oaks, California, and delivered a talk on the latest treatments for osteoporosis. I am an independent pharmaceutical economics research consultant and thus am not limited to studying the effects of drugs undergoing approval through the FDA clinical trial process, which imposes a significant constraint on Amgen’s research activities. For legal reasons related to products liability, pharmaceutical employees can only speak publicly about the FDA-approved uses of their drugs. However, my talk was delivered in-house to the HEOR unit, and was not open to the public, so I assumed within those confines, Amgen’s HEOR staff would speak freely and demonstrate they could “think outside the box.”
The upshot of my talk was that Novartis’s bisphosphonate drug, Zometa (known generically as Zoledronic Acid) represented the best and strongest possible treatment to prevent bone fractures in post-menopausal women suffering from osteoporosis. Zometa is a drug used by oncologists to strengthen the bone structure caused by calcium leaching from patients subjected to certain forms of chemotherapy. In my talk to compare the efficacy of Zometa to other bisphosphonates, I indicated that the oral bisphosphonates (pills), such as Fosamax and Actonel, were like hand guns, while Zometa (given intravenously) was like a howitzer. I noted that in November 2005, the FDA only approved Zometa as a treatment for the consequences of chemotherapy; however, my contacts within Novartis advised me the company would soon launch a clinical trial to expand the use of this drug for treatment of osteoporosis and low bone mineral density.
I personally observed an elderly patient in her 80s trip and and sustain a traumatic fall face down on a concrete driveway, yet she sustained no fracture anywhere on her body thanks to prior treatments with Zometa. The patient struck the concrete with such force that her glasses were knocked off her head and landed 6 feet away at the base of some bushes. This same patient had sustained a compound hip fracture a few years earlier while taking weekly Fosamax pills. In another episode, an octogenarian frail patient fell backwards and struck her head so hard as to cause her to be dazed, yet she suffered no fracture of her skeletal structure anywhere — all thanks to the efficacy of Zometa to strengthen the fragile bones of osteoporotic patients.
Before I could even finish my talk, the illuminaries from Amgen’s Outcomes Research unit began carping at my conclusions. First, a 50-year old Senior Analyst, with gray, curly, shoulder-length hair, who dressed for work each day in blue jeans as a rebel against the suit-and-tie culture, said none of my conclusions were supported by clinical trials. I responded that treatment of osteoporosis with Zometa was then state-of-the-art medicine still years ahead of clinical trials, and that anecdotal case studies such as this were often the source of ideas to be tested with clinical trials.
The Amgen Senior Analyst said he would not accept any of my conclusions, nor allegedly would any competent professional, without a double-blind placebo clinical trial. This same analyst told me after my talk that he had been invited to head the Health Economics and Outcomes Research units at two other pharmaceutical companies, although based on his myopic comments, I seriously doubted it. Again, I responded to the Senior Analyst by asking if his own …
