Health Economics

Biotechnology company Amgen Inc. (AMGN) saw the rate of its shares drop from a high of $77 to around $55 as of October 2, 2007. The decline in Amgen supply followed information of minimized sales projections for its very popular medicine, Aranesp. With declining earnings from medication sales, Amgen is being forced to cut expenditures. The firm revealed it was laying off between 12 – 14% of its workforce and prepared to reduce capital investment by $1.9 billion. See the associated news story is the sources box.

Surprisingly, Amgen plans no reduction in staff in its Global Health And Wellness Business Economics and also Outcomes Research Study (HEOR) system. This system comprises a hodgepodge of professionals with Ph.D. s in economics, pharmacologists, clinical doctors, as well as assorted analysts with data control backgrounds. Their mission is to examine pre-clinical test layout as well as post-clinical trial data to remove some causal partnership between an Amgen drug and also a favorable benefit to professional trial individuals.

Usually, the skilled clinical physicians monitoring a medical test at area areas can observe whether a medicine is having any favorable benefit for clients. These medical professionals are perfectly capable of analyzing the effectiveness of a medication being reviewed in the scientific trial.

The HEOR unit is phoned call to action to validate statistically what the medical professionals claim they observe in the field as well as to look for extra, unplanned take advantage of the medicine to ensure that Amgen can look for a license on the unintended effect. As a result of the lot of medical trials that do not disclose effectiveness of suggested medicines, the primary job of Amgen’s HEOR device appears to be salvaging any kind of possible value or usage for an Amgen drug declined by the clinical area.

There is a great line between adjusting data to illustrate a deeply hidden benefit for people versus trying to find an advantage where none exists. Relying upon various statistical methods, Amgen’s HEOR staff recommends causal connections and also seriously looks for information to confirm them. Just people with a particular way of thinking can be stimulated by the daily prospect of sifting via garbage in hopes of finding a diamond.

From what the HEOR staff told me, repeatedly the data manipulation goes attempting to show the drugs denied by the doctor in clinical tests do in reality reveal some rare, frequently insignificant, benefit to people. The Wellness Business Economics and also Outcomes Research staff would like to believe it is smarter than the medical professionals in the field, since the HEOR staff claim they can locate clinical advantages that medical professionals dealing with people failed to observe.

In my viewpoint, the Amgen HEOR personnel research designs and also their analytical results are commonly tenuous, at best, as well as crazy, at worst. I teach Health Care Business economics at both the undergraduate and graduate level. Having actually seen how my undergraduate trainees review health care plan campaigns as well as the pharmaceutical market, I believe they would easily abuse the assumptions, analyses, as well as verdicts of the Amgen HEOR researches and also reports. Financiers need to wonder why Amgen spends an approximated $25 million in wages for its HEOR professionals if their output is susceptible to rebuke by undergraduate pupils with no pharmaceutical training.

One more indication of the poor quality of Amgen’s Health Economics system is its lack of publications. Amgen certainly takes satisfaction when its team can obtain research results released in peer-reviewed journals. Specialist journal publications by Amgen team help the company’s marketing campaigns, contribute to the eminence of the company, and assist enable them to recruit leading scientists. On October 2, 2007, I searched the Nexis “All Full-Text Medical Journals” data source making use of the key phrase “AMGEN” in the same sentence as “Health Economics” or “Outcomes Research.” An overall of 0 posts were located.

I then repeated this very same search utilizing the “All Medline Testimonial Post References,” which consists of journal magazines pre-1975 to the present. A grand total amount of one write-up appeared entitled “Psychological results associated with anemia-related exhaustion in cancer cells individuals,” which relates to Amgen’s currently declining sales drug Aranesp.

Determined to discover some evidence of concrete released research study by Amgen’s HEOR unit, I then looked the database called “Healthcare Archive News,” which contains attention announcements and also news release concerning also minor clinical and also clinical research searchings for. The database consisted of absolutely no write-ups about any kind of Amgen HEOR medical searchings for yet did checklist a few press releases concerning the visits of David Beier and Joshua Ofman to lead Amgen’s HEOR group.

In the loss of 2005, I was welcomed to go to Amgen’s head office in Thousand Oaks, The golden state, and provided a talk on the current therapies for weakening of bones. The outcome of my talk was that Novartis’s bisphosphonate medicine, Zometa (known generically as Zoledronic Acid) represented the very best as well as toughest possible treatment to stop bone cracks in post-menopausal ladies experiencing weakening of bones.

Zometa is a substance abuse by oncologists to reinforce the bone structure triggered by calcium seeping from individuals based on specific forms of chemotherapy. In my talk with compare the efficiency of Zometa to other bisphosphonates, I suggested that the dental bisphosphonates (pills), such as Fosamax and also Actonel, were like hand guns, while Zometa (given intravenously) resembled a gun.

I noted that in November 2005, the FDA only approved Zometa as a treatment for the effects of radiation treatment; nonetheless, my calls within Novartis advised me the firm would certainly quickly introduce a medical test to increase making use of this drug for therapy of weakening of bones and also low bone mineral density.

I directly observed an elderly client in her 80s trip as well as well as maintain a terrible fall encounter down on a concrete driveway, yet she maintained no fracture anywhere on her body many thanks to prior treatments with Zometa. The individual struck the concrete with such pressure that her glasses were knocked off her head as well as landed 6 feet away at the base of some bushes.

This exact same patient had sustained a substance hip fracture a couple of years previously while taking weekly Fosamax tablets. In another episode, an octogenarian sickly patient dropped in reverse and also struck her head so hard as to create her to be dazed, yet she suffered no crack of her skeletal framework anywhere– all many thanks to the effectiveness of Zometa to reinforce the vulnerable bones of osteoporotic clients.

Before I can also complete my talk, the illuminaries from Amgen’s Outcomes Research device started carping at my conclusions. Initially, a 50-year old Senior Analyst, with gray, curly, shoulder-length hair, that clothed for work every day in jeans as a rebel versus the suit-and-tie culture, stated none of my conclusions were sustained by professional trials. I reacted that treatment of weakening of bones with Zometa was then cutting edge medication still years ahead of professional trials, and that unscientific study such as this were often the resource of suggestions to be examined with clinical tests.