Global Health Economics and Outcomes Research Amgen (AMGN)

4

Remarkably, Amgen plans no reduction in staff in its Global Health Economics and Outcomes Research (HEOR) system. This unit comprises a hodgepodge of experts with Ph.D. s in economics, pharmacists, clinical doctors, and various analysts with information adjustment backgrounds. Their mission is to evaluate pre-clinical trial design and post-clinical trial data to extract some causal relationship in between an Amgen medicine and a positive advantage to clinical trial patients. Typically, the qualified clinical physicians monitoring a clinical trial at field areas can observe whether a drug is having any positive advantage for clients. These physicians are perfectly efficient in examining the effectiveness of a drug being evaluated in the medical trial.

The HEOR device is called to action to validate statistically what the physicians claim they observe in the field and to search for additional, unexpected gain from the medicine so that Amgen can obtain a patent on the unexpected repercussion. Due to the huge number of scientific trials that do not reveal effectiveness of suggested medicines, 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 in between controling information to show a deeply hidden benefit for clients versus searching for an advantage where none exists. Depending on different statistical techniques, Amgen’s HEOR personnel suggests causal relationships and frantically seeks data to verify them. Only individuals with a particular mindset can be promoted by the daily prospect of sifting with trash in hopes of discovering a diamond.

In my opinion, the Amgen HEOR staff study designs and their analytical results are often tenuous, at best, and ludicrous, at worst. Having seen how my undergrad students critique health care policy efforts and the pharmaceutical industry, I have no doubt they would easily tear apart the assumptions, analyses, and conclusions of the Amgen HEOR reports and researches. Investors have to question why Amgen spends an estimated $25 million in wages for its HEOR professionals if their output is vulnerable to rebuke by undergraduate students with no pharmaceutical training.

Another sign of the inadequate quality of Amgen’s Health Economics device is its lack of publications. When its personnel can get research outcomes published in peer-reviewed journals, Amgen certainly takes pride. Professional journal publications by Amgen staff help the company’s marketing campaigns, add to the prestige of the company, and help enable them to recruit leading researchers. On October 2, 2007, I searched the Nexis “All Full-Text Medical Journals” database making use of the keyword “AMGEN” in the very same sentence as “Health Economics” or “Outcomes Research.” A total amount of 0 short articles were found. I then repeated this exact same search utilizing 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 linked with anemia-related tiredness in cancer patients,” which associates with Amgen’s now declining sales drug Aranesp. Desperate to discover some proof of concrete released study by Amgen’s HEOR device, I then searched the database called “Healthcare Archive News,” which contains publicity announcements and news release about even minor scientific and clinical research findings. The database consisted of absolutely no short articles about any Amgen HEOR medical findings but did note a few news release concerning the appointments of David Beier and Joshua Ofman to lead Amgen’s HEOR group.

In the fall of 2005, I was invited to go to Amgen’s head office in Thousand Oaks, California, and delivered a talk on the latest treatments for osteoporosis. I kept in mind that in November 2005, the FDA only authorized Zometa as a therapy for the repercussions of chemotherapy; however, my contacts within Novartis recommended me the company would quickly launch a scientific 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 journey and and sustain a traumatic fall face down on a concrete driveway, yet she sustained no fracture anywhere on her body thanks to previous treatments with Zometa. In another episode, an octogenarian frail patient fell in reverse 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 enhance the delicate bones of osteoporotic clients.

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 every day in dungarees as a rebel versus the suit-and-tie culture, stated none of my conclusions were supported by medical trials. I reacted that therapy of osteoporosis with Zometa was then modern medication still years ahead of clinical trials, and that anecdotal case researches such as this were often the source of concepts to be checked with medical trials.

The Amgen Senior Analyst said he would decline any of my conclusions, nor supposedly would any proficient expert, without a double-blind placebo scientific trial. This very same analyst informed me after my talk that he had been invited to head the Health Economics and Outcomes Research systems at 2 other pharmaceutical companies, although based upon his myopic remarks, I seriously doubted it. Again, I reacted to the Senior Analyst by asking if his own senior mom or aunt or uncle had previously suffered a bone fracture and was in risk of having a considerably reduced quality of life with any additional fracture, would he count on the weak FDA-approved oral bisphosphonates or try to get Zometa therapy for his own loved ones? He answered he would stick to the FDA-approved medicines, even if it implied his senior parent would be crippled with another hip fracture from which he or she could not recover and would swiftly weaken in bed and die.

Next, a 6’3″ board accredited radiologist, who for some unexplained reason gave up a yearly salary of $350,000+ as a radiologist secretive practice to become an industry hack working for Amgen, carped that bisphosphonates, such as Zometa, do not in fact prevent the leaching of calcium from bones however rather reinforce the lattice structure of the bone. Moreover, my talk consisted of no head-to-head comparisons of Zometa with Fosamax or Actonel or other oral bisphosphonate, so he would decline the conclusion. I reacted by asking the radiologist how lots of patients he had treated for osteoporosis while in personal practice. He reacted “none.”.

Oncologists need the medical equivalent of a “howitzer” not a pop gun to boost their cancer patients’ bones, and oncologists’ liked medicine for this treatment was Zometa. Regardless of his objections, I stood by my conclusions that Zometa was the best available therapy for osteoporosis, and I would suggest it as a life-saving treatment for senior patients (male or female) prone to debilitating fractures.

I expected Amgen’s Health Economics staff to be careful in explaining non-FDA approved use of drugs, but I did not prepare for finding a whole department filled with narrow-minded, rigid, demagogues incapable of thinking outside the box. To them, it was either the Amgen means (method) or no means at all.

After my talk, I met added personnel in the Amgen HEOR device, and each one turned out to be less outstanding than the last one. One of the last individuals I fulfilled was a pharmacist with wellness economics obligation for cardiology drugs being developed by Amgen. He asserted he knew how to develop the preliminary price that any pharmaceutical company must charge for any new medicine being brought to the market.

Amgen’s HEOR device is loadeded with people who are out of touch with the healthcare system in America. The gray, shoulder-length haired Senior Analyst at Amgen, for example, suggested the main reason individuals pick to go without medical insurance is that they believe they are invincible and are ready to bet on their wellness. Given the frustrating evidence on absence of cost effective wellness insurance for the working inadequate, if a student in either my undergraduate or graduate Health Care Economics kipped down a project with an asinine comment like that, I would make the student repeat that task.

Their objective is to assess pre-clinical trial design and post-clinical trial data to extract some causal relationship between an Amgen medicine and a positive advantage to scientific trial patients. A grand total of one short article appeared entitled “Psychological results linked with anemia-related fatigue in cancer patients,” which relates to Amgen’s now declining sales drug Aranesp. The database included zero articles about any Amgen HEOR medical findings however did list a couple of press releases worrying the consultations of David Beier and Joshua Ofman to lead Amgen’s HEOR group.

I anticipated Amgen’s Health Economics personnel to be careful in explaining non-FDA authorized use of drugs, however I did not expect discovering an entire department filled with narrow-minded, stiff, demagogues incapable of believing outside the box. One of the last people I met was a pharmacist with health economics obligation for cardiology drugs being established by Amgen.