Biotechnology organisation Amgen Inc. (AMGN) saw the fee of its stocks fall from a high of $seventy seven to round $55 as of October 2, 2007. The decline in Amgen inventory followed news of decreased income forecasts for its best-selling drug, Aranesp. With declining revenues from drug income, Amgen is being pressured to trim expenses. The business enterprise introduced it changed into shedding among 12 – 14% of its group of workers and planned to cut capital prices through $1.9 billion. See the associated information story is the resources container.
Surprisingly, Amgen plans no discount in personnel in its Global Health Economics and Outcomes Research (HEOR) unit. This unit comprises a hodgepodge of experts with Ph.D.S in economics, pharmacists, medical medical doctors, and various analysts with information manipulation backgrounds. Their mission is to investigate pre-medical trial layout and put up-clinical trial facts to extract some causal courting between an Amgen drug and a high-quality gain to medical trial patients. Normally, the equipped clinical doctors supervising a medical trial at subject places can take a look at whether or not a drug is having any tremendous advantage for sufferers. These medical doctors are flawlessly capable of assessing the efficacy of a drug being evaluated inside the scientific trial.
The HEOR unit is known as to movement to confirm statistically what the docs declare they study within the subject and to try to find additional, unintentional advantages from the drug in order that Amgen can follow for a patent at the unintended consequence. Due to the massive variety of scientific trials that do not display efficacy of proposed capsules, the primary work of Amgen’s HEOR unit appears to be salvaging any feasible price or use for an Amgen drug rejected by way of the clinical community.
There is a high-quality line among manipulating facts to illustrate a deeply hidden benefit for sufferers as opposed to trying to find a benefit where none exists. Relying on numerous statistical techniques, Amgen’s HEOR team of workers proposes causal relationships and desperately seeks records to confirm them. Only people with a certain mentality can be stimulated with the aid of the daily prospect of sifting thru rubbish in hopes of finding a diamond.
From what the HEOR personnel informed me, on and at the records manipulation goes looking to show the drugs rejected by way of the clinical experts in medical trials do in fact show a few difficult to understand, often trivial, gain to patients. The Health Economics and Outcomes Research body of workers would like to consider it is smarter than the docs within the area, because the HEOR group of workers declare they can discover medical blessings that docs treating sufferers didn’t observe. In my opinion, the Amgen HEOR workforce studies models and their statistical effects are regularly tenuous, at quality, and ludicrous, at worst. I train Health Care Economics at both the undergraduate and graduate level. Having seen how my undergraduate college students critique fitness care policy initiatives and the pharmaceutical enterprise, I haven’t any doubt they could effortlessly tear aside the assumptions, analyses, and conclusions of the Amgen HEOR research and reports. Investors have to marvel why Amgen spends an expected $25 million in salaries for its HEOR specialists if their output is at risk of rebuke by means of undergraduate students with no pharmaceutical schooling.
Another signal of the bad high-quality of Amgen’s Health Economics unit is its loss of guides. Amgen absolutely takes pleasure while its personnel can get studies results posted in peer-reviewed journals. Professional magazine guides with the aid of Amgen body of workers resource the organization’s advertising and marketing campaigns, add to the prestige of the organisation, and assist permit them to recruit main scientists. On October 2, 2007, I searched the Nexis “All Full-Text Medical Journals” database using the key-word “AMGEN” in the identical sentence as “Health Economics” or “Outcomes Research.” A overall of zero articles have been discovered. I then repeated this identical search the usage of the “All Medline Review Article References,” which incorporates journal courses pre-1975 to the existing. A grand total of one article regarded entitled “Psychological results related to anemia-related fatigue in cancer sufferers,” which pertains to Amgen’s now declining income drug Aranesp. Desperate to discover some proof of exact posted research by Amgen’s HEOR unit, I then searched the database called “Healthcare Archive News,” which contains exposure announcements and press releases about even minor scientific and scientific studies findings. The database contained zero articles about any Amgen HEOR medical findings but did listing some press releases concerning the appointments of David Beier and Joshua Ofman to lead Amgen’s HEOR institution.
In the fall of 2005, I changed into invited to visit Amgen’s headquarters in Thousand Oaks, California, and brought a talk at the contemporary treatments for osteoporosis. The upshot of my talk changed into that Novartis’s bisphosphonate drug, Zometa (regarded generically as Zoledronic Acid) represented the exceptional and most powerful feasible treatment to save you bone fractures in submit-menopausal girls tormented by osteoporosis. Zometa is a drug used by oncologists to reinforce the bone structure caused by calcium leaching from sufferers subjected to positive styles of chemotherapy. In my talk to compare the efficacy of Zometa to other bisphosphonates, I indicated that the oral bisphosphonates (pills), which include Fosamax and Actonel, were like hand guns, while Zometa (given intravenously) became like a howitzer. I referred to that in November 2005, the FDA handiest accredited Zometa as a treatment for the outcomes of chemotherapy; however, my contacts within Novartis cautioned me the business enterprise would quickly release a clinical trial to increase using this drug for remedy of osteoporosis and low bone mineral density.
I personally determined an elderly patient in her 80s experience and and maintain a annoying fall face down on a concrete driveway, but she sustained no fracture everywhere on her frame thanks to earlier remedies with Zometa. The affected person struck the concrete with such force that her glasses were knocked off her head and landed 6 toes away at the base of a few bushes. This identical patient had sustained a compound hip fracture some years in advance while taking weekly Fosamax pills. In another episode, an octogenarian frail affected person fell backwards and struck her head so difficult as to purpose her to be dazed, yet she suffered no fracture of her skeletal shape anywhere — all thanks to the efficacy of Zometa to reinforce the fragile bones of osteoporotic patients.
Before I ought to even end my talk, the illuminaries from Amgen’s Outcomes Research unit started out carping at my conclusions. First, a 50-yr vintage Senior Analyst, with grey, curly, shoulder-duration hair, who dressed for work each day in blue denims as a revolt in opposition to the fit-and-tie lifestyle, said none of my conclusions had been supported by using scientific trials. I answered that remedy of osteoporosis with Zometa become then present day medicinal drug still years in advance of clinical trials, and that anecdotal case research which includes this were regularly the supply of ideas to be examined with clinical trials.
The Amgen Senior Analyst stated he could no longer receive any of my conclusions, nor allegedly could any in a position professional, with out a double-blind placebo clinical trial. This identical analyst informed me after my communicate that he were invited to head the Health Economics and Outcomes Research devices at different pharmaceutical corporations, despite the fact that based on his myopic remarks, I significantly doubted it. Again, I responded to the Senior Analyst with the aid of asking if his very own aged mom or aunt or uncle had formerly suffered a bone fracture and changed into in threat of getting a appreciably reduced nice of existence with any similarly fracture, would he rely upon the weak FDA-accredited oral bisphosphonates or try and get Zometa remedy for his personal relatives? He answered he would stick with the FDA-permitted drugs, even though it supposed his aged parent could be debilitated with another hip fracture from which she or he might not recover and might quick deteriorate in mattress and die.
Next, a 6’three” board certified radiologist, who for a few unexplained purpose gave up an annual profits of $350,000+ as a radiologist in private exercise to grow to be an industry hack running for Amgen, carped that bisphosphonates, including Zometa, do no longer without a doubt inhibit the leaching of calcium from bones however as an alternative make stronger the lattice structure of the bone. Furthermore, my communicate blanketed no head-to-head comparisons of Zometa with Fosamax or Actonel or any other oral bisphosphonate, so he would not accept the realization. I replied by using asking the radiologist how many patients he had treated for osteoporosis whilst in private practice. He replied “none.”
I requested the radiologist if he knew the ultra-modern treatments for osteoporosis as of 2005, and he answered that the oral bisphosphonates have been the trendy. I then talked about that no board licensed oncologist would bear in mind the oral bisphonates for treating most cancers victims with weakened bone structures from chemotherapy. Oncologists need the clinical equivalent of a “howitzer” now not a pop gun to strengthen their most cancers sufferers’ bones, and oncologists’ favored drug for this treatment turned into Zometa. Osteoporosis has the various same traits of weakened bone shape and occasional bone mineral density as takes place with cancer sufferers who’ve passed through positive types of chemotherapy. Despite his objections, I stood by my conclusions that Zometa turned into the satisfactory to be had remedy for osteoporosis, and I might recommend it as a existence-saving remedy for elderly patients (male or woman) vulnerable to immobilizing fractures.
I anticipated Amgen’s Health Economics personnel to be careful in describing non-FDA permitted use of medication, however I did now not expect locating a whole department full of narrow-minded, rigid, demagogues incapable of questioning out of doors the container. To them, it became both the Amgen way (method) or no manner in any respect. The Amgen HEOR junior analysts had caustic expressions on their faces throughout my communicate, and after I asked them in the event that they would permit their own mother and father or grandparents die from the debilitating effects of a hip fracture or get them Zometa remedy if wished, they took their cue from the 6’3″ oncologist and said uniformly they would “permit granny die.” Do we really want heartless humans like this worried in testing the nation’s drug pipeline?
After my speak, I met additional workforce in the Amgen HEOR unit, and each one became out to be less astonishing than the ultimate one. One of the closing human beings I met changed into a pharmacist with health economics obligation for cardiology drugs being developed through Amgen. He instructed me he had little history in economics and consequently could not write any articles appropriate for booklet in economics journals. Yet, he claimed he knew a way to develop the initial charge that any pharmaceutical firm need to price for any new drug being brought to the market. In economics, the price for a normal properly is determined as an equilibrium factor with the aid of the intersection of call for and deliver. But this pharmacist had no need for call for and deliver ideas and appeared to assemble expenses for tablets along with his personal advert hoc methods.
Amgen’s HEOR unit is filled with folks who are out of touch with the fitness care device in America. The grey, shoulder-duration haired Senior Analyst at Amgen, for instance, suggested the primary reason human beings choose to move without health insurance is that they believe they may be invincible and are inclined to gamble on their health. Given the overpowering evidence on lack of less expensive medical insurance for the operating terrible, if a student in either my undergraduate or graduate Health Care Economics became in an undertaking with an asinine remark like that, I might make the student repeat that venture.
Approximately years after my speak at Amgen, the Associated Press circulated a nationwide story on Sept. 18, 2007, with the lead paragraph, “For the primary time, an osteoporosis drug has reduced deaths and prevented new fractures in elderly sufferers with damaged hips . . . .No other osteoporosis drug observe posted inside the last 15 years has shown the sort of pronounced reduction in deaths.” What is the drug referred to in this have a look at? ZOMETA (marketed by means of Novartis for osteoporosis sufferers below the logo name Reclast). Two years before the Associated Press article, I expected this drug might grow to be the most effective remedy for osteoporotic sufferers in danger of hip and different bone fractures. Amgen’s tremendous HEOR staff rejected that forecast.
In my opinion, the Amgen HEOR personnel needs to be terminated or reassigned to other regions where it could contribute to the agency’s backside line. Its pharmaceutical economics modeling and information manipulations appear doubtful, and it seems ethically questionable to investigate statistics with the supposed aim of proving an Amgen drug rejected in clinical trials has some clinical benefit that medical doctors within the discipline overlooked. If Amgen’s CEO and pinnacle management are extreme about cutting fees and disposing of needless prices, then they need to start via disposing of the Global Health Economics and Outcomes Research unit. Until the HEOR unit is eliminated, I will maintain to view Amgen as a poorly controlled company with a bloated, unproductive team of workers.