We need to improve our healthcare system and allow the life science industries to flourish.

By Sean Harper

On healthcare reform it’s hard to find consensus. The one point everyone is in agreement on is that the current system is broken, and something must be done to fix it. The Obama administration and Congress are eager to enact broad reforms to improve care and access, and quickly. This is a commendable aim, one that Amgen fully supports. But in the rush to make change happen, it’s important to consider the long-term consequences of decisions made today.

Reforming the healthcare system can’t begin and end with cutting costs. Striking and maintaining the right balance between reform and preserving medical innovation and patient access will be challenging. Throughout the process, there are a few basic truths that should be kept in mind.

First, new medicines come almost exclusively from industry. I trained as a physician and molecular biologist, focused on the translation of science to innovative medicines “from bench to bedside.” It became clear to me early on that the resources and infrastructure to develop new medicines simply do not exist outside of industry.

A 2001 study conducted by the National Institutes of Health found that of the 47 FDA-approved drugs meeting the study’s threshold of $500 million or more in annual sales, none had been developed entirely by NIH and only four had been developed in part with technologies from NIH funding.¹ Furthermore, as the Congressional Budget Office has noted, most of the costs involved in bringing a new drug to patients come not from the initial discovery research but from clinical testing and regulatory submission—the costs that industry tends to bear.

Second, society has seen a healthy return on its investment in biopharmaceutical innovation. Many studies show that advances in medical technology, including biopharmaceuticals, have resulted in significant gains in patient survival, reductions in hospital use and nursing home admissions, and decreases in other healthcare expenditures.² That said, we still need more comprehensive answers and a fuller understanding of the costs and benefits of different treatment options. It’s important to define value not only in dollar terms, but in terms of quality of life and the amelioration of human suffering.

At Amgen, we are aware that we have an obligation to demonstrate the value of our innovative medicines, and collecting outcomes research data is a vital part of our clinical development activities.

Third, the impact of decisions made now will be felt a generation later and will be very difficult to reverse. Many of us or our loved ones have benefited from recent innovations that have slowed the more crippling forms of arthritis, given more time to people suffering from common cancers such as colon and breast cancer, staved off some dangerous complications of diabetes, and successfully fought off viral hepatitis and other infections. We cannot take for granted that medical progress will continue to march forward. None of these advances would have happened without sustained investment and an environment conducive to innovation. Ten or 20 years from now, when we or perhaps our children are faced with a dreaded diagnosis, will effective new treatments be available to us, or will we find ourselves wondering why we have nothing new to offer? This will clearly be a moment of truth for us as a society.

Now is the time to engage in dialog and share our best ideas for solutions that will both improve our healthcare system and allow the life science industries to grow and flourish. Is it possible to have the best of both worlds? I believe it is. In fact, I believe that both must happen together.

I encourage you to seize the opportunity. Contact your Congressional representative and urge him or her to support bills that offer the greatest benefits for patients today and that keep medical innovation alive and well tomorrow.

Sean Harper is Amgen’s chief medical officer.

Science can guide the determination of what works—and what doesn’t—in healthcare.

By Dennis J. Cotter, Mae Thamer, and Yi Zhang

Epogen (epoetin) therapy for chronic anemia among end-stage renal disease (ESRD) patients is the archetype for costly policies formulated without scientific underpinnings.

Before epoetin was introduced, 16% of anemic ESRD patients were treated with blood transfusions. In 1989, the FDA approved epoetin hormone for treatment of anemia in transfusion-dependent dialysis patients because it elevated red cell levels, or hematocrit (Hct), alleviating the need for transfusions. Although the trials were conducted on ESRD patients who were transfusion dependent, and not on the remaining 83%, proponents saturated the ESRD population with epoetin. By 2005, 99% of all hemodialysis patients received it.

Epoetin’s unbridled prescription was coupled with broad overdosing. In 1991, when Congress imposed a fee-for-dose policy on Medicare, it created a perverse financial incentive to overprescribe epoetin, resulting in a threefold increase in dose. By 2007, 43% of patients exceeded the upper bound of the FDA’s approved target Hct, at a cost of $2 billion/year. In addition to Medicare payment incentives, volume-based discounts and product rebates, misguided quality measures fueled overuse of the drug, which has cost well over $20 billion since its introduction.

Now, in a muddled effort to curtail egregious overuse, Congress wants to establish a fixed epoetin payment based on historically high dosages, offering a $1 billion/year windfall to providers and a serious cost concern to taxpayers.

Despite the FDA’s recent removal of epoetin’s quality-of-life (QoL) claim and a Black-Box warning to providers to use the lowest possible dose, Medicare continues to promote the notion that elevation to higher Hct via epoetin (sold by Amgen) means better QoL. By paying for treatment up to Hct 39% and above—despite documented risks at such high Hct levels—Medicare has tacitly eclipsed FDA’s evidence-based safe Hct target range of 30–36%, while doubling costs to all taxpayers. Four recent clinical trial analyses consistently report high risk at higher targeted Hct.^{1 2 3 4} One analysis demonstrated a relationship between epoetin dose and poorer outcomes; high-dose epoetin was associated with a 57% increased hazard of death or an adverse cardiovascular event.⁴ Controversy continues regarding the benefits of its universal use.⁵ To date, no study has reported a safe and clinically appropriate target Hct—a serious safety concern.

The Institute of Medicine’s 2008 report, Knowing What Works in Health Care, admonished, “… The nation must significantly expand its capacity to use scientific evidence to know ‘what works’ in health care.”⁶ The story of epoetin being written today, at the expense of patient welfare and taxpayer billions, illustrates why science must play a central role in policy decisions. The inchoate actions by Congress and Medicare to fix this policy are not evidence based and highlight the need for science in decision-making. If policy makers continue to disregard the warning signs and show indifference to overuse, wasteful costs, and unsafe care of ESRD patients, then there is a distinct possibility that healthcare reform will not achieve its lofty goals.

The authors are at Medical Technology and Practice Patterns Institute, Bethesda, MD.

The health care "system" in the U.S. needs a top-to-bottom, side-to-side audit before any beneficial so-called "reform" can be realistically discussed, much less, accomplished. Lacking that, every special-interest political activist is throwing around numbers that are, at best, selected data, taken out of context and perspective, that are used to paint the best or worst picture depending on whose ox needs subsidies and whose needs goring. (This Amgen infomertial, passed to us as an objective article, is yet another example - The Scientist needs to review its editorial policy too, or change its moniker).

By audit, I mean a thorough analysis of all dollars in and out, from whom and to whom, defining the target population and patient outcomes. We should be spending our effort arguing over clarifying that big picture so that there can, at least, be general agreement on the facts and sources of those facts with no hiding, slanting, or dodging the basic facts of the matter. Such an accounting would serve to obliterate much of what passes for substantial debate in D.C. today - not to mention, educate the public about the real state of affairs.

The Democrats, posing as the party that cares, are learning, for the umpteenth time and to the continued detriment of the country, that proceeding to a political solution without such an accounting is reckless, divisive and doomed to failure - but what else would you expect from a bunch of lawyers qua politicians more interested in currying votes than solving problems. Instead of educating the public and presenting the obvious facts indisputably and in total, they are seeking compromise between special-interest political activists of all stripes (of their selective choosing) that, if they succeed, will only serve to institutionalize all the inefficiencies and egregious excesses that drive the perception of a "broken system" that needs to be "fixed". What is now a stupendous mix of pigs feeding at the trough of health-care and working at cross-purposes will be cast in stone for the next generations.

The Democratic party, as the Republican party before them, is demonstrating that they are unfit to lead this nation at a time when change is not just desirable but essential if we are to stop and reverse the steady decline of this country's society, economy, and the health-care system which is so essential to the health of individuals as well as the society and economy themselves. Politics as usual, at this critical time, is not change and certainly not change anyone can believe in.

After reading "Healthcare reform: 2 views", I was ready to open up with both barrels, particularly about bias and the use of fear. However, after reading subscriber comments it is apparent that the scientific community is very much on top of this issue.
Universities lay the groundwork for innovation, not only by conducting government and privately funded research but by training the pool of scientists that corporations like Amgen draw from. The notion that innovation will not thrive without an enormously vigorous profit motive, as stated by other commentors, is bunk. I do not know any colleages that entered into the sciences as a road to riches.
It requires very little scientific and medical literature review to spot how much innovation is coming from countries that are not running 'for profit' medical systems.
Future funding of personalized medicine research is paramount. It has the potential for huge savings regarding drug safety issues and efficiency in clinical testing. On the downside, for industry, it could take some unsafe drugs off the market and provide proof of damages in patients previously damaged by drug intervention.
Maintaining good health in this country has to change from an independent resource approach to a community, team effort approach.
It would be very good for leaders of government to have the opportunity to read some of these comments to get a feel for how the scientific community views the health reform issue.

Amgen's Sean Harper's commentary on the necessity of our appreciating the need for support of pharmaceutical firms, which carry out nearly all the research and testing of new therapeutic medications, is fine as far as it goes, except for ONE GLARING OMISSION; namely, that he has somehow failed to mention the outlandishly outsized profits garnered by the pharmaceutical corporations - - which are a matter of well publicized public record. His argument for promoting the need to "allow the life science industries to flourish" is therefore merely a self-promoting harangue that is entirely negated given his omission of the profit picture. The pharmaceutical corporations are doing just fine on their own, thank you, and certainly do not require further support from anyone else. Harper should know better; we are not fooled. His empassioned argument is disingenuous at best. The true situation is much too well known by anyone working in the sciences, as well as the public at large. Pharma is doing just fine - - and at our considerable expense.

Yes, of course we all want industry to continue to have the revenues to persue extensive drug development. But here's two issues Mr. Harper doesn't address:

1-How much money is spent on advertising/the current system of pushing drugs onto doctors? There's definitely inefficiencies there.

2-How much of global revenues are paid by the expensive United States market? If revenues need to be where they are to allow for new drug development, as Americans we should drive the system towards one in which all advanced economies contribute more equally.

The article appeared to be a promotion piece for the pharmaceutical industry.

Health care in the USA costs several times more per capita than other modern western countries and yet does not cover a large percentage of the population leading the USA to have a lower life expectancy and higher rate of death due to patients not being able to afford prescribed medication or follow-up medical treatment.

"The Land of the Free" obviously refers to the fact that the richer you are, the more freedom you can buy.

The problem is how to use our LIMITED resources to provide the best health caare for al Americans.

This requires the expertize of ALL health care professionals, not that of Congress. We need a permanent National Health Board, and Congress shoud stay out of it until asked to vote on FEASIBLE plans.

Since this is not the current discussion we must work to get it there, or face disasstrous changes.
The two views need to merge into this one

These posts show a few of the problems hampering our debate.

Gross level discussions about "broken or not" that then jump to defense of the current system or action plans for reform, leave out a key middle step.

IF the system is broken in some ways, it is broken in discreet ways that have concrete causes.

If it is not broken in some ways, then it works in discreet ways that have concrete foundations.

Example: Is the market for provision of health care services broken or not?

In my POV, it is broken in several ways. Here is one.

The one who uses medical services is not the one who pays for services; and neither the user nor the provider really know how much, or whether, they are going to have to pay, or will receive for a given procedure.

That a doctor has to battle for reimbursement and may not get it; that a patient may get whallopped with a huge bill afterwards; that the actual payor is not at the table when a decision to proceed is made -- each of these is a sign of a nontransparent and dysfunctional market.

In my mind, the dysfunctional market is a key driver of skyrocketing costs - it prevents people from making rational choices.

Just one example.

I would be interested if our politicians -- and if we -- broke things down to concrete problems and causes (and ditto, concrete things that work and what makes them work). The conversation would be more productive and more interesting.

All this flag-waving and trotting out of trite sayings (the system is broken! the system is best in the world!) is the opposite -- boring and unproductive.

So is assigning The Blame to any single player. In my mind most causes of the problem are in the system, not in the way any actors function within it.

Anyone who considers the US system to be "best in the world" and who claims that "90% of the populace is satisfied" is not on the same planet earth I'm on. Have I gotten good care? Sure. But could it be better? By far. I did not learn half the things I now know about the reasons behind my existing health problems until I started doing my own research, primarily because the medical professionals I work with don't have the time to give me information I need--and if they don't have the time to talk to me, they surely don't have the time to listen. And 90% satisfaction is not what I'm hearing from MY friends and relatives--or from strangers on the street. I know few people indeed who haven't had a frustrating encounter with insurance refusals or random denials (or withdrawals) of coverage. Yes, we have skilled people, solid science, great technology... but that's not enough to assure "best" care, particularly in a climate where there are so many incentives to offer high tech or pharmacological solutions as a knee-jerk response, rather than taking time and effort to craft a therapeutic regimen tailored to the patient's needs. One-size-fits-all medicine is not "best"--it's simply most efficient, where what we should be measuring as "best" is medicine that's most effective at bringing the larger populace back to a state of health.

Well - after spending the weekend in the hospital for kidney failure what I initially thought was a VP shunt malfunction, I had time to reflect on our health care model.

I was at a wonderful state of the art hospital, private room w a harbor view, cute nurses and all. I had a lot of time to reflect on what got me in there, a serious miscalculation of fluids and exercise causing temporary kidney failure. I realized how important it is that we have a "social model" of information to PREVENT illness and disease. My admission and kidney failure incident was easily preventable! Yet, when it came time for discharge, there was ltd knowledge, no patient tools, no mobile phone app to use in my everyday life to prevent this from happening again. All the money is spent on treatment!

The socialist model drives prevention. The "capitalist model" drives treatment. Clearly, what is missing - is better knowledge and prevention.

Knowledge and the spread of information is by its purpose a socialistic imperitive. We learn to live smarter, safer, with better use of resources - by sharing what we know. By contrast, we develop solutions and technologies by way of capitalistic innovation. But you cannot allow either to dominate or replace the other. AND there should be seamless integration between the two models. But there is not because there is no PROFIT in prevention, and this is where government or 3rd parties must come in. This is what is "missing" in the U.S. model, and seamless integration between the two. If we can pull this off as a nation, we will learn so much about integrating two very diverse systems that we can apply to the economy, education, and other industries.

Stephen

I forgot to include Medicare budget in my comment.
'national health spending totaling around $2.5 trillion in 2009, and projected to grow to $4.4 trillion by 2018',(LINK
.14 trillion US $ is not a small amount in a budget of% 2.5 trillions.

Referring to Bob's statement on cost of medicine in health care, I furnish statistics here below.
"Of each dollar spent on health care in the United States 31% goes to hospital care, 21% goes to physician services, 10% to pharmaceuticals, 8% to nursing homes, 7% to administrative costs, and 23% to all other categories (diagnostic laboratory services, pharmacies, medical device manufacturers, etc.[7] Reports on the percentage of costs that go to profits varies from 25-30%."
(LinkLINK
GDP of USA is:GDP (purchasing power parity): $14.29 trillion (2008 est.) $14.11 trillion (2007) $13.83 trillion (2006)
GDP (official exchange rate): $14.33 trillion (2008 est.)( source;LINK
One can see where the Dollar goes.Why do not the Hospitals,Physicians ,labs and the Pharma industry contribute?
other than pharma Industries,others could charge less or do pro bono service.pharma, I still can contribute 1% of their Turn over.
Let's see what Pharma companies make in terms of US $
The following is a list of the 20 largest pharmaceutical and biotech companies ranked by healthcare revenue. Some companies (eg, Bayer, Johnson and Johnson and Procter & Gamble) have additional revenue not included here. The phrase Big Pharma is often used to refer to companies with revenue in excess of $3 billion, and/or R&D expenditure in excess of $500 million.
Revenue Rank 2008 Company Country Total Revenues (USD millions) Healthcare R&D 2006 (USD millions) Net income/ (loss) 2006 (USD millions) Employees 2006
1 Novartis Switzerland 53,324 7,125 11,053 138,000
2 Pfizer USA 48,371 7,599 19,337 122,200
3 Bayer Germany 44,200 1,791 6,450 106,200
4 GlaxoSmithKline United Kingdom 42,813 6,373 10,135 106,000
5 Johnson and Johnson USA 37,020 5,349 7,202 102,695
6 Sanofi-Aventis France 35,645 5,565 5,033 100,735
7 Hoffmann?La Roche Switzerland 33,547 5,258 7,318 100,289
8 AstraZeneca UK/Sweden 26,475 3,902 6,063 50,000+
9 Merck & Co. USA 22,636 4,783 4,434 74,372
10 Abbott Laboratories USA 22,476 2,255 1,717 66,800
11 Wyeth USA 20,351 3,109 4,197 66,663
12 Bristol-Myers Squibb USA 17,914 3,067 1,585 60,000
13 Eli Lilly and Company USA 15,691 3,129 2,663 50,060
14 Amgen USA 14,268 3,366 2,950 48,000
15 Boehringer Ingelheim Germany 13,284 1,977 2,163 43,000
16 Schering-Plough USA 10,594 2,188 1,057 41,500
17 Baxter International USA 10,378 614 1,397 38,428
18 Takeda Pharmaceutical Co. Japan 10,284 1,620 2,870 15,000
19 Genentech USA 9,284 1,773 2,113 33,500
20 Procter & Gamble USA 8,964 n/a 10,340 29,258
Source: Top 50 Pharmaceutical Companies Charts & Lists, Med Ad News, September 2007[21]
[edit]Market leaders in terms of sales
The top 15 pharmaceutical companies by 2008 sales are:[22]
[23]
Rank Company Sales ($m) Based/Headquartered in
1 Pfizer 43,363 US
2 GlaxoSmithKline 36,506 UK
3 Novartis 36,506 Switzerland
4 Sanofi-Aventis 35,642 France
5 AstraZeneca 32,516 UK/Sweden
6 Hoffmann?La Roche 30,336 Switzerland
7 Johnson & Johnson 29,425 US
8 Merck & Co. 26,191 US
9 Abbott 19,466 US
10 Eli Lilly and Company 19,140 US
11 Amgen 15,794 US
12 Wyeth 15,682 US
13 Teva 15,274 Israel
14 Bayer 15,660 Germany
15 Takeda 13,819 Japan
( source;LINK
I think pharma companies can contribute.

What incentive is there for companies like Amgen to promote a more plant-based diet (almost guaranteed to reduce cancer)? Or how about low cost exercise programs at home and work? No I'm not interested in half-hearted efforts done out of either sheer shame or cynical calculation, I want full-blown deep-pocket efforts made to promote health BEFORE you start patting yourself on the back for the wonderful drugs you come up with. Are you people working to make money or make people healthy again? (As if I don't know.)

The idea that there aren't MILLIONS of people willing to work for near dirt wages to find the next big cure and then even forgo the big rewards when they hit pay dirt is pure bunk. Such people exist and I'll bet their ingenuity at scraping up resources would put to shame the entire for-profit pharmaceutical sector.

--As I see it the major cost factor is the cost of medicines.Pharma companies must be asked to donate at least 1% of their turn over to healthcare programme.--


That is simply NOT true. Drugs are only about 10% of total healthcare expenditures in the US. Asking drug companies to contribute 1% of gross sales would not even cover one month's INCREASE in annual total health expenditures, and besides, most already to that through patient assistance programs, compassionate access etc.

Bob Reohr

Good article, but it is written too much in the context of mainstream medicine, i.e. the doctor knows what's better for you than you do. Well, we are learning that this is not always the case.

Some people do not want the treatments thrust upon them. A 75 yr old family friend who was found to have a cerebral aneurism 5 years ago, asked if I would accompany her to see her nsg. During the visit, we fully discussed her treatment options and she decided she would not pursue the coil procedure. I also acted as sounding board for a friend who opted not to have a prostate tumor removed. Both are alive and doing well.

The above are not ordinary cases for discretion in treatment. Most are people with arthritis, depression, high cholesterol, asthma, acid reflux, etc. where the drugs they would take have long term side affects. It would seem in the U.S. that patients are not given all the available treatment options. In the U.S., many health disorders are related to obesity, lack of exercise, and ignorance. But few pursue more reasonable, low risk, low cost alternatives.

We need to better utilize Eastern medicine, biofeedback, diet, and exercise. I was able to go off acid reflux meds after 10 years merely by changing my diet, limiting fat, carbs, and total calorie intake. I did this all on my own.

Why is it that mainstream medicine does not promote many simple and low cost alternatives? No money in it for BIG CORPORATE?

As much as big corporate complains about FDA and reimbursement reg's, I see these reg's as their best friend. PMAs and 510ks limit what reaches the marketplace and into the hands of the consumer, and in doing do, sets the price and reimbursement. Does the higher price tag and barring of alternatives equate to the same high levels of safety and efficacy? It might, if the process were not compromised by conflicts of interest and lobby pressures at the respective government agencies.

If there's one thing I'd like to see come out of health care reform, it's a more FREE market, more alternatives, more treatment options, more independant science and reviews.

Last year, I had my 7th brain shunt revision in 17 years. It would be a real stretch to call these CNS shunts "medical technology." Most CNS shunt designs are 15 to 30 years old. We would have better designs today were it not for FDA regs and mfrs with moral misgivings. CNS Shunts are actually quite simple when you understand them. But the field of neurosurgery is widely at odds over their particulars, and the current level of diagnostics is stuck in the 1950s. Device manufacturers seem content to see this continue. There's little competition! They sell more product the more they fail and are mis-understood. And there seems to be a gentleman's agreement not to criticize each other's products. Some in industry have even commented, "it's only business." I wonder if they feel that way about the jetd they fly on?

Well, as a patient and consumer, I wish more companies were put to the test. "Competition is always a good thing."

Stephen

US health care is expensive because we have a perverse payment system that encourages us to get care that has an extremely marginal benefit to cost ratio. That is the EPO story in a nutshell. Our doctors order a CT on every patient with belly pain because it might possibly be helpful, insurance will cover and they might even get sued if they don't. Fixing this will not be simple but needs to be done. No single "solution" exists. For example Bob Roehr is unfortunately wrong about MD costs. Per hour worked and over the lifespan British MD's do about as well as American ones (I've worked both places). Free medical training, saner hours, paid retirement and social benefits are good ideas but are not free and balance the higher US salaries.

As I see it the major cost factor is the cost of medicines.Pharma companies must be asked to donate at least 1% of their turn over to healthcare programme.

From a European point of view, it is amazing that there is no consensus of the population on the big problems of the US health system (exploding cost & high number of uninsured).

Once there will be some consensus that there is a problem, a very obvious approach would be to simply copy the rest of the world, like e.g. Canada: Introduce more regulation of the cost and make membership more obligatory.

There seems to be a cultural problem that prevents Americans to accept that less freedom is sometimes more efficient. So they spend so much and still get so little broad, general healthcare (not the top 1%). It is amazing that these inevitable changes are taking so long.

It is unbelievable that one would describe something as being "broken" when it serves over 90% of the population satisfactorily. That is truly a "throwing the baby out with the bathwater" concept. It is my opinion that, this is not about health care. It is about placing control of all the money that provides health care into the hands of earmarking politicians. If it was truly about improving health care, then all of the politicians should be required (Obama included) to sign up for it. If that were made a condition of passage, the program would never see the light of day. If they were really trying to solve the problem, they would let the market place continue to regulate costs and privately financed charities such as the Red Cross to take care of the 3% or 4% who need short or long term help.

The second sentence of the article says "one point everyone is in agreement on is that the current system is broken"--but not Senator Mel Martinez, R-FL--and lots of other Republicans who are fighting improvements every step of the way. I watched video on Senator Martinez's own website where he says "we have the best healthcare system in the world". If you have a high paying job with a "Mercedes-style" health insurance plan payed for by your employer (in his case the taxpayer) you might actually believe that! But, if Senator Martinez did any HOMEWORK he would know the truth--but that would require actual work and, more importantly, intellectual honesty.

Health costs in the United States have doubled every 10 years for the last 40 years, Princeton University health economist Uwe Reinhardt told a Capitol Hill briefing on July 31.

?The supply side of the [health care] sector seems to assume that the continuation of that trend is a firm social contract between them and the rest of society?that from here to kingdom come we will double your revenue every ten years. Any deviation from that [growth curve] is viewed as a give back.?

Dr. Reinhardt said proposals that Medicare cut anticipated growth of their total spending over ten years ($11 trillion) by 1.4% has sent the health industry into apoplexy. ?It makes me worry about America, that health care couldn?t manage the type of cuts we are talking about.?

That anecdote epitomizes the difficulty that health reform faces; interest groups feel entitled a fixed if not growing slice of the health dollar and will fight any changes.

One major reason why health care costs more in the US than Europe, that few people want to talk about, is that we pay doctors a lot more. AND while others focus on the GP, we have a deficit there but tons of specialists who are paid even more.

Reforming health care will take a lot of time and effort, there are no simple fixes.

Bob Roehr