Showing posts with label diabetes. Show all posts
Showing posts with label diabetes. Show all posts

Monday, April 14, 2014

Planned Obsolescence Disguised as Innovation, Oligopoly Disguised as a Free Market, and the Enrichment of Oligarchs

The New York Times published another article in its series on the high cost of US health care.  This one, focused on the care of type 1 diabetes mellitus and other chronic diseases, shines some light on the business management practices that now determine how our health care system functions, or not, and implies who benefits the most from them.

Planned Obsolescence Disguised as Innovation

The article first discussed the brave new world of type 1 diabetes treatment.  The introductory theme was:

Today, the routine care costs of many chronic illnesses eclipse that of acute care because new treatments that keep patients well have become a multibillion-dollar business opportunity for device and drug makers and medical providers.

Much of modern diabetes treatment seems to depend on medical devices and disposable medical supplies:

That captive audience of Type 1 diabetics has spawned lines of high-priced gadgets and disposable accouterments, borrowing business models from technology companies like Apple: Each pump and monitor requires the separate purchase of an array of items that are often brand and model specific.

A steady stream of new models and updates often offer dubious improvement: colored pumps; talking, bilingual meters; sensors reporting minute-by-minute sugar readouts. [Diabetes patient] Ms. Hayley’s new pump will cost $7,350 (she will pay $2,500 under the terms of her insurance). But she will also need to pay her part for supplies, including $100 monitor probes that must be replaced every week, disposable tubing that she must change every three days and 10 or so test strips every day.

Of course, the device and supply manufacturers claim that the high prices reflect the value of the wondrous new innovations:

Companies that produce the treatments say the higher costs reflect medical advances and the need to recoup money spent on research.

Yet now the Times reporter was able to find physicians who claim the "innovations" are really just the latest version of planned obsolescence:

Diabetes experts say a good part of what companies label as innovation amounts to planned obsolescence. Just as Apple customers can no longer buy an iPhone 3 even if they were content with it, diabetics are nudged to keep up with the latest model.
For example,

Those companies spend millions of dollars recruiting patients at health fairs, through physicians’ offices and with aggressive advertising — often urging them to get devices and treatments that are not necessary, doctors say. 'They may be better in some abstract sense, but the clinical relevance is minor,' said Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center.

'People don’t need a meter that talks to them,' he added. 'There’s an incredible waste of money.'


Pharmaceutical companies have also discovered this model.

insulin ... has been produced with genetic engineering and protected by patents, so that a medicine that cost a few dollars when Ms. Hayley was a child now often sells for more than $200 a vial, meaning some patients must pay more than $4,000 a year.

In particular,

Synthetic human insulin is safer for patients, who sometimes developed reactions to animal insulin. But it is made by only three companies: Eli Lilly, Sanofi and Novo Nordisk. Manufactured in microbes, each one’s product has minor dissimilarities that reflect the type of cell in which it was made. Since the companies owned the cell lines, it is nearly impossible for other companies to make exact copies or even similar versions that would be cheaper, even once the patents expire. And the pharmaceutical companies defend the patents ferociously.

What’s more, the three companies continued to refine their product, adding chemical groups that made the insulin absorb somewhat more quickly or evenly, for example. They are called insulin analogues, and their benefits are promoted tirelessly to doctors and patients.


Of course, the pharmaceutical companies also claim that it's all about innnovation,

Dr. Todd Hobbs, chief medical officer of Novo Nordisk, defended the rising prices of insulin, linking them to medical benefits. 'The cost to develop these new insulin products has been enormous, and the cost of the insulin to the consumer in developed countries has risen to enable these and future advancements to occur,' he wrote in an email.
 Not everyone is convinced,

'The insulins are tweaked for minor benefits that may help a small number of patients with difficult-to-control diabetes, and result in major price increases for all,' [Kings College, London, UK Professor] Dr. Pickup said. Because of analogues, he added, Britain’s National Health Service has had to spend 130 percent more on insulin in the past five years.

In the United States, said Dr. Zonszein at Montefiore, the price of Humalog, Lilly’s analogue insulin, was typically two to four times that of its older human insulin line, called Humulin. 'There is not a lot of difference between Humulin and analogues,' he said, but he noted that Humulin was getting 'hard to find.' Sanofi Aventis has stopped selling its older product in the United States, and Mr. Kliff, the financial analyst, said other companies were likely to follow suit, effectively forcing patients to use the costlier versions.


The arguments about valuable innovation also do not explain why the prognosis of diabetes in the US does not seem to reflect all the money we spend on the disease,

Complication rates from diabetes in the United States are generally higher than in other developed countries. That is true even though the United States spends more per patient and per capita treating diabetes than elsewhere, said Ping Zhang, an economist at the Centers for Disease Control and Prevention.

The high costs are taking their toll on public coffers, since 62 percent of that treatment money comes from government insurers. The cumulative outlays for treating Type 1 and Type 2 diabetes reached nearly $200 billion in 2012, or about 7 percent of America’s health care bill.

So to summarize, there is considerable evidence that companies that make drugs and devices to manage type 1 diabetes constantly provide "innovations," yet most are minor changes that encourage obsolescence of previous products, but do not provide important increases in benefits or reductions in harm for patients. 


Oligopoly Disguised as a Free Market

Many in the US sing the praises of our supposed free-market health care system.  As noted above however, the insulin market is an oligopoly, dominated by three companies.  The diabetes device market is also dominated by a few companies, and in particular, the insulin pump market is dominated by a single company,

Medtronic is the dominant insulin pump manufacturer, serving 65 percent of American patients and the majority of those worldwide. Though smaller companies sell cheaper pumps, it is hard to make inroads: Once familiar with the Medtronic system and its extensive support network for troubleshooting problems, patients are reluctant to switch. Doctors are leery of prescribing equipment from a new company that may be out of business in a year; their office computer may not sync with the new software anyway.

Of course, Medtronic public relations will justify it all again based on innovation,

Medtronic declined to talk about specific prices, but said a core tenet was to make only 'a fair profit.' Amanda Sheldon, a spokeswoman, added: 'We are committed to reinvesting in research and development of new technologies to improve the lives of people with diabetes, and our current pricing structure ensures that we can bring new products to market.'

The article also discussed the prices of treating chronic diseases other than diabetes.  For example, see how a nominally non-profit hospital priced treatments for chronic diseases,

Dr. Kivi was on high doses of steroids for debilitating joint pain that left him unable to walk at times.

But when his last three-hour infusion at NYU Langone Medical Center’s outpatient clinic generated a bill of $133,000 — and his insurer paid $99,593 — Dr. Kivi was so outraged that he decided to risk switching to another drug that he could inject by himself at home. 

However,  this pricing appears to have been facilitated by the hospital's increasing market domination generated by its purchase of physician practices,

He had moved his care to NYU Langone to follow his longtime doctor, who had moved her practice from a nearby hospital where the same infusion had been billed at $19,000. The average price that hospitals paid for Dr. Kivi’s dose of Remicade late last year was about $1,200, according to Medicare data.

So in summary, a few companies now dominate the production of drugs and devices for the management of diabetes, and a few large hospitals may increasingly dominate the treatment of particular chronic diseases.  Such oligopolists are able to increase prices without improving treatment to or outcomes of patients.

Enrichment of the Oligarchs

This example shows how the current US health care system is dominated by huge organizations, mostly for-profit corporations but including some nominally non-profit corporations that act similarly.  They loudly proclaim innovation, but much of that innovation seems to provide few benefits to patients, and actually appears to be planned obsolescence.  The result is high and ever-rising prices. So if patients do not benefit from this, who does?

It does not appear to be the health care professionals,

Meanwhile, as the price of supplies rises, endocrinologists remain among the lowest-paid specialists in American medicine, meaning severe physician shortages in many areas and long waits to see a doctor.

We  have seen other examples of how leaders of the big health care organizations have become as rich as royalty.  Therefore, let us consider the pay of the leaders of the organizations mentioned above.  I will focus on the two US based corporations, Eli Lilly and Medtronic, and the New York hospital, NYU Langone Medical Center.

Eli Lilly

According to the company's 2014 proxy statement, the 2013 total compensation of its five highest paid hired executives was

- John C Lechleiter PhD, CEO                                      $11,217,000

- Derica W Rice, CFO                                                   $5,176,822

- Jan M Lundberg, PhD, EVP, Science and Technology   $4,774,535

- Michael J Harrington, General Counsel                          $3,174,222

- Erico A Conterno, President Lilly Diabetes                    $3,009,041

Note that all of these executives save Mr Harrington have also amassed more than 100,000 shares of company stock, and Dr Lechleiter has amassed more than 1,000,000.

It should be no surprise, given our recent discussion (e.g., here) of the currently symbiotic relationship among top health care corporations and academic medicine, that several of the members of the Lilly board of directors that has exercised stewardship over the company, and is thus responsible for these gargantuan compensation packages and the business practices discussed above are top academic leaders.  These include,

- Alfred G Gilman, MD, PhD, Regental Professor Emeritus, recent (until 2009) executive vice presdient, provost, and dean of medicine, University of Texas Southwestern 

- William G Kaelin Jr, MD, Professor of Medicine, Associate Director of Basic Science, Dana-Farber Cancer Center, Harvard University

- Marschall S Runge MD, Executive Dean and Chair of the Department of Medicine, University of North Carolina Medical School

- Katherine Baicker PhD, Professor of Health Economics, Harvard University School of Public Health  (I must note that Prof Baicker is also - amazingly - on the Medicare Payment Advisory Committee, MEDPAC).

- Ellen R Marram, Trustee, New York-Presbyterian Hospital

- Ralph Alvarez, President's Council, University of Miami

- R David Hooper, Trustee, Children's Hospital of Colorado

- Franklyn G Pendergast MD PhD, Professor, Mayo Medical School

All but the newest directors were paid at least $250,000 a year by the company (and thus by the executives the directors are supposed to supervise), and all but the newest directors had accumulated tens of thousands of shares of stock or the equivalent as pay for their services.


Medtronic

Similarly, according to the company's 2013 proxy (the latest now available), CEO Omar Ishrak made $8,975,866 in 2013, and the next four highest paid executives all made over $2,500,000 each.   Mr Ishrak owned or could acquire the equivalent of more than 500,000 shares of stock, and the other top paid executives owned of could acquire from over 100,000 to over 1,000,000 shares of stock.

Again, the executives were nominally supervised by a board of directors that included an academic and non-profit leader, Dr Victor J Dzau, MD former chancellor for health affairs at Duke University, and president-elect of the Institute of Medicine (note that we discussed Dr Dzau's conflicts of interest most recently here).  It also included a former government leader, Michael O Leavitt, former US Secretary of Health and Human Services; and a hospital leader, Preetha Reddy, Managing Director of Apollo Hospitals Enterprise Limited (India). 

NYU Langone Medical Center

The Medical Center's 2011 US form 990 is old, but the latest available, and is remarkably obscure, omitting, for example, mentioning the titles of any of the people listed as highest paid officers and employees.  The current CEO, was listed as receiving total compensation of just over $2.000,000.  Four individuals then received over $1,000,000.  The 990 form also mentioned that the Medical Center provided some individuals with first class travel, tax gross-up payments, housing allowances, and reimbursement for personal services.  Neither the 990, nor the center's web-site makes all the possible conflicts of interest of its trustees obvious.   

So in summary, the large organizations, for-profit and non-profit, that are able to greatly increase their prices through planned obsolescence disguised as innovation, and oligopoly disguised as free markets, are able to make their top executives very rich, and also enrich those who are supposed to exercise stewardship over them. 


Summary

An extensive journalistic investigation revealed how certain aspects of chronic care in the US health care system are dominated by a few large organizations.  These organizations are able to charge very high prices, mainly through market domination, and with the aid of marketing and public relations that tout planned obsolescence as valuable innovation.  The leaders of these organizations have become wealthy, often fabulously so.  This state of affairs has not been challenged by those who are supposed to provide stewardship, including many prominent academics.

The US health care system is the most expensive, on a per capita basis, in the world, and far more expensive than that in any other developed country.  Yet there is no evidence that its results are superior to those of other countries.  What evidence there is suggests in fact that our results are mediocre at best.

The current example suggests how the US system differs from those of other countries.  It has an ostensible free market focus.  Yet the system appears more to be an oligopoly, with most of its market components dominated by a few large organizations, run as an oligarchy, by a small, overlapping in-group of managers, executives and their cronies, with elements of corporatism, that is with the cooperation of, rather than regulation by government entities and leaders

A real free market health care system would include a level playing field.  This could only be achieved by the government acting as a fair umpire, not a crony.  Anti-competitive practices would have to end.  Oligopolies would have to be broken.  Deceptive marketing and public relations would have to be exposed.  Leaders would have to be made accountable, especially for putting patients' and the public's health ahead of their own enrichment.  All this would be horribly difficult, as the oligarchs have amassed much money and control, and would oppose, possibly violently, any effort to challenge them.  If we do not challenge them in the US, however, not only will our health care continue to become ever more expensive, less accessible, and less beneficial to patients, but we will all cease to be citizens of one of the first real democracies, and end up serfs instead. 

Thursday, February 07, 2008

Is More Always Better? - the ACCORD Study Results

The big medical news today was that the intensive treatment arm of the ACCORD (Action to Control Cardiovascular Risk in Diabetes) study will be stopped because a preliminary analysis revealed that patients given intensive treatment to lower their blood sugars were more likely to die than those given less intense treatment. The trial and these results were summarize in a news release from the National Institutes of Health:


In this trial of adults with type 2 diabetes at especially high risk for heart attack and stroke, the medical strategy to intensively lower blood glucose (sugar) below current recommendations increased the risk of death compared with a less-intensive standard treatment strategy. Study participants receiving intensive blood glucose lowering treatment will now receive the less-intensive standard treatment.

The ACCORD (Action to Control Cardiovascular Risk in Diabetes) study enrolled 10,251 participants. Of these, 257 in the intensive treatment group have died, compared with 203 within the standard treatment group. This is a difference of 54 deaths, or 3 per 1,000 participants each year, over an average of almost four years of treatment.

The intensive treatment group had a target blood sugar goal, measured by hemoglobin A1C, of less than 6 percent.

In ACCORD, intensive treatment group participants achieved, on average, A1C values lower than standard treatment group participants. Half of the participants in the intensive treatment group achieved an A1C of less than 6.4 percent, and half of the participants in the standard treatment group achieved an A1C of less than 7.5 percent.

These results shocked quite a few distinguished experts.

  • "Its striking that more is not necessarily better. You'd think that lowering blood sugar more would give better results, but it's exactly the opposite" - Dr Douglas Weaver, Co-Director, Heart and Vascular Institute, Henry Ford Hospital, President-Elect, American College of Cardiology (via USA Today).
  • "It's confusing and disturbing that this happened. For 50 years, we've talked about getting blood sugar very low. Everything in the literature would suggest this is the right thing to do." - Dr James Dove, President of the American College of Cardiology (via the New York Times).
  • "It's profoundly disappointing. This presents a real dilemma to patients and their physicians. How intensive should treatment be? We just don't know." Dr Richard Kahn, Chief Scientific and Medical Officer, American Diabetes Association (via the Washington Post).

Actually, what is striking is that these results should have come as such a surprise. There has never, repeat never been good evidence that intensive treatment to lower glucose provides clinical benefits that outweigh the harms for patients with type 2 diabetes. (Type 2 diabetes is the most common type of diabetes that begins in adulthood, and that does not require insulin treatment for patients to survive.) Thus, the notion that there was 50 years of evidence that "more is better" in terms of treatment of this kind of diabetes using existing drugs and methods was little more than a myth.

For review of the existing evidence about the benefits and harms of intensive treatment, see the Appendix below.

As McCormack and Greenhalgh noted,(1) there are psychological reasons why people, even highly trained professionals, tend to believe more is better. Unfortunately, these reasons have been abetted by the influence of financial incentives.

A lot of people make a lot of money from intensive diabetes treatments. Drug-makers sell more drugs and biologics, device-makers sell more diabetes tests, and doctors are paid for more office visits. Pharmaceutical, biotechnology, and device companies have marketed diabetes tests and treatments with great enthusiasm.

Also, these companies have fostered conflicts of interest that may have influenced how physicians, academics, and organizational leaders think and act. These companies have paid physicians and academics as consultants, speakers, advisors, etc. These companies have also lavishly contributed to professional societies and not-for-profit organizations that are positioned to influence diabetes care. For example, the American College of Cardiology and American Diabetes Association, whose leaders were quoted above, have received considerable funding from pharmaceutical companies that make diabetes drugs and related products (see report by the Center for Science in the Public Interest here for older data, and the ADA 2006 annual report here, which included $1 million plus contributions from Abbott/Abbott Diabetes Care, BD Medical Diabetes Care, Eli Lilly and Company, GlaxoSmithKline, Merck & Co., Inc., Novo Nordisk, Pfizer Inc, sanofi-aventis, and Takeda Pharmaceuticals North America). Is it any surprise that individuals and organizations receiving pharmaceutical/ biotechnology/ device companies' largesse are less likely to question the prevailing wisdom that more treatment is always better?

I strongly hope that the results of the ACCORD study prompt a re-examination of what we really know about treating diabetes, our general acceptance that more, more intense, more high-tech, more recent, more invasive, more expensive is always better, and our laissez faire notions about financial transactions between companies which make profits by selling goods and services and professionals whom the public trusts to put patients' welfare first.

Appendix - Quick Review of Evidence About Intensive Glucose Lowering Treatment for Type 2 Diabetes

Although there have been a multitude of studies of type 2 diabetes treatment, nearly all of them only assessed surrogate or secondary endpoints. None assessed the development of complications of diabetes that could affect how patients feel, function, or survive.

There really have only been two large-scale, prospective controlled trials of the clinical effects of treatment (critically summarized in two articles in the British Medical Journal). (1-2). The first major controlled trial to assess the clinical effects of more and less intense treatment of diabetes was the University Group Diabetes Program Study (UGDPS), reported in 1970. That trial's counter-intuitive result was that treatment with the major class of oral drugs used at that time, the sulfonylureas, seemed to increase mortality. After the study was published in 1970, there seemed to be a tremendous effort to explain away its findings. I remember the study being dismissed as controversial, if not discredited, when I was in medical school. Almost no one seemed to take its results seriously.

The UKPDS study, reported in 1998, was the only other large, prospective, long-term, randomized controlled trial of intensive treatment of type 2 diabetes. It did show one benefit of intensive treatment.(3) Such treatment lowered the rates of surrogate endpoints related to microvascular (small vessel) complications of diabetes, that is, the rates of performance of laser treatment of retinal disease, retinal changes on examination, and increased albumin excretion in the urine. However, intensive treatment did not decrease the risks of clinical endpoints related to microvascular disease, that is, endpoints that would affect how patients feel or function, such as loss of visual acuity, blindness, or kidney failure. Intensive treatment also did not lower the rate of any macrovascular (large vessel) clinical complications, i.e., of myocardial infarction (heart attack), heart failure, stroke, need for amputation, or death.

On the other hand, patients taking intensive therapy continuously were subject to the risk of hypoglycemia (low blood sugar). Risks of serious hypoglycemic events were 0.6% per year for patient taking oral glucose lowering drugs, and 2.3% for patients taking insulin.

Thus, from this study, it is not clear that the only clear benefits produced by intensive therapy that might affect how patients feel or function, reducing the need for laser treatments of retinal disease, were worth the risks of severe hypoglycemia, which can result in confusion, falls, accidents, or even death.

However, as McCormack and Greenhalgh noted, the results of the UKPDS study were widely mininterpreted as "convincing evidence that tight blood glucose control is an important goal for type 2 diabetes," and that the main finding of the study was "intensive treatment of type 2 diabetes is beneficial."

References

1. McCormack J, Greenhalgh T. Seeing what you want to see in randomised controlled trials: versions and perversions of UKPDS data. Brit Med J 2000; 320: 1720-3.

2. Shaughnessy AF, Slawson DC. Blowing the whistle on review articles: what should we know about the treatment of type 2 diabetes? Brit Med J 2004;

3. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulfonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352: 837-853.

ADDENDUM (7 February, 2008) - See also comments on DBs Medical Rants.