Of Rights and the Rules

Marc Rendell, MD

Due to the high prevalence of Diabetes and the many serious health problems which result, the health care burden of this disease on our society is enormous. We now are on the threshold of a major expansion of health care in our population. U.S. President Barack Obama has rightly recognized that health care is a fundamental human right, not to be denied to those less financially successful. Despite some adamant objections, he succeeded in passing into law a program to guarantee health care to most individuals, irrespective of employment or financial resources. Naturally, he has passed on the costs of his program to the segments of our society capable of paying for their own care, thus saddling them with the additional burden of those who were unable to pay. Unfortunately, his generosity has come at a time of diminished economic success in the United States. The historical dominance of the American economy has suffered from international competitors such as China, which has extracted increased productivity from its populace, many of whom are denied the high living standards of the United States. In our country, ever increasing regulations, some justified, others questionable have slowed our innovation and production. American companies, competing against inexorable economic forces, have taken advantage of lower labor standards and costs sending jobs overseas, depriving our work force of employment necessary to pay for our needs, including health care. The Obamacare reform is seen as an additional cost to be borne by our economic system, leading to the perception that it may cause further loss of jobs. Those who endorse universal health care point to the fact that the United States has been the only highly developed country without this social benefit. However, this persuasive argument has suffered somewhat recently as the economies of major European countries have been threatened by overwhelming debt, in part due to the social benefit of health care for all.

Health care cost is largely generated by chronic diseases, often resulting in long drawn out end of life events which consume massive resources. No disease represents a greater challenge to the economics of universal health care than diabetes, due to its high prevalence and many associated diseases and disabilities. In the United States in 2007 the total cost of diabetes was estimated at $174 billion. After adjusting for population age and sex differences, average medical expenditures among people with diagnosed diabetes were 2.3 times higher than for those without diabetes. Men with diabetes miss an average of 11 work days each year and women miss about 9. Add to this that many of the underprivileged targeted by the new health care program have a higher rate of diabetes than the general population. African American and Latino populations are also twice as likely as the European-American population to develop diabetes. Furthermore, immigrants to the United States, exposed to our dietary excesses, tend to develop diabetes at a much higher rate than their ethnic groups overseas. There are many economic forces at work as we try to find a way to develop effective care for diabetes at the lowest cost.

THE HIGH COST OF INNOVATION IN HEALTH CARE
Advances in health care are economically beneficial. Better treatments result in decreased health problems, less disability, and better quality of life. Over time, a net economic advantage to society occurs. However, there is a fundamental public misperception of the course of scientific progress. In our conception of the battle against disease and disability, we look to the cure, one extraordinary advance which will overcome a terrible health problem. Our dreams are nurtured in the remarkable history of great achievements in health care. We remember Louis Pasteur and the rabies vaccine, Alexander Fleming and his discovery of penicillin, and, above all, in our recent history, Jonas Salk and Albert Sabin, and their development of polio vaccine, ending the dread summer epidemics of paralysis which destroyed the lives of so many of our children.

In our optimism, we came to expect that these advances would continue and bring an end to cancer, Alzheimer’s disease, and diabetes. We grow impatient as the years pass and our scientists fail to announce the cure.

What we don’t recognize in our public consciousness is that most scientific advances take place in small incremental steps. Despite the NASA successes, we do not yet live in colonies on the Moon or Mars; yet we enjoy the international integration resulting from communications satellites developed as a result of space exploration. People still have heart attacks, but less frequently since the advent of the statin drugs to lower cholesterol levels. Many people are now surviving cancer as a result of new chemotherapeutic drugs.

Incremental progress in care of diabetes has been continual. Fifty years ago, patients could not easily determine their blood sugars, using urine testing as the sole indication of high values. The advent of strips coated with the glucose oxidase enzyme changed that situation, giving patients the ability to manage their own insulin regimens based on their self monitored glucose values. Insulin pumps afford the means to continually self administer varying doses of insulin. There are now indwelling glucose probes which can continually read out blood sugar levels. A number of new oral and injectable medications which treat insulin resistance are now available, including several which actually promote weight loss.

The problem we face today is that progress is expensive. It is estimated that the cost of bringing a new drug to market is over a billion dollars. This cost is in large part driven by expanding regulatory requirements. The FDA is charged with ensuring the safety and effectiveness of new agents prior to marketing. This is a great challenge, given that studies of investigational drugs are carried out in relatively small sample populations. Problems with new agents often arise only after the general population is exposed in everyday clinical use. The FDA contributes to the misunderstanding that there can be no guarantees of safety. When problems arise, the public, the press, and elected officials rise up in criticism of the regulatory process. It would be far better if new agents were released for use at earlier stages of development, after evidence of comparative safety, with the understanding that true long term safety can only be assured by large population trials of long duration. The costs of these lengthy trials would be covered by sales of drugs at early time points and for longer periods of time than the presently allocated patent lifetime of only 11 years.
The present attempt to offer universal health care is facing the challenge of dealing with common, costly diseases epitomized by diabetes. Furthermore, African American and Latino populations, who as I mentioned have a higher rate of diabetes, are overrepresented among those without current health insurance.

So it is that we now confront not only the formidable health challenges of diabetes, but also face the economic reality of trying to care for a costly disease which is spreading in our population.

From 1980 through 2010, the crude prevalence of diagnosed diabetes increased by 176% (from 2.5% to 6.9%). A large part of this increased prevalence is ascribed to a dramatic increase in obesity in the United States.

WHAT DEFINITELY IS NOT GOING TO SOLVE THE PROBLEM
The instinctive response of administrators is to invoke short term solutions to fix problems. They do this by creating regulations which may not truly address the issues and nearly always impose significant burdens. So it has been with the cost controls applied to diabetes. Glucose testing strips, for example, are vital to self management of diabetes and Medicare had to deal with excess use of strips. Some patients acquired their strips and then turned around and sold them on the streets. To curtail the high costs of glucose strips (usually 50 cents or more per strip), Medicare created an arbitrary three strips per day limit for patients on insulin and only one daily for non insulin-treated patients. Clearly for insulin-treated patients, particularly those with very brittle diabetes, who experience large swings in blood sugar, and those on pumps, this allocation is completely inadequate. For non-insulin treated patients, it is often important to know both fasting and post supper glucose levels on the same day. Medicare allowed deviations from these imposed both taken steps to fight limits if justification was clearly documented in the medical record, not simply on the prescription. The Medicare program created four regional Durable Medical Equipment zones with ordained suppliers. They have used this structure to channel requests for diabetes supplies, most notably glucose strips, away from local pharmacies. Patients and physicians find themselves filing requests for glucose monitoring supplies to far off companies. Medicare then developed an audit system to check if excess use of strips was justified. Rather than questioning the treating physician, they demanded medical records from the Durable Medical Equipment supplier. However, the supplier did not have those records.

To overcome this obstacle, Medicare asked the suppliers to obtain medical records, although they were not treating physicians. This is in direct violation of privacy protections enacted in the Health Information Portability and Accountability Act (HIPAA) of 1996. According to HIPAA, patient records can only be released with consent of the patient. Not to be deterred, Medicare administrators granted the DME suppliers an exception to HIPAA by labeling them as health providers, entitled to obtain records. As a result, patient records containing sensitive private information are now being requested and sent all over the United States, with no cause other than to meet audit requests by Medicare.

To make matters worse, a number of unscrupulous companies developed, many concentrated in South Florida, who initiated multiple requests for strips and then tried to get physicians to order other unnecessary medical supplies for patients, such as back braces and air mattresses. One of my unfortunate patients has a whole room full of glucose testing supplies sent against her will. In contrast, another patient of mine with Type 1 diabetes and an insulin pump, was only able to get one strip daily. At the same time, private records are now open reading in places far from the privileged relationship between patients and their doctors.

Another disturbing trend is the imposition of strict limits on medications, with insulin limitations exemplifying this concern. Due to cost controls, some insurers ration the amount of insulin used by patients down to the level of units per day. Pharmacists have actually delayed life sustaining insulin refills to some of my Type 1 patients unless they receive approval from me for very slight changes in insulin dose.

HOPE FOR BETTER DAYS FOR CARE OF OUR DIABETES COMMUNITY
The financial reality of diabetes must be addressed, but not by arbitrary administrative rationing of vital supplies and equipment. We must not limit innovation in the hope of reducing economic burdens. On the contrary, we must embrace slow progress to the goal of better health care.

The great cost of diabetes is not in the advances in treating Type 1 insulin dependent patients; such cases constitute a small minority. Rather it is Type 2 diabetes with its huge burden of associated diseases which is our true challenge. It is important to recognize that Type 2 diabetes in most patients is really a symptom of obesity. The goal must be to attack obesity as the root cause of diabetes. Overweight is a frustrating condition, popularly attributed to overindulgence in caloric pleasure. Although overeating is a major cause of weight gain, there are other major contributing factors. Lack of physical activity is likewise a promoter of fat accumulation. In the past, work was synonymous with physical labor. No longer so in our society; heavy lifting can now mean shifting computer information in large databases. Our children enjoy their play time moving icons on video games rather than running, swinging, and climbing—resulting in an alarming increase in obese children in our society.

Diabetes is a public health problem which must be addressed by a true partnership involving the medical community, government, and our people. Our physicians have been guided by a conventional belief that it is fruitless to try to change human behavior. Little attempt is made by doctors to modify lifestyle. As physicians, we hide behind our pharmaceutical agents and use them to treat conditions which are really symptoms of a problem. The government attempts to control costs by coming up with ever changing new methods of health care delivery: Medicare and Medicaid, HMOs, and Accountable Health Organizations. After government imposed controls fail, rationing of needed care becomes the norm. At the same time, we the people come to expect doctors and the government to hand us good health, despite our preferred habits, which may be harmful.

It is now mandatory to change our social approach to face the challenge of diabetes, requiring a joint effort to reduce the social impact of the disease. Our society has successfully accomplished this before. Universal vaccination was not just a scientific success; it took a strong government-led approach to guarantee immunization to all our children. Many of the dread infectious diseases of history have disappeared as the result of this endeavor: smallpox, polio, as well as measles, mumps and now, hopefully, cervical cancer due to human papilloma virus vaccination. The great damage inflicted by smoking is slowly yielding to a combination of punitive taxes, strict non smoking regulations, and above all, constant information to the general public warning of the great risks of cigarettes. Hypertension, which promotes heart attacks and strokes, is aggressively treated by our doctors who convince patients to limit salt intake and take drugs despite the silent nature of high blood pressure.

The same combination approach used to fight infectious disease, smoking, and high blood pressure can be brought to bear on diabetes. Mayor Bloomberg of New York City took a symbolic step in banning large volume soft drinks, high in sugar and calories. His example should be followed on a large scale. First lady Michelle Obama gets a modicum of respectful publicity for her campaign on behalf of nutritional improvement for our children, but that media attention needs to increase ten fold. It certainly does not hurt that our president is physically fit, playing basketball despite his age, and that he quit smoking, efforts needed to change the public consciousness. From a regulatory standpoint, it is reasonable to reward lifestyle changes. Our health care insurance premiums should reflect the reality of lifestyle. Those who choose to remain at normal body weight and refrain from smoking should have lower health care premiums than those who do not make an effort. Health care behavior can change. More than any other people, Americans are very interested in their health. It is not our health care reimbursement system which is responsible for a budget that occupies almost 20% of our GDP. Rather, it is the genuine concern that our people have about their bodies and the avoidance of disease. As a society, we can harness the great energy of the American people to successfully reduce the burden of diabetes while we advance in our scientific treatments. We must impact diabetes and other common chronic illnesses to protect this vital need.

ABOUT THE AUTHOR
Marc Rendell, M.D., is the director of the Creighton Diabetes Center, medical director of the Rose Salter Medical Research Foundation, and the executive director of the Association of Diabetes Investigators in Omaha, Nebraska.