Diabetes Care: Avandia is a Symptom of the Problem with US Healthcare

My head was spinning from the webbed controversy over the type 2 diabetes drug, Avandia, which has been reported to have caused 304 deaths in the third quarter of 2009.

...once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged. A committee of independent experts found in 2007 that Avandia might increase the risk of heart attack but recommended that it remain on the market, and an F.D.A. oversight board voted 8 to 7 to accept that advice. New York Times

Who is to blame here? I know a little something about the pharmaceutical industry--how drugs get to market, and how doctors and patients are informed. I have worked in a professional capacity with many global pharmaceutical companies and in many therapeutic areas, including diabetes. The benefits of the pharmaceutical industry’s advances in medical science and their development of treatments for incurable diseases far outweighs the risks associated with poor outcomes. However, I am not here to defend the industry. Glaxo Smithkline should pull Avandia off the market. But there is something even more important to recognize...

Avandia is a symptom of what’s wrong with healthcare and drug regulation in the United States. It is also a reflection of how poorly our physicians are educated. There are two major issues that Congress should be evaluating:

1. The expertise and ethics involved in FDA’s approval process for new drugs (NDAs). How did Avandia receive approval from the FDA – even with evidence of documented risks to diabetes patients?
2. How best practice care and guidelines are diffused and disseminated to those physicians (mostly primary care physicians) who treat patients with diabetes?

Reporting of the Avandia Scandal
I was shocked that none of the news programs or any of the press thought it important to address the complexities of type 2 diabetes as the Avandia scandal emerged. How can the dangers of a drug be discussed without addressing the disease? I’m not sure if this was a reluctance to get involved in the pathology behind the disease (too boring, too dry and too hard to explain) or if there is a general assumption that EVERONE knows enough about type 2 diabetes already. It is a gross assumption.

Type 2 diabetes (it accounts for 90-95% of all diabetes patients), Coronary Heart Disease
and Metabolic Syndrome (Insulin Resistance and Sydrome X) are terms that are tossed around interchangeably, but are rarely defined. In fact, Metabolic Syndrome has become somewhat clichéd – and often (inexcusably) overused as a euphemism for the overweight and under-educated. To make it simple Type 2 diabetes can be defined by two defects – the inability to secret insulin, and the body’s resistance to the action of insulin (breaking down sugar in the blood). These two defects are associated with dyslipidemia, obesity and hypertension (markers of Metabolic Syndrome) --which in turn are all risk factors for Coronary Heart Disease. You can have Metabolic Syndrome without having diabetes and you can have Coronary Heart/Vascular Disease without diabetes but every person with type 2 diabetes should also be treated for Heart Disease (CHD).

Furthermore, CHD is the leading cause of death (800,000 per year); diabetes accounts for 160,000-180,000 deaths per year and the leading cause of death for diabetes is – you guessed it – Coronary Heart disease. (How many of those 800,000 people who are reported to have died from CHD are actually people with type 2 diabetes, but undiagnosed?)

The first question is how did the FDA continue to approve a drug for market in 2007 if there was evidence that it could cause heart attacks for a patient population already at risk for CHD? What was the FDA thinking? How was that risk serving the interest of United States public healthcare? It wasn’t.

After FDA Approval
It is well documented that primary care physicians are overwhelmed by the high number of type 2 diabetes patients that walk through their doors, and how to care for them. When a new drug like Avandia is presented to the market – how does a primary care physician learn about its benefits and its risks? There are many ways a doctor can learn about a new drug:

1. Pharmaceutical representative calling on a doctor’s office and presenting the new drug
2. Continuing Medical Education (CMEs). The AACME is an organization which serves as the body accrediting institutions and organizations offering continuing medical education. They approve the Continuing Medical Education programs that are developed for physicians by these institutions and usually sponsored (funded) by the pharmaceutical industry.
3. Pharmaceutical Advisory Board members who are practicing doctors (often called Key Opinion Leaders) affiliated with the development of the drug, will participate in AACME approved symposia or lectures on a new drug/ its benefits. Often these KOLs will disseminate information about the efficacy of a drug so well that a phone call may be all it takes for one less informed physician to feel comfortable in prescribing a drug he knows little about.

Because Type 2 diabetes is such a complex disease with so many variables (as described before) and because primary care physicians (not endocrinologists or diabetologists) are caring for these patients, professional competencies are tested.

The management of people diagnosed with diabetes increasingly challenges health care personnel in the United States. The number of people with diabetes increases by ~ 1 million yearly,1 and diabetes was the primary diagnosis in 23.8 million visits to office-based physicians in 2006, most commonly to general practitioners, family physicians, and internists.2 Managing diabetes requires practitioners to be competent in complexities of disease management as well as in patient communication, counseling, and education—understanding how multiple psychosocial factors affect patient care and outcomes. Primary care practitioners (PCPs) are therefore required to master both physiological and psychosocial approaches to treatment and management. Yet many are challenged in doing so. Spectrum Diabetes Journal

Isn’t it time for Congress to assess how de-regulated private healthcare (including education of licensed physicians) isn’t serving public health? Avandia has really put this problem into the spotlight – if only Congress (and the media!) would address the core issues. The FDA acts as a lame watchdog, and without a regulatory roadmap – or a sound infrastructure to translate new medical therapies into clinical applications in a systematic way, medical advances and new therapies cannot result into tangible public benefits.. There has got to be a better way. President Obama, are you listening?

Kris Freeman: Risking Success with Diabetes

Whistler Olympic Park, BC (Feb 20)
On Saturday, Kris Freeman took 45th place in the Men’s 30 kilometer pursuit cross-country ski race. Freeman is the first Olympic endurance athlete with Type 1 diabetes. At the 11.25 km mark of the race, Freeman was just 6.2 seconds behind the lead. On the 4th lap of the race his blood sugar crashed and he “stopped and laid on the ground for a moment." Fortunately a German coach saw Freeman and ran to his side - giving him some Gatorade and some “goo” (glucose gel) and Freeman managed to get up and finish the race.

It’s all about calculated risk for people with insulin dependent or type 1 diabetes. We might have the technology that allows us to calibrate the exact amount of insulin required to do almost anything--swim 500 meters, run a marathon or cross country ski a 30 kilometer race. But it all comes down to trial and error. Sometimes it all goes wrong, and the amount of insulin in our bodies overtakes our ability to move or to think and we just have to stop. It is called a hypoglycemic reaction and it is the most threatening aspect of managing insulin dependent diabetes. Some of the symptoms felt during a hypo include confusion, dizziness, pounding heart, racing pulse, trembling, weakness, anxiety, poor concentration and finally passing out, if you don’t get glucose into your body (to refuel your cells) right away.

It must have been an earth shattering disappointment for Kris Freeman, but I have to hand it to him. He did what many type 1’s do everyday when we have a hypo – although under less extreme circumstances – the best of us get up and we don’t quit. I have had moments too – as a teenager competing in track and field and letting the team down by not being able to complete my sprint because of a hypo; as a young professional having to excuse myself from the podium and the wide-eyed audience because I needed a coke or some candy for my “condition,” and finally as a mother, who has to explain to her young daughter why she must open a can of juice without buying it in the supermarket (Mom, they will arrest you!) or risk passing out in the aisle. I never quit sprinting in high school or enjoying speaking publicly or being honest with my daughter about my diabetes.

I would also never compare myself to Kris Freeman. I am not a world class athlete who has spent most of her life training to compete in elite competitions qualifying for the Olympic Winter Games. But I do have an idea what his body’s stress response was on that fourth lap. Insulin is a dangerous drug, and if you don’t get the simple carbohydrates into your bloodstream during a hypoglycemic reaction immediately, you will pass out. I am certain Freeman felt the hypo coming on – but how could he give up on his chance for an Olympic medal before his body did? He may have pushed his own physical limitations until he had to stop and lie down. That’s what happens – you just can’t go any further – as if the earth falls away from under your feet. I can only imagine the deafening sound of the passing skis rushing by Freeman’s head in the snow because everything is more intense (sounds, colors, feelings) when a hypo occurs. It’s possible that he may have looked around for help and gave up, because vision often becomes tunneled and vague – like the reverse negative of a photograph and that’s when fear steps in… but I am certain he had one thought and one thought only – I NEED GLUCOSE -- in any liquid form, and getting into his body as quickly and easily as possible. As Freeman’s blood sugar began to crawl back up and he brushed the snow off his legs, I wonder if he felt regret and vulnerability, perhaps bad luck and some embarrassment --magnified by the millions of viewers and fans, journalists and coaches who might have been shocked by what happened. But Freeman stood up and finished the race.

Kris Freeman is a hero, not because he is an Olympic athlete. No, I am a fan because he has not given up. A few days before the cross country racing began, he told Matt Lauer and Meredith Vieira on The Today Show, “One of the very first things people told me is what I couldn’t do… that I couldn’t be an Olympic Cross country skier. I worked with my doctors and proved them wrong.”

There will be other races like the Men's 50 km race February 28th, and I’ll be one of his fans right behind him hoping he’ll get a gold, silver or bronze. He deserves it.

“Only those who will risk going too far can possibly find out how far one can go.” TS Eliot

Eating Abroad with Diabetes - Hong Kong

Check out my piece on a fantastic blog called "A Sweet Life." Here is the link.

Diabetes and DKA - Bad News for the United Kingdom's NHS (and the BBC)

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Today, the BBC reported "a shocking number of children being rushed to hospital each year with potentially fatal complications of diabetes" in an article entitled "Better child-diabetes care urged." The complication at issue here is Diabetic Ketoacidosis or DKA (which develops when you have too little insulin in you blood), and it is affecting more children than any other subset of patients affected by diabetes. There are an estimated 25,000 children with diagnosed type 1 diabetes in the United Kingdom, and the BBC reports that there were 13,465 cases of DKA from April 2008 through 2009. A quarter (3,300) of these cases were children and young people. Why?

What the BBC doesn't tell us is what percentage of the 3,300 were undiagnosed when they were brought into the hospital emergency room. People with type 1 diabetes often recount diagnosis by discussing the blood sugar number which led to its validation. "850" "700" "1012" are some of the blood sugar numbers that have been recalled by patients I know (mine was 960) who might not remember much about their first day of diabetes except for that number which may indicate DKA. The blood sugar level of a newly diagnosed type 1 child or adult can often hover around 1000, far above 250 mg/dl, the level at which DKA can begin. (Normal range is 70-120 mg/dl)

Just what is Diabetic Ketoacidosis? The Mayo Clinic is a useful tool for understanding diabetes and diabetes complications at a very basic level and offers patients a FAQ sheet explaining causes, symptoms and prevention. More weighty definitions can be found from other sources, such as medscape:

DKA is a complex disordered metabolic state characterized by hyperglycemia, acidosis and kentonuria...ketones are acids that build up in the blood and appear in the urine when your body doesn't have enough insulin and are produced when fat cells break down in the blood. When the accumulated ketones exceed the body's capacity to extract them, they overflow into urine (ie, ketinuria). If the situation is not treated promptly, blood serum levels become acidic (ketoacidosis) - this is when shallow breathing usually begins to offset high levels of carbon dioxide in the blood. Other symptoms include thirst, nausea, vomiting, abdominal pain, confusion and shortness of breath. If untreated DKA can lead to coma or cerebral edema. Anywhere from 1-10% of all cases are fatal.

There are a few issues here which the BBC hasn't adequately covered: aside from the the report stating that many families find it hard to access diabetes specialist care, there is no mention of General Physician education and awareness about detection of type 1 diabetes, what the symptoms of diabetes are (although they do describe symptoms of DKA) and where to go for help.

Finally, it is harder to detect DKA in children because children (and teens) are undergoing normal physiological processes (growing), which may frequently require adjustments of clinical management of diabetes. Hormonal and psychological changes during puberty may be critical in conditioning management. Winter colds, flu and other common illnesses may also destabilize control. But essentially, vigilance and routine blood testing and insulin treatment for the diagnosed type 1 child with diabetes can and should help prevent diabetic ketoacidosis.

Diabetes UK, the charity who reported the figures to the BBC, was sited as saying that the rise "could be blamed on children being diagnosed later" (maybe too late is a better way to put it? or because diabetes was undetected?) or perhaps "a failure to manage their condition properly once a diagnosis had been made."

HAITI: Reprint of JDRF Letter to Diabetes Commmunity

To:	The JDRF Family
From:	Shannon Allen, International Board of Directors Adam Singer, International Board of Chancellors
Re:	JDRF Program for People with Diabetes in Haiti
Date:	February 2, 2010

In the midst of the tragedy in Haiti is an underlying story that touches the hearts of everyone with a tie to diabetes.

From our personal connections to type 1 diabetes - as a parent of a child with type 1 and an adult living with the disease for 30 years - we know that managing diabetes is incredibly difficult in the best of circumstances. We have had a glimpse of how challenging it is given the devastation and chaos in Haiti. One estimate says there are over 300,000 Haitians with some form of diabetes.

Over the past three weeks, several JDRF-funded investigators have selflessly volunteered their time and talents to work in clinics in Haiti or to gather and transport the supplies necessary for diabetes care. Their stories are heartbreaking. As one example, we would refer you to the website created by Dr. Mark Atkinson (http://www.theatkinsonsinhaiti.com/) a JDRF investigator who has, since the 1990s, been leading medical missions to Haiti. Mark just returned last week from nine days in Haiti.

A large number of JDRF voices have weighed in on this issue, and what we hear from them is consistent - the aid that is having the most impact is delivered efficiently through a number of professional, focused, and well-established organizations with long histories in Haiti delivering on such efforts.

Hearing this, JDRF's International Board has discussed the situation at length and determined how we can best respond as an organization and as individuals.

Firstly, we have been in touch with a number of our partners, both corporate and private, and will continue to encourage and support their efforts to provide diabetes supplies directly to the people of Haiti. Across the board, their response has been monumental. We have also been in contact with partners, researchers and medical professionals on the ground in Haiti, and will continue to coordinate with them to see what the Haitian people need.

Secondly, we have developed options for those within the JDRF community who wish to directly contribute to the cause. Ways you can contribute include:

• The International Diabetes Federation (IDF), a partner of JDRF in programs around the world, has established the Diabetes Trust Fund for Haiti. The money collected will be used to support people with diabetes during the emergency and will help provide services for them in the longer term. You can contribute directly to the fund at http://www.idf.org/idf-diabetes-trust-fund-haiti.
• The Insulin for Life Foundation is a not-for-profit organization that collects and distributes insulin and other diabetes supplies to needy people throughout the world. Insulin for Life, in conjunction with the IDF, is currently collecting supplies to be sent to Haiti to be distributed through the Haitian Foundation for Diabetes and Cardiovascular Diseases (Fhadimac). Donations of insulin, syringes, alcohol pads and glucose test strips may be mailed to:
  

Insulin for Life USA
PO Box 2840
Oklahoma City, OK 73101

Please note that it is vital that any donated insulin and test strips must not be past their expiration date, or they will not be accepted. For more information, or to contribute financially to help cover shipping costs, you can go to http://www.insulinforlifeusa.org/.

• Fhadimac houses the only dedicated diabetes clinic in Haiti, which, amazingly, is still standing and providing services. They are overwhelmed yet are somehow able to give care to the many Haitians with diabetes showing up with no medicine, food, shoes, etc. As of this weekend they received a shipment which allows them to support 200 Haitians with diabetes for a month. We know that we can make a huge improvement for them by spreading the word. To support their efforts, please visit: http://www.fhadimac.org/index-e.php
  

Finally, we anticipate that in the coming months, hundreds, or even thousands, of Haitians with diabetes may relocate temporarily or permanently to the United States, Canada, and other countries where JDRF has a presence. JDRF leadership will work with our local chapters to welcome and support these people as they arrive in our communities. One of our great strengths is our ability to help those affected by diabetes by the outreach efforts of our chapters.

These steps represent an initial program to provide JDRF volunteers and staff with opportunities to help people in Haiti with diabetes. We will continue to monitor the situation and report on the efforts of our JDRF friends there.

If you have any questions or need more information, please feel free to email JDRF atoutreach@jdrf.org, with Haiti Relief in the subject line.

Thank you for your generosity and willingness to help the Haitian diabetes community at this time of critical need.