DC Medical Malpractice & Patient Safety Blog

Most people understand that TV chef Paula Deen's brand of cuisine is to healthful eating as channel-surfing is to exercise. There's nothing wrong with her high-fat, high-sugar recipes, as long as you follow the rule, "Everything in moderation."

But when Deen chose to keep her diabetes secret from her public for three years, then burst onto the Big Pharma promotional scene with the announcement not only of her disease, but her new status as a pitchwoman for the diabetes drug Victoza, the flag of hypocrisy is raised.

In a commentary published in the Los Angeles Times, writer Karen Stabiner outlines the dangers of Deen’s consumer seduction. “… [T]he media storm surrounding the news of her illness is exactly the sort of publicity bonanza the pharmaceutical company Novo Nordisk must have dreamed of when it hired Deen … for its new marketing campaign. It's Deen's job, along with her sons, to help us see ‘Diabetes in a new light,’ according to the company's website. …’Live a life that's delicious.’

It sounds like so much fun; almost makes you want to sign up for Type 2 diabetes. Surely Deen fans with the disease will start asking their doctors if the $500-a-month Novo Nordisk drug she takes might be right for them, not because they need a new medication but because it will catapult them to one degree of separation from Deen — which is, after all, what celebrity endorsements are all about.”

The Food and Drug Administration has rules about celebrities flogging prescription drugs. The commercial has to put the financial connection into the fine print of the ad, and the commercial also has to fairly state all the downsides of the drug. But try to keep track of what's said as this information rushes by at the end of the commercial.

Novo Nordisk, the maker of Victoza, has a new Paula Deen website that shows what the required information will include once it trots out Deen in actual ads.

Among other things, the website tells us: "Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic [blood sugar] control on diet and exercise." It also says: "Victoza® is not a substitute for insulin. ... The concurrent use of Victoza® and insulin has not been studied."

So it makes you wonder what exactly Victoza is good for. Paula Deen surely will tell us.

Diabetes is a life-threatening disease whose complicated treatment we described recently.
As Stabiner points out, it remains a huge, expensive American health-care issue.

• More than 25 million Americans—more than 8 in 100 people—have diabetes; at the current diagnosis rate, 1 in 3 Americans will have it by 2050. Most of these cases are Type 2 (adult onset) diabetes for which obesity is the primary 1 risk factor.


• Juvenile and Type 2 diabetes together cost more than $174 billion annually from medical expenses and lowered productivity.


• The incidence of diabetes has leveled off for the first time in a generation, but only among the privileged; poor and minority populations lack their access to care, but not to inexpensive and ubiquitous fast and processed food, the very diet that promotes obesity.

Stabiner decries the “delicious” life Deen purports to live, courtesy her expensive pharmaceutical helper. Diabetes is manageable, but only with a commitment to lifestyle changes that might be difficult, but are free. In contrast to the la-dee-da Deen campaign, Stabiner explains how easy it is for a diabetic to endanger himself or herself:

• skip a meal, any meal, any day;


• eat too much or too little of just about anything;


• consume hidden sugar in a restaurant dish;


• eat a spontaneous snack;


• sit on an airplane delayed for departure without having packed a candy bar;


• have a glass of Champagne at a wedding;


• eat one too many isn't-fruit-good-for-you strawberries.

The well-managed diabetes life is measured, and difficult. But, Stabiner says, “Novo Nordisk is selling swell, alongside drug companies that promise to medicate away depression, gas, incontinence, clogged arteries and fibromyalgia. …

”Support and encouragement is one thing, but what we're being sold is magical thinking. In the battle between health-care reality and fantasy, Paula Deen is small potatoes … but what she represents matters: another attempt to market immortality to a culture that's particularly in love with misbehaving, followed by an easy fix.”

Not everything can be fixed with a pill. Most things shouldn’t be, and although you're a rightfully popular personality, Ms. Deen, to suggest otherwise is misleading.

If you want the facts and not the fluff about diabetes, link to the website[www.diabetes.org/] of the American Diabetes Association. Link here to learn about drug support and prescription discount programs.

First published on Technorati.

Diabetes is an affliction of modern life. Americans have abundant and relatively inexpensive food. We have a lack of interest and/or time for exercise. We are predisposed toward a high incidence of the disease and its devastating consequences.

Diabetes is a disorder of the metabolism. Its signature—high blood sugar—is the result of the body not producing enough insulin or the cells not properly using the insulin that is produced. It is nasty business: Diabetes can deprive people of their sight, their limbs, their lives.

There are three types: Type 1, commonly called juvenile diabetes because it presents early in life, requires insulin injections because the body just doesn’t make enough. Type 2, commonly called adult-onset diabetes, results from resistance to insulin—the body doesn’t use the hormone properly. Gestational diabetes occurs among woman without a history of diabetes but whose pregnancies raise their blood sugar; it can predispose them toward Type 2 diabetes.

Although genes play a role, adult-onset diabetes often results from lifestyle choices. As such, it’s the type that responds best to both medical and personal interventions. You’ve probably heard claims that many Type 2 diabetics who clean up their dietary act and get regular exercise can control, if not beat, this dread disease.

Maybe. But doctors at the American board of Internal Medicine analyzed which interventions had the biggest effect on diabetes patients, and they concluded that the best practice for diabetic patients involves significant physician involvement.

By comparing interventions—those that are managed by physicians (prescribing medicine for high blood pressure, for example) and those that are controlled by patients (eating a proper diet), they found that if the entire population of all U.S. patients diagnosed with diabetes met aggressive targets for lowering blood pressure, LDL cholesterol and blood glucose levels—all goals that must be monitored by doctors—they would have a 16 percent increase in quality-adjusted life-years and a nearly 23 percent reduction in 15-year mortality.

“Managing diabetes and preventing its associated morbidities require active physician-patient partnerships,” they concluded.

Diabetics who want to lead normal lives must take responsibility for understanding their disease and managing it to the best of their ability. But the team-based approach to treating diabetes clearly seems superior.

Another study, as reported on MedPage Today, supports this view. As stated in the Annals of Family Medicine, these researchers concluded that the involvement of nurse care managers working with patients and primary care physicians was associated with improved control of not only diabetes, but also depression and heart disease.

Even the most motivated diabetic can mismanage his or her medications, can struggle with adhering to rigid regimens and is subject to associated disorders—nearly 2 in 10 diabetes patients suffer from depression. The study examined a program called TEAMcare, a collaboration among a nurse care manager, physicians and patients that increased initiation of various types of medication, rates of treatment adjustment and self-monitoring by patients,

"Results of this trial suggest that improving specific patient and clinician behaviors (close monitoring of disease control parameters and timely treatment adjustments to achieve individualized goals) can improve disease control and quality of life among patients with multiple conditions and complex healthcare needs," the researchers wrote.

As MedPage noted, it’s difficult to exercise good disease control for patients with multiple chronic diseases because they often have multiple doctors, complex treatment regimens and a higher risk of harmful drug interactions. Depression exacerbates these challenges.

So if you or someone close to you has diabetes, read about standards of medical practice for diabetes here on our site. Make sure all of your care providers are aware of what you’re doing apart from their particular focus. Are your primary care doctor and endocrinologist doctors aware of your nutrition and exercise habits? Do your doctors and pharmacists have current records of all the medications you’re taking and are they aware if you’re struggling to adhere to their respective prescriptions? Are they aware if your depression is sapping the energy you need to exercise?

Diabetes is complicated. It takes a village to treat it.

In 1999, the FDA approved the drug Actos for Type 2 diabetes. Its popularity grew substantially after its primary competitor, Avandia, was linked to increased risk of heart attack. In 2010, the drug generated $3.4 billion in sales for its manufacturer, Takeda Pharmaceuticals.

Now, Actos is under fire, too.

The drug was recalled this summer in France and Germany in the wake of increased incidents of bladder cancer among people who took Actos. Similar reports have occurred in the U.S., where the FDA has allowed the drug to remain on the market provided warning labels are added to the packaging.

Earlier this month, the first lawsuits over Actos’ alleged role in bladder cancer were filed in the U.S., and many more are expected to be forthcoming. The lawsuits charge that Takeda failed to disclose data showing an increased bladder cancer risk.

If you are a diabetic who takes this drug, notify your doctor immediately if you develop:

• blood in your urine;


• an urgent need to urinate;


• pain during urination; or


• pain in the back of lower abdomen.

In an AP story published by the Atlanta Constitution, Dr. Harlan Krumholz, a Yale School of Medicine professor who directs its Center for Outcomes Research and Evaluation, said it wasn’t clear if the bladder cancer risk is real, but that Actos and Avandia both are linked to heart risks, weight gain and possibly bone loss and fractures.

“The consensus,” he said, “already is that (Actos) should only be considered ... after patients have exhausted all other options."

A drug prescribed for smoking cessation is linked to an increased risk of heart problems, according to a study published July 4 in CMAJ (Canadian Medical Association Journal). Varenicline, known by the brand name Chantix, was associated with a 72% increased risk of a serious cardiovascular "event."

That sounds huge, but the scientific number-crunching shakes out a bit differently. Although attention must be paid, many critical minds are not ready to dump the drug. Fifty-two (1.06%) of the participants who took Chantix had serious cardiovascular events compared with 27 (0.82%) of those who took a placebo.

One bottom line for smokers who may want to rationalize continuing to puff: It's always better to stop smoking. No excuses.

When varenicline was launched in 2006, the FDA noted that it could raise the risk of cardiac problems, and the federal agency recently updated the label for Chantix to reflect that risk among smokers with heart disease. And we wrote about the drug a couple of years ago. But the new study's authors said, "These increased risks ... are seen in smokers with or without heart disease."

The irony, of course, is that one major risk of smoking is heart disease.

The Chantix-using subjects of this trial were able to abstain from smoking at a significantly higher rate, an achievement that should potentially confer a cardiovascular benefit. Many members of the medical community believe the drug should remained a valuable treatment option, given the devastating effects of smoking. Apart from heart issues, nicotine and the other ingredients of cigarette smoke, of course, compromise lung function and can lead to lung cancer, and also increase the risk of stroke and diabetes.

The results were based on a review of 14 studies of approximately 8,200 smokers or users of smokeless tobacco. Most had no history of heart disease. They were followed for as long as a year, a comparatively short term that gives many researchers pause. It's possible, for example, that the risk diminishes over time.

Dr. Taylor Hays from the Mayo Clinic opined, "Although these results suggest a measure of caution should be taken in prescribing varenicline for tobacco dependence treatment ... [T]he risk for cardiovascular events is low and is far outweighed by the benefits of diminishing the truly 'heartbreaking' effects of cigarette smoking."

If you're taking Chantix, don't stop without consulting your doctor. If you're unable to stop smoking via other methods, discuss the cost-benefit question of treatment with Chantix.

Diabetes medication Avandia will be pulled from pharmacy shelves in November because it poses a major risk of heart attack, the Food and Drug Administration has announced.

Under a new program effective Nov. 18, 2011, only certified physicians will be allowed to prescribe the drug, and then only to patients who've been informed of the risks and who will fill their prescriptions by mail order through specific pharmacies.

The new FDA guidelines limit the drug to patients already successfully treated with it or to those for whom it's pretty much a last-ditch effort to control blood glucose medically. In addition, healthcare providers and patients have to enroll in the Avandia-Rosiglitazone Medicines Access Program to prescribe and receive rosiglitazone medicines.

The restrictions to access are so tough that virtually no one will be able to obtain the drug, says Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, who has long advocated more restrictions on the use of rosiglitazone (Avandia's generic name).

Avandia is also sold as a component in the combination drugs Avandamet and Avandaryl. It was approved in 1999 to lower blood-sugar levels in patients with type 2 diabetes. In 2007, Nissen published an analysis showing that the drug increased heart attack risk by about 40% in people with type 2 diabetes, who are already much more prone to heart attacks than people without the disease.

Subsequent studies confirmed the greater heart attack risk. In June 2010, more than half of the members of an FDA advisory committee recommended pulling Avandia from the market or tightening restrictions on its use, and in September, the FDA decided to impose restrictions.

Source: TheHeart.org

You can read the FDA’s decision here.

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are warning healthcare professionals that sharing blood glucose monitoring machines carries the risk of transmitting the hepatitis B virus (HBV) and other infectious diseases. Their simple advice: One monitor per diabetic patient.

In recent years, the number of reported HBV outbreaks linked to blood glucose monitoring has increased, particularly in nursing homes and assisted-living facilities, but also in any setting (e.g. clinics, health fairs, schools, camps and senior centers, among others) where blood glucose monitoring equipment is shared, or where those performing the monitoring do not follow basic infection control practices.

While stressing that reusable fingerstick lancing devices should never be used for more than one person to avoid the risk of transmitting bloodborne pathogens, the FDA and CDC also maintain that the glucose meters themselves can also pose an infection risk, since it can be difficult to ensure that blood has been completely removed from these devices. They point to a 2005 multicenter survey that indicated that 30% of blood glucose meters used routinely in the surveyed hospitals had detectable blood on their surfaces.

Therefore, the FDA and CDC advise that whenever possible, blood glucose meters should be used for one patient only. Otherwise, meters should be cleaned and disinfected after every use to prevent carry-over of blood and infectious agents. In addition, hands should be washed and gloves changed between patients.

Source: FDA Patient Safety News

Time was when the Food and Drug Administration would give a new drug the go-ahead for marketing based on a handful of studies involving no more than a few thousand patients. Then millions of prescriptions would be written over the next few years, and the drug would finally have its real test of safety on the open market, with the American consumer as the guinea pig. If the drug flunked the real-world test, it would be taken off the market, with a flurry of product liability lawsuits and calls for regulatory reform. This script is familiar from fen-Phen to Vioxx.

Now with the FDA's decision to split the baby in half with the diabetes drug Avandia, many are saying a new and different era of prescription drug safety is upon us. Instead of the old Up-Or-Down, and sometimes later Out, the FDA is setting up what one drug industry commentator, Gooznews, calls Permission Slip Medicine.

To get a prescription filled for Avandia -- and presumably other controversial drugs down the road -- a patient will have to hand the pharmacist a signed slip of paper acknowledging that he or she has discussed the medication with the doctor and both have decided together that they really, really want to have this drug, despite the availability of other alternatives like Actos which doesn't seem to carry the risk of heart attack and stroke that Avandia apparently has.

I say "apparently has" for Avandia, because the drug agency says it's not really sure. Part of its decision to punt on Avandia, keeping it available but harder to get, included posting on the FDA website a series of memos from top level agency staffers showing how very sophisticated drug reviewers could read the same studies and come to opposite conclusions on safety and the need for more research. Click here to see the memos. Note the contrast between the memo by FDA firebrand David Graham, who wanted Avandia yanked completely from pharmacy shelves, as has happened in Europe, and more conciliatory memos by long-time agency officials like Robert Temple.

In the old days, the other option for an in-between drug like Avandia would have been to add a dire statement to the official product labeling about the newly discovered risk. This has already happened for Avandia. These warnings are often called black box warnings because they appear in bold face at the very beginning of the columns of dense prose of the official language published in the Physicians Desk Reference and various online sources.

But who reads the black box warnings? Certainly lawyers like me do, when a client comes calling with a serious injury or death and it turns out the drug culprit didn't have such a black box warning, or their doctor didn't mention it to them. But if my experience is any measure, many doctors pay little attention to the official label. That's part of the long-running scandal of prescription drug education in the United States, which is dominated by the legions of drug salespersons who regularly trundle their briefcases of free samples and glossy handouts down the back hallways of doctor offices.

The new FDA action is intended to force doctor and patient to sit down quietly together and make a reasoned decision about whether this drug is right for this patient, despite the bad stuff that has happened to other people. That may be a good thing.

Avandia is one of the growing class of drugs that once you're on it, you swallow the pill every day for the rest of your life. The goal for Avandia is to lower blood sugar in diabetics, and that can prevent other bad long-term issues like diabetic blindness (retinopathy) and kidney disease. So the good intent is there.

But with a safer alternative apparently out there, what's the point of loading extra risk onto the patient? That's a dialogue that the FDA has now shifted from its officials onto the desks of individual doctors.

As if there is not already a multitude of problems awaiting those who lead an inactive lifestyle, researchers recently found yet another inactivity-related condition that threatens human health, a condition called non-alcoholic fatty liver disease (NAFLD), according to Medical News Today.

In an article published in The Journal of Physiology, Dr. John Thyfault of the University of Missouri reports his research group’s findings that established a link between low aerobic fitness level and fatty liver disease. His group carefully bred two groups of rats of different levels of intrinsic aerobic capacity, so that after 17 generations the rats in the “fit” group can run 1500 meters, whereas the “unfit” rats can undertake only 200 meters.

Rats in the “fit” group normally live healthy lives, even though they are not more active than those in the unfit group. However, those in the “unfit” group often display clear symptoms of NAFLD, including fibrosis, which is a form of liver damage seen in alcohol abuse patients.

Fatty liver disease causes fat deposit in patients’ livers and elevated levels of fat in their blood. The “unfit” rats in Thyfault’s study also were found to have poor fat processing power. These effects together result in high fat retention in patients, making them prone to obesity and its related risks of heart disease, strokes and diabetes.

Many people have a tendency to underestimate the devastating effects of diabetes, as Tara Parker-Pope points out in her recent NY Times article. She cites studies where participants ranked various diseases, giving diabetes only 4s and 5s on a scale of 1 to 10 (10 being the worst).

Several factors give people this optimistic view of diabetes: lack of direct fatalities, knowledge that people live seemingly normal lives with the disease, and knowledge that the disease is manageable with medications.

But as Parker-Pope notes, this view is erroneous:

But diabetes is anything but minor. It wreaks havoc on the entire body, affecting everything from hearing and vision to sexual function, mental health and sleep. It is the leading cause of blindness, amputations and kidney failure, and it can triple the risk for heart attack and stroke.

“It is a disease that does have the ability to eat you alive,” said Dr. John B. Buse, a professor at the University of North Carolina School of Medicine who is the diabetes association’s president for medicine and science. “It can be just awful — it’s almost unimaginable how bad it can be.”

This is particularly true for people who lack the time or income for proper self-care. The "treatable" nature of diabetes generally applies only to those who have access to regular medical care. Even people with health insurance sometimes find the required standard of care too costly.

Diabetes is also associated with a wide range of other health problems, as the article lists, from liver disease to depression to hearing loss.

In short, nobody should be underestimating the effects of this disease.

Even doctors who treat diabetics can fail to take the disease seriously enough and fail to give diabetics the care they need to avoid the consequences of high blood sugar.