a dangerous deception
DRUG BUST by Alan Cassels
• The people’s briefing note on prescription drugs
Have you been told you have diabetes? Has someone in your family – possibly an elderly parent – been given a label of ‘pre- diabetes?’ Or maybe you’ve been on the receiving end of insulin or diabetes drugs?
If so, you might be surprised to learn the diabetes industry is shamelessly trying to get everyone – especially older people who are otherwise healthy – and their doctors to start worrying about this disease. Their ominous message is that an aging, sedentary population of people, who eat poorly or don’t get enough exercise, is set to become part of a diabetes epidemic of mammoth proportions where up to 10 percent of the population live with the disease. Right now, nearly 300 million people worldwide are said to have the disease. The Canadian Diabetes Association (CDA) notes there are currently almost nine million Canadians with diabetes or prediabetes and they say that by 2020, 9.9% of Canadians will be living with diabetes.
That’s an incredulous number – nearly 10 percent of the population will have a ‘disease’ that is largely, but not completely, altered by diet and exercise? Yet an older and slower society explains only part of it. What you won’t hear from those in the diabetes industry is that the significant rise in projected diabetics is more likely due to skilful diabetes mongering than anything else. Elevations in blood sugar are used to terrify the population into checking and altering their levels in order to avoid the risks of blindness, amputations and the cardiovascular disease (heart attacks and so on) that could result. The CDA recommends screening healthy people over 40 for the disease, a recommendation that is neither supported by evidence, nor promoted by screening experts who aren’t working for or supported by the pharmaceutical industry.
This saga is a suspense driven narrative with many plot twists, but the easiest way to unravel it is by following the money. The pharmaceutical industry, for at least the last decade, has been very heavily investing in diabetes research, banking on the fact that it’s relatively easy to sell people on the idea they need to alter their blood sugars with insulin or drugs. In addition to investing in drug research, they’ve also been very heavily investing in marketing rhetoric, playing the refrain that uncontrolled blood sugars (like high cholesterol or high blood pressure) is a road to the grave, ignored at your peril. The industry gives liberally to those organizations that see their task as educating about diabetes. They fund the experts who educate doctors about the disease and lobby governments to pay for diabetes products for all people, even if those drugs are more dangerous than the disease itself, which is what we saw with former blockbuster Avandia, removed from the market in Europe and rarely prescribed here.
You can’t talk about diabetes without talking about insulin, which helps glucose (a type of sugar) enter your cells. If your pancreas doesn’t produce enough insulin, you’ve got type 1 diabetes, but if your body can’t respond to the body’s production of insulin, it’s type II diabetes, in which glucose levels in your body rise.
You should never ignore the signals of extreme thirst, excessive urination or unexplained weight loss, which could be a sign of diabetes. Yet if you feel fine and are sent for a blood test and then told you are diabetic or ‘pre-diabetic,’ do you really have to follow the paradigm of “intensive glucose control?” That’s the name of the game where checking and rechecking your blood sugars and using drugs and insulin starts to become a central part of your life.
That paradigm, I’m sad to report, rests on a major deception. Despite studies in tens of thousands of patients, “intensive glucose control” does very little to alter the rates at which people go on to develop worrisome diabetes complications such as blindness or the need for amputations. The deception is that by focusing on the blood sugar, the ‘surrogate’ marker, we forget that what’s most important is the ‘hard endpoint,’ the overall health of the patient.
Dr. John Yudkin, Emeritus Professor of Medicine and former director of the International Health and Medical Education Centre at University College London, was in Vancouver last month talking about this subject. He wrote a fascinating article published in BMJ (British Medical Journal), pointing out how foolish this obsession with surrogates can be. (Google “The Idolatry of the Surrogate.”)
In relation to diabetes, he wrote, “Glycemia’s reputation as a valid surrogate end point has been tarnished by studies showing that intensified glucose lowering does not reduce cardiovascular disease.” He’s among other critics who say that drugs or insulins may alter a surrogate marker (the level of your blood sugar), but have no effect on whether people live longer or healthier lives.
Worse yet, it is possible to alter a surrogate point and cause other forms of illness. That’s what we saw with Avandia, which could alter your blood sugars but was linked to heart failure (as well as liver damage, weight gain and anaemia.) Yudkin explains that the “hard” end points generally show much smaller responses to interventions than surrogate markers [and so] many of the widely accepted strategies for diabetes may be based on artificially inflated expectations.”
So if altering blood sugars with drugs is such a potential boondoggle, why have the newest and most heavily marketed drugs for type 2 diabetes been doing so well? These include the drugs exenatide (Byetta), liraglutide (Victoza), sitagliptin (Januvia), saxagliptin (Onglyza) and linagliptin (Tradjenta), which stimulate the body to produce insulin and hence alter your blood sugars. The market leader in the class is sitagliptin (Januvia), living in blockbuster territory –with sales at $4 billion per year – even with growing concerns that there are no long-term effectiveness data, no data to prove the drugs prevent death or cardiovascular disease and concerns they cause adverse effects, primarily to the pancreas.
A report last month in BMJ cited two of these new drugs, noting that those called DPP-4 inhibitors –Sitagliptin (Januvia) and saxagliptin (Onglyza) – are now being used by millions of patients and have potentially harmful effects. As they face lawsuits over patients who say they were harmed, the U.S. Food and Drug Administration (USFDA) and the European Medicines Agency are looking closer to see if the drugs could lead to pancreatitis and pancreatic cancer.
Adverse effects seen in post-market reports are controversial because you can never be really sure if the drug or something else caused them. The US drug watchdog group, Quarterwatch, examined adverse drug reports made to the FDA over 12 months ending in June of 2012 and found all five of these agents showed a “marked signal for reported pancreatitis,” compared to other antidiabetes drugs, including over 100 reported cases of pancreatic cancer among the five.
BMJ identifies a recurrent theme we’ve seen with antidiabetes drugs, stating, “The story is familiar. A new class of antidiabetes agents is rushed to market and widely promoted in the absence of any evidence of long-term beneficial outcomes. Evidence of harm accumulates, but is vigorously discounted.”
Let me add to that: high blood sugars are paraded as the enemy that needs to be brought down at all costs, despite the ‘collateral damage’ that may be inflicted on other organs in doing so. Intensive monitoring of blood glucose is very good for the drug and insulin industry, but not so good perhaps for your pancreas, which you can’t live without.
Closer to home, it appears the Therapeutics Initiative at UBC, which has been providing physicians an independent voice on drugs for the past 20 years, has finally been dealt its deathblow. The administration at UBC, where drug research money abounds and where the Dean of Medicine, incredibly, sits on the board of LifeSciences British Columbia, the main lobby group for BC’s pharmaceutical industry, doesn’t seem to be too worried about our pancreases.
They are doing the Liberals’ bidding and letting the TI die a silent death, even as TI would have warned our doctors of the dangers of these new drugs. It’s a shame that the one homegrown solution to save us from the dangers of new drugs may have been the worst casualty of the last election.
Alan Cassels is the author of Seeking Sickness: Medical Screening and the Misguided Hunt for Disease. Follow him on Twitter @AKECassels or www.alancassels.com