Expensive New Diabetes Drugs Add Nothing But Cost And Complications

This is the fourth in an ongoing series of blogs exposing the rampant misuse of the medications so aggressively promoted by greedy drug companies.

I am very lucky in having the perfect partner in this truth-vs-power effort to contradict Pharma propaganda with evidence based fact.

Dick Bijl is President of the International Society of Drug Bulletins (ISDB), an impressive association of 53 national drug bulletins from all around the world, each of which publishes the best available data on the pluses and minuses of different medications.

Drug bulletins help patients and doctors see through the misleading misinformation generated by ubiquitous Pharma marketing.

I highly recommend Dick's previous blogs:
Many Commonly Used Drugs Are Useless 

Weight Loss Pills And Products Don't Work And Aren't Safe

In this blog, Dick takes on the diabetes racket: He writes: "Diabetes mellitus is one of the developed world's most frequently encountered and deadly diseases. Its prevalence is increasing every year as a consequence of our sedentary life-styles, fast food dietary habits, and rising obesity rates.

Diabetes lowers quality of life and life expectancy via small blood vessel disease (causing blindness, kidney failure, and nerve dysfunction) and large blood vessel disease (causing heart attacks and stroke).

There are two forms: Type 1 Diabetes (insulin-dependent) and Type 2 Diabetes (non-insulin dependent). In this blog, I will concentrate only on the second type- elevated blood glucose caused by decreased sensitivity to the metabolic effects of insulin.

First off, many doctors and patients ignore a crucial recommendation contained in all available guidelines. Improved diet and increased exercise is definitely the first-line treatment of patients with newly identified Type 2 diabetes.

Medication may be necessary, but should always be considered a last resort, not a first choice. The two oldest groups of oral blood glucose lowering drugs remain the best.

Metformine, a biguanide originally marketed all the way back in 1959, remains the first-line drug of choice. There is good evidence that it reduces cardiovascular complications and mortality, especially in overweight patients. Side effects are mild, usually gastro-intestinal complaints (like nausea and abdominal pain) that often subside.

The next best choice, the sulfonylureas (tolbutamide, glibenclamide, gliclazide, glimepiride and glipizide) have also been around for a long time. Documented effects are mainly on small vessels disease. 

Many other Type 2 diabetes drugs have been introduced in more recent years- always with disappointing, and sometimes with alarming, results.

Troglitazone was the first member of the group of thiazolidinedion derivatives introduced in1998 in the USA and Japan. By 2000, it had to be taken off the market, because of serious liver-failure and related deaths.

Soon, the second thiazolidinedion derivative- rosiglitazone- was marketed with the claim that it lowered cardiovascular risk. Several complications (weight-increase, heart-failure, bone-fractures) were detected soon after its market introduction and by 2007, the FDA had concluded that it actually increased the risk of myocardial infarction. Perhaps tens of thousands of diabetes patients had early deaths before it was finally taken off market.

Although it is still on the market, the third thiazolidinedion- Pioglitazone- increases the risk of heart failure and may cause bladder cancer. All the thiazolidines were marketed as new and safe drugs that lowered the cardiovascular risks. But none ever proved any positive effect on cardiovascular safety and all are more dangerous than the old tried and true Metformine, which is still the best first-line drug for type 2 diabetes.

Diabetes is such a huge and profitable market that Pharma is ever active in producing new and more expensive drugs. Unfortunately, they are great for profits, not great for patients.

There are a great variety of glucagon-like peptide (GLP)-1-receptoragonists (exenatide, dulaglutide, liraglutide and lixisenatide) and a variety of dipeptidyl peptidase-4 (DPP-4)-inhibitors (alogliptin, linagliptin, saxagliptin, sitagliptin and vildagliptin)- but no proof any of these reduce cardiovascular morbidity and mortality.

Recently several types of sodium dependent glucose cotransporter-2(SGLT-2-) inhibitors were introduced (canagliflozine, dapagliflozine and empagliflozine). Their long-term safety is unknown and there are no data on risk of cardiovascular incidents. But they all have risks. Canagliflozine is associated with urinary infections, genital fungal infections, arterial hypotension, dehydration, aggravations of kidney failure and drug interactions. There are concerns that dapagliflozine increases breast, bladder and prostate cancer. Empagliflozine is associated with keto-acidosis.
So the medication scorecard is clear. From the patients' perspective, the old drugs win, the new drugs lose. From Pharma's perspective, the old drugs lose, the new drugs win. 

There is no evidence of long term safety for any of these new oral blood glucose lowering drugs, especially regarding cardiovascular adverse events and malignancies. There is also no proof that they actually lower cardiovascular diseases related to diabetes. The existing evidence is only that they lower blood glucose levels. There is no proof that they improve at all on what we already have for the treatment of type 2 diabetes: diet, exercise, metformine, sulfonylurea, and if none of these does work, insulin."

Thanks so much, Dick, for clearing the fog in the Pharma wars. The basic remaining question is why the newer drugs for diabetes are prescribed so often, when they are so expensive, so ineffective, and so unsafe. The paradoxical answer is that they are prescribed so much precisely because they are so much more expensive than the old drugs. Obscene profit gives Pharma the motive and the means to aggressively market second rate drugs to docs and patients, who naively believe that newer and more costly must be better.

Drug companies are great at marketing and at influencing politicians to protect their ridiculously high monopoly pricing. The one thing drug companies are not very good at is developing better drugs. Tried and true meds are often much better, and always much cheaper, than the hyped stuff you see on TV on get from your doctor. Be informed. 

Allen Frances is a professor emeritus at Duke University and was the chairman of the DSM-IV task force.