Amy Tenderich, a well respected blogger about diabetes wrote an article worth reading, “10 Reasons Why the Actos Pre-Diabetes study is Dumb.”
She makes a few very good points why Actos is not a wonder drug for pre-diabetes (bottom line: the risks outweigh the benefits for most patients), but I want to point out that the Actos study is not an isolated “dumb” study.
Her article also prompted me to want to point out something that really needs to be said: Pre-diabetes and type 2 diabetes are NOT a “fat people” disease. But let’s talk about Actos, first.
Does the study show Actos is a safe and effective treatment for preventing pre-diabetes? Well, certainly, not the safest drug (is there really any “safe” drug?), and it if became widely used for pre-diabetes, I am sure personal injury attorneys across the country will be updating their websites to add “Have you or a loved one suffered (fill in health ailments) after taking Actos…?”
She states, “The study was financed by the company that makes this drug! No surprise it came out in their favor! Talk about your self-fulfilling prophecies.”
All drug companies are in it for the money. They are businesses, not charitable organizations. But that does not make self-funded studies necessarily dumb or slanted — the entire FDA approval system does that just fine without any outside help. Takeda Pharmaceutical Company (makers of Actos) are not like Jack Abramoff illegally pedaling influence under the radar. Drug company “Casino Jacks” work a little more above ground — because they can. Legally.
Studies that are used as a basis for obtaining FDA approval are always going to be slanted towards winning a favorable decision. The FDA even coaches on the approaches they want to see and can eliminate stuff they do not want to see to get a drug pushed through. So let’s call the system dumb, rather than one particular study dumb (think Rezulin, a drug with “great” study findings approved on the FDA fast track that was removed from the market almost as fast as it was approved due to liver failure and death.)
Another example of a “dumb” system in place was when the FDA rescinded approval on albuterol inhalers that worked great and made them illegal in the U.S. in favor of an inferior product that costs more, delivers medication less effectively, and has resulted in a rise in asthma-related deaths. Oh. And there is no generic available now either so some insurance companies won’t cover it.
Why did the FDA do this? Because environmentalists convinced the FDA the propellant in albuterol was bad for the environment and pushed a new drug company product (that had lots of money and now “owns” the fast acting inhaler market.) This decision had nothing to do with safety or science, but everything to do with outside interests and money.
If self-funded drug studies are dumb, know that the drug approval and oversight system in the United States is major dumb.
Sorry, but pre-diabetes and type 2 diabetes is not about being fat.
Before I begin my next rant, I want to make clear in no way did Amy Tenderich’s article insinuate people are to blame for their own diabetes situation. Her post entirely directed missiles at the Actos folks. So my next points, while she got me to thinking, are not directed back at her. Her intent, I believe, was simply to defend our right to safe and effective treatment.
However, Tenderich points out that weight gain, a known side effect of Actos, is contraindicated for type 2 diabetes patients. But the truth is, that the majority of people who, historically have developed pre-diabetes and type 2 diabetes, did so without being significantly overweight. The majority at-risk group seemed to be susceptible to pre-d and type 2 due the natural aging process and what may be linked to unfortunate genes. It is only during the past few decades that we have seen an increase in the number of obese patients also suffering from pre-diabetes and type 2.
Type 2 diabetes used to be the “old peoples’ disease.” Now it is the “fat peoples’ disease.” I take issue with this this widely accepted distortion of facts (worse than any Actos’ study.) Fat does not = diabetes. Lots of things do. And, diabetes does not = fat.
The “just lose weight and you will be okay” approach simply does not work for the majority of people with pre-diabetes, type 2 diabetes, and other serious metabolic disorders like polycystic ovarian syndrome. Our bodies do not work right in the first place. Sometimes, we really do need (safe) medications to make it possible to lose weight and manage blood sugars.
Thin type 2 diabetes happens. A lot.
Writer Jeff O’Connell, talks about his own experience with familial “thin diabetes:”
…”As a result, we stay thin instead of gaining weight, as is often the case for people with insulin resistance and type-2 diabetes. In fact, insulin resistance is typically thought to cause weight gain, and vice versa. All of which makes the “thin man’s diabetes” that much more perplexing. “The physiques of people at high risk of diabetes are becoming less stereotypical, making the disease harder to diagnose,” says Dr. Berkowitz. His observations are supported by science: “If you look at distributions of large numbers of people, it’s striking that not only do the overweight tend to be insulin resistant, but 10 percent to 15 percent of non-obese people are, as well,” says Donald W. Bowden, Ph.D., director of the center for diabetes research at Wake Forest University school of medicine. Clearly, no one should assume he’s immune to this disease.”
O’Connell is not alone in his “thin diabetes” and Dr. Berkowitz is not alone in his beliefs. Asian countries, where obesity is not a wide-spread problem, are now seeing epidemic increases in the number of non-obese patients with type 2 diabetes — and patients not only are thin, but much younger than they have been historically. There clearly is something more going on here than just weight itself. Global warming? PCBs? Diet soda? Cell phones? Infomercials? We might as well blame anything at this point because no one really seems to be paying attention to the causes and instead just blame “fat America.”
Perhaps the reason people gain weight has a lot more to do with what triggers pre-diabetes and type 2 diabetes than the weight itself. That is, weight issues are a symptom, not the direct cause.
Why do some women gain enormous amount of weight during pregnancy and never have gestational diabetes, while those gaining moderate amounts do? Why can your best friend eat all day and never gain an ounce, yet people who have type 2 diabetes can look at a doughnut and gain 5 lbs?
Are the triggers more common? Stronger than they were 50 years ago?
The truth is, the scientific jury is still out on all the causes and why’s — they know the chicken and the egg go together — but not which one causes the other. We know that reactive hypoglycemia — unrelated to obesity — also causes type 2 diabetes and that what was once the “old peoples’ disease” has fast becoming the “it can happen to just about anyone” disease.
- Even a Thin Person Can Get Diabetes. Jeff O’Connell. Men’s Health, MSNBC Health.
- Does Adding Exenatide to Insulin Treatment Benefit Patients with Type 2 Diabetes? (American College of Physicians) – PDF
- 1o Reasons Why the Actos Pre-Diabetes Study is Dumb. Amy Tenderich. DiabetesMine.
- Study: Diabetics in Asia Are Younger, Thinner. Time Magazine.