A new study, financed by Eli Lilly & Forest Labs, claims to have found the cause of fibromyalgia, along with proposing a treatment. The claim falls flat on examination, but Eli Lilly & Forest Labs now have a pathway to reinvent old drugs for a new disease—so they can repatent the drugs!

by Heidi Stevenson

Word is out that the cause of fibromyalgia has been found, and that it’s now possible to develop treatments for this miserable and debilitating disease. It’s heartening in one sense: At least people with fibromyalgia can now get a real diagnosis, instead of being told that it’s all in their heads. However, the claim that a cause has been found is, to put it mildly, premature.

Fibromyalgia, also called chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME), is a chronic condition that involves musculoskeletal pain anywhere in the body along with characteristic tenderness in a few spots. Its sufferers are often accused of malingering and their lives can be severely disrupted, with many unable to continue to do even the most basic of daily tasks. So, this announcement of finding the cause could be greeted with a sense of relief: “At least I can get a diagnosis now!”

That is understandable and certainly a step in the right direction. However, let’s take a look at what the study claims to have found. The authors concluded:

The excessive sensory innervation to the glabrous skin AVS [arteriole-venule shunts] is a likely source of severe pain and tenderness in the hands of FM [fibromyalgia] patients. Importantly, glabrous AVS regulate blood flow to the skin in humans for thermoregulation and to other tissues such as skeletal muscle during periods of increased metabolic demand. Therefore, blood flow dysregulation as a result of excessive innervation to AVS would likely contribute to the widespread deep pain and fatigue of FM. SNRI [serotonin and norepinephrine reuptake inhibitor] compounds may provide partial therapeutic benefit by enhancing the impact of sympathetically mediated inhibitory modulation of the excess sensory innervation.^[1]

We’ll get into what all that means in a bit. However, first take note that their conclusion includes a potential treatment, even though the study had nothing to do with treating fibromyalgia! Why would that be? Pharmaceutical corporations, Eli Lilly and Forest Laboratories, funded the study. These Big Pharma corporations produce two of the biggest selling SNRIs. Eli Lilly produces duloxetine, brand named Cymbalta and Yentreve, and Forest produces escitalopram, brand named Lexapro.

Cause of Fibromyalgia?

Let’s take a look at what the authors concluded about the cause of fibromyalgia. First, some word definitions. Glabrous refers to skin that is smooth and hair-free, such as the palm of the hand. An arteriole is a small artery that leads to capillaries. A venule is a small vein that leads away from capillaries. Arteriole-venule shunt simply refers to the short lengths of arterioles and venules that transition from arteries to capillaries (arterioles) and capillaries to veins (venules).

So, they’re saying that blood flow to the small blood vessels in the hands is not properly regulated, and that this dysregulation is the result of excessive growth of fine nerves around the small blood vessels in the palms of the hands.

The lead researcher was Dr. Frank L. Rice, president of Integrated Tissue Dynamics LLC (Intidyn), the company that was primarily responsible for producing the study, along with Albany Medical College. He stated:

Instead of being in the brain, the pathology consists of excessive sensory nerve fibers around specialized blood vessel structures located in the palms of the hands. This discovery provides concrete evidence of a fibromyalgia-specific pathology which can now be used for diagnosing the disease, and as a novel starting point for developing more effective therapeutics.

So how does blood that doesn’t flow properly in the hands as a result of too many nerves cause pain throughout the body? Dr. Rice produced a paper published on Intidyn’s website^[2] to popularize the results. In it, he uses an analogy, comparing your body’s blood flow with an automobile’s cooling system and makes these comparisons:

• Blood is the coolant.
• Heart is the pump.
• Muscles are the engine.
• Lungs and skin are the radiator.

Somehow, we’re supposed to comprehend that the human body is analogous to a car’s function! Rice goes on at length to make the comparison so he can indicate that a flaw in the automobile’s thermostat, which can result in dysregulation of an auto’s temperature regulation, is equivalent to a defect of the nerves serving the small blood vessels in the palms of the hand. So, he says, this “extremely excessive amount of sensory fibers” causes “extreme tenderness in the hands of most fibromyalgia patients” and:

Of perhaps more importance, the excess sensory fibers on the AVS could interfere with the regulation of blood flow throughout the body including deep tissues including the muscles. This interference could result in a lack of proper nutrition to the muscles during exercise leading to a build up of lactic acid that could contribute to wide spread aching and fatigue.

So, at best, this claimed great finding of what causes CFS is a guess, based on a single finding that Rice and his team have defined as an “extremely excessive amount of sensory fibers”, along with an assumption—just an assumption, no proof—that it’s causing a dysregulation of blood flow.

Big Pharma’s Repatent Game

Even more significant, though, is that the question of how and why this “extremely excessive amount of sensory fibers” exists! How and why did it start to develop? No one is born with CFS/ME. They don’t ask whether it’s a result of something wrong somewhere else in the body. They don’t ask what causes it. There’s absolutely no curiosity about why there should be so much excess in nerve fibers in the palms of the hands. In fact, they don’t even know if it’s the only place in the body with this distinction! The fact is that, at best, they may have found a symptom of fibromyalgia. In no sense have they found the cause.

How could they have any interest in the cause of fibromyalgia? If they did, they would not have stopped at this point to claim that they’d found it—because obviously, they have not!

This study was financed for the purpose of getting a result that can profit Eli Lilly and Forest Laboratories. Why else would they proclaim that they’d found the “cause” of CFS? Why else would the study propose treatment?

The treatment, SNRI drugs, is produced by the financers. First, they needed “proof” that the disease actually exists, which this study nicely provides. Now, with this study in hand, they can do trials to show that their drugs will treat fibromyalgia. Then, they can patent the drugs—again!

It’s been done before, and this method has become a major Big Pharma procedure, allowing the reuse of old drugs—to patent them again and regain exclusive use for the new purpose. When its patent had expired, Eli Lilly’s Prozac, the first SSRI antidepressant, was given new life under the name Serafem for the treatment of premenstrual syndrome.

Eli Lilly’s an old hand at this game.

Sources:

1. Excessive Peptidergic Sensory Innervation of Cutaneous Arteriole-Venule Shunts (AVS) in the Palmar Glabrous Skin of Fibromyalgia Patients: Implications for Widespread Deep Tissue Pain and Fatigue; Pain Medicine; Albrecht PJ, Hou Q, Argoff CE, Storey JR, Wymer JP, and Rice FL; doi: 10.1111/pme.12139.
2. Women with Fibromyalagia Have A Real Pathology Among Nerve Endings to Blood Vessels
3. Researchers discover a rational source of pain in skin of patients with fibromyalgia
4. Fibromyalgia Mystery Finally Solved!