Wednesday, September 23, 2009
Serious Medicine for the Paralytic Care of Digestive Tract Paralysis
Editor's note: This is the first part of a two-part guest article detailing critical issues surrounding gastroparesis, and pseudo-obstruction, serious illnesses that cause paralysis of the digestive system.
As Michael Smith, a member of the board of directors of G-PACT, the Gastroparesis Patient Association for Cures and Treatments, points out, it's quite likely that research on gastroparesis will spin off research-benefits for sufferers from diabetes, lupus, scleroderma and cystic fibrosis, among other maladies.
Such spinoffs, of course, are part of the familiar "virtuous cycle" pattern of medical research. As Dr. Arthur Axelrad of Canadians for Health Research has pointed out, it was research on cancerous cells that made it possible to better understand how normal cells behave, thus vastly improving the chances that transplanted organs would be accepted by the host tissue.
But just as positive spinoffs are a constant in medical research, so are negative similarities. Mr. Smith's warnings about the deleterious impact of a) government decisionmaking, b) some DC-based advocacy groups, and c) trial lawyers are applicable to virtually every sector of medicine. Sooner or later, all supporters of a Serious Medicine Strategy find themselves in the same boat--so the sooner we all realize that commonality, the better!
Here is Mr. Smith's article, “Serious Medicine for the Paralytic Care of Digestive Tract Paralysis”:
The five million Americans suffering from digestive tract paralysis have been awaiting the revolution in medical technology that transformed the care of diseases such as polio and HIV-AIDS that James Pinkerton discusses at Serious Medicine Strategy.
Unfortunately, patients such as myself have not been invited to participate. This has not been for a lack of pure scientific will or achievement. Researchers dealing with digestive tract paralysis have discovered that the digestive tract has its own brain (the myenteric plexus, feeding off of the spinal column) and nervous system (the enteric nervous system). Researchers like Dr. Michael Gershon of Columbia University have made their life’s work studying and unraveling the massive complexity of this system.
Unfortunately, government agencies, such as the Food and Drug Administration, have ignored these details for decades, in favor of a "big picture" approach that fears the introduction of any risk in the treatment of complex medical conditions, in favor of a suffocating "we know it better" nannyism which I would hope would not be transported into the decisionmaking process of any health payment reform program. This nannyism is fully supported by groups such as Public Citizen, which chase drugs that treat digestive tract paralysis off of the US market--and, by the way, are funded by various class-action law firms throughout the US who seek to sue drug makers who dare to make such drugs out of the market.
What is Digestive Tract Paralysis? When asked, the layperson who has not been touched by one of this condition would assume that the digestive tract simply moves or that it functions off of gravity. A person not touched by this condition would realize that the digestive tract is controlled by an intricate set of nerves and muscles that when damaged by flu, trauma, spinal cord paralysis, cancer, diabetes, lupus, scleroderma or cystic fibrosis, essentially "shorts out" in the same manner as a circuit board struck by lightning. The result, in most people permanent is frankly chaos; unmitigated chest pain, similar to angina, caused by a esophagus that has lost nervous system control, a stomach that twists into uncontrollable spasm from the inability even to properly process the body’s own bacteria, much less food or liquid and a bowel that fails causing a person to poison themselves from the inability to process waste.
Why are the diseases of digestive tract paralysis unknown? Up until the beginning of the 1990’s, there really were no safe, effective treatments for the conditions. Even if you were a gastroenterologist capable of diagnosing digestive tract paralysis, you might not have been comfortable accepting patients with this diagnosis, as the only options you really had to offer were artificial nutrition and ostomy.
The early 90’s saw the development of a number of medications known as “digestive prokinetics”, medicines designed to reset the stalled peristalsis of the digestive tract through the amplification of various neurotransmitters in the gut, such as dopamine, serotonin and acetycholine. Unlike laxatives, these drugs were designed to “smooth out” the electrical rhythm of the gut, not just to purge it, but preserve its proper function. Without proper function, patients eventually not only faced paralysis of the digestive tract, but the after-effects of the situation, liver damage from artificial nutrition pumped through an IV that contained substances that were practically milk, heart damage from having these substances pumped through your cardiovascular system for 12 hours a day and neurologic damage from lack of proper nutrients. In addition, cost should be looked at as well. For patients, the choice between a pill for $45 a month, TPN for $2000 a month and intestinal transplant for $200,000 to $500,000 was an easy one.
Unfortunately, the FDA has never seen the choice in this fashion. FDA never keen on analyzing comparative risk or benefit of various treatments, saw risks in the use of digestive prokinetics that others simply did not see. In the case of Zelnorm, the last digestive prokinetic on the US market (which has the capability of regenerating digestive nerve and muscle tissue), FDA removed from the USA market due to a vague assessment of a 0.1% risk of cardiovascular side effects (i.e.- heart attack or angina), this was despite additional reports that the individuals who had these side effects had pre-existing cardiovascular conditions. With regard to a second prokinetic, Propulsid, Food and Drug removed it from the US market because 70 people suffered a cardiac condition known as prolonged QT syndrome, a condition that could have been diagnosed through the use of EKG. A final prokinetic, Domperidone which helps to restore proper swallowing function in individuals with paralysis never saw the light of day in the US, this despite the fact that its sister drug Reglan remains on the US market, despite the fact that it causes a Parkinson’s Disease like condition in about half of our patients, and unfortunately represents the mainline prokinetic left on the US market. A recent exchange of letters between myself and former FDA Acting Commissioner Dr. Frank Torti highlights our frustrations and our hope for proper, but dashed solutions.
At the crux of the FDA’s inability to properly deal with digestive tract paralysis are two groups and the failure of due process for all stakeholders in the discussion. The Ralph Nader-founded group Public Citizen has been at the forefront of attacking and successfully removing from the US market the digestive prokinetics. They have engaged in the “Jello stuck to the Wall” strategy of attacking all of these medicines for a wide variety of side effects, gallstones, ovarian cysts, etc. until they found a proper side effect to knock the medicines off of the US market. This information would be then fed into two places; the first being Public Citizens for–profit book Good Drugs, Bad Drugs; the second to, various class action law firms who have been successful not only in knocking drugs off of the US market,but in knocking drug company interest away from digestive tract paralysis.
During this period, patients suffering from digestive tract paralysis have seemingly lacked the comparable standing granted to Public Citizen and the class action lawyers. A hearing that was supposed to take place upon the removal of Zelnorm from the US market never take place. An educational session run by one of our sister organizations to educate the FDA on these conditions obviously fell on deaf ears. Attempts to work through Congress to advance awareness have at best been a long uphill climb.
On the other hand, Sidney Wolfe, head of Public Citizen’s Health Research Group, now sits on the FDA”s Drug Safety Advisory Committee, the Committee responsible for overseeing all drug safety initiatives at the FDA.
Michael S. Smith, Esq. of New York, New York has had Chronic Intestinal Pseudo-Obstruction for twenty-two years. He is presently director and Counsel to G-PACT (www.g-pact.org), a national 501 (c) (3) non-profit dedicated to supporting the digestive paralysis community while fostering awareness of digestive paralysis and the need for better cures and treatments. He is also a Director of the Digestive Disease National Coalition, a group dedicated to advocating for better cures and treatments for all digestive diseases. If you have any questions or comments about this article, please do not hesitate to email him at MSmith8338@aol.com.
Editor's note: In a second article, coming soon, Mr. Smith will profile G-PACT's proposals for changing system and the obstacles to such change. And once again, I think that readers coming across the spectrum of Serious Medicine issues will see commonalities with their own specific concerns.
Posted by James P. Pinkerton at 2:50 PM