Archive for the ‘NIH’ Category

Spinal Stroke: An atypical cause of back pain

Monday, April 11th, 2011

When one hears the word stroke, what typically comes to mind is a “brain attack” with slurred speech or numbness and weakness of the right or left side of the body. Well, the spinal cord is considered part of the central nervous system and is truly a direct connection to the brain. All of the data received through nerve endings in our bodies passes through the spinal cord to be interpreted in the brain. Likewise, the messages our brain is sending to our bodies, both consciously and unconsciously (e.g. walk, run, write, speak; and digest food, breath, increase heart rate, etc.), travel through the spinal cord to our peripheral nerves.

The spinal cord is a vital structure that has its own blood supply, much like other organs, including the heart and brain. Just like the blood vessels supplying the other organs, the spinal arteries, especially the anterior spinal artery, can become occluded (i.e. blocked) resulting in spinal cord ischemia or infarction. The nerve information can no longer travel to and from the brain or the body freely; it is interrupted. This equates to a “stroke” of the spinal cord with resultant numbness, weakness, paralysis, as well as bowel and bladder dysfunction below the level of the infarction/stroke.

What causes a “spinal stroke”?

The most common cause of spinal stroke is the same as that for brain stroke or heart attack……atherosclerosis, an accumulation of cholesterol plaque in the arterial wall that ultimately blocks the artery. No blood flow means no oxygen or nutrients to the cells and tissues of the spinal cord resulting in them “starving to death.” There are other causes, as well; anything that compresses one of the supply arteries can block blood flow to a region of the cord and result in “stroke.”

Tumors, either primary or metastatic, can compresses blood vessels and other structures as they grow in the spinal region. Anterior disc herniations and disc ruptures or bone fragments from traumatic fractures of the vertebrae can compress blood vessels in the immediate vicinity.

Collections of pus from infectious processes can interrupt the blood supply either by compressing a vessel or disintegrating the blood vessel.  Small pieces of blood clots (called emboli) can break-off from larger clots (called thrombi) and circulate through the bloodstream until they get “stuck” in a smaller vessel somewhere else in the body; the spinal artery is just one location. Other systemic diseases can result in vasculitis, or an inflammation of the blood vessel, that leads to clotting and occlusion of that vessel, and the spinal artery is just one of the vessels that can be affected.

Surgery and spinal stroke

Interestingly, inter-abdominal and spinal surgical procedures can also lead to spinal cord ischemia and stroke. Individuals undergoing repair of an aortic aneurysm or iliac-to-femoral artery bypass often require “cross-clamping” of the aorta above the level of the surgery. The “golden hour” referred to in heart attack victims can also be applied to other vascular ischemic conditions, like spinal artery ischemia; if complications arise and the cross-clamp time is too long, it can result in ischemia from which the patient may never recover, remaining paralyzed for life. Similarly, an aortic dissection can disrupt blood flow to the smaller arteries branching from the aorta to feed the spinal cord leading to ischemia.

Spinal surgeries take one of two approaches, anterior (going through the belly) or posterior (going through the back). Because of the proximity of all of the vital structures, including the major blood vessels, small errors or retained fragments can lead to occlusion or disruption of the spinal blood supply.

Who is at risk for spinal stroke?

Those individuals with risk factors for heart disease or brain stroke are also at risk for spinal stroke since they share a common etiology. This includes those individuals with poorly-controlled diabetes, high cholesterol or dyslipidemia, abnormal clotting of the blood, peripheral arterial disease or history of aneurysms.

What are the symptoms of a spinal stroke?

Most patients present with sudden, severe pain, much like a heart attack, in either the chest or the back or both. This pain is typically rapidly followed by numbness, or loss of pain sensation and temperature sensation, in the extremities below the level of the stroke. Because of the anatomy of the blood supply, vibration sensation and position sense are maintained in the affected region since the posterior region of the cord has a different blood supply. As the spinal stroke progresses over an hour or so, the extremities affected become weaker and weaker, often experiencing paralysis, and the bowel and bladder lose their innervation leading to dysfunction and incontinence. This is a fairly rapid progression, much different that other myelopathies.

What is the treatment?

Due to the relative rarity of this condition, not many studies have been done regarding treatments. Unlike “heart attack” or “brain attack,” there are no standards of care except for aspirin therapy and (potentially) anti-platelet therapy after the stroke has occurred. More often than not, there is a delay in diagnosing the condition due to the rarity of the condition and the need to confirm the diagnosis by a diffusion-weighted enhanced MRI of the spine, such that “clot-busting” agents are time-excluded from use. Treatments are then focused on preventing additional vascular events, preventing deep vein thromboses in the paralyzed limbs, preventing bladder infections and fecal impactions, preventing decubitus ulcers and soft tissue infections, and preventing the additional morbidity associated with paralysis. This is not a comforting thought!

We are blessed with today’s medical technological advances that allow for so many life-saving procedures and procedures that preserve body function, such as spinal surgery, vascular stenting procedures and epidural injections. Unfortunately, some of these procedures have increased the incidence of spinal strokes due to the nature of the procedures themselves. The current epidemic of obesity and metabolic syndrome is also indicative of more cases of diabetes and atherosclerotic vascular disease which, according to the law of probability, will increase the incidence of this potentially devastating medical condition.

Clinical Trials Underway

Do you know someone who has had a spinal stroke? What was his or her age? What might have precipitated the “attack”? Some individuals have been in their early 20′s when the attack occurred. Needless to say, this is truly devastating! With all of our advanced technology, we should be doing a better job of preventing, diagnosing and treating this condition. The National Institutes of Health (NIH) does offer clinical trials for this condition; please refer to their website for further information. ( http://www.ninds.nih.gov/disorders/spinal_infarction/spinal_infarction.htm)

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Makena: Drug to fight prematurity leads to major firestorm.

Thursday, April 7th, 2011

Last week, I started following a still emerging story about a drug that I had never heard of before called Makena. The medication is a synthetic form of progesterone that is used for women who have a high risk of prematurely delivering a baby based on having had a premature delivery in the past. The drug must be injected by these women weekly for 18-20 weeks of their pregnancy.

According to the Baltimore Sun, the controversy surrounding this drug began when the “…K-V Pharmaceutical Co. boosted the total cost of the drug during a pregnancy from about $400 to $30,000, igniting a firestorm of objections.” This was possible because originally the medication was created by a compounding pharmacy mixing it together for patient use. Then in February, the FDA granted K-V Pharmaceutical Co. the exclusive rights to manufacture the medication for seven years.

If raising the cost of the medication 75 times its original cost (from $10-20/dose to $1,500/dose) were not enough, the Baltimore Sun reports that the company then went on to “sen[d] letters to pharmacies threatening that the FDA would punish them if they compounded their own versions of the drug.”  However, the FDA, amid a loud outcry of complaints, has “…declared it would do no such thing.  In its statement, the FDA noted that the drug was important and K-V ‘received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug’s effectiveness.’”

What has been so interesting are the implications of this story and the reactions to it. Clearly, the original decision by the pharmaceutical company to raise the cost of the drug 75 times the old cost is an attempt to make money from their exclusive rights. I can hardly imagine that there is any reason other than profit creation for this move given that they did not have costs associated with research and development or any other clearly identifiable costs. So, aside from my initial reaction of disgust that this might make it harder for women who need this medication to protect their children, I also thought about the bigger implications.

First of all, the cost issue is not so simple as it first appears.  As another article from the Baltimore Sun mentioned, “[t]he burden for many will fall on insurance companies, which may have to raise rates. The increase will also affect already strapped Medicaid programs.” The increased costs of drugs impact many Americans directly – those without insurance or those for whom even co-pays are a major budgetary struggle. However, the costs here also reach all of us. If the costs associated with the company’s increased profit are borne by the insurance companies and Medicaid, it also means that the costs are going to be felt by all of us who pay for health insurance or whose companies pay for health insurance and yes, by all of us, who pay taxes.

Secondly, for those women who do not realize that they could still go to a compounding pharmacy for this prescription and for whom it is not covered by insurance, the increased cost may mean that some woman will go without these injections. The Baltimore Sun article reports that:

About 500,000 U.S. infants are born prematurely each year. The March of Dimes estimates that about 10,000 of those premature births could be prevented if eligible women received Makena.

The implications here deal with both the health and safety of the unborn child who is now at risk of premature birth. But, unfortunately, they also have an associated monetary cost. The cost of a baby being born prematurely is also going to weigh on the insurance companies and is, therefore, going to be shared by all in the form of potentially increased premiums.

Given the intense criticism in the news, K-V Pharmaceutical Company moderately changed course in the last few days, according to Medical News Today and said they would bring the cost of Makena down to $690 per dose from the originally announced price of $1,500 per dose. While this is lower, this is hardly a significant adjustment given that the compounded version costs between $10-20 per dose. The March of Dimes, which originally backed FDA approval of the drug and was allowing the pharmaceutical company’s use of its name and logo, is apparently embarrassed by KV Pharmaceutical’s decisions. According to an article on the nonprofitquarterly.org, “…the March of Dimes is backing out of a sponsorship deal with the [pharmaceutical] company that sells [Makena]. Last Friday, the nation’s leading nonprofit focused on the health of pregnant women and babies said it would no longer allow St. Louis-based, KV Pharmaceutical Co. to use its name or logo in any of the drug company’s promotions.”

The response from the March of Dimes is not KV Pharmaceutical Co.’s only trouble as the Wall Street Journal is reporting that after the FDA announcement that it will not take action against pharmacies that compound the drug, and the company subsequently announced that it would cut the cost, the company’s shares fell 5.2%.  Reuter’s is reporting that this represents a drop of more than 20 percent.  Congress is also in an uproar about this issue.  The Reuter’s article says that elected officials are creating pressure for more to do be done on this issue.

What do you think should be done about KV Pharmaceutical Co.? Are they really any different from any of the other pharmaceutical companies? Is it relevant to consider that this is a so-called orphan drug and that the company has exclusive rights because of this? Do you think that allowing compounding pharmacies to create the drug for woman separate from the FDA approved drug is a sufficient solution? What about the bigger question of companies creating inflated prices for their products and having insurance (and all of us) foot the bill?

 

Research – Stem Cells: Adult Stem Cells Producing As Much Excitement in Research Community as Embryonic Cells

Sunday, April 25th, 2010

We continue to report on stem cell research since it is clear that the joy and exuberance of researchers may one day (hopefully not too far away) translate into cure and joy for many afflicted with and suffering from  a variety of diseases.  While our earlier reports have somewhat centered on stem cell research in the field of cerebral palsy, rep0rts continue to surface as to a variety of other positive advances relating to adult disorders.  

As a side note – you may wonder why a law firm, whose task it is to represent those injured by the negligence of others, would have any interest in positive medical news.  The answer is quite simple – having had the privilege of representing injured clients and making their lives a bit better monetarily, lawyers are always limited in just how much they can do to improve the quality of life for their clients. It is the medical community that will ultimately make the difference in alleviating if not curing these life-altering disabilities.  Therefore, we at Nash & Associates have  decided that in our blog, we will not only report on strictly legal issues (verdicts, key appellate decisions, changes in the law, etc.), but also on key medical news  (the good, the bad and the ugly) including significant medical advances. Contrary to what many cynics say about the legal profession – it is not all about the money.

This point in history marks a period of approximately one year since President Obama removed limitations on research into embryonic stem cells.  While significant amounts of research money was to be devoted toward this research, the financial crisis has no doubt had an impact on freeing up this financial commitment.  What is of significance, however, is that the answers to many advances in treatment options using stem cells may lie in non-embryonic stem cells. A recent posting in Top News suggests that the excitement in the research community is in large part based on their recent discovery that adult stem cells taken from a patient’s bone marrow or belly fat may yield positive results equaling those of embryonic stem cells.

Dr. Joshua Hare, Director of the Interdisciplinary Stem Cell Institute at the University Of Miami Medical School stated that adult stem cells are more flexible than they had thought. The embryonic stem cell may not be the one that proves to be really successful in the actual therapy.

His institution has already been injecting the area around a patient’s heart so as to help heal the tissue injured in a heart attack.  It is also noteworthy that adult cells are also being used in research programs to bring about improvement in functioning of patients with  injured spinal cords.

For those of you interested in advances in stem cell research, there are many excellent blogs and reports appearing on almost a monthly, if not weekly basis. You may want to check out The Stem CellThe Stem Cell Blog and a new friend of ours on Twitter – cellresearch. There is also a very helpful and informative site created by the National Institute of Health, which provides a very good basic understanding for the public of what stem cells are, the government’s policy on stem cell research, current research projects and the like.