Archive for the ‘Clinical Trials’ Category

Week in Review (April 16 – 20, 2011) The Eye Opener Health, Law and Medicine Blog

Saturday, May 21st, 2011

From the Editor (Brian Nash)

Another week of great posts (IMHO) by our blawgers. Apparently, I’m not the only one who thinks so since we have now surpassed 21,000 page views in the last 30 days. The number keeps rising. Our sincere gratitude to all our readers!

Our topics were once again quite varied. They spanned the law, health, science and medicine. We even had a piece on a local event – Marathon Kids. This piece is part of our new program to promote charities and civic organizations in our own backyard – Baltimore and Washington.

We try week in and week out to find topics of interest for you, our readers. If you ever have any suggestions for topics of interest to you, please leave a comment or send us an email or fill-out the contact form with your thoughts and suggestions. We’d love to hear from you.

Let’s get to it then. What did we cover this past week that you might be interested in reading? Take a look -

Why early settlement is a win-win for all

By: Michael Sanders

There is an old adage in the law that cases settle on the courthouse steps. There is a reason for that. When the parties are actually walking into court to try their case, they seem to suddenly recognize that there are significant risks to going to trial, and that there is serious money at stake. When you go to trial, only one side can win. The other side goes home a loser. Faced with such a stark outcome, both sides tend to become more reasonable in their assessment of their case and more willing to talk settlement. After all, despite all the years of experience that trial attorneys amass, no one can ever predict what a jury is going to do in any specific case. As one mediator I know likes to tell the litigants, going to court is like going to Vegas:  you roll the dice and you take your chances. Read more….

Milk from Mom: Effective in preventing common infant complication (NEC)

By: Jason Penn

The debate among parents regarding the use of human milk vs. formula wages on, but according to a recent study, you can chalk one up for the human body.  That study, headed by the Johns Hopkins University in Baltimore, concluded that premature babies fed human donor milk were less likely to develop the intestinal condition necrotizing enterocolitis (NEC).  Both sides has its advocates, willing to do battle at any time. When it comes to NEC, Mom’s milk has the decided advantage. Read more….

H.I.V. treatment advances, but what are the implications of terminating research early?

By: Sarah Keogh

Last week, I read some exciting news about H.I.V. treatment and transmission. A New York Times article reported that a large clinical trial found that “[p]eople infected with the virus that causes AIDS are far less likely to infect their sexual partners if they are put on treatment immediately instead of waiting until their immune systems begin to deteriorate…” The study found that “[p]atients with H.I.V. were 96 percent less likely to pass on the infection if they were taking antiretroviral drugs…” These findings are overwhelmingly positive and the implication for public health is huge. Read more….

A Windy, Rainy but Fabulous Day in Baltimore: Marathon Kids Final Mile Celebration

By: Rachel Leyko

Despite the wind and rain, this past Saturday I volunteered at the Marathon Kids Final Mile Celebration Event at Western Polytechnic High School in Northwest Baltimore.  I learned of the event through the Junior League of Baltimore and to be honest, prior to Saturday, I did not know much about the organization, its purpose or effect on the children it sought to serve.  However, after Saturday’s event, not only was I impressed with the purpose of Marathon Kids, but I saw firsthand the positive effect this program has had on the children who have participated. Read more….

Acquired Brain Injuries: Causes and Impact

By: Theresa Neumann

On the heels of Jason Penn’s blogregarding calling “911″ for signs of a possible stroke, I decided to introduce a variety of acquired brain injuries for further discussion in future blogs since damage to the brain results in some of the most catastrophic injuries possibly sustained by the human body with significant “collateral damage” for all of the friends and family involved in the individual’s life. Read more….


Sneak Peak of the Week Ahead

Some topics we’ll be covering next week…and then some…

  • You or someone you know has been diagnosed with cancer, now you have to deal with the horror. Jon Stefanuca will be writing a piece based on our experiences with a number of clients “living with cancer.”
  • Mike Sanders and I have both recently resolved cases involving families who have lost a child. Mike’s involved the death of a fetus very near term. He’ll share that story and the experience of the case with you.
  • Maybe those of you who have children with special needs are familiar with the local (Maryland and Washington, D.C.) resources to help you and your child. For those who may not be or just want to learn more, Jason Penn will be providing information on this next week.
  • You may have heard the recent news about labeling of certain medications for children. Sarah Keogh will report on this and also delve into some practical problems and issues that parents face every day in terms of medicating their children.
  • We’re going to begin a new series on exactly what is recoverable in our jurisdictions (Washington, D.C and Maryland) under what is known as the Survival Act and the Wrongful Death Act. We’ll be paying particular attention to issues involving what’s known as pecuniary benefits, loss wages and diminished earning capacity. Should be educational. We hope you enjoy it.

Have a great weekend, Everyone!

H.I.V. treatment advances, but what are the implications of terminating research early?

Wednesday, May 18th, 2011

Scientific Method; image from: scifiles.larc.nasa.gov

Last week, I read some exciting news about H.I.V. treatment and transmission. A New York Times article reported that a large clinical trial found that “[p]eople infected with the virus that causes AIDS are far less likely to infect their sexual partners if they are put on treatment immediately instead of waiting until their immune systems begin to deteriorate…” The study found that “[p]atients with H.I.V. were 96 percent less likely to pass on the infection if they were taking antiretroviral drugs…” These findings are overwhelmingly positive and the implication for public health is huge.

The study details are fascinating, particularly in regards to the results. For example:

The $73 million trial, known as HPTN 052, involved 1,763 couples in 13 cities on four continents. One member of each couple was infected with H.I.V.; the other was not. In half the couples, chosen at random, the infected partner was put on antiretroviral drugs as soon as he or she tested positive for the virus.

In the other half, the infected person started treatment only when his or her CD4 count — a measure of the immune system’s strength — dropped below 250 per cubic millimeter.

In 28 of the couples, the uninfected person became infected with the partner’s strain of the virus. Twenty-seven of those 28 infections took place in couples in which the partner who was infected first was not yet getting treatment.

What I found most interesting, however, was that the study was not completed. The reported findings were the preliminary results from the clinical trials. In fact, the article explained that “[t]he data was so convincing that the trial, scheduled to last until 2015, is effectively being ended early.”

The way these results were discovered and released during the course of the study was what intrigued me. Here’s how the study data was described:

“[U]nblinded” to an independent safety review panel, which is standard procedure in clinical trials. When the panel realized how much protection early treatment afforded, it recommended that drug regimens be offered to all participants. Although participants will still be followed, the trial is effectively over because it will no longer be a comparison between two groups on different regimens.

This means that the clinical trial was stopped before reaching completion so that all of the participating couples could receive treatment.

The implications of ending this trial short are complicated. For the participants, the decision can be nothing but positive since it may provide the study participants with the opportunity to receive treatment that could hopefully lead to a dramatically decreased likelihood of infection with a potentially deadly disease. For many others around the world who have a partner with H.I.V., the implications are likewise a boon for public health. The release of these early results may impact treatment of H.I.V. infected individuals around the world who may now be able to protect their partners from infection. However, the end of this study is not as clear-cut in terms of research and ethical implications as it might seem.

I originally became aware of the idea that clinical studies are sometimes cut short in the mid 1990s. My father, an occupational health doctor who died in 1999, was involved in the CARET studies during the 1990s. This large-scale double blind study was looking at whether beta-carotene and retinyl palmitate would be able to prevent lung cancer in heavy smokers and workers who had been exposed to asbestos.  However, the study was ended prematurely based on interim results that suggested an adverse affect on the study participants. Since I was only a high school student at the time that the trial was ended, I did not know many of the details at the time. I understood the basic idea that if a medical research study was causing harm to the participants, that it must be ended. When I read the recent news about the H.I.V. treatment study, it prompted me to try to learn more about how and when clinical studies are interrupted.

There was an article published called “Stopping the active intervention: CARET” that I found enlightening about how and why the CARET studies were ended.  The article provides an overview that I found helpful in thinking about the current H.I.V. study:

The optimal design of a randomized clinical intervention trial, where the outcome is a disease endpoint, includes a set of criteria for stopping the active intervention before planned. These criteria, called “stopping rules,” guide the review of findings by key study scientists and an independent set of reviewers. If the pattern of outcome, effect or harm, is large enough to be attributed to the intervention, the trial is halted, regardless of the planned completion date or the readiness of staff to end the trial.

While in the H.I.V. study, the impact was positive, rather than negative as in the CARET study, the procedure seems to be similar. A procedure in the study allowed for data to be unblinded and examined by an independent panel which then recommended that the trial be stopped early.

However, this does present two potential problems. One is that the study, scientifically speaking, did not reach its full conclusions. It may not provide as much evidence of implications as it might have if it had continued or if the study population had been larger. For example, the New York Times article mentioned the following:

Although the trial was relatively large, there are some limitations on interpreting the data.

More than 90 percent of the couples in the trial, who lived in Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, the United States and Zimbabwe, were heterosexual.

“We would have liked to have a substantial number of men as potential study subjects, but they just weren’t interested,” Dr. Cohen said.

Although common sense suggests the results would be similar in the contexts of homosexual sex and sex between people who are not couples, strictly speaking, the results apply only to the type of people studied, Dr. Fauci said.

Another implication is that the results may not be as scientifically accurate if the trials are stopped early.  A study published in JAMA entitled “Stopping Randomized Trials Early for Benefit and Estimation of Treatment Effects: Systematic Review and Meta-regression Analysis” explains:

Although randomized controlled trials (RCTs) generally provide credible evidence of treatment effects, multiple problems may emerge when investigators terminate a trial earlier than planned, especially when the decision to terminate the trial is based on the finding of an apparently beneficial treatment effect. Bias may arise because large random fluctuations of the estimated treatment effect can occur, particularly early in the progress of a trial. When investigators stop a trial based on an apparently beneficial treatment effect, their results may therefore provide misleading estimates of the benefit. Statistical modeling suggests that RCTs stopped early for benefit (truncated RCTs) will systematically overestimate treatment effects, and empirical data demonstrate that truncated RCTs often show implausibly large treatment effects.

(internal footnotes omitted)

So, perhaps, if the trial were continued, the results would not have been as overwhelmingly positive. Perhaps the percentage of partners infected in the two groups would not have been as widely divergent. But perhaps they would – and would you want to gamble with someone’s life?

Have you ever been involved in a clinical research study that has been ended early? Was it for positive or negative results? What should be done to maximize public health and safety while still providing the benefits of full blind research studies?

 

Robot Anesthesiologists?

Tuesday, April 19th, 2011

robotic intubationFor anyone contemplating serious surgery, it can be a scary endeavor. From going through it myself and talking to others, I know that the main fear we have going into it is that the surgeon will make a mistake during the surgery, or that we will develop serious complications such as a hematoma, infection, etc. that leads to death or paralysis. While these are very real risks of many forms of surgery, there is another aspect of surgical procedures that gets less attention from patients – the anesthesiologist. While it may get little notice from patients, anesthesiology is a highly complex field of medicine in which doctors (and certified nurse anesthetists) train for years to be able to do it well. This post will focus on just one aspect of anesthesiology known as intubation, and a new development in robotics that may improve the procedure.

What is intubation?

At its most basic, intubation is the process by which the anesthesiologist places a thin plastic tube into the patient’s windpipe to maintain an airway or to facilitate mechanical ventilation. While this is done in a variety of serious medical situations, it is almost always done during major surgery when the patient is under general anesthesia. During such surgery, the patient is rendered unconscious and is unable to breathe on his or her own. Therefore, the anesthesiologist has to essentially breathe for the patient during the surgery, either using a ventilator or sometimes compressing a bag that replaces natural breathing. The process of intubation allows this artificial breathing to take place. Because intubation itself is a painful procedure (remember – a tube is being inserted far down your throat), the patient is usually given paralytic drugs (drugs to induce paralysis) before intubation. This is a key point we’ll come back to later.

Risks of Intubation

While it may sound as simple as sliding a tube down the throat, intubation carries its own risks separate and apart from the risks of anesthesia itself (risks from anesthesia can include death, paralysis, brain damage and a whole host of other less serious injuries). With intubation, there are minor risks such as chipped teeth, lacerations in the gums and sore throat. However, there are many more serious risks as well, including perforation of the trachea, mistakenly placing the tube down the esophagus (a more common occurrence than you might think), aspiration of stomach contents, vocal cord injury, decreased oxygen and elevated carbon dioxide, and nerve injury. Intubation is a serious procedure that requires a high degree of skill and training to do it well and safely.

What if the tube does not get placed properly?

Inability to secure the airway is a major problem in intubation. To understand why, you have to remember that before the tube is placed, the anesthesiologist paralyzes you with drugs. Therefore, before the tube is placed, you stop breathing on your own. It is then critical that the tube be placed quickly and accurately to ensure that you don’t suffer from a lack of oxygen (or ventilation – the exchange of oxygen and carbon dioxide). So what happens when the anesthesiologist has trouble getting the tube in? It just so happens that I have some personal familiarity with that scenario.

A few years ago I had back surgery. The surgery itself was not complex as far as spine surgeries go (it always amazes me how surgeons are able to describe cutting open your back and operating on your spine as casually as they might describe changing a light bulb). It essentially consisted of trimming off a small piece of disc that was pressing on my spinal cord and causing pain to radiate down into my leg and foot.  I was in and out of the hospital the same day, but of course I was under general anesthesia so I had to spend a couple of hours in the Post Anesthesia Recovery Room (PACU) to make sure that I was not suffering from any ill effects of the anesthesia. While waking up, and still groggy, the anesthesiologist walked up to me and said, “I just want to let you know – you were really hard to intubate. If you ever have surgery again, be sure to tell your doctor that you’re really hard to intubate.”

I asked the doctor what he meant by that. He told me that because of the anatomy of my mouth and throat, he had had a really difficult time getting the tube into my airway. Keep in mind, the tube was placed down my throat after I was given drugs to paralyze me. Even in my post-anesthesia addled state, I knew enough to ask the obvious question – what would have happened if he couldn’t have gotten the tube down in time? He was casual in his response. “Oh, we would have given you drugs to wake you back up.” How comforting. My next thought was, “Maybe you could have checked my anatomy out before you gave me paralyzing drugs.” I didn’t ask that because I am sure they did check me pre-operatively.  That is standard procedure before giving anesthesia to make sure that the anesthesiologist knows the patient’s anatomy and can anticipate problems. Apparently, my anatomy was a little more vexing than he had bargained for. However, he was finally able to get the tube in and the surgery went well.

The use of robotics

Because of the ever-present risk of serious complications, researchers are always working on improving intubation to minimize risk. It has always been a hands-on procedure that depended on the skill of the individual performing it. Now we may be moving into a whole new world of intubation thanks to advances in robotics.

Medical News Today is reporting that Dr. Thomas Hemmerling of McGill University and his team have developed a robotic system for intubation that can be operated via remote control. According to Dr. Hemmerling:

The [device] allows us to operate a robotically mounted video-laryngoscope using a joystick from a remote workstation. This robotic system enables the anesthesiologist to insert an endotracheal tube safely into the patient’s trachea with precision.

The system is still in development. It has been widely tested with mannequins that mimic human anatomy, and clinical testing on patients has now begun. Dr. Hemmerling hopes that the new device will allow anesthesiologists to intubate patients using less force and higher precision, which should help to improve patient safety. Even with the use of robotics, I would think that intubation, including pre-operative assessment of individual anatomy, is going to require close hands-on involvement in order to ensure that it is done safely and properly, but it is always exciting to see what was once science fiction being used in real-life surgeries.

What you can do

While robotic anesthesiology is still down the road for most of us, there are still things you can do to minimize your risk of injury. Before agreeing to surgery, most of us do a good job of vetting our surgeon – how experienced he or she is, how many similar procedures he or she has performed. How many times have you heard a friend describe his or her surgeon as “the best?” Yet virtually no one who has been a patient – at least in my experience – makes any inquiry into the experience level of the anesthesiologist, even though a mistake by this person can render you paralyzed or brain-dead (or even dead) in a matter of minutes.

If you are planning on undergoing serious surgery, I would encourage you to discuss the anesthesia care with your surgeon. Find out ahead of time who your anesthesiologist is going to be (if that’s possible), and discuss your situation with that person. No doubt you will be evaluated by the anesthesiology team before your surgery, but it may well be the same day as your surgery, and it will feel like just another routine matter like signing a few forms. Keep in mind, however, that anesthesiology is just as important as the surgery itself. Stay informed and ask questions. Treat your pre-operative session with the anesthesiologist as if your life and health were depending on it – it just may!

And as for robotics, I’m curious what your comfort level would be if your doctor suggested using a robot to intubate you? Would you be willing to try the procedure, or would you prefer the traditional hands-on, human approach?

Image from “Today’s Medical Developments”

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)

Image from homebusinessandfamilylife.com

New Microchip Promises to Make Life Much Easier for Paraplegic Patients

Friday, February 11th, 2011

Hope for those with paraplegia?

Researchers in the U.K. have developed a revolutionary microchip muscle stimulator that will enable patients with paraplegia to exercise multiple muscles at the same time. According to the Engineering and Physical Sciences Research Council (EPSRC), the microchip developed by Professor Andreas Demosthenous from University College of London and his team is truly unique.

The microchip chip is small enough (approximately the size of a child’s fingernail) that it can be implanted directly into the spinal canal. Unlike previous models, the new implant incorporates the muscle stimulator and the electrodes into a singular unit.  The unit is properly sealed to protect against moisture, which could lead to corrosion of the electrodes.

The creation of the implant has been made possible by new laser processing technology, which enabled researchers to micro-pack all components into one unit. With this new laser technology, researchers were able to cut much tinier electrodes from platinum. The electrodes are then folded into a 3D shape that resembles pages in a book. Each electrode can be wrapped around a nerve root. The electrode is then welded to the microchip located in the spinal cavity.

Because the implant comes with multiple electrodes, which can be connected to multiple nerve roots, it is capable of controlling entire muscle groups. In patients with paraplegia, the devise can be used to stimulate or trigger multiple paralyzed muscles at the same time. Researchers also claim that the new device will also be used in patients with bladder or bowel incontinence.  Because the device has multiple electrodes, some electrodes can be connected to nerve roots that control bladder muscles or nerves that control bowel capacity.

Although all of this may sound a bit scifi, the implant will be available for pilot studies sometime this year. If you or someone you know is paraplegic, this research is worth following. It clearly promises to offer life-chaining benefits to patients with paraplegia. If you know of other research on similar devices, we’d love for you to share that information with our readers. We’ll try to keep an eye on the progress and implementation of this device from the UK and keep you posted if and when developments occur.

Update:New Painless Test for Colon Cancer Details – Still Experimental but Hope Abounds.

Monday, November 1st, 2010

Two weeks ago, this blog highlighted the issue of doctors not following recommended colon cancer screening guidelines. While the standard tests for colon cancer (primarily colonoscopy and flexible sigmoidoscopy) will likely remain in place for now, new information is coming out on a new test that may one day be used to detect colon cancer – a DNA stool test.  As reported by MedicalNewsToday.com and others, the test uses a stool sample and detects alterations in DNA that are linked to the presence of tumors.  Therefore, actual imaging of the colon is not necessary.

The test has been developed by a Wisconsin company called Exact Sciences.  What is key about this new test is that it is non-invasive, meaning that it does not involve any bodily penetration.  This would be a boon for those patients who put off getting tested because they don’t want to undergo more invasive procedures, or who don’t want to take time away from their busy lives to do it.  This new test can even be done at home.

Researchers at the Mayo Clinic have already tried out this new test on humans with surprisingly good results.  On a test involving 1,100 participants, the DNA test detected 85% of cancers and 65% of pre-cancerous adenomas larger than 1 cm.  87% of Stage I to Stage III cancers were caught by the new test, which is excellent news because the earlier cancer is detected, the better chance there is of a cure.

We must emphasize that this new test is experimental only at this stage.  Additional human trials are expected to get underway in 2011.  There is no word on when this test may become available for wide-spread use.  We will continue to post updates on this exciting new front.

Who’s Hawking Rx Drugs? Is It Really an Effective Medication or Just Effective Marketing?

Thursday, October 28th, 2010

We have all seen the non-stop drug ads on TV – a pill or injection that will cure whatever it is that ails us. Public advertising, however, is just one way that pharmaceutical companies get their drugs into the market place. Behind the scenes, there is a full-blown marketing campaign that the public never sees in which drug companies hire doctors (tens of thousands of doctors) to spread the word on their drugs, primarily by giving talks to other doctors.  An ongoing investigation by ProPublica reveals that some of these doctors have significant disciplinary actions in their past:

A review of physician licensing records in the 15 most-populous states and three others found sanctions against more than 250 speakers, including some of the highest paid. Their misconduct included inappropriately prescribing drugs, providing poor care or having sex with patients. Some of the doctors had even lost their licenses.  More than 40 have received FDA warnings for research misconduct, lost hospital privileges or been convicted of crimes. And at least 20 more have had two or more malpractice judgments or settlements. This accounting is by no means complete; many state regulators don’t post these actions on their web sites.

There is no doubt that the pharmaceutical industry (sometimes referred to as Big Pharma) is a huge industry.  According to IMS Health,a healthcare information and consulting company, prescription drugs generate $300 billion in sales in the United States alone.  Therefore, the pressure on drug companies to market their products is immense. For the doctors out there, doing free-lance work for drug companies can be a very lucrative side-business, with some physicians earning as much as $1,500 to $2,000 for giving a single talk to a group of doctors. While there is nothing wrong with marketing a legal product, the public must be assured that the marketing is honest and that the drugs in question are being prescribed because they are effective drugs, not simply because the drug companies have an effective marketing campaign.

“Without question the public should care,” said Dr. Joseph Ross, an assistant professor of medicine at Yale School of Medicine who has written about the industry’s influence on physicians. “You would never want your kid learning from a bad teacher. Why would you want your doctor learning from a bad doctor, someone who hasn’t displayed good judgment in the past?”

Big Pharma appears to be turning a relatively blind eye to the situation. As part of its investigation, ProPublica compiled a database of physicians who work for the drug companies, and then cross-checked these doctors’ credentials and state disciplinary records.  The drug companies themselves could have taken this approach in vetting their doctors, but most do not bother to do so. Most companies “rely on self-reporting and checks of federal databases.”  However, it is the state disciplinary records that typically contain the relevant data on doctors who have been disciplined (and even state authorities do not always post such infractions on their websites). Lisa Bero, a pharmacy professor at University of California, San Francisco, questions the way that Big Pharma checks on its doctors:

Did they not do background checks on these people?  Why did they pick them? If they did things in their background that are questionable, what about the information they’re giving to me now?

In addition to disciplinary actions, ProPublica also raises questions as to these doctors’ credentials, e.g. medical research, academic appointments and professional society involvement, that would make them especially qualified to speak on medical conditions and ways to treat them. The investigation highlights a Las Vegas endocrinologist who has earned over $300,000 from Big Pharma. However, ProPublica contends that it was unable to locate any credentials on this doctor other than his schooling and some 20-year-old research articles. Furthermore, an online brochure from a recent presentation given by this doctor indicated that he was the chief of endocrinology at a local hospital, but “an official there said he hasn’t held that title since 2008.” Such stories only add to the serious questions as to how Big Pharma is selecting its doctors.

Certainly, a lot of good can come from honest marketing of effective new drugs. Especially in out-of-the way places, a talk by a knowledgeable physician can be a great source of information on new treatments available for a certain disease. If a new drug is truly effective, then by all means the word needs to get out on that drug because such drugs allow us to live longer and to live more comfortably with what were once debilitating diseases.  However, the public must demand honest assessment of these drugs. When drug companies allow unscrupulous doctors to hawk their wares, it raises legitimate suspicion as to whether these drugs are so popular because they are truly effective or simply because they had a good marketing blitz.

If you are curious about a specific doctor, ProPublica has a searchable database of doctors who do work for drug companies. Also, ProPublica has published several follow-up and/or related articles which can be found here.

Cerebral Palsy: Cord Blood Stem Cell Research and Treatment in Clinical Trials – Update

Thursday, April 29th, 2010

For those of  you who follow our blogs, you know well that this is a topic of interest for us.  It bears repeating – our job as lawyers is to properly investigate potential claims of malpractice in areas such as cerebral palsy and seek redress for our clients when the evidence demonstrates a connection between birth injuries and medical care, but the much more important topic for our clients and victims of cerebral palsy is in the field of medical research. It is through research efforts – including clinical trials – that this dreaded condition will be ameliorated and hopefully eradicated. Trust me, after practicing law for over 35 years, I’m not worried about job security – the frailties of the human condition will more than suffice to fill our file cabinets with people to help due to the negligence of others.

We have reported previously on various topics involving cord blood and stem cell research as they relate to a number of conditions, including cerebral palsy.  It seems that months have passed since there has been any significant news about two programs underway: one at the Medical College of Georgia and the other at Duke.  Earlier this month, an update came across the social media network via a post by Singularity Hub – Cord Blood Stem Cell Treatment for Cerebral Palsy in Clinical Trial | Singularity Hub.

Here’s our encapsulated version regarding the studies and Singularity Hub’s report.

Photo provided by MSNBC

Duke University

According to the website ClincalTrials.gov, Duke began a clinical therapeutic trial – identifier: NCT00593242 - in January 2008 (estimated completion date of January 2011) whose primary purpose is listed as treatment of newborns with hypoxic ischemic encephalopathy (HIE) – inadequate oxygenation in the perinatal period for purposes of this study – through the controlled “collection, preparation and infusion of a baby’s own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.” For information concerning the inclusion and exclusion criteria for participation in this clinical trial, see the online posting. Essentially, the babies are then to be “followed for neurodevelopmental outcome at 4 – 6 and 9 – 12 months at Duke’s Special Infant Care Clinic. MRI’s will be obtained between postnatal weeks 1 and 4, and, for study purposes at 4 – 6 postnatal months.”

While other aspects of processing and administration are no doubt part of the key components of this project, it is readily apparent that the end-point goal is discovery of an effective treatment of cerebral palsy for the identified neonates in the study and then development of a second stage clinical trial to take such treatment modality to a greater number of potential beneficiaries.

Medical College of Georgia

For detailed information on this study, which began in February of this year, similar information is available through ClinicalTrials.gov under identifier NCT01072370.  This clinical trial investigation has a patient population consisting of children from ages of 2 to 12, “whose parents have saved their infant’s cord blood, who have non-progressive motor disability, and whose parents intend to have a cord blood infusion.”  Again – for full details regarding inclusion and exclusion criteria, see the full online posting.

For those parents who may be interested in determining if their child would qualify to participate, the study is still recruiting participants.  The contact information is also available at this link: Contact: James E Carroll, M.D.     706-721-3371     jcarroll@mcg.edu

Today’s report from Singularity Hub provides some encouraging – albeit anecdotal – news of potential progress.

The anecdotal evidence in support of treating cerebral palsy with cord blood stem cells is astounding. Much of it has actually been been performed at Duke University by one of the investigators in the pilot study: Joanne Kurtzberg. Among those that have been successfully treated at Duke include Ryan Schneider, Maia Friedlander, Chloe Levine, and Dallas Hextell. All had CP or CP-like symptoms and all made remarkable recoveries after cord blood stem cell treatments. Dallas Hextell, who showed improvements just 5 days after his therapy was featured on the Today show (the original report contains video compliments of MSNBC).

In addition to the early good news coming out of these projects, one other lesson is learned – for the time being, the storage of cord blood is an important component for those hoping to participate in such studies – particularly that being conducted at the Medical College of Georgia.  We have earlier reported on this topic as well.  You may want to refer to our early posting for some basic information if you are interested.

Obviously, the implications – if these projects prove to be successful – are far-reaching. The enthusiasm of the participants in these research projects is not limited to them alone. The words of the author, Aaron Saenz, from Singularity Hub somewhat tells it all:

So we have some exciting news for cerebral palsy, and some exciting news for those thinking about cord blood. What about the rest of us? Well the MCG and Duke work has some far reaching implications. Neurological damage, whether it’s caused by oxygen deprivation or some other injury, is one of the most difficult things to heal in the body. Work in animals (like that done by Carroll on rats) show that stem cells can not only help damaged brain cells recover, but they can also replace cells that have died. We may find that stem cells therapies have a wide range of applications for many different forms of brain damage. Kurtzberg is researching many different ways cord blood could be used (autologous or through donors) to treat a variety of conditions. In other words, today stem cells conquer cerebral palsy…tomorrow, the world.

Let’s all hope that Mr. Saenz is a prophet.

Have you ever wondered how people get in clinical trials? Well, you should check this out.

Monday, April 26th, 2010

Are you aware of clinical trials that may be in your neighborhood? I just happened to come across this link to clinical trials.  Perhaps you are a lot more savvy than I (which would not surprise me one bit), but you can get ongoing information on these clinical trials by going to a website called Clinical Connection.

For example, there’s one in Baltimore for overweight folks being conducted at Harbor Hospital involving a new investigational medication.

In fact, if you go to this link, you will see that there are over 15 clinical trials for all types of conditions in the Baltimore area alone. If you are willing to travel 50 miles or less, there are even more in which you can enroll.

Do you have moderate or severe pain from osteoarthritis of the hip or knee?  Well Annapolis just might the place for you to visit and try out a new drug.  You have to be  over 18 years of age and according to the website, “study participants may be compensated for time and travel. All study-related care is provided at no cost and health insurance is not required to participate.”  I don’t know what “may be compensated” means – but if you are interested, check it out.

On the national level, the home page of Clinical Connection says there are 105,555 clinical trials underway – and there’s probably at least one in your neighborhood.

Do you suffer from chronic low back pain of greater than 3 months duration? That’s right – there’s a trial for you taking place at 7 locations, including California, Arizona, Florida, Washington and Nevada.

You name the condition – there just may be some free study out there waiting for you to volunteer.

These programs undoubtedly have very extensive packets of information about the study guidelines and the risks and benefits of the drug or therapy under study.  These trials are called clinical trials since the manufacturer has presumablyjumped over the hurdles of early non-clinical research in order to take the next step – how does our product work with real people?

Make sure you understand what you are signing up for before doing so.  Who knows, it may turn out that you get some real benefit from participating – hopefully you will not be a statistic in terms of adverse outcome. Just take time to understand what you are getting yourself into and what rights you are waiving.  If you’re good to go, we wish you well!