Life on Wheels (81 page)

A company in Israel, NESS, offers the H200, an external device that aids grip. It is of value for people with quadriplegia—who would need assistance putting it on and removing it—and for people with stroke or traumatic brain injury (www.nessltd.com).

People with trauma at high levels in the spinal cord are unable to breathe on their own. This happens because the phrenic nerve, which causes the diaphragm muscles to contract, does not receive the automatic nerve impulses that it needs to work properly. Therefore, the diaphragm does not contract, and the lungs are not pulled down to create the vacuum that draws in air.

Phrenic nerve stimulation is an FES method to assist breathing by creating impulses in the phrenic nerve. Some people are able to be partly or entirely freed of a ventilator thanks to the implant. Christopher Reeve had been using the approach, first experimented with in 1964.

Cybernetics Neurotechnology has been performing studies using an implant in the human brain, which can allow a person to literally “think” an activity to happen. As of 2007, users have been able to control the movement of a cursor on a computer screen using Cybernetics’ BrainGate Neural Interface System. A sensor is planted in the motor cortex of the brain. It analyzes brain signals that the user can learn to control. The goal is for a user with quadriplegia to be able to access environmental controls, use the telephone, and control lights and television, and so on. The company also intends to explore the potential for the BrainGate system to control muscles. They are performing clinical trials for persons with SCI, muscular dystrophy, “lockedin syndrome,” and stroke (www.cyberkinetics.com).

The days of the lone scientist who makes a historic discovery are pretty much over. Hidden knowledge that could be found that way has been found already. Dr. Ron Cohen of Acorda Therapeutics says:

Times have changed, indeed. Researchers are now trained in years of intensive study and clinical internship. People are increasingly specialized in pursuits such as molecular biology, genetic engineering, or microsurgery. Such specialization naturally requires people to work in teams, each applying focused knowledge according to her or his appropriate role in the process. Research today is necessarily a collaborative process.

Researchers also have access to a tremendous amount of previous experience and information, now all the more accessible via the Internet and dedicated medical information services like Medline. Computers have expanded the precision and capabilities of testing and measurement equipment many thousand-fold, making it possible to see into worlds that were previously closed to the microscope. Calculations done in a moment by a computer would have taken months—or years—by hand.

Researchers now operate under much more stringent regulatory and ethical standards. Compared to the history of medical research, wanton experimentation is all but completely ended. Researchers go to great extremes to verify the value of human trials before they proceed. The FDA demands that they offer extensive proof of their studies before permission is given for human trials. There will always be risk with experiments, but, when the initial groundwork is done well, the likelihood of life-threatening reactions to testing are very low. These, at least, are the standards you should apply to any research project that you might consider participating in as a subject.

Researchers rely heavily on grant money from many sources, public or private. If they conduct work that proves fruitless or unverifiable, they run the risk of not being able to acquire additional funding. Remember, learning from what doesn’t work is different than having a failed experiment. The test is not always whether they produce a usable therapy, but whether they gain valuable information toward that end. Either way, researchers are very motivated to work in a highly organized fashion. It affects their ability to keep working by means of qualifying for grant money.

The only way that these labs can exist is to pursue funding from different sources, with many projects going at once. It is not unusual for several donors to contribute to the same research, though, when future licensing or other commercial interests are involved, such funding is carefully defined according to who would be entitled to possible commercial fruits of the work.

Commercial funding, such as that by Acorda, inevitably overlaps government money. The government does not mind investing in research that might result in a commercial product. It helps the economy, so Washington does not regard this as a conflict of interest. Says Acorda founder Ron Cohen:

Paralyzed Veterans of America’s Melinda Kelley says that:

Researchers are often the unheralded heroes, working on extensive studies that are highly detailed, challenging, and time consuming. Some of them could probably be out in offices and hospitals treating patients and making much more money, but they chose the course where they feel they can make the most difference. They seem to be more interested in taking pride in their work than in following the money, which they have to beg for through the grueling process of grant writing and approval. Their motive is compassion; results are their reward. Dr. Noble says:

Dr. Richard Borgens of the Center for Paralysis Research at Purdue University studied limb regeneration in salamanders as a graduate student. He won an award for the work from the National Paraplegic Foundation and encountered a room full of chair users at the award ceremony. He found himself uncomfortable as a person who could walk among so many wheelchair riders, having never even seen a person with quadriplegia. The human character of his work became clear, and he says:

Not all research can be performed on cells in dishes or simulated on a computer. Some tests require a working biologic system that parallels human beings, such as that in rats and dogs. Spinal cord research is not just about how to get a nerve to grow, as we’ve already seen. It is about the immensely complex system of chain reactions that occur in the real environment of living physiology. It is about the response of the body to a substance you might place into the system by any of a number of methods. It is about finding out that there are other factors at play that might not appear until you try what seems like a viable approach. This living research can only be studied in animals.

According to the American Academy of Neurology (AAN), less than 1% of research animals are dogs or cats. Ninety percent of research animals are rodents, such as rats and mice. AAN points out that more than 10 million unwanted animals are put to death each year in animal shelters, and only 1% of that total is released for research. In fact, most research animals are carefully bred for their purpose. AAN also points out that animal subjects have produced benefits for the veterinary community as well, benefiting animals as well as humans.
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Although some animal rights activists might draw comparisons to human experimentation in Nazi Germany, remember that such atrocities were performed with no concern for the experience of the subjects, often without the use of anesthetics, watching suffering of the deepest kind in order to “learn” from it. In the present, highly regulated setting of medical research, government inspectors make unannounced visits to determine the conditions of animal research. Besides, says the AAN:

Using animals for research is widely supported by physicians, 97% of whom responded to an American Medical Association study with support for their continued use. The AAN says that “medical progress is simply not possible without animal research, and millions of people will pay the price if it is curtailed.” They are concerned that animal rights activists will compromise promising research into Parkinson’s and Alzheimer’s disease, traumatic brain injury, meningitis, spinal cord paralysis, stroke, epilepsy, and many others. The AAN says that animals are used “with the dignity, gentleness, and respect to which they are entitled.”

There was a time when research was sometimes carried out indiscriminately without concern for the suffering of the subject animals, but that time is past. There are very strict guidelines that laboratories must follow, and those that do not conform risk being forced out of operation. Dr. Noble notes:

You might find that the issue of using animals in research raises conflicts for you, as you attempt to balance your desire for less pain and greater independence in your own life with an ethical and moral position regarding the treatment of all living creatures. This person with an SCI sympathizes with what animals were undergoing but doesn’t want research to stop:

Before any research can be approved for use, clinical studies must be performed. At first, animal subjects are used, but ultimately human trials will be necessary. You might well be a candidate to participate in studies of therapies before they are approved for public use. This is a complex and very critical decision to make, one that demands that you be informed and think carefully about the risks that might be involved.

By their nature, research studies entail a degree of risk. The very point is to observe the effects—positive or negative—of the tests. The reason to participate in such a study is to help scientists develop useful therapies, not to get treatment before it is publicly available. There is no guarantee that the tests will be beneficial for you. The motive of most test subjects is the benefit of future persons who will use the therapy if it proves of value. That might include you.

As therapies and technologies evolve in laboratories and universities across the world, they eventually must go through a period of human clinical trials. Once the relative safety and potential efficacy of a therapy are established in animal models, then trials must be performed with a small—and later, a larger—group of humans.

There have been a great many clinical studies performed to evaluate the effects of exercise, pain management, spasticity control, and many other areas. In the coming years, more human trials will assess the regeneration of CNS tissue; some of the studies will involve invasive techniques such as surgery or injection of substances into the brain or spinal cord. Some trials will be specifically for those people with acute (recent) disabilities; others will be for people with chronic (longterm) disabilities.

The goals of these controlled studies are to: