Compassionate Use

Compassionate Use

By Michael Leshinski

A recent news report and subsequent blog posting have sparked my interest in compassionate use waivers. I wanted to know more about the process. What exactly is compassionate use? I’ve provided some links below to help us better understand it.

http://www.research.ucsf.edu/chr/Guide/chrEmerUSE.asp

-This website from the University of California, San Francisco, will give you a detailed explanation of compassionate use as well as discuss some associated ethical issues.

http://www.pfizer.com/research/science_policy/compassionate_use_policy.jsp

-Take a look at this website to learn where some pharmaceutical giants stand on the issue of compassionate use waivers.

http://www.cancerworld.org/CancerWorld/getStaticModFile.aspx?id=1955

-Follow the link above to an article exposing many true life stories related to cancer and compassionate use. The article also discusses how the subject is treated in some European countries.

http://clinicaltrials.gov/ct2/show/NCT00718393

-From a clinical trials watch site, provided by the National Institutes of Health, the site tells about a clinical trial being conducted with patients on compassionate use basis.

http://www.nytimes.com/2008/07/17/business/17dystrophy.html?_r=1&scp=1&sq=compassionate%20use%20waiver&st=cse&oref=slogin

-The link above discusses a legal suit involving a drug company and a family of a sick boy who is being denied treatment for his illness.

Psychiatric Drugs: Not Just for Humans Any More

By Randy Hendrickson

Do animals have thoughts and feelings that are similar to our own? Do they experience anxiety, depression, or cognitive dysfunction? According to the New York Times ( “Pill-Popping Pets” July 13, 2008), pharmaceutical companies are now formulating human drugs for use in companion dogs and cats. These include behavior modification and lifestyle drugs to treat conditions such as cognitive dysfunction, separation anxiety, depression, mood and behavior disorders, and even obesity. One such drug, Clomicalm® (Novartis), is chemically identical to clomipramine (Anafranil®), the tricyclic antidepressant for humans, however, it was packaged with a picture of a happy, smiling yellow lab on the box. It is approved by the FDA for separation anxiety, but also prescribed off-label for canine compulsive disorders. Another drug, Anipryl® (Pfizer) is used to treat cognitive dysfunction and help the animal with memory loss. Similarly, Reconcile® (Eli Lilly), which is used for separation anxiety, is the same chemical compound as Prozac®, except it is beef flavored and chewable. Currently, most of the major pharmaceutical manufacturers have a companion animal division. It is a very lucrative income stream considering that $15 million was spent on behavior modification drugs in the United States in 2005 alone.

According to Melanie Berson from the FDA Center for Veterinary Medicine, “as people are seeing more complex and sophisticated drugs for themselves, they want the same quality for their pets.” There is a growing desire to use behavior-modifying medications in order to have more obedient pets and to control their dogs so they don’t act like dogs. “Owners want their pets to be more like little well-behaved children.”

But this issue is more complicated than merely wanting well-behaved, socially adjusted pets. Behavioral pharmacology advocates maintain that the combination of new drug therapies along with progressive training techniques can solve behavioral problems that in the past usually resulted in euthanasia. Aggression in dogs, for example, is a serious problem. It is the primary reason dogs are brought to clinics, taken to shelters, and often even euthanized. Treatment with psychoactive medications is a good alternative to putting down these animals. Dr. Nicholas Dodman from the Tufts University Animal Behavior Clinic explains, “Prozac, a selective-serotonin reuptake inhibitor (SSRI), prolongs the effects of that neurotransmitter to reduce impulsivity, stabilize moods and lower anxiety.”

Separation anxiety is also a troublesome problem for many dogs. At least 14% of all American dogs have separation anxiety, and it often results in destruction of the home, whining, frantic barking, inappropriate chewing, or sometimes even injury to itself. Dodman claims that although separation anxiety is believed to have genetic origins, the unnatural lives that people lead and subject their animals to trigger these problems. “A dog that lived on a farm and ran around chasing rabbits all day would be more prone to being stable than a dog living in an apartment in Manhattan.”

But is pharmacological treatment more for the health and well-being of the dog or for the convenience of owners? “A lot of ‘behavior problems’ are actually normal behaviors for the animal. Food guarding and aggression toward strangers boost a dog’s survival rate in the wild but don’t cut it in the living room.” Not everyone, however, believes that drugs are the solution to companion animal behavior problems. According to animal behaviorist Dr. Ian Dunbar, although pharmacologic aids may be helpful in some very extreme situations, most cases behavior modification alone is enough. “The rush to the medicine bottle for easily resolved problems . . . shows a disturbing parallel to the human approach to health care. We lead an unhealthy lifestyle and then rely on drugs to correct it.”

The use of psychiatric medicines in treating mood and behavior issues, however, is prompting new questions concerning what exactly separates mankind from animals. What does animal behavioral pharmacology teach us about not only animal minds, but also our own? Is it a coincidence that animal mental illnesses are mirroring those of humans? The causes of behavioral problems and mood disorders are similar for both pets and people—genetics and environment. “Whether cubicle- or cage-bound, we get too little exercise; we don’t hunt, run or play enough to produce naturally mood-elevating neurochemicals. . . . All of the behavioral issues that we have created in ourselves, we are now creating in our pets because they live in the same unhealthy environments that we do. That’s why there is a market for these drugs.”

Little Miss Sunshine Meet Little Miss Melanoma

by Leane Scoz

Awwww, summertime! Whether at the beach, the pool, the park, or backyard, you are bound to come in contact with Earth's big, round, yellow friend in the sky...the sun. But, the way the encounter is handled varies greatly from person to person.

Some people welcome the warm rays from the sun and choose to apply little or no sunscreen at all. Others are deathly afraid of the consequences of the powerful rays and head to the store for a floppy hat and SPF 60. Many others choose to have their cake and eat it too by applying a mid-range SPF in hopes of tanning instead of burning. However, new research should make everyone want to run toward the nearest shade.

According to a recent article in the Washington Post, government cancer statistics revealed the rate of new melanoma cases among younger women jumped 50 percent since 1980. The American Cancer Society reports about 62,000 melanoma cases are diagnosed each year in the United States, with more than 8,400 people dying from the disease. What has caused such a large increase?

National Cancer Institute researchers who led the analysis believe a number of risk factors have contributed to the rise in cases. Stronger rays from the sun are a direct result from the thinning ozone layer and increase in greenhouse gas emissions. People are spending a lot more time outdoors and are not protecting themselves against ultraviolet radiation. Young women are frequently engaging in indoor tanning (tanning bed) use in larger numbers. Researchers also noted that increased awareness, public education campaigns, and better diagnosis may have also played a role in the larger number of reported cases.

So, what's a pale-skinned gal to do? First, remember that ultraviolet radiation is dangerous and a carcinogen. Limit the amount of time spent in the sun. Always use sunscreen (SPF 15 or greater). Get your skin checked at least once a year. And, lastly feel good knowing that you will look much younger and wrinkle-free in your golden years than your sunbathing beauty counterparts who will have acquired leathery skin that matches their handbags and more wrinkles than a Shar-pei puppy.

Survey Results

Question #1: Is it OK to step on an ant?

3 answered yes
1 answered no
1 answered sometimes

Question #2: Is it OK to swat a fly?

3 answered yes
2 answered sometimes

Question #3: Is it OK to put down a dog?

1 answered yes
4 answered sometimes

Question #4: Is it OK to put down a human?

1 answered yes
1 answered no
3 answered sometimes

Question #5: Is it OK to abort the fetus before the third trimester?

1 answered yes
2 answered no
1 answered sometimes
1 answered undecided


This survey was anonymous, thanks for participating!

All Those Bugs at the Gym, Oh My!

By: Jenny Walters

A recent article on Cnn.com entitled Germ warfare moves to the gym by Linda Saether dealt with the ever increases germs that are present at gyms around the U.S.

According to Dr. Brian Adams, director of University of Cincinnati Sports Dermatology Clinic, “Gyms are great for fitness, but like fun in the sun, you just have to be careful.”[1]

The main microorganisms present at gyms include bacteria, fungi, and viruses. Germs are able to travel to and from many gym –goers’ due to the number of people who share equipment, exercise mats, lockers, and showers. In addition, the activities that gym-goers’ take part in also put them at risk.

Dr. Adams stated: “The first several layers of skin are like a castle wall protecting the athlete from outside marauders. Abrasions from mats and weigh equipment, blisters from constant rubbing while running or using weight equipment both help to break down the castle wall and allow microorganisms to enter the skin.”

Sweating is also another way that germs can enter the body at a gym. According to Dr. Adams: “Sweating super-hydrates the skin and makes the athletes more likely to develop blisters. Sweating by itself may alter the castle and allow penetration of the bugs.”

Bugs that can cause problems include fungi, which can cause athlete’s foot, to viruses that can cause herpes or potentially deadly infections known as MRSA, or methicillin-resistant staphylococcus aureus.

A first line of defense for the gym-goer is disinfectant. Before an individual uses any piece of equipment, he/she needs to wipe down the equipment with disinfectant wipes. The disinfectant wipes will kill any germs that were present on the gym equipment.

One gym-goer has her germ-fighting weapons all contained in her “ultrabreathable, pink, Nike backpack.” Her backpack contains a clean water bottle, plastic bags, workout gear, a clean towel, flip-flops for the shower, a fresh bag of wipes and “everyone’s weapon of choice, the don’t-leave-home-without-it pocket hand sanitizer.”

Due to news of MRSA spreading in gyms, germ fighting has been taken “up a notch.” Gyms today are offering hand sanitizers located throughout the gym and many other germ fighting products.

This article brings light to the age of being vigilant about germs. For me, a nurse a mother, I have the word vigilant about germs embedded into my brain. My husband thinks I go a little overboard, but I would rather be safe than worry about the germs my daughter has been exposed to throughout the day. However, as my pediatrician says, germs are everywhere and it’s good to be exposed to some now and than.

[1] Saether L. Germ warfare moves to the gym. July 2008. Available at: http://www.cnn.com/2008/HEALTH/07/10/hfh.fighting.germs/index.html. Accessed on July 18, 2008.

How to keep our children pain-free

By: Jenny Walters

A recent article on Cnn.com entitled How to keep your kids pain-free by Elizabeth Cohen, dealt with 5 ways that a parent can use to help alleviate a child’s pain.

Dr. Jodi Greenwald, a pediatrician in Roswell, Georgia, uses a “secret weapon” for pediatric pain relief, a pinwheel. Dr. Greenwald stated: “Tell them to blow the pinwheel to make it turn, and you’re accomplishing two things…It distracts the child while they’re getting a shot and it makes them take deep breaths, which helps them relax.”[1]

Following giving birth to her son, Jennifer Crain discovered an anti-pain weapon too; a pacifier dipped in sucrose water. Nurses used this during her son’s circumcision. Researchers believe that sucking on sugar water changes the neurochemicals in the brain of the neonate.

Pediatric pain experts report that “sadly, too many children aren’t getting any pain relief, even something as simple as a pinwheel or sugar water.” A recent study in the Journal of American Medical Association, found that “four out of five babies in the neonatal intensive are unit received no pain relief when they had to undergo painful procedures.”

A study in France also found that U.S. doctors do not give pain relief to babies and children as often as they should. According to Dr. Brenda McClain, director of pediatric pain management at Yale-New Haven Children’s Hospital in Connecticut: “We may not see children’s pain as that severe. But pediatric pain needs to be taken seriously. However, most of the time I don’t think we see it that way.”

Below are five techniques that a parent can use to help alleviate a child’s pain:

1. For babies, ask about a pacifier dipped in sucrose water: Doctors say this works wonders in babies. If your pediatrician does not have sucrose water, you can make your own by dipping a pacifier into a mixture of one teaspoon table sugar and four teaspoons water. You can give your baby the pacifier about 30 minutes before a shot or procedure.

2. Ask for a topical pain cream: Creams can help take the sting out of a needle stuck. However, many doctors don’t use the topical creams, because they complain they take too long to work and they have to “sit there and wait until the cream takes effect.” You can ask your doctor for a prescription and apply the cream before you arrive at the doctor’s office. The cream needs to be applied 30 minutes to two hours before the procedure or shot.

3. Distract your child: Talking to your child about anything, but what is going on. Parents make the mistake of saying things like “We’ll get ice cream when it’s over” or “I know it hurts.” Instead it is better to talk to your child about good memories. For example, “Remember the time we went to Disney and you got to meet Mickey Mouse.”

4. Ask about alternative treatments: Acupuncture, music therapy, and hypnosis have all been used to treat children’s pain.

5. Don’t be afraid of opiates: According to pediatric pain experts, opiates can help a child in sever pain, and the risks are small. “It is very rare for children to get more pain medicine than they need or to get addicted to pain medicine” according to pain management program at the Seattle Cancer Care Alliance.

Overall, if your child is not getting enough pain relief, you, as the parent, may have to step in.

This article was not only important to me as a parent, but also as a neonatal intensive care nurse. In the neonatal intensive care unit (NICU), we used a specific pain scales designed specifically for the neonates, and we used sugar water and various pain medications to help alleviate the neonate’s pain.

I have to disagree somewhat with the research findings of “four out of five babies in the neonatal intensive are unit received no pain relief when they had to undergo painful procedures.” Pain was one the biggest concerns in the NICU. We were adamant about preventing and managing the neonate’s pain. Although there are and will always be a hand full of nurses and doctors who do not make pain management their priority, the majority of nurses and doctors are very much so concerned with pain management for neonates and children alike.

[1] Cohen E. How to keep your kids pain-free. July 2008. Available at: http://us.cnn.com/2008/HEALTH/07/10/ep.child.pain/index.html. Accessed on July 18, 2008.

Could Coral Reefs Really Be In Danger?

By: Jenny Walters

A recent featured report on National Public Radio (NPR) entitled Study: Global Coral Crisis Is In Full Bloom, by John Nielsen dealt with the increasing loss of coral reefs around the world.

According to Nielsen, “coral reefs around the world are in bad shape these days.”[1] A recently published paper by Kent Carpenter, a reef expert at Virginia’s Old Dominion University, reported, “as much as a third of the world’s coral species may now be headed toward extinction, thanks to problems ranging from destructive fishing boats to ocean waters warmed by global climate change.”

Carpenter went on to state “problems faced by these important ecosystems may be worse than a lot of experts think they are…A third of the world’s coral species are now declining toward extinction, partly owing to increased outbreaks of coral diseases…This is a whole ecosystem that we could potentially be losing.”1

Carpenter’s paper was prepared with the aid of the coral researchers affiliated with the International Union for Conservation of Nature, a nonprofit conservation group whose scientific work is widely thought to be definitive.1 The coral researchers put together the “‘red list’ that concludes that a third of the world’s coral species may be declining toward extinction.” The researchers also found some evidence of “a link between coral-killing diseases and warming ocean waters.”

Carpenter warns if emission of global warming gases is not reduced soon; even bigger problems will emerge.1 Currently, ocean waters are more acidic as they soak up carbon dioxide, the main global warming gas. Although there is some evidence that coral reefs can adapt to warming waters, such as reefs in some parts of the far Pacific are now thriving in the warming waters, there is no proof they can cope with the more acidic oceans.

Carpenter concluded by saying, “Obviously the overarching problem that has to be solved is the [buildup of man-made] carbon dioxide in the atmosphere.”1

To help solve the problem, wounded reefs such as the Great Barrier Reef have been put off limits to commercial fishermen.1 According to Philip Munday, a reef expert at Australia’s James Cook University reported, following the restriction of commercial fishermen, a large number of big fish have filled the area over a few years. Munday went on to state: “That gives us enormous hope that these populations…can rebound in they’re given the chance to do so. However, these programs won’t protect coral reef problems causes buy global warming, but they might help buy the reefs a little extra time.”

This article shed light on the overwhelming effects that global warming has on our planet. Global warming affects every aspect of our planet. It is everyone’s responsibility to help fight the effects of global warming.

[1] Nielson J. Study: global coral crisis is in full bloom. July 2008. Available at: http://www.npr.org/templates/story/story.php?storyId=92432491. Accessed on July 13, 2008.

Cardiac CT Angiograms: Weighing the Costs and Risks

By Randy Hendrickson

Although multislice cardiac computed tomography (CT) angiograms are the newest technology for imaging the heart and arteries, this technology has never been proven to be superior than the older traditional (and less expensive) diagnostic methods. Patients, physicians, and advocacy groups are questioning the value of these scans and are now demanding proof of their efficacy. According to the New York Times, “[t]he problem is not that these newer treatments never work. It is that once they become available, they are often used indescriminately, in the absence of studies to determine which patients they will benefit.” Even the Centers for Medicare and Medicaid Services questioned the benefits of cardiac CT angiograms and requested more large-scale studies; however, heavy lobbying by the Society of Cardiovascular Computed Tomography caused them back down from this position.

Many cardiologists have been very receptive to this new tool. It “lets them see inside the heart with unprecedented clarity while also providing them with a new source of income. A faith in innovation, often driven by financial incentives, encourages American doctors and hospitals to adopt new technologies even without proof that they work better than older techniques.” Cardiac CT angiogram scanners are expensive, over $1 million. Once a scanner is purchased, it is in the hospital’s or practice’s best interest to use it as much as possible, even if that means using it on patients who may not really need it. Patients can expect to pay between $500 and $1500 per scan. These scans are being promoted heavily by the media and have been advertised on radio, television, and internet. Both Time magazine (“How New Heart Scanning Technology Can Save Your Life” Sept 2005) and Oprah have both endorsed the cardiac CT angiograms, even though there is little evidence that the scans are worth the cost and the risk. Unlike clinical trials to prove the safety and effectiveness of drugs, medical device manufacturers do not have to conduct studies to show patient benefits. They only have to demonstrate that the scanners are safe and provide accurate images.

Additionally, because this technology uses a series of x-rays to produce a composite image of the beating heart, it also exposes patients to large amounts (approximately 21 millisieverts) of radiation, equivalent to that produced by over 1,000 standard chest x-rays. With radiation exposure, the doses are cumulative and additive over time. Dr. David J. Brenner, from the Center for Radiological Research at Columbia University, explains that “each scan creates an additional lifetime risk of cancer that is somewhere between 1 in 200 and 1 in 5,000, and younger patients and women are at higher risk.”

At best, this is a new technology that hasn’t yet quite found its best application. “Even cardiologists who think the CT scans are overused say they may one day prove valuable. If manufacturers can produce scanners that can determine which plaques are stable and which are likely to rupture, the machines could revolutionize the treatment of heart disease.” In the meantime, CT angiograms continue to be used in greater and greater numbers, despite the unclear benefit and potential risks.

Denying Treatment

Denying Treatment

By Michael Leshinski

The NY Times reports on Jan. 17^th about a dying, teenage boy who is being denied treatment for a serious illness and a lawsuit with the company who manufactures the drug that he needs to survive. The disease is Duchenne muscular dystrophy and the afflicted is merely 16 years old. The National Institutes of Health describe Duchenne muscular dystrophy as a “rapidly-worsening form of muscular dystrophy” that usually affects males. The disease is inherited and relatively rare. According to the family, a bio-tech company called PTC Therapeutics initially made a commitment to treat his rare disease, but had recently denied ever making these statements.

The mother of the sick child had previously been an advocate for this same bio-tech company, but has presumably stopped since suit had been filed. Representatives from PTC Therapeutics have strongly stated that “We haven’t promised the drug to anyone.” Imagine that you had a horrific but curable disease, and the treatment was kept just out of your reach. How disheartening that must be. In regards to the drug treatment, the family’s major setback is the fact that the wheelchair bound teen no longer qualifies to be included in the drug’s clinical trial, because he does not have the use of his legs. You can’t get treatment for the disease, because you can’t walk and you can’t walk because you have the disease. What can a person do?

The next logical step is to apply for a compassionate use waiver, since the drug is experimental and the company would not be held responsible for any unfortunate consequences. The company, however, is reluctant to give the drug to anyone. Also, even if they did, is it fair to give the drug to just one person?

Staying Alive

Controversies over end-of-life care are sometimes as inevitable as death itself.

While Philip Nitschke and Jack Kevorkian have injected euthanasia into the public consciousness, a recent Canadian case has stirred the pot in the opposite direction—leading to the refusal of three doctors to continue to treat a dying man.

Samuel Golubchuk, an 84-year old Winnipeg man, died last month after being kept on life support for eight months at Grace Hospital. His family had lobbied doctors to keep him on life support since November, citing Orthodox Jewish law. A court ordered doctors to keep Golubchuk alive, and a trial would have commenced in September.

Golubchuk entered the hospital in October with pneumonia and pulmonary hypertension. Doctors wanted to take Golubchuk off life support because his condition deteriorated to the point that treatment—which included the cutting of infected flesh from his body—amounted to “torture,” according to one doctor. The case forced the closure of two intensive care beds and the transfer of nursing staff to help keep Golubchuk alive.

As one doctor asked, “how heroic should we be?” Is it right to divert resources from the treatment of others to keep alive a dying man? And is it ethical to inflict pain, with no hope of improvement, to fulfill a family’s wishes? The doctors treating Golubchuk didn’t think so, drawing an “ethical line in the sand” before withdrawing from the case.

In a perfect world, individual choice and medical opinion would always align for the best possible outcome. But as the Golubchuk case shows, the two can sometimes lead to ugly legal battles. And since the case never made it to the Canadian courts, the question at issue remains in the balance: Who has the right to determine when life support should be removed?

Golubchuk died without being removed from life support, and his family claimed victory following his death. But did anyone actually win?

Is it Ok to...?

By Michael Leshinski

After reading a few articles on the net concerning different subjects, and also Jenny's post below, I've decided to create a short quiz. Since myself and anyone else that I know do not have the answers, it is really more like a survey. Please check out the link below.

What do you think?


It only takes a few minutes and I will post the results in a week or so.

Medical Conferences Leave Large Carbon Footprint

By Randy Hendrickson


In the British Medical Journal (“Are International Medical Conferences an Outdated Luxury the Planet Can’t Afford?” June 28, 2008; 336:1466), Malcolm Green argues that because of the changes in climate and the dramatic increase in carbon dioxide and greenhouse gases in the atmosphere, it is our moral responsibility to reduce our carbon footprint as much as possible, for the sake of future generations. One of the ways to do this is to eliminate large medical conferences that involve long-distance travel for thousands of people. Large conferences at distant locations are no longer necessary or justifiable in terms of the carbon burden imposed by the air travel involved. Green estimates that the overall impact from travel to conferences would be at least 6 billion person miles a year or 600,000 tons of carbon.


These conferences could easily be replaced by virtual networks that could accommodate sessions, presentations, and posters. “Sessions could be set up to link as many network participants as is desirable, with a chair to catalyze and control the discussions.” By using these ways to communicate we would be saving energy, time, and carbon emissions. In addition, the costs of setting up virtual conferences would be much less than flying people around the world and paying for expensive hotels. This new way to exchange information will require a new mindset and ways of working, but most people are already familiar with the technology. In addition, “there would be no jet lag, no interminable waits at the airport, no lost luggage, no weekends away traveling.”

Parents Want Alternatives

by Leane Scoz

Autism is a developmental disorder defined by impairment in social interaction and communication, and the presence of repetitive or unusual behavior and interests. The Center for Disease Control and Prevention (CDC) reports that 1 in 150 children under the age of 8 have an autism spectrum disorder (ASD). With a cure yet to be found, parents of autistic children are seeking alternative treatments over the limited conventional treatments currently available.

Chelation is one alternative therapy gaining rapid popularity among the autistic population. The unproven treatment, which removes heavy metals from the body, is believed to help children with autism by removing levels of mercury from the body. According to a recent CBS News article, the theory behind the treatment stems from the believe that mercury in vaccines triggers autism.

Since this theory has never been scientifically proven and mercury (thimerosal) has been discontinued in childhood vaccines since 2001, scientists believe the proposed government study to test chelation treatment on autistic children is unethical and dangerous. Many parents of autistic children disagree and are even resorting to using chelation without results from a study to prove whether it is beneficial or not. In fact, CBS News reports the proposed study is on hold due to safety concerns after an animal study linked the treatment to lasting brain problems in rats.

The concerns are certainly not without merit since a 5-year-old autistic boy died after undergoing chelation therapy in 2005 and hundreds of lawsuits are currently underway because of the effects of chelation therapy. However, parents of autistic children are not deterred. An estimated 3,000 autistic children in the United States participate in chelation treatment at any given time. Some children are under the care of a physician during treatment and others under the care of their parents since chelation therapy can be done with a variety of over-the-counter dietary supplements.

Parents of autistic children simply want answers. They want their children to live a normal life, free of a developmental disorder. If regulated medicine can not provide them with the answers they are seeking, they have not choice but to resort to alternative treatments, such as chelation. But, at what cost? Is it really worth putting your child's health and well-being in danger in the hopes of possibly finding an answer? It is an ethical question autistic parents will struggle with until a cure for autism is discovered.

A Cure for MS: Caffeine

by Leane Scoz

Caffeine. The helper that gets people out of bed and out the door in the mornings. The best friend of college students pulling all-nighters. The co-worker that keeps the office staff awake throughout the day. The cure for multiple sclerosis (MS)?

According to a recent Web MD headline on CBS News, a new study involving mice found that large amounts of caffeine blocked key steps in the development of MS. A dose of caffeine, equivalent to six to eight cups of coffee a day, was effective in preventing the compound, adenosine, from getting into the brain and triggering the onset of the disease.

The study is the work of Oklahoma Medical Research Foundation scientist, Linda Thompson, PhD, and according to her, "the results were completely unexpected." The study's principal author, Margaret Bynoe, PhD, does not believe it is wise for people to start drinking more coffee due to these initial results. She acknowledges that caffeine has not been proven to be protective in humans yet and believes future studies may unveil other adenosine blockers that could be more useful. However, the results are still encouraging.

MS is a chronic, often disabling, autoimmune disease that attacks the central nervous system. Numerous physical and mental symptoms occur because of the disease and often progress to physical and cognitive disability. About 400,000 people in the United States have MS. These people are our family members, friends, neighbors, and co-workers. Since a cure does not currently exist for the disease, people suffering from MS rely on treatments, therapies, and research studies for hope.

It is crazy to think that a cure for MS could be in the kitchen pantries of most Americans right now. Hopefully, answers will be available in the near future since studies involving human subjects are in the planning process. Until then, let's all sit back and toast that great cup of java. Who knows...maybe Americans really do run on Dunkin!

Declaration of Istanbul: International Standards for Organ Transplantation Practices

By Randy Hendrickson

The Istanbul Summit, a meeting convened by the The Transplantation Society and the International Society of Nephrology held April 30 – May 1, 2008, created a set of international ethical principles for organ transplantation practices. Poor people who sell their organs are being exploited, by both richer people within their own countries as well as by transplant tourists from abroad. The Declaration of Istanbul focused on prohibiting exploitive practices such as organ trafficking, transplant tourism, and transplant commercialism and “aims to halt these unethical activities and to foster safe and accountable practices that meet the needs of transplant recipients while protecting donors.”

A summary of the Declaration, written by the Steering Committee of the Istanbul Summit appears in The Lancet (“Organ Trafficking and Transplantation Tourism and Commercialism: The Declaration of Istanbul” --July 5, 2008; 372(9632):5-6) and describes how the policies advocated by the Declaration will help to combat unethical transplant practices on an international level. Provisions of the Declaration include:

• Defining what is meant by organ trafficking, transplant commercialism, and transplant tourism;
  


• Universal approaches for provision of care to living donors and standards that support donation from dead donors;
  


• Reinforcing the efforts of governments of countries where these practices occur to take action in adopting and enforcing stiff laws to end these wrongful practices.

According to the Steering Committee of the Istanbul Summit,

“The legacy of transplantation is threatened by organ trafficking and transplant tourism. The Declaration of Istanbul on Organ Trafficking and Transplant Tourism aims to combat these activities and to preserve the nobility of organ donation. The success of transplantation as a life-saving treatment does not require—nor justify—victimizing the world’s poor people as the source of organs for the rich.”

Should Gender Be a Consideration in Transplant Organ Allocation?

By Randy Hendrickson

A Swiss study reported in The Lancet (July 5, 2008) evaluated the kidney transplant outcomes according to the gender of both donors and recipients. Under the direction of Gratwohl and colleagues, the study concluded that gender plays an important role in the success rate of kidney transplantation. Using data collected from the Collaborative Transplant Study database, a 195,000 deceased donor transplant registry, their study showed that the success rate was poorest for female organ recipients receiving a kidney from male donors, both in the short term (1 year) as well as the long term (2 to 10 years). The male donor–female recipient pairs that were studied had “poorer functional outcome, and progressive chronic interstitial damage and tubular microcalcifications, than same-sex donors and recipients.”

According to Gratwohl,

"Our multi-variable analysis showed that transplantation of kidneys from male donor into female recipients caused an increased rate of graft failure, which suggests an immunological H-Y effect in renal transplantation during the first year after transplantation that extends to 10 years of follow-up ... Consideration of sex should be integrated into future prospective analyses and decisions on organ allocation.”

In addition, they found that being a female donor, regardless of the gender of the recipient, was associated with reduced outcomes. Similarly, corneal transplants between same-sex individuals had an 88% 2-year survival rate compared with only 77% for different sex transplants.

So does the weight of the evidence make sex a legitimate factor in deciding who gets what for organ transplants?

Are Apes People Too?

By Jenny Walters

A recent article entitled Animal-Rights Farm: Apes rights and the myth of animal equality by William Saletan discussed a “resolution headed for passage in the Spanish parliament” that will be supporting the Great Ape Project.[1]

The Great Ape Project (GAP) is an organization whose founding declaration states apes “may not be killed” or “arbitrarily deprived of their liberty.” The Spanish proposal will treat great apes “like humans of limited capacity, such as children or those who are mentally incompetent and are afforded guardians or caretakers to represent their interests.” The passage of this proposal would, “commit the (Spanish) government to ending involuntary use of apes in circuses, TV ads, and dangerous experiments.1

Peter Singer, the co-founder of GAP, states: “There is no sound moral reason why possession of basic rights should be limited to members of a particular species.” Saletan went on to state: “To borrow Martin Luther King’s rule, you should be judged by what’s inside you, not what’s on the surface.”1

Opponents of the GAP view this proposal as “egalitarian extremism.” Spanish newspapers and citizens complain that ape rights are “distracting lawmakers from human problems.”

According to one anti-animal rights reporter: “Animal rights activist believe a rat, is a pig, is a dog, is a boy.”1 In contrast, GAP believes “great apes experience an emotional and intellectual conscience similar to that of human children.” GAP demands humans, chimps, bonobos, gorillas, and orangutans are “members of the community of equals.” Singer adds: “GAP may pave the way for the extension of rights to all primates, or all mammals, or all animals.”1

The mission statement for GAP states, “great apes are entitled to rights based on their ‘morally significant characteristics.’”1 The mission reads as follows:

The idea is founded upon undeniable scientific proof that non-human great apes share more than genetically similar DNA with their human counterparts. They enjoy a rich emotional and cultural existence in which they experience emotions such as fear, anxiety and happiness. They share the intellectual capacity to create and use tools, learn and teach other languages. They remember their past and plan for their future. It is in recognition of these and other morally significant qualities that the Great Ape Project was founded.[2]

Saletan believes the GAP mission statement appeals to discrimination, not to universal equality; as most animals can’t make tool and don’t teach languages. He went on to compare the GAP mission to a “Moral Majority for vegans.”1

In a final note in the article, Saletan used a quote from George Orwell’s Animal Farm: “All animal are equal. But some animals are more equal than others.”1

This article was interesting in pointing out both sides of the argument for great ape rights. The article reports: “We are closer genetically to a chimp than a mouse is to rat.”1 The article also describes how some animal rights activists believe “a rat, is a pig, is a dog, is a boy.” Personally, I am not sold on this of being the same as a rat. However, I do feel there should be basic rights set on place for all animals and I do support the GAP proposal.

As a pet owner, I can tell each of my dogs have their own unique personalities. To me, they are just furry humans.

[1] Saletan W. Animal-rights farm: ape rights and the myth of animal equality. July 2008. Available at: http://www.slate.com/id/2194568/. Accessed on July 3, 2008.
[2] The Great Ape Project. Mission statement. Available at: http://www.greatapeproject.org/index.php. Accessed on July 4, 2008.

Right to Die

Right to Die

By Michael Leshinski

Much as been said on the topic of assisted suicides, euthanasia and the right to die, especially during the Kevorkian era of the late 1990s. Since Kevorkian’s prison sentence and recent parole, the subject has been placed on the backburner. Although it has never really left, the hot topic has resurfaced this time in Germany. Doctor-assisted suicides are not legal in the United States, with the exception being the state of Oregon. However, no German law currently exists against the aiding of suicide. On the other hand, mercy killing and euthanasia are not legal in Germany. Some would say, what's the difference? Well, The New York Times reported yesterday that German Chancellor Merkel is pushing for new laws against the advertising of assisted suicide after a German right to die proponent has publicly boasted of success. Apparently, Roger Kusch, wants to be the German Jack Kevorkian. However, there are many more factors working in Kusch’s favor, including the fact that he is an attorney who knows how to stay within legal limits of assisting suicide.

Kusch made national news in Germany by assisting in the suicide of a 79 year old lady, who did not wish to live anymore. According to the Times, the elderly woman was in relatively good condition for a person of her age. Instead, she opted for suicide because she was afraid to move into a nursing home and was tired of living a life of solitude. What a choice, death or nursing home?! If Germans really want to die, all they have to do is cross the border into Switzerland, where there are (tolerant) basically no laws on the books against it. In typical Swiss neutrality, the government allows institutes to perform the “service”. This story is bound to stir up some controversy throughout the world and America since it is a seemingly irresolvable debate just like abortion and gay marriage.

Fungi Makes for Fun Guys

by Leane Scoz

Psilocybin mushrooms, a.k.a. shrooms, magic mushrooms, boomers, can be traced back a million years, originating in East Africa. The fungi have been widely eaten by Europeans and Native Americans in Central and South America since the late 18th century. Psychedelic mushrooms eventually made their way to the United States and became a popular recreational drug during the 1960s with the advent of the hippie era.

The use of psychedelic mushrooms is subjective and unpredictable. The hallucinogenic experience can produce effects that are physical, sensory, emotional, and psychological. Although their consumption is illegal in most countries, including the United States, shrooms have been the subject of several psychedelic research projects in recent years.

A 2006 press release from Johns Hopkins University outlined a rigorous scientific study involving 36 college educated men and women and showed how the mushrooms produced mystical/spiritual experiences for research subjects. According to the National Institute on Drug Abuse (NIDA), the research marked a new systematic approach to studying certain hallucinogenic compounds and showed signs of therapeutic potential and value in research into the nature of consciousness and sensory perception.

A recent Associated Press article summarized a report published on July 1, 2008 in the Journal of Pharmacology that provided follow-up to the initial study. The report showed that more than 60 percent of the research subjects reported substantial increases in life satisfaction since the psilocybin experiment. The volunteers reported feeling more creative, self-confident, flexible, and optimistic. They also indicated that they felt more sensitive, tolerant, loving and compassionate since their hallucinogenic research experience.

According to a Newsweek article related to the same research project, the study of hallucinogenic compounds is and has always been controversial despite their potential to reveal secrets of the conscious mind. This is largely due to the federal government's decision to make hallucinogenic drugs, such as psilocybin and LSD, illegal in the 1960s after heavy persuasion by the media. Psychedelic research is not easily funded or sponsored and, until these recent published findings, this type of research has been difficult to legitimize.

Why do scientists continue to pursue this avenue of research? Because of the findings in research projects such as the Johns Hopkins experiment, psilocybin has shown promise in treating conditions including Obsessive Compulsive Spectrum Disorders (OCSD), anxiety in terminally ill cancer patients, and Post-Traumatic Stress Disorder (PTSD).