Friday, December 7, 2007

Soaring STI rates in teens

It makes me wonder whether this has anything to do with those abstinence campaigns. You know, don't teach the kids about pregnancy and STD prevention, just tell them not to have sex until they're married.

http://www.webmd.com/sexual-conditions/news/20071113/chlamydia-std-rates-soar-in-us?src=rss_psychtoday

Monday, December 3, 2007

WIRED MAGAZINE: ISSUE 15.12

Inside India's Underground Trade in Human Remains

By Scott Carney Email 11.27.07 | 12:00 AM

A constable in a sweat-stained undershirt and checkered blue sarong lays a ragged cloth over a patch of mud. He jerks open the back door of a decrepit Indian-made Tata Sumo SUV — what passes for an evidence locker at this rustic police outpost in the Indian state of West Bengal. A hundred human skulls tumble out onto the cloth, making a hollow clatter as they fall to the ground. They've lost most of their teeth bouncing around the back of the truck. Bits of bone and enamel scatter like snowflakes around the growing pile.

Standing next to the truck, the ranking officer smiles and lets out a satisfied grunt. "Now you can see how big the bone business is here," he says. I crouch down and pick up a skull. It's lighter than I expected. I hold it up to my nose. It smells like fried chicken.

Before the authorities intercepted it, this cache was moving along a well-established pipeline for human skeletal remains. For 150 years, India's bone trade has followed a route from remote Indian villages to the world's most distinguished medical schools.

Skeletons aren't easy to get. In the US, for instance, most corpses receive a prompt burial, and bodies donated to science usually end up on the dissection table, their bones sawed to pieces and destined for cremation. So most skeletons used for medical study come from overseas. Often they arrive without the informed consent of their former owners and in violation of the laws of their country of origin.


India has long been the world's primary source of bones used in medical study, renowned for producing specimens scrubbed to a pristine white patina and fitted with high-quality connecting hardware. In 1985, however, the Indian government outlawed the export of human remains, and the global supply of skeletons collapsed. Western countries turned to China and Eastern Europe, but those regions produce relatively few skeletons. They have little experience producing display-quality specimens, and their products are regarded as inferior.

Now, 22 years after India's export ban, there are signs that the trade never ended. Black-market vendors in West Bengal continue to supply human skeletons and skulls using the time-honored method: Rob graves, separate soft flesh from unyielding calcium, and deliver the bones to distributors — who assemble them and ship them to dealers around the globe.

Exports to North America are still small compared with pre-ban levels, but shipments are finding their way to American medical programs. Suppliers have ample incentive — it's a lucrative business. The skulls on the ground before me, for instance, would fetch an estimated $70,000 overseas.

The constable grabs the cloth by its corners and gathers the evidence into a bundle. "You know, I've never seen anything like this," he says. "I hope I don't again."

A massive low-pressure system over the Bay of Bengal is threatening to flood the state of West Bengal. Newspapers have already dubbed the storm a "watery apocalypse" after eight people drowned in floods before it even touched land. I'm driving to the tiny village of Purbasthali — about 80 miles outside of Kolkata, the state capital — the site of the processing plant where the police discovered their load of skulls. My rented Toyota Qualis gets stuck in the mud half a mile from the facility, so I jump out to make my way on foot. The sky is pitch-black, the rain suffocating. Toads the size of boxing gloves hop across the muddy track.

When police arrived to investigate last spring, they could smell the stench of rotting flesh from nearly a mile away. Sections of spine strung together with twine dangled from the rafters, an officer told me. Hundreds of bones were scattered on the floor in some sort of ordering system.

This bone factory had been operating for more than 100 years when two of its workers, drinking at a bar, bragged that they were hired to dig bodies out of graves. Shocked villagers dragged them to a police station, where they confessed. The workers said a man named Mukti Biswas ran the factory. The authorities knew him well. In 2006, police had arrested Biswas as the kingpin of a grave-robbing ring; he was released a day later, news reports said, "because of his political links." The police took him into custody once again, but he was let out on bail and has since taken flight.

After 10 minutes of slogging through the mud, I make out the flicker of a gas lamp. I peek into the doorway of a wood-frame house. A family of four sitting on the dirt floor stares back at me.

"Do you know Mukti Biswas?" I ask.

"The bastard still owes me money," replies Manoj Pal, a twentysomething man with a thin mustache. His family has been working at the bone factory for generations, he says. He offers to show me around, and we head out along the bank of the Bhagirathi River.

The processing plant is little more than a bamboo hut with a tarpaulin roof — one of a dozen bone factories Pal says he knows about. In April, the authorities confiscated piles of bones, buckets of hydrochloric acid, and two barrels full of a caustic chemical they have yet to identify. All that's left is a dirt floor with a large concrete vat sunk into the ground.

A third-generation bone trader, Biswas had no problem finding dead bodies. As caretaker of the village's cremation ground, he claimed to have a license to dispose of the dead. But police told reporters he was robbing graves. Biswas pilfered corpses from cemeteries, morgues, and funeral pyres; he would drag the deceased from the flames as soon as the families left. He employed almost a dozen people to shepherd the bones through the various stages of de-fleshing and curing. For this work, Pal says he earned $1.25 a day. He also received a bonus for keeping the bones from a given body together so they represented a biological individual rather than a mishmash of parts — a feature prized by doctors.

Pal explains the factory's production process. First the corpses were wrapped in netting and anchored in the river, where bacteria and fish reduced a body to a loose pile of bones and mush in a week or so. The crew then scrubbed the bones and boiled them in a cauldron of water and caustic soda to dissolve any remaining flesh. That left the calcium surfaces with a yellow tint. To bring them up to medical white, bones were then left in sunlight for a week before being soaked in hydrochloric acid.

Biswas sold complete skeletons wholesale for $45 to a medical supply company called Young Brothers, which wired the pieces together, painted on medical diagrams, and sawed away sections of the skulls to reveal internal structures. Then Young Brothers sold the bones to dealers around the world.

Shining my flashlight on the floor, I pick up a wet rag. The translator lets out a low hiss. "I hope you know that's a death shroud," he says. I drop the cloth and wipe my hand on my shirt.

Top: A police officer in Burdwan, West Bengal, displays a cache of skulls confiscated from a bone factory run by Mukti Biswas on the outskirts of Kolkata. Middle: The gated entrance to Young Brothers in Kolkata. The company sells human remains at wholesale prices. Bottom: A bag of femurs recovered by West Bengal police.
Photos: Scott Carney

The empirical study of human anatomy took off with Leonardo da Vinci's sketches in the 15th century; the earliest extant articulated skeleton dates from 1543. As medicine advanced, physicians were expected to have a systematic understanding of the human body's inner workings. By the beginning of the 19th century, Europe's demand for human remains far outstripped supply.

In England, home of many of the world's preeminent medical institutions, grave robbing became so commonplace that certain cemeteries were famous for battles between grieving families and marauding medical students. To contain the problem, the government passed the Anatomy Act of 1832, allowing doctors to take any corpse that was left unclaimed in a city morgue or hospital. The law put an end to grave robbery, but the supply of legal skeletons still couldn't keep up with demand. So British doctors looked to the colonies. In India, members of the dom caste, who traditionally performed cremations, were pressed into service processing bones. In the 1850s, Calcutta Medical College processed 900 skeletons a year, mostly for shipment abroad. A century later, a newly independent India dominated the world market for human bones.

In 1985, the Chicago Tribune reported that India had exported about 60,000 skulls and skeletons the year before. The supply was sufficient for every medical student in the developed world to buy a bone box along with their textbooks. Price: $300.

If most of the merchandise was stolen, at least exporting it was legal. "For years, we ran everything aboveboard," Bimalendu Bhattacharjee, a former president of the Indian Association of Exporters of Anatomical Specimens, told the Los Angeles Times in 1991. "No one advertised, but everyone knew it was going on." At their height, Kolkata's bone factories took in an estimated $1 million a year.

But it couldn't last. The graveyards of West Bengal were being picked clean, and the lure of ready money soon attracted criminal elements. The industry shuddered to a halt in March 1985, when a bone trader was arrested after exporting 1,500 child skeletons. Because they're relatively rare and illustrate transitional stages in osteological development, child skeletons command higher prices. Indian newspapers claimed that children were being kidnapped and killed for their bones.

Panic spread with news of the arrest. In the months after the indictment, vigilantes combed the cities searching for members of the alleged kidnappers' network. In September, an Australian tourist was killed and a Japanese tourist was beaten by a mob after rumors spread that they were involved in the conspiracy. The attacks might have been enough to stall India's bone industry, but the government had already taken action: A few weeks earlier, India's Supreme Court interpreted the national Import/Export Control Act to prohibit the export of human tissue.

In the absence of competing suppliers in other countries, the court's decision effectively shut down international trade in human skeletons. Medical schools in the US and Europe begged the Indian government to reverse the export ban, to no avail.

Since then, natural human bone has been difficult to come by. The voracious demand for fresh cadavers in medical education consumes nearly all donated corpses in the US, and in any case, processing skeletons is a slow, messy business that few people care to take on. When high-quality specimens do become available, they tend to be costly. A complete skeleton in good condition now retails for several thousand dollars, and orders can take months, even years, to fulfill. Students no longer buy their own bone boxes; instead, schools usually keep an inventory that's replaced only when specimens are damaged or stolen. Stanford Medical School allocates half a skeleton, cleaved down the middle, for every two students. Such policies mean that many established institutions already have all the bones they need. The biggest buyers of skeletons are new and growing schools throughout the world that need to outfit their labs.

Some institutions have turned to plastic replicas. But artificial substitutes aren't ideal. "Plastic models are reproductions of a single specimen and don't include the range of variations found in real osteology," says Samuel Kennedy, who stocks the anatomy program at Harvard Medical School. Students trained on facsimiles never see these differences among individuals. Moreover, the models aren't entirely accurate. "The molding process doesn't capture the detail of a real specimen," Kennedy adds."This is especially critical in the skull."

In the US, major dealers like Kilgore International are making do selling replicas. "My father would have done almost anything to get back into the bone business," says Craig Kilgore, who runs the company his father founded. "He was legally blind but would still come to the office and write letters to anyone, anywhere in the world, that he felt could be of help to reopen the supply."

His father, who died in 1995, didn't live to see the turnaround.

Tucked away on a side street between one of Kolkata's largest graveyards and one of its busiest hospitals, Young Brothers' headquarters looks more like an abandoned warehouse than a leading distributor of human skeletons. The rusted front gate appears to have been padlocked and forgotten a decade ago. Above the entrance, the company sign is a tableau of peeling paint.

It wasn't always this way. The building was bustling with activity in 2001, according to former Kolkata Health Department chief Javed Ahmed Khan. At the time, neighbors complained that the Young Brothers offices stank of death. Huge piles of bones lay drying on the roof. When the police refused to file a case, Khan raided the building with a posse of bamboo-wielding heavies.

"There were two rooms full of human skeletons," Khan recalls. It took five trucks to haul them away. He also seized thousands of documents, including invoices to companies all around the world. "They were sending shipments to Thailand, Brazil, Europe, and the United States," he says.

Sixteen years after the export ban, it was as if the law had never taken effect. "We used to fill orders all over the world," says a clerk employed by Young Brothers between 1999 and 2001, who requested anonymity. "We used to buy bones from Mukti Biswas. I saw more than 5,000 dead bodies." There were other suppliers, too, and factories up and down the length of West Bengal. The company took in roughly $15,000 a month.

Khan's raid prompted the police to arrest Young Brothers' owner, Vinesh Aron. He spent two nights in jail before being released.

Today, there are no bones on the roof. I've been poking around the area for an hour or so, interviewing neighbors, when a white van pulls up to the building. A man dressed in a pink-checkered shirt steps out. He walks briskly to a side door and knocks: Vinesh Aron.

Aron sees me snapping photos and knocks more forcefully, but the assistant inside is having trouble with the lock. As I try to formulate a question, my translator shoves a microphone in his face and asks whether he's still shipping skeletons to the West. Looking flustered, Aron blurts, "We won that case!" The entrance cracks open and he slips in before the door slams in my face.

In a subsequent phone conversation, Aron says he now sells medical models and charts, but no bones. However, a vendor of surgical instrument supplies who claims to be his brother-in-law says Young Brothers is the only bone distributor in the country. "My brother-in-law is the only man who still does this in India. He is the only one with guts," he says. Then he offers to dig up a skeleton for me for 1,000 rupees ($25).

The most recent Young Brothers catalog (2006-2007) takes care to inform customers that it abides by the law. It lists a wide assortment of bones at wholesale prices, noting that they're "for sale in India only." Indian skeletons are somehow making it out of the country anyway.

In Canada, Osta International sells human bones throughout the US and Europe. The 40-year-old company offers to fill orders immediately. "About half of our business is in the States," says Christian Ruediger, who runs the business with his father, Hans.

Ruediger admits that Osta stocks bones from India, presumably smuggled out of the country in violation of the export law. Until a few years ago, he got them from a distributor in Paris, but that source dried up in 2001 — around the time Javed Khan raided Young Brothers. Since then, he has bought his stock from a middleman in Singapore. He declines to provide the name. "We want to keep a low profile," he says.

Of some 30 institutions I contacted in the course of researching this article, the handful that admitted to buying bones in the past few years declined to reveal their sources or speak on record. Osta's name came up twice. "I bought a complete skeleton and a dissected human demonstration skull from Osta," a professor at a prestigious Virginia college says. "Both were excellent."

Another Osta customer is a firm called Dentsply Rinn, which offers a plastic model head containing a real skull, used in training dentists. "It's very difficult to procure human bones," marketing manager Kimberly Brown says. "Our requirements stipulate that the skulls must be of a certain size and grade and without certain anatomical defects. But we have no requirement for their origin."

Indian authorities express a similar lack of concern. Although the international bone trade violates the national export law and local statutes against grave desecration, officials look the other way."This is not a new thing," says Rajeev Kumar, West Bengal's deputy inspector general of police. "There's no evidence that they were killing people." The police took an interest in Biswas only because the bodies of a few important people went missing. "We are trying to implement the law based on the stress society places on it," he adds. "Society does not see this as a very serious thing."

The need to study human bones in medicine is well established. The need to obtain the informed consent of people whose bones are studied is not. The reemergence of India's bone trade reflects the tension between these requirements. Someday doctors may develop a supply chain based on voluntary donation. Meanwhile, the bone factories of Kolkata are open for business.


Friday, November 30, 2007

Circumcision Breakthrough in HIV Transmission

Earlier this year, the Lancet reported that circumsized males carry a lower risk of contracting HIV through sexual intercourse. In the African continent, where most men are uncircumsized, and any scientific evidence that points toward curbing the outbreak of AIDS is helpful, this scientific breakthrough is most welcome.
In Zambia, radio correspondent Kennedy Gondwe made a public announcement that he was undergoing the circumcision procedure on the air, and received mixed responses. Gondwe stressed the relative ease of the procedure and noted he was up and driving back home in no time. Some listeners responded that Gondwe's testimonial angered them, while others felt confident they could now undergo this somewhat-taboo procedure. Gondwe also makes it known that he gets tested for HIV several times a year. It is great to read about someone using their access to the public to help educate others on this important issue.
I applaud Gondwe for his actions and for his attempt to scale back the fears and questions about circumcision. I just hope that when African men begin to line up at the doctor for this procedure, that the sex safe practices are preached and reiterated again. Several health agencies in the UN advocate circumcision in light of the the Lancet report, but also "the procedure offers only partial protection and that abstinence, condom use, having few partners and delaying the first sexual experience are all among the steps that need to be encouraged."
I do hope that the main tenets of safe sex are stressed in Africa, where the struggle with the Aids is all too well known. I hope that the news of circumcision curbing transmission of HIV does not present a sort of "get out of jail free" card for African men.

Thursday, November 29, 2007

So, Which Side Was That Again, Eh...? The Horror of Wrong-Sided Surgery

You’re having surgery. All the authorizations have been given—all the forms signed…and preparations made.

You trust your surgeon’s credentials, education and expertise in providing you with the care you need. You have every confidence in the nursing staff.

Yet, you can’t arrive at the hospital before stopping at an art store to pick up…permanent markers—just as a precaution. “X” marks the spot, right?

You want to make sure there’s no question WHICH side of your body the surgery is to be performed on.

Sound wacky? Not when you consider that tales of doctors operating on the wrong side of a patient’s body—or removing the wrong organ or limb—happen with frightening frequency in hospitals across the country. The most recent case, involving an 82-year old Rhode Island patient, resulted in a $50,000 fine being levied against the hospital.

While the overall percentages are low, so-called “wrong-site surgery” occurs more often than is being reported, and has prompted a review of procedures and implementation of guidelines for hospitals to follow to prevent occurrences. Review the article and relate your own opinion on what can or should be done.

http://tinyurl.com/3bxcbx

Monday, November 19, 2007

Toss the kids in jail and throw away the key

LA Times, Monday, November 19, 2007 – Henry Weinstein

U.S. leads in child life sentences, study says

California has sentenced more juveniles to life in prison without possibility of parole than any state in the nation except Pennsylvania, according to a new study by the University of San Francisco’s Center for Law and Global Justice.”

The article goes on to say that the US leads all other nations in children under 18 serving life sentences and that “51% of juveniles sentenced to life without parole were first-time offenders” and that black juveniles were 10 times more likely than white to be given life without parole.

What makes the nation with one of the highest standards of living most likely to incarcerate its children? Is it because our children are worse, more evil than the children in the rest of the world? Is it because we as a nation no longer know how to raise children with moral values intact? Or is it because our legal system is punitive and dysfunctional? What should we do to help the next generation? Continue to try to throw all the ‘bad ones’ in jail? Is there any evidence that this method working?

Sunday, November 18, 2007

Dr. Venter and the MycoLaboratorium

Dr. Craig Venter cracked the human genome in the year 2000 using the genetic information of 5 individuals to sequence the human genome. More recently, Dr. Venter has patented the "mycoplasma laboratorium," a potential, partially synthetic living self-replicating organism, with an artificial genome derived from the genetic code of the mycoplasma genitalium and manipulated for functionality. Although, the artificial microbe has yet to successfully implant, Venter insists the future of this organism will result in revolutionary commercial advances. Development of the mycoplasma laboratorium hold evidence for numerous methods of use, such as green fuels to replace oil and coal, digest toxic waste, and absorb greenhouse gases in the atmosphere. Designer microbes tailored to deal with pollution and excess carbon dioxide will also help meet the demands of future fuel needs.


 

Today, people can have their DNA analyzed for the potential of harmful genetic predisposition to life-threatening diseases thanks to Dr. Venter's work and the technology which supports it. In the future, the advances of the mycoplasma laboratorium may provide the technology necessary to relieve the world of its dependence on environmental pollutants as resources of energy.


 

Craig Venter: Creating life in a lab using DNA. Telegraph. UK. Available at: http://www.telegraph.co.uk/earth/main.jhtml?xml=/earth/2007/10/16/scilife116.xml&page=3. Accessed November 19, 2007.


 


 


 

Ethics in transplant

http://www6.comcast.net/news/articles/health/2007/11/13/AIDS.Transplants/

Recently, a woman contracted HIV and Hepatitis C because she received a kidney transplant from an HIV/Hepatitic C positive donor.

I don't know the I understand the process of organ donation enough to assume that the donor (who is dead, obviously) was screened for some devastating diseases before approving him or her as a donor. However, both the donor network organization adn the hospital where she received her organ knew that this donor was at a high-risk for these diseases and did not inform the organ recipient. Three other recipeints of this particular donor's organs also contracted both diseases through their new organs. There are several unethical issues in this case.

I beleive from what I understand is the reasoning for believing this man was high risk (he was a sexually active homosexual) is unethical. Though I do not have the specific research available, I believe that HIV is transmitted through heterosexual sex than through homosexual sex today. In addition, HIV can be transmitted through many other various ways. When I had my first open heart surgery in 1986, they were just beginning to screen blood donations for HIV. I was lucky enough to have 11 family members partake in direct donation, where their blood was set aside for me only. Therefore, I know that I did not receive containimated blood. However, anyone who received a blood transfusion around that time could have easily contracted HIV no matter their homosexuality or gender. As a nurse, my mother walked out of work through the ER one day and stepped directly on a used needle. It went through her shoe and into her foot. Thankfully, her repeated blood tests have shown she did not contract anything through this unfortunate accident, but it could have easily happened. Legally, we should not be judging anyone based on their sexuality, but contracting HIV has not been a "gay men" disease for some time (although in this case it was correct).

Second, if a donor is suspected to have infectious diseases, why in the world are they even considered to be a donor? WHY? How is that ethical? The recipient needs a new organ because they are fighting for his or her life. How is giving that person, especially an individual can be maintained on other life saving measures as is in this case, a diseased organ fixing the problem? In fact, it just creates other problems.

Transplant patients have to say of immunosuppresants for a great of time, if not their entire lives, in order to minimize the risk of organ rejection. Therefore, the person has a weakened, compromised immune system. Therefore, she is less capable of fighting and living with the viruses she contracted through her new, "healthy" organ.

What is perhaps the worst breech of ethics in this case is that the organ donation organization and the transplanting hospital knew of the risk and no one told the patient. They made a life changing decision for this patient that was not theirs to make. In fact, her history suggests that had she have known about the risk of these diseases, she would have declined the organ. Those who took this decision out of the recipients hands essentially killed her. Their decision led to her being infected with HIV, and although we have come a long way in helping HIV patients to lead much longer, healtheir lives than in the 1980s, it is still a death sentence.

Friday, November 16, 2007

Insurance in a Big Box

After several years of avoiding Walmart due to my disgust at its deplorable working conditions and treatment of its employees, well...I'm not going back there, but perhaps I'll stop trashing this mega-chain as much as I do. Finally folding (somewhat) to the pressure, Walmart is "Rolling Back" its stingy health insurance plans to provide somewhat more reasonable coverage for its 1.4 million employees.

For years, Walmart offered health insurance to its employees that cost too much for people who earn in the ballpark of $20,000/year. Bending under the pressure, Walmart has offered several different plans, with ranging deductibles, lessened the amount of time part time employees can be eligible, and lowered the cost of prescriptions to $4 for a monthly prescription.

While I won't be supporting Walmart anytime soon, or ever, I do feel this is the step in the right directions for one of our nation's top employers. Human resources are a company's number one asset--why not protect them?

Sidebar: TI grew up in a very small town which thrived as a mining and industrial town many decades ago. Obviously, those industries are long gone, as well as the thousands of jobs that accompanied them. About 15 years ago, Walmart rolled into town and thousands people from the surrounding areas lined up for jobs. This is common for the areas Walmart thrives in. I've just always been bothered by the company's lack of respect for employees, and that they take for granted the people who think themselves very fortunate to work there. Oh, and my parents are both union members and my father-in-law in a Regional Rep in the UAW.

Follow Up on Earlier Post

A few weeks ago, I posted about the common trend in parents waiving vaccinations (recommended by the CDC) for their children. Following up on that, I read an article in the New York Times regarding the dramatic decrease in deaths due to these diseases and thought I'd share. Good info for anyone on the fence about vaccinating their children.

Tuesday, November 13, 2007

Army Soldiers Subjected to Experimental Trauma Care Without Informed Consent

An article published in the New York Times on November 6th discussed some ethical issues pertaining to the leadership and conduction of clinical studies of one of the top military trauma surgeons. Col. John Holcomb is the head of the Army’s Institute of Surgical Research based on the campus of the Brook Army medical Center in San Antonio. He is a strong advocate of clinical trials to improve trauma care; however, research in trauma medicine can be an ethical challenge because it involves novel treatments on severely injured patients who cannot give informed consent. Holcombe’s argument in support of conducting these clinical trials is that any ethical concerns “pale in comparison to the toll that traumatic injuries take on civilians and soldiers every day.”

One of the ethical issues is regarding the use of Factor VII, which promotes clotting in severe cases of bleeding. Some physicians feel that there is a lack of data on the benefits of Factor VII use (including some evidence that it can increase risk of blood clots), however Army surgeons have aggressively treated trauma patients with it under Holcombe’s direction. A clinical trial showed that Factor VII reduced the need for transfusions in patients and showed a nonsignificant trend toward reducing mortality (N=300). A larger trial to confirm outcomes is currently underway. Defending the use of Factor VII, Holcombe was quoted as stating, “You have a drug that you know is safe from the prospective randomized controlled clinical trials, and you have to make a decision. It’s not something you can decide to talk about. It’s really yes or no. You have a lot of people bleeding to death in Iraq.”

Holcome has also been criticized for advocating and participating in an ongoing clinical study of Polyheme, an experimental blood substitute that failed in a previous clinical study. The completed study, which ran from 2003 through last year, included patients with severe traumatic injuries who could not give informed consent. 54% of patients receiving Polyheme in the study experienced severe adverse events. It is interesting to note, however, that the FDA approved the currently ongoing trial even after review of the unpublished negative data of the first trial. This seems to indicate that the current evidence supports that the potential benefits of Polyheme outweigh the risks. Per Holcombe, “We’re not irresponsible people going out and doing evil experiments on small groups of patients.”

Source: http://www.nytimes.com/2007/11/06/health/06prof.html?emc=eta1

Monday, November 12, 2007

Halloween-related ethics

Halloween Blog:

So, being a total paranormal aficionado, I thought you might find this interesting. This is the first of its kind that I know of, and was written up by the paranormal researchers at Eastern Paranormal (www.easternparanormal.com). Interesting for our class is the regards to faking s̩ances, invoking evil spirits, or practicing of the occult Рwe have recently talked about the ethical treatment of a persons body and respective parts Рso why not have some respect for their soul ?! Happy Halloween!

Paranormal Ethics
By: Gabreael
January 14, 2006
Dictionary.com's definition of ethics is as follows:

1. A set of principles of right conduct.
2. A theory or a system of moral values: “An ethic of service is at war with a craving for gain” (Gregg Easterbrook).
3. ethics (used with a sing. verb) The study of the general nature of morals and of the specific moral choices to be made by a person; moral philosophy.
4. ethics (used with a sing. or pl. verb) The rules or standards governing the conduct of a person or the members of a profession: medical ethics.

Today I am writing about a disturbing trend that many in the paranormal field are whispering about, that is the ethics, or rather the lack there of being practiced by some groups in the field today. Below is a list of seven practices which should never be tolerated by any serious investigation groups:

1. Identity Theft. Identity theft is starting an organization intentionally with an identical or almost identical name to another well known group or former well known group. This is being done by individuals hoping that this will increase their search engine placement. This is a despicable act. If you know of a founder who has participated in such behavior you should immediately disassociate yourself from that group. It shows their true character. When founding a group at the very least you should do the following when searching for a name:

a. Google the name.
b. Do a "Who is" on the name.
c. Buy your name domain. You can get free domain hosting very often with
www.godaddy.com with the purchase of your domain cost.

2. The open participation in a seance in private residence investigations. If a group wants to conduct a seance in the course of experiments for data or lack of data collection OUTSIDE of investigations in a controlled environment that is that private group’s prerogative. However, conducting a seance in a private investigation where activity is occurring is an unethical practice. Simply due to the fact that you open up the home to the possibility of more activity. I have personally witnessed several cases I was contacted on that this was the case. Any TRUE medium/psychic should NEVER need to participate in a seance to retrieve or communicate information.

3. Drinking on investigations. You should never consume alcohol or drugs on an investigation. This includes celebrating at the end of an investigation at that location. Last year I was contacted by someone that had a somewhat intense haunting in their former home that was only made worse three fold because of this sort of behavior. They had an investigation group come in, they had pictures of beer cans and such around during the investigation. The next time the group came back one of their members got a scratch running down their back. The home owner ended up selling the home for considerably less than the going market price because of the increased activity.

4. Provoking spirits. This is where a group comes in and intentionally invokes spirits by provoking them in a negative manner. This is done by making comments like, "You're a coward, I dare you to...." Again I was contacted a couple of years ago by a family that this had incurred in their home by a group. The family ended up having to move because the activity increased ten fold after that. We have some great paranormal photos. Not in one case was provoking used. Speaking openly to them while you are taking EVP's and shooting pictures is fine in a polite manner. It is when a group puts a negative spin on the tone of the investigation the leaves the door open for increased activity in the home.

5. Knowingly posting fraudulent evidence on your website. We have all witnessed groups posting everything from oil painting picture clips to intentionally hoaxed pictures. When a group does this they might as well shut their doors. They have lost all accountability. Evidence posted on your website should be run through a battery of test before posted publicly. Remember! If in doubt throw it out!

6. Affiliation with "Dark Art" practices. I am referring to Satanist, HooDoo Voodoo practitioners and the like. If you come to the realization that one of your members are participating in such practices you need to disassociate them immediately. Because of my deep study of demonology through the years I have been consulted on several incubus cases where Satanic ritual practices and HooDoo practices had been preformed prior to the attacks. You never want to knowingly include such a person in a serious investigation. Often these sort of people have dark entities attached to them that can make a volatile situation even more so.

7. Association fraud. Anyone who has had any kind of media coverage has had to deal with this. We have been contacted and by several former businesses stating that a group has contacted them claiming association with us when they have none requesting to do an investigation at their site. One time they were even stupid enough to put it in an email that was immediately forwarded to me by a contact. This is a deplorable act. We then went on to TOTALLY not recommend this group because of this DOCUMENTED behavior. All paranormal groups should have an "About Us Page" that clearly states who their members and associates are. We know of one group here in Eastern Carolina last year that posted they were conducting an investigation with TAPS on their website. They were not, and rightfully so were totally debunked.

Sunday, November 11, 2007

More on DTC

Last month, I discussed the efficacy of sleeping pills and the use of advertising to sell Rozerem, a newer sleeping pill. I recently came across this report in the New England Journal of Medicine which examines the spending on Direct to Consumer (DTC)marketing of pharmaceuticals in its first decade. In 1996, Pharma spent 11.6 billion dollars on DTC marketing, which grew in 10 years to 29.9 billion dollars in 2005! I find this statistic ridiculous, that billions of dollars are being spent yearly and the costs of pharmaceuticals are rising as well. I can't see how this can be justified in our government. This article also mentions the steep decline in FDA advertising violation notification which went from 142 in 1997 to only 21 in 2006. Now of course I am sure that Pharma and ad agencies have honed their skills in the past decade to prevent breaking the rules, but I also feel the FDA may be too lax in regulating DTC marketing.
I continue to be shocked in finding information the costs of DTC advertising, and I feel strongly that some portions of the population are getting mixed messages. In trying to find more information on DTC marketing, I came across this info packet (http://www.rx-edge.com/Five_Strategies_for_DTC_Marketing_Success_in_the_Retail_Environment.pdf) from a marketing/advertising company. It is interesting to see some of their strategies and consider what you actually do see in a drugstore.

How efficacious does a microbicide need to be?

In the context of planning clinical trials for anti-HIV vaginal microbicides, some authors use mathematical modeling to demonstrate efficacy, with changing numbers based on differing assumptions. Using these simulations, researchers can demonstrate that even moderately effective microbicides can have a major impact on HIV transmission: “a 60% efficacious product, available to 20% of women and used in 50% of sex acts when a condom is not used could prevent 2.5 million new HIV infection over 3 years in high incidence countries.”[1]

The use of a microbicide is demonstrably a great benefit to the hypothetical population mentioned above. For the many, it clearly saves lives and provides protection to a part of the population that previously had few options. However, what if you were one of the women who used the product correctly and diligently whenever you were supposed to, but you were part of the other 40%, the 40 out of every 100 women for whom the microbicide failed to protect against HIV? You might feel cheated or lied to, that this product was supposed to protect against HIV and it didn’t for you. The accompanying literature explains that the product is not 100% effective, but the product is also put out in the population, because it does save lives. Just not yours.

Every product has this issue; none are 100% effective. So 1 out of every 10 or 100 or 1000 or more becomes infected or isn’t protected. But is 60% efficacy sufficient to justify a trial? Would you use it and depend on it? And if you wouldn’t, should others?



[1] Watts C, Kumuranayake L, Vickerman P, Terris-Presholt F. 12 – 15 May 2002. Microbicides 2002, Antwerpen, Belgium [Abstract] C319, 68.3

Friday, November 9, 2007

Brain-boosting drugs spark ethical debate in UK
08 Nov 2007 13:43:36 GMT
Source: Reuters

By Ben Hirschler LONDON, Nov 8 (Reuters) - A rise in healthy people popping pills to boost performance in exams or work, raises long-term ethical and safety concerns about the effects of such treatments, British doctors said on Thursday. The British Medical Association (BMA) wants a public debate about the risks and benefits of using drugs to improve memory and concentration, sometimes called "cognitive enhancement". The ability of prescription drugs and medical procedures to improve intellectual performance is likely to increase significantly in the next 20 to 30 years as technology advances. "We know that there is likely to be a demand by healthy individuals for this treatment," Dr Tony Calland, chairman of the BMA's Medical Ethics Committee said at the launch of a discussion paper on the issue. "However, given that no drug or invasive medical procedure is risk free, is it ethical to make them available to people who are not ill?" Surreptitious use of brain-boosting prescription drugs is particularly common in the United States and likely to increase in Britain, the BMA said. "There is a growing expectation that the use of these so-called cognitive enhancers in the UK is both imminent and inevitable," the BMA said. Today, the use of pharmaceutical aids to boost performance is mainly confined to certain groups -- notably students cramming for exams. Popular choices include drugs for attention deficit hyperactivity disorder, such as Ritalin, or methylphenidate, made by Novartis AG and others. Another favourite is modafinil, the active ingredient in Cephalon Inc's narcolepsy medicine Provigil. Such drugs are widely available to buy online. BOTOX FOR THE BRAIN In the future scientists may be able to provide more permanent fixes for bad memory or poor concentration through brain stimulation and neurotechnology. This would involve techniques such as transcranial magnetic stimulation -- sometimes referred to as "botox for the brain" -- where magnetic pulses are used to stimulate particular brain regions, and deep brain stimulation, where electrodes are inserted into the brain to transmit tiny electrical currents. These and future medical interventions could benefit individuals and, potentially, wider society, if they increase the competitiveness of the workforce. But "over-enhancement" of the brain's cognitive functions could have damaging side-effects. It may, for instance, impair a normal brain's ability to selectively filter out trivial or traumatic information, resulting in the individual being plagued by unwanted or traumatic memories. (Reporting by Ben Hirschler; Editing by Golnar Motevalli)

Thursday, November 8, 2007

Medicinal marijuana

http://www6.comcast.net/news/articles/health/2007/11/06/Medical.Marijuana/


Above is a link to recent health news article. The story began with an individual who was fired from his job after he failed a drug test, even though his doctor provided a note stating his use was medicinal in a state where medicinal marijuana is legal. This is clearly discrimination. The individual sued to get his job back. However, the Supreme Court found that the firing was just as the individual was using an illegal drug. In 2005, the Supreme Court decided that anyone using marijuana for medicinal uses are still subject to legal repercussions if caught.

What is the purpose of legalizing something if discrimination against those who utilize that legalization is still legal? How can we prosecute people for doing something legal? How do we uphold blatant discrimination against someone who is following the law? The laws are put in the states hands – if the Supreme Court is going to override the state’s laws, what is the point of having state laws to begin with?

Monday, November 5, 2007

Mandated contraception in the poor...?

Because I was having a bit of a difficult time finding something particularly interesting to post and discuss, I consulted my wife, who thought about something she had discussed in her Ethics class. The idea their class was tossing around is the right for poor people to bear children. The sole classmate of my wife who supported it referred to how children are born into the welfare system as a result of their parents being also on welfare. Also, there was an idea thrust forward that was describing the overpopulation of the United States and how that is a problem that would be mitigated by mandating temporary infertility. (Really, according to my wife, the student said "Stupid people breed" and then came up with the euphemisms to cover herself)

Even a cursory evaluation would discern many issues with a policy like that. Before any ethical concerns, the technology is just not there. Sure, we can chemically castrate human beings, male or female, but that is not without permanent ramifications (like being able to bear children down the road). The other option is surgical castration, which, again, is difficult to undo. Even if it were possible, this notion brings up the idea of liability for the United States (or the respective states if this is where it would happen) insofar as contingencies for adverse reactions. Can the government guarantee all temporary castrations will be done without harm to the person? Or can the government guarantee full fertility when breeding privileges are restored? What if something goes wrong? Can the person sue the government for damages?

Add to all of this the ethical consequences of this notion. Look at the value of the dollar in the United States. A person who was once a middle class worker may, by today's standard be considered lower-middle or upper-lower class. So, someone who may have been able to have children may be banned a year or two later. It is funny, because typically, the lower paying jobs - the jobs of the impoverished in this country - make the jobs of the rich easier, whether it is making their hamburger or moping their floors. If those people are helping society function, which empirically they are, why should they not be able to raise a family? How far would the United States be able to go in suffocating people's rights? (Do they not do that enough already?)

As a postscript, in regards to the United States being overpopulated: the infant mortality rate is up, as is the death rate as a whole, so I'm not sure that allowing children to be born any different than how it is today would matter.

Sunday, November 4, 2007

The first animal in orbit

Fifty years ago this week, the first animal went into orbit, setting the manned space program into motion[1]. The USSR launched Laika into space in a small capsule with enough food and water for seven days, and a heating and cooling system intended to keep the small capsule at a living temperature. The intent was that the dog would live for several days, slowly and peacefully dying from lack of oxygen. However, one of the rockets malfunctioned, causing failure of the cooling system, killing Laika after only several hours.

There was never any intent that Laika would come back from space and no way to retrieve her. Although the men in the space program had no guarantee of coming back and undertook the flights knowing the risks and dangers, there were at least systems and plans intended to bring them back from space safely. And the men willingly participated with full knowledge of what might happen. Laika participated willingly, too, but not because she knew or understood the outcome.

I’m not really suggesting that informed consent for animals is appropriate, and I’m not against animal experimentation when necessary. But how necessary was this experiment? The Soviet scientists did not disclose until just recently that Laika died much more quickly than they anticipated, from heat rather than oxygen deprivation. Though failure of the experiment may have contributed to the lack of public disclosure, perhaps they also realized that Laika was a sympathetic figure and people around the world would not appreciate the manner in which she died.

Saturday, November 3, 2007

More Tax Dollars Spent Aiding Drug Addicts

The state of Massachusetts is starting a new program to hand out heroin overdose prevention kits. It is budgeted at less than $50,000, but I personally don't see how the state can be justified in spending tax dollars this way versus putting that money into public schools, drug education programs, or some other more worthy cause. While saving a life is indeed important, I feel this act is simply perpetuating drug use.

Saving lives is the obvious ethical choice. However, how is it ethical to provide this service without the follow through to get that person off of drugs and start their lives over again? Is this program a "Get Out of Death-Free" card? Will this send a message that it is ok to OD, the state of Massachusetts can easily save you? I feel that this program is too lenient on drug users and also irresponsible on behalf of the state.

Friday, November 2, 2007

Elephant on acid, dog head grafts and a seesaw to revive the dead

Madness or genius? Magazine compiles list of most bizarre tests ever conducted in name of scientific inquiry


To ascertain the effects of LSD on elephants, a zoo animal was given a dose 3,000 times larger than a human would take. The animal died within minutes. Photograph: Schalk van Zuydam/AP

One Friday in August 1962 Warren Thomas, director of Lincoln Park Zoo in Oklahoma City, raised his rifle and took aim at Tusko the elephant. With a squeeze of the trigger he scored a direct hit on the animal's rump, firing a cartridge full of the hallucinogenic drug LSD into the animal's bloodstream.

The dose was 3,000 times what a human might take for recreational purposes, and the results were extraordinary. Tusko charged around and trumpeted loudly for a few minutes before keeling over dead.

Thomas and his colleagues maintained the mishap was the result of a scientific experiment to investigate whether LSD brought on an unusual condition in which elephants become aggressive and secrete a sticky fluid from their glands. In a report of the incident submitted to the US journal Science four months later, the team concluded: "It appears that the elephant is highly sensitive to the effects of LSD."

The case of Tusko the elephant is among 10 of the most bizarre experiments carried out in the quest for knowledge and reported in New Scientist magazine today. If there is a fine line between madness and genius, many of those involved firmly crossed it.

One experiment in the 1960s saw 10 soldiers board an aircraft for what they believed was a routine training mission from Fort Hunter Liggett airbase in California. After climbing to around 5,000 feet the plane suddenly lurched to one side and began to fall. Over the intercom, the pilot announced: "We have an emergency. An engine has stalled and the landing gear is not functioning. I'm going to attempt to ditch in the ocean."

While the soldiers faced almost certain death, a steward handed out insurance forms and asked the men to complete them, explaining it was necessary for the army to be covered if they died.

Little did the soldiers know they were completely safe. It was merely an experiment to find out how extreme stress affects cognitive ability, the forms serving as the test. Once the final soldier had completed his form the pilot announced: "Just kidding about that emergency folks!"

A later attempt to repeat the experiment with a new group of unwitting volunteers was ruined by one of the previous soldiers, who had penned a warning on a sickbag.

One of the most gruesome experiments to make New Scientist's list was performed by the Soviet surgeon Vladimir Demikhov. In 1954 he unveiled a two-headed dog, created in the lab by grafting the head, shoulders and front legs of a puppy on to the neck of a German shepherd dog. Journalists brought in to examine the creature noted how milk dribbled from the stump of the puppy's head when it attempted to lap milk. Occasionally, the two would fight, with the German shepherd trying to shake the puppy off, and the puppy retaliating by biting back.

The unfortunate creation lived for six days, though Dr Demikhov repeated the experiment 19 more times over the next 15 years, with the longest-lived lasting a month. Although the work was dismissed as a publicity stunt outside the Soviet Union, Dr Demikhov was credited with developing intricate surgical techniques that paved the way for the first human heart transplant.

Several attempts to unravel the mysteries of human nature also make the list. Clarence Leuba, a psychologist from Yellow Springs, Ohio, set out to discover whether laughing when tickled was a learned or spontaneous reaction, and commandeered his newborn son and later daughter into the study.

Then there was Lawrence LeShan, a researcher from Virginia who in 1942 stood in a room of sleeping boys repeating the phrase "My fingernails taste terribly bitter" to see if he could break their nailbiting habit while they slept.

In another experiment, a doctor called Stubbins Ffirth from Philadelphia decided to drink fresh vomit from yellow fever patients to prove it was not a contagious disease. He claimed to be right when he failed to become ill in 1804, but scientists have since shown yellow fever is extremely contagious, but has to be transmitted directly into the bloodstream, for example from a mosquito bite.

A similarly flawed experiment by Robert Cornish at the University of California in the 1930s attempted to bring dead animals back to life by tilting them up and down on a seesaw. The few that did stir back to life momentarily after death were severely brain damaged.

Predictably, sex also appears on the magazine's list of bizarre experiments. When investigating the sexual arousal of male turkeys researchers at Penn State University were impressed to see that the birds would attempt to mate with lookalike dummies. Piece by piece they removed parts of the dummy and found that the males were still highly aroused when presented with no more than a head on a stick.

Top 10 most bizarre experiments

Elephant receives massive dose of LSD to see if it induces temporary madness.
Conclusion: LSD is fatal to elephants

Aircraft passengers told they are about to die in crash make more mistakes in written test.
Conclusion: Extreme stress harms cognitive ability

Two-headed dogs created by Soviet surgeon, above, but die within a month.
Conclusion: Tissue rejection makes animals incompatible

Psychologist begins experiments on son to test if laughing is spontaneous when tickled.
Conclusion: Laughing is an innate response to tickling

A room of nail-biting boys is played a recording or spoken announcements to break the habit while they sleep.
Conclusion: Sleep learning is possible. Others prove otherwise

To test if people can sleep through anything, volunteers have their eyes taped open and bright lights shone in their eyes.
Conclusion: The men dozed off in 12 minutes

People asked to smell ammonia, put hands in a bucket of frogs and watch porn.
Conclusion: Disgust has no single expression.

Doctor rubs vomit from yellow fever patients into open wounds and drinks it.
Conclusion: Mistakenly claims it is not infectious

Animal corpses placed on seesaw to restart circulation and bring them back to life.
Conclusion: Two animals survive with blindness and brain damage

Fake female turkey dismantled limb by limb to find minimum that a male will mate with.
Conclusion: Male turkeys aroused by a head on a stick, but not a headless body

Right to privacy, but what about responsibility?

HIPPA protects the right of patients to keep their medical history private. Privacy is extremely important, especially in small towns where everyone knows everyone. However, many of these small towns also have volunteer ambulance companies. These volunteer companies do abide by recommended body substance isolation (BSI) items, but these only include gloves, masks, and eye protection. EMTs routinely wear short sleeve shirts and shorts, all of which are their own clothes. Though common sense says for the individual to wear long pants and long sleeves if they have open wounds, they respond when a call comes in – they do not have work schedules. Therefore, they respond wearing what they put on in the morning – not necessarily expecting to respond to a call. In the cases of patients who have infectious disease, what are their responsibilities to the emergency personal who respond to their 911 calls? If they do have open wounds and blood is splatters, the potential for the EMT to contract whatever the patient has is very real. Without knowing if the patient has any infectious diseases, how can he or she prevent the spread of that disease? If the patient does disclose his or her status (assuming he or she does have an infectious disease), is it ethical for an emergency room physician to break doctor/patient confidentiality to inform the EMT that the patient has an infectious disease? d

Monday, October 29, 2007

Health Industry Support of Democratic Caucas...

Isn't this a repeat of the mid-nineties? Didn't the healthcare sector pay the republicans to help quell the banshee that was Hillary Rodham Clinton? Weren't they afraid of her influence in turning the industry on its head? (Weren't they successful in doing this?)

Apparently this is a reversal of things, and times. Mrs. Clinton has on her plate a different plan than she was considering in the nineties, less ambitious, and less effective. Though she claims to have plans to be a "healthcare president" (which would mean being strictly adherent to your philosophies), by taking the money from the industry, she is allowing herself admission into a gigantic conflict on interest. What it seems to be amounting to is the industry buying Clinton's compliance into their preferred style of medicine - private and costly. Clinton, and for that matter, anybody who is interested in healthcare for Americans should not fear the industry or worry about having their permission. The United States government has the ability to regulate the industry, or to the extreme, shut it down. No private insurance. Thus, there is no real reason for Hillary to fraternize with the enemy.

Not to say this is extremely important, but some of her fellow Presidential hopefuls address financial concerns through donations and non-questionable sources. Frankly, I expected more from her, as in not providing a place for her to be attacked by her opponents and the population she is trying to enchant. This may, in the long run, damn her campaign.

http://www.nytimes.com/2007/10/29/us/politics/29health.html?_r=1&ref=health&oref=slogin

Sunday, October 28, 2007

HIV Immunization Research Continues in Light of STEP Study Disappointment


 

The latest in a series of failed developmental pursuits of an effective HIV vaccine comes from Merck, who has discontinued its STEP study for ineffectiveness. The announcement was made today by the co-sponsors of this clinical trial, Merck & Co., Inc., and the HIV Vaccine Trials Network (HVTN), which is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health. The study evaluated two primary efficacy endpoints:  whether the vaccine prevented HIV infection and whether the vaccine reduced the amount of virus in those who developed infection.  Results suggest the vaccination may have made recipients more susceptible to infection, in the midst of one of the world's most rampant epidemics.


 

The Merck trials took place in 15 cities in the US, including Los Angeles, New York and Boston. Three Canadian cities and research sites throughout Peru, Brazil Haiti, the Dominican Republic and Jamaica also participated in the study. These trials began December 2004 and included 3,000 participants, determined to be high-risk for infection. Enrollment and vaccination in a second Phase II trial of this vaccine being conducted by the HVTN in South Africa called Phambili, and two additional Phase I trials, have been discontinued. The DSMB for the Phambili trial will evaluate the available data. Researchers in Soweto, Cape Town, Durban and two other sites began contacting South Africa's 801 trial participants on Tuesday, mainly by cellphone text message. The goal is to tell each one individually whether he or she had received a placebo or the vaccine, a process called "unblinding" the trial. Researchers are telling the roughly half who received the vaccine that it might have increased their risk of contracting HIV.


 

Among those who received at least two doses of the vaccine during the STEP study, 19 contracted HIV, compared to 11 of those given placebos. Therefore, the vaccine did not prevent infection in the 741 volunteers who received at least one dose of the three-dose vaccine series, 24 cases of HIV infection were observed, compare to 21 cases of HIV infection observed in 762 participants who received the placebo. Investigators insist the vaccine could not have caused infection as subjects were injected with a killed, adenovirus serotype 5 (Ad5) virus structured in the likeness of the HIV virus. The vaccine could have, however, caused immunological changes that made it easier for the virus to take hold during a later exposure. Investigators found RNA levels of vaccinated-infected individuals were higher than those in the placebo group, who were subsequently infected. "HIV RNA levels in the blood of infected individuals, the standard measure of ongoing HIV replication, were approximately 40,000 copies/mL in the vaccine group and approximately 37,000 copies/mL in the placebo group."1 Results suggest vaccinated subjects with a previous exposure to the virus's structure may acquire more copies of the of virus if infected.


 

Development of an effective AIDS vaccine remains one of the most challenging pursuits of modern medicine. One positive aspect of the Merck's vaccine (MRKAd5) research cannot be denied; it showed that the Phase IIb test-of-concept trial design can yield earlier results with fewer volunteers than a full Phase III trial. "[This] probably saved us all waiting another 2 or 3 years, and the cost," an investigator says. Such trials may be beneficial over the full 10,000-person Phase III trial as research toward the HIV vaccine continue.2


 


 

1.    Vaccination and enrollment are discontinued in phase II trials of Merck's investigational HIV vaccine candidate. Available at: http://www.merck.com/newsroom/press_releases/research_and_development/2007_0921.html. Accessed October 28, 2007.

2.    Disappointment dominated the responses to the halting of immunizations in the STEP trial, but many agree it could hold important lessons for future vaccine strategies. Available at: http://www.iavireport.org/Issues/Issue11-4/Analyze.asp. Accessed October 28, 2007.

Saturday, October 27, 2007

Dr. Norwood.

http://www.phillymag.com/home/articles/did_dr_norwood_go_too_far_part_one/

http://www.phillymag.com/home/articles/did_dr_norwood_go_too_far_part_two/

Above are links to a two part article on Dr. William Norwood. Although he is an incredibly brilliant surgery and has invented three cardiac surgeries that have saved thousands of children with congenital heart defects, he is being accused of failing to obtain a complete, informed consent from parents of his patients. After reading these articles, you will understand why the waters are muddied and a definite answer cannot be reached. I must also state that I am one of the children that Dr. Norwood saved by operating on my heart when I was 4. Although I did not receive one of the procedures he invented and I regret any children who might have been harmed or died while he was perfecting his techniques, I cannot caste a stone at this man as I would not be here without his exceptional brilliance and skilled surgical hand.

However, these articles do raise several ethical points. I can tell you from personal experience that when a doctor tells you there is something wrong with your heart, you are thereafter unable to comprehend what s/he is talking about, even for someone with some degree of medical understanding. I cannot imagine how difficult it would be for a parent to hear about their child’s heart defect, in addition to not having a basic understanding of the medical jargon. Though the parent may sign a consent form, is that really informed consent? What can a doctor do to help a non-medically educated parent understand complex terminology, especially when the parent is extremely emotional distressed? And while this may not necessarily be the circumstances Dr. Norwood is accused of, when an unexpected complication arises during surgery, should the doctor stop the surgery to speak to the parents to make sure they understand the implications of this complication and obtain consent to use further and perhaps more extreme measures to save the child’s life? In the situation where a mother claims she did not know the stent used in her daughter was still experimental, would that have really changed the mother’s decision? Would she have opted not to have a surgery that her daughter needed in order to live? Would she have chose to go against the doctor’s recommendation of a new, improved, better, but still experimental stent? I completely agree that the issue is that the mother did not have an opportunity to make the choices that were hers to make (if that did occur), but I also believe Dr. Norwood was doing what he thought was best for the child. Also remember, that without Dr. Norwood, this child would not have lived as long as she did. Without the procedure he invented, she would have died within days after birth.

Another issue brought to light by Dr. Norwood’s situation is the question of experimentation. While many codes exist to protect and regulate experimentation, the fact remains that medicine cannot advance without experimenting with new procedures. This article lists tons of surgeons who went against laws and hospital policies to perform procedures that were unethical and illegal. However, these “illegal procedures” are now considered routine procedure and lifesaving. I believe patients have rights, including the right to know exactly what a physician is doing to them and the right to refuse treatment. Perhaps Dr. Norwood took the idea of utilitarianism ethics to the extreme in that experimenting on a few kids will certainly benefit the greater good. He had to experiment in some form to perfect three surgeries that save the lives of thousands of kids (each year since the 1980s) with a congenital defect who otherwise would die within a few days of birth.

Where do we set the boundaries of punishment for pushing or overstepping ethical boundaries? Dr. Norwood’s intentions are good – he is trying to make these kids better. He is not a surgeon who is harming his patients by rushing through a surgery to make his golf game as in the case of a Hawaiian surgeon who replaced FDA-approved titanium spinal rods that hadn’t arrived yet with something he found in the operating room that had the same dimensions (patient is now paralyzed).

Friday, October 26, 2007

Jumping Rope with Abe Lincoln and a Groundhog

We've all seen the commercials and print ads for Rozerem, and you must admit how clever you think they are. Also, we've probably all encountered difficulty with sleeping, sometimes days-sometimes a few weeks at a time. I would be hard pressed to ever consider taking any sort of sleeping aid, prescription or OTC (with the exception of an occasional dose of Nyquil), but I have definetely experienced those bouts of poor sleeping. As our lives become increasingly busy and hectic, I think perhaps cutting back on caffeine and engaging in more physical activity (two things which are beneficial in more ways than just as sleep aids) are more healthy and desirable alternatives to help get to sleep at night.

But I did appreciate how some may feel inclined to take a sleep aid. Until now. The New Times published an article this week reporting that sleeping pills are really just mildly effective, that the newer drugs tested cut the time it took to fall asleep by only 12.8 minutes, and increased total sleep time by only 11.4 minutes. Is taking a prescription and ingesting more chemicals worth that? I don't think so.

And that is not all. The same article also reports that older prescription sleep aids such as Halcion and Restoril accounted for signicantly better results than the newer drugs. Yet another case of unneccessary "Me-too" drugs being overly marketed and preying on people who may be in a vulnerable state, in this case, sleep-deprived. As I mentioned above, most people find the Rozerem ads charming; they may march into the doctor's office and specifically request Rozerem. Note the Times article reports Americans spent $4.5 billion dollars on sleep aids last year.

Basically, sleeping pills don't really work, or rather, just aren't as effective as the American consumer is led to believe, according to the analysis. Pharmaceutical companies are latching onto our weaknesses and trying to tell us once again that it can all be solved in a little pill. And if Americans are spending that much money every year on sleeping pills, then it appears physicians are also throwing in the proverbial tower by prescribing these pills. Too bad these physicians can't be like the doctor in Fight Club who tells Tyler Durdan to "get more exercise and chew some valerium root, " instead of prescribing a Valium.

Wednesday, October 24, 2007

Misperceptions regarding HIV protection in vaginal microbicide clinical trials

A number of vaginal microbicides that could decrease the rate of HIV transmission are currently under development and in different clinical trial phases. There are a number of different issues with how to run these trials, ranging from the women who participate being perceived as sex workers or ‘loose,’ to whether it is ethical to stop providing treatment once a trial is over for people who sero-convert during the trial, to whether including contraceptive properties as part of the microbicide will affect the utilization, and finally to whether the use of microbicides will cause a drop in condom use.

One of the reasons for developing vaginal microbicides is to provide women with a tool for protecting themselves when their partners refuse to use condoms. One of the difficulties in developing vaginal microbicides is addressing many different cultures’ requirements; people in some countries prefer ‘dry sex’ (little lubrication), others prefer more lubricated sex; some would avoid a vaginal microbicide that includes contraception, while others would welcome it. A number of different studies have been performed, just to examine and address preferences like these.[1],[2],[3]

In a study that evaluated participants’ perceptions of a candidate microbicide product, a disturbing trend was noted.[4] In this study, though the participants were counseled on what the microbicide could do and did not do, and how important it was to use condoms, the participants’ perception was that by using the gel, they were doing something for their health, regardless of the microbicide’s actual efficacy. In fact, in this particular trial, the microbicide was demonstrated to be ineffective, but there was a persistent belief that it was effective nonetheless, leading to a decreased reliance on condoms.

In many of the cited studies, preferences have been expressed that participants would rather use the microbicide than a condom, even when it has been explained that both are needed for optimum safety.

This is something that people who are running current and future trials need to be intimately aware of; the perception that the gel is so efficacious that condoms do not need to be used, even when it has been carefully explained otherwise, is so strong that if careful steps are not taken, the participants may endanger themselves more than the microbicide can protect them.



[1] Bentley ME, et al. Acceptability of a microbicide among women and their partners in a 4-country phase I trial. Am J Public Health. 2004; 94(7): 1159 – 1164.

[2] Braunstein S, van de Wijgert J. Preferences and practices related to vaginal lubrication: Implications for microbicide acceptability and clinical testing. J Women’s Health. 2005; 14(5): 424 – 433.

[3] Ramjee G, et al. Accetability of Carraguard, a candidate microbicide and methyl cellulose placebo vaginal gels among HIV-positive women and men in Durban, South Africa. AIDS Research & Therapy. 2007; 4:20.

[4] Mantell JE, Morar NS, Meyer L, Ramjee G. “We have our protector”: Misperceptions of protection against HIV among participants in a microbicide efficacy trial. Am J Public Health. 2006; 96(6): 1073 – 1077.

Study reports ties between academia and drug companies

The relationships between physicians and drug companies have been under scrutiny. It is widely known that pharmaceutical companies have given community clinicians gifts, trips, CME funding, and/or lunch for many years. However, the extent to which academic physicians and medical schools have such relationships with drug makers was previously unknown. The October issue of JAMA includes an article reporting results of a study by Campbell et al that examined institutional academic-industry relationships.

The authors surveyed the department chairs of 125 accredited medical schools and the 15 largest independent teaching hospitals in the United States, 459 department chairs (67%) completed the survey. The results showed that institutional relationships with industry appear to be just as widespread as those of community clinicians. More than half of all department chairs surveyed had financial ties with the drug industry (eg, paid consultant, scientific advisory board member, paid speaker) and two-thirds of departments had relationships with industry (eg, receiving research equipment, unrestricted funding, seminar support). A previous study found that third-year medical students receive on average 1 gift or attend 1 activity sponsored by a drug maker each week.

A MedlinePlus news release regarding the publication quotes Campbell, “There is not a single aspect of medicine in which the drug companies do not have substantial and deep relationships, affecting not only doctors-in-training, resident physicians, researchers, physicians-in-practice, the people who review drugs for the federal government and the people who review studies.” In addition, he questions what reasonable justification drug companies have to be involved in the education of medical students.


Sources: 1. Campbell EG et al. Instituational academic-industry relationships. JAMA. 2007;298:1779-1786; 2. U.S. medical schools, drug makers share strong ties. MedlinePlus Web site. Available at: http://www.nlm.nih.gov/medlineplus/news/fullstory_56236.html. Accessed October 17, 2007.

Monday, October 22, 2007

Legalizing not the drug, but the place where it is shot into forearms...?

I have heard of the needle exchange program, and I think it is a good idea, wherein IV drug users can acquire clean, sterile needles on the tab of the municipal government. Although the ultra-conservative Americans would regard it as defiling the fiber of the US, the fact is the drug users will seek whatever means necessary for their next fix. Rather than allowing the transmission rate of HIV and Hepatitis C among others to skyrocket, the public health sector provides clean needles to avert transmission. It has been successful, despite the controversy.

A new program, originated in San Fransisco, California takes this concept to another dimension. In addition to supplying the conventional "clean needle", this institution provides medical assistance in the form of a nurse, as well. Additionally, this is all being set in a "private booth" framework, where these IV drug users will have confidentiality and protection. It should be noted that the staff will not assist, nor condone the activities, but merely to safeguard the lives of the participants should an overdose or some other eventuality occur. After their session of IV drugs, the user will be able to "chill out" in a small cafeteria of sorts and have crumpets and coffee.

What has to be very carefully treaded is the line of condoning activity. Though the mission statement includes the public health department's standpoint, attaching a small breakfast hall adds creature comforts that should not be associated with the lifestyle. Having a nurse may even be excessive, perhaps, because it makes the lifestyle more socially normal. While I think the idea of a safe area to do this activity is good, it may attract more homeless people to utilize drugs if they haven't already. For the homeless person, this is a free meal and a quick medical exam. Thus, the problem then becomes curbing homelessness - and that is a big problem to handle.

As far as "recruiting" new users of drugs, almost every study shows that rate of people becoming new drug users - hard drug users - is mutually exclusive of regulations. The people will do it whether the law wants them to or not. It seems to be the case with habitual marijuana users, cocaine users, heroin users and so on - and it makes sense; those people with addictive type personalities very easily adapt the lifestyle. Those who do not have that personality usually do not. California's ambitions do not encourage the lifestyle, they make it safer - albeit at a social cost to the homeless perhaps.

http://hosted.ap.org/dynamic/stories/S/SUPERVISED_INJECTIONS?SITE=CASRP&SECTION=HOME&TEMPLATE=DEFAULT

Sunday, October 21, 2007

The Widening Gap in Chicago’s Healthcare


 

A recent study, released by the Metropolitan Chicago Breast Cancer Task Force, indicates Chicago has a serious issue with uniformity throughout its healthcare system. In March, the task force set out to uncover why the city's African-American women who acquire breast cancer are dying a much higher rates than white women are. As it stands, Chicago's mortality rate for African-American women battling breast cancer is 68% higher compared to their Caucasian counterparts.1 This gap has widened over the years under the auspices of a "de facto segregated health-care system."

The task force has formulated three major hypotheses for explaining the breast cancer disparities in Chicago: "1) African American women receive fewer mammograms; 2) African American women receive mammograms of inferior quality; and 3) African American women have inadequate access to quality treatment once breast cancer is diagnosed."2 There is a desperate lack of mammogram accessibility and capacity in the areas with the most need. "The institutions with the best quality care are not in the neighborhoods where the need is greatest -- neighborhoods inhabited by poor, minority women."1

The task force has outlined 37 recommendations for a system overhaul of Chicago's healthcare system. The force admits, "some can be implemented immediately, while others will require a longer-term investment, further development and collaboration, additional study and statewide policy changes." Recommendations handed down by the team include, the implementation of a universal, transparent quality control system for mammograms, whereby the collection of quality data, such as the number of cancers detected per 1000 screen mammograms and the rate of false-positive results are shared with the public. In addition, the implementation of an electronic network established between "minority neighborhoods" to central diagnostic hubs, where experts interpret mammograms. The task force conjointly recommends the use of specialized imaging for earlier detection at local mammogram facilities.

The racial gap exists on a national level as well. The national death rates for African-American women are 37% higher than that for white women. No significant answers can be found with genetic influence. The racial gap in New York City is 11%.1 Its well-established network of public hospitals and clinics contribute to the limiting of racial differences in the city's healthcare. Healthcare systems and institutions that participate in quality assessments have proven better for it. Patients live longer with extended to quality of life. Without an overhaul of Chicago's healthcare system, communities will continue to lose their mothers, daughters, sisters and wives. Traditionally, the role of the African-American woman is crucial, particularly to her community, where she is not uncommonly a sergeant to several children, not of her own bearing. A community without mothers and with children left to raise themselves is frightening and never ideal, to say the least.


 

  1. System overhaul key to reducing breast cancer deaths for black women. The Chicago Tribune. 18 October 2007. Available at: www.chicagotribune.com/news/local/chi-cancer_bothoct18,0,2735430.story. Accessed 21 October 2007.


     

  2. Metropolitan Chicago Breast Cancer Task Force. Improving Quality and Reducing Disparities in Breast Cancer Mortality in Metropolitan Chicago. Chicago, IL, October 2007. Available at: http://www.sinai.org/urban/summit/docs/Task%20Force%20Rpt_Oct%202007_FINAL.pdf. Accessed 21 October 2007.