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Posts with tag ethics

Thought for the Day: Pet chemotherapy not so out there

More than 47 percent of people view their pets as family members, according to a 2002 American Veterinary Medical Association survey. It makes sense then that people are routinely treating their pets for ailments that might strike a family member -- like arthritis, heart disease, diabetes, allergies, dementia, obesity, and yes, cancer.

New studies show that Americans are stuffing their pets with more drugs than ever before. They are medicating their dogs, cats, and sometimes other pets as much as they medicate themselves -- and they are doing it with many of the same human drugs they use for themselves, like steroids for inflammation, antibiotics for infection, anti-depressants for anxiety, and even new slendering drugs for obesity.

It's a big market -- pharmaceuticals for pets -- and for those who love their pets so much they can't let go, going to extremes is worth every penny.

Think about this:
  • For dogs and cats alone, Americans spent $2.9 billion on pet drugs in 2005. While this is equal to only one percent of human drug sales, the market has grown by half since 2000.
  • The U.S. Food and Drug Administration (FDA) has approved more than 40 new pet drugs in the past five years.
  • A single three-month course of pet chemotherapy can cost $3,000 -- and chemotherapy doesn't typically extend the life of an animal as much as it soothes symptoms of the disease.
  • Health insurance for pets was nearly invisible in 2002 but has gained popularity over the past few years. Premiums can cost $30 per month, and the total market is expected to climb to $500 million in the next five years.
  • Some human drugs leave pets with unexpected, sometimes deadly, side effects. The drug Rimadyl, made by Pfizer and used as a treatment for dogs with arthritis, has been shown to cause kidney and liver damage in some animals. More than 3,000 pet deaths have been attributed to this drug.
  • Some question the priorities of a society that allows for medically treating pets like they are humans. Dianne Dunning, an ethicist at N.C. State's vet school is concerned that millions of animals are lost, unwanted, and euthanized while millions are spent on pet medicines. David Rothman, an expert in medicine's role in society from Columbia University, says, "If you can't get malaria drugs in some Third World countries, what are we doing with chemotherapy for cats?"
  • Others don't flinch at the expense it requires to keep their pets alive. One man, whose dog was expected to die of lymphoma within weeks, still enjoys the company of his pet some two years later. Chemotherapy saved the dog's life and when asked if he thinks the drugs are too expensive, this man says NO -- because his dog is still here.

Debate over value of animal research

In an analysis of animal research used to understand and treat human diseases, the London School of Hygiene and Tropical Medicine researchers found that using animals, such as mice, had limited value. Only half of the research done using animals translated into the same outcome for humans.

In a BBC News report over the controversy that rages regarding the wisdom of using animals in research, Professor Ian Roberts is quoted as saying, "The debate over this issue is really quite hysterical. At the moment, there is too much emotion and not much science. Anti-vivisectionists say animal testing is of no use at all, and those who do them say we would have no safe and effective treatments if we didn't." Lead researcher Roberts believes animal studies should be used, but not in all cases of research.

The value of animal research was catapulted to front page news headlines earlier this year when six men experienced tragic life-threatening side-effects as they participated in a human clinical trial of the drug TGN1412, which had previously been shown safe and effective during animal studies.

Last March, six healthy young men volunteered at Northwick Park Hospital in London as participants in a clinical trial for a drug called TGN1412, designed to treat leukemia, autoimmune and inflammatory diseases. According to the men, they were told by doctors there would be no serious short-term or long-term side effects. They were each paid £2,000. Within hours, the worst that could happen did, and the men were plunged into a nightmare beyond anything they could have imagined.

The headaches began, followed by convulsions, bloating, organ failure and comas. The men came to be known as the Elephant Men because of the swollen faces and chests they suffered. One of the men suffered gangrene -- all his toes and three of his fingers were amputated. He also suffered heart failure, kidney failure, pneumonia, septicaemia and liver failure. Recently, another participant was told he might be developing cancer as a result of the drug trial. All have been told to expect early death.

Do you feel that animal research used to test drugs and medical procedures meant to treat human ailments and diseases, are credible enough to continue, or do you believe that research using animals should be abandoned?

AP: Researchers escape ethics punishment

In a world of checks and balances, there are procedures that need to be adhered to in order to insure the objectivity of the process. In this case, the stages when a newly-developed drug goes from inception to market.

Drug company develops drug. Experimental drug enters scientifically-based clinical trials run by unbiased objective researchers. If all goes well, and the drug shows benefit in the treatment it was designed for, drug gets approved for use. Patient receives drug. Ideally, patient gets better.

Drug company develops drug. Drug company finances clinical trials, and pays researchers who will determine the effectiveness and safety of experimental drug. No need to continue on, the process is now potentially and ethically compromised.

This morning, from many reputable dead tree publications, runs this headline: AP: Researchers Escape Ethics Punishment. Why? According to the National Institutes of Health, "The majority of federal scientists investigated for improperly accepting personal money from drug companies or biotechnology firms escaped serious punishment, and investigators declined to proceed with several cases involving possible crimes."

The next time a reader comes by and extols the virtues of scientific medical research as the gold standard to which all else should be validated, I am simply pointing them to this investigative outcome. We should all be disillusioned and a wee bit angry that the wolves seem to be guarding the barn.

Woman treated with experimental cancer drug without consent

We recently posted Elephant Man drug trial victim showing signs of cancer, about a horrific ordeal involving six healthy young men who volunteered at Northwick Park Hospital, in London as participants in a clinical trial for a drug called TGN1412, designed to treat leukemia, autoimmune and inflammatory diseases.

According to the men, they were told by doctors there would be no serious short-term or long-term side effects from participating in the drug trial. That wasn't the case. The participants were misled regarding the safety of the experimental drug -- everything went terribly wrong -- and one of the six men has now been told he is showing signs of cancer.

Another egregious event has occurred on the other side of the pond, according to news of an allegation made by a woman who claims she was used as an experimental cancer drug guinea pig without consent.

The story began last year when Trelene Cave was diagnosed with ovarian cancer. Treated at Epsom General Hospital and the Royal Marsden Hospital in Sutton, she was later sent to St George's Hospital for a second opinion before undergoing an operation. The trouble begins when St George's Hospital doctors allegedly treated Cave with Scotroc4, an experimental cancer drug, without her informed consent. She developed a blood clot and almost died.

Cave states in the news report that, "I trusted them totally. Nobody discussed it with me. I just can't understand it."

St George's Healthcare Trust has apologized to her and her husband Norman for the incident. An investigation has been called for into whether St George's Hospital doctors side-stepped ethical guidelines in treating Cave without her knowledge.

Thanks to Joel Arellano of Autoblog for this story tip!

Cloning Dolly to cloning designer humans

Remember Dolly the first successfully cloned sheep? In 1997, a scientist named Ian Wilmut stunned the world when he announced he had successfully cloned a sheep from an adult cell. With a new book, After Dolly, set for release on June 12, Wilmut is suggesting that we should seriously consider cloning babies to put an end to genetic disease. But Wilmut says he is not suggesting the practice of genetic enhancement to create designer babies. It certainly sounds like that is what he is saying when he suggests that parents, with the assistance of scientists, be allowed to combine the cloning of human embryos with genetic modification to eliminate hereditary disease. The process of creating designer babies is the same, the intent of purpose separated by a thin veil. Regardless of what he says he is or is not saying -- what he is describing is the eventuality of designer humans.

Wilmut states, "The use of genetic and reproductive technologies is not a step backward into darkness, but a step forward into the light." But in following Wilmut into his light, will our eventual fate be that of Icarus, who soared toward the sun on wax wings? I don't want to go all Luddite, but I am very uneasy about the ethics and where this all leads. And to take it to the next level, will there one day in the future be two races of humans? The genetically perfect designer human, and the genetically-imperfect unmodified human. How will it work? Who will decide? What do you think? 

Cancer vaccine facing religious Christian-right opposition

Don't say I didn't warn you ahead of time we were going to hit this pothole on the cervical cancer vaccine road.  To briefly recap, last month I noticed Merck was running a television PSA, Tell Someone, in an attempt raise awareness about the virus that can lead to cervical cancer. Not once did it mention anything about the cervical cancer vaccine Merck was hoping to win FDA approval for -- and the same cervical cancer vaccine that will be available as early as next month. Let's remember this vaccine works best if administered to girls before they become sexually active. I mused that this was an intentional preemptive move on the part of Merck to the inevitable resistance from the Christian-right and other religious groups over a vaccine associated with sexual activity.

I predicted it was going to be a controversial issue and debate where sexual activity of teenage girls became the focal point and not the potentially life-saving cancer prevention vaccine. I was betting that the awareness-raising ad campaign from the drug company in the virus link to cervical cancer was an attempt to minimize the debate with an educational approach.

Sure enough, today I ran across a Reuters news article reporting just such an admission on the part of the drug company and discussion we will call the big bump in the road. Merck admits that its educational PSA was an effort to win over the Christian Right to the benefits of a vaccine to prevent cancer. Hang on to your seat -- we are coming up to the pothole.  Merck has revealed its plans to push for the vaccine as mandatory to school admission.

This is where the opposition from the Christian-right becomes more of an abyss than a pothole. The Christian Right feels the cervical cancer vaccine will lead to promiscuity and a false sense of security. Evangelical Christian groups, such as the Family Research Council and Focus on the Family, believe that it should be left up to parents to decide if their daughters are protected against cervical cancer by way of a vaccine. It's all about sex. It's all about the religious philosophies concerning sexual activity and eventually -- and sadly -- little to do with saving lives or preventing cancer.

Cervical cancer virus and vaccine for teenage girls

That there is an effective cervical cancer vaccine about to hit the market is encouraging news. Any successful and safe cancer prevention method is good news. Recently, a public service announcement, PSA, has been airing on television attempting to raise awareness about the virus that can lead to cervical cancer. The PSA I am seeing is coming from Merck, one of the drug companies that will be selling the vaccine. Unless I am mistaken, not once does the PSA mention the vaccine -- only the virus associated with cervical cancer. I believe this is intentional. I believe the drug company might be anticipating a resistance from the parents of teenage daughters to the vaccine based on ethical and moral grounds. If I were a drug company, I would quickly and reasonably decide to try to keep the vaccine above the fray of ethical and moral objections by promoting education about the virus.

Vaccines are a preventative measure against virus, not a treatment for after-exposure to a virus. As such, the ideal population to reach with a cervical cancer vaccine that protects against the sexually-transmitted human papilloma virus, HPV, will be teenage girls before they become sexually active. I predict it is going to be a controversial issue and debate where sexual activity of teenage girls becomes the focal point and not the potentially life-saving cancer prevention vaccine. I am betting the current awareness-raising ad campaign from the drug company in the virus link to cervical cancer is an attempt to minimize the debate with an educational approach. That's my hunch.

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