Archive for August, 2007
August 16th, 2007
An Indian court earlier this month ruled against Swiss pharmaceutical company Novartis’ challenge to India’s right to refuse patents on existing medicines. While international aid agency Oxfam and the Interfaith Center on Corporate Responsibility (ICCR), an institutional investor organization, see the verdict as “an important victory for global public health,” Novartis is worried that the “Indian court ruling will discourage investments in innovation needed to bring better medicines to patients.” Novartis is a widely held stock in socially screened portfolios.
The ramifications of this ruling by the High Court in Chennai reach well beyond India to other developing nations, largely because of India’s important role as a manufacturer of generic drugs. Oxfam reports that over two-thirds of the generic drugs made in India are then exported to other developing countries for considerably less cost than the patented brand medicines. Unicef, Doctors Without Boarders, and other aid programs also depend on the low cost generic medicines manufactured in India.
The lawsuit hinged, in large part, on how drug innovation occurs and if slight differences in medicines, i.e. “incremental innovation,” require new patents for the drugs. Novartis brought India to court challenging the constitutionality of the Section 3(d) of the provision of Indian Law that states patent monopolies will be awarded for only “truly innovative medicines” rather than minor changes of existing medicines. The US Supreme Court also recently ruled in favor of stricter criteria for medicine patents.
“This case has always been about gaining clarity on how innovation is valued and protected in India,” said Carrie Scott, spokesperson for Novartis. “Medical progress occurs through incremental innovation, and Section 3(d) excludes these important developments, ultimately denying patients in India new and better medicines. Effective patent systems help patients because incentives are in place that stimulate long-term research and development efforts needed to develop better medicines and ground-breaking therapies like Glivec.”
However, some drug companies practice “evergreening” with their products, the act of seeking to extend the market exclusivity of a product by introducing small changes that do not offer therapeutic value just before a patent expires. “Evergreening” and “incremental innovation” can be confused. The idea that medicines are developed through incremental innovation is also heavily debated.
The World Trade Organization (WTO) in 1994 confirmed the Agreement on Trade Related Intellectual Property (TRIPS) to balance the rights of developing countries to protect public health and the rights of intellectual property. In 2001, developing and developed nations met again over TRIPS to clarify the agreement. India’s provision is safeguarded by TRIPS, Oxfam reports.
“We are satisfied with the ruling,” said Rohit Malpani, Policy Advisor for Oxfam America. “It seems some pharmaceutical companies think they are beyond TRIPS. As they enter developing nations, they need to create a middle ground to offer medicines. Their approaches need to be voluntary, company-by-company, and medicine-by-medicine. In developing countries, drug companies could have tiered pricing within the country and between countries.”
Oxfam and ICCR saw the Novartis court challenge as a threat to millions of people in developing countries too poor to buy patented medicines. Besides risking public health, Oxfam and ICCR believe the lawsuit threatens to damage Novartis’ reputation in developed and developing countries.
Almost half a million people signed petitions that asked Novartis to pull the case. Oxfam also noted that between 80-90,000 emails and telephone calls were placed to Novartis. Some are worried that there might be a backlash against the company or even a regulatory backlash, lowering its stock price. Emerging markets like India could also see a backlash against the drug maker.
“We felt that if Novartis won the case in India, it would have serious impact in developing nations,” said Lauren Compere, Co-chair of the Access to Health Working Group of the ICCR and Director of Shareholder Advocacy at Boston Common Asset Management. “We are looking at the patents that support the manufacturing of generic pandemic medicines in India. This is a test case for TB, HIV/AIDS and anti-viral drugs that have a big impact in that part of the world. The crux of the issue is patent on non-innovative drugs.”
However, the irony is that currently Novartis doesn’t sell Glivec in India and 99% of the patients prescribed Glivec in India receive it free from Novartis through its Glivec International Patient Assistance Program ( GIPAP.)
Novartis reported that its access-to-medicine programs reached over 33 million patients worldwide in 2006, with contributions totaling nearly a billion Swiss francs. This represented some 2% of its total net sales donated to patients and research into neglected diseases.
Scott told SocialFunds.com, “This case did not threaten the supply of medicines from India to poor countries given the safeguards already in place. Medicines are made available through tiered-pricing solutions, public-private partnerships, shared contribution models and donation programs.”
However, giving away free drugs is not the issue, as much as the 7,500 patients who have received free Glivec might appreciate it. “Medical philanthropy is not sustainable for developing nations,” said Oxfams’s Malpani, “Countries need to have functioning public health care systems.”
“In India, Novartis is faced with a globalization dilemma that characterizes many emerging economic powers today: two markets within one country. India has a booming middle class on one hand, and a vast number of extremely poor people on the other,” said Novartis’ spokesperson Scott. “As a result, in India, we are pursuing a dual, patient-focused strategy. We are aware of the many obstacles poor patients face regarding access to medical care there. At the same time, we take affluent India seriously as a formidable world power with all the rights and obligations that such status brings with it. ”
The Indian court has deferred to the WTO to resolve the question on TRIPS compliance. The Glivec patent appeal is still not decided and the Intellectual Property Appellate Board (IPAB) review continues as a separate proceeding. Although the drug maker could appeal to the Indian Supreme court or ask the Swiss government to present it before the World Court, Novartis told SocialFunds.com the company will likely not appeal the decision. What happens next will be probably be behind the scene, with harder lobbying by Novartis and other drug companies of the Indian government to rewrite laws.
August 14th, 2007
Charts used to check whether babies are the right weight are being revised amid concern that they lead to overfeeding.
Up to now the growth charts used by health visitors have been based on the weight gain of babies given formula milk - which is faster than those being breastfed.
But child health doctors fear that the 20-year-old guidance has been used to pressure some mothers into overfeeding because, according to the charts, their breastfed babies are ‘failing to thrive’.
Some mothers have been told to supplement breast milk with the bottle - or even to stop breastfeeding altogether, it is claimed.
There are fears that overfeeding in infancy brings health problems in later life.
Infants given high-protein bottled milk tend to be larger than those who are breastfeeding, but they may find it harder to shake off the weight in adulthood.
Revising the charts downwards could help slow the obesity epidemic by reflecting the slower weight gain of breastfeeding babies.
The new charts covering children up to the age of two have been drawn up by the World Health Organisation, after a study of 8,000 breastfed babies from six cities around the world, and will be tried out in pilot studies in England before being more widely adopted.
It is estimated the new charts, which are backed by the Royal College of Paediatrics and Child Health, would redefine a quarter of all babies as heavier than the norm.
There will be a lower range of ‘healthy’ weights for all babies, with slightly fewer deemed to be underweight at any age.
For example, under existing charts a healthy one-year-old weighs between 22.5lb and 28.5lb.
But the new chart says the ideal range is from 21lb and 26lb.
Peter Aggett, professor of child health at the University of Central Lancashire, said manufacturers are planning to reduce slightly the calorie content of formula milk to more closely reflect breast milk.
He said: “New mothers often say they feel heavy pressure from health visitors using the old charts to feed up babies they claim are failingto thrive.
“The new charts will be a more accurate guide to what should happen if the babies are being breastfed.
“Formula-fed children tend to gain weight fastest and those who are overweight may end up having health problems in later life such as obesity, high blood pressure, diabetes and heart disease.
“The new charts should prevent babies getting overweight because we’ll be able to warn mothers if their children are overfeeding.”
The Department of Health recommends exclusive breastfeeding up to six months but only 25 per cent of mothers in Britain breastfeed their babies at least some of the time for the first six months.
Many of these also give their babies some formula.
Public Health Minister Dawn Primarolo said: “We are committed to promoting breastfeeding and these new standards will help alleviate mothers’ concerns regarding the difference in growth patterns often observed between breastfed and formula-fed babies.
“Our next step is to consider the practical aspects of implementing them effectively.”
A spokesman for the Infant and Dietetic Foods Association said: “Our main concern is the supply of nutritionally safe infant formula for mothers who cannot or choose not to breast feed.”
He added: “We await the outcome of the pilot study on the implementation of the charts in the UK.”
August 10th, 2007
Women who undergo cosmetic breast augmentation surgeries are three times as likely to commit suicide as those who don’t have surgically enhanced breasts, a new study finds.The increase in suicide risk does not emerge until about 10 years or more after women receive the implants, the research shows.
This latest study adds to a growing body of research finding that women with cosmetic breast implants are much more likely to take their own lives, said study lead investigator Loren Lipworth, a senior epidemiologist at the International Epidemiology Institute in Rockville, Md. “It’s one of five studies that have consistently shown an increased risk of suicide among women with cosmetic breast implants,” she noted.
There’s nothing about the breast implant itself that leads to increased likelihood of suicide, added Lipworth, who is also an assistant professor of preventive medicine at Vanderbilt University Medical Center in Nashville, Tenn. “Some women who get them are more likely to have psychiatric problems leading to suicide,” she speculated.
The study is published in the August issue of Annals of Plastic Surgery
Breast augmentation remained the most popular cosmetic surgery procedure in the United States in 2006, according to the latest statistics released by the American Society of Plastic Surgeons. An estimated 329,000 breast augmentation procedures were performed, with the average surgeon charging about $3,600 per procedure, the society found.
In the most recent study, Lipworth’s team tracked outcomes for more than 3,500 Swedish women who underwent cosmetic breast implant surgery in the years 1965 to 1993. They used death certificate information to analyze the causes of death among women with the implants and compared it to data for the general female population.
After a follow-up of almost 19 years, the suicide rate was three times higher for women with implants compared with the general population. There were 24 suicides in the implant group. The risk of suicide was nearly seven times higher for women who got their implants at age 45 or older, the researchers found.
The excess in risk didn’t become significant until 10 years after the implants were placed.
As to why the risk became statistically significant only later on, Lipworth speculated that, “it’s possible that some women who may have had psychiatric illness prior to the implant may experience improvement in psychological functioning in the short term [after implant], but it’s not sustained. So, 10 or 20 years out, there may be a recurrence or worsening of psychiatric problems.”
Lipworth said the five other studies that also found similar trends were done in five different countries: the United States, Sweden, Denmark, Canada and Finland.
Besides the suicide risk, women with enhanced breasts had higher rates of death from psychiatric disorders, including a threefold increase in deaths caused by alcohol or drug dependence. In all, 38 deaths (about a fifth of the total) in the breast implant group were linked with suicide, psychological problems, or drug or alcohol abuse or dependence, Lipworth said.
The American Society of Plastic Surgeons had no immediate comment on the study.
Another expert, David B. Sarwer, associate professor of psychology at the Center for Human Appearance, University of Pennsylvania School of Medicine, Philadelphia, wrote the “invited discussion” that accompanied the study.
In it, he urged physicians to heed the study results and to assess patients before they undergo cosmetic breast implants and other procedures, in particular looking for psychiatric problems. If a woman is under psychiatric treatment, Sarwer also urged the plastic surgeon to contact her mental health professional to assess whether she is stable enough for the surgery.
In an interview, Sarwer said “women thinking about breast implants or any form of cosmetic surgery should ask themselves three basic questions,” including, What is the nature of my concern? Are the areas I want to improve modest defects that others don’t even see when they are mentioned?
The woman should also ask if her motivation is internal or external. For example, if she is getting a breast augmentation to gain a promotion or save a marriage, that’s not a good sign, he said. However, if she believes the breast change will improve her appearance in a reasonable way, that’s a better sign.
Women should also be asked if they have realistic post-op expectations. Those who agree with statements such as “People will find me much more attractive” or “I’ll have more friends” may be in for difficulties later, Sarwer said.
The news isn’t all bad, he added. “Clearly, there are psychological benefits associated with cosmetic surgery and breast implants,” he said. “But, a small minority of patients have these very unfortunate outcomes.”
August 9th, 2007
Women who are obese just before becoming pregnant face the risk of delivering babies having birth defects, according to a new study by researchers at the University of Texas. The details of the study appear in the Archives of Pediatrics and Adolescent Medicine.
Researchers used data from the National Birth Defects Prevention Study and analyzed over 15,000 cases before arriving at this conclusion. They also examined data from 1997 and 2002 and looked at 10,000 babies with birth defects, comparing them to 4,000 normal babies.
Lead researcher Dr. D. Kim Waller and colleagues found that obese mothers were twice more likely to deliver babies that would have a spinal defect called spina bifida. Other defects involving heart, anus, penis, limbs, diaphragm and navel were also prevalent in babies born to obese mothers.
The researchers said, “A similar mechanism to that occurring in women with diabetes may be responsible for the associations observed between maternal obesity and specific categories of birth defects”. Earlier studies have linked high glucose levels during pregnancy to prevalence of birth defects in offspring.
“Our study supports previous evidence as well as provides new evidence for the associations between maternal obesity and particular categories of birth defects,” the researchers concluded.
The study also found that underweight mothers were at risk of delivering babies with cleft lip.
August 7th, 2007
EXTREMELY obese bodies are becoming a safety hazard in mortuaries, according to pathologists who are calling for new “heavy duty” autopsy facilities as Australians get fatter.
Forensic scientists say they are struggling to cope with a growing number of morbidly obese corpses that are difficult to move and dangerously heavy for standard-size trolleys and lifting hoists.
The bodies presented “major logistical problems” and “significant occupational health and safety issues”, the specialists have cautioned.
Mortuary workers are adding their voices to concerned calls from crematorium and hospital staff about infrastructure that is unsuitable for the growing number of very fat Australians.
Statistics show 3.2 million people are already obese, with the number predicted to climb to 7.2 million in less than 20 years.
The number of obese and morbidly obese bodies handled by a typical mortuary has doubled in the past 20 years.
In a recent study, a third of 255 bodies examined in South Australia were obese.
A further 6 per cent were in the extreme range. “This study demonstrates that forensic facilities are now dealing with individuals of considerable body mass,” University of Adelaide pathologist Roger Byard wrote in The Medical Journal of Australia.
Mortuary equipment was not designed to take such weights, and the faster putrefaction and “skin slippage” of bigger bodies made them even more difficult to handle, Professor Byard said.
He said specially designed mortuaries would soon be needed if the nation failed to curb the fat epidemic.
August 4th, 2007
If you think people have sex for pleasure and for procreation, you’re right. They also have sex to get rid of a headache, to celebrate a special occasion, to get a promotion and to feel closer to God.
New research published in the August issue of Archives of Sexual Behavior has come up with a list of 237 reasons that motivate people to have sex.
Who knew?
Cindy Meston, a professor of psychology at the University of Texas at Austin and the lead author of the paper, said most people assume there are a few simple reasons for having sex: “It feels good, you’re in love, or you want to have a child. We found that people are having sex for lots of other reasons.”
Knowing that, she said, could boost sex education, help devise more effective strategies for preventing the spread of sexually transmitted diseases and lead to improved treatments for people with sexual problems.
“You need to know why people are having sex if you’re trying to put into place a safe-sex program,” Meston said. “If you assume people have sex because they’re in the heat of the moment, then [you tell them to] carry condoms. But if they’re doing it for revenge or because they want to enhance their social status, that will require a different strategy.”
Meston and co-author David Buss conducted their research in two stages. First, they asked a group of more than 400 students and volunteers to simply list “all the reasons you can think of why you, or someone you have known, has engaged in sexual intercourse in the past.” That produced 715 reasons. After deleting identical or very similar entries, the researchers were left with 237.
Some were “pretty shocking,” Meston said, such as “I wanted to give someone else a sexually transmitted disease.” She said she also was surprised that some people said they had sex because “I wanted to get closer to God.”
“Most of the literature shows that religious people have more sexual problems,” she said. “But several people endorsed the idea that religion and sexuality were actually closely linked.”
In the second stage of the research, they asked 1,500 other students to rate how important each of the 237 reasons was in their own sexual behavior.
The students were asked to indicate how frequently each reason had led them to engage in sexual intercourse in the past, on a scale from 1 for never to 5 for all the time. Those who had not had intercourse (27 percent of the women and 32 percent of the men) were asked to indicate the likelihood that each of the reasons would lead them to have sex in the future.
Men, women share reasons
Most of the students gave the usual reasons for having sex: “I was attracted to the person,” “It feels good” and, “I wanted to show my affection” were high on the lists of both men and women. Lesser priorities on both lists were reasons such as, “Someone offered me money to do it,” “I felt sorry for the person,” “I wanted to punish myself” and, “Because of a bet.”
Meston said she was somewhat surprised by the similarities between the genders. Men were more likely to endorse having sex for physical reasons (such as, “The person was too hot to resist”) and to boost their social status (”I wanted to brag to my friends about my conquests.”) But there was no difference in the emotional reasons, such as, “I wanted to express my love for the person.”
“The stereotype that men have sex for physical reasons and women have sex for love — our data didn’t really support that,” Meston said. “These young men and women were having sex for physical pleasure and also for emotional attachment, feeling connected to another person.”
Meston and Buss said their findings contradict the stereotype that women, more than men, use sex to obtain special favors. In their study, men were more likely to endorse reasons for having sex that involved utilitarian goals (”To get a favor from someone”).
Leonore Tiefer, a sex therapist and psychologist at New York University School of Medicine, said the findings did not really answer the question, “Why Humans Have Sex,” as the title of the paper asserts.
“It’s why Texas students say they have sex,” Tiefer said.
Nevertheless, she said, it’s “useful to discuss motives, as opposed to just counting.”
Meston acknowledged the limitation of her research and said she planned to look at other populations.
August 1st, 2007
Diet pills are prominent in the marketplace today. They are indeed a very tempting avenue to take if you are trying to lose weight.If you have been trying unsuccessfully so far, the temptation to add diet pills to your efforts is great. Diet pills offer us everything we want to achieve in a quick fix.
The attraction of diet pills and there appealing weight loss claims can be hard to pass up as is evidenced by vast growth in this industry in the past few years.
But are all diet pills as safe and effective as they claim to be?
But the big question still remains - Do diet pills actually work? And if they do in fact work, which diet pill is right for me?
The effectiveness of diet pills and their ingredients therein have been studied at length by various research groups and organizations throughout the world.
Problematically this research has brought together or published in such a way that consumers have been able to gain a complete understanding of the research and compare the different diet pills and weight loss products available on the market in order to make an educated purchasing decision.
This lack of organization and subsequent publication of information has made it difficult at best for consumers to be 100% comfortable in making their decision when it comes to diet pills and weight loss products.
With recent estimates on consumer spending at $50 billion per year on weight loss products, the weight loss market has exploded and as such consumers have become increasingly more concerned with the effectiveness and the safety of the products that they may be considering.
At weight-loss-won we endeavor to help consumers in this market to avoid buying potentially harmful, worthless, or even fraudulent weight loss products.
We have reviewed many of the current diet pills on the market today and their ingredients. Just below you’ll find an overview of some of the more common and popular diet pills on the market today.
As expected as part of our research and review of diet pills we came across a wide variety of effectiveness with the products and even some with know side effects.