Outsourcing drug trials

Many UK firms, particularly utilities, telecom and the finance industry, went through a period of outsourcing their customer departments to India where there is a vast and skilled workforce who the companies’ jobs done cheaper and faster. Many found that it may have saved money but it hugely increased customer complaints and a sense of being dislocated from their money and accounts, and now it looks as if the pharmaceutical industry in the United States is heading down that same road.

This time the complaints are not about the jobs that are being outsourced, but about the dangers to the health and safety of the Indian workers. It’s all about the development of new drugs, because the cost of bringing a new one to market is, on average, $1 billion. The bulk of that cost is devoted to human clinical trials — the most crucial and time-consuming phase of drug development. Faced with tight regulations at home and shrinking profits due to expiring drug patents, western drug makers are looking to expedite the process by outsourcing safety and efficacy studies to developing countries, a large proportion of them to India. An amendment proposed last year by the technical advisory committee of India’s Health Ministry would further allow drug companies to test their products widely on patients in India before they’re proved safe at home, which is causing alarm bells to ring as drug testing can be a dangerous business for the volunteers.

The UK has had some experience of just how dangerous that can be in 2006, when six men nearly died in a safety trial when given an experimental antibody drug called TGN1412. This was its first human trial, and the drug caused multiple organ failure in all six men. Speedy action on the part of the doctors saved their lives, but the concern is that such experiments could be potentially devastating in a country that lacks the medical infrastructure to care for people harmed by untested drugs. There are currently some 400 clinical trials underway in India, where the business is expected to be worth $1 billion to $1.5 billion by 2010. For western drug companies, it’s a boon: India’s vast pool of qualified, English-speaking doctors and lower labour costs make clinical trials up to 50% to 60% cheaper and it’s not just money the drug companies are saving.

India also offers a crucial savings on time. A drug patent lasts 20 years; during the first seven or eight years of that period, typically, a new drug is tied up in several rounds of human clinical trials. That leaves little time for the drug maker to market and profit from the product. To speed up trials, pharmaceutical companies need to recruit large numbers of subjects quickly, something that is often not possible in western countries, where most patients have health insurance or government benefits and are reluctant to sign up. In India, by contrast, much of the population has no health insurance, and public health services can be widely variable. The promise of getting regular medical attention by enrolling in a trial is often too valuable to pass up so that many patients enter into clinical trials because they have no better option to receiving care.

This is not just a theoretical problem; already, toxic drugs have posed problems. In 2002, a human trial in India, along with 31 other countries, of Novo Nordisk’s diabetes drug ragaglitazar had to be suspended after a trial in mice revealed that the compound caused urinary bladder tumors. In 2003, news circulated that researchers from India-based Sun Pharmaceuticals had given the anticancer drug letrozole to 430 young women to see if it would induce ovulation, despite the fact that the drug is known to be toxic to embryos.

No one wants to deny such a rich source of income to India, but if clinical trials which will affect thousands of patients are not properly monitored and conducted then we could be facing new drugs marketed with too much haste and not enough control.

What happens in the USA is often what happens in the UK a short time later, but I hope this is one trend that does not make it across the Atlantic unless we get some very strong reassurances about the need to outsource a vital component of our healthcare system.

The fertile gender difference

When it comes to planning a family, looking at the couple’s diet is often a first step but this usually comes down to having a balanced, healthy diet of lots of fruit and vegetables and with minimum potential risks such as additives, fats, alcohol and smoking. However, some preliminary research from Australia seems to indicate that there may be a different factor to consider when looking at fertility and reproductive success.

This research is based on long-term studies on Australian black field crickets, so no tests on humans yet, but its finding could be highly relevant. Lead researcher Rob Brooks and his team have discovered that the lifespan of both male and female crickets is maximized on high-carbohydrate, low-protein diets, and reported this finding in the latest issue of Current Biology. But the interesting fact to emerge is that reproductive success differs dramatically between the sexes when the carbohydrate-protein balance is changed. Males have the greatest reproductive success with a diet that favours carbohydrates to protein by eight-to-one. Females have greatest success when the protein/carbohydrate ratio is just one-to-one.

More research is clearly needed, but to maximise fertility in the meantime, the best course is to follow the anti-inflammatory or wellness diet. This is based on principles that have been shown to promote longevity and reproductive health in both men and women throughout their lives, and if you would like a copy of it please contact us.

Magnetic help for cancer

Any fans of the late Tommy Cooper out there? Well, a new scientific development would certainly have caused those famous eyebrows to wiggle. Instead of levitating a human, scientists seem to have found a way to levitate cancer cells. Magicians never reveal their tricks, but scientists like to share, so before we cry Abracadabra, just how is it done?

It’s not done with mirrors, but with magnets apparently. By binding magnetic nanoparticles (very tiny particles of materials which can occur naturally, or be manufactured, so that they are smaller than normal – usually sized between 1 and 100 nanometers) to cancer cells. Researchers at the Georgia Institute of Technology in the USA took human ovarian cancer cells and made the cancerous cells rise to the skin surface by simply passing a magnet over them.

It may seem like magic, but the trick lies in the nanoparticles. The particles are ten nanometers or less in size and have traces of cobalt inside a ball of magnetite. Those metallic pieces are attached to a protein that only binds to a specific protein found on the surface of ovarian cancer cells. The researchers injected the nanoparticles, which also contained a colored dye, into mice with human ovarian cancer cells. The nanoparticles circulated though the mouse’s body and attached themselves to the cancer cells.

Then the researchers applied a magnet to the stomach of the mice and the cells rose and colored the skin of the mice. The researchers focused on ovarian cancer initially because of their previous research. However, they note that the nanoparticles were originally developed to bind to viruses, and depending on the protein being used, could also bind to proteins on the surface of other cancer cells, bacteria, and viruses.

It’s not ready to use yet however, as before any potential therapy can be applied to real human patients, the nanoparticles will have to pass clinical trials. The Georgia Tech scientists hope to begin two separate clinical trials within the year and their method would be to bring the cancer cells to the nanoparticles. By taking the blood and fluids out of the body and running them through a machine the nanoparticles would act like a filter, grabbing hold of any cancer cells that pass next to them while the healthy fluids pass back into the body. This way the nanoparticles never enter the body, decreasing the chances of any adverse reaction. The research could be used to identify and remove cancer cells, as well as bacteria and viruses, as in principle this technique could be applied to any pathogen that is found in the blood stream according to John McDonald, coauthor of the paper that appeared in the Journal of the American Chemical Society.

Stem cells created for 10 genetic disorders

It was reported back in November 2007 last year that research teams in Wisconsin and Japan had reprogrammed skin cells, and that the cells had behaved like stem cells in a series of lab tests. This new technique could lead to treatments for diseases including Parkinson’s and more developments keep coming in.

Just last week, Harvard team of scientists said they had reprogrammed skin cells from two elderly patients with ALS, (Amyotrophic Lateral Sclerosis) a degenerative motor neuron disease, and grew the reprogrammed skin cells into nerve cells.

Now, scientists at the Harvard Stem Cell Institute in the USA say they have created stems cells for 10 genetic disorders, which will allow researchers to watch the diseases develop in a lab dish and watch what goes right, and wrong. This early step, using a new technique, could help speed up efforts to find treatments for some of the most confounding ailments and was reported online Thursday in the journal Cell.

Dr. George Daley and his colleagues used ordinary skin cells and bone marrow from people with a variety of diseases, including Parkinson’s, Huntington’s and Down syndrome to produce the stem cells. Like the previous research, this technique reprogrammed the cells, giving them the chameleon-like qualities of embryonic stem cells, which can morph into all kinds of tissue, such as heart, nerve and brain. As with embryonic stem cells, the hope is to speed medical research into the degenerative diseases for which there are currently no good treatments and, more importantly, no good animal models for the most part in studying them.

Mobile phones and children

There has been plenty of media coverage about the over use of mobile phones, particularly in adults, and the potential health hazards. It is the radiation emissions from the phones that could place users at risk of brain conditions including Alzheimer’s disease, and they have also been linked to cellular DNA damage, and children and teenagers are particularly vulnerable. Nor does the phone have to be switched on to cause a problem: even on standby mobile phones (and cordless phones) create a magnetic field.

It was in 2005 that research by the Irish Doctors Environmental Association (IDEA) first claimed to have found the first proof of health problems caused by mobile phones. They estimated that up to five per cent of the population could be suffering headaches, mood swings and hearing problems caused by radiation from handsets. At that time too, experts advising the Government warned that children under eight should not be given mobile phones because of the potential health risks. Now news is in from Canada where the Toronto department of public health has announced that children under the age of eight should not use a mobile, or cell, phone only in an emergency and young teenagers should restrict their use to just 10 minutes a day. Loren Vanderlinden, a health department supervisor and author of the report, has said that new studies are starting to suggest that long-term mobile phone usage may increase the risk of brain tumours, and this goes much further than the more tentative position of the UK health officials a few years ago when they also warned parents not to let children use a mobile.

WHAT CAN YOU DO?

It may be hard, if not impossible to wean a teenager from their mobile phone or to restrict the time they are on it. However, there are some options for reducing the radiation that can help anyone who has prolonged use of a mobile. First it might be helpful to know what are the symptoms of over use:

** “Hot ear” effect / feel your brain is heated up
** Headache Fatigue / tiredness
** Nausea
** General discomfort
** Blurred vision

One of the ways to counteract the radiation is to have a device attached to the phone to affect how cells “receive / react” to wave radiations and usually this is done through some form of magnet. There is a website that offers Biophone and Bioguard – a unique technology that they claim is scientifically proven and works with a number of phones including Nokia, Sony Ericsson, Motorola, Samsung, and others – so if you want to know more visit them at www.biofona.co.uk and browse through the site.

Oh Really?

This week’s winner in the ‘how did they get money to research that’ contest comes from a recent study, which appeared in the American Journal of Clinical Nutrition. I know you are going to struggle to believe this, but apparently watching too much TV is associated with poor health, in particular, lack of weight loss and an increased risk of excess weight/obesity. Oh really? The researchers looked at a group of young adults aged 26-36 and assessed them for waist size, TV viewing time, amount of food and drink consumed during TV viewing, and physical activity levels during leisure time.

I want to help you here, so be aware that if you want to reduce your waistline, then reduce your tv hours first. Apparently, women who watched 3 or more hours a day had an 89% increased risk of severe obesity compared to those watching 1 hour of TV a day or less. Unfairly, it seems to me, men get off more lightly – but that is still no excuse for hanging on to the remote. Men watching 3 or more hours of TV a day were more than twice as likely to have moderate obesity compared to those watching 1 hour of TV a day or less.

You might have thought this would be offset by what people did in their spare time, but it seems not to have been the case. Whether you rollerblade or sit and watch the world go by is not particularly influential when compared to how much tv you watch. There is also the fact that watching tv is also associated with snacking, not generally on carrot and celery sticks, so that could also be a factor. TV turns the mind off, which turns off the mind/body connection and the internal desire to eat healthy food, and someone who watches a lot of television is more likely to be influenced by advertisements, which generally encourage you to eat more of the sweets/crisps/chocolates rather than healthier options.

Osteoporosis drugs questionmark

Some years ago I set up the Natural Progesterone Information Service to provide women with the latest news on natural hormones rather than synthetic ones such as HRT. One of the things that John Lee talked a lot about all those years ago was how in his opinion the biphosphonate drugs given for osteoporosis were actually weakening the bone rather than helping to build it. He had seen great results with women using natural progesterone to build bone density, though the medical profession did not accept that progesterone could work more effectively than the drugs. Now after all these years, more questions have emerged about whether long-term use of bone-building drugs for osteoporosis may actually lead to weaker bones in a small number of people who use them. Case reports show an unusual fracture pattern in people who have used bone-building drugs, the biphosphonates, for five years or more.

If you are taking such drugs please ensure you are also having regular bone scans to check your progess and it would be worth looking at your diet and natural supplements that can help build bone such as horsetail and silica. If you would like information on natural progesterone for osteoporosis and HRT replacement (I no longer have any connection with the service since I gave up running it) you can obtain a booklet from the Natural Progesterone Information Service, tel: 07000 784849 or visit their website at www.npis.info.
Wellspring Trading in Guernsey also have an excellent free booklet on natural progesterone cream which is written by my good friend and colleague, Dr Shirley Bond – a private GP who specialises in hormone therapy for women. Wellspring’s telephone number is – 01481 233 370.

Pets and pregnancy – A warning

A new study shows that pregnant women who use flea and tick shampoos on pets may double the risk of autism in their children. This preliminary finding comes from the Childhood Autism Risks from Genetics and the Environment study (CHARGE) – a case-control study from the University of California Davis, in the US.

The results are part of an ongoing research project which is following 2,000 children – some with autism, some with developmental delay, and some with typical development – and compares individual genetic patterns with exposure to medications, chemicals, food products, and other environmental factors.

It is believed that it is pyrethrins, commonly used chemicals in insecticides, that may play a role in triggering autism in certain children. Pyrethrins are extracted from Chrysanthemum flowers and are regarded as low in toxicity and there are commercial pyrethrum formulas that are considered safe to use in food preparation areas where flies and other insects can be found. One other product where Pyrethrins are widely used is in lice-control shampoos for humans and pets.

As I mentioned earlier, this is only a preliminary study but it would be a sensible precaution for pregnant women to avoid contact with lice-control shampoos. Let someone else shampoo the dog, or look for shampoos that treat lice naturally with ingredients such as tea tree oil, and not pyrethrins.

An effective vaccine for bird flu?

The words ‘bird flu’ have struck terror into many in the food industry as well as those concerned for wildlife. The H5N1 avian flu virus has become entrenched among birds in much of Asia and parts of Europe, Africa and the Middle East. It rarely infects people but it has killed 243 people out of 385 infected in 15 countries, according to the World Health Organization.

Experts fear the constantly mutating virus could change into a form easily transmitted from person to person, perhaps sweeping the world and killing millions. At least 16 companies are working on vaccines against H5N1, and although it may be too early to claim complete victory, a DNA-based vaccine against bird flu has been developed by Vical Inc. This is a US company based in San Diego who research and develop biopharmaceutical products based on a patented DNA delivery technology. They have previously been involved in developing gene-based treatments for cancer and infectious disease vaccines, and with the bird flu vaccine they are claiming that it can safely stimulate the immune system to levels expected to protect against this disease.

However, their study is a small one, using only 100 volunteers, although 67% of the patients receiving the higher dose had immune responses that could protect against infection with the H5N1 avian flu virus, with no serious adverse reactions after two injections. This was a Phase I clinical trial, meant to demonstrate the vaccine is safe, and is continuing.

DNA vaccines use bits of genetic material called plasmids. They are meant to generate an immune response against a specific bit of the virus and are designed to last longer than standard vaccines under conditions of heat and cold. If successful, Vical says a DNA-based vaccine could be made in six to eight weeks, compared with four to six months for influenza vaccines made the current way, using bits of the actual virus grown in chicken eggs and this shorter time scale is a tremendous advantage when dealing with a potentially worldwide infectious disease.

Why low cholesterol is not always a good thing

I know that in the media there is a lot of emphasis placed on the dangers of high cholesterol, however what many people fail to realise is that cholesterol is essential for your health. It’s present in every single cell in your body where it helps to produce cell membranes, hormones, vitamin D and bile acids to help you digest fat.

Cholesterol also helps in the formation of your memories and is vital for neurological function, and now scientists have discovered that there is one specific area where having low levels of one type of cholesterol has been linked to memory loss and Alzheimer’s disease.

Scientists studied more than 3,500 civil servants to investigate how levels of HDL or “good” cholesterol were associated with memory. HDL cholesterol can influence the formation of the beta-amyloid “plaques” that are a distinctive feature in the brains of Alzheimer’s patients. Higher levels of HDL are also believed to protect against damage to blood supply caused by the narrowing of the arteries.

After the five-year study period, the researchers found that people with low levels of HDL were 53% more likely to suffer memory loss than people with the highest levels of HDL. Those with impaired memory are at an increased risk of developing dementia later in life, and that is not the only area where low cholesterol levels can cause you health problems.

The Risks of Low Cholesterol

Other risks related to neurological function are depression, suicidal tendencies and may lead to violent behaviour and aggression. Cholesterol levels that are too low can also increase your risk of cancer and Parkinson’s disease so trying to reduce your cholesterol to unreasonably low levels is doing your long-term health no favours.

Why do cholesterol levels rise?

High cholesterol has become such a hot topic that many people don’t realise that it is not a disease in itself. It is actually a perfectly normal response when something has gone wrong and your body needs to make new, healthy cells. Because cholesterol is produced whenever your cells become damaged, it will show as high cholesterol levels, but if you have a lot of damaged cells, you’re also going to have a lot of cholesterol in your bloodstream. This is a good thing, because it means your cells are being repaired.

Instead of just trying to reduce the high cholesterol, it makes more sense to search for what’s causing the damage in the first place, rather than moving straight on to cholesterol-lowering drugs.

One of the most common causes of high cholesterol is inflammation, and that can be brought on by a number of factors, including:

** Too many processed foods
** Smoking
** Not enough exercise
** Emotional stress

Healthy cholesterol levels are essential to keep your cells functioning at their best, and all of those risk factors above are within your control so that might be the place to start. If stress is the issue, have a look at the website for my book on How To Cope Successfully With Stress at www.sortingstressout.com

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