Posts Tagged ‘FDA’

Asthma drug treatments in the dock – again

Wednesday, March 3rd, 2010

The US government is issuing new restrictions on four widely used asthma drugs – the long-acting beta agonists (LABAs), Foradil (formoterol fumarate), Serevent (salmeterol xinofoate), Advair (fluticasone propionate and salmeterol) and Symbicort (budesonide and formoterol fumarate dihydrate) – saying they should never be used without other asthma controllers to prevent a life-threatening risk.

These medications, which relax muscles in the lung’s airways, can be helpful for some patients but they may also mask symptoms that can trigger serious asthma attacks, especially in children.

An analysis of clinical trials showed that the severe worsening of asthma symptoms which can result from the use of these drugs can put patients in hospital and even result in death.

New labels are therefore to be required by the Food and Drug Administration stating that the drugs should be used for the shortest possible duration, and only in combination with other medications, such as inhaled steroids, that relieve airway inflammation.

See also: Asthma treatments – ancient and modern.

Crohn’s disease treatment update

Tuesday, February 9th, 2010

The treatment of Crohn’s disease usually involves the use of anti-inflammatory drugs, but these are frequently only partially effective and are also associated with serious side effects. Many patients eventually require surgery in spite of the use of these medicines.

The serious risks associated with Crohn’s medications have again been highlighted recently by a study which found that the immunosuppressant thiopurine drugs – one of the cornerstones of Crohn’s treatment – can increase the risk of cancers linked to viral infections.

Patients receiving thiopurines – such as azathioprine and Imuran – were found to have a more than five-fold increase in the risk of lymphoma compared with those who had never received these drugs. Older male patients with a longer history of inflammatory bowel disease also have an increased risk of lymphoma.

Another recent study indicated that patients with inflammatory bowel disease, especially those receiving thiopurine medications, may also be at increased risk of developing non-melanoma skin cancers.

Only in the last few days, a new warning has been issued about the drug Tysabri (Natalizumab), the multiple sclerosis medication that was approved for use in moderate to severe Crohn’s disease in early 2008.

Tysabri, which had previously been linked with a rare but deadly brain disease called progressive multifocal leukoencephalopathy (PML), has now been confirmed to increase the risk of this disease. Whilst there have been no reports of PML in patients taking Tysabri for less than 12 months, the rate in patients who use the drug for two to three years is estimated to be one case per 1,000 patients.

The search for a better treatment alternative continues with a new multi-centre trial, funded to the tune of $4.7 million, which is about to compare the use of the conventional management strategy featuring gradual escalation of drug therapy with a newer approach combining immunosuppression with a tumor necrosis factor alpha blocking drug and an anti-metabolite.

Turning to studies that are already bearing fruit, potential sources of relief for Crohn’s are being revealed by research looking at the effects of certain nutrients on the activity of this disease. For example, it appears that it may be advantageous for Crohn’s patients to vary the types of fat that they consume, especially to increase the amount of Omega-3 fatty acids and decrease the Omega-6 fats that are now found in extremely high quantities in the average Western diet.

Several studies have suggested that Omega-3 fats – available from oily fish, and fish oil supplements – exert a protective effect by modulating intestinal inflammation, and a new study has found that a high intake of total, saturated and monounsaturated fats, and a higher ratio of Omega-6 to Omega-3 polyunsaturated fatty acids, is associated with higher disease activity.

Another new study has identified a further novel treatment avenue for people with Crohn’s or other inflammatory bowel diseases, in the readily available vitamin D. The study shows, for the first time, that vitamin D deficiency can contribute to Crohn’s disease, and that supplementing with this nutrient can counter the effects of the disease.

Vitamin D impacts the immune system, specifically the innate immune system that acts as the body’s first defense against microbial invaders, and it appears that the inflammatory response, which is thought to underlie autoimmune conditions, is probably the result of a defect in the handling of intestinal bacteria by the innate immune system.

Another potentially hopeful recent study, has found that two compounds extracted from cannabis – the cannabinoids THC and cannabidiol – appear to be able to restore the gut membrane barrier by allowing epithelial cells to form tighter bonds.

Studies being carried out at Nottingham into the use of live hookworm as a therapeutic agent in Crohn’s and other autoimmune diseases is still a very long way from demonstrating efficacy, mainly due to the low numbers of worms having been used in these trials to date, and the inadequately short period that the worms have been left in place.

Nevertheless, existing research, already suggests a high degree of success from the use of hookworm, and the efficacy of this treatment is regularly confirmed by patients who have chosen not to wait for further trials, and have obtained a supply of helminths elsewhere.

Helminthic therapy is therefore arguably the current treatment of choice for Crohn’s disease, especially as it provides freedom from the long-term side effects associated with so many of the available drug treatments. Unfortunately, the FDA has recently banned the supply of helminths to anyone within the US, so American citizens who are too ill to travel are now effectively denied access to this treatment, which is available everywhere else in the world, via the internet, from Autoimmune Therapies.

The erosion of choice in healthcare

Thursday, January 14th, 2010

Those who frequent the Yahoo Helminthic Therapy forum will know that, in early November, 2009, the US Food and Drug Administrtation moved against Autoimmune Therapies, the company that supplies therapeutic doses of hookworm and whipworm to individuals who wish to use these organisms as a treatment for allergy and autoimmune disorders.

By declaring these natural ‘probiotics’ to be pharmaceuticals, the FDA effectively ended AIT’s production and shipping of helminths from within the US but, with no other company anywhere in the world able to supply these particular organisms to the scores of very sick individuals who need them, Jasper Lawrence and his colleagues were determined to continue to meet their obligations to customers, so Jasper was left with no option but to abandon his home, and leave family and friends in order to relocate in haste to another country.

Shortly after this event, I heard of two somewhat similar cases in which small companies selling completely natural products have been prosecuted by government agencies.

A small US farmer selling unadulterated, raw milk – as drunk by humans since animals were first domesticated – was prosecuted after a sting operation by a local Health Department, and a small UK firm selling a sleep-aid made solely from common grasses was prosecuted by local Trading Standards officials in Wales.

Unfortunately, these are not isolated incidents, but just further examples of the steady – one might even say stealthy – erosion of the choices available to individuals who prefer alternative or natural approaches to healthcare. And, sadly, the vast majority of citizens in the US and Europe are blissfully unaware of what is taking place.

Those who are not already aware of the situation will find enlightenment in these two blogs by Jon Barron – Alternative Health – Now You See It, Now You Don’t and Nutritional Freedom, the Frog in the Water.

I feel sure that, one day, justice and common sense will prevail and consumers will assert their right to have whatever form of healing they choose for themselves, but it could be a long time yet before this happens and things may well get much more difficult in the meantime.

Those who ask what can be done about this situation might care to examine the work of Dr Joseph Mercola, whose website has been the most visited natural medicine site in the world for the last seven years, and is now also in the top ten most visited general health sites.

In the last year, mercola.com has been instrumental in educating the public about the truth behind the Swine Flu debacle. In partnership with the National Vaccine Information Centre, mercola.com helped avoid the use of squalene in the H1N1 vaccine in the US, as well as helping to prevent mandatory H1N1 vaccination, and saving the majority of US citizens from being duped by the massive PR media campaigns into accepting an unsafe and ineffective vaccine.

This is just one example of what can be achieved when individuals are appropriately informed and enabled by the internet to make a stand against scheming corporations and a clueless government, and I urge everyone who cares about maintaining freedom of choice in healthcare to join the Mercola online community and/or to bookmark the Mercola Natural Health Newsletter (or RSS link) and the Mercola Vital Votes Blog (or RSS link).

This will keep you up to date with the latest news on health and provide sound, impartial advice on how to maintain your well-being by the most natural means possible. It will also keep you abreast of the activities of those who would sacrifice your health for dubious motives. The latter are clearly stealing some of the skirmishes but, if they go on to win the war, it will be because we have let them!

As for the three companies mentioned above, the prosecution of the Bechard family by the Missouri State Milk Board and Attorney General for selling raw milk in contravention of state regulations is ongoing. The Welsh sleep-aid manufacturer is now getting back on its feet following its prosecution, and has already picked up an award for its reformulated product, Asphalia, which I can personally vouch for as a remarkably effective and side effect-free sleep-aid. Autoimmune Therapies, meanwhile, have completed the relocation of their production department and should begin shipping hookworm again this week, with whipworm to follow in a few weeks time.