Raising money for orphan disease

Orphan diseases are the diseases those affect a very less number of people (say 100-5000 person in a country). 

Generally, pharmaceutical companies spend few billion dollars to conduct pre-clinical (using animals) and clinical (using healthy human and patients) research for develop a new medicine. Drug development generally take about 10 years. Before approving any new medicine for marketing, food and drug administration review all experimental data to confirm that medicine is safe and effective in managing/curing a disease. Generally pharmaceutical companies obtain patent (say for 10-20 years) to sale the a new medicine (and other companies can not sell same medicine till patent expires) as per patent agreement) for recovering research cost. 

In case of developing orphan drugs (the medicine used to treat orphan disease) pharmaceutical companies have difficulty to conduct extensive research  that requires lot of money and they may not get back money from few patients those use these medicine. Therefore US government passed orphan drug act in 1983 to relax few stringent criteria set to develop new medicine. Even though this effort decreases financial burden for pharmaceutical companies and few pharmaceutical companies are committed to develop medicine are orphan diseases, these efforts are not enough because the number of orphan diseases are increases every year. 

To void this gap, researchers at academic institutes are conducting research to develop new medicine. As research grants from National Institute of Health (NIH) and National Science Foundation (NSF) declined and became competitive, researchers from academic institutes and small pharma/biotech companies had been looking for alternative source of funding.

BeneFunder,  is an nonprofit organization which is raising money from wealthy Americans to fund for drug development for rare diseases apart from research on environment and computer science.  Founders of this philanthropic research funding platform realized that Americans donate 10 times more than grants issued by NIH for scientific research. Therefore the founders developed this organization to collect donation for research and donation to this organization is exempted from tax. Professor Gert Lanckrit, Ph.D., department of Computer Science and Engineering, University of California, San Diego co-founded BeneFunder. Dr. Lanckrit spoke about his experience at 1st Rare disease conference at University of California, Davis on March 5, 2015. Professor Lanckrit told that they invited financial adviser (from financial institutes like Merrill Lynch)  to visit different research lab working on innovative product. Informed financial adviser than help donors to decide in which research their money should be spent. Few donors also visit research lab to learn about latent technologies available to fight orphan disease and meet patients of orphan diseases to realize how their donations are improving life of patients. BeneFunder has employees who develop easy and attractive tools to teach financial adviser and donors.  

     

Taking care of teeth and gum

Brush two times in a day to keep gum and teeth clean. If teeth is not cleaned properly after eating food, bacteria grow and acid is released that decays teeth. Improperly cleaned teeth support development of tartar that facilitate loosening of gum. This in long run can loosen your teeth and teeth will fall early. Very hard brush can damage enamel while very soft brush can not remove dart from teeth. For many people, brushing can not remove food particles between teeth. In such case dental flush should be used to keep teeth and gum healthy.  Many times unhealthy and inflamed gum is responsible for bad breath.  

Weak teeth is sensitive to cold and hot drinks. Special medicated tooth paste are available to treat such condition, but teeth must be kept clean to get benefit of such medicated products.

Chewing gum can be helpful to keep mouth moist, but persons having deep bite problem must avoid regular use of chewing gum. 

Demerit of mercury filling...


Important website(s).
1. http://www.ada.org/en/science-research/ada-seal-of-acceptance/product-category-information/toothpaste

How animals are useful in drug development?

Before any drug is tested on humans it has to be tested on animals.

As a preliminary study, companies test the effect of new chemicals on animals. After the new chemical passes safety and efficacy standards then companies obtain permission from food and drug administration (FDA) for testing the effect of chemical on interested human subjects.   

FDA (and/ other relevant authorities) scrutinize the data of animal study to analyse the beneficial effect of new chemical on animals. After FDA is satisfied with the data then it permit to test chemicals on humans as per set standards and protocols. 

Suppose a company wants to market a new medicine to treat diabetes. It select a suitable animal model of mice/rat, and induce diabetes by administering streptozotocin and then administer new chemical to test if it decreases blood sugar. Some time isolated animal tissues are also helpful to test the effect of new chemical. When FDA is satisfied with the fact that new chemical decrease blood sugar level and safe to animal, FDA permits to test the effect of new chemicals on healthy and diabetes patients. If the new chemical meets safety and efficacy standard then company gets FDA nod to market it and now the new chemical becomes a medicine.

For science research, animal study protocol need to be approved by ethics committee. Animals are treated humanly and are maintained under standard laboratory conditions (room temperature, suitable humidity,  environment with minimal noise, sufficient food and water). 

References:

1. Mark Mathieu. New Drug Development: A regulatory overview. Parexel Intl Corp. 

2. Goswami SK, Manikanta V, Suma KG, Razdan R, Inmadar MN. Efficacy of Ellagic acid and sildenafil in Diabetes induced sexual dysfunction. Pharmacog Mag 2014; 10(Suppl S3): 581-7. 

3. Goswami SK, Inamdar MN. Screening of new compounds for the management of erectile dysfunction. J Young Pharm 2014; 6(4):51-55.

Long term use of painkiller may decrease sexual function

Long term use of painkillers like nonsteroidal anti-inflammatory drugs (NSAIDS) that reduce inflammation and pain may cause sexual dysfunction like erectile dysfunction. Approximately 30% of the male patients taking NSAIDs reported moderate or severe erectile dysfunction. If you are taking NSAIDs and feel that your erectile function decreased then you must consult doctor.  

Reference: 

Gleason JM, Slezak JM, Jung H, Reynolds K, Van den Eeden SK, Haque R, Quinn VP, Loo RK, Jacobsen SJ. Regular nonsteroidal anti-inflammatory drug use and erectile dysfunction. J Urol. 2011;185(4):1388-93. 

Cinnamon may increase sexual function of aged male

Sexual function in aged male decreases due to endothelial dysfunction (impairment of penile blood vessel and penile smooth muscle to relax) and increase in activity of bad enzymes like arginase and Rho-kinase. Cinnamon may be helpful in increasing sexual function by inhibiting action of bad enzymes and increasing penile endothelial smooth muscle. 

As per a recently published article, methanol extract of Cinnamon increased sexual function of 2 year aged rat. Fifty percent of the aged rats had lost sexual function and another fifty percent of the rats had decreased sexual function. Cinnamon extract increased sexual function of aged rats those had low sexual function and increased sexual function of a rat that was unresponsive to sexual stimuli.  

Reference:

Goswami SK, Inamdar MN, Jamwal R, Dethe S. Efficacy of Cinnamomum cassia Blume. in age induced sexual dysfunction of rats. J Young Pharm. 2013 Dec;5(4):148-53.

Cinnamon can increase sexual function

Cinnamon can increase sexual function. It has been included in Ayurvedic formulation for increasing sexual function. In a recent study methanol extract of Cinnamon increased sexual function of rats at 100 mg/kg body weight. Cinnamon inhibits enzyme called arginase and Rho-kinase those are responsible for erectile dysfunction (difficulty in penile erection for satisfactory sexual activity).

References:

Goswami SK, Pandre MK, Jamwal R, Dethe S, Agarwal A, Inamdar MN.Screening for Rho-kinase 2 inhibitory potential of Indian medicinal plants used in management of erectile dysfunction. J Ethnopharmacol. 2012 18;144(3):483-9. 

Goswami SK, Inamdar MN, Jamwal R, Dethe S. Effect of Cinnamomum cassia Methanol Extract and Sildenafil on Arginase and Sexual Function of Young Male Wistar Rats. J Sex Med. 2014 Apr 23. doi: 10.1111/jsm.12535. [Epub ahead of print]

Long term use of antacid may decrease its efficiency

Acids secreted by stomach helps to kill harmful bacteria in gastrointestinal (GI) tract apart from digesting food. Long term use of antacid may decrease production of acid or increase the pH in GI tract. This situation can favor development of certain harmful bacteria in GI tract.These bacteria can spread other diseases and release endotoxin that can worsen ulcer.  Therefore, do not use antacids for long time without consulting doctor.