Trigeminal Neuralgia: The suicide disease

Trigeminal Neuralgia is a type of facial pain / headache causing sharp, shooting pain on one side of the face. It is one of the most painful diseases known to mankind. It is also called ‘suicide disease’, because of the severity of the pain.

Symptoms

People suffering from trigeminal neuralgia usually have a sharp, shooting, electric shock like pain on one side of the face / head. Trigeminal nerves are basically a set of 3 nerves that provide sensation to either side of the face. Trigeminal pain can affect different parts of the face. Initially the sharp pain is occasional and very short lasting. Gradually the pain becomes more permanent. It is more common in elderly people, over the age of 50 years. It is slightly more common in women.

Triggers Trigeminal Pain Attacks

Trigeminal neuralgia pain can be triggered by trivial things like cold air, touch, speaking, shaving, brushing teeth and chewing food. Pain is usually felt in the cheeks, lips, nose, ears, eyes, teeth, jaw, scalp or the entire side of the face. It almost always affects only one side of the face. Unlike migraine headache, the trigeminal pain does not change from one side of the face to the other. It is very common to find trigeminal neuralgia sufferers refusing to talk /open their mouth. They may cover that part of the face to avoid touch or air contact. Frequently they end up with dentists, thinking it is a dental problem.

How is trigeminal neuralgia diagnosed?

If trigeminal neuralgia is suspected, it is advisable to consult with a neuro physician or pain physician. After having the clinical history and performing a neurological examination, the physician may order a MRI or CT of the brain. Once diagnosis is confirmed, appropriate treatment is started.

How is trigeminal neuralgia treated?

Initial treatment for trigeminal neuralgia includes medications like carbamazepine (tegretol), oxcarbazepine, gabapentin, pregabalin, baclofen, etc. Typically, the medication is started at low doses and adjusted according the effect. With medications, mild cases of trigeminal neuralgia pain can be controlled. Taking long term medications can cause some side effects.

What are the advanced treatment options for trigeminal neuralgia?

If oral medications are not providing adequate satisfactory pain relief or if there are medication related side effects, other advanced options are available. Radiofrequency ablation of the trigeminal ganglion is newer modality of treatment available for trigeminal neuralgia sufferers. Radiofrequency thermal ablation of trigeminal ganglion, performed under x-ray guidance, provides safe, long term relief from trigeminal neuralgia pain.

It is a day care procedure performed under IV sedation. Once RF ablation is performed, patient can stop taking usual oral medications. Percutaneous pain interventional procedures like radiofrequency ablation of trigeminal ganglion are repeatable at a later date, if required. Trigeminal pain sufferers above 50 years of age are also good candidates for radiofrequency ablations. Older techniques like glycerol injections and balloon compression have been replaced by RF ablations now. Majority of insurance companies including the government schemes approve RF ablation for trigeminal neuralgia sufferers.

What is the role for surgery in trigeminal neuralgia?

Surgeries are reserved for patients, not responding to oral medications and conservative management. It may be suitable for trigeminal neuralgia due to secondary causes like tumours or trigeminal neuralgia in younger patients.Surgeries called microvascular decompression are offered by neurosurgeons for trigeminal neuralgia. Microvascular decompression surgeries have more risk involved and are costly. If performed successfully, these neuro surgeries can provide long term pain relief. Thanks to the advent of all the above mentioned treatments, trigeminal neuralgia sufferers don’t have to suffer in pain anymore.

by

Dr.Akshaya Srikanth B

LIPIDS AND STROKE: A RESEARCH UPDATE

Stroke, predominantly ischaemic stroke, is a leading cause of mortality, morbidity and  long-term disability. Moreover, the fact that one in four strokes occur in individuals who have previously had a stroke, highlights the need for urgent action to reduce the residual risk of recurrent events.

Guidelines recommend low-density lipoprotein cholesterol (LDL-C) as the primary lipid target for reducing the risk of recurrent stroke. However, mounting evidence suggests that other lipid parameters might be also predictive of cardiovascular risk and provide additional benefit. Little is so far known about the effects of non-traditional lipid factors or emerging biomarkers on recurrent stroke risk.

Previous studies have indicated that atherogenic dyslipidaemia, the combination of elevated triglycerides and low plasma concentration of high-density lipoprotein cholesterol (HDL-C) may be implicated in recurrent stroke risk. For example, in the Vitamin Intervention for Stroke Prevention study database including 3680 patients with a recent 120 days noncardioembolic stroke, the triglycerides/high-density lipoprotein cholesterol (HDL-C) ration, often termed as the atherogenic index, was consistently and independently associated with stroke risk, with the highest triglycerides/HDL-C ratio quintile associated with a 56% increase in recurrent stroke risk versus reference (low quintile). Consistent findings were also reported for the Women's Health Initiative Observational Study in Postmenopausal women. 

Recent analyses from the PERFORM (Prevention of Cerebrovascular and Cardiovascular Events of Ischemic Origin With Terutroban in Patients With a History of Ischemic Stroke or Transient Ischemic Attack) and SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) trials, discussed in this month’s Landmark trial, add to this body of evidence. Atherogenic dyslipidaemia, defined as low HDL-C (?40 mg/dL or 1.01 mmol/L) and elevated triglycerides (?150 mg/dL or 1.7 mmol/L), was an important contributor to residual cardiovascular risk in patients with a prior stroke or transient ischaemic attack (TIA) who were receiving best medical therapy, including statin. In both trials, patients with this dyslipidaemic profile had a 36-40% increased risk of recurrent stroke, despite other cardiovascular risk factors including LDL-C being well controlled by best evidence-based medicine.

The question remains: how best to address this high residual risk for recurrent stroke. Clinical trials of current therapies, including fibrates and niacin, have been less than definitive. Whether novel therapies offer future potential has yet to be addressed by prospective trials specifically targeting atherogenic dyslipidaemia. Indeed, the Residual Risk Reduction Initiative echoes the call to action made by the authors of this analysis for trials in this patient population. 

Finally, while much of the focus has been on lipid-related residual cardiovascular risk, a recent analysis from the Treating to New Targets Study also makes the case for consideration of non-lipid biomarkers. In patients with established coronary heart disease (CHD) at LDL-C goal, plasma levels of lipoprotein(a), neopterin, NT-proBNP, and sRAGE were all shown to be associated with the risk of recurrent major cardiovascular events. Lipoprotein(a) has already been linked with risk for ischaemic stroke, however, with the exception of niacin, current therapies are ineffective in targeting this lipoprotein. Whether novel agents in development may provide benefit has been the subject of much interest, given that monoclonal antibody therapy targeting PCSK9 has been shown to be effective in lowering liporprotein(a) levels by 25-30%, on top of statin therapy. Clinical trials in patients with a previous stroke are clearly needed to address the paucity of evidence relating to emerging biomarkers that may contribute to residual risk for recurrent stroke in patients receiving best evidence-based medicine. 

by

Dr.Akshaya Srikanth, PharmD.

2 of 3 Smokers Will Die Early If They Don’t Quit

Two-thirds of smokers will die early from their habit if they don’t quit, a new study suggests.

The findings indicate that it’s never too late to quit smoking, one expert said.

Researchers analyzed data from more than 200,000 people taking part in a study conducted by the Sax Institute in Australia. The study is a long-term investigation of healthy aging.

“We knew smoking was bad, but we now have direct independent evidence that confirms the disturbing findings that have been emerging internationally,” Emily Banks, scientific director of the Sax study and a researcher at the Australian National University, said in an institute news release.

“Even with the very low rates of smoking that we have in Australia, we found that smokers have around threefold the risk of premature death of those who have never smoked. We also found smokers will die an estimated 10 years earlier than nonsmokers,” she added.

Compared with not smoking, having just 10 cigarettes a day doubles the risk of dying early. And smoking a pack a day increases the risk four- to fivefold, according to the study published Feb. 24 in the journal BMC Medicine.

It was long thought that smoking-related diseases would kill about half of smokers early, but newer research has put the figure as high as 67 percent. 

My Suggestion: “It’s never too late to quit, no matter what your age or how much you smoke,”

by Dr.Akshaya Srikanth B, Pharm.D, BCPS.

Cola Raises Cancer Risk Due to Its Caramel Coloring

Research has found that 4-methylimidazole (4-Mel), the chemical that gives cola its

appealing caramel color is a potential carcinogen.

There aren't any federal regulations that restrict use of 4-Mel, but according to the report, more than half of Americans between age 6 to 64 drink enough soda on a regular basis to elevate their cancer risk.

Researchers from the Consumer Reports and the Center for a Livable Future at Johns Hopkins Bloomberg School of Public Health, tested 110 samples of cola and other soft drink beverages.

All of the samples, except for the clear beverages, contained 3.4 to 352.5 micrograms of 4-Mel per 12-ounce bottle or can. While there aren't federal regulations on how much of the chemical manufacturers can put in beverages, California does require companies to include a cancer warning label if the drink contains more than 29 micrograms in a 12-ounce bottle or can. The average person age 6 to 64 drank as much as two and a half cans of cola per day. Approximately one-third of children between ages 3 and 5 drank two-thirds of a can each day. People between age 16 and 44 were the most frequent cola drinkers, consuming as many as three cans per day.

Through this analysis, the researchers concluded that within the next 70 years, there could be at as many as 5,000 incidences of cancer directly related to cola consumption. But cracking down on the soft drink industry won't completely eliminate the chemical from the American diet. Unfortunately, dark-colored carbonated beverages are not the only source of 4-Mel. 

The chemical is also used in soy and barbecue sauce, pancake syrup and some soups. The study is published in PLOS One.

Read more: Cola Raises Cancer Risk Due to Its Caramel Coloring
by 
Dr.Akshaya Srikanth Bhagavathula, PharmD. BCPS.

A New One-Pill-a-Day Treatment for HIV has been approved

As expected, there’s a new single pill regimen for HIV, this one containing abacavir (ABC)/lamivudine (3TC)/dolutegravir (DTG), and it’s called Triumeq. 

The most important study for this combination was the SINGLE study, which showed that ABC/3TC + DTG (given as two pills) was superior to TDF/FTC/EFV (given as one), the difference based primarily on tolerability advantage of the former. It was a novel double-blind study, as all three drugs were different in each treatment arm.

Another benefit DTG-based regimens — whether given with ABC/3TC or TDF/FTC as separate pills — is that to date, no treatment-naive patient with virologic failure has developed resistance to DTG. I suspect it will happen one of these days, but the data thus far suggest at the very least DTG resistance will be a rare event.

Needless to say, but will say it anyway for emphasis, all patients starting this regimen will need to be tested for HLA-B*5701 and found to be negative. Wonder if pharmacies will enforce this, or whether it will be left up to the prescribers. Here’s the landmark study that proved this testing essentially excludes severe hypersensitivity to ABC, quite an amazing story in pharmacogenomics.

An unresolved question is whether ABC is associated with an increased risk of cardiovascular disease. This FDA meta analysis of randomized clinical trials didn’t think so, but around half of the observational studies did, including the updated DAD study. NA-ACCORD data will be of great interest, whenever they appear.

As of Sunday, August 24, the price of ABC/3TC/DTG is not known (at least to me) — and it could be a real game changer, since both ABC and 3TC are already generic. Says Ben Young over on TheBody: “If ViiV Healthcare manages to set the price of Triumeq in accordance with the generic status of abacavir and lamivudine, the cost should be substantially lower than the price of the other single-tablet regimens that contain all on-patent components.” Yep.

I suspect people will call it “Trii” (rhymes with “Cy”, as in “Cy Young”) for a while, just like they called TDF/FTC/EVG/COBI “Quad”.

So what are some upcoming single-tablet regimens? Tenofovir alafenamide (TAF) with FTC/EVG/COBI. TAF/FTC/DRV/COBI. DTG/rilpivirine. And inevitably, generic TDF/3TC/EFV, which is widely available globally.

Regardless, sure beats the old days.

Know more how to improve adherence to HIV patients: MEDICATION ADHERENCE COUNSELING FOR HIV PATIENTS BY PHARMACIST

by
Dr.Akshaya Srikanth, PharmD.

Act Now, or Face Aatastrophic Post-Antibiotic Era

The Antibiotic Resistance Coalition, comprising civil society organisations and stakeholders from multiple sectors on six continents, has called on World Health Organization (WHO) Member States to pass a critical resolution (Combating antimicrobial resistance, including antibiotic resistance) at the 67th World Health Assembly that would spark concerted global action to control the escalating antimicrobial resistance crisis.

“Antimicrobial resistance—and particularly antibiotic resistance—is the most pressing public health issue facing the global community,” said Otto Cars, founder of ReAct (Action on Antibiotic Resistance). “If the resolution is not passed, and the WHO and its Member States do not act quickly, there will be disastrous global health consequences.” Public health researchers estimate that, each year, millions of people around the world are infected with antibiotic-resistant bacteria, and hundreds of thousands of them die. Without immediate action, that toll is expected to worsen.

“We are on the precipice of a post-antibiotic era,” said Tim Reed, executive director of Health Action International. “Without a radical shift in the way antibiotics are marketed and used—and unless we overcome the gap in antibiotics discovery—antibiotic resistance will continue to become one of

the greatest threats to humankind.”

The Antibiotic Resistance Coalition, in its declaration released today, asserts that consumer protection and public health must trump the pursuit of profit, and that effective antibiotics are global public goods. The

Coalition also calls for international leadership and action to, in part:

• Prohibit the promotion and advertising of antibiotics;

• Promote new, needs-driven and open research and development models based on the principle of de-linkage (divorcing price from research and development costs and sales volumes);

• Phase out the use of antimicrobials for routine disease prevention in livestock, and end their use, altogether, for growth promotion;

• Build robust systems, in all countries, to monitor and report antibiotic use and resistance trends in humans and animals; and

• Improve public awareness to support an ecological understanding of human-bacteria interaction and behaviour change around antibiotic use.

“Member States must deliver a strong mandate to the WHO to not only develop a pressing action plan on antimicrobial resistance, but also to ensure that public health is prioritised over commercial interests,” said Yoke Ling-Chee, program director with Third World Network. “Access to affordable and effective antibiotics is of particular importance for developing countries.”

The Antibiotic Resistance Coalition will deliver an intervention to the World Health Assembly prior to the vote. The Antibiotic Resistance Coalition is also inviting other civil society organisations around the world to sign its declaration, which is available at www.reactgroup.org/arcdeclaration 

Antimicrobial resistance is a general term that refers to resistance to a compound that kills or stops the growth of microorganisms, including bacteria, fungus, parasites and viruses. Antibiotic resistance refers specifically to resistance to anti-bacterial agents.

The Antibiotic Resistance Coalition consists of numerous civil society organisations and stakeholders from six continents working in the health, agriculture, consumer and development sectors. It advocates for policy change and action to prevent the post-antibiotic era from becoming a bleak reality. 

by 

Dr.Akshaya Srikanth, PharmD.

HERBAL MEDICINE - WORTH HEALING

The herbalist had 23 wives and raised more than 200 children

According to the official records, herbalist Li Ching-Yuen was born in China in 1677 (although he himself claimed that he was born in 1736). Throughout his long life, he constantly practiced herbalism and martial arts. In 1930, the New York Times newspaper printed an article in which they published official Chinese government documents that were uncovered. These documents, dating back to 1827, contained official congratulations on Li Ching-Yuen's 150th birthday. Later documents, dating back to 1877, contained official congratulations on his 200th birthday.

How did he do that?

Li Ching-Yuen expressed his longevity formula in one sentence: "Retain a calm heart, sit like a turtle, walk swiftly like a pigeon, and sleep like a dog".

Let's add a few more interesting historical facts to this story. Chinese army general Yang Sen invited Li to visit him, and offered him an opportunity to teach Chinese soldiers martial arts. The general could not believe how youthful his guest was, even though he had reached an age of 250 years old.

Li Ching-Yuen died on the 6th of May in 1933. He told his students that he had completed all his tasks in this lifetime, and he was now ready to come home.

Is this a true story? No one knows the truth, but if you read this story using your heart and not a limited rational mind, then you can understand the subtle meaning of it and learn a lot more.

It is possible to find other interesting stories about Western health prodigies and Eastern Yogis who lived for over 100 years. Not only did they survive for this long, they also thrived—youthful, active, and full of enthusiasm. What could we learn from them?

Holistic medicine is all that we need

These days, even modern medicine agrees: 70% of all illnesses materialise because of negative thoughts or emotional stress. Illnesses attributed to this cause are called “psychosomatic,” and they are the biggest headache of the whole mainstream healthcare system.

Sometimes several days of elevated stress is all that is needed to open up a gastric ulcer. Sometimes several years of it is all it takes to develop diabetes or heart disease, not to mention poor general health, lowered productivity, and lack of happiness. Doctors and scientists unanimously agree that our thoughts directly affect the activity of our organs and the state of our bodies in general. Ancient medicine is classified as holistic, because it takes care not only of the physical body, but also of the psyche, as well as one's personal lifestyle. This method allows one to remove the cause of the illness, rather than merely treating the symptoms, therefore stopping it from reappearing. Modern medicine, on the other hand, deals with the consequences of the illness—bodily ailments. This is why the illness often comes back, since the cause of the illness is not actually being treated.

This is where one of the biggest secrets to health reveals itself—our thoughts can heal us. There are multiple recorded stories that discuss people who were severely ill and healed themselves with the power of thought, despite doctors losing all hope. One of such impressive story tells us about Morris Goodman, who, in 1981, was involved in a plane crash and was supposed to die due to irreversible spine damage and a punctured diaphragm. The man's life was supported by a breathing ventilator, and the only movement he could do was blinking. However, this man was aware of the power of thought, and in just a few days successfully regenerated his own diaphragm and could breathe independently. He also consciously regenerated his damaged spinal cord and started to move all of his limbs. Doctors could not understand the situation at all because this just “could not be happening.” After a few months, however, Morris Goodman began to walk again, and eventually fully recovered. This is only one of many cases that are happening all around us. Thoughts cannot only make the body ill, but can also help it recover from incurable diseases.

Causes of hard to cure diseases from a different angle

The ancient ayurvedic health sciences not only prove the existence of psychosomatic illnesses, but also present a list of specific illnesses caused by specific character traits. What else could the thoughts be dependent on if not on the character?

Here are a few examples that could explain the causes of disease you or your loved ones may be suffering from:

1. Jealousy - causes oncological diseases, weakens the immune system.

2. Vengefulness - causes insomnia and throat diseases.

3. Inability to find a solution to a situation - causes lung diseases.

4. Lacking moral principals - causes chronic diseases, infections, and skin diseases.

5. Being too categorical or unwavering in beliefs - causes diabetes, migraines, and inflammations.

6. Lying - causes alcoholism, fungal infections, and weakens the immune system.

7. Aggressiveness - causes gastric ulcers, acid reflux, and warts.

8. Reticence - causes schizophrenia and kidney diseases.

9. Cruelty - causes epilepsy, asthma, and anemia.

10. Seeking conflicts - causes thyroid enlargement.

11. Apathy - causes diabetes.

12. Inconsistency or being fickle - causes infertility.

13. Being rude or insulting - causes diabetes and heart diseases.

14. Anxiety - causes digestive system disorders, heart, and skin diseases.

15. Greed - causes oncological diseases, obesity, and heart diseases.

How can we know this is truth? Many great things in this world can only be tested by experience and not by thinking about them. Ayurveda is an ancient science that still works today and is used by many great people.

An interesting fact is that it is enough to cure your character, and the relevant diseases go away permanently. This is especially important to know for those who suffer from diseases such as diabetes and cancer, for which modern medicine does not have a cure yet.

Three ways to live healthfully and truly feel good. It will involve working on yourself—however, this investment will pay off greatly in the long run. Here are three methods, tested throughout three millenniums:

1. Start monitoring your thoughts. Spend five minutes every evening writing down how you felt that day. Remember the situations you encountered and emotions you felt. What negative character traits does that uncover? What do you plan to do tomorrow to start improving yourself and to change those particular character traits? It is very important to write everything down.

2. Try to think more about things that make you happy. This is the miracle of positive thinking. When you concentrate on the things that you like, it's as if you move to a different frequency of vibrations, and the body starts to heal itself. Even better, there will be a greater number of good things in your life, because everything you think about becomes reality, including the problems that bother you. Concentrate on things you enjoy and watch how everything begins to change.

3. Try out meditation. During meditation, the body and mind rest and heal themselves. You can read more about meditation in the article “How To Own A New Ferrari And Be As Smart As Einstein, Just By Calmly Sitting On Your Couch”.

Illness is simply our body's signal about an incorrect (or, rather, non-beneficial) lifestyle. Firstly it manifests as anxiety, fear, and negative thoughts. Only then, if no effort is made to work on oneself, the body sends a more powerful signal to get your attention and make you think about what you are doing wrong, in the form of physical symptoms.

Leave only the useful and meaningful things in your life. Because everything that is useful to you is always useful to others.

by

Dr.Akshaya Srikanth, 

Pharm.D India

ADVERSE DRUG REACTION CASE REPORTS IN ELDERS

Ciprofloxacin Delirium and myoclonus in an elderly patient: case report

An 85 year old man received oral ciprofloxacin 500mg daily for an infected right hip joint. On the seventh day he experienced generalized myoclonic jerks, hallucination and delirium which improved with a small dose of clonazepam. Ciprofloxacin was permanently withdrawn after his symptoms recurred twice following re-administration. No further episodes of delirium myoclonic jerks occurred.

Jayathissa S. Eet al. Myoclonus and delirium associated with ciprofloxacin. Age and Ageing 39: 762, No. 6, Nov 2010.

Metformin Lactic acidiosis and vision loss in an elderly patient: case report 

A 67 year old woman developed lactic acidiosis and transient vision loss during treatment with metformin for type 2 diabetes mellitus. The woman, who had a history of coronary disease, hypertension and osteoarthritis, and who had been receiving metformin (dosage, route and duration of treatment not stated), presented to an emergency department with acute bilateral vision loss. Her vision loss had started the previous afternoon. Examination revealed a rectal temperature of 32.3o, a HR 55 beats/min, a BP of 117/94mm Hg, a respiratory rate of 34 breaths/min and a pulse oximeter reading of 98%. She was awake and alert but her visual acuity and fields were not intact and she had mid-sized pupils that were slow to react. Laboratory tests showed a pH OF 6.65 and a lactate level of 10.9mmol/L. Her creatinine level was 7.0 mg/dL from a baseline of 1.3 mg/dL and her serum metformin concentration was 28 microgram/mL. She also had hyperkalaemia with a potassium level of 7.1mmol/L. The woman was treated with calcium gluconate, insulin and glucose for hyperkalaemia and sodium bicarbonate for her metabolic acidiosis. Following a lack of response, emergency haemodialysis was initiated. Her vision returned 10 hours after admission with an acuity of 20/30 bilaterally. Her blood pH increased to 7.48, her hypothermia resolved and her laboratory values normalized. She was discharged without metformin therapy. Author comment: ‘’This patient’s metabolic acidiosis resulted from long-term metformin use in the setting of an elevated creatinine, which ultimately caused decreased excretion of the drug. Her presenting complaint was vision loss’’.

Kreshak AA, et al. Transient vision loss in a patient with metformin-associated lactic acidiosis. American Journal of Emergency Medicines 28: 1059e5-1059e7, No.9, Nov 2010.

Corticosteroids/methotrexate Kaposi’s sarcoma in an elderly patient: case report

A 65-year old man developed kaposi’s sarcoma with colonic and skin lesions, following treatment with methotrexate and corticosteroids, including prednisone for ulcerative colitis(UC).

Following a diagnosis of left sided UC and spondyloarthropathy in November 1993, immunomodulatory therapy with mercaptopurine and azathioprine was initiated; treatment was subsequently withdrawn due to gastrointestinal intolerance. In June 2001, methotrexate (dosage and route not stated) was introduced but was suspended in November 2007 to prevent potential drug-related toxicities; prednisone 5mg/day (route not stated) was administered continuously throughout this period. In August 2008, he was admitted for IV steroid therapy (details not stated) following an acute disease episode. During admission he developed violaceous reddish-brown nodules on both legs (time to reaction onset not clearly stated). Investigation revealed active UC with multiple reddish elevated lesions in the last 25cm of the colon, and thickening of the rectum and sigmoid colon walls. Skin histology showed a small, non-encapsulated dermal lesion composed of dilated, irregular and spiculated blood vessels, lined by few prominent endothelial cells; lymphocytes and macrophages comprised an associated infiltrate. Immunohistochemistry with CD34 and CD31 were positive; staining for human herpes virus 8 (HHV-8) showed moderate and focal nuclear positivity. Colonic kaposi’s sarcoma was the preliminary diagnosis. Anti-HHV-8 serology demonstrated an IgG antibody titre of 1/40. A protocolectomy was performed, confirming the presence of multiple nodular lesions of the sigmoid colon and rectum. Labelling for HHV-8 was positive. Multifocal kaposi’s sarcoma of the colon was the final diagnosis. The man’s skin lesions resolved after surgery and steroid withdrawal. At 12 months follow-up, he had no symptoms and no recurrence of skin lesions.
Rodriguez-Pelaez M, et al. kaposi’s sarcoma: An opportunistic infection by human herpesvirus-8 in ulcerative colitis. Journal of Crohn’s and colitis 4: 586-590, No.5, Nov 2010.

Influenza virus vaccine/influenza A virus vaccine H1N1 Guillain-Barre syndrome in an elderly patient: case report

A 75 year old man, with severe chronic obstructive pulmonary disease and dyspnoea, was hospitalized with worsening dyspnoea, cough and purulent expectoration. He reported a progressive debility in his lower limbs for the past week. Neurological examinations revealed grade 4/5 debility in his lower limbs and loss of osteotendinous reflexes. He had received a seasonal influenza virus vaccine 8 weeks earlier and an influenza A viral vaccine, H1N1 vaccine 2 weeks before the onset of the symptoms (route and doses not stated ). A lumber puncture and an electromyogram revealed albumino-cytological dissociation and acute demyelinating neuropathy affecting his lower limbs, respectively. Guillain-Barre syndrome secondary to influenza vaccine was suspected. He received immunoglobulins and rehabilitation. The weakness in his extremities and his respiratory process improved markedly; he was discharged and monitored. Author comment: There was casual effect between the vaccinations and Guillain-Barre syndrome, although it was not possible to determine which of the two was supposed to be responsible, whether it was the result of a sum of probabilities or a cumulative effect of antigen stimulation. Nieto ML, et al. Gullain-Barre syndrome secondary to H1N1 influenza vaccine.

Revista Clinica Espanola 210: 485-486, No. 9, Oct 2010.

by

Akshaya Srikanth

Pharm.D Resident

Hyderabad, India

DIA to organize 2-day conference on pharmacovigilance in Bengaluru on March 3 & 4

Drug Information Association (DIA) is organizing a two-day Pharmacovigilance conference in Bengaluru on March 3 and 4, 2012  The event will be held at The Park hotel. The theme of the event is  “Future Perspectives in Pharmacovigilance.’

The key objective of the event is to explain the current global safety reporting requirements for prescription and over the counter drugs.

There is also need to discuss the new pragmatic approaches to pharmacovigilance as proposed in the Council for International Organizations of Medical Sciences (CIOMS) working group. Over the two days, experts will deliberate and provide inspection program of regulatory agencies in the area of clinical safety from US and Europe, stated Kaushik Desai, director DIA India.

The key note speakers are from India and abroad. They are Dr YK Gupta, department of clinical pharmacology, All India Institute of Medical Sciences, Moin Don, executive director PVCON, Pharmacovigilance Consulting Services, Stewart Geary, vice president, and deputy director of Corporate Regulatory Compliance, Safety & QA, Eisai Co. Ltd and Dr Vivek Ahuja, director, Pharmacovigilance, Asia Pacific, Baxter Healthcare.

While Programme co-chairs are Moin Don and Dr Ahuja, the programme committee members constitute Dr BR Jagashetty, Karnataka drugs controller, Dr Gupta, Prof. Parathasarthy Gurumurthy, professor and head of the department of clinical pharmacy, JSS College of Pharmacy Medical College Hospital, Mysore, RK Giridhar, vice president, BPO Pharma Services, Accenture, Dr Chitra Lele, chief scientific officer, Sciformix Corp.

International speakers panel covers Dr Sidney Kahn, principal scientist, Sciformix Pharmacovigilance Services, Dr Sumit Munjal, consultant, (oncology), Global Medical Safety, Johnson & Johnson, a division of Janseen-Cilag Ltd., Johnson & Johnson, UK and Angela Pitwood, VP, Pharmacovigilance, Indipharm Inc. US.

Some of the topics are safety and management during early drug development programme, US &EU safety regulations upsides-New FDA Rule/ DSURs, safety and regulatory writing, medical device vigilance, panel discussion on Schedule Y and Empowerment to Ethics Committees(ECs) and Institutional Review Boards (IRBs), India: as pharmacovigilance outsourcing destination, safety during clinical trials through medical monitoring, integrating pharmacovigilance in medical and para medical curriculum., Utility of Cloud Computing in pharmacovigilance data base domain.

The organizers recommend that the conference should be attended by those from clinical research, risk management, compliance, medical information, regulatory affairs, academia and pharmacology.

USFDA & EU Essentials of Drug Safety and Pharmacovigilance - India Seminar 2012 at Mumbai

Global Compliance Panel, MUMBAI,INDIA
This training course is designed to give pharmaceutical and biologic companies operating in the U.S.
EU an understanding of product safety and regulatory compliance.The course will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities.
Product safety makes headlines every day - and the impact on a company’s image, consumer confidence, and Wall Street’s opinion is profound. While good safety data has historically been a prerequisite for product approval, recent media attention has intensified public and Congressional scrutiny and resulted in regulations such as the FDA Amendment Act and its strengthened requirements for monitoring post-marketing safety.
Agenda:

• Overview of Pharmacovigilance
• Assessing Adverse Event Cases
• Reporting Adverse Events
• Global Regulatory Requirements
• Inspections and Audits
• Pharmacovigilance Best Practices
• Preparing for an Inspection
• Case Studies with Real-Life Inspection Findings
• Background to Signal Detection
• Signaling Exercises
• Data Mining Exercises
• Pharmacovigilance and Risk Management Process

Who will benefit: 

• Drug safety and Pharmacovigilance
• Regulatory affairs
• Clinical development
• Executives (including C-Level) with any Legal responsibility for drug safety
• Clinical safety staff
• Pharmacovigilance specialists
• Regulatory affairs professionals
• Quality management specialists
• Management involved in clinical oversight
• Pharmacovigilance
• Pharmacoepidemiology
• Regulatory affairs

DATE AND VENUE:

March 5th, 6th and 7th, 2012

at Mumbai, INDIA

Conference Timings: 9:00 am - 6:00 pm

For more details: http://hum-molgen.org/meetings/meetings/5118.html

5th ISCR Annual Conference receives overwhelming response from industry

Dr Prem Kumar Reddy inaugurating the conference

The fifth annual conference of Indian Society for Clinical Research (ISCR) was recently held at Taj Krishna in Hyderabad. The theme for this year's conference was ‘Beyond Efficiency to Excellence’ and was attended by over 400 delegates from India and abroad.

Dr Prem Kumar Reddy, a leading authority on cancer research, inaugurated the conference and delivered the keynote address. This was followed by a welcome address by Dr Krathish Bopanna, President, ISCR. Bindhya Cariappa, Chairperson, Scientific Committee presented an overview of the conference, which was followed by a vote of thanks by Dr Radhika Bobba, Chairperson, Local Organising Committee. 

A panel discussion in progress

In synchrony to ISCR's objective of ensuring that the conference serves as a platform for the best minds in clinical research to share innovative views and best practices in clinical research, this year’s sessions focussed on excellence in line with the conference theme. The two-day conference had two clinical research tracks that touched upon each aspect of clinical development and covered early development, regulatory affairs, medical writing, clinical research technology, ethics, investigator site perspectives, project management, data management, quality assurance, pharmacovigilance, biostatistics and a discussion on the perception of clinical trials in India.  

Delegates attended Akshaya, Mandar Kelkar,
 Dr.Parthasarathi, Anand Harugery

The conference was preceded by four workshops on study management, medical writing, statistics and pharmacovigilance. Unique to this conference was also the young clinical research debate conducted at the end of day one of the conference. The conference was concluded by a valedictory speech by Dr PM Bhargava, scientist and recipient of Padma Bhushan and a vote of thanks to delegates, speakers, sponsors, organisers and volunteers. 

Participants at the conference

Speakers who attended the conference were Dr Rajesh Karan, Novartis; Dr Julius Vaz, Dr Reddy's Laboratories; Dr Shreemanta K Parida, Dept of Biotechnology; Dr Deven Parmar, Wockhardt; Dr Sudhakar Mairpadi, Phillips; Shenaz Vakharia, Theraverity; Dr Shashidhar Rao, Novartis; Dr Sanjay A Pai, Columbia Asia; Dr Roopa, Basrur, Parexel; Dr Graham Bunn, Medidata Solutions; Gunjan Jain, Oracle; Dr SD Rajendran, Sristek; Dr Ajay Parker, SIRO Clinpharm; Carol Isaacson Barash, Genetics, Ethics and Policy Consulting; Dr Gauri Gholap, Optra Systems; Sudip Sinha, CliniRx; Dr Mubarak Naqvi, Sanofi Aventis; Dr Aamir Shaikh, Assansa; Dr Ajoy Roy, Parexel; Dhiren Joshi, Voisin Life Sciences; Vivek Ahuja, Baxter; Dr Manish Kumar Shah, Pfizer; Narasimha Kumar, Parexel; Dr Sneha Limaye, CRF; Dr Milind Antani, Nishith Desai Associates; Gourav Kumar, Apollo Hospitals; Dr Vishwanath Iyer, Novartis; Dr Chitra Lele, Sciformix; Tommy Pedersen, Quintiles; Bindhya Cariappa, ClinTec international; Dr Rupam, KIMS; PV Rao, eminent media person; Dr Suresh Menon, Novartis; Professor Sarma, NALSAR; Dr Nimita Limaye, Siro Clinpharm; Dr Hema Bajaj, Sanofi Aventis; Mark Aubrey, Daiichi Sankyo; Dr Raghunatha Rao, NIMS; Dr Purvish Parikh, Americares and Dr Senthil Rajappa, Indo-American Cancer Hospital. The resounding success of the conference has raised the bar for the sixth annual conference to be held in Mumbai next year.

Source:ExpressPharma

by

Akshaya Srikanth

Pharm.D Intern

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