My Clinical Trials Diary

Despite massive advertising and booming prescriptions, use and sales, the new atypical antipsychotic medications such as Seroquel and Abilify – used to treat schizophrenia , bipolar disorder, depression and other illnesses – lack sufficient evidence to support their widespread and generalized usage. This according to a new study out of the Stanford University School of Medicine and University of Chicago. In the past decade, atypical antipsychotics have rocketed past many commonly prescribed, but older antidepressant and other psychiatric medications. Although initially touted as having few side effects, followup studies have found that atypical antipsychotics have serious side effects, including significant weight gain that can lead to diabetes and heart disease. “Because these drugs have safety issues, physicians should prescribe them only when they are sure patients will get substantial benefits,” said Randall Stafford, M.D., Ph.D., a Stanford associate pro...

May the holidays be filled with fun, laughter, health and happiness! Love and Peace! Vidya Sury  

Shri Arun Madhavan's talk at Purna Pragnya. He speaks of what the children of Purna Pragnya must feel when they leave after finishing their studies. He gives a glimpse of the fundamentally simple meaning of our life.

News item: Source BioSpectrum, Asia Edition Singapore, Nov 4, 2010: Sanofi Pasteur, the vaccines division of Sanofi-aventis Group, has announced that its dengue vaccine is in final stage of clinical development. Sanofi Pasteur’s dengue vaccine, the world’s most clinically advanced dengue vaccine candidate entered its first phase III clinical study in Australia.  This study is part of a global phase III clinical study program aimed at advancing the development of a novel vaccine for the prevention of dengue disease in children and adults. Currently, there is no specific treatment available for dengue fever, which is a threat to nearly three billion people and a public health priority in many countries of Latin America and Asia where epidemics occur.  Phase III studies are the ultimate steps in the clinical development of a vaccine before it is submitted to regulatory authorities for evaluation for market authorization. Sanofi Pasteur’s candidate dengue ...

After tests revealed too-rapid release of active ingredient about one million fentanyl patches for chronic pain have been recalled from store and pharmacy shelves. Approximately one million fentanyl patches for chronic pain have been recalled from store and pharmacy shelves. The U.S. Food and Drug Administration and drug maker Actavis Inc. are working to get the word out, but they are targeting retailers and wholesalers, not consumers. Continue reading

FDA Decides Not to Ban Avandia, but Puts Restrictions on How It’s Used. By Daniel J. DeNoon WebMD Health News Sept. 23, 2010 -- The FDA will not ban Avandia -- but stringent restrictions will make it far harder for doctors to prescribe the safety-troubled diabetes drug. The European Medicines Agency took harsher action. European sales of Avandia-containing drugs will be suspended over the next few months, although the agency did not formally withdraw approval. The 600,000 U.S. patients currently taking Avandia can continue to take the drug only if their doctors officially attest that their patients understand the risks, that the drug is helping them, and that no other diabetes drug can keep their blood sugar under control. New Avandia prescriptions can only be written for patients who, for medical reasons, cannot take Actos . Actos, a diabetes medication in the same class as Avandia, does not cause the heart problems linked to Avandia. "Avandia will be ava...

Once-Daily Capsules Cut MS Relapses, Delay Progression   By Daniel J. DeNoon WebMD Health News   Sept. 22, 2010 -- The FDA today approved Novartis' Gilenya, the first oral drug for multiple sclerosis (MS). Gilenya (formerly spelled Gilenia, generic name fingolimod) last June received the overwhelming approval of an FDA expert advisory panel. Gilenya treats the relapsing form of MS. The drug significantly reduces MS attacks. However, it has serious side effects, with possible heart, lung, and eye toxicity and increased risk of infection. Patients must be closely monitored, and regular eye exams are advised. In MS, white blood cells attack the myelin sheaths that protect nerve cells. Gilenya, the first drug in its class, keeps white blood cells penned up in lymph nodes by taking away the chemical key they need to unlock the lymph node door. Fewer white blood cells mean fewer MS attacks. But it also means less protection against infections. Novartis will set ...