Pharmaceutical Industry discussion, review, analysis, news and information.

It is with a heavy heart that I tell you that this is my last post. Due to circumstances beyond my control I will no longer be writing PharmaGazette.

I've been doing this since last Sept and have learned much but the most important thing I take with me is the friends I've made. Those of you that I've emailed with over the last 10 months I've already let you know where you can contact me so we can stay in touch. If anyone else wants to chat pop me an email at pharmagazette (at) yahoo (dot) com. I'll enjoy hearing from you.

The world of pharmaceuticals was new to me but I take away with me a broader understanding and appreciation for the subject. I hope that some of the articles posted here have given you the same curiosity and thirst for knowledge.

Thank you all for you support and take care!

Of equal importance to prescription medicines are the tools and gadgets that go along with keeping people healthy.

There are a number of good sites that bring web folks up-to-date information on all the newest medical products being tested and developed.

Here's a list of the best:

• Medgadget
• Doctors' Gadgets
• Coolest Gadgets - Medical
• Gizmodo - Medical Gadgets
• Engadget - Medical
• LatestGadgetstoBuy - Medical

Remember that a lot of these really are "gadgets" some are not tested for medical safety. Some are futuristic pipe dreams. Some make claims that they can "cure" or "stabilize" illnesses that are untrue. Some may work for your friend but cause damage to your health. Always research and discuss with your doctor any product that you are thinking of purchasing with specific medical instruction.

Another week with a vast array of articles on health issues that couldn't be covered here. As usual they cover a wide range of topics such as sleep apnea and breast cancer to Fentanyl and Fragile X Syndrome.

All are interesting and informative and worth reading. Use a little of your weekend down time to check some of them out.

• Not All Women Complete Radiation for Breast Cancer (Reuters Health)
• Nutrition Critical after Severe Brain Injury (Reuters Health)
• Scientists Define 21 New Genes Associated with Crohn's Disease (National Institute of Diabetes and Digestive and Kidney Diseases)
• Sleep Apnea Linked to Night Heart Attacks (HealthDay)
• Spinal Cord Stem Cells May Act as Nerve Repair System (HealthDay)
• Gene Interacts with Hormone to Impair Thinking (Reuters Health)
• Information from CDC and FDA on the Safety of Gardasil Vaccine (Centers for Disease Control and Prevention)
• Inhaled Sugar Helps Clear Lungs in Cystic Fibrosis (Reuters Health)
• Laser Resurfacing Produces Long-Term Results (HealthDay)
• Learn More about Fragile X Syndrome (Centers for Disease Control and Prevention)
• Oxygen Therapies May Ease Headache Pain (Reuters Health)
• Pregnancy Results Good with Single-Embryo Transfer (Reuters Health)
• Prenatal Fish Oil May Lower Child's Asthma Risk (Reuters Health)
• CDC Reports 1,000 Fentanyl Overdoses in 2 Years (Reuters Health)

Enjoy and have a great weekend!

Research from a new study indicates that the AIDS drug Isentress (raltegravir) has significant benefits to patients who have received other treatments that were not successful. The drug doubles the likelihood that, despite being immune to other medications, AIDS infected patients will beat back the virus.

"We now have a drug that can bring many people back from a downward curve with no hope for resurrection of the immune system and no hope for control of the virus," said study author Dr. Roy Steigbigel, head of the HIV Center at Stony Brook University in a report published in the New England Journal of Medicine.

The drug appears to be successful on patients who have been inconsistent with their drug regime and thus developed resistance to medications, those that develop resistance in spite of strictly following the regime and those that are infected by a resistant strain of the virus.

Raltegravir has already been approved by the federal government as a "salvage therapy" based on early results of the study which was funded by the drug's manufacturer Merck & Co.

[Source: MedLinePlus]

The U.S. Food and Drug Administration has granted a six month pediatric exclusivity to Ortho-McNeil-Janssen Pharmaceuticals for its drug Topamax for use in patients aged 1 to 24 months with partial onset seizures.

The extension does not give the drug FDA approval but instead allows the pharmaceutical 6 months to continue to investigate the use of Topamax on this specific segment of patients.

Currently Topamax is approved for use with patients 10 years of age and older with partial onset seizures or generalized tonic-clonic seizures. It is also indicated in adults for the treatment of migraine headaches.

Recent research may have found a link between the use of Topamax and birth defects and recently, along with other epilepsy drugs, narrowly escaped being required to have a black box warning by the FDA.

[Source: PRNewsWire]

The Agency for Healthcare Research and Quality release a report stating that between 2002 and 2005 the number of prescriptions filled for antidepressants rose 16 million.

The increase from 154 million to 170 million, which does not include refills, breaks down as follows:

• 29% of the prescriptions were written by psychiatrists (medical practitioners who specialize in the treatment of mental illness)
• 23% were written by general practitioners (doctors who provide primary care but are trained in a specialty.
• 21% were written by family doctors (doctors who provide primary care who have completed a residency in family medicine)
• 10% were written by internal medicine specialists (doctors who complete a residency in internal medicine and who specialize in the diagnosis and non-surgical treatment of adults with illnesses that are hard to diagnose or manage.

The study included only prescriptions written in an outpatient setting. Prescriptions that were administered in an inpatient setting or in a clinic or medical doctor's office were not included in the analysis.

[Source: PharmaLot and Agency for Healthcare Research and Quality

In a report published in the online edition of The Lancet Dr. Robert J. Motzer, from Sloan-Kettering Cancer Center in New York reported that treatment with everolimus improved the progression-free survival of patients with advanced kidney cancer who had not responded to other treatments.

The study involved 410 patients with kidney cancer that has metastasized to other parts of the body despite treatments with sunitab and/or sorfenib. Patients received either everolimus or a placebo once a day in addition to supportive care.

Everolimus, which has already been U.S. Food and Drug Administration approved as Certican, is indicated for the prevention of heart transplant rejection and if new approval is granted as a cancer drug, use of the agent would greatly expand.

The progression rate of the kidney cancer was found to be 37% in the everolimus group as compared to 65% in the placebo group with survival time being 4 months for patients receiving everolimus and 1.9 months for those receiving placebo.

Side effects of the drug included mouth sores, rash and fatigue were more common in the everolimus group but were found to be mild or moderate.

[Source: YahooNews]

Only one month after Johnson & Johnson was required to put a black box warning on Regranex and a week after the U.S. Food and Drug Administration rejected a black box warning on epilepsy drugs, research has found that J&J's Topamax may increase the risk of birth defects.

The study, a small one of 203 patients, found a 14-fold increase in the risk of birth defects in patients taking the epilepsy drug Topamax. The risk was potentially even higher in patients that took Topamax with valproate (Depakote) or other epilepsy medications.

Due to the small size of the study, experts have stressed that more research is needed to confirm the possible birth defect link. Experts also stated that pregnant women who suffer from epilepsy should not stop taking there drug as the seizures without the medication can have an even greater damaging effect on the fetus. However patients taking the medication for the purpose of migraine relief and who are pregnant or contemplate getting pregnant are prompted to talk to the health care provider about a suitable alternative.

Epilepsy Drugs to get FDA Warning

Epilepsy Drugs Likely to Avoid FDA Black Box Warning

Alcoholics’ Quality of Life Improves with Topiramate

[Source:FiercePharma]

The vast majority of online search engines are pretty much useless but Nutritionpedia is not one of them.

Nutritionpedia provides nutritional facts and information on over 72,000 food items. You went out with friends and went off your diet. Want to know what that Burger King Bacon Double Cheese Burger set you back in calories? Try 570 calories with 148% of your daily recommended fat allowance. Not good! So the next day for lunch you try to make up for it with a McDonald's Chicken Cesear Salad. Calories 228, fat 27%. Much better!

Nutritionpedia covers over 70 fast-food and casual dining restaurants and includes information on meals, snacks, coffee, ice cream, baked goods and pizza. Put into the search box the food you are looking for and it takes you to a page with the nutritional information for that product.

Also available, in different sections, is information on diet, reading food labels, protein, calories, fats, BMI and carbs. A helpful site for those that keep track of the calories, fat, salt and other nutritional contents of meals they consume.

A recent study published in the Journal of American Medical Association found that the erectile dysfunction drug Viagra worked effectively at fighting sexual dysfunction in women taking antidepressants.

The study included 98 women whose depression was in remission but were still experiencing sexual problems such as pain during intercourse, lack of arousal and lack of interest. Over an 8 week period the women took a pill up to two hours prior to sex; half were given Viagra and the other half a placebo.

72% of the women taking the Viagra reported improvement while 73% of those on the placebo pill reported no improvement.

"By treating this bothersome treatment-associated adverse effect in patients who have been effectively treated for depression, but need to continue on their medication to avoid relapse or recurrence, patients can remain antidepressant-adherent, reduce the current high rates of premature medication discontinuation, and improve depression disease management outcomes," wrote lead author George Nurnberg of the University of New Mexico School of Medicine.

Currently Viagra is only U.S. Food and Drug Administration approved for use by men.

[Source:YahooNews]