Novartis' Galvus gains EU support
Filed under: Type 2, Adult Onset, Drugs, Research
An advisory committee for the European Medicines Agency (EMEA) gave a thumbs up on type 2 diabetes drug Galvus. The EMEA's recommendations are usually endorsed by the European Commission within a few months.
Galvus, marketed by Swiss drugmaker Novartis, is a new oral anti-hyperglycemic agent of the DPP-4 class of drugs. Known as vildagliptin, it inhibits the inactivation of GLP-1 and GIP by DPP-4, allowing insulin secretion in the beta cells and suppression of glucagon from the islets of Langerhans.
In the United States, Galvus is awaiting Food and Drug Administration approval. The agency has delayed approval twice, requesting additional clinical data on vildagliptin, including proof the skin lesions and kidney impairments seen in an earlier animal study have not occurred in humans. The delays have carved a big market lead for Januvia, a similar drug marketed by Merck.
Galvus is one of Novartis' most important drugs under development. No wonder, it could potentially generate $1 billion or more in revenue. If only the same amount of money was spent on supportive diet and exercise programs for those at risk for type 2 diabetes. Photo by rodrigo senna at flickr.
Avandia controversy stirs Congress to investigate FDA
Filed under: Type 2, Adult Onset, Drugs, Research, Daily News
Remember learning about "checks and balances" in U.S. History class? When state leaders gathered in 1787 to draft the Constitution, they established three branches of government (legislative/executive/judicial) to protect individual freedom and prevent government from abusing its own power. Now, Congress is questioning the balance of powers over at the Food and Drug Administration (FDA).
Republicans and Democrats in the House and Senate have called for an investigation into the FDA in the wake of the New England Journal of Medicine study which suggests the popular diabetes medication, Avandia, significantly increases the risk of heart attacks. A House hearing is set for June 6.
Original trials by the drug's maker, GlaxoSmithKline, revealed twice the rate of ischemic heart disease for patients taking Avandia versus recipients of placebos. The medical reviewer for the FDA initially expressed concern, but determined the risk was more benign following further analysis.
Internally, the FDA has one set of officials who approve drugs and another set who track the safety of drugs after approval. But there is an unequal balance of power between the safety and approval offices. Congressional investigators report the safety group recommended months ago Avandia receive its severest warning. The review group disagreed. Here's the catch -- the reviewers hold more power than the safety officials.
Senator Charles E. Grassley, Republican of Iowa and others in Congress have pushed for a separation of the approval and safety offices, and increased power for the safety group. Just this month, Senator Grassley proposed such a split, but it failed by one vote. House staffers believe the Avandia case re-ignites Senator Grassley's proposal as the House is soon entering debates to change the drug agency. Here is a previous post covering the Avandia concerns and the full story on the FDA.
Big savings today with IT based diabetes care
Filed under: Type 1, Type 2, Childhood, Adult Onset, Lifestyle, Research, Products, Support, Complications
Last month Bev addressed a news article that found high tech diabetes management did not equate to better diabetes care. Doctors felt that electronic care is only as good as the patient willing to participate beyond office visits. However, another service is trying to evolve the preconceived notions with a more developed system - and a bigger bang for the buck. How does $14.5 billion sound?
Information technology enabled diabetes management (ITDM) was found to be beneficial in avoiding diabetic complications - MILLIONS of cases. This is an overzealous finding - considering the word prevent is permanent and should probably be replaced with delayed. Even the DCCT knew that much. However, the study was conducted over a period exclusive to the program, and not the lifespan of diabetics in the study. However patient compliance did grow from less than 50% to approximately 80%. That would evoke a few halleluiahs from doctors. Another reason in support of ITDM is the fact that an electronic diabetes registry offers Medicare and other payers the ability to save quite a bit. Over 10 years, the overall net savings is estimated to be $14.5 billion. Does that figure include COLA - cost of long-term diabetes complications adjustment? The complications that did not occur in 2008 saved Medicare and payers $1.45 billion. Score! What is the inflation adjusted cost of those delayed complications occurring in 2013?
The headcount standing at 20 million diabetics, at a savings of $1.45 billion per year - I asked for clarification on that figure. The savings is speculative because the company is anticipating saving costs on preventing diabetic complications. That's optimistic but not entirely realistic.
[RESEARCH] Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: two year results of a randomised controlled trial
Objectives To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up.
Design Randomised controlled trial.
Setting Nine Dutch hospitals.
Participants 283 patients with 6-12 weeks of sciatica.
Interventions Early surgery or an intended six months of continued conservative treatment, with delayed surgery if needed.
Main outcome measures Scores from Roland disability questionnaire for sciatica, visual analogue scale for leg pain, and Likert self rating scale of global perceived recovery.
Results Of the 141 patients assigned to undergo early surgery, 125 (89%) underwent microdiscectomy. Of the 142 patients assigned to conservative treatment, 62 (44%) eventually required surgery, seven doing so in the second year of follow-up. There was no significant overall difference between treatment arms in disability scores during the first two years (P=0.25). Improvement in leg pain was faster for patients randomised to early surgery, with a significant difference between "areas under the curves" over two years (P=0.05). This short term benefit of early surgery was no longer significant by six months and continued to narrow between six months and 24 months. Patient satisfaction decreased slightly between one and two years for both groups. At two years 20% of all patients reported an unsatisfactory outcome.
Conclusions Early surgery achieved more rapid relief of sciatica than conservative care, but outcomes were similar by one year and these did not change during the second year.
Trial Registry ISRCT No 26872154.
Flu or a heart attack
Filed under: Prevention, Women Heart Health
Nausea, vomiting and abdominal pain are symptoms of many conditions. During this flu season, don't just disregard your stomach illness as the flu and don't just pass it off as bad food that you ate. A lesson that I learned first hand from my doctor after my flu like symptoms kept coming and going. Conversations with my doctor about personal and family medical history, stress, and ongoing symptoms prompted her to order tests I thought were a little abnormal since I thought I had the flu. These upcoming tests opened my eyes and curiosity to hop on the Internet to do more research. I personally have battled cancer and my whole family has a large history of cancer, heart disease and diabetes. So with this in mind, my doctor has ordered up several tests to determine nothing else is wrong besides the nasty flu bug. With my personal cancer and lupus medical history and my family heart disease and diabetes medical history, the tests make more sense to me now.The obvious diagnosis of most nausea and vomiting is food poisoning. Nausea or vomiting one to eight hours after a meal may indicate food poisoning. However, certain food born bacteria, such as salmonella, can take longer to produce symptoms. If you are a woman and are pregnant, you experience nausea and vomiting. A viral infection such as the flu can induce vomiting and another well known cause for vomiting is ulcers.
Now a little awareness for the not so obvious reasons for vomiting and nausea. Heart attacks, gastroparesis (most common in diabetics), and certain cancers. Coronary artery disease is the leading cause of death and disability in women after menopause and symptoms of a heart attack at times can be vague and mild in women and include nausea and vomiting. Gastroparesis means paralysis of the muscles of the stomach. Gastroparesis results in delayed emptying of food from the stomach into the small intestine and can cause one to have extreme nausea and vomiting. Certain types of cancers like stomach cancer can cause nausea, vomiting, and abdominal pain.
So if you have persistent indigestion, nausea and vomiting off and on, don't just take it for granted that you have food poisoning or the stomach flu. Talk to your doctor about ongoing symptoms that you are experiencing so that they can get to the root of the problem better and give you a more thorough diagnosis.Permalink | Email this | Linking Blogs | Comments
Want to quit lighting up? Pop a pill instead
For those who are trying to kick a smoking habit, there is a new pill in town. Champix, recently approved in England, is a pill that can be taken two times per day and helps curb the nicotine cravings and reduces other negative withdrawal symptoms. As mentioned by Maggie Vink on our sister blog, That's Fit, the drug currently has a success rate of approximately 50%. The approval of Champix comes at an opportune time for many English smokers wishing to quit. Beginning July 1, a national ban on smoking in enclosed spaces will take effect. Although I am not a smoker, I have many a friend who deal with this addiction. Watching them go through the grueling process of quitting is always painful. The fact that there is a new hope for those who want to quit is absolutely fabulous. I am looking forward to hearing how the general public feels about this pill.
FDA slaps diabetes drugs Avandia and Actos with black box label
Filed under: Type 2, Adult Onset, Drugs
Call the art director and the printer. It's time for a label redesign.
Glaxo just finished revving up the printing press for their aggressive PR campaign assuring us all Avandia is safe. Yesterday, the FDA ordered Glaxo to add their strictest warning to bottles of Avandia - the dreaded black box label. They also ordered the black box label be placed on Avandia's closest competitor, Actos, manufactured by Takeda Pharmaceuticals and Eli Lilly & Company.
This bomb was dropped by FDA commissioner, Dr. Andrew C. von Eschenbach, in the midst of a packed House hearing investigating the FDA's questionable handling of Avandia. In a written statement, he said the agency asked Avandia and Actos makers to add the more prominent black box warning of heart failure because the drugs were being prescribed to patients with significant heart failure, despite existing warnings on the bottle. Dr. Nissen's May 21 study, which sparked the controversy, revealed a 43 percent higher risk of a different side effect, heart attack.
Revealed to the public only yesterday, turns out the FDA had requested drug makers for the black box label on May 23, a mere two days following publication of Dr. Nissen's study in the New England Medical Journal.
Democrats on the House committee strongly criticized the FDA, while some Republicans challenged Democrats were drawing conclusions with uncertain data. Representative Virginia Foxx, Republican of North Carolina, questioned whether those researching the drug had spoken only to Democrats on the committee and not the FDA. She then called for the press to investigate if certain members of Congress conspired with a few FDA staffers to seriously embarrass the drug agency.
Democrats asked Dr. von Eschenbach if the FDA needed more authority to require drug safety studies or correct drug advertisements. He replied more money is needed, not authority. He also said separating the drug agency's safety and approval offices, suggested by some Congressional critics of the agency, was more destructive than constructive.
In a testimonial moment, Representative Diane E. Watson, Democrat of California, said her doctor ordered her off Avandia after she developed a heart murmur. She said Avandia should have heart attack on the label, and she thinks she was headed toward one at the time.
In an awkard moment for the FDA, Representative Stephen F. Lynch, Democrat of Massachusetts, asked the FDA officials to look at the current Avandia label and find the warning about heart attacks. As Representative Lynch repeatedly asked the officials if they had found the warning yet, one official eventually pointed to an embarrassingly small table in the labeling information. Dr. von Eschenbach explained the agency was working toward improving readability of all drug labels. Can you just see a spoof of this scene on NBC's Saturday Night Live? See the full story in the New York Times.
Get in the drug label printing business, there is a fortune to be made.
The Honeymoon Period
Filed under: Type 1, Type 2, Childhood, Adult Onset, Diet, Lifestyle, Research, Support
Not exactly romantic like a honeymoon, but definitely a significant event preceding a life long commitment -- the Honeymoon Period is a period of time when a patient is first diagnosed with type 1 diabetes.
During this time, patients sometimes seem as though their diabetes appears to go away. The patient's insulin needs are minimal and some patients may actually find they can maintain normal or near normal blood glucose taking little or no insulin. This can last between a few months to as long as a year.
Dr. Richard Bernstein, the best-selling author of "The Diabetes Solution" answered the following question from a mother regarding her child's diabetes and the influence of diet. He said:
If every newly diagnosed child with diabetes were put on our program at the time of diagnosis, we would rarely encounter the horror stories that we hear from nearly every parent. These include the roller coaster blood sugars with frequent and severe hypos, the need for snacks, the fear of delayed meals, personality changes and growth retardation. Furthermore, we find that the "honeymoon period" can be prolonged indefinitely if blood sugars remain within the normal range (about 90 mg/dl). Prolongation of the honeymoon period not only makes diabetes control much easier, but also preserves the pancreatic beta cells.
If Dr. Bernstein's idea about controlling the length of the Honeymoon Period through diet is possible - is it possible to ward off the onset of autoimmune diabetes (type 1 diabetes) through diet. The belief may be heavily supported by contrarians, who traditionally contest conventional medical wisdom. I'll admit - I could be one of them. I own Dr. Bernstein's Diabetes Solution and I have to hand it to him - at first glance I thought I voluntarily entered a diabetic Twilight Zone. Then I reminded myself why I bought the book in the first place.
New Pill Could be Better than Byetta
Filed under: Type 2, Adult Onset, Drugs, Research
A small molecule has been identified that controls diabetes in mice and may pave the way to the development of easier treatment for adult-onset diabetes.This key molecule, called Boc5, can stimulate insulin function and reduce body weight by 20%. The molecule stimulates the production of the glucagon-like peptide1 (GLP1), responsible for metabolizing glucose. The study intended to discover ways to sensitize insulin by stimulating production of GLP1. Boc5 is not powerful enough to become a diabetes or weight loss drug. But researchers suggest that similar compounds could join the latest generation of diabetes drugs, called "incretin mimetics." The first FDA-approved incretin mimetic was Byetta. A second such drug, with the generic name liraglutide, is in clinical trials.
The problem with the existing FDA approved incretin mimetic treatments is that they are large molecules that must be administered through injection. Boc5 is a small fry with big potential. Being a smaller molecule gives hope for a new generation in diabetes treatment in the form of a pill many of us would be happy to swallow.
Prolific professor receives Texas honors for diabetes research
Filed under: Type 2, Diet, Research, Exercise
And the award goes to...Dr. Steven Haffner. You probably haven't heard of Dr. Haffner (pictured), but he's one of those hard-working researchers whose work has contributed to our understanding of diabetes. Specifically, Haffner has helped point us in a new direction when it comes to combating Type 2 diabetes. His work has helped demonstrate that diet and exercise can delay or even prevent the onset of Type 2 diabetes. Notably, a 2001 study in which he was the lead researcher, showed that even modest weight loss and exercise cut T2 risk by fifty-eight percent in at-risk folks. Why is this so important? It means that even if you've been diagnosed with T2 diabetes, even if you're at risk for it, and the state of your health is poor, you can still help yourself through lifestyle change. Studies like this have showed that it's never too late for T2 diabetics. Haffner, who is an epidemiologist by trade, got the nod of approval and a big thank you on Thursday from his home base institution - the University of Texas. The school has named him 2007 Presidential Distinguished Scholar at the University of Texas Health Science Center. The award comes with a $5,000 stipend. It honors those who have attained excellence in research in their particular field. He is currently looking into the effectiveness of behavioral interventions in cutting heart disease risk in Type 2 diabetics.
All very nice. But here's what caught my eye about the good Dr. Haffner. He has published more than four hundred research papers in the course of his career. Four hundred! Makes you feel kinda lazy by comparison, huh? Darn high achievers. Pass the remote...