Pfizer and Washington University Announce a Groundbreaking Collaboration

Pfizer and Washington University Announce a Groundbreaking Collaboration

NEW YORK, N.Y., May 17 - In a first-of-a-kind collaboration between academia and industry, Pfizer Inc. will give scientists at Washington University School of Medicine in St. Louis unprecedented access to information regarding more than 500 pharmaceuticals and pharmaceutical candidates in a partnership that focuses on discovering new uses for existing compounds. Under the five-year agreement announced today, Pfizer will provide $22.5 million to Washington University and give its scientists access to research data on a large array of Pfizer pharmaceutical candidates that are currently or were formerly in clinical testing.

You can read the full press release here (PDF). 

Perifosine gets on the FDA Fast Track

Keryx Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the Treatment of Refractory Advanced Colorectal Cancer

NEW YORK, April 5, 2010 /PRNewswire via COMTEX/ --Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer.

The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.

SCH 530348 is now vorapaxar (thrombin receptor antagonist)

What used to be a Schering-Plough pipeline drug is now a Merck pipeline drug. SCH 530348 is now vorapaxar and it's a new oral antiplatelet medication called a thrombin receptor antagonist, or TRA. If you're a cardiologist, you've probably heard of this compound.  If you look for it on ClinicalTrials.gov, you'll find the following studies:

• Trial to Assess the Safety and Effects of SCH 530348 in Japanese Subjects With Acute Coronary Syndrome (P04772)(COMPLETED)
• Trial to Assess the Effects of SCH 530348 in Preventing Heart Attack and Stroke in Patients With Acute Coronary Syndrome (TRA•CER) (Study P04736AM2)
• Trial to Assess the Safety of SCH 530348 in Japanese Subjects With Cerebral Infarction (Study P05005AM5)(COMPLETED)
• Trial to Assess the Effects of SCH 530348 in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (Study P04737AM2)
• Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573AM1) (COMPLETED)
• Trial to Assess the Ocular Safety of SCH 530348 in Patients With Atherosclerosis (Study P05183AM1)

Dimebon (latrepirdine) for Alzheimer's Disease?

NEW YORK & SAN FRANCISCO--(BUSINESS WIRE)--Mar 3, 2010 - Pfizer  Inc. (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) today announced results from two Phase 3 trials of the investigational drug dimebon (latrepirdine*) in patients with Alzheimer's disease (AD). In the CONNECTION trial, dimebon did not meet its co-primary or secondary efficacy endpoints compared to placebo. Co-primary endpoints were measures of cognition and global function.

“The results from the CONNECTION study are unexpected, and we are disappointed for the Alzheimer's community,” said Dr. David Hung, president and chief executive officer of Medivation. “We are working with our colleagues at Pfizer to better understand the CONNECTION data and we plan to present these data at an upcoming medical meeting.”

Autism: searching for a cure

We currently have drug therapies for a wide variety of conditions. We have ways to treat diabetes and reduce the risk for heart attacks. We have medications for depression and anxiety. We even have medications for schizophrenia and bipolar disorder.

When will we find a drug treatment for autism?

If you visit ClinicalTrials.gov, you'll find almost 200 trials if you type the word "autism" into the search box. Roughly half of those studies are recruiting volunteers, but the problem is that many parents do not wish to subject their children to clinical studies. So, how will researchers conduct their research? How will the medical community find a cure or treatment for autism unless we have enough clinical studies evaluating various treatment options?

Speaking of treatments, there's a startup company based in Cambridge, MA called Seaside Therapeutics and this company is testing a compound that dampens synaptic activity by mimicking GABA (an inhibitory chemical messenger in the brain). The company is evaluating this compound in patients who have fragile X and also in those who have autism.

Sanofi-Aventis ends development of idrabiotaparinux and eplivanserin

Sanofi-Aventis announced that it will stop the development of idrabiotaparinux and eplivanserin. Have you heard of these agents?

• Idrabiotaparinux is a novel synthetic anticoagulant that links idraparinux, a specific, indirect factor Xa inhibitor, to biotin.
• Eplivanserin was being developed for insomnia.

These drugs got close. Sanofi-Aventis also announced it will buy the U.S. health care company Chattem Inc. for about $1.9 billion in cash. Sanofi-Aventis said the deal would create the world's fifth-largest consumer health care company.

Pharmaceutical Industry Raises Drug Prices by 9%

According to this story on the NY Times, Professor Schondelmeyer found that prices for the name-brand drugs most widely used by the Medicare population rose by 9.3 percent in the last year. Professor Stephen W. Schondelmeyer is a pharmaceutical economics professor at the University of Minnesota.

We know that it costs billions of dollars to research and develop a drug. Those costs are not trivial. We also know that the pharmaceutical industry is a for-profit industry and certain compounds end up being very profitable. Where is the balance? How do we ensure that new drugs are being discovered and that patients are receiving adequate and affordable treatment?

How should doctors receive education about new drugs?

We have seen so many new drugs and even new classes of drugs emerge over the last ten years. How do most physicians learn about new drugs? Many (certainly not all) community practitioners would say they learn what they need to know from the drug reps. Others indicate continuing medical education or CME activities as their main source of information regarding new drugs. Back in the "old days," docs would also attend many promotional/marketing dinners and social functions to learn about new medications. Those days are ending as PhRMA code regulations get stricter.

So what is the most effective way for physicians to learn about new drugs? They are so busy and easily overwhelmed by their workload that many have a difficult time keeping up with the latest science, the latest medical news, or even urgent FDA alerts and warnings.

Most of the clinical studies evaluating new drugs are performed by the drug manufacturer. Most of the CME activities that include any information related to new drugs are often underwritten by pharmaceutical companies, but the educational content is developed independently to be fair-balanced and is not influenced by industry. You won't see certified-CME activities that focus only on a single drug (maybe the only exception is when that's the only drug that's out there for a specific condition).

If a new drug comes out, do doctors really know how to use it safely and effectively? How can they accomplish this unless they receive fair-balanced education that highlights the clinical utility of such new agents? This becomes especially important when we're talking about brand new classes of drugs that have entirely new mechanisms of actions and pharmacological profiles.

There has been a lot of talk recently about industry-supported CME (certified continuing medical education). Some think that it's a bad idea for industry to support CME. Others feel that the lack of industry support may have a significant negative impact on physician continuing education. Why? Because the availability of fair-balanced educational programs may shrink considerably. What would happen if physicians only get exposed to marketing/promotional messages about new drugs and they don't get exposed to fair-balanced continuing education about those same products?

Grand Rounds July 14, 2009: Technology and Healthcare

Welcome to Grand Rounds Vol. 5 No. 43 @ Medicine & Technology. The theme is this week is to look at different ways technology is changing the world of healthcare. I am your host this week and I hope you'll enjoy some of these interesting stories.

To start things off, we see Marya (Healthcare, etc.) talking about patient rights and the potential effects of false positive results. This may lead to unnecessary tests and/or medications and possibly even some invasive procedures. Do we really need to biopsy every small incidentaloma that appears on imaging studies? Perhaps as diagnostic testing improves over time, we will have fewer false positives.

Ramona (Suture for a Living) reminds us that we must not Forget HIPAA Privacy Rules as we continue to expand the use of electronic health records (EHRs). We know that EHR adoption will increase rapidly over the next several years as billions of dollars get channeled from the government.

Jolie (I am Dr. Jolie Bookspan, The Fitness Fixer) describes some of the high-tech things she got to do as a military research scientist. I wonder what those pilots experience as they go through acceleration testing and undergo serious g-force effects.

Bongi (other things amanzi) writes about a funny story that happened during his Saturday rounds when his boss focused on clothes and not on anyone's morning breath (improved breathalyzers in the future should pick up faint signals of ETOH during morning rounds).

Alison (Shoot Up or Put Up) talks how the internet has provided her with some useful tips to help her live with diabetes. The web is full of both reliable and unreliable health information for patients. Even healthcare professional sometimes get misguided by the information that can be found online.

Ryan (ACP Internist) shares an awesome acronym of the week: SHUTi, a new Internet program that shows promise for helping people get to sleep. Can stories, quizzes and games really teach people to have better sleep habits? Let's see.

Hank (InsureBlog) talks about how some patients are cleaning up their own hospital rooms. Perhaps once we have some fully-automated cleaning robots, we should be free of that problem. We just need iRobot to make make some hospital-grade Roomba and Scooba cleaning robots.

Nancy (Teen Health 411) writes about an exciting electronic Wellness Assessment for Youth - called WAY2GO! that's coming to We're Talking Teen Health at the Palo Alto Medical Foundation (PAMF). Thanks to a partnership between the Health Trust, Vive, and PAMF, teens will be able to get a personalized health report back with links to a new service providing free personal health coaching via the web and their cell phones.

Sam (Canadian Medicine) writes about Dr. Bob Thirsk, a Canadian physician who is living on the International Space Station. What's he doing up there? Providing medical care for his fellow astronauts and operating the Canadarm2. I'd love to head out to space some day.

Jay (Colorado Health Insurance Insider) suggests that change in protocol for breech births may actually benefit mothers, babies, and health insurance companies. Is it possible that surgical technology has made it too convenient to opt for a C-section? What if we performed fewer C-sections?

Dr. Charles (The Examining Room of Dr. Charles) writes about the low-tech importance of empathy in taking a family history, and the precarious control of emotions that is needed in being a good listener. What does that look like? A level-headed, composed and somewhat thoughtful response.

OTW (On The Wards) writes how the increasing prevalence of drug-resistant bacteria is generating a need for newer weapons against infectious diseases. Why do we have all these superbugs? Are healthcare professionals too eager to prescribe antibiotics? Let's hope some advances in drug development will lead to more effective therapies against these multi-drug-resistant organisms.

Clinical Cases (Clinical Cases and Images - Blog) writes about ways to improve medical RSS aggregators. Do you even know what RSS stands for? What about Web 2.0? Speaking of RSS and Web 2.0, do you Twitter? Make sure to follow interesting medical bloggers on Twitter. You can start by following me @DrJosephKim

Allergy Notes (Allergy Notes) talks about one of my favorite topics: chocolate. Or, actually, chocolate allergies. I think if I ever developed that, I'd be taking Benadryl all the time. It's hard for me to imagine a life without chocolate. I could live without many things, but I'd really miss chocolate. If I developed a chocolate allergy that resulted in anaphylaxis, I'd probably go through several epi-pens each day.

Murali (SharpBrains) discusses the Pros and Cons of the most common assessments to identify cognitive problems, introducing the opportunity presented by innovative computerized neuropsychological tests. I think I'd prefer going through a battery of assessment tests over a brain biopsy. How about you?

Barb (Florencedotcom) writes about the well-known IT caveat "garbage in-garbage out," and what it means since the medication use system we rely on is rife with failure points. I haven't thought about GIGO in a very long time. We definitely need more drug safety specialists to help prevent medication errors. Computerized Prescriber Order Entry (CPOE) may reduce some errors, but it won't eliminate all of them.

In a guest post, Michael (Health Business Blog) talks about how Dr. Francis Collins (nominated as the head of the NIH) is getting a bum rap. What do you think about the Human Genome Project? I think it's rather amazing to see how far we've come in human genomic science.

The Samurai Radiologist (The Samurai Radiologist) asks: Which background music/sound is optimal for cognitive activities such as film interpretation? A quick and dirty study while on call suggests classical music. Bach, to be precise. In my former life, I used to play the oboe (but I wasn't one of those crazy, fanatical oboe players).

Randel (Disruptive Women in Health Care) blogs about the medical device industry, particularly the “use (or underuse)” of technology as it relates to what she describes as an “arcane” payment system. Although comparative effectiveness research must be used to test new medical technology, reform in the payment system is equally necessary.

Jan (Doc Gurley, Posts From An Insane Healthcare System) covers new information about the placebo effect, including a hierarchy of results (did you know big pills work better than small ones?). In her article, she also points out that positively reinforcing a result makes it more likely to happen. So does this mean all those TV and internet drug adds are boosting a drug's efficacy?

David (HealthBlawg :: David Harlow’s Health Care Law Blog) spoke with Prof. Rodwin about his proposal that all de-identified health data be subject to public ownership, so that private companies cannot restrict access to it and/or monetize it. Public ownership would ensure availability of data for comprehensive public health and evidence-based medicine uses.

Chris (Life in the Fast Lane) offers some pointers to help ‘Web 2.0 laggards’ pull their heads out of the ground and off-load the stress of information overload. Fear of information overload is a barrier preventing doctors from using web resources. But, given that humanity has been experiencing information overload since the invention of the Gutenberg press, ignoring web resources to avoid confronting this daunting problem is a maladaptive, self-defeating strategy.

Well, that wraps it up for this week. Thanks for attending Grand Rounds here at Medicine and Technology. And next week, head over to our surprise, last-minute guest host's site: www.docgurley.com (Doc Gurley, Posts From An Insane Healthcare System), for details on how you can submit. In addition to hosting Grand Rounds, Doc Gurley also will be, that same weekend, speaking at the Mystery Writer's conference in Marin about death, mayhem and the urban underside of life. If you're looking for inspiration, or a theme for Grand Rounds' July 21 submissions, the code word for next week's Grand Rounds is...mystery! Get your submission in early and win big Big BIG karma points! [AND, if you're a San Francisco Bay Area health blogger, send an email to Doc Gurley at docgurley (at) gmail (dot) com for details about the first ever health bloggers' meet-and-greet - ALSO on July 21!]

Hospital worker may have exposed patients to hepatitis C

This is a very sad and disturbing story. A surgical technician has at Rose Medical Center in Denver has admitted to secretly injecting herself in a bathroom and using unclean syringes as replacements for patients. Kristen Diane Parker had hepatitis C, presumably from IV drug use, and she took patient fentanyl injections and replaced them with saline. She worked at Rose from October 2008 to April 2009. So far, nine patients who had surgery there during that time have tested positive for hepatitis C. That is really a shame. Parker should have gotten professional help for her drug addiction. Now, Parker is in federal custody facing three drug-related charges. If she is found to have done serious harm to a patient, she could face up to 20 years in prison. If a patient dies due to her actions, she could face life in prison.

According to CNN, in a statement to police, Parker said, "I can't take back what I did, but I will have to live with it for the rest of my life, and so does everyone else." Rose Medical Center is contacting 4,700 patients who had surgery at Rose during the time Parker was employed there. Another 1,200 patients may have been infected between May 4, 2009, and July 1, 2009, when Parker worked at Audubon Ambulatory Surgical Center in Colorado Springs.

Hepatitis C can be treated, but the treatment regimen isn't easy to take. Advances in antiviral therapies have improved outcomes for hepatitis C and several new and novel agents are in development. Advances in drug development may lead to a quick and easy cure for hepatitis C. Wouldn't that be nice? I know many people who are infected with hepatitis C due to blood transfusions. We (as the medical community) didn't know how to identify hepatitis C before 1992. It was called non-A, non-B viral hepatitis. We now call it hepatitis C. Chronic infection can lead to cirrhosis and liver failure. It can even lead to liver cancer. To read the CNN story, click here.

Advances in Technology and Medicine

I've been thinking about some of the major advances in medical technology over the past decade. We've seen some significant new drugs, new drug delivery systems, and tremendous innovations in medical devices. These advances have improved the care of acute and chronic medical conditions and have taken the field of medicine to a whole new level. Despite our growing understanding of the medical science, healthcare professionals still admit that there are many medical phenomenons that we simply can't explain. For instance, the spontaneous regression of cancer is something that we as medical professionals can't really explain. Will advances in medical technology someday provide us with a clear explanation?

Would You Purchase Drugs Online?

What do you think about this concept about purchasing drugs online? How can you really trust your source? Would you buy from an online pharmacy? What if the online pharmacy was across the globe?

We live in a world where people are selling counterfeit drugs and it's becoming more and more difficult to discern the reliability of some generic manufacturers. On the flip side, because of soaring drug costs, it's becoming more difficult for patients to afford their medications here in the United States. The same drug may be much cheaper if you go to a different country. Why? That doesn't seem quite fair, does it? For instance, many generic drugs are manufactured in India. Would you feel comfortable purchasing pills directly from India? Can you trust a foreign pharmacy? Do you even need a prescription to do that? You may be surprised to know that in many other countries, you can purchase prescription medications without a prescription. Drugs like antibiotics are literally over-the-counter.

Soaring drug costs are a huge burden to our current healthcare system. New drug development costs billions of dollars. Pharmaceutical companies spend a large amount to market their drugs. As a result, new drugs are branded and no generics are available. Drug costs are high. Patients are getting desperate and resorting to unusual means. Some patients are cutting their pills in half. Others are taking their daily medications every-other-day. As a result, blood pressures are rising in those with hypertension, glucose control is worsening in patients with diabetes, and patients are ending up in the hospital.

MIT Researchers Develop a Novel Drug-Delivery Gel

Shuguang Zhang, associate director of MIT's Center for Biomedical Engineering and his team have shown that a special gel may be used to deliver medications such as insulin, hormones, growth factors, or monoclonal antibodies like trastuzumab (Herceptin). The gel is being called a "nanofiber hydrogel scaffold." Wow, try explaining that to patients. This research was funded in part by the National Institutes of Health (NIH) and the High Q Foundation. The High Q Foundation, Inc. is a private philanthropic foundation that was established in 2002 with the mission of bringing together academia, industry, governmental agencies, and other funding organizations in the search for Huntington disease (HD) treatments.

The end of axitinib

Pfizer was developing axitinib (a tyrosine kinase inhibitor or TKI) for the treatment of pancreatic cancer. Unfortunately, recent Phase III results were disappointing. As a result, Pfizer has terminated development on this agent. This is just another failure example of all the money, time, and energy spent on drug development research. It really is a shame because we need more effective therapies in oncology.