Weekly Roundup – 1/27/12

January 27, 2012

It is the mildest winter I can remember.  Today was slated to reach 60 degrees in Washington, D.C.  No preparation of hot comfort foods, no roaring fires, no ice skating parties, no snow ball fights.  DC has moved further south, apparently.

In the meantime, here is a bit of what happened this week that caught my eye:

  • Consent Decree Signed with Ranbaxy – A consent decree was filed by the U.S. Department of Justice resulting an injunction against generic manufacturer Ranbaxy addressing current good manufacturing practice (CGMP) as well as data integrity issues in India and CGMP issues at its U.S. facility located in Gloversville, New York, now closed.  The company will have to achieve compliance with third party audits to confirm.  The decree creates provisions for liquidated damages, among other things.
  • FDA Approves First Once Weekly Diabetes Treatment – Amylin Pharmaceuticals announced today that the FDA has approved Bydureon (extended release exenatide) as the first once weekly treatment for diabetes.  Bydureon is a glocagon-like peptide-1 (GLP-1) receptor agonist that is indicated in addition to diet and exercise to improve glycemic control in adults with Type 2 diabetes.  Bydureon uses proprietary technology from Alkermes to provide the controlled release of exenatide.  In addition to the company’s press release on the approval, there is also a link to a multi-media release complete with video.
  • FDA Approves Treatment for Advanced Kidney Cancer – Pfizer’s Inlyta (axitinib) was approved this week by FDA for the treatment of advanced kidney cancer – the seventh kidney cancer drug to be approved since 2005.  According to the company release, Inlyta is indicated for use after failure of one prior systemic therapy.  Inlyta is a kinase inhibitor designed to selectively inhibit VEGF receptors 1, 2, and 3 that influence tumor grown and is an oral therapy.
  • FDA Reopens Comment Period on DTC Rule Regarding Major Statements – The FDA is reopening the comment period on specific data related to a proposed rule first published in a March 29, 2010 Federal Register Notice to establish standards that would be considered in determining whether the major statement in DTC TV and radio ads regarding side effects is presented clearly.  The agency added a document to the docket entitled “Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in DTC Prescription Drug TV Ads” for which it is seeking further comment.

That’s it for me this week folks.  I have been travelling a good deal and posting has been tough, but hopefully I’m around the next few weeks.

Photo taken by friend Anne Hainsworth and used with permission.

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Patience Patients – Are e-Patients Waiting for e-Docs?

January 25, 2012

Every so often when I have giving a talk on social media I ask the audience how many of them are on Facebook.   Usually nearly everyone in the audience raises a hand.  Then I ask how many of them are using a “cloud” based platform regularly.  Nearly all hands come down.  In fact, applications and platforms like Facebook have become so ubiquitous in our lives, we don’t even realize that when we use them, we are using cloud based technologies. And if we don’t realize we are using them, we are also probably not so attuned to the ways that new and emerging technologies and communications are changing our lives.  In a similar vein, I think many physicians see the way technology changes the way their patients are accessing medical information, but perhaps not realizing the change it demands on the practice of medicine.

Each day I step on my Withings scale in my bathroom, equipped with WiFi which then sends my weight into a cloud where I can retrieve it in a chart (lately not an attractive chart) on my i-Pad.  I can attach a cuff to my i-Pad which will then also take my blood pressure on my i-Pad and plot it out along with my weight in either chart or graph form by date and available for my physician.

The problem is that my physician then hand enters the readings into my chart with a pen and paper.

Change has happened.  The number of medically related apps is prolific.  Some, the FDA has deemed as medical apps, such as my blood pressure cuff, and have provided guidance for their development, use and approval.  Others may have a medically related purpose but are not medical apps – such as a calorie counter.  I have an app that will track my bicycle ride and estimate the calories burned and even post it on the Internet.

Patients are changing.  They are accessing medical information differently, they are storing it differently and they are consuming it more voraciously.  This access to medical information and tools means that many patients are more medically conversant and knowledgeable than the patient of just five years ago.  Medical literacy is likely on the rise.

It also changes the way physician and patient communicate.  Five years ago, I never would have considered the need for email between my physician and myself, thinking it impractical.  Today, I think a physician needs to have some portal of access for the exchange of data and information.  Here are my readings – blood pressure, blood sugar, whatever… – for the week.  The medical record will reflect information not just gathered at an exam in the office, but that gathered by my apps when I am not in the office.  And when I’m diagnosed with a new condition, I fully expect either the physician or someone in his or her office to not only prescribe some medication, but to pull out an i-Pad to steer me to some good resources, including apps.  If the condition is one where there are few treatment options and I’m expected to consider a clinical trial, the i-Pad should have a clinical trials app that lets us look at what’s available together.

The use of e-tools has become so ubiquitous, many physicians may not be aware the extent to which the patient experience is being changed.

Past milestones have had an impact on the medical literacy of patients.  Direct-to-Consumer advertising is one – where patients got greater exposure and understanding of treatments.  Search engines were another – where patients could seek out information from that great data base in the ether.  But the advent of social media with access to medical app support takes the patient to a whole new level, compelling physicians to change with them – from keeping electronic records to changing the means by which they communicate.

Posted in New and Social Media | 2 Comments

Clinical Trials and Search

January 23, 2012

You are sitting in the doctor’s office on that crinkly paper that pops every time you move. Your physician is leaning against a table and has just uttered some words that were a diagnosis.  It is a serious diagnosis.  For a while, you don’t even hear anything else.  The news has made time stop for a bit as you realize your life will never be the same.  You don’t even hear anything the doctor is saying at this point.

However, at some point, you or your care partner will begin to take action.  You will likely want to learn as much as you can about your new enemy and about opportunities that might be available to you.  And one of the first places you will probably go is the Internet. What happens when you do?

As a little experiment, I entered several different disease states into the search bar.  What came up was interesting.  What didn’t come up was also interesting.

Entering the terms “breast cancer”, “prostate cancer”, “diabetes”, “HIV” and “hypertension”.  Using diabetes as an example – what came up on the first upper page of the search were (1) ads for unspecified treatments, (2) ads for meal plans, (3) ads for supplies and (4) ads for getting information about signs and symptoms.  What also came up aside from ads were a link to the NIH site for information about diabetes, a link to the American Diabetes Association and links about signs and symptoms.  If you scroll down, you get more of the same.

What didn’t appear were any resources, paid or otherwise, that link to information about clinical trials and diabetes.

Of course, a person interested in clinical trials would enter that in the search term.  But wouldn’t it also be logical for a link to clinical trials would appear along with links to organizations, diets, treatments and supplies?  If a patient were interested in supplies, wouldn’t they also put that in the search term box?

So let’s take it to the next level and put in “diabetes clinical trials”.  This time you do get some paid ads regarding diabetes clinical trials, along with ads for cancer clinical trials.  You also get an ad for NIH clinical trials.  Other than ads, what you get are two links to trials information – one at ClinicalTrials.gov and one at the Mayo Clinic.  But above them are links to information about the subject of diabetes clinical trials (such as why you should participate in them).

There is no question that search engines are equipped to find clinical trials for a person determined to find them.  But it would also appear that clinical trials are not one of the subjects to appear when one is searching for information about a particular condition.  Yet if they did appear, it might cause some to inquire further once presented with the option.

This means two things.  One, linear search has its limits and eventually we may be better served by search that more comprehensively displays our options – not unlike the apparently now defunct Google Wheel which presented various directions for a search once the term was entered.

Second, whatever the type of search mechanism, as the results above clearly demonstrate, the search engine optimization of clinical trial materials is essential.

We may be a way off from having a different search option than the current linear search, but in any case, good search engine optimization and good search engine marketing might go a long way to expanding the pool of potential patients for future clinical trials.

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Weekly Roundup – 1/13/12

January 13, 2012

It has been a rather slow week for much interesting news – and so a twist to the Weekly Roundup this week.

From time to time, I look to see what is going on with pharma and FDA in the various social media platforms – taking the temperature on Twitter or looking to see how folks are doing on YouTube.  I thought that this week for the Weekly Roundup, it might be fun to feature a few videos that caught my eye when looking over all of the pharma and FDA YouTube channels.  The industry, for the most part, has not exactly mastered YouTube, though there have been some exceptions and some bursts of creativity. Here are a few that caught my eye this week for being either innovative or interesting. Had a lot of trouble embedding them, so there are links to the videos.

  • It Gets Better – As many know, there has for a while now been a campaign known as the “It Gets Better” project that speaks out to lesbian and gay youth to let them know that if they are the victims of bullying, they can get help and life will eventually get better and many different people and institutions have posted videos to send that message including government agencies and high profile celebrities.  Posted this week to YouTube, GSK joins them putting up the company’s own “It Gets Better” video featuring an entire chorus of GSK employees.  You can view it here.
  • Connecting Hearts Abroad – YouTube is a wonderful way to bring home an understanding of what can be, and is being, done on the ground in the way of global development and philanthropy.  LinkTV created ViewChange.org which is a great example of bringing stories from around the world that we wouldn’t normally see about global development.   For pharma, YouTube is a great way to demonstrate that kind of philanthropy in action, but is largely under utilized.  This week Lilly put up three videos about a program called “Connecting Hearts Abroad”.  The first video introduces the program by Lilly to choose up to 200 employees to send around the world during 2011 to serve in a volunteer capacity for community development, education and in health clinics .  You can view the inaugural video here.    What would make this really great is to have the employees take videos that show the work done in-country and then put those up on this channel in their own playlist.
  • Managing Chronic Disease in Rwanda – In the same vein, the Medtronic Foundation is bringing us video from an in-country effort.  They support Partners in Health which worked with the Rwandan Ministry of Health to create a model for the management of chronic disease.  This video, actually posted a month ago, overviews the project in a simple, but very effective way and you can view it here.
  • Raising Disease Awareness and Having Fun – The people at the PfizerUK channel rarely disappoint.  In this video you can see a few hundred people on the street in London wearing flesh colored body suits sculpt themselves on the street into the shape of a hand to raise awareness of Dupuytren’s Disease.  Clever, short and attractive and getting a very impressive number of viewings, and you can be one of them by clicking here.

That was fun wasn’t it?  Now go forth and emulate….

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Vacancies on FDA Advisory Committees

January 11, 2012

Anyone attending an FDA Advisory Committee meeting will likely discern right away that the job of serving in the capacity as a member is probably not terribly exciting.  You have to travel from where you live, review mountains of data, speak credibly and act responsibly only after revealing a lot of information about your financial relationships.  You have to sit for hours in what is likely a not very comfortable chair. You have to be patient.  And that is only the beginning.

Some have speculated that increased scrutiny for potential conflict of interests among those serving on FDA advisory committees will keep large numbers of otherwise qualified people from serving.  No judgment on that front is being rendered on that front today.

But in conjunction with yesterday’s posting that looked at the upcoming advisory committee meeting schedule for 2012, one could see that a good number of meetings were scheduled for some of the committees.  Take the Oncologic Drugs Advisory Committee (ODAC) for example – it 7 meetings scheduled to cover 14 days during the year, but you can see below, the committee has several vacancies now and more scheduled to come this year.

Looking solely at the vacancies for drugs, biologics and devices, there are 116 vacancies.  According to FDA Track, the agency has made progress in filling vacant positions.  While the agency has a goal of reaching 10% vacancy, it is now at 20% which is down from the 25% vacancy reported in October 2010.

Below are listed the committees along with the current number of vacancies.  Note that these numbers were taken from each site of each advisory committee, but in addition, each of the committees will have some members who will also be rotating off this year, making the number of people needed to fill vacant slots even higher.

Drugs

  • Anesthetic Analgesic – 8
  • Anti-Infective – 6
  • Anti-Viral – 5 (including the Chair)
  • Arthritis – 8 (including the Chair)
  • Cardiovascular – 1
  • Dermatological – 4
  • Drug Safety – 1
  • Endocrinology – 3
  • Gastroenterology – 4
  • Medical Imaging – 12
  • Non-Prescription – 5
  • Oncologic – 4
  • Peripheral/CNS – 5 (including the Chair)
  • Pharmaceutical Science – 14
  • PsychoPharmacologic – 1
  • Pulmonary Allergy – 1
  • Reproductive – 6 (including the Chair)

Biologics

  • Allergenic – 0
  • Blood Products – 5
  • Cellular Tissues Gene – 1
  • Transmissible Spongiform – 2
  • Vaccines Related Biologics – 1

Devices

  • Anesthesiology – 4 (Including the Chair)
  • Circulatory – 0
  • Clinical Chemistry – 0
  • Dental – 0
  • Ear Nose Throat – 0
  • Gastro Urology – 0
  • General Plastic Surgery – 1
  • General Hospital – 0
  • Hematology – 0
  • Immunological – 2
  • Med Devices Dispute – 0
  • Microbiology – 0
  • Molecular & Cl Genetics – 1
  • Neurological – 0
  • Obstetrics – 0
  • Ophthalmic – 2
  • Orthopedic – 0
  • Radiological – 0
Posted in Advisory Committee Prepapartion | 1 Comment