Mark S. Senak's Blog, page 38

Weekly Roundup 5.30.14

This is just awful.  A whole week without a posting.  Not because I did not have anything to talk about, but because I did not have anything like time on my side.  It was one of those weeks.  I did have time during my dog walks, however, to note that my neighborhood is almost wholly infused with the sublime scent of honeysuckle, reminding me of being a child in my grandmother’s garden.  I have always liked honeysuckle.  It is also a harbinger in my mind that summer is just about here.  As a kid, the period after Memorial Day was the beginning of summer, even though it doesn’t officially begin until later in the month, emotionally speaking – it is summer!

And for those not interested in that, but in FDA, there were a lot of things popping this week and here are a few of them:

FDA OKs Test for Identifying Certain Types of Kidney Disease – The agency announced this week that it would allow marketing of the first non-invasive test that would help identify when a specific type of kidney disease is due to autoimmune causes or because of infection.  The condition is called membranous glomerulonephritis (MGN) which is a chronic disease that can cause damage to a cluster of blood vessels in the kidney and which can damage the kidney as it progresses.  The test is called the EUROIMMUN Anti-PLA2R IFA blood test.  Since treatment depends on the kind of disease one is experiencing, the test can help in getting access to treatment according to the FDA spokesperson.  While the test helps determine the cause, the test should not be used alone to diagnose.


Agency Approves First Implantable Device with Remote Monitoring to Measure Pulmonary Artery Pressure – There was just no way to shorten that headline.  But speaking of approvals of a first kind for a device, here is another one. FDA approved CarioMEMS HF System which is an implantable wireless device that measures the pulmonary artery (PA) pressure and heart rates of patients with Class III heart failure who have been hospitalized within the previous year.  The goal of having such a system is to reduce possible future heart failure-related hospitalizations by providing data from the home that can be reviewed by physicians who can then make treatment decisions.


Draft Guidance on Proprietary Names of Drugs – A not uncommon question about drugs is about the process for naming them.  Here to shed some light on the process is a draft guidance issued by FDA entitled “Best Practices in Developing Proprietary Names for Drugs“.  It focuses on the safety aspects for naming, i.e., avoiding medication errors with similar names and provides a systematic framework for evaluating names before submitting them to the agency for review.  FDA held public meetings in 2003 to discuss the topic and again in 2008.  Interested persons can comment on the draft guidance at www.regulations.gov.


Final Guidance on Expedited Programs for Serious Conditions – Drugs and Biologics – After initial publication last year on a draft guidance, FDA issued a final guidance entitled “Expedited Programs for Serious Conditions – Drugs and Biologics” that is intended to speed the availability of new therapies to patients with serious conditions, especially when there are no satisfactory alternative therapies, while seeking to preserve the standards for safety and effectiveness.  Among other things, the Guidance provides definitions for the concept – a serious condition, available therapies, unmet medical need and delineates the differences between Fast Track, Breathrough Therapy, Accelerated Approval and Priority Review.


Before You Get in That Tanning Bed – You should probably know that this week FDA moved to reclassify sunlamp products from Class I (low risk) to Class II (moderate risk), requiring the products to carry a visible black-box warning that explicitly states that it should not be used on persons under 18 years of age and added information and warnings to be included in marketing materials.

That’s it for me this week.  Again sorry for the lack of posts this past week.  Busy, busy, busy. Have a good weekend everyone!

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Weekly Roundup 5.23.14

We were all feeling a little pent up this Winter and delighted to see Spring.  And what is more delightful than seeing others delighted?  Check out the Weekly Roundup video of dairy cows greeting the meadow after a winter in the barn.  It will make you feel good.

And while you are busy feeling good and before enjoying the holiday weekend, take note of a few of the things that happened this week out of FDA:

FDA Moves on Illegal Online Pharmacies – In conjunction with other federal and international agencies, FDA went after online pharmacies selling unapproved prescription drugs to U.S. consumers.  Inspections were conducted at U.S. based international mail facilities resulting in discovery of many packages that were ordered from online sources outside of the U.S.  The action was part of an operation that resulted in detention and seizure of nearly 20,000 packages containing unapproved or counterfeit drugs.  According to the FDA spokesperson people ordering drugs outside of the legitimate supply chain cannot know if the product they receive even contains the correct active ingredient, dose or even if it is the intended medicine.


FDA Approves First Gene-Based Test to Determine Red Blood Cell Types in Transfusion – BioArray Solutions Ltd. of Warren, New Jersey received approval for its Immucor Precise Type Human Erythrocyte Antigen (HEA) Melectular BeachChip Test, the first molecular assay to be used to assist in determining blood compatibility in the U.S.  The product was reviewed in March by the Blood Products Advisory Committee.  An FDA spokesperson was quoted as saying that the assay “provides an alternative to serological typing and may enhance patient care in certain situations”.


FDA Approves New Ulcerative Colitis and Crohn’s Disease Treatment – An injectable to treat adults with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn’s disease  was approved this week by FDA.  While not a cure, the treatment offers a new option for patients who have not responded adequately to convention therapies.  Entyvio is an itegrin receptor antagonist.  While no cases of progressive multifocal leukoencephalopathy (PML) were seen in clinical trials of this drug, PML has been seen in use with another type of integrin receptor antagonist and so post-marketing studies will continue on that front.

That’s it for me this week.  Kick back and enjoy your time in the meadow.

Video courtesy of Anne Becker.

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Media, Science and Emerging Pathogens – Communications in a Time of Outbreak

Accuracy and consistency in communications is always important.  On important issues, misinformation can lead to serious consequences.  That is especially true in the field of public health.

In watching the media coverage of the outbreak of  Middle East Respiratory Syndrome – known as MERS – one cannot help but to be reminded of the early days of the AIDS epidemic.  And of the SARS outbreak in 2002-2003.

In the earliest days of AIDS, the disease was identified by those whom it seemed to most affect – homosexuals – and so the first name for it was Gay Related Immune Deficiency or GRID.  As the epidemic spread beyond the initial epicenter, it was proposed that the name be Acquired Immune Deficiency Syndrome or AIDS.

MERS has its name based on its place of origin – the Middle East.  But cases have been spreading both numerically and geographically, with the first cases imported into the U.S. this month, followed by the first case of transmission.  SARS – which like MERS is a coronavirus – was an outbreak that began in 2002 in Asia and spread to other regions around the globe.  SARS stood for Severe Acute Respiratory Syndrome and did not have a name based on its geography of origin.

It is better for public health officials to avoid using a name for an emerging pathogen that is tied to a geography or a particular group of people who are affected for three reasons. First, when the pathogen moves on from either the geography or people, the name is no longer really accurate – but historical.  And second, disease – particularly communicable disease – stigmatizes. Stigma is an enemy of public health for  host of reasons. Third, people outside the target zone may feel a sense of false security.

The reporting on MERS has picked up in the U.S. since the appearance of some imported cases and one apparent transmission in this country.  As a consequence, that means more people are writing about a condition not wholly understood, increasing the likelihood of speculation and error. Under those circumstances, consistency can easily be disrupted which in turn, can undermine public understanding and confidence in what is being reported. In addition, circumstances change as medical understanding advances. In this article from 1982 on AIDS, it is stated that “epidemiologists have found no evidence that the condition is spread from person to person like influenza or measles. Therefore, they say, the general public need not fear an epidemic.”  In other words, understanding is going to evolve.

A great public service – either on the part of a governmental agency or a non-profit – would be to provide a writer’s guide for journalists on emerging pathogens where the latest information could be housed – not just on MERS, but on Ebola, H7N9 or whatever else comes our way. This would be beyond Q&A, but would provide insight into the nuances of each as well as providing insights into best reporting practices from a public health perspective. It could be especially useful in today’s environment where many reporters are generalists and not healthcare specialists and many are citizen journalists.  And the beauty of an electronic writer’s guide is that it could be regularly updated with information from several sources.

Everyone has learned a lot since the early days of the AIDS epidemic, no doubt.  But there is always room for improvement.

Photo:  CDC/Maureen Metcalf; Azaibi Tamin

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Weekly Roundup 5.16.14

The Weekly Roundup is late after a much-needed day of respite.  Sorry about that.  A little bit of Spring Fever mixed with a lot of need to catch up on things around home.

In any case, there is a little that happened this week, some of which is of great interest.

Lower Starting Dose for Sleep Drug - A label change was announced this week when FDA decided to lower the recommended staring dose for sleep aid Lunesta (eszopicione).  The move was to avoid the possibility that levels in some patients may be high enough the morning after that activities and alertness could be impaired and therefore the agency was recommending that the starting dose be cut in half from 2 milligrams to 2 for both men and women, leaving less drug remaining in the body in the morning hours.  Last year, FDA also announced dose reduction for other sleep drugs containing zolpidem.


HIV Prevention Through Medication –  PrEP – or pre-exposure prophylaxis is accomplished through the use of a single pill that contains two medications used to treat HIV.  CDC is recommending that individuals who are at high risk of HIV exposure that daily use of these medications can be a prophylaxis strategy to consider.  The agency is recommending that PrEP is for people who do not have HIV, but are at substantial risk – which is considered to be someone, for example, who is in a relationship with an individual who has HIV.  CDC will be holding “Grand Rounds” on the topic this Tuesday, May 20 from 1-2 PM.


MERS On the Rise – WHO noted this week a number of MERS cases – the Middle East Respiratory Syndrome – and while the reported cases appear to rise in number, there has also been a growing geography with not only the first imported cases into the U.S., but also reports of the first in-country U.S. transmission in Illinois – a case where the exposure did not apparently result in illness.  The news prompted an update from the Centers for Disease Control, a transcript of which can be found here.

That’s it for me this week.  Sorry about the tardiness.  Hope you all had a good weekend.

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Looking Beyond Patient Engagement for Pharma and Social Media

As we wait for the anticipated guidance from FDA regarding the use of social media by the pharmaceutical industry, one of the many aspects discussed as been that of patient engagement with the industry.  The Internet is highly utilized for the pursuit of health care information and social media – as part of the Internet experience – is a forum where people can seek, exchange and comment on that information – with or without the industry.

For some in industry, it has been without.  As a highly regulated industry, some medical product manufacturers have been reticent to participate and become involved.  Others have established big and wide social media footprints.  Of those involved, most are involved on a corporate level with varying degrees of engagement, while still others have been involved on a product level.  And many good articles have been written on the subject of how consumers of health care information may or may not wish to engage with industry.  A lot of the focus on social media and pharma has been on the topic of patient engagement.

But especially for the medical products industry – pharma, biotech and devices – there is important reason to be involved with social media beyond the matter of patient engagement. That is because it is an essential component in the way that we communicate in general and in the reporting that goes on by media.

It used to be that a television reporter would provide a broadcast news outlet with very limited reporting on a regular basis.  On the evening news, there would be a segment about a newsworthy item likely to appeal to a mass audience.  Social media – twitter in particular – opened the way for reporters to report on several items a day – as many as they like – and the subject matter could be quite granular.  Social media has engineered a new kind of journalism for many in the business.  And if one looks on twitter, there are a huge number of health care beat journalists who are quite active on twitter.

Likewise the investor community – and investor reporters – are quite active social media users.

Finally, a topic I have mentioned before – while the number of overall users of Twitter does not match that of Facebook – Twitter is the medium for reporting news and at medical meetings there is a lot of news to report, and hence, a good deal to follow.  Reporters, scientists, physicians, patient groups are all commenting and reporting on what they are seeing and hearing that is of interest at meetings and the increase in twitter use at medical meetings from year to year is huge, with particular increases reported for the ASCO and ASH meetings.  This is also why pharma web sites (and medical society websties) need to be optimized for mobile, because people aren’t walking around medical meetings using their laptops – they are on their phones.

I touched on this topic as part of a posting about a larger topic – the Sunset on the ROI question for social media, but I thought it important enough to give it its own posting following a talk I was giving where people in the audience seemed so focused on patient engagement.  Social media is patient engagement, but it is much, much more.

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Weekly Roundup 5.9.14

Spring lasted about 20 minutes. It was very cool and rainy. Then it was sunny and temperate. Now, temperatures in the 90s are predicted for early next week.  Spring was sort of short, but it was lovely. The azaleas are going wild, the hydrangeas don’t look to excited, but my peonies are standing tall and boasting a lot of buds ready to blossom, which is a vast improvement over last year when I had only a handful of blooms – it was embarrassing really.

We do not have a wealth of blossoms out of FDA this week, but there was a little news worth reporting and here it is:

FDA, Aspirin and Heart Health – The agency issued advice this week on the daily use of aspirin as a means of preventing a first heart attack stating that after a review of available evidence and data, the agency does not believe that the evidence supports the general use of aspirin to prevent a first heart attack – which will be news to my physician.  In any case, they state that there is a favorable benefit-risk ratio for secondary prevention for a heart attack.  It does not say how the agency arrived at this decision, but they did note that there are clinical trials currently underway that would provide new information which could change the recommendation in the future.  That may be in keeping with a purely scientific approach, but won’t do much from a communications approach for patients and consumers.


New Drug Approved to Help Reduce Risk of Heart Attacks and Strokes – But on the other side of the coin – This week the agency announced approval for Merck’s Zontivity (vorapaxar) – a first-in-class called a protease-activated receptor-1 to reduce risk of heart attack, stroke or cardiovascular death and to resstore blood flow to the heart in patients with a previous heart attack or blockage.  The drug is an anti-platelet agent which decreases the formation of blood clots thereby decreasing the risk of a heart attack or stroke.  The drug label will include a Boxed Warning about the issue of increased risk for bleeding.


Exciting Prosthetic Arm Gets FDA Marketing Allowance – A bit late with the Weekly Roundup this week, but glad so that this story could be included.  FDA announced it would allow the marketing of the first prosthetic arm that can translate signals from a person’s muscles to perform complex tasks.  Electrodes in the artificial arm are able to detect electrical activity close to where the arm is attached.  The electrodes convey the signals to a built in computer processor that then translates them into specific movement.  It is the same shape and weight as an adult arm.  In addition, the system can accommodate people who have suffered limb loss at the shoulder, mid-upper arm or mid-lower arm, though not at the elbow or wrist joint.

That’s it for me this week.  I hope you all have a wonderful weekend and that you enjoyed Spring.

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Emerging Viral Outbreaks

Last Friday, May 2, at around 3 PM, the Centers for Disease Control and Prevention (CDC) in Atlanta held a press conference about the first detected case in the United States related to the coronavirus known as Middle East Respiratory Syndrome (MERS).

According to the CDC press release, the case was confirmed in someone who traveled to the United States from the Middle East in late April, first to Chicago and then to Indiana. To date, the release notes, there have been 401 confirmed MERS cases across 12 countries. The transcript of the agency’s press briefing on the issue can be found here.  A link to the badge material to the right can be found here.

June 5 will be the 33rd anniversary of the 1981 publication of the CDC’s Morbidity and Mortality Weekly Report (MMWR) which carried the first notice about a series of rare cases of pneumonia in five previously healthy gay men in Los Angeles.  Less than a month later, the New York Times carried an article about 41 cases of a rare cancer seen in gay men.  These were the first reports of the beginning of the AIDS epidemic, though it was not called that yet.  By the end of that year, there were 270 cases of immune deficiency reported with 121 deaths.  We all know the ultimate story of numbers and scope.

While MERS received headlines in the U.S. on Friday, it is one of many pathogens that have been worth noting.  There as also been an active outbreak of Ebola in Western Africa and there has been on-going watch over cases of H7N9 influenza in Asia, primarily in China.

For those interested in tracking these pathogens other than when they hit headlines, the World Health Organization provides regular updates on these and other troublesome outbreaks through its Global Alert and Response (GAR) System.  GAR provides resources where you can look at profiles of individual countries; check out profiles of specific diseases; or subscribe to regular updates via Disease Outbreak News which provides nearly daily updates of reports.  You will get updates number of reported cases, laboratory confirmations, geographies affected, and recommendations.

There is a lot going on in the world.  Big things can cause big problems.  So can microbes. Best to keep an eye on them – thanks to WHO for the resources.

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Weekly Roundup 5.2.14

I need a bear hug from Friday.

April showers.  We had a lot of them.  Some of them, as you know, were snow showers.  This week, in particular, saw buckets of rain in many areas of the country – sometimes violent buckets – and here in the Mid-Atlantic states, we got our fair share of driving rain which can only mean that we are in for some really, really prolific May flowers.  Looking at my peonies, I am already counting many more buds getting ready to blossom over last year’s somewhat anemic crop.

While there were buckets of rain, there was not a downpour of news out of FDA.  No new warning letters (still only 2 so far this year) and not much press release action of note.  But I’ve looked around at a few other sources and here are a few interesting things from the week.

Approval of Zykadia for Late Stage Lung Cancer Drug - FDA announced that Novartis had received an accelerated approval for Zykadia (ceritinib), a anapestic lymphoma kinase (ALK) tyrosine kinase inhibitor, for patients with a certain type of late-stage non-small cell lunch cancer (NSCL) which comprises about 85 percent of all lung cancers, though only 207 percent of those patients are ALK-positive.  Zykadia is the fourth drug with breakthrough therapy designation to receive FDA approval and is being approved four months prior to the PDUFA date.  According to the company release, the approval of the drug occurred less than three and a half years after the first patient entered a clinical trial for the compound.


White Paper on Pharma Tweetchats - Boehringer Ingelheim published a white paper this week - How Pharma Tweetchats Can Drive Healthcare Innovation – which covers a variety of topics including helping people understand what a Tweetchat is, how to set one up, and why they are useful particularly for healthcare and pharma.  It is particularly nice that this asset comes by way of a pharma company so that others can learn – peer to peer counseling.


PRSA Health Academy – The Public Relations Society of America will be holding the 2014 Health Academy Conference – “ New Realities, New Rules:  Sharpening Your Competitive Edge in Healthcare PR ” here in Washington, D.C.  next week May 7-9.  One of the keynote speakers is Ezra Klein, editor-in-chief of Vox.com who will be speaking on “How Washington Really Works” and I, for one, can’t wait to find out.  You can see the whole program here.  And another speaker, less known, but one of my faves – is me – giving a talk on Friday morning called “ Fair or Foul – Working Within FDA’s Rules for Digital Communications “.  And you are asking yourself – what rules?  Well drop by and find out.

That’s it for me this week folks.  I hope you all have wonderful weekends.

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Mind and Heart

The Washington Post recently carried an article regarding an investigative compound being studied for the treatment of Duchenne muscular dystrophy which affects young boys – a condition for which there is no current treatment.  The course of the condition means that that those affected will face physical decline that robs one of one’s ability to use muscles – to walk and eventually – to live.

The piece highlights a clinical trial for an investigative compound to treat the disease and the grassroots effort that was organized to call attention to the need for a treatment and to remember the plight of patients who did not have time to wait for the full process of investigation and approval.

The story captures so very well the tug of war that exists between the societal need for demonstrating safety and efficacy of a compound and the need of individuals who desperately need something – anything – that can save them. The families of the boys used several means to spread the word, including social media tools.

This made me think back to the earliest years of the AIDS epidemic.  The approval of new drugs took a much longer time than it generally takes today. Not only were there no treatments for the underlying cause of the disease – HIV – many of the opportunistic infections that one got as a result of having a compromised immune system had been somewhat rare diseases where treatments were somewhat undeveloped. I made the rounds of hospitals in Manhattan doing deathbed wills for people who shouldn’t have had to face their own mortality for decades to come – a painful memory that is never far from the surface for me. The death toll for a subset of the population was enormous. It wasn’t just the fact that people were going to die, it was the way they were going to die that added so much exponential suffering.  And the excruciating slowness with which new treatments were brought to market had to change.

As a result of a good deal of activism by a lot of AIDS activists, things did change. Activism forged the circumstance by which there was dialog and reconsideration and new standards.  Today, decisions on drugs are made within a specific time frame – one that can sometimes be accelerated.  And from the grim circumstances of the AIDS epidemic came accelerated approval and priority review.

For the boys with Duchenne’s, according to the article, FDA has provided a path forward for the drug being studied that may include accelerated approval. While not guaranteeing approval by any means, it is a move that holds out some degree of hope.

Naturally, science and judgment play the essential role in developing new treatments, but from time to time, so does activism that can eventually forge a new and better framework. The mind and the heart don’t work well without one another.

For a really thorough overview providing a history of accelerated approval – “A History of Accelerated Approval:   Overcoming the FDA’s Bureaucratic Barriers in Order to Expedite Desperately Needed Drugs to Critically Ill Patients“.

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Weekly Roundup – 4.25.14

It has been one of those weeks where each day I felt it was supposed to be the day after. Monday I thought was Tuesday, Tuesday, Wednesday and so on. Here at last, I think, is Friday – the real one.  May your weekend go slowly and your Mondays with speed.

There were some interesting developments this week – here are a few:

FDA Approves New Stomach Cancer Treatment - FDA announced approval of Lilly’s Cyramza (ramucirumab) – another approval under FDA’s priority review program and an orphan drug designation – for the treatment of advanced stomach cancer.  The treatment is an angiogenesis inhibitor that acts by blocking the blood supply to tumors and is intended for patients were surgery cannot remove the cancer or which has spread after treatment with a fluoropyrimidine or platinum contianing therapy.  The company put out a multi-media release on the approval with a good deal of clinical trial detail.  Cyramza has a Boxed Warning for increased risk of hemorrhage, including severe and sometimes fatal events.


Expedited Program Proposed for Medical Devices – The agency announced this week that it was proposing a new program that would provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose needs are unmet by existing technology.  The program will feature earlier involvement with FDA staff and a collaboratively developed plan for collecting the necessary data for approval.  The agency stressed that the Expedited Access PMA or “EAP” is not a new pathway to market, but a new approach to facilitate development under the existing framework.


FDA Say E-nuff Regarding Lack of E-Cigarette Regulation – It was only a matter of time, and many wonder what took so long, but this week FDA unveiled a proposal that would extend tobacco regulating authority that is in place over many products such as cigars, pipe tobacco, water pipes and other means of delivery for nicotine including the e-cigarette.  The goal was stated as making the next generation tobacco-free.  The regulation would bring all of these products and apply the same rules that are now applied to tobacco with respect to new product development and marketing.  A full court communications press was staged by FDA including provision of the proposed rule for comment, a blog posting from the Commissioner, a consumer update and a web page on the topic.


First Test for HPV Approved - Another landmark first from the agency this week when it was announced that the first human papillomavirus (HPV) test was approved for use.  Approved for women 25 and older, the release states that the test will serve as an indicator for physicians and patients to screen a patient to assess the need to undergo additional diagnostic testing for cervical cancer.  The approval is an expansion upon an earlier indication for the test whereby it was used in conjunction with a Pap test.

That’s it for me this week.  Fairly sure that it is Friday today, I wish you a good weekend.

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