Thursday, June 19, 2014

The Naming of Biosimilars

At the cutting edge of all our progress in personalized medicine is the development of  biologics. These are medicines that are manufactured or extracted from biological rather than chemical sources. Biologic is used to describe the structure in the original or innovator medicine that was developed and biosimilar is used to describe the medicines that are developed that are similar to the original biologic.

Biologics and biosimilars hold great promise for the next generation of personalized medicine but only if we are able to track their effect on individuals. These are powerful new medicines. Consumers should know what they are getting and healthcare providers should be able to track the effects of what their patients get. While it is good to have these new medicines it is essential to be able to track them once they are given to patients.

To make this point we sent a letter to the FDA Commissioner today that was signed by over twenty-one partner organizations reaffirming the importance of giving each product a unique name . The value of what we know about the impact of these products would be substantially diminished if we are unable to track the products once they are approved. 

It is good science, good practice, and common sense that each product should have s prefix or suffix added to its name so it can be tracked. All that is needed is a distinguishable name. That should be an easy call for the FDA to make and one that responsible companies should applaud.

Tuesday, June 3, 2014

Sugar Sweetened Beverages--- Less is More than Enough

And so it continues...The Alliance is the lead signator supporting the NYC Health Department. Tomorrow (June 4) the Court of Appeals for the State of New York will hear oral arguments N.Y. Statewide Coalition of Hisp. Chambers of Comm. v. N.Y.C. Dep’t of Health and Mental Hygiene.  You can watch the debate live—oral arguments will be streamed from the Court of Appeals’ website starting at 2 p.m. E.T. Court’s summary of the case is available here:

Monday, May 12, 2014

Pesticides cause illnesses is not new news.

For decades we have known about the hazards of pesticides and yet the headline from 34 minutes ago is "Pesticides Suspected in Spike of Illnesses in Washington State".  Try breathing the air in Fresno and you will understand why so many children there have asthma.  Workers throughout the nation have known about these hazards, complained about them, and pleaded for action.  At best they have received an acknowledgement of their situation.  We now have evidence about the hazards of some pesticides as endocrine disrupting chemicals.  The science is there but what is still missing is the will to act.

Thursday, April 24, 2014

Science will Drive Innovation

El Mundo, one of the most prestigious newspapers in Spain, has a business supplement on innovation and entrepreneurship.  They invited me to write an article on innovation and it was published yesterday.  The original article in English is what follows below.

Innovation in health is being driven by two major changes—the science behind the understanding of health and disease and the expectation that consumers need to be better informed about their own health.

Science has moved us from looking at single causal factors to recognizing that there are many factors that impact on our health and that these factors are connected in ways that we previously were unable to measure. This means that innovation in health will be less about the separate parts of the body (heart, lung, brain) and more about the systems that are key to wellness. Our historic view of microbes as something that must be destroyed has been upended and provides a great example of why a change in focus from single causes and functions to co-dependencies is so important in understanding the mechanics of our health ecosystem.

We know that microbes are found in and outside of every person and for the most part help to keep your body working well. Some aid in digestion while others on the skin actually protect you from having harmful microbes pass through your skin. We need to be able to understand what they do and how to help them do what they need to do. Taking a systems approach to microbes requires us to collect and analyze data on our microbiome by looking at it as one interrelated system. And the solutions and business opportunities are in the products and technologies that work with this system.

At the same time, the vision of health that was defined by longevity is being recalibrated to focus on wellness, activity, and productivity and the quality of those longer years of life. With this new definition comes the demand for more information to be made available to consumers in a meaningful way. The Internet has trained consumers worldwide that information should be available within a few clicks. And this is especially true for the information about our own health and the health of others.

The blossoming area of biometrics and ways that this information can be gathered creates opportunities to market an array of new products. Professional athletes are the earliest beneficiaries of some of the new products that marry biometrics with giving immediate feedback.

For the average weekend fitness warrior there is now wearable technology embedded in clothes, e.g., smart fabrics, that monitor heart rate and pulse and transmit this information through wireless technology. A person can have the information sent to a cell phone or a computer where their every movement and its effect on their body can be studied and monitored. And the opportunities for innovation exist in the devices that are being developed, their use, the analysis of the data, and even in the development of protocols of what happens when there is a breach in a person’s privacy.

Innovation means addressing desires and wants even before a person recognizes there is a need. It is science that will be the key gateway to our future and the successful entrepreneur who will monetize it by new products or services.

Friday, February 28, 2014

Affordable Care Act and the Alliance

Between September 30, 2013 and February 23, 2014 the Health Promotion Advisers at the Alliance spoke to 15,862 consumers about what the Affordable Care Act means to them.  There were many important lessons but the top ten were:
  1. All consumers know that insurance is important to have.
  2. The state you live in makes a huge difference.
  3. Consumers like to know what are all of their options.
  4. Technology is a great tool but it is not enough.
  5. Mobile platforms are essential.  
  6. If you have never had health insurance, or even if you did, the language of insurance is confusing.
  7. Comparisons based solely on monthly cost is the wrong way to make a selection.
  8. Co-pays should be more accurately described as "you pay"
  9. Coverage for mental health needs to be upfront.  
  10. Conversations with an informed and trusted source are key.

Wednesday, July 10, 2013

Devious Maids is an Insult to Everyone

Raul Reyes' commentary in USA Today is on the mark  The new show "Devious Maids" should go into television oblivion.  While it is an adaptation of a novela (Spanish soap opera) the producers overlooked that in the Spanish original all the characters were Hispanic. That makes for a very different story line. The producers even missed in the translation of the title which in English would be, "They are the Joys of the Home."  

Just as damaging are the defensive statements that the story of the maids should also be told. Huh? It is not their story that is being told and most important of all the story where Hispanics are maids has been told so many times.  This type of show only reinforces stereotypes. 

We need other stories about Hispanics and there are plenty of good ones still waiting to be told.

Thursday, April 25, 2013

Coca-Cola Joins BIO

I was reading today's POLITICO Influence that I receive by email when I was surprised to read: "COCA-COLA JOINS BIO: Coca-Cola Company has joined the Biotechnology Industry Organization. The trade group is expanding its multinational members. The group also added Scott Vitters, general manager of the PlantBottle Packaging Platform for Coca-Cola Company, to its Industrial and Environmental Section Governing Board."

Expanding its members?  When I looked at the webpage for BIO it indicated that it was the world's largest biotechnology organization  Now that is what I call expansion.