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In a recent, widely anticipated decision that pertains to rights to some of what makes us us, a federal judge ruled in favor of patients, medical societies, and researchers, who were suing Myriad and the Utah University research foundation, owners of the patent on the two genes whose mutations had been associated with increased risk for breast and ovarian cancer, BRCA1 and BRCA2. Their ownership had allowed them to retain complete rights for these widely prescribed diagnostic tests, which have remained prohibitively expensive for many patients (currently at more than $3,000).

Interestingly, in taking the decision to invalidate such patents, the Department of Justice differs in its opinion from the US Patent and Trade Marks Office (USPTO). Meanwhile the status quo will be maintained. The Biotechnology Industry Organization (BIO), the organization that lobbies for the pharma and biotech companies, has been arguing since the beginning of the case that preventing patenting of human genes will literally impede life science innovation and had stated after the court’s decision that carrying this one out would: “undermine U.S. global leadership and investment in the life sciences”. A variety of people have spoken for and against the decision. The New York Times just wrote an article citing several of them.

The US government filled a “friend of the court” (or “Amicus curiae”) opinion entitled: ”BRIEF FOR THE UNITED STATES AS AMICUS CURIAE IN SUPPORT OF NEITHER PARTY” (you can read the pdf here ). As expected with these types of opinions (see Wiki)- and indicated by its title – the intent was not to support either of the parties. The last point listed in the government’s opinion constitutes a good summary: “Isolated Genomic DNA Is Not Patent-Eligible Merely Because It Is Useful Or Requires Investment To Identify.”

As someone who has dedicated her life to improving human health: I understand the need to recognize and reward discoveries, so that they may continue to advance the available diagnostic and therapeutic interventions. At the same time, in my opinion, a balance needs to found – or maybe a line needs to be drawn. Otherwise, these innovations will remain out of the reach of many patients who need them. The exact balance may not be easy to figure out or accept by consensus.

To what point should we own things we just happened to be the first to discover/figure out? Should various entities (researchers, universities, companies) own pieces of everybody’s proteins, DNA, or maybe their constituent atoms, electrons or the even more ephemeral particles and their interactions? These are all things that make us us. Or, going in the opposite direction, should each disease/syndrome or epidemic have owners that need to be paid before we could proceed with curing them? Am I right to assume that in such case, arrangements and payments would need to be exchanged between the owner of the gene and the person who had discovered the disease, with corresponding arrangements with those who had patented the smaller molecular or atomic pieces of the puzzle? How are we ever going to navigate such complex territorial and legal claims? Maybe Google could develop maps of the human body charting out the parcels to indicate ownership? I am on the opinion that we should only own things we create ourselves. In relation to this specific discussion, I think it is appropriate to own the rights to a new method to test or to control a gene, or a newly created molecule that could be used for diagnostic or therapeutic effect.

I know patients who were unable to take advantage of the BRCA test because of its prohibitive price and who knows how many more cases we might have failed to diagnose and treat because of these legally imposed economic barriers. Can you imagine that currently the actual cost of performing such a diagnostic test is only a few dollars? Would it be possible to compromise by assessing limits on the profit margin of diagnostic tests? I feel that we need to ensure that the initial intent – or what many say is – of our efforts to improve human health is not compromised.

What is your opinion? Should those sequencing one of the genes we all share – and its mutations – gain the exclusive rights to any diagnostic or therapeutic intervention that is related to that gene? Do you know who owns YOUR genes?

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I just returned from the NIH where I was invited to lecture on translating science into therapies. I had presented my science there before and I was not quite sure how interesting they might find my broader perspective, which I had entitled: “The long course from ‘the Aha!’ to cures: can we do better – together?“

The standing room only audience provided a first clue that emphasis is evolving at the NIH… During the Q&A and in talking individually to several people, I could sense their intense interest and excitement regarding the many challenges – and opportunities – created by the translation of basic science into positive health outcomes. Several independently pointed out that Francis Collins, M.D., Ph.D., took no break from being confirmed to making his first appearance as the new NIH chief where he announced what he hoped to accomplish during his term. The overall underlying message was clear: no time to spare!

For those relying mainly on the funding that comes from the NIH to carry on science, it is very important to understand what the change at the NIH helm might mean for its future directions and priorities to increase chances of successful funding. In the bigger picture, all of us will be affected as the NIH-sponsored research is a major – if not the major – source for the new ideas that become one day life saving treatments. I dare to say that the success of these ideas is in no small measure due to the fact that the NIH, throughout various administrations (maybe in spite of?), has been one of the original and perennial implementers of innovation models, yet not even themselves might think of it that way. For instance, the NIH has a signature initiative called an “RFA” (requests for applications), where they invite independent researchers to submit proposals related to specific scientific and health questions, and they fund the winners. Isn’t this a classic case of “crowd-sourcing”, implemented way before the term was coined? The NIH also has an “RFP” (request for proposals) mechanism by which they contract projects with the various independent winners and create the network needed to sustain the project – isn’t that what is called elsewhere “out-sourcing” and “open innovation”?

I could not find a script of Collins’ speech, but I watched it for you! Here is a short run down of what he announced as his top 5 priorities for the NIH during his term:

  1. Apply new high throughput (“comprehensive”) technologies (e.g., nanotechnologies, genome wide-scans, proteomics) to understand fundamental biology questions as well as causes for different diseases.
  2. Emphasize translation of basic sciences into treatments, making “discoveries amenable for public benefit”
  3. Put science to work for the benefit of the heath care reform: “inform the conversation based on scientific evidence not on prejudice” by performing comparative effectiveness studies (e.g., study effect of life style changes vs. therapies for treatment of diabetes)
  4. Put greater focus on global health, including AIDS, malaria, tuberculosis and other major diseases in developing countries, by working with them in research and helping them develop their own capabilities
  5. Reinvigorate the biomedical research enterprise by making sure that funds are available to support younger investigators, increase work force diversity, encourage risk taking and innovation.  

I for one, cannot but applaud and embrace all these goals. Even as an academic researcher, I have always sought to “begin with the end in mind”, or how I like to refer to it “going back to the future”. In my case, this means starting with examining the real life case (the patient) to formulate the questions to take back to the lab for study in detail, increasing the chance that the answers from our research would be used to alter for the better the patient’s health in future

Some of the more hard core basic researchers might not entirely feel comfortable with the emphasis on translation. I agree that there is a fundamental need for fundamental research: the pursuit of questions that are so “out there” that no one can really tell where they might lead us or what they might connect with. Yet, after putting a lot of bright dots on… the blue sky, some need to concentrate on seeing patterns and be able to connect them, yet others will need to start figuring out how we might touch upon the new dots and patterns. I see the issue of translating science not as an imposition on fundamental research, but as an invitation to an open intellectual dialogue between basic, applied and clinical scientists, as well as product developers, regulators, and the public, where all can contribute with their own proficiency: the “constructive interference” effect. It is still not easy most of the times, as many places still operate based on narrow definitions of expertise and make make others feel as strangers in a stranger land. Thus, making scientific innovation happen for the benefit of humankind will require skilled, open-minded, and maybe fearless translators who can make sense of various intellectual languages and lands

Here is a list of related links:

Francis Collins, M.D., Ph.D., inaugural address to the NIH

About Translational research

The NIH Overview

In Wikipedia

Nature Medicine: In the land of the monolingual

NIH Funding opportunities for translational research

NIH-RAID (Rapid Access to Interventional Development 

NIH Translational research meetings

The NIH Roadmap

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How about this reply to the ‘what’s in it for me?’ question on everyone’s mind when it comes to the US health care reform: “Freedom to innovate!”

The health care reform proposal spurred a lot of discussion that seems to have fueled more emotional energy than rational arguments, not surprisingly used for political, business, and who knows what other purposes! The new reform has been presented by many as a dangerous threat to personal freedom, strongly resonating with a nation which fiercely values its freedom above all. I want to submit the idea that a well-thought-out reform would more likely enhance our overall capacity to make personal choices beyond the existing health care plans and such would increase our degree of individual freedom. In addition, having competitive options is very much in line with the overall philosophy of the American society and could have a very beneficial effect on innovation in the US.

People strongly react to such ‘push buttons’ and they fear the unknown. I could share some different personal experiences as someone who had lived in other places where universal health care options are available. For instance, I grew up not missing a single day of school. Good genetics? Maybe! Being vaccinated against all the childhood diseases and attending schools that had dedicated physician, dentist, and assistants on site… more likely! My parents also never had to take time off (for me to see the doctor or to nurse me) and never had to worry about paying medical bills if I would have gotten sick. My experience as a parent in the US was different. Most of us agree that it is not working well and that repeating the same and expecting different  – usually better ! – results equals insanity.

A reform is creating the opportunity to innovate the health care in the US.We have a great opportunity to analyse the highs and lows of several different systems currently run in different parts of the world. A new system in the US does not need to be the same as the European or Canadian systems, but could incorporate their successful features. However, the administration, congress, media, providers and consumers – we all – should collaborate to innovate the health care in the US.

A health care reform will also enhance the overall opportunities to innovate in the US.  The availability of a good employer-independent option has the potential to release a lot of people from their current ‘job lock,’ or even from its de luxe version: the ‘golden cuffs.’ Due to worries of not being able to provide health care for their young children, energetic workers are often stuck in jobs they would rather change. More ‘seasoned’ skilled workers are often worried about not being able to cover for their own potential health issues likely to increase during their gray years. Under current circumstances all these people are understandably seeking work with companies that provide generous health plans that most smaller companies cannot offer. A good employer-independent option would level the playing field: many small(er) companies, including New Co, a major source of US innovation, would have an easier time attracting valuable employees. Having put the fear of not being able to cover health bills behind them, many workers could then seek better job fits for their skills and passions. Does anybody doubt that being motivated by our passions rather than our fears has positive effects upon the output? Innovating health care in the US has the potential to trigger a chain reaction with a tremendous beneficial impact on the overall US innovation capacity.

Coming back to ‘what’s in it for’ us personally, let’s add another thought. Many studies indicate that stress is bad for our health. Losing the serious stress over not being able to afford the medical bills for ourselves, family, and employees might itself increase our overall well-being!

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