Print BCTV: Second Chances -- New life in Congress for STEM visas; MODDERN Cures Act

Second Chances

Transcript of BioCentury This Week TV Episode 130




Benjamin Corb, director of public affairs of the American Society for Biochemistry and Molecular Biology ASBMB), Rockville, Md.

Demetrios Papademetriou, president of the Migration Policy Institute (MPI), Washington, D.C.

Myrl Weinberg, president of the National Health Council (NHC), Washington, D.C.



Microsoft Corp. (NASDAQ:MSFT), Redmond, Wash.

Rep. Leonard Lance (R-N.J.)

Sen. Amy Klobauchar (D-Minn.)

Sen. Chris Coons (D-Del.)

Sen. Marco Rubio(R-Fla.)

Sen. Orrin Hatch (R-Utah)

The Baltimore Sun, Baltimore, Md.



Steve Usdin, Senior Editor




STEVE USDIN: Congress switches gears on keeping life scientists in America. And can patient advocates persuade Congress to unlock dormant therapies? I'm Steve Usdin and welcome to BioCentury This Week.


NARRATOR: Your trusted source for biotechnology, information, and analysis-- BioCentury This Week.


STEVE USDIN: Leaders of both parties in Congress say they want it, but it hasn't happened. Why? Six months ago, BioCentury This Week focused a spotlight on an unnoticed hole in the immigration debate. Both Democrats and Republicans wanted to give a green card to anyone that graduated with an advanced degree in the STEM fields -- Science, Technology, Engineering and Math.


But, as BioCentury highlighted, the original bills in Congress excluded the life sciences. A Masters in computer science would be a ticket to stay, but someone graduating with a Ph.D. in microbiology might have to leave. Partisan bickering killed the STEM visa legislation in the last Congress, but now broad immigration reform has bipartisan support. And this time, the life sciences are included in the STEM legislation introduced by Republican senators Hatch and Rubio, and their Democratic colleagues Klobauchar and Coons.


To discuss the prospects for STEM visa legislation, we're for joined again by Demetri Papademetriou, president of the Migration Policy Institute, a nonpartisan think tank, and Ben Corb, director of public affairs of the American Society for Biochemistry and Molecular Biology. Demetri, the last time we talked about this, we were talking about the fact that life scientists had been excluded from legislation that would give visas to STEM graduates. This time they seem to be included in legislation. They are included. What changed?


DEMETRIOS PAPADEMETRIOU: Fundamentally, somebody asked the legislators to include them. And it was a no-brainer then. And, as a result, we now have them included in this particular piece of legislation that we all hope is going to move forward.


STEVE USDIN: And we're going to talk about the prospects for it moving forward in the rest of the show. But Ben, I wanted to ask you, what have you been hearing from your members about this. Do they view including life scientists in green card visa legislation as a threat in a competitive job market? Or do they think that it's an advantage and something that should be done.


BENJAMIN CORB: My members are concerned, always, about ensuring that we have the best and brightest here in this country. And obviously, with open positions, we, as a society, we would love to have American-born students taking and filling the jobs. However, there is a need. And at a time in which other countries are investing more than we are in research funding, you would never want to lose the opportunity to have the best and brightest not only studying here, but staying here to do the research.


STEVE USDIN: And Demetri, I want to take a step back. The hope is that there will be comprehensive immigration reform and that this would get be folded into that. What are the realities beyond that? How realistic is it that we're going to see comprehensive immigration reform?


DEMETRIOS PAPADEMETRIOU: More realistic than any other time in the past 20 years. I don't think that, in this particular issue, we have seen so much energy behind moving forward with a comprehensive bill. Things that seem to have been impossible three or four months ago, including that there would be so many Republican senators that would agree to things that the Republican Party had always opposed actually be agreeing with Democrats on fundamental issues on this bill is nothing less remarkable.


STEVE USDIN: And is that the result of the presidential election and the fact that so many Hispanic Americans voted for President Obama?


DEMETRIOS PAPADEMETRIOU: I think this may have been one of the motivators early on. I think now that people have gotten into the groove. They've realized that things have to be changed. I think the country, in a sense, is done with its anti-immigration, anti-illegal immigration passion. And everybody wants to move forward. This issue needs to be taken off the table.


The more people get involved in this, the more they want to have it done. An awful lot of political capital is on the table. As a result, everything is moving in a single direction at this point. But let's not forget that we still don't have the bill.


Once you introduce a bill, which now it appears that will be right after the Easter recess, then we're going to start a new round, where all of those people who are working toward a common purpose will start sort of coming apart a bit because they don't like this provision, or that provision, or the third provision. So we're going to go through a couple of months of hearings, et cetera, et cetera, that are going to be very, very risky in terms of what may happen by the summertime.


STEVE USDIN: So we don't have a comprehensive bill, but we do have a bill on this narrow issue of the STEM visas. And that's the Immigration Innovation Act. It's got a lot of interesting provisions. Ben, what do you think of it? What do you think it would do for science?


BENJAMIN CORB: The provisions are certainly interesting. There would be an increase in the number of H1B, the temporary visas that are most often used in this area, which would be a good thing, allowing more people to stay here. One of the really interesting aspects of this piece of legislation is a fund -- an increase in the cost for the visa for the company, which is sponsoring the student, or the foreign-born national to stay here, but a fund that would go toward the Department of Education to fund programs for teachers to increase the amount of scientists and engineers, and the efforts, and the initiatives that we have here in this country, so we can build the next generation of scientists here, within our borders.


STEVE USDIN: That's interesting. We talked about that in the last show. It seemed to have been an idea that Microsoft suggested.


DEMETRIOS PAPADEMETRIOU: Indeed, Microsoft was actually suggesting that they'd be willing to pay up to $10,000 for more visas. And then if they needed more visas than the ceiling would allow, they were willing to pay up to $20,000 per visa. The proviso was that all that money goes toward educating and hiring more teachers for math, sciences, et cetera, et cetera. So I'm very glad. I think this is very smart. I've never been particularly happy with the way that part of this $1,500 fee has been allocated. This makes a lot of sense.


STEVE USDIN: Well, we're talking today about STEM visas for international bioscience graduates. How many foreign-born college and university students are studying in the U.S.? Here are the numbers.


NARRATOR: You're watching BioCentury This Week.




STEVE USDIN: We're back with Ben Corb and Demetri Papademetriou, talking about the politics of STEM immigration.


I want to get back to the Immigration Innovation Act, what's called the I-squared bill, and talk about some of its provisions. One of them is that it would give a green card automatically to scientists who graduate with a STEM degree, right?


DEMETRIOS PAPADEMETRIOU: Right. But there will have to be an employer involved in this. In other words, the whole idea of this is that it's not enough to graduate with a degree, but you have to have graduated with the right kind of a degree, presumably from the right kind of university, that an employer would be interested in your services.


And that always makes a lot of sense. It obviates the need for labor market tests and all of these other kinds of things. It's the ultimate test of a need. An employer is willing to pay you a fair wage, and he or she has a job for you.


STEVE USDIN: Another aspect of it, though, for the separate category visas, for the H1B visas, is that it would give scientists and anybody else who has an H1B visa a lot more flexibility, right? They wouldn't be tied as firmly to a particular employer.


BENJAMIN CORB: That's correct. And that would be helpful. In addition to the flexibility, so that if something with the employer were to not work out, or a better opportunity were to arise, there'd be some ability to move on to another job and grow professionally.


It also increases the number of H1B visas by 50,000, which is great. It increases the cap, and the cap would be based on market need. So if there was not a need, if we were to suddenly start graduating and generating postdoctoral students here in this country, we could lower the cap and keep the jobs in house.


The other thing that this bill does is it allows unused green cards and unused visas that exist within the U.S. system to be put towards these scientists that are coming from other countries, so we can still perhaps be at the caps that exist today and apply them towards the workforce that they need.


STEVE USDIN: That's interesting, Demetri. So what is this about -- what are the unused green cards? And is this bill going to end up increasing net immigration?


DEMETRIOS PAPADEMETRIOU: I suspect that it will increase net immigration, particularly when we think of immigration as green cards, rather than those temporary, even if they're long temporary, work visas, the H1B, et cetera.


So you're going to have to increase green cards. This way, employers who have already invested in the relationship with a smart Ph.D. or whatever in any of the sciences, life sciences, engineering, or what have you, can actually sponsor that individual to have a permanent status here, to get a green card. That's essential. It will fix that.


The other provisions that Ben has talked about make an awful lot of sense. There is always this undercurrent whereby some employers will take advantage, to different degrees, of the fact that this particular person who holds the visa is tied to them.


So that creates all sorts of bad incentives for misbehavior. It doesn't happen frequently, but it does happen. So given an opportunity to the individual to walk off a job without having to lose his or her right to stay in the United States and look--


STEVE USDIN: That gives more power to these people.


DEMETRIOS PAPADEMETRIOU: More power to the individual. It's better for the visa category itself. It's better because people realize that this is something in which fairness and equity plays a role, et cetera, et cetera. So that's important.


STEVE USDIN: Ben, we've just got a few more seconds left. But I want to ask you about American competitiveness. Especially in this age of sequestration, we've been talking about people coming here. Are you seeing anything from your members going abroad?


BENJAMIN CORB: We are. In fact, I did a survey out to my membership to ask them, what's the impact that they have of sequester?


Unfortunately, a number of scientists and our members have discussed the possibility of moving to Singapore, to Germany, to China, because of more lucrative funding opportunities there. Just a few weeks ago, the Baltimore Sun did a piece that highlighted some really high level scientists who have left this country for that exact reason.


STEVE USDIN: I want to thank Demetri and Ben.


Next we're going to check in on patient advocates who are asking Congress to unlock dormant cures.


NARRATOR: BioCentury, named the 2012 Commentator of the Year by the European Mediscience Awards for excellence in communications and clear, concise commentary.




NARRATOR 1: Now back to BioCentury This Week.


NARRATOR 2: In May, 2011, BioCentury This Week examined a problem that frustrates patient advocates -- how to stimulate the development of potential therapies that lay dormant because they have no patent protection. Patient advocates led by the National Health Council found a champion in New Jersey Republican representative Leonard Lance. But Representative Lance's bill, The Modern Cures Act, didn't survive the last congressional session. The National Health Council is again pushing for its passage in the 113th Congress. This time, the advocacy group is getting support from the Hempel family, who hope modern cures will help children like Addi and Cassi Hempel, suffering from Neimann Pick, a rare disease that causes symptoms like Alzheimer's.


STEVE USDIN: To discuss the Modern Cures campaign, we're joined by Myrl Weinberg, president of the National Health Council. I wanted to start with asking you about this idea of a dormant cure. What exactly is a dormant cure or dormant therapy?


MYRL WEINBERG: A dormant therapy we define as one that meets an unmet medical need, which usually means that someone has no treatment at all, or a very ineffective one. And it also, as we heard, has no patent protection.


STEVE USDIN: And what is it that the legislation in the Modern Cures Act does to try to make it possible to develop these dormant therapies?


MYRL WEINBERG: Well what we did because these patents have run out or they don't exist for these products, and therefore the products just sat on the shelves as potential products. They are compounds that are within companies that are going nowhere. And so what we did was we identified a way to incentivize the development of those dormant therapies into treatments.


And so we created this special category called dormant therapies. And if a therapy comes forward as a dormant therapy, is approved by FDA, then that company gets 15 years of data exclusivity, which means there will be no generic or other competition on the market. And it will then be worth their investment.


STEVE USDIN: And do you have any idea of how many of these so-called dormant therapies that there are, how common this is?


MYRL WEINBERG: We think there are probably tens of thousands. We know that when a company files with the IRS to get a patent for a particular compound, they go ahead and file for all the related compounds to block competition. And so when they develop a few of those compounds that they now have patents for, the others just sit there. And they're sometimes tens of thousands. So if we start to bring forth quite a number of these, we really expect there will be in the not too distant future, there could be thousands of new products for people who have no treatments at all.


STEVE USDIN: And in the introduction to today, we mentioned the Hempel twins. Is a dormant therapy something that could help them.


MYRL WEINBERG: Well it could. And it certainly could have in the past. Chris and Hugh Hempel have spent years researching products, and then even developing their own product for their own children, who would die without it. This should never happen.


And so what a dormant therapy would do is the product that they're trying to develop, which we would call a dormant therapy because it's not eligible for a patent, is a product that no company will touch. And therefore they won't move it into development because there's no return on their investment. So what we would have done, and hopefully could do in the future, is we could make it viable for that company to go ahead and develop that product, and save those parents all those years of effort.


STEVE USDIN: And I guess some people would look at this, and they would say, well why should the government be giving people monopolies on these kinds of products? And is it going to cost the health system even more?


MYRL WEINBERG: Well I think it would not cost the health system more. But I think that if we didn't have a period of time for companies legitimately to recover the millions of dollars that they've invested in developing products that will save people's lives, then we would have no new products. And so we are the country in the world that develops probably the most products, the most effective, and we need this system. We just have to find a way to pay for it. And as they are developing those products, clearly generics and others are developing their own kinds of products that will hit the market as soon as the patent runs out, or the data exclusivity runs out on the patented product. We need that system.


STEVE USDIN: And I want to shift to another aspect of the Modern Cures Act, which is around stimulating the development of diagnostics. Part is around companion diagnostics. What's that about?


MYRL WEINBERG: Well what we know now is that we had in the world the technical ability to develop what we call advanced diagnostics. And if we can incentivize the development of these advanced diagnostics, then we will know much more precisely for whom products work, and for whom they do not. And right now we know for a fact that about 40 to 60 percent of the people who take a product are actually helped. And the others, the product doesn't work. It can cause harm. It can have side effects.


So what we want to know with these advanced diagnostics, which will tell us which products work for which people, then we will be able to have the people get the right product that meets their condition. We'll have prescribers know that when they prescribe a medicine it's going to work. And the whole system will save money. Because we won't be giving products to people who would not benefit from them.


STEVE USDIN: And what is it that's in the Modern Cures Act that will provide that kind of incentive?


MYRL WEINBERG: So we have two things. One is that we have if a company develops what we call a companion diagnostic, which means that the same time it's developing the drug or the other treatment, then they will get six months of extended data exclusivity. So again, protection from competition. Actually if that's at the same time, it's 12 months. If they develop it after the product is on the market, they'll have six months of data exclusivity.


STEVE USDIN: And we'll get to the second aspect of the diagnostics part of the Modern Cures Act in just a moment. And we'll have more with Myrl Weinberg in just a moment. But first, here are some of the goals of the Modern Cures Act.







STEVE USDIN: Let's get some final thoughts about the Modern Cures Act from our guest, Myrl Weinberg, President of the National Health Council. Myrl, I wanted to ask you about this third aspect of the bill, which is trying to create new reimbursement patterns for diagnostics. What's that about?


MYRL WEINBERG: Well, right now, diagnostics, there's not a real incentive to develop them because the rates that they set for reimbursement for these diagnostics is literally based on the 1980s rates. And so there's been no allowance for that current cost of research and development for these very advanced diagnostics. There's no allowance for the actual impact on the person's quality of life. And there's no allowance for what the new diagnostic might save the whole system. So this bill would create a pathway and a procedure in order to update the way that reimbursement rates are set, and take those other things into account.


STEVE USDIN: And when you're talking about reimbursements rates, you said, is that for Medicare or would it also spill over into the private sector?


MYRL WEINBERG: It would spill over, because a lot of the rates that are set through Medicare, in actuality are sort of followed by and picked up by the private sector.


STEVE USDIN: I don't see a lot of enthusiasm in Washington these days for things that are going to increase costs, especially for health care. What's going to be your argument back when people are going to say, you're just talking about paying more for diagnostics?


MYRL WEINBERG: Well, we are, but I think what we're going to say is that we've had a cost estimate done of this bill ourselves. And it's not that expensive to begin with. It's about $20 million over 10 years. What Congress doesn't do, I think as you know, is they don't really calculate the savings. But a part of our argument will be that we can show that if you're giving a product -- I'll give you an example -- to a person with Alzheimer's and there's data to show that 70% of the time that product will not work. Clearly, if you get it to the 30% of people that need it, they get better. They're not using the health care system as much. And the other people are not spending money or the system isn't spending money on that product will save a lot.


STEVE USDIN: I'm interested in the idea also from the Modern Cures Act, is that it was originated by a patient group and by patients. What was your thinking in doing this? And what's been the response that you've received on the Hill?


MYRL WEINBERG: Well, our thinking is that we're an umbrella for patient advocacy groups and so our members are national patient advocacy organizations. It was really from them, and the people that work in this area, that they were able to identify for us these barriers. And so with them and our other members, which include providers, and pharma companies, and health insurers, and others, we were able to really look at these problems and come up with a way to resolve them.


The fact that it is patient groups, about 50, representing 133 million people with chronic disease and disability, we've been very well received on the Hill, because people want to do the right thing for these individuals that are suffering. And so right now it's been very positive and we have no, I would say, no serious opposition.


STEVE USDIN: And the bill, just to be clear, it was introduced in the last session. It didn't pass. And you're hoping that it's going to be, and expecting that it's going to be reintroduced very soon in this session.


MYRL WEINBERG: That's exactly right. We expected to be reintroduced in the House by Representative Lance again in the very near future, and in the Senate a little bit later.


STEVE USDIN: And do you expect that it would be passed ultimately as a standalone bill, or are you hoping that it would get attached to something? And do you have kind of ideas about what it might get attached to?


MYRL WEINBERG: We actually just want it to be passed, right? So it doesn't matter to us particularly if it's standalone or attached. I think the likelihood is it will probably be attached to some other legislation rather than standalone. It could even be potentially passed in two parts in the Senate, we know that. So we're just waiting right now to see what would be the best vehicle to help us ensure passage.


STEVE USDIN: Have you heard from companies that are developing drugs, as to whether or not either one of those aspects of the bill would actually result in the development of new therapies, and what kind of timelines?


MYRL WEINBERG: We have, and I think it's important to know that our membership, in addition to the patient groups which control our governance, includes about 20 of those companies. They've been very involved in helping us understand what this bill would mean for their companies. They're very supportive. They're looking internally of how they can have this work to their advantage.


And from what we're hearing is that they will be very supportive in producing a lot more new treatments, potentially for smaller populations, but for whom they can expand that treatment later. And it just feels really good right now that we're going to get this done.


STEVE USDIN: That's our show for this week. I'd like to thank Ben Corb, Dimitri Papadimitriou, and Myrl Weinberg. Remember, you can share your thoughts about today's show on Twitter. Join the conversation by using the hashtag, #BioCenturyTV. I'm Steve Usdin, I'll see you next week.