Today, the Supreme Court ruled in the case of Association for Molecular Pathology v. Myriad Genetics Inc. The court voted unanimously to overturn Myriad’s patents on the naturally occurring DNA fragments containing the BRCA1 and BRCA2 genes, while in the same ruling upheld the patents on forms of the genes never found in nature.
The ASBMB applauds the Supreme Court for overturning the patents on the isolated BRCA1 and BRCA2 genes. On behalf of the court, Justice Clarence Thomas wrote, “Many of Myriad’s patent descriptions simply detail the ‘iterative process’ of discovery by which Myriad narrowed the possible locations for the gene sequences that it sought… But extensive effort alone is insufficient to satisfy the demands of” patent eligibility. The sequences and structures of genes, whether in the context of the genome or in isolation, and sequences derived from genomic DNA, like messenger RNA and protein, are naturally occurring and should not be eligible for patenting.
However, the ASBMB is disappointed that the patents on complementary DNA, or cDNA, were upheld. Thomas wrote, “cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a ‘product of nature’ and is patent eligible.” Obviousness is a test that the U.S. Patent and Trademark Office uses to determine if something is patent worthy, and obvious inventions are not patent eligible. ASBMB’s position is that the BRCA1 and BRCA2 cDNAs are obvious derivations of the mRNAs, do not represent novel inventions and should not be eligible for patent protection.
The patents on the cDNA versions of BRCA1 and BRCA2 make important scientific tools unavailable to researchers and may slow progress in developing new tools for diagnosing heritable breast cancer. However, striking down Myriad’s patents on genomic DNA is an important victory toward improving breast-cancer diagnostics. Stay tuned to the Policy Blotter as we closely monitor the developments in this continuing case.
Last month, we analyzed the raw numbers published by the National Institutes of Health regarding the effects of sequestration. Each institute was able to set its own budget, and each institute has implemented very different strategies to compensating for these cuts. Aside from knowing that the NIH had to cut roughly $1.5 billion from its budget, we have not had specifics on how this would affect the NIH overall.
Yesterday, the NIH released its own agency-wide fact sheet on the effects of sequestration. The sheet says that approximately 700 fewer grants will be awarded, stipends for National Research Service Awards will not increase, and the National Clinical Center will accept roughly 7 percent fewer patients. Other than this, the sheet is fairly light on the specific effects of sequestration. The programs that are to be cut or curtailed have been left to the discretion of the individual institutes and are not mentioned in this fact sheet. Nor are specific cuts to the NIH intramural research program, even though NIH suggests this program will sustain a spending cut similar to that of the extramural community.
While the biomedical community focuses on the NIH and how it responds to sequestration, the real effects of budget cuts will be felt around the country in individual research labs by students, postdocs and faculty members. The ASBMB has created a survey to try to capture how sequestration is affecting the American research enterprise. We strongly encourage you to fill out the survey and tell us your story about how budget cuts have affected you and those around you. Then send the survey to all of the scientists you know—biologists, physicists, sociologists and beyond. We’re interested in everyone’s story! We will compile these stories and take them to Capitol Hill to help make a convincing argument that budget cuts are having a devastating effect on the research enterprise.
Today, Congress returns from their Memorial Day holiday. Much of the political news in the coming months will focus on scandals rather than legislation. However, Congress will be in session for the next two months with a brief break for Independence Day, and they are sure to do some legislating, right? Here is a preview of some of the policy issues we will be following during the D.C. summer.
On May 21, the Senate Judiciary committee passed the Border Security, Economic Opportunity, and Immigration Modernization Act (S.744). This bill contains provisions that would make it easier for those earning a doctorate in the U.S. in a science, technology, engineering or math field to stay and work in this country. Additionally, the price of H1-B work visas would be increased, and some of the revenue from this fee increase would go towards STEM training programs in the Department of Education and the National Science Foundation. This bill will be brought to the floor of the U.S. Senate in early June. The bill is expected to pass, but it faces an uncertain fate in the U.S. House.
Science agency legislation
At the end of April, the scientific community learned of draft legislation written by the House Science, Space and Technology committee that would impose additional rules on the NSF and its peer-review system. Scientific societies, including ASBMB, have expressed opposition to this draft legislation. As a result, the draft bill, which was supposed to be introduced and marked up in early May, has been in limbo as SST leadership determines the best path forward with the bill. In our discussions with Congressional offices about this bill, we have found SST Democrats to be uniformly opposed to this draft legislation while SST Republicans vary from strong to lukewarm support. Those expressing lukewarm support for the draft bill indicated they were not sure this debate over peer review was a worthy pursuit for the committee, but they were not necessarily willing to go against the will of committee leadership to oppose it.
In addition, the America COMPETES Act, which sets the goals of NSF and a variety of other science agencies, needs to be updated and reauthorized this year. This document has a list of guiding principles that many in the scientific community would like to see embodied in the new COMPETES bill.
Budget sequestration went into effect on March 1 cutting roughly 5 percent from the budgets of nearly every federal agency, including the National Institutes of Health and the NSF. However, this is not the end of federal austerity. The Budget Control Act of 2011 placed spending caps on the government for through 2021. If Congress and the president cannot agree on fiscal 2014 appropriations that result in spending less than the FY14 cap, across-the-board cuts will again be implemented to bring federal spending down to the level of these caps.
The FY14 appropriations need to be in place by the end of the federal fiscal year, Sep. 30. The previous debates in Washington about the federal budget have gone down to the wire, and we expect the FY14 appropriations fight to be no different. Thus, expect this debate to heat up during the two weeks Congress is in session during September. This is when we will find out Congress’ plans for science funding through the next fiscal year.
Stay tuned to the Blotter as we keep up with these and other science-policy issues throughout the summer!
On Tuesday, ASBMB Public Affairs Director Ben Corb attended a meeting with the staff members of the U.S. House Science, Space and Technology committee that drafted the High Quality Research Act. The SST staff wanted to have a discussion with the scientific community to clear up misconceptions about the bill. The reality is that very little was clarified.
Over 70 representatives of research organizations attended the meeting to ask questions of SST staff. SST staff indicated this version of the draft bill was for discussion only and never intended for introduction or debate in the full House. Corb and the other research representatives in attendance questioned why draft legislation was the first step in this discussion instead of consultations with the scientific community. SST staff indicated that House majority members had concerns about some grants funded by the NSF, and this draft legislation was written in response to those concerns. It was then pointed out that studies done by the National Institutes of Health and the National Science Foundation concerning improvements to peer review would have been a logical starting place to begin writing such legislation.
When questioned about how the specifics of the draft bill and how it would affect the peer-review process, SST staff said that the intent of the draft legislation was never to alter peer review. Rather, the goal was to add another layer of review after peer review that would improve accountability in the NSF grant funding process. SST staff said this would amount to program officers writing two to three sentences verifying that every grant application recommended for funding is important for the progress of science and the nation. This explanation, though, is confusing. How does this additional layer of bureaucracy achieve the committee’s stated goal of improving accountability in peer review and ensuring “that taxpayer dollars are spent on the highest-quality research possible”? Is the committee suggesting that program officers need to be held accountable for the grants recommended for funding by peer reviewers, and to what end?
Despite the sometimes tense back-and-forth between attendees, SST staff indicated that the leadership of the committee had no intention of abandoning the bill.
Yesterday, Jeremy Berg, President of the ASBMB, and formerly co-chair of the NIH committee on enhancing peer review, sent a letter to all of the members of the House SST committee, including the chair of the committee, Rep. Lamar Smith, R-Texas. The draft bill “places an additional burden on investigators and program staff to prove the value of their research before conclusions can be reached and is contrary to the scientific method,” writes Berg. He continues “The ASBMB strongly opposes the High Quality Research Act and any act that so fecklessly damages the peer-review process, as well as any attempt to politicize peer-reviewed science.” The ASBMB has also published a position statement on the peer-review process.
Stay tuned to the Blotter for further updates.
Peer review at the National Science Foundation has been the focus of recent inquiries from the U.S. House Science, Space and Technology committee. Chairman Lamar Smith, R-Texas, had requested the notes of the peer reviewers and program officers pertaining to five grants awarded by the NSF. In a letter to NSF Acting Director Cora Marrett, Smith said he had “concerns regarding some grants approved by the Foundation and how closely they adhere to NSF’s ‘intellectual merit’ guideline.” President Obama, White House officials, House Democrats and scientific societies all spoke out against Smith’s requests for the confidential peer review documents.
Yesterday, Marrett sent a letter to Smith refusing his request for the peer-review documents. The reason behind the refusal was the need to safeguard the confidentiality of the entire peer-review process. Smith said he was “disappointed” at the refusal, but he indicated that the discussion about peer review at NSF is not over.
The ASBMB staunchly defends the peer-review process. Check back next week for updates on how the society has made its voice heard on Capitol Hill with regard to the ongoing debate over peer review.
As the National Institutes of Health, the National Science Foundation and other federal agencies come to grips with sequestration, there is news that some agencies may get a reprieve. In April, the Federal Aviation Administration began furloughing air traffic controllers, causing significant flight delays. This public display of the effects of sequestration caused Congress to rapidly pass a bill that allowed the Secretary of Transportation to divert $250 million to the FAA to prevent further furloughs.
While President Obama approved of the FAA fix, he has stated that he has little appetite for similar fixes to other federal agencies. Nevertheless, members of both chambers and parties have already filed bills to restore funding to specific federal programs, including the NIH, Head Start and a variety of other programs. It is not clear which, if any, of these bills will pass both houses of Congress, much less be signed into law by Obama.
The ASBMB does not favor a piecemeal approach to fixing sequestration. Federal funding for science research comes from several federal agencies, and exempting one agency from sequestration would not help scientists funded by other agencies. The ASBMB would prefer overturning sequestration altogether. Stay tuned to the Policy Blotter for more updates on sequestration.
Rep. Lamar Smith, R-Texas, chair of the House Science, Space and Technology committee has spurred two distinct, yet related, discussions regarding peer review and the National Science Foundation. First, in an April 25 letter to NSF Acting Director Cora Marrett, Smith wrote, “I have concerns regarding some grants approved by the Foundation and how closely they adhere to NSF’s ‘intellectual merit’ guideline.” Smith went on to request the notes from the peer reviewers and NSF program officers regarding five grants awarded by the agency. Rep. Eddie Bernice Johnson, D-Texas, ranking member of the SST committee, wrote a fierce response and called Smith’s request, “the first step on a path that would destroy the merit-based review process at NSF.” Since this exchange two weeks ago, fellow Democrats, former NSF directors and assistant directors and many scientific societies have joined Johnson in calling on Smith to rescind his letter. The deadline Smith gave Marrett to respond with the requested materials was May 9. Marrett has asked for a one-week extension.
The second track concerns the High Quality Research Act, a draft bill proposed by Smith. This act would require the NSF director to make a written statement that every grant funded by the agency will “advance the national health, prosperity, or welfare, and to secure the national defense.” Proponents of this legislation claim it will improve peer review by ensuring that taxpayer dollars are used appropriately. Critics state that this legislation essentially asks the NSF director to predict the value of every grant issued by the agency. Just last week, a staff member of the Science, Space and Technology committee spoke to ScienceInsider about the bill. The staff member confirmed that Smith and others on the committee want to ensure a level of “accountability and thoughtfulness” in the funding decisions of the agency, which, they claim, will not affect the peer-review process. Nevertheless, the bill has met stiff resistance in Congress and the scientific community. Even the White House Office of Science and Technology Policy Director John Holdren and President Obama have spoken out against Congressional intrusion into peer-review at NSF and other agencies. This bill, while troubling, is unlikely to become law.
The ASBMB supports Congress’ right to question the actions of federal agencies and demand accountability for how taxpayer money is spent. However, the recent events concerning peer review at NSF are troubling. Peer review is not perfect, and conversations have been started at the NSF and National Institutes of Health on ways to improve it. Yet these conversations are not represented in Smith’s bill, and it is not clear how the provisions in the bill would actually improve peer review without endangering important research. We will continue to monitor this story as it develops.