Whenever we ponder national security our optimistic focus is drawn to the Cold War’s “mutually assured destruction”. After all it worked. Who wants to die pursuing their future? Now suicidal “soloists”, North Korea’s propagandized puppets, and religious radicals seeking salvation by dying, clutter news coverage almost every day. Instinctively we hope deliberate martyrdom motivates a small minority of mankind. We blindly trust that most still think mass murder is immoral or at least unlikely to promote either human welfare or our own. Not so with microbes. They are here. Their mindless evolutionary pursuit of their survival here on earth s unrelenting. For microbes, there is only now. They are multiplying. And they are the perfect weapon for deranged minorities. Can self-proclaimed “germaphobe” Donald Trump ignore this issue? Will he expressly say again as millions die, “who knew”? Well, research universities know. Clearly NIH’s budget must be broadened not reduced.
A NY Times op-ed (March 25) headlined “The Real Threat to National Security” reiterates what Bill Gates warned two years ago, “of all the things that can kill more than 10 million people around the world the most likely is an epidemic stemming from either natural causes or bioterrorism.” NIH can fight them both but not alone and not without congressional support. Trump Administration proposals to significantly increase military expenditures within our discretionary 2018 budget, while slicing NIH by18 percent not only demonstrate his misdirected emphasis regarding overall national science priorities, cutting NIH is now unsound from a military perspective. As we argue below, research universities must engage more forcefully on this issue. Continue reading There Are No Microbe Martyrs
The seismic disruption of President Trump’s 2018 budgeted NIH funding cuts cannot be ignored because their future impact will not be erased this time by the usual congressional brush-off of “dead-on-arrival”.
Nobel Prize recipient and former NIH and NCI Director Harold Varmus has warned us in a NYT guest editorial today.
“A substantial N.I.H. budget cut would undermine the fiscal stability of universities and medical schools, many of which depend on N.I.H. funding; it would erode America’s leadership in medical research; and it would diminish opportunities to discover new ways to prevent and treat diseases.”
In his op-ed Dr. Varmus explains in concise detail why the proposed deep cuts may later be partially compromised but not entirely cancelled, thus undermining the continuation of grants already committed to their Bayh-Dole development of much-needed biomedical therapies, already scarce new projects, and the training of today’s junior scientists. Research universities must act now if they and NIH are to be spared the existential harm of further lowering NIH’s decade long flattened funding. Continue reading Dr. Varmus Warns Convincingly. Universities Must Back Him with Specifics
Trump’s budget may be “dead on arrival” but like the memorable movie title “There Will be Blood” its proposed cuts to federally funded science and medical research are deep, wide and for many university research programs, bloody. We do not yet know what will happen to NSF but if NIH’s $5.8 billion cut is any indication, the outlook for NSF and the other grant facilities is equally bloody. Read the science budget proposals. The nation’s innovation ecosystem has been put on the chopping block. Continue reading EMERGENCY Red Alert
Our last post referenced the Advanced Patent Law Institute opening Panel’s concerns about the decline of investment in commercialization caused by a precipitous decline in patent reliability and pervasive patent legal uncertainty. Life science commercialization drew extra emphasis because of the seemingly simple but complex ramifications of price controls for prescription drug products. Bayh-Dole march-in’s compulsory licensing and importation of drugs through Canada were joined last week by prominent discussion of repealing the “nonintervention” law, the statutory prohibition of direct negotiations with drug makers over the price of Medicare prescription by President Trump replacing the insurance companies and PBM’s who negotiate now.
Many believe such negotiations will lower prices. In some cases maybe yes …in others maybe no. Trump said they would save 3 billion dollars. CBO has said savings, if any, would be small. Negotiators however must be ready to disagree. Non-agreement means reducing access to certain medicines because disagreement means removal from patient formularies. While the conference was pondering the commercialization effects of price controls at the USPTO President Trump was meeting with Representatives Cummings to discuss the direct negotiations issue. Speaker Ryan could not have been pleased to see the meeting get two day’s news coverage.
On Saturday NPR commentator Scott Simon caught up with Rep Cummings to learn more about his White House meeting. Cummings said not only that the meeting went well but that Friday night he was advised by the president that he would try to insert repeal of the non-interference law into the contentious ACA repeal debate which began last week. The meeting went well for Cummings to be sure. For Trump …not so much. There is no way Cummings will support ACA’s Repeal and Replace no matter what Trump does but the meeting and its outcome added more uncertainty to the commercialization issue. When Simon asked Cummings about the meeting’s outcome this weekend Cummings, who is one of the president’s harshest critics, cleverly drew Trump back into the direct negotiations debate….
CUMMINGS: I think that we have a chance. As a matter of fact, as late as yesterday – last night – he told me that he’s going to try to get it into his bill.
SIMON: He told you this last night, Friday night.
CUMMINGS: Last night, that’s right. So we’ll see what happens. You know, with President Trump you – I think you have to wait and see. You’re going to have a good conversation. It sounds like he’s going in the direction that you’re going in, and people have told me you step out of the room and next thing you know maybe something has changed. But the conversation that we had with him was a very good one.
Earlier in his interview Simon asked why direct negotiations were not provided for during ACA’s original enactment, noting that true negotiations can only occur when one of the parties can walk away if they do not agree. In effect, he was asking if the president was ready to exclude formerly included drugs from patient formularies. Continue reading Trump is Trapped Again
The long-expected clash between Republican campaign rhetoric and the political reality of Republican control begins in the House this week. And what happens to R&D funding in the budget process is still unclear, but because of its size and future benefits as distinguished from immediate impact, its current $130+billion will not be unnoticed by a revenue-starved “controlled” Congress.
Beyond this week’s start of House committee consideration of ACA, including its repeal of revenue producers. And the administration has promised “details” this week on its $54 bn. increase in discretionary defense spending. This implies an equivalent decrease in non-military civilian discretionary spending. Discretionary spending is about a third of our entire federal budget. The remaining two thirds are mandatory paying for debt interest, and the Social Security/ Medicare entitlements Trump has vowed to leave untouched. Like the “Wall” new expenses, must be offset by future budget savings, either from future reductions in mandatory entitlements or from discretionary expenditures like the Depts. of State, EPA, and AID. Repealing small fry funding for the Arts, Head Start Americorps, and the Corporation for Public Broadcasting contribute little to the savings needed to offset Trump’s announced spending increases and tax reductions. Other spending offset sources like more revenue or increased debt have their own problems. So, to put it bluntly, R&D’s annual $130bn. appropriation which includes future basic science funding at NIH, NSA, and DOE is a very tempting offsets target. Will R&D funding it be trimmed… and if so how much? Two Trump budgets (for 2016 and 2017) must clear the House this Spring. And while the coming budget battle may be too complex to knowledgeably monitor both, for those of us who care about federally funded basic research, it makes sense to pay attention, stay alert and be ready to act if R&D funding goes on the chopping block. Here’s the problem. R&D funding invests in the future. The budget quagmire is now. If a deadlock among Republicans emerges Republicans collectively must resolve it because there is no one else to blame. They have postponed defining their actual positions for years. Will they now postpone implementation of long term investment expenditures whose beneficial effect is not immediate?
Continue reading Will Federally Funded Basic Research Be Victimized By Republican Budget Unrest?
Bayh-Dole’s (B-D) commercialization of federally-funded basic research is the bridge connecting annual $130+ bn. congressional funding to its congressionally intended public benefits of jobs, economic development and scientific progress. This B-D bridge’s on-ramp is controlled by federal grant agencies, each with its own mission. Life science’s on-ramp is supervised by NIH. Its off-ramp exit is policed by the FDA. Life science’s high-risk commercialization crossing to the off-ramp is difficult, long and costly. Its chances of reaching and using the FDA managed off-ramp are statistically slim. Continue reading Elimination of Further R&D Funding
The pre-election clamor about prescription drug pricing took an interesting turn last week following President Trump’s meeting with prescription drug-makers at the White House. Earlier this year pricing abuse by rogue firms whose lack of competition in certain markets enabled upward price ratcheting attracted glaring press outrage leading to presidential campaign promises to curb prescription drug pricing if elected. Unfortunately, top down price controls cannot cure this market malady. Indeed, by choking-off investment in basic life science research to develop cures advancing competition they will only worsen it. Post-AIA uncertainty plaguing commercialization is shrinking independent private investment in the long and costly development of high-risk life science products, shielding sole suppliers to certain patient markets from competition. Continue reading Trump Moves Towards Life Science Support
Like the proverbial “tango”, research university commercialization of basic research “takes two”; university TTOs and private sector investors. To attract such investment its subject matter must promise prudently estimated commercial development returns. Investors also must estimate that such development can be executed and competitively distributed at a price sufficient to provide a reasonable return on their investment. Such “reasonableness” in markets is a function of lost alternative opportunity costs, applied research risk, development and added capital costs, endpoint market demand and sometimes regulatory approvals. Patents may provide protection from competitive duplication for a limited period, but sales at the product’s optimal price point are the ultimate determinant of investor success. Optimal price selection combines experience, economics, art and science in functional complexity not normally housed in government. Bayh Dole’s market-based dynamic does not intrude on the price selection of product developers because in its absence prospective investors cannot prudently estimate their potential return on investment. The wisdom of this approach is not only theoretically obvious, we have seen this movie before with “CRADA”. Continue reading CRADA. . .Market Reasonable vs. Politics Reasonable
Because TT commercialization requires prudent private sector investment, increasing uncertainty regarding post-patent and post-development patent and pricing reliability threatens Bayh-Dole TT commercialization. Patent reliability and investor pricing aegis are critical prerequisites private sector entrance into commercialization partnerships. Both are now under attack. now it appears that R&D funding for disposition by federal grant agencies also is under concerted attack. When the NY Times and the Wall Street Journal publish op-eds attacking federal funding attacking NIH and research universities, the attack is confirmed and must be met head-on. Continue reading Bayh-Dole Commercialization Under Attack
This New York Times above-the-fold hit piece is designed to support price-based march-in and generally damage Bayh-Dole. It tells us that enemies of B-D obviously plan to engage again and to use drug pricing as their weapon of choice. Engineered by James Love of KEI, it attacks a seemingly successful CRADA partnership, refers to unrealized capital gains as “profit’ (which could be wiped out by a future adverse FDA ruling), misstates NIH’s repeated conclusions that price-based BD march-in is not authorized by BD, factually saying it is now available to curb drug pricing. Continue reading Harnessing the U.S. Taxpayer to Fight Cancer and Make Profits – The New York Times