Take Action to Stop Slick Political Propaganda to Repeal and Replace ACA

The ACLU says it well in condemning the Repeal of the Affordable Care Act with a replacement that is not affordable for majority of ever poorer Americans ( a group that gets larger every year) across the nation:

• Millions of Americans would lose coverage
• It would gut Medicaid to the tune of $880 billion—harming people with disabilities who rely on Medicaid for essential services
• It would block Medicaid patients from seeking care at Planned Parenthood—restricting access to cancer screenings, breast exams and STI tests and treatments, and forcing health centers to close.
• It would attack women’s ability to buy private insurance that covers abortion.Source: In Hands Off Our Healthcare: Don’t Repeal The ACA the ACLU states its case at https://ssl.capwiz.com/aclu-action/issues/alert/?alertid=76013626

Why is the ACLU so involved in this fight to prevent the American Health Care Act from being passed? Because health care is a civil right in all advanced democratic countries with exception of U.S. under Republicans who are too cheap to spend needed money to provide quality health care plan for all Americans. Those in power continue to espouse ideology that gives more money out of the pockets of hard working taxpayers to the extremely wealthy, large corporations and market-based health care system companies that enrich themselves at the expense of quality care for all. Paul Ryan is so excited about the American Health Care Act because it fulfills his dream since his frat days—to stop supporting poor people with needed health care. )http://readersupportednews.org/news-section2/318-66/42545-paul-ryan-ive-been-dreaming-about-kicking-the-poor-off-medicaid-since-i-was-a-frat-boy) Paul Ryan doesn’t believe health care is a universal right but rather a privilege that can be removed when the cost is too high in his mind and those of his like-minded brothers.

Those opposed to universal health care have used fear-based ideology in past to deny Americans same quality of preventive and therapeutic care that other foreign nations provide their citizens as “socialist”, claim such a system would destroy choice for patients, and would place too much power in hands of governments. The propaganda that patients want to control their own choices so much that they would choose not to have mandated insurance to provide care when needed and that “access” is the most important value even if the accessible plans are unaffordable. Access is worthless if one can’t afford the price of insurance under plan that gives expensive alternative choices and eliminates the needed subsidies to pay for that more expensive policy. Just as the new proposed budget is heartless, the American Health Care Act is a cruel joke on our citizenry.  And especially so for the population in rural red states that voted forThrump, the biggest con man of them all.

“Repealing the ACA threatens our civil rights and liberties and harms millions of vulnerable people.” Tell your members of Congress to oppose the American Health Care Act and remember the need to bring relief to the suffering and least able to protect themselves from slick talking politicians.

Action Item

Go to https://ssl.capwiz.com/aclu-action/issues/alert/?alertid=76013626&type=CO&emsrc=Nat_Appeal_AutologinEnabled&emissue=reproductivefreedom_disabilityrights&emtype=capwiz&ms=eml_170317_reproductivefreedom_disabilityrights_ACArepeal&__af=query_string_encrypted

And follow suggestions for contacting your representatives and voice your opinion about repeal of ACA without equivalent or better health care. We have to communicate the sham nature of the propaganda in behalf of huge tax cuts to the wealthy and increased income for the middle men health care companies  that run our “market” health care.

Highlights of Bioscience Events Week of March 19, 2017

• HBA, Monday Evening, March 20, 2017, Fireside Chat: The Future of Medicine with Former NBC Medical Journalist Dr. Nancy Snyderman, Featured speakers: Nancy Snyderman, Consulting global health professor, former otolaryngologist, former chief medical editor, Stanford University; Jennifer Lovejoy, Chief science officer, Arivale; Ramji Srinivasan, Chief executive officer, Counsyl; Darren Brown, Executive vice president, employee benefits, ABD Insurance & Financial Services
• EPPICon 2017, Saturday, March 25, 2017. Event: 11th Annual flagship event of EPPIC Global, Keynote Speakers: Ira Mellman, PhD (Genentech) and D. J. Patil (Chief Data Scientist, White House Office of Science and Technology)
• CABS, Saturday Afternoon, March 25, 2017, Topic: “Precision Medicine for oncology and immunology”

You can download the details for the upcoming events this week and those through June 2017 with Audreys Picks March 19 2017.

Audrey

 

 

FDA Commissioner Pick Preferred to Other Potential Candidates

In “Stand Up For Science” written by Steve Usdin, Washington Editor, BioCentury this week, we learn how little the industry has done to speak up for value of science and sense. Some of the Trump Administration’s potential candidates alongside talk of totally upending the proven drug approval system were met with chagrin by many and still pose very serious risks even with the appointment of Scott Gottlieb, a past conservative high-level employee of the FDA under the George W. Bush administration and supporter of deregulation. He is expected to be approved but industry is still not out of the woods from crazy thinking by the cost slashing army of Trump and far-right anti-science politicians. The agency still faces potential budget reductions and political attacks on the wisdom and decision-making of the agency’s professionals.  Steve Usdin advises “The Risks Are That Two Decades Of Progress Toward More Efficient, Science-Based Regulation Would Stop” and be replaced with approval of drugs with only Phase I studies and market force controlled review alone.

Usdin reports that the industry abdicated its responsibility to be involved in stating the “criteria for an acceptable FDA commissioner, to commit itself to rally support for any nominee who meets those criteria and to adamantly oppose one who falls short.” Rather they remained silent and sat on the sidelines. So far we are lucky with Gottlieb who is still viewed as too close to industry due to his venture capital history but at least he is physician with agency experience. Note that his approval is not assured as Trump listens to Peter Thiel who recommended a poorly qualified candidate for the job, Jim O’Neill. (https://www.nytimes.com/2017/03/10/health/fda-scott-gottlieb.html?_r=0)

Now Trumpcare Has Arrived, Is It Passable? 

The Republican American Health Care Act known as Trumpcare was quickly put together without the care and concern needed to develop a program that would deliver on the President’s campaign promises of a better, more affordable plan for everybody. The big elephant in the room is how to finance this campaign promise from a party ideologically not committed to provide care for our poorer citizens. Trumpcare  simply stated “covers fewer Americans, increases costs for low-income and senior citizens, increases the deficit, defunds Planned Parenthood and does next to nothing to reduce overall health care costs.” The San Jose Mercury editorial of March 9^th summarizes the rushed GOP health care plan as a disaster. (http://www.mercurynews.com/2017/03/08/editorial-why-paul-ryans-health-care-plan-is-an-unmitigated-disaster/)

California will suffer huge lost payments from the Federal government as will other states which expanded Medicaid. “By a conservative estimate, the state stands to receive $8 billion less a year from the federal government to cover its health care costs for low-income families qualifying for Medi-Cal.” The rich will stand to gain huge tax reductions and the poor will lose coverage. Tom Price doesn’t understand or, maybe does, but doesn’t care that low income folks can’t use promised tax credits to replace lost subsidies under Obamacare. The cost of health care is being shifted to the individuals and taxpayers who are least able to pay for it. Trumpcare is a path to destroying Medicaid which reached so many poorer Americians.

 Highlights of Bay Area Bioscience Events Week of March 12, 2017

• UCSC Clinical Trials Course: March 13-17, 2017, Event: Clinical Trials Essentials: An Intensive One-Week Course, Event Dates: Monday March 13- Friday, March 17 2017
• Bio2Device Group, Tuesday Evening, March 14, 2017, Topic: “Brink of Catastrophe: Catching Addiction Early,” Speaker: David Deacon, CEO, DxRx Inc
• WIB, Thursday Evening, March 16, 2017, Event: WIB-San Francisco Bay Area Women’s History Month Event: Leveraging Partnerships in the Growing Immuno-Oncology Space; Moderator: Stacy Feld, VP, Consumer Venture Investments & External Innovation, J&J Innovation – JJDC; Panelists: Julie Hambleton, MD, VP and Head of US Medical, Bristol-Myers Squibb; Sylvaine Cases, PhD, VP of Oncology Scientific Innovation, Janssen R&D and J&J Innovation;Jane Grogan, PhD, Head of Adaptive Tumor Immunity and Principal Scientist, Genentech
• CABS, Saturday Afternoon, March 18, 2017, Topic: “NGS for cancer and autoimmune diseases”

You can download the details for the upcoming events this week and those through April 2017 with Audreys Picks March 12, 2017.

Audrey

Republican Efforts to Steam Roll Repeal and Replace Obamacare Hitting Obstacles

The Republican leadership, especially, Paul Ryan has been almost gleeful about their party’s positioning right now to achieve their economic programs which seek to turn the clock back on liberal social programs and other trends they want to reverse under their leadership. They may do some unfortunate things in their attempt to stop the inevitable trends in the U.S. but they aren’t expected to succeed in the end. They can’t take away health insurance from 32 million Americans without some consequences to their political viability.

Taking healthcare entitlement programs back to earlier times with far less people insured, higher prices for the least able to pay for it, poorer quality healthcare for all and higher death rates due to poor quality health care is not likely in the end. Once Americans like a program we know historically the Congress can’t take it away. “The chaos surrounding Republican efforts to “repeal and replace” the Affordable Care Act illustrates just how difficult this rollback would be. The idea of repealing the ACA first and coming up with a replacement later died quickly, forcing Republicans to confront the fact that they cannot agree on what the new plan should be. Some want to keep the Medicaid expansion, some balk at requiring higher deductibles, some worry about reducing subsidies, and many fear political damage from throwing millions of people off health insurance. The disunity of the repeal forces is so palpable that former House Speaker John Boehner, who once led the charge to repeal the ACA, now admits that repeal is “not going to happen” and that “most of the framework of the Affordable Care Act” will remain in place.”(Source: Things look bleak for liberals now. But they’ll beat Trump in the end. He and his movement will fade, and the values and priorities of the left will eventually triumph by Ruy Teixeira, Washington Post, March 3, 2017 at https://www.washingtonpost.com/posteverything/wp/2017/03/03/optimistic-leftist/?hpid=hp_no-name_opinion-card-c%3Ahomepage%2Fstory&utm_term=.6504f57b1f42)

Highlights of Bay Area Life Science Events for Week of March 5, 2017

• JLABS, Tuesday Morning, March 7, 2017, Topic: “Value of Biotechnology Business,” Speaker: John Selig | Managing Partner, Mavericks Capital
• BMES and B2Device Group, Tuesday Evening, March 7, 2017, Event: BMES and B2DG for a Happy Hour

You can download the details for the upcoming events this week and those through May 2017 with audreys-picks-march-5-2017.

Audrey

Healthcare in Tumultuous Times

It seems that Republican Congresspersons are recognizing that their constituents mostly want Obamacare and certainly don’t want it repealed without replacement with program of equal or greater quality. The local constituent and Indivisible-inspired voter protests this past week while Congressmen and Congresswomen are home for break has aroused strong complaints about representatives not doing their job, not standing up to Trump and in some cases having disappeared and/or refusing to meet with their constituents or hold town hall meetings. The Trump Administration has declared these protests as Democratic inspired or not representing constituents but rather being paid protestors. Constituents haven’t agreed with this characterization of their attempts to speak with representatives and get their questions answered.

The Paul Ryan plan for Obamacare and Medicaid is not what constituents want. “It’s a cobbled-together mess that slashes Medicaid expansion funding, relies on mysterious tax credits to finance health care for a lucky few and does NOTHING to protect people with pre-existing conditions.” (Karli Wallace Thompson, Campaign Manager Democracy for America email Feb. 23. 2017

 

Highlights of Bay Area Life Science Events Week of Feb. 26, 2017

• Bio2Device Group, Tuesday Morning, Feb. 28, 2017, Topic: “Machine Learning as the Backbone for Predictive Failure Analytics of Devices,” Speaker: Ramki Pitchuiyer , Founder and CEO, eKryp
• HBA Webinar, Tuesday, Feb. 28, 2017, Webinar – Creating a Feedback-Rich Culture, Featured speakers: Juliana Wood, Assoc. director online learning resources, Healthcare Businesswomen’s Association; Deborah Riegel, Principal and director of learning, The Boda Group; Priya Nalkur-Pai, Leadership coach,The Boda Group
• Palo Alto AWIS, Tuesday Evening, Feb. 28, 2017, Topic: “Inside the World of Engineering and Scientific Consulting ,” Speakers: Meredith Sellers, PhD, is a Managing Engineer, Farzana Ansari, PhD, is an Associate and Jenny Irwin is a University Recruiting Manager in Human Resources
• GGPF, Wednesday Evening, March 1, 2017, Topic: “Blocky Functionalization of Thermo-Reversible sPS and PEEK Gels,” Speaker: Prof. Robert B. Moore, Dept. of Chemistry, Virginia Tech

You can download the details for the upcoming events this week and those through April 2017 with audreys-picks-feb-26-2017.

Audrey

Understanding Republican Ideas on Healthcare Programs

Tom Price has been approved as head of Health and Human Services so we can expect that agency’s activities affecting life science and healthcare soon. Paul Ryan has already talked about movements against Obamacare coming this next week. We know Tom Price has larger plans beyond Obamacare replacement including changing Medicare from current status to one with vouchers. Remember the Republican background strategy is to wring out large sums of money from entitlement programs to fund their other initiatives. McConnell just spoke about liking Trump’s position on cutting taxes—that’s code for we are using his popularity to provide major tax cuts to higher income Americans and corporations. Company taxes are to be cut from 35% to 20% while Trump wants a lower number of 15%.

Be alert to the use of propaganda to push their party’s money-saving ideas with entitlement programs taking the brunt of the reductions.  Paul Ryan spoke about Republicans not wanting “government-run” healthcare but rather “patient-centered healthcare” while others refer to government-run program as socialism. “Patient-centered healthcare that gets everybody access to affordable healthcare coverage, so that they can buy whatever they want to buy,” Speaker Ryan tells Interviewer on recent 60 Minutes show. (http://www.cbsnews.com/news/60-minutes-highlights-outtakes-from-paul-ryan-interview/)

“Patient-centered” doesn’t mean better health care focused on patient needs but is code for there will be more of the costs passed on to the patient. Earlier attacks on a single-payer healthcare system used the American Medical Association members opposition to potentially losing their status as businessmen running single-doctor practice or multiple-doctor practice. This business model for doctors is now becoming history as more doctors today work for profit-making health care provider corporations including hospitals called “providers.”  The big profit now goes to these providers.  The majority of physicians are now employees. “The American Medical Association reported in its 2012 Practice Benchmark Survey that a slight majority (53 percent) of physicians owned their practices, down from 61 percent in 2007/2008; 42 percent of physicians were employees, and 5 percent were independent contractors.¹ ….More recent data from the September 2014 Survey of America’s Physicians: Practice Patterns and Perspectives, conducted by Merritt Hawkins for The Physicians Foundation, indicate that only 35 percent of all physicians identify as independent.² Among family medicine physicians, the rate drops to 31 percent. “

There is great variety across states with the bottom ten states ranging from 7 to 24 percent independent MDs.Source: The Physician Employment Trend,at http://www.aafp.org/fpm/2015/0700/p11.pdf

Obamacare was making large strides toward lowering the tax payer cost of healthcare while expanding services not lowering them as the Price plan will do.

Single-payer health care isn’t new in California. Senator Sheila Kuehl’s single-payer bills that passed the Legislature in 2006 and 2008 were vetoed by then Republican Governor Arnold Schwarzenegger. The San Jose Mercury News front page story on Feb. 18, 2017 entitled “Is State Ready to Go It Alone? highlights efforts to establish a single-payer plan in California to cover 38 million Californians, including undocumented residents.  State Senators Ricardo Lara, D-Bell Gardens and Toni Atkins, D-San Diego coauthored Healthy California Act 562 a new government health care system. The major obstacle to achieving is this whether or not California will still receive the $22 billion in federal funding provided to cover private insurance subsidies.

Suggestions for Action for this Week

1) Head to TownHallProject.com to find a town hall in your area. At https://townhallproject.com/

2) Use Resistance Recess to find a town hall or rally near you, along with talking points specific to fighting for health care while representatives are home on recess. At https://www.resistancerecess.com/event/resist-recess/search/

3) If you can’t attend a meeting or make a personal visit, give your representative a call. At http://www.house.gov/representatives/find/

 What to Ask For

1) Demand that your representatives protect Medicaid. Republicans have long been advocating to turn Medicaid into a block-grant program. Block-granting is an old idea that was already used to gut welfare and would almost certainly mean major cuts. You can read more about the tactic in a 2014 article from The Nation by Mike Konczal and Bryce Covert. At https://www.thenation.com/article/why-its-time-take-our-basic-needs-market/

2) Fight for a real alternative to the Affordable Care Act: Medicare For All. Representative John Conyers recently introduced HR 676, the Expanded and Improved Medicare for All Act, a bill that would implement a single-payer “Medicare For All” system. Tell members of the House of Representatives to co-sponsor the bill and to advocate for it publicly and loudly. For more ways to get involved, check out Medicare4All or sign up for the Campaign for Guaranteed Healthcare

3) Defend the gains of the Affordable Care Act. While nowhere near perfect, the ACA has made coverage possible for more than 20 million people and cut the uninsured rate by nearly half. Tell your representatives that we can NOT go backwards. Resistance Recess provides talking points for defending the program.

Highlights of Upcoming Bay Area Bioscience Events

• JLABS, Tuesday Morning, Feb. 21, 2017; Topic: “The Basics of Managing the Board;” Speaker: Carol Sands | Founder and Managing Member, The Angels’ Forum
• Bio2Device Group Morning meeting, Feb. 21, 2017 Cancelled.
• QB3, Tuesday Afternoons, Feb. 21, 28, March 7 & 14, 2017, Program: “QB3’s Berkeley SBIR workshop: The Art, Science, and Politics of Writing a Successful SBIR Proposal,” Instructor: Gabrielle G. Leblanc, Ph.D.
• ASQ Biomedical Division NCDG, Wednesday Evening, Feb. 22, 2017, Topic: “CER: Controlled Environment Rooms – Validating & Operating for Medical Devices,” Speaker: Featured Speaker: Thomas Lypka;Moderator: Gary Seeger
• BioScience Forum, Wednesday Evening, Feb. 22, 2017, Topic: “Next Generation Circulating Tumor Cell (CTC) Technology and Oncology Drug Development: New Insights into Clonal Heterogeneity, Genomic Instability and Drug Responsiveness,” Speaker: Murali Krishna Prahalad, Ph.D., President & CEO,Epic Sciences, Inc
• HBA Supper Club, Thursday Evening, Feb. 23, 2017
• JLABS, Thursday Morning, Feb. 23, 2017; Event: Meet with… Mountain Group Partners and TriStar Health Partners; Speakers: Brian Laden, Co-founder & Managing Director, TriStar Health Partners;Joe Cook, III, Principal Partner, Mountain Group Partners
• HBA Saturday Morning, Feb. 25, 2017, Event: “Meaningful Work: Finding Significance In Your Career with Cindy Miller PhD;” Featured speaker: Cindy Miller, Coach and organization development consultant, Cindy Miller Associates

You can download the details for the upcoming events this week and those through April 2017 with audreys-picks-feb-19-2017.

Audrey

Assault on Obamacare, FDA Protections and Medicare Move Ahead

The future impact of the Trump administration on healthcare services and sales of life science industry products is still unknown but all stakeholders—insurance companies, physicians, hospitals, patients, drug and medical device companies are concerned. The successful approval of Tom Price yesterday by the Senate for Secretary of Health and Human Services adds another potential unsettling player to the mix. His previous role in House was clear cut. He was against Obamacare and had shown negative attitudes toward affordable health care services and women’s health care, specifically. His direction has been to save money by cutting expenditures for entitlement programs and shifting greater cost to the patient without concern that many Americans cannot afford the cost of system he envisions. The conservative Republican objective is probably at bottom of his thinking once again which is to free up money to provide more tax benefits to industry and wealthy.

The Republican approach to healthcare has underestimated the (1) popularity of Obamacare with the majority of Americans and the (2) latters’ fear of repealing ACA without replacing it with comparable or improved care and their (3) absolute disdain for plans to make Medicare a voucher program and/or increase age of eligibility. The Democratic approach was to make the US market-based health care system more cost efficient while it delivered better care to all Americans. They always preferred moving more toward Single Payer system which would cut costs by removing fat from corporate profits. The mandatory enrollment of all citizens provided a better distribution of the healthy and unhealthy, young and old that made a better health care system where all were sharing costs. It wasn’t perfect but was moving in right direction. No one had noticed that the ACA has portions that affect all citizens not just those with lower incomes and help with paying costs, not just the lower income ones. See “You might think the ferocious debate over repealing and replacing the Affordable Care Act doesn’t affect you because you get your health insurance through work. Or you’re 65 and on Medicare.But on both counts, you’re dead wrong.” See article at http://www.mercurynews.com/2017/02/04/repeal-and-replace-all-americans-could-lose-obamacare-protections/

The turmoil at the beginning of Trump’s term has stirred up tempers and activism to level never seen before. Peaceful protests are a surprise to Trump and Bannon who prefer violent disagreements like that which occurred at UC Berkeley recently to which their response of sending in Federal troops is more fitting response for their thinking. Trump is a bully and loved to physically fight as he grew up. This behavior resulted in his being sent to military school as child. We saw this pugilistic side during the campaign when he encouraged supporters to beat up those in disagreement. He doesn’t know how to settle differences lawfully as demonstrated with his recent travel ban being overturned. He insists he will win out because that is what he wants and doesn’t care what is best for country. We knew his temperament was not fit to govern but bringing in equally unfit advisors is not helping matters.

It’s hard to predict how the Republican-controlled Congress will proceed. Will they continue to give Trump whatever he wants in order to maintain their political power, even if his acts are against the democratic values of our society? Some “adults” in their midst worry that they will become owners of a healthcare system in disaster—to be newly named “Trumpcare”—which will negatively affect their reelectability. Caving into international corporations as demonstrated in recent meeting between Trump and heads of large pharma companies to make deals to enrich them at cost of taxpayers doesn’t bode well for promises he made on campaign trail. He totally walked away from promises to achieve reduced drug pricing. We understand that Republicans are pushing for Right to Try laws which will remove protection from toxic drugs as well as preparing laws to change Medicare. We need to be ready to push back.

But we need to maintain hope that these times will pass. We have learned in the past two weeks that our actions are making a difference. Resistance to irrational decisions when done with overwhelming numbers seems to be basis for hope. We need to have patience but must be persistent in moving ahead.

Here are just a few signs of persistence supporting hope pointed out by Debra Ness of National Partnerships for Women and Families :

• “Women and men around the world marched in solidarity — the largest Inauguration weekend protest in history — and continue to protest after each and every injustice;
• More phone calls were made to the U.S. Capitol switchboard in recent days than at any other time in U.S. history — by nearly double;
• Efforts to repeal the Affordable Care Act have been chilled and delayed by public outrage, and opponents are in disarray;
• The Trump administration has already reversed course on several ill-advised actions due to waves of activist opposition; and
• The media are calling “alternative facts” what they are … lies “

We need to keep abreast of actions of agencies and representatives in order to resist their bad actions.

Overview of Bay Area Life Science Meetings Week of Feb. 12

• Bio2Device Group and EPPIcon, Tuesday Evening, Feb. 14, 2017; Topic: “Immuno-oncology 2017 – The crux of the matter, the thrill of the chase,” Speaker: Alex Franzusoff, PhD, Senior Vice President, Research and Product Development, PACT Pharma, Inc
• Codex, Wednesday Mid Day, Feb. 15, 2017; Topic: “Human Decisions and Machine Predictions;” Speaker: Prof. Jens Ludwig, Director, University of Chicago Crime Lab
• HBA, Webinar, Wednesday Evening, Feb. 15, 2017; Event:”Webinar: Career Advice For Scientists and Other Smart Women;” Featured speakers: Linda Brock, Scientist, virology and immunology; Laura Rush,Executive director, clinical and translational research unit, Ohio University; Jennifer Cook, Head of pharma, Europe region; 2016 HBA Woman of the Year, Roche; Michele Holcomb, COO and senior vice president, portfolio, search and partnerships – global research and development, Teva Pharmaceuticals; Suzanne Schwartz, CDRH associate director for science and strategic partnerships, FDA
• WIB-San Francisco Bay Area, Thursday Evening, Feb. 16, 2017, Topic: “Speed Networking at BD Biosciences”

You can download the details for the upcoming events this week and those through April 2017 with audreys-picks-feb-12-2017.

Audrey

Trump Administration Shoots from Hip Without Knowledge of Industry

Donald Trump once again demonstrates he and his inner circle advisors are ignorant of the U.S. Drug Industry and its history and progress. He continues to spout sound bites from his campaign without understanding his hasty actions to reform the FDA and appoint an inexperienced new commissioner are likely to produce a major setback in the progress of the agency which with 8 years of steady professional leadership has made major advancements. Under the George W. Bush Administration there were gaps in leadership of the agency, examples of politicization of the agency that tarnished its reputation and slowed down approvals. We know that this agency needs capable person with science/medical background at the helm and then longevity in holding the office.

Examples of Trump’s nonsensical  sound bites coming out of last week’s meeting with pharmaceutical executives include: Promise to cut regulations “at a level that nobody’s ever seen before” to establish “a quick process” for approving new products, while still providing “tremendous protection for the people.” Such statements are ignorant of the facts that industry has worked closely with FDA to accelerate new drug approvals, which now have been reduced to only 10 months on average and with major decrease in time for breakthrough and priority therapies. Whenever he mentions cutting regulations, remember this is code for taking away necessary protections for our people and giving industry free rein to accumulate more profits.

The Pharma industry recognizes the benefit of an efficient, rigorous FDA regulatory system that approves therapies that demonstrate a certain level of safety and efficacy to gain acceptance from clinicians, patients, and payers that set coverage and reimbursement levels commensurate with value. This costly and complex vetting process is not a hindrance but rather sets a highly prized “gold standard” that facilitates market approval around the world. This high bar for FDA approval enhances market position for U.S. companies’ drugs and bolsters exclusivity and protects patents around the world.

The FDA has already speeded up its approval process for generic drugs, largely due to a user fee program adopted five years ago. See new administration’s acts that will put the agency’s effectiveness in jeopardy.

(Does pharma Really Want to Overhaul FDA? Feb 01, 2017 by Jill Wechsler, PharmTech.com at http://www.pharmtech.com/does-pharma-really-want-overhaul-fda)

Harry Wachob, Founder and President of the Bio2Device Group has summarized some the relevant highlights in talk Jan. 31:

• The White House freezing all new and pending federal regulations forced the Department of Health and Human Services to withdraw a dozen rules, including one that could delay eligibility for those with exchange plans, Medicare Part D or Medicaid.
• The latest addition to Trump’s possible FDA commissioners is Joseph Gulfo, an outspoken critic of the agency who has penned a manifesto for its reform. “Dr. Joseph Gulfo is an advocate of approving drugs based on safety and surrogate efficacy data.”
• FDA Cites 22 case studies of different drugs, vaccines and devices that failed trials, making the case for the Phase III as the Gold Standard.
• Regulators in North America and Europe evaluate safety before human trials can proceed, they do not currently demand meaningful evidence for potential efficacy, writes McGill bioethicist Jonathan Kimmelman. “We believe that many (first-in-human) studies are launched on the basis of flimsy, under-scrutinized evidence.“
• Require drug sponsors to include negative results from animal studies in documents submitted to investigators and ethics committees.
• Allow trials to proceed only after careful vetting of the preclinical evidence by independent experts.
• Encourage reviewers to consider a broad base of evidence in assessing the probability that a drug will prove clinically useful: for example, how have other drugs in the same class performed in trials?
• President Donald Trump’s move to instate a federal hiring freeze quickly set off concerns in the pharmaceutical industry as experts said a handcuffed FDA (500+ jobs frozen) might not be able to keep up with an influx of drug applications.
• The FDA is set to receive 1,600 abbreviated new drug applications this fiscal year. Already, the generics industry, which counts on strong FDA staffing to green light cheap alternatives to branded drugs, has voiced its concerns.
• In total, there are 4,000 generic applications pending at the FDA, according to GPhA, and 850 open positions at the agency’s CDER. Among that group are 150 openings for generic drug reviewers.

Trump ‘s requirement that 2 regulations must be cut out for every new regulation approved doesn’t fit the life science industry and will set the FDA back 100 years.

Highlights of Bay Area Life Science Meetings Week of Feb. 5, 2017

• Stanford University Innovator’s Workbench Speaker’s Series, hosted by the Byers Center for Biodesign at Stanford University, Monday Evening, Feb. 6, 2017; Speakers: Michael “Mick” Farrell, CEO of ResMed and Peter Farrell, Founder & Executive Chairman of ResMed, Interviewer: David Cassak
• Bio2Device Group, Tuesday Morning, Feb. 7, 2017, Topic: “New Breakthrough Technology- Quoros -Taming the Microbial World,” Speaker: Manuel Serrano, VP of Formulation Development, LiveLeaf
• JLABS, Wednesday Early Evening, Feb. 8, 2017, Topic: ”She Started It: A Film Screening,” Speakers: Moira Gunn | Assistant Professor, Business Analytics and Information Systems, University of San Francisco, Laura Shawver | CEO, Cleave Biosciences,Moderator: Jim Viola | Innovation Activation Specialist, Johnson & Johnson

• AWIS Journal Club, Wedesday Evening, Feb. 8, 2017, Event: Journal Club

• WIB, Thursday Morning, Feb. 9, 2017, Event: “WIB-National Webinar “Class II Medical Device Innovation and IP Strategy: Case Study in Women’s Health Products,” Speaker: Debra Kurtz, President, Kurtz Consulting Inc

You can download the details for the upcoming events this week and those through April 2017 with audreys-picks-feb-5-2017.

Audrey

 

I often feel overwhelmed by the actions of Trump and his advisors and frustrated as to how to respond to stop his immoral and unjust actions, seemingly designed to create chaos and give attention to himself through constant media coverage. His attacks on healthcare with vacillation on his intent with regard to Medicaid and Medicare as well as the replacement for Obama care are frightening. Watching the resulting disruption created by his pronouncements, apparently authored by Bannon without any careful review, are chilling. I agree with others that it feels like the Twilight Zone. The deliberate departures from never before contested ethical and behavioral expectations is not normal. But these are not normal times.

I learned a long time ago that you can’t reason with irrational people but you can build boundaries to not get hooked into their craziness as I tried to do during the election. Now when considering what action to take that will work to unseat him is different. We are drawing on methods of Tea Party and standing up by putting pressure on our elected congressmen and showing up. These latter methods are having impact on reversing his Executive Orders this past week. But we need to develop a successful strategy to get all the irrational members of his staff including Stephen Bannon and, more recently, Gen. Michael Flynn, as well as Trump out of White House asap and thwart their hateful, irrational acts in the meantime.

The below article gave me new way to think about how to fight his attacks on established health care programs and undermine his actions.
http://www.salon.com/2017/01/15/dont-think-of-a-rampaging-elephant-linguist-george-lakoff-explains-how-the-democrats-helped-elect-trump/#.WH5dLSJVRZx.email (Salon.com)

The first attack out the gate on Obamacare and seeming lack of rational replacement plan are driving the health care market crazy and introducing a lot of instability for health care providers, patients and insurers. At first pursuing an election promise of repealing Obamacare was extremely appealing to Republican representatives and Senators, but now that they will own a destroyed health care system to be called Trumpcare is rather frightening to them. There are several alternative Republican plans being considered but no matter what they choose, they will throw the system into chaos and have to spend far more money (something the conservatives abhor and wanted to avoid) as well as potentially throw election of 2018 and 2020 back to Democrats. A recent leak of lawmaker’ statements from their retreat indicate they are not supportive of the Trump staff actions.

So how do we proceed in the face of the threat to healthcare? There is the nomination of Tom Price to head the Department of Health and Human Services which moved from review by Health Committee to that of Finance Committee. Republicans committee members seem ready to approve him so it is unclear whether Democratic opposition can win out.

Overview of Bay Area Life Science Events Week of Jan. 30, 2017

• Bio2Device Group, Tuesday Morning, Jan. 31, 2017, Topic: GutCheck: an “EKG for the Gut,” Speaker: Steve Axelrod, CEO, G-Tech Medical
• QB3, Tuesday, Jan. 31, 2017, Event: Join the QB3/Rosenman Institute tour of Applied Materials’ state-of-the-art materials fab in Sunnyvale
• HBA, Tuesday MidDay, Jan. 31, 2017, Event: Webinar – Coaches, Mentors and Sponsors: Why You Need This Trio for Career Success
• Palo Alto AWIS, Tuesday Evening, Jan. 31, 2017, Topic: “Learn to Lead: Conduct Your Orchestra”
• Medtech Frontiers, Thursday Evening, Feb. 2, 2017, Topic: “Moving Beyond Wearables: Flexible Hybrid Electronics and Human Monitoring, Speaker: Paul Semenza, Director of Commercialization, NextFlex-America’s Flexible Hybrid Electronics Manufacturing Institute

You can download the details for the upcoming events this week and those through April 2017 with audreys-picks-jan-29-2017.

Audrey

 

Future of FDA under New Administration?

In a carefully researched article entitled “Whither FDA? by Steve Usdin, Washington Editor, BioCentury, the author considers decisions by the new leadership and their possible impact on the FDA. The agency has been on a 15-year bi-partisan path of regulatory reform. His vision does not include a substantial lowering of the threshold for product approvals. The agency is bound by laws and regulations which regardless of next commissioner’s philosophy are unlikely to be changed by the Congress. The industry professionals at the FDA can hopefully lead the agency in an agenda that is “firmly grounded in science, not politics.”

The Congress needs to quickly reauthorize user fees for reviews of new drugs, generic drugs, devices and biosimilars so as not to force need to terminate large numbers of professional review staff. There are 15,000 staff members who, hopefully, can control political appointees by the weight of their influence.

The naming of competent head respected by the public and stakeholders as commissioner will be important to avoid chaos. Some names floated have frightened industry but we hope Congress helps shift replacement decision to one that makes sense for a science-based agency.

Overview of Upcoming Life Science Events the Week of Jan. 22, 2017

• PMWC 2017 Silicon Valley, Jan. 23-25, 2017, Date and Time: Monday – Wednesday, Jan. 22-25, 2017, 8:00am – 5:00pm
• UCSC Extension Course, Mondays, Jan. 23-April 10, 2017; Event: “ Validating Software for Medical Devices and Emerging Technologies”
• Bio2Device Group, Tuesday Morning, Jan. 24, 2017, Topic: “Q4 numbers, views from JP Morgan and an open discussion of what the Trump Administration’s Impact may be on Healthcare,” Speaker/Moderator: Harry Wachob and Attendees
• JLABS, Thursday Morning, Jan. 26, 2017; Topic: “Who’s Who in 2017: A Rocky Road for Healthcare Investments?” Speaker: Jonathan Norris | Managing Director, Silicon Valley Bank
• California Life Sciences Association, Thursday Afternoon, Jan. 26, 2017, Topic: “Federal Grants Management – Accounting and Compliance”
• PBSS, Friday MidDay, Jan. 27, 2017, Topic: “Stem cell gene therapy to cure diseases: overview, a success story and current advances,” Speaker: Maria Grazia Roncarolo, MD

You can download the details for the upcoming events this week and those through April 2017 with audreys-picks-jan-22-2017.

Audrey

 

Major GOP Assault Using Budget Reconciliation Process to Void Affordable Care Act Underway

Both the GOP controlled Senate and House of Representatives have now started the process of ACA repeal using budget process called budget reconciliation. Both the budget and the follow up “reconciliation” bill can pass the Senate by a simple majority vote after limited debate versus face Democratic filibuster requiring 60 votes to pass. Several Republicans have expressed concern of repealing the act without a viable replacement. GOP leadership claims they will move quickly to replace it but haven’t offered a timeline. Insurers will take action as soon as they see likelihood of repeal occurring. This alone can be tragic for health care for so many Americans.

Some suggest that some pieces of the law such as mandating that insurance companies cover people with pre-exiting medical conditions, cannot be modified in a fast-track reconciliation measure being used by the Congress. You are probably receiving requests to sign petitions and donate money to inform Congressmen and women who don’t understand the financials of the ACA. In simple terms between 20 and 30 million Americans will lose coverage with repeal, but that shocking number hasn’t slowed down the rhetoric and sounds bites of repeal and replace.

There are so many attacks on progressive values and established programs like the ACA, Medicare and Medicaid all at once based on Republican leadership strategy of moving all actions so fast that Democrats and citizens can’t respond effectively. They are interconnected. If one destroys the progress made with the ACA in achieving fuller medical access to our citizens, other long standing programs like Medicare and Medicaid are at risk.

Remember the Affordable Health Care is flawed in eyes of Republicans who worry about business interests being threatened. The Congress rejected a single-payer approach which would do away with our market-placed system which raises the cost of health care. Republicans are repealing it before they know what might eventually take its place. Under an incoming President without any seeming civic interests, the Congress for the most part is turning a deaf ear to crisis that could result from their actions.

Committed opposition can defeat the GOP plans to ramrod this legislation and appointment of Tom Price as head of health agency. Call, write, sign petitions, attend town halls, organize protests and get to know aides who listen to reason. Be polite, persuasive – and persistent.  There are several events underway in our area today and this week.
(“Republican ACA Repeal Bill Would Unravel the Market Even Before It Goes into Effect,” written by Topher Spiro and Thomas Huelskoetter,Nov. 16, 2016, at https://www.americanprogress.org/issues/healthcare/reports/2016/11/16/292394/republican-aca-repeal-bill-would-unravel-the-market-even-before-it-goes-into-effect/

Highlights of Upcoming Life Science Events Week of Jan. 15, 2017

• Bio2Device Group, Tuesday Morning, Jan. 17, 2017, Topic: “Supply Chains for New Product Introductions, “ Speaker: Farzin Shadpour, Head of Global Supply Chain & Procurement, Theranos
• WIB, JP Morgan Conference Wrap Up, Wednesday Morning, January 18, 2017
• HBA San Francisco Bay Area, Thursday Evening, Jan. 19, 2017; Event: “Insights and Trends from the 2017 J.P. Morgan Healthcare Conference”
• Women’s March, Saturday, Jan. 21, 2017;The Women’s March is a national movement to unify and empower everyone who stands for human rights, civil liberties, and social justice for all. There are two local marches on January 21 – one in Oakland and one in San Francisco. These events are not sponsored by AWIS, but we encourage your participation. Oakland: 10am – 3pm, Saturday, January 21, 2017. Visit the Facebook Oakland event page for more information.San Francisco: 4pm – 9pm, Saturday, January 21, 2017. Visit the Facebook San Francisco event page for more information. There are also events in San Jose.

You can download the details for the upcoming events this week and those through April 2017 with audreys-picks-jan-15-2017.

Audrey