Tag Archives: Obama

Follow the Money: The Affordable Care Act, not the Subsidized Care Act


Covering the Uninsured

Like many, I rejoiced at the news of the Supreme Court’s decision upholding the individual mandate and the key provisions of the Patient Protection and Affordable Care Act (PPACA). As a doctor and medical ethicist, I think it is an important step in healthcare reform.

And it is now certain that the presidential election will hinge at least in part on health reform. Voters will have a clear choice on the PPACA: Romney will repeal, and Obama will implement. Which do you want, America?

President Obama and his supporters tout the law’s promise to make affordable health insurance available to many of the 32 million Americans who do not have medical insurance. This is a terrific accomplishment, as are the protections for those who already have insurance, such as eliminating limits on lifetime claims.

At the same time, for the ensuing political debate and the evaluation of the PPACA overall, much more than these accomplishments have to take center stage. Focusing on the uninsured will not win over the electorate. Too many Americans who vote have insurance, and are not fearful about losing it, so the plight of the uninsured is one step removed.

The Elephant in the Room – Cost of Healthcare

Instead, the cost of healthcare is the elephant in the room. The healthcare budget has been increasing faster than the economy for more than 50 years and there is no end in sight. Spending on healthcare now comprises 18% of GDP and continues to grow. Nobody believes that this is sustainable. Democrats and Republicans disagree about how to curb the growth (more on this below) but not that it is necessary to do so.

The growth threatens to upend the federal budget as well as state budgets by causing unsustainable increases in Medicare and Medicaid spending. And it weakens American business. As long as the expense of providing healthcare insurance for your employees is large and growing out of control, it is difficult to hire or to compete with businesses in countries with affordable healthcare.

Obama took on healthcare reform, according to all reports, at least largely because he saw that allowing this growth to continue was simply irresponsible. And he eventually settled on the individual mandate as the essential first step. Once everybody is contributing, and everybody has health insurance, one can start the process of rationalizing and controlling the system.

It would be great if we could control cost without first getting everybody into the system, but that isn’t going to happen. Heck, even Romney knew that when he was governor of Massachusetts, which is why he supported the individual mandate then. The current Republican “proposals” (yes, they do deserve quotation marks) have no hope of achieving this important aim.

The politics

It’s necessary that Obama and other defenders of the PPACA make this argument, and own this aspect of the law, since if they do not, they are ignoring a very real concern about its effect on the budget, at their peril.

Critics of the ACA point out that simply making people join a system that is out of control is like putting your foot on the accelerator of a truck with no brakes. The idea that providing insurance to the uninsured will by itself control costs, by simply getting them to treat health problems before they get serious, is not well supported by the literature. Many preventive measures save lives, but even the best mostly do so at some expense, rather than also saving money.

Instead, Obama and the ACA supporters should be honest that getting everybody (or, almost everybody) insured was simply the first step in controlling costs. Once everybody is in the system, we can make changes that can finally adjust incentives in ways that reward providing essential, cost-effective care rather than providing inessential, expensive care.

As Atul Gawande pointed out in an excellent article in the New Yorker in 2009, the PPACA includes massive numbers of pilot projects to explore ways to improve care and control costs at the same time. Approaches have to include all good ideas, many of which are not possible without a system that includes all possible patients.

As Obama used to emphasize, it’s about finding ways to “bend the curve,” and slow the increase in healthcare spending, not reducing spending from current levels. We don’t have to give up what we have to control spending. In fact, the best way to make sure that we will have to give up what we have is to let prices continue to go up in the future, until even the middle class cannot afford the cost.

But that means that Obama and his team have to explain the sort of mechanisms that we can hope will allow PPACA to lead to truly “Affordable Care” not just subsidized care. They must admit that these mechanisms are still uncertain but at least hold out the best hope of finally controlling costs, to keep the newly insured insured, and to save American medicine.

Can Obama Avoid this Argument?

Some political pundits or advisors will say that Obama should just focus on the easy wins in the law, such as covering the uninsured, eliminating lifetime limits and cost adjustments based on new or pre-existing conditions, allowing young adults to stay on their parents’ insurance, and eliminating the doughnut hole in pharmaceutical coverage for seniors. Why admit that there is a big challenge that comes next, and that the law just sets up the country for having to make decisions to control costs?

The short answer is that you can’t avoid it and addressing the question. Americans know that you can’t get something for nothing. And the size of the federal deficit, and the criticism of federal spending in current discourse, has made it clear that money is not limitless.

If Obama didn’t want to have this discussion, and make this case, he shouldn’t have gone down this road in the first place. It’s “all in” in the poker sense, not just the solve-the-uninsured sense.

Ducking the questions is not honest, and it is not good politics. The discussion of the PPACA must include straight talk about how it will allow us to finally confront and address the ever growing health budget. Above and beyond celebrating the success in covering so many of the insured.

Peter H. Schwartz, M.D., Ph.D.
IU Center for Bioethics

A Minimal Genome, A Giant Step? Research Ethics in the News

In late May the J. Craig Venter Institute (JCVI) announced the creation of the “First Self-Replicating, Synthetic Bacterial Cell.” (The research team’s report was published simultaneously: Gibson DG, …, Venter JC. Creation of a Bacterial Cell Controlled by a Chemically Synthesized Genome. Science. 2010 May 20. PubMed PMID: 20488990.) With $40 million and over a decade of work, the team produced the synthetic cell by piecing together a replica of a bacterial genome (Mycoplasma mycoides) and transplanting this DNA “software” into a cell from a related bacteria (Mycoplasma capricolum). When the cell began to replicate the information from its “synthetic genome,” the JCVI declared success.

What will be the scientific and social impact of this research? Both researchers and ethicists appear to be of two minds: the synthetic cell is big news, but maybe not worth the “hype” everyone is more than willing to supply. For example, while announcing JCVI’s discovery with great fanfare (suggesting solutions for the flu vaccine, greenhouse gas, and even the BP oil spill), Venter insists in The Wall Street Journal that this is not the creation of life ex nihilo. In fact, he refers us to Arthur Kornberg’s work in 1967 to make a copy of a virus. Perhaps the history lesson is meant to reassure the public; although considered by President Johnson to be “a very spectacular breakthrough,” Kornberg’s work was completed over forty years ago and, while the effort did have a scientific impact, we’re not overrun with zombies … yet.

Ethicists responded similarly: part “hype”, part reassurance. Arthur Caplan (in January 2009) reminded us that ethicists have been thinking and writing about the risks and benefits of synthetic biology for a long time. In fact, Caplan was one of the authors on paper published in 1999: Cho MK, Magnus D, Caplan AL, McGee D. Policy forum: genetics. Ethical considerations in synthesizing a minimal genome. Science. 1999 Dec 10;286(5447):2087, 2089-90. PubMed PMID: 10617419. Caplan echoes these reassuring sentiments in his recent Breaking Bioethics commentary: “The regulatory, social and legal challenges can be solved.” He, nevertheless, insists that grander issues might now be at stake:  “The real fallout from the Venter group’s achievement is subtle but more powerful. The scientists are chipping away at the view that there is something unique and unknowable about life itself. From this day forward, we know that the right chemical messages, presented in the right order and put in the right chemical context, can produce life.”

Julian Savulescu, quoted at BBC News, also looked at both sides of the coin. According to Savulescu the risks and benefits of synthetic biology are “in the far future,” but also “unparalleled”: “If this research goes in one direction Dr Venter may get the Nobel prize, but if it goes in another direction there will be no Nobel prizes to give because there will be no people to give them.”

On the very day of Venter’s press release, President Obama sent a letter to Amy Gutmann, the director of the recently formed Presidential Commission for the Study of Bioethical Issues. The Commission now has six months to complete “a study of the implications of this scientific milestone.” Reporting to the Science and Technology Advisor, Dr. John P. Holdren, the Commission will also develop recommendations for how the Federal government should anticipate and respond to similar scientific developments. Erik Parens, writing for the Hastings Center’s Bioethics Forum wonders if the new commission’s focus on “practical” questions will limit its ability to address the larger philosophical implications of synthetic biology. Although not responding directly to Parens, Jonathan Moreno takes a quick look at one of these big philosophical questions at Science Progress. Not unlike Venter’s reference to Kornberg, Moreno remembers early investigations of the idea that scientists are overstepping natural boundaries and “playing God.” By producing “an organic substance from non-organic matter,” chemist Friedrich Wohler crossed a “natural” boundary in 1828. This was a big deal for chemistry and for the philosophy of science. While Moreno, it seems, believes the ethical issues and philosophical questions are not insurmountable, he graciously opens the debate to a variety of voices: “Whatever challenge it may pose to our contemporary assumptions, it would be foolish to reject wisdom from any source in helping us decide where the path should lead, divine ones included.”

Readers looking for a thorough introduction to ethical issues of synthetic biology may wish to begin with:

Michele S. Garfinkel, Drew Endy, Gerald L. Epstein, and Robert M. Friedman, “Synthetic Biology,” in From Birth to Death and Bench to Clinic: The Hastings Center Bioethics Briefing Book for Journalists, Policymakers, and Campaigns, ed. Mary Crowley (Garrison, NY: The Hastings Center, 2008), 163-168.

The Synthetic Biology Project, established at the Woodrow Wilson International Center for Scholars and partnering with both The Hastings Center and the JCVI, also provides many resources on the subject, including:

Erik Parens, Josephine Johnston, and Jacob Moses. Ethical issues in synthetic biology: an overview of the debates. Synbio 3; 2009 June. [PDF – 585 KB]

For an international perspective, visit SYNBIOSAFE, a project funded by a grant from the European Commission. Browse four years of related links and publications on the site, or begin with this review, commissioned by the Biotechnology and Biological Sciences Research Council:

Andrew Balmer and Paul Martin. Synthetic biology: social and ethical challenges. May 2008. [PDF – 493 KB]

Related News Links

Sharon Schmickle. Genetic research: What are the risks of terrorism or accidents? MinnPost. June 1, 2010.
Natalie Angier. Peering over the fortress that is the mighty cell. The New York Times. May 31, 2010.
Scientist: ‘We didn’t create life from scratch’. CNN Health. May 21, 2010.
Life after the synthetic cell. Nature. 2010 May 27;465(7297):422-4. [PDF – 220 KB]
Michele Norris and David Rejeski. The ethics of creating synthetic life. All Things Considered. NPR. May 20, 2010.
Jonathan D. Moreno. Synthetic Biology Grows Up. Science Progress. May 20, 2010.

Other Research Ethics News

John Fauber. Doctors’ role in drug studies criticized. Journal Sentinel. May 30, 2010.
Harold Varmus. Ten years on–the human genome and medicine. N Engl J Med. 2010 May 27;362(21):2028-9.
Sarah Boseley. Andrew Wakefield case highlights the importance of ethics in science. Guardian. May 24, 2010.
Marie Woolf. NHS uses babies’ blood for secret database. The Times. May 23, 2010.
NIH. Financial Conflict of Interest Notice of Proposed Rule Making. NIH News. May 20, 2010.
Aaron S. Kesselheim, David M. Studdert, Michelle M. Mello. Whistle-blowers’ experiences in fraud litigation against pharmaceutical companies. N Engl J Med. 2010 May 13;362(19):1832-9.
U.S. group urges FDA to halt Glaxo’s Avandia trial. Reuters. May 11, 2010.
Eric M. Meslin. Problem solvers: what to expect from our new bioethics commission. Science Progress. May 7, 2010.
Sean Philpott and Udo Schuklenk. A study that should not have been done. Bioethics Forum. May 5, 2010.
Marcia Angell. Big pharma, bad medicine. Boston Review. May/June 2010.

– J.O.

Obama Fills The Presidential Commision for the Study of Bioethical Issues: Research Ethics in the News

The White House announced the remaining members of the The Presidential Commission for the Study of Bioethical Issues on April 7, 2010 [press release – PDF]. The new members are:

Lonnie Ali, M.B.A
Anita L. Allen, J.D., Ph.D.
Barbara F. Atkinson, M.D.
Nita A. Farahany, J.D., Ph.D.
Alexander G. Garza, M.D.
Christine Grady, R.N., Ph.D.
Stephen L. Hauser, M.D.
Raju S. Kucherlapati, Ph.D.
Nelson Lee Michael, M.D., Ph.D.
Daniel Sulmasy, M.D., Ph.D.

President Obama appointed the Commission’s Chair (Amy Gutmann, Ph.D.) and Vice Chair (James W. Wagner, Ph.D.) in November 2009 (press release). According to Executive Order 13521 [PDF], the Commission’s members serve two year terms without compensation. The new Commission “works with the goal of identifying and promoting policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in an ethically responsible manner.” Prior Presidents convened similar commissions. In 2001, President Bush created the President’s Council on Bioethics which replaced President Clinton’s National Bioethics Advisory Commission, created in 1996. A list of former commissions and their publications is provided on the Bioethics.gov website.

Related

Andrew Plemmons Pratt. Practical Science. Science Progress. April 8, 2010.
Jere Odell. Obama stops The President’s Council on Bioethics: Research Ethics in the News. Indiana Bioethics. June 24, 2009.

Other Research Ethics News

Robin Erb. In blood debate, new consent effort aims to open research doors. Detroit Free Press. April 8, 2010.

Lisbeth Fog. Tensions remain over biological access protocol. SciDevNet. April 2, 2010.

Ann E. Mills and Patti M. Tereskerz. The Uncertain Future of Gene Patents. Bioethics Forum. April 1, 2010.

Duff Wilson. Pfizer gives details on payments to doctors. The New York Times. March 31, 2010.

Donna Dickenson. Bioethics à la Française: the new French bioethics laws. BioNews. March 29, 2010.

Steve E. Nissen. Setting the RECORD Straight. JAMA. 2010;303(12):1194-1195.

Carla K. Johnson. Top US psychiatrist calls for ethics cleanup. [AP] Google News. March 23, 2010.

Gerd Antes. The new CONSORT statement. BMJ 2010;340:c1432. | doi:10.1136/bmj.c1432

Jocelyn Kaiser. Should NIH-Funded Researchers Be Required to Publicly Reveal Conflicts? ScienceInsider. March 16, 2010.

Jonathan D. Moreno. Red Tape Around Stem Cells? Science Progress. March 16, 2010.

— J.O.

New Rules for Stem Cell Research: Research Ethics in the News

On Monday, July 6, 2009 Dr. Raynard S. Kington, acting director of the NIH, announced that the Obama administration had released the new rules on federal funding for stem cell research (Guidelines, 2009). The rules implement Executive Order 13505, Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The new guidelines expand the number of potential cell lines available for use in federally funded research. The Washington Post estimates that 700 embryonic stem cell lines are currently in existence. Researchers may seek approval to use these cell lines, if the cells were acquired from embryos created for reproductive purposes and contributed by properly informed, consenting donors.

The New York Times quotes ethicist, R. Alta Charo, applauding the new rules as “a huge step forward”. Jonathon Moreno at Science Progress, also supports the change, declaring that the new rules are “a welcome reprieve for scientists, advocates, and patients who saw research opportunities contract under the eight years of the Bush administration’s distorted policy”. Moreno also notes: “the new guidelines are similar to those proposed in the Center for American Progress/Science Progress report, ‘A Life Sciences Crucible: Stem Cell Research and Innovation Done Responsibly and Ethically,’ published in January”. Among the critics of stem cell research, Richard Doerflinger of the U.S. Conference of Catholic Bishops lamented in The Washington Post: “For the first time in history, the federal government will encourage the destruction of human life at a very early stage for federally funded research”. For a wider range of reactions, one might wish to browse the 49,000 comments a version of guidelines received when an earlier draft was posted for public comment on April 23, 2009.

References

National Institutes of Health (NIH). National Institutes of Health Guidelines for Human Stem Cell Research. NIH, 2009.

Executive Order 13505, Removing barriers to responsible scientific research involving human stem cells. The White House, March 9, 2009.

Vedantam S. Rules on stem cell research are eased. The Washington Post. July 7, 2009.

Harris G. Rules will allow financing for old stem cell lines. The New York Times. July 6, 2009.

Moreno J. Back to the future: final stem cell rules support ethics and innovation. Science Progress, July 6, 2009.

National Institutes of Health (NIH). Listing of comments on Draft NIH Human Stem Cell Guidelines. NIH, 2009.

Other Stories on the New Stem Cell Guidelines

Shapiro J. New funding rules issued on stem cell research. NPR Morning Edition, July 7, 2009.

SNAP Analysis: Stem cell rules mean big change up to Congress. Reuters, July 6, 2009.

Related:

The Human Stem Cell Study Group, Indiana University Center for Bioethics. 2001-2002.

Research Ethics and Stem Cells. Stem Cell Information: The National Institutes of Health.

Insoo Hyun, “Stem Cells,” in From Birth to Death and Bench to Clinic: The Hastings Center Bioethics Briefing Book for Journalists, Policymakers, and Campaigns, ed. Mary Crowley (Garrison, NY: The Hastings Center, 2008), 159-162. Online at: http://www.thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2248

Siegel A. Ethics of stem cell research. The Stanford Encyclopedia of Philosophy (Fall 2008 Edition), Edward N. Zalta (ed.). Online at: http://plato.stanford.edu/archives/fall2008/entries/stem-cells/

Other Research Ethics News:

JAMA Conflicts Policy: now you see it, now you don’t. David Armstrong, WSJ Health Blog. July 10, 2009.

Helping science, making money. [Review of O’Meara A. Chasing Medical Miracles. Walker, 2009.] Scott Gottlieb, The Wall Street Journal. July 10, 2009.

Pick to lead health agency draws praise and some concern. Gardiner Harris, The New York Times. July 8, 2009.

International Research Standards: Xenotransplantation. Chris MacDonald, The Research Ethics Blog. July 6, 2009.

Life after fraud. Alison McCook, The Scientist.  July 1, 2009; 23(7):28.

Paying egg donors for research: in defense of New York’s landmark decision. Bonnie Steinbock, Bioethics Forum. July 1, 2009.

Better ethics, cheaper drugs. The Boston Globe. July 1, 2009.

Grant system leads cancer researchers to play it safe. Gina Kolata, The New York Times. June 27, 2009.

State stem cell board needs overhaul, group says. Sandy Kleffman, San Jose Mercury News. June 26, 2009.

Obama’s Bioethics Commission: Providing Practical Policy Options. John H. Evans, Bioethics Forum. June 26, 2009.

Obama stops The President’s Council on Bioethics: Research Ethics in the News

[UPDATE: President Obama Establishes New Presidential Commission for the Study of Bioethical Issues, Names Commission Leadership, November 24, 2009.]

Last week, Nicholas Wade reported in The New York Times that the President had pulled the plug on the most-recent version of the President’s Council on Bioethics. According to White House press officer, Reid Cherlin, President Obama disbanded the Council because it was “a philosophically leaning advisory group.” Wade also reports that Obama plans to create a new, more practical, bioethics commission in the future–Cherlin did not offer a timeframe.

James W. Fossett and Michelle N. Meyer respond in today’s Bioethics Forum with a (tongue-in-cheek) “who cares”–a comment in support of a federal commission focused on empirical research on bioethical issues. Similarly, Michael Cook, yesterday at BioEdge, speculated (but less happily) that this direction would mean “no more seminars; lots more Facebook.” Other reactions to this news include “Less Philosophy, More Policy” from Andrew Plemmons Pratt at Science Progress and a good-bye letter from Peter Augustine Lawler in the conservative publication The Weekly Standard.

Related:

President’s bioethics council disbanded. Alex Witze, The Great Beyond. June 19, 2009.

Gilbert Meilaender, Paul McHugh, Benjamin Carson, Nicholas Eberstadt, Jean Bethke Elshtain, Alfonso Gómez-Lobo, William Hurlbut, Donald Landry, Peter Lawler, and Diana Schaub. Federal Funding of Embryonic Stem Cell Research Science and Society. Bioethics Forum, March 25, 2009.

Other Research Ethics News:

EU legislation increases clinical-trial workloads. Nature News. June 24, 2009.

Drug ‘reports’ found to be faked. Stuart Laidlaw, Toronto Star. June 22, 2009.

Commentary: A Costly and Wasteful FDA. Henry I. Miller, Forbes. June 20, 2009.

NY to pay for eggs for research. Elie Dolgin, The Scientist. June 17, 2009.