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Francis Collins (right), former head of the National Human Genome Research Institute, was named one of GQ magazine’s rock stars of science. He is now working on a book on personalized medicine. Credit: Ben Watts

Francis Collins shares his thoughts on the present and future of consumer genetic medicine.

MIT Technology Review, June 15, 2009, by Emily Singer  —  Just exactly how accurate are direct-to-consumer genetic tests? Francis Collins, the former head of the National Human Genome Research Institute, decided to find out for himself while researching a new book on personalized medicine. (Collins published the book, The Language of God: A Scientist Presents Evidence for Belief, in 2006.)

Collins, who played a central role in the human genome project and who is rumored to be the next head of the National Institutes of Health, announced at the Consumer Genetics Conference in Boston last week that he had had his genome analyzed by the big three of direct-to-consumer genetic testing: 23andMe, Navigenics, and DecodeMe. He ordered the tests under a fake name, lest the genomics superstar get special treatment–his speech at the conference was the first the companies heard that they had had Collins’ DNA in hand.

Collins said that sequence-wise, the tests “appear to be highly accurate”–there were almost no differences in the genotype information generated in the three different analyses. But there were significant differences in the numbers of genetic variations used to calculate disease risk, as well as the final risk score. For example, one company used five single nucleotide polymorphisms or SNPs to calculate risk for a particular disease, pronouncing Collins at low risk. Another used ten, placing him at high risk, and the third used 15, concluding he is at average risk. Collins also said the analyses provided little information on his “carrier status”, meaning whether he carried genetic risk factors that didn’t influence his own risk of disease but could be passed down to future generations.

Collins speech last week was more upbeat than one he gave at the Personal Genomes conference in Cold Spring Harbor last fall. In that lecture, he emphasized the potential difficulty in finding the as-yet remaining genetic variations underlying the heritability of disease. In the latest speech, he instead emphasized what could come out of genome-wide association studies–new targets for drugs.

“We have undervalued these studies,” he said at the conference. “Even if a variant has a small impact on disease risk, that doesn’t mean it’s not a good risk target.” In type 2 diabetes, for example, two of the nine common genetic variants that have so far been linked to the disease are involved in the pathway targeted by two major diabetes drugs. “[Pharma companies and others] have not jumped on this as rigorously as they could,” said Collins. “Perhaps because it’s a bit overwhelming–there are so many of them.”

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Group therapy

MIT Technology Review, June 15, 2009, by Courtney Humphries  —  Genetic differences affect how patients respond to monoclonal-antibody therapies. PIKAMAB believes that it can sort patients into specific groups and tailor treatments accordingly. This company wants to improve monoclonal-antibody therapies by tailoring them to patients’ genotypes.

Monoclonal antibodies, which are engineered to hone in on very specific biological targets, have taken off therapeutically in recent years: several are now approved for treating cancers and autoimmune diseases, and nearly 200 are in clinical trials. But one of the challenges of monoclonal-antibody therapy is the fact that some people respond very well to the drugs while others respond only moderately or not at all.

A startup called PIKAMAB, based in Menlo Park, CA, believes that it can make monoclonal antibodies more effective by grouping patients together based on their genotype and offering a customized antibody developed for that genotype. The company hopes that this “stratified” approach to drug development and treatment will help drug companies achieve better results.

Monoclonal antibodies bind only to specific target molecules, giving them a precision that many other drugs lack. These Y-shaped molecules, which are naturally produced by immune cells called B cells, have a nearly identical base but arms that can vary depending on their intended target. The arms bind precisely to the target while the base of the Y provides an anchor for circulating immune cells to attach to.

Monoclonal antibodies were first identified as potential cancer treatments three decades ago, as the molecules could be engineered to bind to cancer cells and provoke an immune response against them. They have also proved useful for treating autoimmune disease and are under investigation as a treatment for many other conditions.

But scientists have found that patients respond differently to these drugs, largely because the antibodies are not able to bind to the immune cells of all patients equally well. Studies have found that the process, called antibody-dependent cell-mediated cytotoxicity (ADCC), plays a major role in how well several monoclonal-antibody drugs work. How an immune cell attaches to an antibody depends on one of two protein receptors at the cell’s surface. People have natural genetic variations in these receptors: certain variations prevent immune cells from binding to antibodies, and these patients respond poorly to these antibody therapies.

Vijay Ramakrishnan, founder and CEO of PIKAMAB, believes that monoclonal-antibody therapies could be improved by taking into account the genetic background of each patient. “A one-size-fits-all antibody drug in this case doesn’t work,” he says.

PIKAMAB’s approach is to first sort patients depending on whether they are expected to respond to a treatment or not. The company is marketing a “theragnostic” test that separates patients into one of nine groups in a matrix according to their receptor type and an analysis of their immune cells. At one end of the matrix are patients likely to respond well to an existing drug; at the other end are those who are likely to respond poorly. Ramakrishnan says that this test alone can benefit treatment, as it could help a clinician decide whether to begin a monoclonal therapy right away in an excellent responder or eschew the drug in favor of other options in a poor responder.

The next step is to develop a portfolio of antibodies that are customized for each group of patients within the matrix. The drugs would be altered slightly so that they can bind specifically to the receptors in patients of each genotype. Ramakrishnan says that the portfolio could consist of a minimum of four and a maximum of nine drugs (one for each group) to achieve a high response rate in each group.

The approach is different from “personalized” medicine that is tailored to an individual. Instead, Ramakrishnan says, this “stratified” approach offers some personalization but in a more manageable way. He believes that a stratified approach to monoclonal-antibody therapies can offer advantages to pharmaceutical companies. If they begin stratifying patients in clinical trials, they could achieve better results and help justify the treatments to regulatory agencies and insurers, he says. Companies could also put a higher premium on drugs if those drugs came with theragnostic tests.

PIKAMAB hopes to work with pharmaceutical companies to create commercial theragnostic tests and stratified therapies involving drugs that are already on the market or in development. Together, they also plan to develop their own monoclonal antibodies.

“I think it’s useful to have a predictive test that can accurately describe whether a particular individual has a receptor that will make ADCC easier or harder to exploit as an anti-tumor mechanism,” says Louis Weiner, a cancer immunologist at Georgetown University who has no ties to PIKAMAB. Weiner is, however, skeptical that customized antibodies are necessary to improve monoclonal-antibody therapies. He sees more potential in “high affinity” monoclonal antibodies that bind tightly to immune cells regardless of a patient’s genotype.

Ramakrishnan argues that such drugs may not completely optimize the responses of all genotypes, and that there is room for further improvement with customized drugs. He points out that when monoclonal antibodies are used to treat cancer, it is usually in combination with radiation or other treatment. By optimizing the drugs, he says, it may be possible that certain patients could receive them as stand-alone therapies, thereby reducing the side effects and cost of treatment.

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Credit: Technology Review 

A Boston hospital aims to collect genome information from all consenting patients.

MIT Technology Review, June 15, 2009, by Emily Singer  —  Boston’s Brigham and Women’s Hospital (BWH) has announced plans to collect blood samples for genetic analysis from all consenting patients and then feed that information into a large database, allowing scientists to analyze patients’ genomes alongside detailed medical histories. The project aims to take advantage of the immense amount of patient information available in the hospital’s electronic medical-record system, which is one of the most sophisticated in the country and houses a level of medical detail missing from most large-scale genetic studies of disease. The project could also serve as a model for how to incorporate genomic information into both electronic medical records and clinical care.

A growing number of both academic and privately funded efforts aim to link patients’ genomes with their symptoms, but the BWH project is unique in its scope. As an academic medical center affiliated with Harvard Medical School, BWH serves a wide variety of patients, with nearly 400,000 routine visits, 58,000 emergency-room visits, and approximately 46,000 in-patient admissions per year. Researchers ultimately aim to open the project to the entire Partner’s Healthcare System, a local network of hospitals and medical centers that sees hundreds of thousands of patients.

While new genomics technologies have allowed scientists to identify hundreds of genetic variants that raise the risk for different diseases, the role that these variants play in individuals is still unclear, as is how to use the information to tailor treatment and prevention strategies for individual patients.

Christine Seidman, director of cardiovascular genetics at BWH and leader of the project, hopes that the new database will allow physicians and scientists to explore these questions in a rigorous way. “Say we have a group of people with a number of genetic risk factors for cardiovascular disease,” says Seidman. “Can aggressive treatment, including exercise, blood-pressure control, and statins, reduce their risk to that of someone without these risk factors?”

Other potential questions include the impact of various cancer-linked genetic variations on prognosis and responsiveness to different treatments, and the effect of cardiovascular-disease risk factors over time–for example, when a patient is 20, 40, and 60 years old.

Researchers plan to launch a pilot project involving 600 patients this fall, which will help determine how willing people are to enroll in the project, the level of genetic counseling needed to explain the project to potential participants, and how to minimize disruption to physicians’ work flow and patients’ visits.

Seidman says that it’s difficult to estimate the percentage of patients who will be willing to participate. About 90 percent of her patients have signed up for research studies of particular diseases. But in these cases, the potential benefit to patients or family members is clearer. A similar hospital-wide study that recently launched at Northwestern University garnered approximately 30 to 60 percent participation rates.

Initially, participants will not be given the results of their genetic tests. This differs from other research projects, which have trended toward open patient participation, and even open access. For instance, the Personal Genome Project, an effort headed by George Church at Harvard University, has deposited genomic information from its 10 initial volunteers into a public database, along with medical and other information, and it will do the same for thousands of additional participants. BWH is also developing new technology to manage the additional information that will ultimately become part of a patient’s medical record.

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Phone genome: This mock-up shows the iPhone application that Illumina is developing to allow consumers to interact with their genetic information. In this case, the user can search for her genetic variations by gene and chromosome.
Credit: Illumina

A new sequencing service aims to take whole-genome sequencing mainstream.

MIT Technology Review, June 15, 2009, by Emily Singer  —  The cost of a personal genome has dropped from about the price of a luxury sedan to, well, the price of a slightly less luxurious nice car. Illumina, a genomics technology company headquartered in San Diego, announced the launch of a $48,000 genome-sequencing service at the Consumer Genetics Conference in Boston on Wednesday.

It won’t be the first consumer genome service–Knome, a startup in Cambridge, MA, already offers genome sequencing for just under $100,000–but Illumina is the first company preparing to offer high-volume personal-genome sequencing. Knome, which uses Illumina technology to perform its sequencing, is a boutique service that offers both genome analysis and interpretation.

Many within the genomics industry believe that, as soon as the price is right, an individual’s genome will be sequenced routinely and become part of her medical record. Within the genome lie clues to each person’s risk for disease, his or her reaction to different medications, and other medically useful information.

While $48,000 is still out of reach for most consumers, the price reflects an exponential drop in the cost of sequencing technologies in recent years. James Watson’s genome, sequenced in 2007, cost about $2 million, and Knome initially offered its service at $350,000. A third company, Complete Genomics, announced plans for a $5,000 sequencing service, although this will initially be available only to academic institutions and industry for research and clinical trials rather than for personal use. “It’s like watching the price of gas fall,” says George Church, a genomics technologist at Harvard University who has developed his own sequencing technology.

Unlike most consumer-genomics companies, which offer tests directly through the Internet, Illumina’s genome-sequencing service will require a physician’s prescription. In fact, the company will implement a seven-day waiting period after an individual surrenders his saliva for analysis to give customers time to make sure that they truly want to know the contents of their genome.

The $48,000 price tag comes with 30-fold coverage of the entire genome (an individual’s DNA must be analyzed multiple times to generate a comprehensive sequence) but minimal analysis of the information that it holds. Instead, Illumina will leave the analysis to others, announcing partnerships with four major consumer-genomics companies: Knome, 23andMe, Navigenics, and Decode. Jay Flatley, Illumina’s chief executive officer, said at the Consumer Genetics Conference that each company will develop its own analysis packages at an additional cost, and consumers will be able to pick the one that they want.

It’s the analysis of the genome rather than the sequencing itself that is proving to be the most difficult aspect of personalized genomic medicine. While scientists have identified hundreds of genetic variations linked to risk of specific diseases, the meaning of the vast majority of the genome is still unknown. And in most cases, scientists don’t yet know how to combine genetic risk factors with environmental risk factors to produce accurate predictions for the likelihood of developing a specific disease.

Currently, 23andMe, Navigenics, and Decode use gene chips to analyze specific genetic variations commonly found in different populations that have been linked to diseases and other traits. Whole-genome sequencing captures a much higher volume of genetic information, as well as additional types of genetic variation, such as deletions and duplications of segments of the genome. Knome already provides analysis of the entire genome and thus will likely have a leg up on the competition in terms of interpretation. Jorge Conde, Knome’s president, says that the company will still offer its $99,000 service, which includes in-person interpretation by a panel of experts. In contrast, Knome’s service, provided through Illumina, would be automated.

Flatley has already had his genome sequenced and has announced three others currently being analyzed: Hermann Hauser, a venture capitalist with Amadeus Capital Partners who was involved with Solexa, the startup on which Illumina’s sequencing technology is based; Henry Louis Gates Jr., a Harvard professor who has used genomics to explore African-American history; and Gates’s father, Henry Gates Sr.

Illumina is also developing an application for the iPhone that would allow consumers to interact with their genetic information in different ways. One example is a feature that determines which statin medication an individual should take, as well as the optimal dose, based on her genome.

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A medical geneticist plans to find out.

MIT Technology Review, June 15, 2009, by Emily Singer  —  Even as the Obama administration scrambles to find new ways to rein in health-care costs, a new trend in consumer medicine might boost unnecessary spending.

A number of direct-to-consumer companies now offer genetic testing over the Internet, providing customers with estimates of their risk of developing different diseases and other information. Many people then take these reports to their physicians, “who have little idea of how to interpret them, let alone how to act on them,” says Michael Murray, a medical geneticist at Brigham and Women’s Hospital, in Boston. “No one has a handle on the economic cost to health care.”

Over the long term, geneticists and physicians hope that genetic testing for disease risk will reduce health-care costs by enabling targeted early screening and better preventative medicine. But in the near term, as clinicians and scientists learn how to use genetic information, the results of direct-to-consumer tests might prompt physicians to order screening tests and other procedures that they likely would not do otherwise. “We don’t have the foggiest idea whether this is generating a ton of downstream cost,” says Murray, who discussed the issue at the Consumer Genetics Conference in Boston last week. “My hunch is, if not now, it probably will.”

Murray hopes to have a more concrete answer soon. He is surveying health-care providers who have received these types of inquiries from patients to find out what questions patients ask and whether follow-up tests were ordered based on the results.

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The emerging market of direct-to-consumer genetic testing gets down to business.

MIT Technology Review, June 15, 2009, by Emily Singer  —  Want to share your genome online with friends and family? Find out how well you metabolize B vitamins? Determine if you’re genetically susceptible to forming blood clots on long flights? All of this is possible with a credit card and an Internet connection, thanks to the growing field of direct-to-consumer genetic testing, which aims to move genetic tests out of the doctor’s office and into the hands of individuals.

The first annual Consumer Genetics Show, which started today in Boston, highlights some of what’s available to today’s consumer. A number of genomics startups have booths lined up along the conference hall, offering everything from genetic tests that give individuals insight into their heart health, nutritional requirements, and optimal weight-loss strategies to full genome sequences. Inside the hall, meanwhile, scientists, physicians, and entrepreneurs are grappling with some of the controversies that have grown along with the field. Foremost among these concerns: How good is the information delivered by these tests? How well can people understand the results? And how effectively can they help people manage their health?

To date, medical genetics has been largely limited to tests ordered by physicians for rare disorders triggered by defects in single genes, such as cystic fibrosis. But as the price of genetic technologies has plummeted–the cost of sequencing a genome has dropped 10,000-fold in the past four years–the possibilities for genetic testing have grown. Scientists have identified hundreds of genetic variations that can raise the risk of common diseases, such as diabetes and heart disease; point to particular ancestries; and even influence traits, such as height.

A number of companies offering direct-to-consumer genetic testing have cropped up in the past two years to capitalize on these advances, from 23andMe and Navigenics, which offer genome-wide scans to identify specific disease-linked genetic variations, to Knome, which offers whole-genome sequencing to the wealthy. Any doubts that personal genomics is making its way into the mainstream can be assuaged with a look at Interleukin genetics, a startup that sells genetic tests for heart-disease risk, B vitamin metabolism, and other factors through Amway, the direct-sales company. “With minimal advertising, these companies have captured the imagination of the public,” says Robert Green, a neurologist at Boston University and one of the conference organizers. “The public is eager to know more about genetics.”

Along with this burst in genetic knowledge, however, comes a number of concerns. Scientists question how useful the currently available information is in managing one’s health. “The most important issues in consumer genomics are around consumer utility and whether the kind of information available right now is useful to consumers medically and personally, and whether it has any potential for harm, either through misleading people, misunderstanding, or false reassurance,” says Green. At this point, nongenetic factors, such as family history, body mass index, and history of smoking, often provide a better predictor of disease risk than does genetics, he says.

A second worry is how genetic information is delivered to consumers. “The effort is to shift the focus from the physician, who usually focuses on specific problems, to the consumer, who is looking for a more broad-based view,” says Jorge Conde, president of Knome, which is based in Cambridge, MA. “There are a lot of questions around how to do that in a way that is digestible and relevant and responsible for someone not trained in genetics.”

Different companies handle this different ways, some providing information online, others offering genetic counseling. “I think genetic counseling is very important because lots of people make no distinction between single-gene disorders, like cystic fibrosis, and genetic factors that may elevate their risk for, say, heart disease in a modest way,” says Michael Christman, president of the Coriell Institute for Medical Research, a nonprofit research center in Camden, NJ. Common complex diseases, such as heart disease, Alzheimer’s, and type 2 diabetes, are caused by a combination of genetic and environmental factors, making it difficult to predict the impact of a single linked genetic variation in an individual patient. “In the absence of someone very knowledgeable to explain this, there is the potential for gross interpretation of what it really means,” says Christman.

Most direct-to-consumer genetic-testing companies have declined to release sales figures, so despite the public attention, it’s unclear whether their business models are succeeding. But most people seemed unconcerned. “If you look at the first commercial transactions on the Internet, few of the early companies necessarily survived intact, but the ideas they invented became the industry,” says James Heywood, cofounder of PatientsLikeMe, a company based in Cambridge, MA, that collects, shares, and analyzes data on patients with different diseases. “It’s like going back to the invention of the computer: was it the computer that was important, or was it the applications that were invented to use on it? Who knows what application will effectively build this new market?”

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Making Medicine Personal

MIT Technology Review, June 15, 2009  —  A number of scientists bared their genetic souls recently as part of the Personal Genome Project, a study at Harvard University Medical School. They were among the first of the eventually 100,000 volunteers who will agree to place their genetic profiles on the Internet.

Genetic profiling can provide information on what diseases may befall us. And knowledge of an individual’s genetic makeup may also help scientists figure out how to treat diseases-part of an emerging field known as personalized medicine.

As many doctors freely admit, says Julie Johnson, director of the Center of Phamacogenomics at the University of Florida (UF), prescribing medicine is “more of an art than a science.” Approved drugs work-but not 100 percent of the time, and not for 100 percent of the population. Some people have no response to certain drugs, and others experience severe side effects.

What determines whether a particular treatment is effective or leads to severe side effects is our genes, scientists believe. Personalized medicine holds the promise of tailored medical treatments based on genetic information, rather than a one-size-fits-all approach.

The UF center participated in studies on warfarin, a blood thinner prescribed for millions of Americans to prevent heart attack or clotting after a heart attack. Too little of the drug causes a risk of clotting, and too much can cause excessive bleeding. “There’s a very narrow window, and there’s a great deal of variability among patients,” says Johnson. “A lot of work in the past decade has uncovered several genes that help explain a great deal of that variability.” In 2007, the FDA cleared a genetic test for sensitivity to warfarin to help doctors prescribe the correct dosage, although the tests are not yet widely implemented.

The UF center is also focusing research on drugs prescribed for hypertension, in an attempt to find the genes that “will predict how much a person’s blood pressure will go down if they’re administered certain medicines,” says Johnson.

Speeding the Process

Part of what has contributed to the increasing interest in personalized medicine is the speed and cost of sequencing genomes. The first human genome took many years and millions of dollars to sequence. The price has already dropped into the thousands instead of millions of dollars, and it’s expected to continue to fall. The journal Science listed “faster, cheaper genome sequencing” as one of the top scientific advances in 2008.

These advances have increased the speed of research in the field. John Reed, the president and CEO of Burnham Institute for Medical Research, a center with campuses in San Diego, CA, and Orlando, FL, says that the Florida campus has engaged in major initiatives related to personalized medicine. While Burnham’s research has traditionally focused on cancer and on neurodegenerative and inflammatory diseases, the scientific team is expanding into obesity, diabetes, and metabolism research.

“We all have friends who can eat french fries every day and never gain weight, while the rest of us will have a hard time getting the belt to fit,” says Reed. “There are genetic differences in how we metabolize food-individual metabolic rates, hormone signaling-that’s all just being worked out.” Burnham is partnering with the clinical research institute at Florida Hospital, particularly the diabetes center, to engage in research on the metabolic systems of the patients there.

A related field of research involves investigating which chemicals can affect the actions of proteins, encoded by specific genes. This is a natural path to drug discovery, but it can also aid in genomic research. “A chemical probe can be used in basic research to help identify the role of a protein or a pathway, aiding in understanding the biology of a particular gene,” says Patrick Griffin, chair of Molecular Therapeutics at Scripps Florida, a campus of Scripps Research Institute headquartered in California.

The National Institutes of Health (NIH) funds four molecule-screening centers in the United States to rapidly test a library of chemicals against specific proteins. Scripps Florida operates one of the four centers.

Burnham operates a second of those NIH molecule-screening centers at both its California and Florida research centers. Currently, its screening output can tackle half a million chemicals in one day, but the new system being developed in Orlando will be able to handle as many as 2.2 million chemicals a day.

The fields of genome research and rapid drug discovery are coming together to enhance each other, says Reed. “We’ll be able to, with far more accuracy, define for whom a drug is really going to work, and to avoid a lot of trial and error that we experience when we’re confronted with a health issue.” He and other researchers in the field see a time not too far in the future when understanding individual genomes will lead to better, more effective medical treatments for everyone.

KevinMD.com, June 16, 2009, NEW HAMPSHIRE  —  I was seeing patients during the actual speech, so I had to rely on the transcript.

The points that interested me the most were any language pertaining to malpractice, addressing the AMA’s recent concerns about the public plan option, and reforming the physician payment system.

I think he did pretty well.

Regarding the physician payment system, he again addressed McAllen, Texas, which is fast becoming the symbol of what’s wrong with American health care. Not sure the city is comfortable with that notoriety.

Here’s what Obama said:

That starts with reforming the way we compensate our doctors and hospitals. We need to bundle payments so you aren’t paid for every single treatment you offer a patient with a chronic condition like diabetes, but instead are paid for how you treat the overall disease. We need to create incentives for physicians to team up – because we know that when that happens, it results in a healthier patient. We need to give doctors bonuses for good health outcomes – so that we are not promoting just more treatment, but better care.And we need to rethink the cost of a medical education, and do more to reward medical students who choose a career as a primary care physicians and who choose to work in underserved areas instead of a more lucrative path. That’s why we are making a substantial investment in the National Health Service Corps that will make medical training more affordable for primary care doctors and nurse practitioners so they aren’t drowning in debt when they enter the workforce.

Standard policy-speak about bundling payments. But, unlike the majority health policy columnists and editorials in The New York Times, he goes out of his way to blame the system, not doctors. Obviously, this is because the President is addressing the AMA, but the way to court doctors is not to wholly blame them for the health system’s ills.

Regarding primary care, the idea of simply investing more in the National Health Service Corps is grossly inadequate. First off, any improvement in primary care numbers will be seen in 5 to 10 years minimum, and second, primary care doctors are needed everywhere, not just in underserved areas.

I like that he addressed the cost of medical education, but doing something about it is another matter entirely.

Here’s what Obama said about malpractice:

I recognize that it will be hard to make some of these changes if doctors feel like they are constantly looking over their shoulder for fear of lawsuits. Some doctors may feel the need to order more tests and treatments to avoid being legally vulnerable. That’s a real issue. And while I’m not advocating caps on malpractice awards which I believe can be unfair to people who’ve been wrongfully harmed, I do think we need to explore a range of ideas about how to put patient safety first, let doctors focus on practicing medicine, and encourage broader use of evidence-based guidelines. That’s how we can scale back the excessive defensive medicine reinforcing our current system of more treatment rather than better care.

These changes need to go hand-in-hand with other reforms.

Probably the best we could have expected. He acknowledged that malpractice reform needs to go hand in hand with health reform, and admitted that defensive medicine is indeed a factor in medical decision making today. I agree that malpractice caps are a non-starter, and like single-payer, hope that cap supporters realize that it’s a political impossibility.

I hope that this could be the start of a more constructive dialogue where doctors are offered liability protection if they adhere to evidence-based guidelines. Under the current political environment, that is probably the best scenario that doctors can hope for. And, to be honest, I think it’s a reasonable compromise.

And finally, here’s what he said about the public plan option:

Now, I know there’s some concern about a public option. In particular, I understand that you are concerned that today’s Medicare rates will be applied broadly in a way that means our cost savings are coming off your backs. These are legitimate concerns, but ones, I believe, that can be overcome. As I stated earlier, the reforms we propose are to reward best practices, focus on patient care, not the current piece-work reimbursement. What we seek is more stability and a health care system on a sound financial footing. And these reforms need to take place regardless of what happens with a public option. With reform, we will ensure that you are being reimbursed in a thoughtful way tied to patient outcomes instead of relying on yearly negotiations about the Sustainable Growth Rate formula that’s based on politics and the state of the federal budget in any given year. The alternative is a world where health care costs grow at an unsustainable rate, threatening your reimbursements and the stability of our health care system.

What are not legitimate concerns are those being put forward claiming a public option is somehow a Trojan horse for a single-payer system. I’ll be honest. There are countries where a single-payer system may be working. But I believe – and I’ve even taken some flak from members of my own party for this belief – that it is important for us to build on our traditions here in the United States. So, when you hear the naysayers claim that I’m trying to bring about government-run health care, know this – they are not telling the truth.

Good to see him address this important physician concern, namely, a public plan option using Medicare rates, and using this approach as a “back door” to a single-payer system. It’s clear that he’ll use the repeal of the SGR formula as a bargaining chip, perhaps to get the AMA’s support of a “weak” public plan.

Right now, there are no details of what a plan would look like, so I can’t really give an informed opinion on it. A plan that coerces doctors to take it on condition of accepting Medicare, or one that pays doctors less than 130 to 150 percent of Medicare rates, are the only deal-breakers, in my view. The AMA is clearly shooting for the moon when they say they were “opposed” to the public plan, and I think both sides will eventually settle on a “weak” version, meaning, it will remain but not at a marked competitive advantage with private insurers. I can live with that.

So, in the end, I thought the President did a pretty good job. Especially with his malpractice language, acknowledgment of the practice of defensive medicine, and the fact that he’s aware that doctors are concerned about the how “our cost savings are coming off your backs.”

Will it make a difference? We’ll see. But I can say that the speech could have been a lot more antagonistic to physicians than it actually was.

Kevin Pho MD practices medicine in New Hampshire