In some ways, the United States has come a long way since Lyndon Johnson declared the "war on poverty." But in others, we're still at square one. We now have a variety of federally-supported nutrition programs, but the health care system remains senselessly disconnected from the "social determinants of health." In this regard, the United States has fallen behind the rest of the world. If a politician in India announced a public health plan that neglected malnutrition, he would be ridiculed. Here, leaders make this kind of omission all the time. Almost all of the debate about the 2010 Affordable Care Act was consumed with questions about health care access and quality. But if we really want to improve the health of millions of people, we have to address the conditions that make them sick.
Some links and readings posted by Gary B. Rollman, Emeritus Professor of Psychology, University of Western Ontario
Friday, July 29, 2011
Treating the Cause, Not the Illness - NYTimes.com
In some ways, the United States has come a long way since Lyndon Johnson declared the "war on poverty." But in others, we're still at square one. We now have a variety of federally-supported nutrition programs, but the health care system remains senselessly disconnected from the "social determinants of health." In this regard, the United States has fallen behind the rest of the world. If a politician in India announced a public health plan that neglected malnutrition, he would be ridiculed. Here, leaders make this kind of omission all the time. Almost all of the debate about the 2010 Affordable Care Act was consumed with questions about health care access and quality. But if we really want to improve the health of millions of people, we have to address the conditions that make them sick.
The Epocrates App Provides Drug Information, and Drug Ads - NYTimes.com
Epocrates has won over nearly half of the nation's doctors for its free smartphone apps that lets them look up information on drug dosing, interactions and insurance coverage while seeing a patient.
But like so much else on the Web, "free" comes with a price: doctors must wade through marketing messages on Epocrates that try to sway their choices of which drugs to prescribe.
The apps can select messages based on each doctor's search and prescription histories, and the company has ambitious plans for expanded smartphone offerings. One possibility is a virtual sales rep that would help drug makers get their wares in front of physicians who decline to see human sales representatives.
The marketing messages are difficult to ignore. For example, a psychiatrist in Massachusetts who recently opened Epocrates (pronounced ee-POC-ra-teez) on his iPhone said that before he could look up any drugs, he had to click past "DocAlert" messages onhypertension, bipolar disorder and migraines. Two of the three showed they had been paid for by pharmaceutical companies promoting their products.
"Some doctors will not have time for that nonsense," said the psychiatrist, Dr. Daniel J. Carlat, who also writes a blog and newsletter on medical issues.
Of course, any casual user of the Web is bombarded with ads derived from their browsing history.
However, the marketing through Epocrates is more insidious, according to Dr. Adriane Fugh-Berman, an associate professor of medicine at Georgetown University and founder of PharmedOut, a nonprofit group critical of drug companies' marketing practices.
"With targeted ads in Google, you may buy something that's an unwise purchase," she said. "But when a physician is influenced in Epocrates, it's the patient who's bearing the financial and health risk."
Dr. Fugh-Berman and other critics of drug marketing say the apps promote more expensive and sometimes less effective drugs. The companies say they are helping doctors find the best medicines.
Dr. Rachel E. Sherman, associate director of medical policy at the Food and Drug Administration, said the agency was trying to get a handle on all the emerging electronic channels of communication used by drug makers."It's a mess," she said.
Epocrates is betting that the 320,000 physicians who use its apps, much like those who use Google and other advertising-supported data services, will tolerate some marketing to get the information they want at no charge. Epocrates is also used by a million nurses, pharmacists and medical students.
One in five doctors will not see drug sales representatives at work, according to the market research firm SK&A, and Epocrates says that getting a smartphone sales pitch in front of doctors just as they are writing prescriptions is immensely valuable to pharmaceutical companies.
Epocrates says drug makers get $3 in increased sales from every dollar spent on DocAlerts. The claim comes from comparing prescription records of doctors who see DocAlerts with those who do not, company officials said. But they declined to share the research, saying it was paid for by drug companies and was confidential.
Pfizer, the world's largest drug maker, has certainly found the marketing channel to be an effective way to reach doctors. "The beauty of the work we do with Epocrates is that we literally put ourselves in the palm of their hand," said Dr. Freda Lewis Hall, chief medical officer at Pfizer.
Epocrates says drug makers can present alerts to doctors based on specific drugs or classes of drugs they have looked up and by specialty, geography and insurance plan. The company will also send alerts to "customer target lists" — specific physicians, like those identified by pharmaceutical manufacturers as being the most frequent prescribers.
Epocrates acknowledges the challenges of balancing the needs of its two groups of customers: medical professionals and drug companies.
"The credibility of our brand is dependent in large part on the medical community's continued perception of us as independent from our health care industry clients, particularly pharmaceutical companies," the company said in a securities filing this year.
Pharmaceutical companies provide at least 70 percent of Epocrates's revenue, which totaled $104 million last year and is projected to be $125 million this year, according to analysts at William Blair & Company, the investment house that helped underwrite the company's initial public offering in February. (Shares sold for $16 then and closed at $16.50 on Thursday.)
"Our first commitment is the value to the physician," Rosemary A. Crane, president and chief executive of Epocrates, said in an interview.
Ms. Crane said the company's drug descriptions were unbiased and opened "a trusted channel" for drug makers to communicate with physicians through doctor alerts, which are downloaded each time the doctor updates the frequently changing drug information on the app. Ms. Crane said that having alerts based on tracking what doctors look up made the alerts more relevant to the physicians receiving the messages.
But such data tracking is opposed by some doctors and lawmakers. The Supreme Court last month overturned a Vermont law that would have restricted IMS Health, an industry data firm, from providing to drug marketers the prescription histories of individual physicians.
"The physicians know we never share their identities with the pharmaceutical companies," Ms. Crane said. Epocrates acts as a middleman in focusing the alerts and proving they work based on prescription data from IMS.
Some doctors say they easily look past the commercial messaging in Epocrates, although studies suggest otherwise. Doctors exposed to drug company information often prescribe more often, at a higher cost and with less quality, according to a review of 58 studiespublished last year in PLoS Medicine, a journal of the Public Library of Science.
Epocrates is far larger than its main competitors. Medscape Mobile, from WebMD, offers a free but less comprehensive smartphone look-up service with pharmaceutical sponsorship. UpToDate, from Wolters Kluwer Health, has a Web-based disease reference guide that, it emphasizes, does not accept money from pharmaceutical companies. But UpToDate costs $395 to $495 a year, and its first iPhone app just became available on Monday.
Dr. Robert M. Schiller, chairman of family medicine at Beth Israel Medical Center in New York, said he often uses Epocrates to look up drugs and advises medical students to use it, too.
"I have it on my iPhone," he said. "It's great for the convenience, being in a room with a patient and checking a medication. But the biggest problem is that it's supported by the pharmaceutical industry."
Drug companies, Dr. Schiller said, sponsor information that favors them. "To extent that this is a product that will influence physician prescribing behavior because it's so efficient and useful, it really needs to have minimal bias," he said. "And how do you assure that?"
Epocrates has a staff of some 15 doctors of medicine and pharmacy, Ms. Crane said, who write their own unbiased content and are protected by firewalls against industry influence.
But the company as a whole is becoming more ingrained in drug maker's plans. The company is used by all of the top 20 drug makers, and in doctor's offices, as smartphones permeate the medical profession.
Epocrates introduced a product for small medical practices on Wednesday to help with electronic health records. It provides clinical advice, too, in disease areas selected by drug company sponsors. Ms. Crane said Epocrates picks the authors of those resource guides.
Epocrates was founded in 1998 by two Stanford students. Ms. Crane is the first former pharmaceutical executive to lead Epocrates, joining in 2008 after 26 years at Johnson & Johnson and Bristol-Myers Squibb. She succeeded Kirk Loevner, who had come from Apple and the Internet Shopping Network and declined to comment for this article.
"It is a unique market, unlike any I have seen before," Mr. Loevner said in a 2009 interview with a Silicon Valley consultant. "You have a drug industry that spends $14 billion a year to influence people who prescribe drugs. There are only 600,000 people who are allowed to prescribe drugs, so there is $14 billion spent against 600,000 people. If you have a channel to reach these physicians, it is a gold mine."
Sunday, July 24, 2011
Rule Changes Proposed for Research on Humans - NYTimes.com
The government is proposing sweeping changes in the rules covering research involving human subjects, an effort officials say would strengthen protections while reducing red tape that can impede studies.
The officials said the changes were needed to deal with a vastly altered research climate, whose new features include genomics studies using patients' DNA samples, the use of the Internet and a growing reliance on studies that take place at many sites at once.
"These are the first substantial changes that have been made to the rules governing human subjects in decades, so this is really quite a historic moment," Kathy Hudson, a deputy director of the National Institutes of Health, said in a telephone news conference on Friday.
The changes would be in the rules that cover topics like the informed consent that research participants must provide and the institutional review boards that oversee research at universities and hospitals. Initially drawn up by the Department of Health and Human Services in the 1970s and '80s, the system was adopted by 14 other federal agencies and departments in 1991 and became known as the Common Rule.
But some experts said it had become too cumbersome.
"It's a terrible drag on getting good research done," said Dr. Robert J. Levine, a professor of medicine and a bioethicist at Yale who headed the university's institutional review board for 31 years. He said Sunday that while he had not thoroughly reviewed the government's lengthy proposal, he was encouraged by what he had seen.
The process is still at an early stage. The government has described possible changes and asked for public comment over the next 60 days; after that, specific rules will be formulated and again sent out for comment.
The government said its proposal was consistent with President Obama's executive order in January calling on agencies to weed out unnecessary regulations. But some of the proposed changes would add regulation.
One change would expand the rules' coverage to all studies conducted at institutions that receive money from any of the 15 federal agencies that have adopted the Common Rule. For example, if a university gets financing from the National Institutes of Health, then even a study at that university paid for by a drug company would be covered by the rules.
While that would encompass more medical research, it was not clear whether trials financed by drug companies and conducted at individual physicians' offices would be covered.
Another proposed change would allow a single institutional review board to oversee studies that take place at multiple sites.
Right now, the institutional review board at each location generally must endorse a trial, which can lead to long delays. Federal officials said that besides eliminating redundancy and delays, having a single reviewer that is truly accountable for its decisions might actually strengthen oversight.
Other proposed changes would be aimed at making it less cumbersome to do surveys or other social science research in which the risks to participants are usually less than for medical studies.
Carl Wieman, associate director for science at the White House Office of Science and Technology Policy, said it was now difficult to observe teachers and students in classrooms to help determine what makes a good teacher, given all the consent required. "You're not doing anything here except watching people," he said.
Another possible change would be that donors of blood, DNA or tissue samples would be asked to give consent before those samples could be used in subsequent research. Now, if the identity of the donor cannot be determined, samples can often be used for further research without permission. But Dr. Hudson, of the health institutes, said that with modern DNA sequencing, biological specimens are "inherently identifiable." So the proposal would make consent required.