Friday, May 17, 2013
In the old days, sales representatives from drug companies would chat up local pharmacists to learn what drugs doctors were prescribing. Now such shoulder-rubbing is becoming a quaint memory — thanks to vast databases of patient and doctor information being used by pharmaceutical companies to market drugs.
The information allows drug makers to know which drugs a doctor is prescribing and how that compares to a colleague across town. They know whether patients are filling their prescriptions — and refilling them on time. They know details of patients' medical conditions and lab tests, and sometimes even their age, income and ethnic backgrounds.
The result, said one marketing consultant, is what would happen if Arthur Miller's Willy Loman met up with the data whizzes of Michael Lewis's "Moneyball." "There's a group of geeks, if you will, who are running the numbers and helping the sales guys be much more efficient," said Chris Wright, managing director of ZS Associates, which conducts such analyses for pharmaceutical companies.
Drug makers say they are putting the information to good use, by helping a doctor improve the chances that their patients take their medications as prescribed, or making sure they are prescribing the right drug to the right patients.
Some doctors, however, expressed discomfort with the idea of sensitive data being used to sell drugs, even though federal law requires that any personally identifiable information be removed. "I think the doctors tend not to be aware of the depths to which they are being analyzed and studied by people trying to sell them drugs and other medical products," said Dr. Jerry Avorn, a professor of medicine at Harvard Medical School and a pioneer of programs for doctors aimed at counteracting the marketing efforts of drug makers. "Almost by definition, a lot of this stuff happens under the radar — there may be a sales pitch, but the doctor may not know that sales pitch is being informed by their own prescribing patterns."
The research firm IMS Health has tracked information about which drugs doctors prescribe since the 1990s, and over the last decade, the list of available information has expanded to include insurance claims data, which yields a trove of intelligence about patients' medical diagnoses and insurance coverage. Additional details about patients, including income, education and ethnicity, can also be available.
One company, SDI Health, promises to provide clients with "actionable analysis" by tracking people — on an anonymous basis — as they move through the "patient experience." That includes, according to their Web site, filling prescriptions at a pharmacy, visiting a doctor, being admitted to the hospital and undergoing lab tests.
"Through our unique and proprietary patient-linking technology, we connect all aspects of a patient's behavior," the company's Web site states. IMS Health acquired SDI in 2011.
"The sales representative theoretically has the ability to understand not only the doctor's behavior, and which other physicians are key opinion leaders that the doctor listens to, but also the behavior of that doctor's patients," said Jerry Maynor, the director of marketing for North America at Cegedim Strategic Data, one of the companies that performs data analyses.
Some said that tracking physicians' behavior was no different from techniques other industries use to sell products, including following a consumer's Internet activity. But David Orentlicher, a law professor at Indiana University who writes on medical ethics issues, said the pharmaceutical companies' use of data has become more invasive. "A lot of the information comes out of the doctor-patient encounter," he said.
Privacy advocates also pointed to research showing that people in anonymous databases can sometimes be re-identified. "It just seems like it skirts the edge of the laws that do exist," said Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center who is a critic of pharmaceutical marketing tactics.
Doctors who object to the use of their prescribing data by pharmaceutical companies can opt out through a program set up by the American Medical Association in 2006. But doctors cannot block the use of their insurance claims and other data, and some doctors complain that few know the program exists. About 31,650 of the nation's more than 767,000 practicing physicians, roughly 4 percent, have enrolled in the opt-out program since it was created, according to the A.M.A., which also sells information about doctors to companies like IMS.
Drug makers and their consultants say their techniques can help doctors by providing information that is customized to their needs. To sell the respiratory drug Spiriva, for instance, the German drug maker Boehringer Ingelheim uses insurance and prescribing data to focus on doctors with patients who have chronic obstructive pulmonary disease but who are not frequently prescribing long-acting drugs like Spiriva, which have been shown to reduce sudden attacks of severe complications in people with the disease, compared to shorter-acting drugs.
"You start analyzing what they're doing and you can find out if, through a combination of factors, you can intervene," said Paul Fonteyne, the president and chief executive of Boehringer Ingelheim USA.
Some pharmaceutical companies and consultants said the industry mainly used the data to market to big decision-makers like insurers, by demonstrating that their drugs are more cost-effective or show better outcomes for patients. Boehringer Ingelheim and the insurance company Humana, for example, recently announced a partnership aimed at improving the health and reducing costs for people with C.O.P.D. and other chronic diseases.
"At the end of the day, calling on doctors in terms of a personal selling model is a lot less important to selling your drug," said Andrew Kress, a senior vice president at IMS. "You can read a dark side to any of this, but the reality is that most manufacturers that IMS does research for are really trying to engage in a much more productive dialogue with the health care providers."
Companies are refining their pitches to doctors in part because it is getting harder to market to them. Studies show physicians are less willing to speak to sales representatives, either because they are opposed to such pitches, or because they are under pressure to see more patients. At the same time, the industry has laid off thousands of sales representatives in an effort to save money as once best-selling drugs have lost their patent protection.
"The industry is now having a harder time getting direct access to physicians," said Edward Rhoads, a managing partner and principal at the New England Consulting Group. As a result, he said, drug companies are asking, "How can we get the information into the community in a different way? There's a big emphasis in understanding how physicians influence each other."
This field, called influence-mapping, seeks to put a high-tech twist on the old idea that nothing sells a product better than word of mouth. One company, Activate Networks, applies technology licensed from Harvard University to draw connections between physicians with patients in common, then uses those ties to accelerate the adoption of newly introduced drugs.
"You can tell a lot about a physician's behavior by looking at what the people they have relationship with are doing," said Peter DeWan, the chief scientific officer at Activate Networks.
Mr. DeWan said his company assigned physicians a ranking based on how connected they were, which helped companies decide where to send a representative, or whom to invite to a talk about a drug.
But some doctors questioned whether these techniques were best for patients. Just because doctors are well connected doesn't mean they are prescribing the right drugs, said Dr. David C. May, a cardiologist who practices in a northern suburb of Dallas and is chairman of the board of governors for the American College of Cardiology.
"We have seen, in our particular part of Dallas, situations in which the physicians were aggressively marketed to and the drugs were perhaps inappropriately used early on," he said.
Dr. Larry Miller, the chief executive of Activate Networks, noted that the company also advised clients like insurance companies, which are using the same networks to persuade doctors to choose more inexpensive treatments. "You still have to be very careful," Dr. Miller said. "We all know our own networks and know who we respect."
Wednesday, May 15, 2013
My mother fought cancer for almost a decade and died at 56. She held out long enough to meet the first of her grandchildren and to hold them in her arms. But my other children will never have the chance to know her and experience how loving and gracious she was.
We often speak of "Mommy's mommy," and I find myself trying to explain the illness that took her away from us. They have asked if the same could happen to me. I have always told them not to worry, but the truth is I carry a "faulty" gene, BRCA1, which sharply increases my risk of developing breast cancer and ovarian cancer.
My doctors estimated that I had an 87 percent risk of breast cancer and a 50 percent risk of ovarian cancer, although the risk is different in the case of each woman.
Only a fraction of breast cancers result from an inherited gene mutation. Those with a defect in BRCA1 have a 65 percent risk of getting it, on average.
Once I knew that this was my reality, I decided to be proactive and to minimize the risk as much I could. I made a decision to have a preventive double mastectomy. I started with the breasts, as my risk of breast cancer is higher than my risk of ovarian cancer, and the surgery is more complex.
On April 27, I finished the three months of medical procedures that the mastectomies involved. During that time I have been able to keep this private and to carry on with my work.
But I am writing about it now because I hope that other women can benefit from my experience. Cancer is still a word that strikes fear into people's hearts, producing a deep sense of powerlessness. But today it is possible to find out through a blood test whether you are highly susceptible to breast and ovarian cancer, and then take action.
My own process began on Feb. 2 with a procedure known as a "nipple delay," which rules out disease in the breast ducts behind the nipple and draws extra blood flow to the area. This causes some pain and a lot of bruising, but it increases the chance of saving the nipple.
Two weeks later I had the major surgery, where the breast tissue is removed and temporary fillers are put in place. The operation can take eight hours. You wake up with drain tubes and expanders in your breasts. It does feel like a scene out of a science-fiction film. But days after surgery you can be back to a normal life.
Nine weeks later, the final surgery is completed with the reconstruction of the breasts with an implant. There have been many advances in this procedure in the last few years, and the results can be beautiful.
I wanted to write this to tell other women that the decision to have a mastectomy was not easy. But it is one I am very happy that I made. My chances of developing breast cancer have dropped from 87 percent to under 5 percent. I can tell my children that they don't need to fear they will lose me to breast cancer.
It is reassuring that they see nothing that makes them uncomfortable. They can see my small scars and that's it. Everything else is just Mommy, the same as she always was. And they know that I love them and will do anything to be with them as long as I can. On a personal note, I do not feel any less of a woman. I feel empowered that I made a strong choice that in no way diminishes my femininity.
I am fortunate to have a partner, Brad Pitt, who is so loving and supportive. So to anyone who has a wife or girlfriend going through this, know that you are a very important part of the transition. Brad was at the Pink Lotus Breast Center, where I was treated, for every minute of the surgeries. We managed to find moments to laugh together. We knew this was the right thing to do for our family and that it would bring us closer. And it has.
For any woman reading this, I hope it helps you to know you have options. I want to encourage every woman, especially if you have a family history of breast or ovarian cancer, to seek out the information and medical experts who can help you through this aspect of your life, and to make your own informed choices.
I acknowledge that there are many wonderful holistic doctors working on alternatives to surgery. My own regimen will be posted in due course on the Web site of the Pink Lotus Breast Center. I hope that this will be helpful to other women.
Breast cancer alone kills some 458,000 people each year, according to the World Health Organization, mainly in low- and middle-income countries. It has got to be a priority to ensure that more women can access gene testing and lifesaving preventive treatment, whatever their means and background, wherever they live. The cost of testing for BRCA1 and BRCA2, at more than $3,000 in the United States, remains an obstacle for many women.
I choose not to keep my story private because there are many women who do not know that they might be living under the shadow of cancer. It is my hope that they, too, will be able to get gene tested, and that if they have a high risk they, too, will know that they have strong options.
Life comes with many challenges. The ones that should not scare us are the ones we can take on and take control of.
That's how much the company paid Dr. Tria in fees for promoting its products and training doctors in Asia to use them from 2009 to 2011, according to disclosures required by the state of Massachusetts, where Dr. Tria is licensed. In 2010, Dr. Tria earned $421,905 from private industry — more than any other Massachusetts-licensed physician that year.
Dr. Tria may be an outlier, but gifts and payments to physicians from drug and medical device companies have been rampant in medicine for decades. Over a two-and-a-half-year period, device and drug companies shelled outover $76 million just to physicians licensed in Massachusetts, according to a study published online this month in The New England Journal of Medicine. That amount does not include outlays of less than $50, which are exempt from disclosure.
The companies treat doctors to dinner, pay them to attend lectures, and underwrite conferences and continuing medical education courses. Asked whether such payments could pose a conflict of interest for physicians, Dr. Tria said, "It's a legitimate concern."
A spokesman for St. Peter's said Dr. Tria had disclosed his financial relationships with industry to the hospital and refused to elaborate on the hospital's policy.
Information about these sorts of payments to physicians is available for the first time now in a handful of states that have passed laws requiring corporations to disclose payments to health providers. Next year, the data should be available nationwide when the federal Physician Payment Sunshine Act goes into effect. Corporations were supposed to start collecting the information last year.
"For many decades, we had no information — these were closely held industry secrets," said Susan Chimonas, of Columbia University, who has researched industry payments to physicians. "We are just starting to get a sense of how much money companies are spending on the marketing and consulting arrangements."
The data will be a treasure trove for researchers. For patients, the question is what to make of this information and whether to seek it out when choosing a physician or making an important medical decision. Orthopedic surgeons, cardiologists and psychiatrists received the most lucrative payments, the new study found. Primary care physicians — such as internists and pediatricians — were least likely to receive payments.
In Massachusetts, companies are required only to broadly categorize the purpose of the payments, and nearly 90 percent of them were described as "compensation for bona fide services." Dr. Aaron S. Kesselheim, an assistant professor at Harvard and the lead author of the new study, says that though the reported information can be vague, it can still be useful.
"It's another piece of data for patients to examine as they consider treatment options," he said. "If they go to an orthopedic surgeon who recommends a knee transplant, and they go to another who recommends watching and physical therapy, it might be interesting for the patient to wonder to what extent those two physicians have relationships with industry."
The question may also be appropriate if a physician changes a patient's prescription for no apparent reason, or prescribes a new or more expensive drug instead an older, tried-and-true alternative, said Dr. Joseph S. Ross, an internist and assistant professor of medicine at Yale.
"We know physicians are more likely to overprescribe or potentially prescribe inappropriately when they have a financial relationship with industry," Dr. Ross said. His own research has found that many physicians do not think there is anything inappropriate about industry gifts as long as they're not too lavish.
The size of the gift is not a determinant of its influence, experts say. Even a small gift can generate positive feelings and influence attitudes and behavior. "I don't think doctors ever set out to make decisions that are not in the best interest of their patients," said Dr. Deborah R. Korenstein, associate professor at Mount Sinai and a co-author of the study by Dr. Ross.
"But there are subconscious influences that people can't control, and that's why patients, and doctors, need to be concerned," she said.
A paper Dr. Korenstein published in 2011 found that more than a dozen expert panels that developed national clinical practice guidelines for managing diabetes and high cholesterol were dominated by physicians with financial conflicts of interest — that is, they were receiving payments from companies with an interest in how these diseases are managed.
Physicians often do not realize that they are being manipulated when drug companies offer to pay them consulting fees — for example, for listening to pharmaceutical representatives describe new medications and evaluating their performance. The real purpose "is just to get the doctor to listen to the reps over and over again," said Dr. Adriane Fugh-Berman, director ofPharmedOut, a project at Georgetown University Medical Center that focuses on the influence of drug company marketing.
Dr. Fugh-Berman advises patients to avoid physicians who see drug reps and dispense samples. "Ask, 'Could I have a tried-and-true drug?' 'Could I have a generic version?' "
Although many schools and hospitals have adopted new policies that guide interactions with industry, they exempt physicians who are not staff employees and do not restrict the doctors' income. Tufts University Medical Center adopted a policy in 2010 that required physicians to get approval and review if they were paid more than $25,000 in a year by a private company. But a Tufts associate professor, Dr. Yoav Golan, an infectious disease specialist, was paid $340,754 by drug companies in 2011, including $100,000 from Forest Laboratories, $73,918 from Merck and $42,109 from Pfizer, according to disclosures filed in Massachusetts.
A Tufts spokeswoman, Julie Jette, said the payments were approved by the university. "The policy wasn't intended to be a cap," she said. Dr. Golan did not respond to an e-mail requesting comment.
Dr. Chimonas said she would encourage physicians and their professional groups "to think about how all the information that is coming out is going to be interpreted or understood by the public."
"It's so important for patients to be able to trust their physicians," she said.
Monday, May 13, 2013
Tuesday, May 7, 2013
Just weeks before the long-awaited publication of a new edition of the so-called bible of mental disorders, the federal government's most prominent psychiatric expert has said the book suffers from a scientific "lack of validity."
The expert, Dr. Thomas R. Insel, director of the National Institute of Mental Health, said in an interview Monday that his goal was to reshape the direction of psychiatric research to focus on biology,genetics and neuroscience so that scientists can define disorders by their causes, rather than their symptoms.
While the Diagnostic and Statistical Manual of Mental Disorders, or D.S.M., is the best tool now available for clinicians treating patients and should not be tossed out, he said, it does not reflect the complexity of many disorders, and its way of categorizing mental illnesses should not guide research.
"As long as the research community takes the D.S.M. to be a bible, we'll never make progress," Dr. Insel said, adding, "People think that everything has to match D.S.M. criteria, but you know what? Biology never read that book."
The revision, known as the D.S.M.-5 and the first since 1994, has stirred unprecedented questioning from the public, patient groups and, most fundamentally, senior figures in psychiatry who have challenged not only decisions about specific diagnoses but the scientific basis of the entire enterprise. Basic research into the biology of mental disorders and treatment has stalled, they say, confounded by the labyrinth of the brain.
Decades of spending on neuroscience have taught scientists mostly what they do not know, undermining some of their most elemental assumptions. Genetic glitches that appear to increase the risk of schizophrenia in one person may predispose others toautism-like symptoms, or bipolar disorder. The mechanisms of the field's most commonly used drugs — antidepressants like Prozac, and antipsychosis medications like Zyprexa — have revealed nothing about the causes of those disorders. And major drugmakers have scaled back psychiatric drug development, having virtually no new biological "targets" to shoot for.
Dr. Insel is one of a growing number of scientists who think that the field needs an entirely new paradigm for understanding mental disorders, though neither he nor anyone else knows exactly what it will look like.
Even the chairman of the task force making revisions to the D.S.M., Dr. David J. Kupfer, a professor of psychiatry at the University of Pittsburgh, said the new manual was faced with doing the best it could with the scientific evidence available.
"The problem that we've had in dealing with the data that we've had over the five to 10 years since we began the revision process of D.S.M.-5 is a failure of our neuroscience and biology to give us the level of diagnostic criteria, a level of sensitivity and specificity that we would be able to introduce into the diagnostic manual," Dr. Kupfer said.
The creators of the D.S.M. in the 1960s and '70s "were real heroes at the time," said Dr. Steven E. Hyman, a psychiatrist and neuroscientist at the Broad Institute and a former director at the National Institute of Mental Health. "They chose a model in which all psychiatric illnesses were represented as categories discontinuous with 'normal.' But this is totally wrong in a way they couldn't have imagined. So in fact what they produced was an absolute scientific nightmare. Many people who get one diagnosis get five diagnoses, but they don't have five diseases — they have one underlying condition."
Dr. Hyman, Dr. Insel and other experts said they hoped that the science of psychiatry would follow the direction of cancer research, which is moving from classifying tumors by where they occur in the body to characterizing them by their genetic and molecular signatures.
About two years ago, to spur a move in that direction, Dr. Insel started a federal project called Research Domain Criteria, or RDoC, which he highlighted in a blog post last week. Dr. Insel said in the blog that the National Institute of Mental Health would be "reorienting its research away from D.S.M. categories" because "patients with mental disorders deserve better." His commentary has created ripples throughout the mental health community.
Dr. Insel said in the interview that his motivation was not to disparage the D.S.M. as a clinical tool, but to encourage researchers and especially outside reviewers who screen proposals for financing from his agency to disregard its categories and investigate the biological underpinnings of disorders instead. He said he had heard from scientists whose proposals to study processes common to depression, schizophrenia and psychosis were rejected by grant reviewers because they cut across D.S.M. disease categories.
"They didn't get it," Dr. Insel said of the reviewers. "What we're trying to do with RDoC is say actually this is a fresh way to think about it." He added that he hoped researchers would also participate in projects funded through the Obama administration's new brain initiative.
Dr. Michael First, a psychiatry professor at Columbia who edited the last edition of the manual, said, "RDoC is clearly the way of the future," although it would take years to get results that could apply to patients. In the meantime, he said, "RDoC can't do what the D.S.M. does. The D.S.M. is what clinicians use. Patients will always come into offices with symptoms."
For at least a decade, Dr. First and others said, patients will continue to be diagnosed with D.S.M. categories as a guide, and insurance companies will reimburse with such diagnoses in mind.
Dr. Jeffrey Lieberman, the chairman of the psychiatry department at Columbia and president-elect of the American Psychiatric Association, which publishes the D.S.M., said that the new edition's refinements were "based on research in the last 20 years that will improve the utility of this guide for practitioners, and improve, however incrementally, the care patients receive."
He added: "The last thing we want to do is be defensive or apologetic about the state of our field. But at the same time, we're not satisfied with it either. There's nothing we'd like better than to have more scientific progress."