Pharmaceutical Industry

Does the Vaccine Matter?

Erin Drankoski — Fri, 16 Oct 2009 08:05:00 -0400

Drive too fast along Red Lion Road, beside Philadelphia's Northeast Airport, and you will miss the low-rise cement building where the biotech company MedImmune has been quietly pumping out swine flu vaccine at about a million doses a week. Through the summer and fall, workers wearing protective gear that covered them from head to toe brewed up batches of live, genetically modified flu virus. Robots then injected tiny doses of virus-laden fluid into glass vials, which were mounted into nasal spritzers, labeled, and readied for shipment at the direction of the

Government Orders Columbia to Tell Patients 'True Nature' of Drug Study

Erin Drankoski — Wed, 07 Oct 2009 06:56:00 -0400

The man who would be known as Patient No. 1 emerged from routine open-heart surgery at Columbia University Medical Center in stable condition. Then he began to bleed uncontrollably. Surgeons rushed him back to the operating room to reopen his chest, but by the time they could stop the hemorrhaging, Patient No. 1 was barely breathing and in a coma.

On Aug. 15, 2000, shortly before he was discharged on his way to a nursing home, a physician wrote a terse final diagnosis in his chart: "Medical disaster."

Health Debate Short on Evidence-Based Science

Erin Drankoski — Wed, 09 Sep 2009 11:56:00 -0400

The public's faith in President Barack Obama's plan for health care reform is fading. Proposals ranging from the public insurance option to reimbursing physicians for end-of-life counseling are mired in a debate that's as overheated as August temperatures. Even the seemingly self-evident idea that the nation has a moral duty to make sure all citizens have basic access to health care is up for grabs. But there's one aspect of health care reform that California voters support almost universally: better medical evidence.

America, Heal Thyself

Erin Drankoski — Mon, 24 Aug 2009 10:21:00 -0400

It's no secret that the United States has the most expensive health care system in the world. We spend nearly twice as much per person as do other developed countries for health outcomes that are no better and in some cases much worse. Moreover, the citizens of most other countries, including Canada and the U.K., who are routinely reviled by opponents of "socialized" medicine, express greater satisfaction with their health care systems than we do with ours.

Brain Gain

Cecille Isidro — Mon, 27 Apr 2009 11:46:00 -0400

Cancer Screening: Doing More Harm than Good?

Erin Drankoski — Wed, 01 Apr 2009 16:35:00 -0400

Suzanne Bull always half expected that she'd get cancer. After all, she lived in Marin County, California, where breast cancer rates are among the highest in the country. Still, she was determined to do whatever she could to protect herself. She ate right and exercised, and every year, she went into San Francisco to get a mammogram.

Suicide-Linked Cymbalta Promoted for Minor Conditions | The Epoch Times

Cecille Isidro — Tue, 17 Mar 2009 18:32:00 -0400

But some, like Shannon Brownlee, author of “Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer,” question the revenue-driven prescribathon. Should drugs “that may have a really serious side effect called suicide,” be used for simple knee ...

Shannon Brownlee on WSCH6-TV Portland | 'Book Discussion: 'Overtreated''

Communications — Fri, 25 Jul 2008 08:34:00 -0400

Shannon Brownlee discusses her new book Overtreated: Why Too Much Medicine Is Making Us Sicker And Poorer on NBC affiliate WSCH6. LINK to video

Naming Names: Is There an (Unbiased) Doctor in the House?

Cecille Isidro — Wed, 23 Jul 2008 01:29:00 -0400

Journalists often forget that conflicts of interest may biasthe opinions of their expert sources. Jeanne Lenzer and ShannonBrownlee explain how, in an attempt to disentangle commercialmessages from science, they have compiled a list of nearly 100independent medical experts to whom reporters can turn.

Ho hum, another medical scandal in the news. Earlier this monthUS Senator Chuck Grassley announced his intention to investigateAlan Schatzberg, chairman of the psychiatry department at StanfordUniversity and the incoming president of the American PsychiatricAssociation, about his multimillion dollar interest in CorceptTherapeutics, a company that is seeking to market a drug thatDr Schatzberg is researching with federal funding, and the extentto which he disclosed and was required to disclose that interestto Stanford.¹ In June the New York Times broke a front pagestory about the alleged failure of three top research psychiatristsat Harvard, each of them a proponent of drug treatment for psychiatricconditions in children, to report that since 2000 they had collectivelyreceived more than $4.2m (£2.1m; 2.6m) from various drugcompanies.²

After ignoring the growing controversy over conflict of interestfor years, journalists now seem only too happy to expose wrongdoingin medicine. Yet when it comes to reporting medical news, thoseself same reporters often seem to forget that conflicts of interestmight also bias the opinions of their expert sources. The mediaare filled with happy talk about "medical breakthroughs" thatis based on information gathered from sources with ties to theindustry. Yet simply knowing that conflicts of interest cancreate bias doesn’t answer the question of which studieswe ought to believe. Because journalists fail to seek out sourceswho can offer an independent perspective, many medical storiesin the popular media are either unbalanced or simply wrong.

In an attempt to disentangle commercial messages from scienceand to contribute to better reporting we took a drastic stepthat we believe can go to the heart of the problem: we decidedto name names. We created a list of nearly 100 internationalmedical experts in a wide variety of disciplines. But contraryto the "gotcha" tradition of journalism, the list’s membersare not physicians on the take but rather the reverse: theyare leading independent experts, many of them sources we havecultivated over years of reporting. It includes, from journalpublishing, two former editors of the New England Journal ofMedicine, the former editor of the Western Journal of Medicine,and a senior editor of PLoS Medicine; former advisers to theUS Food and Drug Administration; physician educators; researchers;bioethicists; epidemiologists, methodologists, geneticists,and clinicians from various specialties; medical whistleblowers;and several medical journalists.

Those applying to be on the list fill out a form affirming thatthey have not received "any financial support in any form frompharmaceutical or medical device manufacturers during the pastfive years" and that they don’t have other affiliationsor financial involvements that would present a conflict of interest.A three member board decides whether to accept applicants. Wealso maintain a "page 2" list of experts who willingly disclosetheir conflicts of interest or have ended their industry tiesbut only within the past five years. Despite their recent commercialties, these experts are included in the list because they haveprovided key insights into the inner workings of partnershipsbetween physicians and the industry—and thus have bittenthe hand that feeds them, in effect.

The reaction to the list, which has been embraced enthusiasticallyby our fellow reporters and roundly condemned by several alliesof the drug industry, suggests that the effect of simply gatheringthese names together could well go beyond making life a littleeasier for our fellow journalists.

Seeking Unbiased Sources

The need for such a resource is evident from studies showingthat bias and poor reporting on medical topics are widespreadin the popular media. Gary Schwitzer, a professor of journalismat the University of Minnesota, publishes HealthNewsReview.org,a website that reviews healthcare news for balance, accuracy,and completeness. Schwitzer and a team of academic researchersanalysed 500 stories published in top outlets between April2006 and April 2008 for two key criteria: did the journalistquote an independent expert, someone not involved in the relevantresearch; and did they make some attempt to report potentialconflicts of interest. The result? Half the stories failed tomeet these two very basic requirements.³

In another study Alan Cassels, a pharmaceutical policy researcherat the University of British Columbia, and his colleagues analysedmedia coverage of five prescription drugs published in 193 Canadiannewspapers in 2000.⁴ Cassels, who is on our list, found thatthe stories were overwhelmingly positive towards the drugs:all 193 articles included at least one drug benefit, while 68%(132/193) failed to mention any potential harm. Two thirds ofthe stories quoted a source by name, but only a scant 3% (5/164)included information about conflicts of interest for sourceswho were not government or industry officials.

In the view of one list member, Arnold Relman, former editorin chief of the New England Journal of Medicine and professoremeritus of medicine and of social medicine at Harvard MedicalSchool, such bias fails to serve the public good. "The publichas a lot at stake, and the media has a responsibility alwaysto be aware of the source of information and the conflicts thosesources might have when they report the results of clinicalresearch," he said. "People who have a financial stake in theresults of clinical research can well be biased in the way researchis conducted, in the way they report it, and what they say aboutit when interviewed by the media."

Changing the Status Quo

The question is why reporters seem unable to grasp the connectionbetween the large body of evidence showing that financial conflictsof interest create bias in medical research and the need forthe media to seek out independent sources. To be fair, journalistsface a daunting task when trying to sift through medical research,and many are as yet unaware of the profound influence the drugindustry has over research results and the ways in which theindustry shapes medical "truths." Many reporters also fail torealise that the individuals and organisations they turn tofor expert commentary, such as professional groups and charities,professional guideline authors, federal advisory panellists,and patients’ groups, often depend financially on theindustry. Thus there is a self reinforcing process in whichcommercially sponsored researchers, whose prominence is enhancedby the industry’s public relations machine, are dubbed"experts," while independent sources are cited less often.

From informal conversations with colleagues we also know thatother factors are at work when reporters fail to take conflictsof interest into account. Some confess that they hesitate toask sources about any potential conflicts for fear that thesource will take umbrage and refuse to be interviewed. Othersassume that if a study appears in a peer reviewed journal itmust be valid.

One of the solutions to the problem of biased news reporting,in the view of Michael Wilkes, professor of medicine and directorof global health at the University of California, Davis, isgreater transparency.⁵ We think the list is a step in that direction.The chief requirement for membership, besides a recognised areaof expertise, is that the expert must not have taken any industryfunding for at least the past five years. Beliefs about certaindrugs or treatments were not criteria for inclusion or exclusion.Indeed, the list includes experts who sit at opposite polesof the spectrum of beliefs on certain issues.

Backlash and Honor

Within days of our announcing that we would make our list availableto reporters the requests began pouring in. Thus far we havesent a copy of the list to 105 reporters, authors, and editorsfrom such media outlets as the New York Times, Newsweek, Forbes,Fortune, Bloomberg News, the Washington Post, US News &World Report, the Canadian Broadcasting Corporation, Medscape,and many other publications across the US and several othernations. Senators and a state attorney general have also requestedit.

Surprisingly, we are also receiving requests from recognisedexperts who wanted to be onthe list. Being a member, it seems,is a badge of honour, say several of the list members we interviewedfor the BMJ. Others, like list member Barnett Kramer, want toimprove the quality of medical reporting. Kramer, a medicaloncologist and associate director for disease prevention atthe US National Institutes of Health, said, "Working journalistscan be overwhelmed by PR, and they are often looking for expertswho can make comments." It’s useful, he said, to haveexperts "who are not involved directly with the research andhave no potential conflicts of interest relevant to the research."

The other surprise came after the publication of a story wewrote in the online magazine Slate that mentioned the list.⁶Within days bloggers were furiously accusing us of everythingfrom biased, sloppy reporting to being members of the Churchof Scientology (which is opposed to psychiatric drugs). Manyof our critics—virtually all of them backed by the industry—opinedthat our list was undoubtedly filled with experts who were onthe payrolls of plaintiffs’ attorneys. (A few have testifiedin court cases, and those who have been paid for their testimonyhave disclosed it for the list.) This venom was unexpected,as we imagined that the list would be viewed as a positive steptowards helping reporters identify doctors and other expertswho can address thorny and complex medical issues without havingcompeting financial interests. Now we think we understand thebacklash a little better.

One of the problems recognised by Schwitzer is that many journalistsrely for story ideas on news releases from the industry’spublic relations departments, and some even use releases asthe sole source of information on experts to interview. By offeringan alternative list of highly credible, independent experts,the industry may fear that its paid key opinion leaders⁷ andthe professional societies whose favour they cultivate willno longer be the first source of medical news.

Peter Gøtzsche, director of the Nordic Cochrane Centreand a member of the Danish group Doctors Without Sponsors, describedwhy he joined the list: "Industry knows that buying doctorsis an effective marketing tool . . . far more effective thanthe dollars they spend on drug representatives. This leads toless than optimal health care for patients."

Beyond the list’s usefulness to journalists, we hope thatit will also be used by government agencies, medical journaleditors, and professional societies as they seek out expertsto serve as editorialists and members of clinical guidelineand advisory panels. The FDA, for example, has a copy of thelist. We would be pleased to send it to other agencies and professionalsocieties.

It is widely claimed that genuine experts in medicine who aren’tfunded by the industry are nearly impossible to find. Indeed,one expert who declined our invitation to be listed said, "Ifyou eliminate people to whom industry turns for advice, you’reeliminating people who are more likely to have something worthsaying."

Readers can decide for themselves whether our list of independentexperts includes any experts with "something worth saying."

The list of independent medical experts

John Abramson, clinicalinstructor, Harvard Medical School

Marcia Angell, former editorin chief, New England Journal of Medicine

David Antonuccio,professor, Department of Psychiatry and Behavioral Sciences,University of Nevada

Michael J Barry, chief of general medicineunit, Massachusetts General Hospital, Harvard Medical School

KenBassett, professor of family practice, pharmacology, and therapeutics,University of British Columbia

Lisa Bero, professor, Universityof California, San Francisco

Stephen Bezruchka, Departmentof Health Services and Department of Global Health, School ofPublic Health and Community Medicine, University of Washington,Seattle

Laura Boylan, assistant professor, Department of Neurology,New York University

Phil Brewer, university medical director,Quinnipiac University, Connecticut; and past medical safetyfellow, US National Highway Traffic Safety Administration

HowardBrody, director, US Institute for the Medical Humanities

StevenR Brown, Banner Good Samaritan family medicine residency, Universityof Arizona College of Medicine

Daniel Carlat, assistant clinicalprofessor of psychiatry, Tufts University School of Medicine,and editor in chief, The Carlat Psychiatry Report

Alan Cassels,pharmaceutical policy researcher, University of Victoria, BritishColumbia

Robert Cook-Deegan, director, Center for Genome Ethics,Law and Policy, Duke Institute for Genome Sciences and Policy

SamS Dahr, Retina Center of Oklahoma

John M Davis, Gilman professorof psychiatry, University of Ilinois at Chicago

Raymond DeVries, professor, bioethics programme, University of MichiganMedical School

Richard Deyo, Kaiser Permanente professor ofevidence based family medicine, Department of Family Medicine,Oregon Health and Science University

Kay Dickersin, director,US Cochrane Center

Mark Ebell, deputy editor, American FamilyPhysician, and professor, University of Georgia

Carl Elliott,University of Minnesota Center for Bioethics

David J Elpern

MargaretEwen, Health Action International, Netherlands

Anne RochonFord, coordinator, Women and Health Protection, Canada

AdrianeFugh-Berman, professor, Department of Physiology and Biophysics,Georgetown University Medical Center, and director, PharmedOut.org

JosephGlenmullen, clinical instructor in psychiatry, Harvard MedicalSchool

Robert Goodman, founder and director of No Free Lunchand general internist at Montefiore Medical Center, New York

MerrillGoozner, director, Integrity in Science, US Center for Sciencein the Public Interest

Peter Gøtzsche, director, NordicCochrane Centre, Denmark

Mark E Helm, medical director, EBRx,Arkansas Evidence-Based Prescription Drug Program, and assistantprofessor, College of Pharmacy, University of Arkansas for MedicalSciences

David Himmelstein, associate professor of medicine,Harvard University

Jerome Hoffman, professor of medicine andemergency medicine, University of California, Los Angeles

JohnP A Ioaniddis, professor and chairman, Department of Hygieneand Epidemiology, University of Ioannina School of Medicine,Ioannina, Greece, and Institute for Clinical Research and HealthPolicy Studies, Department of Medicine, Tufts-New England MedicalCenter, Tufts University School of Medicine

Peter Juni, headof division, Institute of Social and Preventive Medicine, Universityof Bern, and director, Clinical Trials Unit, Bern UniversityHospital

Jon Jureidini, head, Department of Psychological Medicine,Children’s Youth and Women’s Health Service, Adelaide,and associate professor, disciplines of psychiatry and paediatrics,University of Adelaide

Scott Kim, assistant professor of psychiatry

PeterD Kramer, clinical professor of psychiatry and human behaviour,Brown University, Providence, Rhode Island

Barnett Kramer,associate director for disease prevention, US National Institutesof Health

Sheldon Krimsky, Tufts University, and Council forResponsible Genetics

Stefan Kruszewski, Stefan P Kruszewskiand Associates

Richard A Lange, professor of medicine, JohnsHopkins Hospital, Baltimore

Jeffrey Lacasse, assistant professor,Department of Social Work, College of Human Services, ArizonaState University at West Campus

Dara K Lee, staff cardiologist,Presbyterian Heart Group, Albuquerque, and vice president, MedicalStaff Affairs, Presbyterian Hospital, Albuquerque

GretchenLeFever, director of patient safety and performance excellence,Sentara, US

Trudo Lemmens, associate professor, Canada

JonathanLeo, associate professor of neuroanatomy, US

Joe Lex, emergencyphysician, US

Joel Lexchin, professor, School of Health Policyand Management, York University, Toronto

Abby Lippman, professor,McGill University, Montreal

Peter Lurie, Health Research Groupat Public Citizen, United States

William K Mallon, associateprofessor of clinical emergency medicine, Keck School of Medicineat the University of Southern California, and director, Divisionof International, LAC+USC Medical Center, Los Angeles

PeterR Mansfield, director, Healthy Skepticism, Australia

LindaMarsa, freelance journalist, US

Charlea Massion, Center forEducation in Family and Community Medicine, Stanford UniversitySchool of Medicine, and member of board of directors, AmericanCollege of Women’s Health Physicians

Charles Medawar,Social Audit, UK

Steven Miles, professor of medicine, Centerfor Bioethics, University of Minnesota

Barbara Mintzes, assistantprofessor, Department of Anesthesiology, Pharmacology and Therapeutics,University of British Columbia

Steven Morgan, associate professorand associate director, Centre for Health Services and PolicyResearch, School of Population and Public Health, Universityof British Columbia

Ray Moynihan, journalist, Australia

VijayaMusini, assistant professor, Department of Anesthesiology, Pharmacologyand Therapeutics, University of British Columbia, and TherapeuticsInitiative, Canada

Thomas L Perry, clinical assistant professor,Department of Anesthesiology, Pharmacology and Therapeuticsand Department of Medicine, University of British Columbia

BrucePsaty, professor of medicine and epidemiology, University ofWashington Cardiovascular Health Research Unit

Arnold Relman,former editor in chief, New England Journal of Medicine

DavidRind, senior deputy editor, UpToDate, and assistant clinicalprofessor of medicine, Harvard Medical School

Charles Rosen,clinical professor of surgery, University of California, Irvine,and founding director, US Association for Ethics in Spine Surgery

HayaRubin, director, research and evaluation, Palo Alto MedicalResearch Institute, California, and adjunct professor of medicine,Johns Hopkins University, Baltimore

Larry Sasich

John Schumann,assistant professor of medicine, University of Chicago, andMacLean Center for Clinical Medical Ethics, Chicago

Lisa Schwartz,Dartmouth Institute for Health Policy and Clinical Practice,Lebanon, New Hampshire

Gary Schwitzer, director, health journalism,MA programme, University of Minnesota School of Journalism andMass Communication

Vera Hassner Sharav, Alliance for HumanResearch Protection, US

Allen Shaughnessy, professor, TuftsUniversity School of Medicine, Boston, Massachusetts

AnthonySo, programme on global health and technology access, TerrySanford Institute of Public Policy, Duke University, Durham,North Carolina

Robert C Solomon, American College of EmergencyPhysicians, and medical editor in chief, ACEP News, US

DesSpence, general practitioner, Glasgow, and UK spokesman of NoFree Lunch

Sydney Z Spiesel, clinical professor of paediatrics,Yale University School of Medicine, and regular commentatorfor Slate and US National Public Radio

Alex Sugerman, attorney,Prescription Access Litigation, US

Leonore Tiefer, New ViewCampaign, and New York University School of Medicine

AlexanderTsai, residency training programme, Department of Psychiatry,University of California at San Francisco

Jennifer Washburn,journalist, US

H Gilbert Welch, Dartmouth Institute for HealthPolicy and Clinical Practice, Lebanon, New Hampshire

MichaelWilkes, professor of medicine and director of global health,University of California, and former vice dean of educationand former editor in chief, Western Journal of Medicine, Universityof California, Davis

Sidney Wolfe, director, Health ResearchGroup of Public Citizen, US

Steven Woloshin, Veterans AffairsOutcomes Group

Alastair Wood, US

Steffie Woolhandler, associateprofessor of medicine, Harvard University

James Wright, managingdirector, Therapeutics Initiative, Canada

Gavin Yamey, senioreditor, PLoS Medicine, US

References

Garber K. Committee questions a top psychiatrist. US News & World Report. www.usnews.com/articles/news/national/2008/06/26/committee-questions-a-top-psychiatrist.html.
Lenzer J. Review launched after Harvard psychiatrist failed to disclose industry funding. BMJ 2008;336:1327.[Free Full Text]
Schwitzer G. How do US journalists cover treatments, tests, products, and procedures? An evaluation of 500 stories. PLoS Med 2008;5:e95.[CrossRef][Medline]
Cassels A, Hughes MA, Cole C, Mintzes B, Lexchin J, McCormack JP. Drugs in the news: an analysis of Canadian newspaper coverage of new prescription drugs. CMAJ 2003;168:1133-7.[Abstract/Free Full Text]
Shuchman M, Wilkes MS. Medical scientists and health news reporting: a case of miscommunication. Ann Intern Med 1997;126:976-82.[Abstract/Free Full Text]
Brownlee S, Lenzer J. Stealth marketers: are doctors shilling for drug companies on public radio? Slate, www.slate.com/id/2190775/.
Moynihan R. Key opinion leaders: independent experts or drug representatives in disguise? BMJ 2008;336:1402-3.[Free Full Text]

Shannon Brownlee in the Indianapolis Star | 'One Drug, Many Uses. Good idea?'

Communications — Sun, 29 Jun 2008 07:34:00 -0400

..."I think the question is, should one drug compound do so much?" said Shannon Brownlee, author of Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer.

"This is a drug that may have a really serious side effect called suicide," Brownlee said. "Don't we have other drugs available that are safer and just as effective for such things as the management of chronic knee and low back pain?"... LINK